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Instructions for use Vista 120/Vista 120S Vista 120 CMS WARNING To properly use this medical device, read and comply with these instructions for use. Patient Monitor Software 3.n

Vista 120&120 CMS 2.2 - Draeger...10 Instructions for use Vista 120/Vista 120S SW 3.n Responsibility of the Manufacturer Dräger only considers itself responsible for any effect on

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Page 1: Vista 120&120 CMS 2.2 - Draeger...10 Instructions for use Vista 120/Vista 120S SW 3.n Responsibility of the Manufacturer Dräger only considers itself responsible for any effect on

Instructions for use

Vista 120/Vista 120SVista 120 CMS

WARNING To properly use this medical device, read and comply with these instructions for use.

Patient MonitorSoftware 3.n

Page 2: Vista 120&120 CMS 2.2 - Draeger...10 Instructions for use Vista 120/Vista 120S SW 3.n Responsibility of the Manufacturer Dräger only considers itself responsible for any effect on
Page 3: Vista 120&120 CMS 2.2 - Draeger...10 Instructions for use Vista 120/Vista 120S SW 3.n Responsibility of the Manufacturer Dräger only considers itself responsible for any effect on

Instructions for use

Vista 120/Vista 120S

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Instructions for use Vista 120/Vista 120S SW 3.n 3

Screen images

Schematic renderings of screen images are used, which may differ in appearance or in configuration from the actual screen images.

Definition of the safety information

Abbreviations and symbols

For explanations refer to sections “Abbreviations” and “Symbols” in chapter “Overview”.

WARNING A WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in death or serious injury.

CAUTION A CAUTION statement provides important information about a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or in damage to the medical device or other property.

NOTE A NOTE provides additional information intended to avoid inconvenience during operation.

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Instructions for use Vista 120/Vista 120S SW 3.n 5

Contents

Contents

Responsibility of the Manufacturer . . . . . . . 9Responsibility of the Manufacturer . . . . . . . . . . 10

For your safety and that of your patients. . . 11General safety information . . . . . . . . . . . . . . . . 12Product-specific safety information. . . . . . . . . . 15Protecting Personal Information . . . . . . . . . . . . 21Security. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Application . . . . . . . . . . . . . . . . . . . . . . . . . . . 25Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . 26Restrictions for use. . . . . . . . . . . . . . . . . . . . . . 26Intended user . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28Front view. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28Side view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30Back view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . 34Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Getting started . . . . . . . . . . . . . . . . . . . . . . . . 39Initial inspection . . . . . . . . . . . . . . . . . . . . . . . . 40Installing the monitor . . . . . . . . . . . . . . . . . . . . 40Connecting the power cord. . . . . . . . . . . . . . . . 40Checking the monitor . . . . . . . . . . . . . . . . . . . . 41Checking the strip recorder . . . . . . . . . . . . . . . 41Setting the date and time . . . . . . . . . . . . . . . . . 41

System configuration. . . . . . . . . . . . . . . . . . . 43Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44Opening User Maintain Menu. . . . . . . . . . . . . . 44Entering Demo mode . . . . . . . . . . . . . . . . . . . . 44Entering Standby mode . . . . . . . . . . . . . . . . . . 44Entering Night mode. . . . . . . . . . . . . . . . . . . . . 45Entering Privacy mode . . . . . . . . . . . . . . . . . . . 45Entering NFC mode* . . . . . . . . . . . . . . . . . . . . 46Selecting lead placement . . . . . . . . . . . . . . . . . 46

Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48Using keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Changing monitor settings. . . . . . . . . . . . . . . . 51Adjusting volume . . . . . . . . . . . . . . . . . . . . . . . 51Checking the monitor version . . . . . . . . . . . . . 52Networked monitoring . . . . . . . . . . . . . . . . . . . 52Setting languages . . . . . . . . . . . . . . . . . . . . . . 52Setting keyboard languages . . . . . . . . . . . . . . 52Understanding screens . . . . . . . . . . . . . . . . . . 53Calibrating screens . . . . . . . . . . . . . . . . . . . . . 53Disabling the touch screen . . . . . . . . . . . . . . . 53Using the barcode scanner . . . . . . . . . . . . . . . 53

Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56Alarm categories . . . . . . . . . . . . . . . . . . . . . . . 56Selecting alarm tone type . . . . . . . . . . . . . . . . 56Alarm levels. . . . . . . . . . . . . . . . . . . . . . . . . . . 57Controlling alarm . . . . . . . . . . . . . . . . . . . . . . 58

Alarm information . . . . . . . . . . . . . . . . . . . . . 63Physiological alarm information. . . . . . . . . . . . 64Technical alarm information. . . . . . . . . . . . . . . 68Prompts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79Adjustable range of alarm limits . . . . . . . . . . . 82

Managing patients . . . . . . . . . . . . . . . . . . . . . 85Confirming a patient . . . . . . . . . . . . . . . . . . . . 86Admitting a patient. . . . . . . . . . . . . . . . . . . . . . 86Quick admit . . . . . . . . . . . . . . . . . . . . . . . . . . . 87Barcode admit . . . . . . . . . . . . . . . . . . . . . . . . . 87Managing patient information . . . . . . . . . . . . . 88Central monitoring system. . . . . . . . . . . . . . . . 89

User interface . . . . . . . . . . . . . . . . . . . . . . . . 91Setting interface style . . . . . . . . . . . . . . . . . . . 92Selecting display parameters . . . . . . . . . . . . . 92Changing waveform position . . . . . . . . . . . . . . 92Changing interface layout . . . . . . . . . . . . . . . . 93Viewing short trend screen . . . . . . . . . . . . . . . 93Viewing OxyCRG screen. . . . . . . . . . . . . . . . . 93Viewing large font screen . . . . . . . . . . . . . . . . 94Viewing the Bed View Window . . . . . . . . . . . . 94Opening the Bed View Window. . . . . . . . . . . . 95Settings of the Bed View Window . . . . . . . . . . 95Changing Parameter and Waveform Colors . . 95

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Contents

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Displaying the timer . . . . . . . . . . . . . . . . . . . . . 95

Monitoring ECG . . . . . . . . . . . . . . . . . . . . . . . 97Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98ECG safety information . . . . . . . . . . . . . . . . . . 98ECG display . . . . . . . . . . . . . . . . . . . . . . . . . . . 100Selecting calculation lead. . . . . . . . . . . . . . . . . 101Monitoring procedure . . . . . . . . . . . . . . . . . . . . 102Selecting lead type . . . . . . . . . . . . . . . . . . . . . . 102Installing electrodes . . . . . . . . . . . . . . . . . . . . . 102ECG menu setup . . . . . . . . . . . . . . . . . . . . . . . 105ST segment monitoring . . . . . . . . . . . . . . . . . . 107Arrhythmia monitoring . . . . . . . . . . . . . . . . . . . 108ECG leadwires and trunk cables (New added). . . . . . . . . . . . . . . . . . . . . . . . . . . 112

Monitoring RESP . . . . . . . . . . . . . . . . . . . . . . 117Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118RESP safety information . . . . . . . . . . . . . . . . . 118Electrode placement for monitoring resp . . . . . 119Cardiac overlay . . . . . . . . . . . . . . . . . . . . . . . . 120Chest expansion. . . . . . . . . . . . . . . . . . . . . . . . 120Abdominal breathing . . . . . . . . . . . . . . . . . . . . 120Selecting RESP lead . . . . . . . . . . . . . . . . . . . . 120Changing hold type . . . . . . . . . . . . . . . . . . . . . 121Changing the size of the respiration waveform . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121Changing the apnea alarm time . . . . . . . . . . . . 121

Monitoring SpO2 . . . . . . . . . . . . . . . . . . . . . . . 123Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124SpO2 safety information . . . . . . . . . . . . . . . . . . 124Measuring SpO2 . . . . . . . . . . . . . . . . . . . . . . . . 125Measurement limitations . . . . . . . . . . . . . . . . . 128Perfusion Index (PI)* . . . . . . . . . . . . . . . . . . . . 129SpO2 Alarm Delays . . . . . . . . . . . . . . . . . . . . . 129SatSeconds Alarm Management* . . . . . . . . . . 129Measuring SpO2 and NIBP Simultaneously . . . 131Setting pitch tone . . . . . . . . . . . . . . . . . . . . . . . 131Setting sensitivity . . . . . . . . . . . . . . . . . . . . . . . 131

Monitoring PR . . . . . . . . . . . . . . . . . . . . . . . . . 133Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134Setting PR Source . . . . . . . . . . . . . . . . . . . . . . 134Setting PR volume . . . . . . . . . . . . . . . . . . . . . . 134Selecting the active alarm source . . . . . . . . . . 134

Monitoring NIBP . . . . . . . . . . . . . . . . . . . . . . . 137

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138NIBP safety information. . . . . . . . . . . . . . . . . . 138Measurement limitations . . . . . . . . . . . . . . . . . 140Measurement procedures . . . . . . . . . . . . . . . . 141Operation prompts. . . . . . . . . . . . . . . . . . . . . . 142Correcting the measurement if limb is not at heart Level. . . . . . . . . . . . . . . . . . . . . . . 142NIBP Multi-Review Window. . . . . . . . . . . . . . . 143Resetting NIBP . . . . . . . . . . . . . . . . . . . . . . . . 143Calibrating NIBP . . . . . . . . . . . . . . . . . . . . . . . 143Leak test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143Setting inflation mode . . . . . . . . . . . . . . . . . . . 144Assisting Venipuncture . . . . . . . . . . . . . . . . . . 145

Monitoring TEMP. . . . . . . . . . . . . . . . . . . . . . 147Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148TEMP safety information . . . . . . . . . . . . . . . . . 148Selecting TEMP sensor type . . . . . . . . . . . . . . 149Switching T1/T2 On/Off . . . . . . . . . . . . . . . . . . 149TEMP monitoring setup. . . . . . . . . . . . . . . . . . 149Calculating temp difference. . . . . . . . . . . . . . . 149

Monitoring IBP (optional) . . . . . . . . . . . . . . . 151Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152IBP safety information . . . . . . . . . . . . . . . . . . . 152Monitoring procedures. . . . . . . . . . . . . . . . . . . 153Selecting a pressure for monitoring. . . . . . . . . 153Zeroing the pressure transducer . . . . . . . . . . . 154Troubleshooting the pressure zeroing (taking Art for example) . . . . . . . . . . . . . . . . . . 154IBP calibration . . . . . . . . . . . . . . . . . . . . . . . . . 154Changing the IBP Waveform Ruler . . . . . . . . . 155IBP Waveform Overlapping. . . . . . . . . . . . . . . 155Measuring PAWP . . . . . . . . . . . . . . . . . . . . . . 155Calculating PPV . . . . . . . . . . . . . . . . . . . . . . . 157

Monitoring CO2 (optional) . . . . . . . . . . . . . . 159Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160CO2 safety information . . . . . . . . . . . . . . . . . . 160Monitoring procedures. . . . . . . . . . . . . . . . . . . 161Setting CO2 waveform setup. . . . . . . . . . . . . . 166Setting CO2 corrections. . . . . . . . . . . . . . . . . . 166Setting Apnea Alarm Time . . . . . . . . . . . . . . . 167

Monitoring C.O. (optional) . . . . . . . . . . . . . . 169Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170C.O. Safety Information. . . . . . . . . . . . . . . . . . 170

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Contents

C.O. Monitoring . . . . . . . . . . . . . . . . . . . . . . . . 171Performing C.O. Measurement. . . . . . . . . . . . . 172Blood Temperature Monitoring . . . . . . . . . . . . . 174

Gas monitoring (optional) . . . . . . . . . . . . . . . 175Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176Intended use. . . . . . . . . . . . . . . . . . . . . . . . . . . 176Getting started . . . . . . . . . . . . . . . . . . . . . . . . . 176Operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . 186

Monitoring BIS (optional). . . . . . . . . . . . . . . . 191Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192BIS safety information . . . . . . . . . . . . . . . . . . . 193BIS monitoring setup . . . . . . . . . . . . . . . . . . . . 195BIS continuous impedance check . . . . . . . . . . 195BIS sensor check . . . . . . . . . . . . . . . . . . . . . . . 196BIS sensor window. . . . . . . . . . . . . . . . . . . . . . 196Changing the BIS smoothing rate. . . . . . . . . . . 197Switching secondary parameters on and off . . 197Changing the scale of the EEG wave. . . . . . . . 198Setting the trend length . . . . . . . . . . . . . . . . . . 198Switching BIS filters on or off . . . . . . . . . . . . . . 198

Connecting Ventilators/Anesthesia Machines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 199Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200Setting the baud rate . . . . . . . . . . . . . . . . . . . . 200Opening the Medibus/X Window . . . . . . . . . . . 200Ventilator/Anesthesia Machine Monitoring Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201Respiratory Loop Interface . . . . . . . . . . . . . . . . 202Viewing Loops . . . . . . . . . . . . . . . . . . . . . . . . . 202Storing and Reviewing Loops. . . . . . . . . . . . . . 202Changing Loops Type. . . . . . . . . . . . . . . . . . . . 203Showing/Hiding the Reference Loop . . . . . . . . 203Resizing the Loops . . . . . . . . . . . . . . . . . . . . . . 203Alarms from Ventilator/Anesthesia Machine. . . 203

Freeze . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206Entering/exiting freeze status . . . . . . . . . . . . . . 206Setting freeze duration . . . . . . . . . . . . . . . . . . . 207Reviewing frozen waveform . . . . . . . . . . . . . . . 207

Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 209Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 210

Trend graph review . . . . . . . . . . . . . . . . . . . . . 210Trend table review . . . . . . . . . . . . . . . . . . . . . . 211NIBP review. . . . . . . . . . . . . . . . . . . . . . . . . . . 211Alarm review . . . . . . . . . . . . . . . . . . . . . . . . . . 211ARR review . . . . . . . . . . . . . . . . . . . . . . . . . . . 212Full disclosure waveform review . . . . . . . . . . . 213

Calculation and titration table . . . . . . . . . . . 215Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216Drug Calculation . . . . . . . . . . . . . . . . . . . . . . . 216Titration Table . . . . . . . . . . . . . . . . . . . . . . . . . 217Hemodynamic Calculation. . . . . . . . . . . . . . . . 218Oxygenation Calculation . . . . . . . . . . . . . . . . . 219Ventilation Calculation . . . . . . . . . . . . . . . . . . . 221Renal Function Calculation . . . . . . . . . . . . . . . 222

Strip recording. . . . . . . . . . . . . . . . . . . . . . . . 225General information. . . . . . . . . . . . . . . . . . . . . 226Performance of the recorder . . . . . . . . . . . . . . 226Starting and stopping strip recording. . . . . . . . 227Recorder operations and status messages. . . 228

Other Functions. . . . . . . . . . . . . . . . . . . . . . . 231Nurse call . . . . . . . . . . . . . . . . . . . . . . . . . . . . 232Analog Output and Defibrillator Synchronization. . . . . . . . . . . . . . . . . . . . . . . . 232Wi-Fi (optional) . . . . . . . . . . . . . . . . . . . . . . . . 232Storing Data in the Storage Device . . . . . . . . . 234

Using battery . . . . . . . . . . . . . . . . . . . . . . . . . 237Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 238Battery power indicator . . . . . . . . . . . . . . . . . . 238Battery status on the main screen. . . . . . . . . . 238Checking battery performance . . . . . . . . . . . . 239Replacing the battery . . . . . . . . . . . . . . . . . . . 240Recycling the battery. . . . . . . . . . . . . . . . . . . . 241Maintaining the battery . . . . . . . . . . . . . . . . . . 241

Care and cleaning . . . . . . . . . . . . . . . . . . . . . 243Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 244General points . . . . . . . . . . . . . . . . . . . . . . . . . 244Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 244Disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . 246Cleaning and Disinfecting Other Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . 248

Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . 249

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8 Instructions for use Vista 120/Vista 120S SW 3.n

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251Replacing fuse . . . . . . . . . . . . . . . . . . . . . . . . . 251

Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 253Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 254

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . 255Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 256ECG accessories . . . . . . . . . . . . . . . . . . . . . . . 256SpO2 accessories. . . . . . . . . . . . . . . . . . . . . . . 258NIBP accessories . . . . . . . . . . . . . . . . . . . . . . . 258Temp accessories. . . . . . . . . . . . . . . . . . . . . . . 259IBP accessories . . . . . . . . . . . . . . . . . . . . . . . . 260CO2 accessories . . . . . . . . . . . . . . . . . . . . . . . 260C.O. Accessories . . . . . . . . . . . . . . . . . . . . . . . 261BIS Accessories . . . . . . . . . . . . . . . . . . . . . . . . 262Anesthesia gas accessories. . . . . . . . . . . . . . . 262Device accessories . . . . . . . . . . . . . . . . . . . . . 262

Technical data. . . . . . . . . . . . . . . . . . . . . . . . . 265Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 266Classification . . . . . . . . . . . . . . . . . . . . . . . . . . 266Device specifications . . . . . . . . . . . . . . . . . . . . 266Function configuration . . . . . . . . . . . . . . . . . . . 267Ambient conditions . . . . . . . . . . . . . . . . . . . . . . 268Leakage current . . . . . . . . . . . . . . . . . . . . . . . . 268Power supply . . . . . . . . . . . . . . . . . . . . . . . . . . 269Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 270Recorder. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 270Data management . . . . . . . . . . . . . . . . . . . . . . 271Wi-Fi . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 272ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 272RESP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 277NIBP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 278SpO2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 279PR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 281TEMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 281IBP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 282CO2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 283C.O. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 291AG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 292BIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 293Interfaces . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 293

EMC Declaration . . . . . . . . . . . . . . . . . . . . . . . 297

General information. . . . . . . . . . . . . . . . . . . . . 298Electromagnetic emissions . . . . . . . . . . . . . . . 298Electromagnetic environment . . . . . . . . . . . . . 299Electromagnetic immunity . . . . . . . . . . . . . . . . 299Recommended separation distances to portable and mobile RF telecommunication devices . . . . . . . . . . . . . . . 305

Default settings . . . . . . . . . . . . . . . . . . . . . . . 307Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 308Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 308User Configuration . . . . . . . . . . . . . . . . . . . . . 308Patient information default settings . . . . . . . . . 308Alarm default settings . . . . . . . . . . . . . . . . . . . 309ECG default settings . . . . . . . . . . . . . . . . . . . . 309RESP default settings . . . . . . . . . . . . . . . . . . . 311SpO2 default settings. . . . . . . . . . . . . . . . . . . . 311PR default settings . . . . . . . . . . . . . . . . . . . . . 312NIBP default settings. . . . . . . . . . . . . . . . . . . . 312TEMP default settings . . . . . . . . . . . . . . . . . . . 313IBP default settings . . . . . . . . . . . . . . . . . . . . . 313CO2 default settings . . . . . . . . . . . . . . . . . . . . 314C.O. default settings . . . . . . . . . . . . . . . . . . . . 314C.O. default settings . . . . . . . . . . . . . . . . . . . . 315Ventilator/Anesthesia Machine Monitoring default settings . . . . . . . . . . . . . . . 315

Passwords . . . . . . . . . . . . . . . . . . . . . . . . . . . 317

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Instructions for use Vista 120/Vista 120S SW 3.n 9

Responsibility of the Manufacturer

Responsibility of the Manufacturer

Responsibility of the Manufacturer . . . . . . . 10

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Responsibility of the Manufacturer

10 Instructions for use Vista 120/Vista 120S SW 3.n

Responsibility of the Manufacturer

Dräger only considers itself responsible for any effect on safety, reliability and performance of the equipment if:

Assembly operations, extensions, re-adjustments, modifications or repairs are carried out by persons authorized by Dräger, and

The electrical installation of the relevant room complies with national standards, and

The instrument is used in accordance with the instructions for use.

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Instructions for use Vista 120/Vista 120S SW 3.n 11

For your safety and that of your patients

For your safety and that of your patients

General safety information . . . . . . . . . . . . . . 12Strictly follow these instructions for use . . . . . . 12Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . 12Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . 12Connected devices. . . . . . . . . . . . . . . . . . . . . . 13Not for use in areas of explosion hazard . . . . . 13Safe connection with other electrical equipment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13Patient safety . . . . . . . . . . . . . . . . . . . . . . . . . . 13Information on Electromagnetic Compatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . 13Sterile accessories . . . . . . . . . . . . . . . . . . . . . . 14Installing accessories . . . . . . . . . . . . . . . . . . . . 14

Product-specific safety information . . . . . . . 15

Protecting Personal Information. . . . . . . . . . 21

Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

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12 Instructions for use Vista 120/Vista 120S SW 3.n

General safety information

The following WARNING and CAUTION statements apply to general operation of the medical device.

WARNING and CAUTION statements specific to subsystems or particular features of the medical device appear in the respective sections of these Instructions for Use or in the Instructions for Use of another product being used with this device.

Strictly follow these instructions for use

Maintenance

Accessories

WARNING Risk of incorrect operation and of incorrect use

Any use of the medical device requires full understanding and strict observation of all sections of these instructions for use. The medical device must only be used for the purpose specified under "Intended Use".

Strictly observe all WARNING and CAUTION statements throughout these instructions for use and all statements on medical device labels. Failure to observe these safety information statements constitutes a use of the medical device that is inconsistent with its intended use.

WARNING Risk of medical device failure and of patient injury

The medical device must be inspected and serviced regularly by service personnel. Repair and complex maintenance carried out on the medical device must be performed by experts.

If the above is not complied with, medical device failure and patient injury may occur. Observe chapter "Maintenance".

Dräger recommends that a service contract is obtained with DrägerService and that all repairs are performed by DrägerService. For maintenance Dräger recommends the use of authentic Dräger repair parts.

WARNING Risk due to incompatible accessories

Dräger has tested only the compatibility of accessories listed in the chapter "Accessories".

If other, incompatible accessories are used, there is a risk of patient injury due to medical device failure.

Dräger recommends that the medical device is only used together with accessories listed in the current list of accessories.

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Instructions for use Vista 120/Vista 120S SW 3.n 13

For your safety and that of your patients

Connected devices

Not for use in areas of explosion hazard

Safe connection with other electrical equipment

Patient safety

The design of the medical device, the accompanying documentation, and the labeling on the medical device are based on the assumption that the purchase and the use of the medical device are restricted to professionals, and that certain inherent characteristics of the medical device are known to the user. Instructions and WARNING and CAUTION statements are therefore largely limited to the specifics of the Dräger medical device.

These instructions for use do not contain references to various hazards which are obvious to professionals who operate this medical device as well as references to the consequences of medical device misuse, and to potentially adverse effects in patients with different underlying diseases. Medical device modification or misuse can be dangerous.

Information on Electromagnetic Compatibility

General information on electromagnetic compatibility (EMC) according to international EMC standard IEC 60601-1-2:

Medical electrical equipment is subject to special precautionary measures concerning electromagnetic compatibility (EMC) and must be installed and put into operation in accordance with the EMC information provided in this Instructions for Use.

Portable and mobile RF communications equipment can affect medical electrical equipment.

WARNING Risk of electric shock and of device malfunction

Any connected devices or device combinations not complying with the requirements mentioned in these Instructions for Use may compromise the correct functioning of the medical device. Before operating any combination of devices, refer to and strictly comply with the Instructions for Use for all connected devices and device combinations.

WARNING To avoid risk of electric shock, this equipment must be connected to a supply mains with protective earth.

WARNING Risk of fire

The medical device is not approved for use in areas where combustible or explosive gas mixtures are likely to occur.

CAUTION Risk of patient injury

Electrical connections to equipment not listed in these Instructions for Use or these Assembly Instructions must only be made when approved by each respective manufacturer.

CAUTION Risk of patient injury

Do not make therapeutic decisions based solely on individual measured values and monitoring parameters.

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14 Instructions for use Vista 120/Vista 120S SW 3.n

Sterile accessories

Installing accessories

Strictly observe Assembly Instructions and Instructions for Use.

WARNING Do not connect connectors with an ESD warning symbol and do not touch the pins of such connectors without implementing ESD

protective measures. Such protective measures may include antistatic clothing and shoes, touching a ground stud before and during connection of the pins, or using electrically insulating and antistatic gloves. All relevant personnel must be instructed in these ESD protective measures.

WARNING Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of Vista 120/Vista 120S, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could occur.

CAUTION Risk of medical device failure and of patient injury

Do not use sterile-packaged accessories if the packaging has been opened, is damaged, or if there are other signs of non-sterility.

Single-use accessories must not be reused, reprocessed, or resterilized.

CAUTION Risk of device failure

Install accessories to the basic device in accordance with the instructions for use of the basic device. Make sure that there is a safe connection to the basic device.

CAUTION Risk of incorrect use

The accessories are not available individually. Only one copy of the instructions for use is included in the bulk package and must therefore be kept in a location accessible for users.

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Instructions for use Vista 120/Vista 120S SW 3.n 15

For your safety and that of your patients

Product-specific safety information

WARNING Before using Vista 120/Vista 120S, patient cables, electrodes etc. should be checked. Replacement should be taken if there is any evident defect or signs of aging which may impair the safety or performance.

WARNING The power receptacle must be a three-wire grounded outlet. A hospital grade outlet is required. Never adapt the three-prong plug from the monitor to fit a two-slot outlet.

WARNING Route all cables carefully to avoid possible entanglement, apnea, or electrical interference. For the device mounted over the patient, sufficient precautionary measures should be taken to prevent it from falling on the patient.

WARNING Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of alarm volume to a low level or off during patient monitoring may result in a hazard to the patient. Remember that the most reliable method of patient monitoring combines close personal surveillance with correct operation of monitoring equipment.

WARNING Ensure that the volume is properly set up. When the sound pressure of audible alarm is below or equivalent to the ambient noise, it may be difficult for the operator to distinguish the audio alarm.

WARNING When interfacing with other equipment, a test for leakage current must be performed by qualified hospital technical personnel before using with patients.

WARNING During monitoring, if the power supply is off and there is no battery for standby, the monitor will be off. The settings configured by the user can be stored, and settings not configured by user keep no change. That is, the last settings used will be recovered when the power is restored.

WARNING Keep away from fire immediately when leakage or foul odor is detected.

WARNING The device and accessories are to be disposed of according to local regulations after their useful lives. Alternatively, they can be returned to the dealer or the manufacturer for recycling or proper disposal. Batteries are hazardous waste. Do NOT dispose them together with house-hold garbage. At the end of their life hand the batteries over to the applicable collection points for the recycling of waste batteries. For more detailed information about recycling of this product or battery, contact the local Dräger sales representative.

WARNING This equipment is not intended for home usage.

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16 Instructions for use Vista 120/Vista 120S SW 3.n

WARNING Devices connected to the equipment must meet the requirements of the applicable IEC standards (e.g., IEC 60950 “Safety standards for information technology equipment” and IEC 60601-1 “Safety standards for medical electrical equipment”) The system configuration must meet the requirements of the IEC 60601-1 “Medical electrical systems” standard. Any personnel who connect devices to the equipment’s signal input/output port is responsible for providing evidence that the safety certification of the devices has been performed in accordance to the IEC 60601-1.

WARNING The operator can not touch the patients or signal port simultaneously.

WARNING Do not service or maintain the monitor or any accessory which is in use with the patient.

WARNING After defibrillation, the ECG display recovers within 10 s if the correct electrodes are used and applied based on the manufacturers' instructions.

WARNING The monitor is not intended for use in a hyperbaric chamber or an MRI (Magnetic Resonance Imaging) environment.

WARNING The alarm log is cleared either when the monitor is turned off, or when the monitor is powered down in a finite duration.

WARNING Ensure the current alarm preset is appropriate prior to use on each patient.

WARNING The appliance coupler or mains plug is used as isolation means from supply mains. Position the monitor in a location where the operator can easily access the disconnection device.

WARNING Assembly of the monitor and modifications during actual service life shall be evaluated based on the requirements of IEC60601-1.

WARNING Additional multiple socket-outlets or extension cords can not be connected to the system.

WARNING Only items that have been specified as part of the system or specified as being compatible with the system can be connected to the system.

WARNING If several items of medical equipment are interconnected, pay attention to the sum of the leakage currents, otherwise it may cause shock hazard. Consult your service personnel.

WARNING Only recommended batteries can be used for the monitor.

WARNING Without use of data store function, all data measured (including trend data, review data, alarm events and so on) will be cleared either when the monitor is turned off or when the monitor is powered down in the process of monitoring.

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Instructions for use Vista 120/Vista 120S SW 3.n 17

For your safety and that of your patients

WARNING Connecting any accessory (such as external printer) or other device (such as the computer) to this monitor makes a medical system. In that case, additional safety measures should be taken during installation of the system, and the system shall provide:

a) Within the patient environment, a level of safety comparable to that provided by medical electrical equipment complying with IEC/EN 60601-1, and

b) Outside the patient environment, the level of safety appropriate for non-medical electrical equipment complying with other IEC or ISO safety standards.

WARNING All the accessories connected to system must be installed outside the patient vicinity, if they do not meet the requirement of IEC/EN 60601-1.

WARNING The medical electrical equipment needs to be installed and put into service according to the EMC Information provided in this user manual.

WARNING Portable and mobile RF communications equipment can affect medical electrical equipment, refer to the recommended separation distances provided in this user manual.

WARNING Using accessories other than those specified may result in increased electromagnetic emission or decreased electromagnetic immunity of the monitoring equipment.

WARNING The monitor should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the user must check that normal operation is possible in the necessary configuration before starting monitoring patients.

WARNING Do not touch accessible parts of medical or non-medical electrical equipment in the patient environment and the patient simultaneously, such as USB connector, VGA connector or other signal input/output connectors.

WARNING SHOCK HAZARD - Do not connect electrical equipment, which has not been supplied as a part of the system, to the multiple portable socket-outlet supplying the system.

WARNING SHOCK HAZARD - Do not connect electrical equipment, which has been supplied as a part of the system, directly to the wall outlet when the non-medical equipment is intended to be supplied by a multiple portable socket-outlet with an isolation transformer.

WARNING Operation of the equipment exceeding specified physiological signal or the operational specification may cause inaccurate results.

WARNING The equipment can provide protective means to prevent the patient from being burned when used with HF surgical equipment. The equipment can protect against the effects of the discharge of a defibrillator. Use only Dräger-approved accessories.

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18 Instructions for use Vista 120/Vista 120S SW 3.n

WARNING To protect the monitor from damage during defibrillation, for accurate measurement information and to protect against noise and other interference, use only accessories specified by Dräger.

WARNING When the monitor is used with HF surgical equipment, avoid conductive connections of the transducer and the cables to the HF surgical equipment. This is to protect against burns to the patient.

WARNING No modification of this equipment is allowed without authorization of the manufacturer. If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe operation.

WARNING Extreme care must be exercised when applying medical electrical equipment. Many parts of the human/machine circuit are conductive, such as the patient, connectors, transducers. It is very important that these conductive parts do not come into contact with other grounded, conductive parts when connected to the isolated patient input of the device. Such contact would bridge the patient's isolation and cancel the protection provided by the isolated input. In particular, there must be no contact of the neutral electrode and ground.

WARNING Magnetic and electrical fields are capable of interfering with the proper performance of the device. For this reason make sure that all external devices operated in the vicinity of the monitor comply with the relevant EMC requirements. X-ray equipment or MRI devices are a possible source of interference as they may emit higher levels of electromagnetic radiation.

WARNING Devices connecting with monitor should be equipotential.

WARNING If the protective grounding (protective earth) system is doubtful, the monitor must be supplied by internal power only.

WARNING The monitor is equipped with wireless AP/Wi-Fi to receive RF electromagnetic energy. Therefore, any other equipment complying with CISPR radiation requirements may also interfere with the wireless communication and make it interrupted.

WARNING Wireless LAN equipment contains an intentional RF radiator that has the potential of interfering with other medical equipment, including patient implanted devices. Be sure to perform the electromagnetic compatibility test, as described in the Wireless LAN System Installation, before installation and any time new medical equipment is added to the Wireless LAN coverage area.

WARNING The packaging is to be disposed of according to local or hospital’s regulations; otherwise, it may cause environmental contamination. Place the packaging at the place which is inaccessible to children.

WARNING Clinical decision making based on the output of the device is left to the discretion of the provider.

WARNING The monitor is suitable for use in the presence of electrosurgery. When the monitor is used with HF surgical equipment, user (doctor or nurse) should be cautious about patient safety.

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Instructions for use Vista 120/Vista 120S SW 3.n 19

For your safety and that of your patients

WARNING Do not touch the patient, table, or the monitor during defibrillation.

WARNING Make sure networking function is used in a secure network environment.

WARNING Only patient cable and other accessories supplied by Dräger shall be used. The performance and electric shock protection cannot be guaranteed, and the patient may be injured otherwise. Prior to use, check the disposable or sterilized accessories for any sign of damage. Do not use them if any damage is detected.

CAUTION Do not immerse transducers in liquid. When using solutions, use sterile wipes to avoid pouring fluids directly on the transducer.

CAUTION Do not use autoclave or gas to sterilize the monitor, recorder or any accessories.

CAUTION Disposable devices are intended for single use only. They should not be reused as performance could degrade or contamination could occur.

CAUTION Remove a battery whose life cycle has expired from the monitor immediately.

CAUTION Avoid liquid splashing on the device.

CAUTION Touchscreen is fragile, be gentle when using it and avoid using force that may cause damage to it.

CAUTION Electromagnetic Interference - Ensure that the environment in which the patient monitor is installed is not subject to any sources of strong electromagnetic interference, such as radio transmitters, mobile telephones, microwaves, etc.

CAUTION Protect the device against mechanical damage resulting from falls, impacts, and vibration.

CAUTION A ventilated environment is required for monitor installation. Do not block up the ventilation grille at the back of the device.

CAUTION The device must be connected to the ground to avoid the signal interference.

CAUTION Keep the environment clean. Avoid vibration. Keep it far away from corrosive medicine, dust area, high temperature and humid environment.

CAUTION Before connecting the monitor to the AC power, make sure the voltage and the power frequency are consistent with the requirements indicated on the device label or in this user manual.

CAUTION Poor connection might be caused by frequently plugging and unplugging the power cord. Check the power cord regularly and replace it in time.

CAUTION To protect eyes from damage, don't look directly into barcode scanner’s light.

NOTE Position the device in a location where the operator can easily see the screen and access the operating controls.

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20 Instructions for use Vista 120/Vista 120S SW 3.n

NOTE The monitor can only be used on one patient at a time.

NOTE If the monitor gets damp, put it in dry circumstance to dry it until it can work normally. If liquid pours on the monitor, contact DrägerService.

NOTE Do not use this monitor for diagnostic purposes.

NOTE The pictures and dialog boxes in these Instructions for Use are for reference only.

NOTE Regular preventive maintenance should be carried every two years. The user is responsible for any requirements specific to their country.

NOTE When the monitor is connected to CMS, the period for alarm signal sent to network port is less than 0.5 s.

NOTE The monitor may not be compatible with all models of USB flash drives. Use the USB flash drives that are recommended by Dräger.

NOTE When there's measurement beyond range, invalid measurement or no measurement value, it will display -?-.

NOTE Where applicable, materials, with which the patient or third person can come into contact, must be conforming to standard ISO 10993-1.

NOTE In normal use, the operator shall stand in front of the monitor.

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Instructions for use Vista 120/Vista 120S SW 3.n 21

For your safety and that of your patients

Protecting Personal Information

Protecting personal health information is a major component of security strategy. To protect the personal information and ensure the proper device performance, the user should take necessary precautions in accordance with local laws and regulations and institution’s policies. Dräger recommends health care organizations or medical institutions to implement a comprehensive and multifaceted strategy to protect the information and systems from internal and external security threats.

To ensure the patients’ safety and protect their personal health information, the user should implement practices or measures that include:

1 Physical safeguards - physical safety measures to ensure that unauthorized personnel do not have access to the monitor.

2 Operational safeguards - safety measures during operation.

3 Administrative safeguards - safety measures in management.

4 Technical safeguards - safety measures in technical field.

CAUTION The access/operation of the monitor/Vista 120 CMS is restricted to authorized personnel only. Assign only staff with a specific role the right to use the monitor/Vista 120 CMS.

CAUTION Ensure that all device components maintaining personal information (other than removable media) are physically secure (i.e. cannot remove without tools).

CAUTION Ensure that the data are deleted after the patient is discharged (Refer to Section Deleting data stored in the storage device).

CAUTION Ensure that the monitor is connected only to the device authorized/approved by Dräger. Users should operate all Dräger deployed and supported monitors within Dräger authorized specifications, including Dräger approved software, software configuration, security configuration, etc.

CAUTION Protect all the passwords to prevent unauthorized changes. Only the manufacturer’s service personnel are allowed to modify the Factory Maintain settings.

CAUTION Anti-virus measures such as USB device virus scanning should be carried out prior to using USB flash drive.

CAUTION Firewalls and/or other security devices should be in place between the medical system and any externally accessible systems. It’s recommended to use Windows defender firewall or any other firewall that can defend against DoS and DDoS attacks, and keep it up to date.

CAUTION DoS and DDoS protection of the router or switch must be turned on for defensing against attacks.

CAUTION To avoid malicious tampering and theft of data transmitted by the network, it is recommended to switch on the encryption function. After the encryption function is turned on (it is set to on by default), the monitor will authenticate the accessed Vista 120 CMS and Gateway devices and encrypt the transmitted data to ensure the security.

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22 Instructions for use Vista 120/Vista 120S SW 3.n

CAUTION When building the networking environment: 1) If a wireless router is used, please turn on the MAC address filtering function of the wireless router and add the MAC address of the monitor to the rule list. The wireless router only allows devices in the rule list to access the wireless network. 2) It is suggested to build a VLAN, assign the LAN ports where the approved switch port, monitor and Vista 120 CMS are into the same VLAN, and isolate it from other VLANs.

CAUTION When the monitor is returned for maintenance, disposed of, or removed from the medical institution for other reasons, it is necessary to ensure that all patient data are removed from the monitor (Refer to Section Deleting data stored in the storage device).

CAUTION Please protect the privacy for the information and the data displayed on the screen, and for the information and the data stored in the monitor.

CAUTION For security, disable all unused USB and network ports.

NOTE Log files generated by the monitor are used for system troubleshooting and do not contain protected medical data.

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Instructions for use Vista 120/Vista 120S SW 3.n 23

For your safety and that of your patients

Security

For more security operations, select Menu > User Maintain and input user maintain password > Security. In this menu:

Select User Password > Modify to enter Modify User Password submenu, the user can change the password according to the prompts. For safety considerations, change the password periodically, and a combination of words and numbers is recommended. If Old Password is forgotten, contact DrägerService.

Set Firewall to On to protect against hacker attacking.

Click Firewall Rules to check rule details.

Set Packets Limit value for traffic monitoring. If the data traffic per minute exceeds the threshold, the monitor will trigger the alarm to remind the user.

Set CMS/Gateway Encryption to Off or AES (default) when user connects the monitor with network server (Vista 120 CMS or gateway).

Set HL7 to On/Off. The monitor supports HL7 protocol to upload data. To avoid hacker attacking, setting HL7 to Off is normally recommended.

User can also set HL7 IP address of client-side in User Maintain > Network Maintain.

NOTE When the monitor is turned on for the first time, modify the User Maintain password according to the prompts. The default initial User Maintain password can be found in Section Passwords.

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Application

Application

Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Restrictions for use . . . . . . . . . . . . . . . . . . . . 26

Intended user . . . . . . . . . . . . . . . . . . . . . . . . . 26

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Application

26 Instructions for use Vista 120/Vista 120S SW 3.n

Intended use

The Vista 120 series patient monitors (Vista 120, Vista 120S), hereafter called the monitor, are intended to monitor multiple parameters including ECG (3-lead or 5-lead selectable), respiration (RESP), functional arterial oxygen saturation (SpO2), invasive or non-invasive blood pressure (IBP, NIBP), temperature (dual-TEMP), end-tidal CO2, Cardiac Output (C.O.), AG and bispectral index (BIS). BIS is only applicable to Vista 120.

The monitor is intended to be used only under regular supervision of clinical personnel. It is applicable to adult, pediatric, and neonatal usage in a hospital environment and during patient transport inside a healthcare facility.

The arrhythmia detection, ST Segment analysis and BIS are intended for adult and pediatric patients.

The monitor and AG module are suitable for use within the patient environment.

Restrictions for use

Intended user

Users of this device must be trained and experienced medical professionals.

CAUTION Device is for use in health care facilities only and exclusively by persons with specific training and experience in its use.

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Instructions for use Vista 120/Vista 120S SW 3.n 27

Overview

Overview

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Front view . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Side view . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Back view . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . 34

Symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

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Overview

28 Instructions for use Vista 120/Vista 120S SW 3.n

Overview

The monitor is optimized for surgical, cardiac, medical and neonatal care environments, and can store data for both trends and events. The user can also view and record graphical and tabular trends (vital signs).

Vista 120 has a 15-inch TFT color flat panel display, and Vista 120S has a 12.1-inch TFT color flat panel display. Up to 13 waveforms for Vista 120 and 11 waveforms for Vista 120S can be displayed on the screen.

Front view

Front view of Vista 120 is the same as that of Vista 120S, thus take Vista 120 as an example:

A

BCDEFG

H

J

I

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Instructions for use Vista 120/Vista 120S SW 3.n 29

Overview

A Alarm indicator When an alarm occurs, the alarm indicator will light or flash. The alarm level is color coded.

B Audio Pause/ Audio Off

Upon the configuration, pressing this button to pause or turn off the audio alarm. Further information can be found in the chapter "Audio Alarm Paused"and chapter "Audio Alarm Off".

C NIBP measurement

Press to inflate the cuff and perform NIBP measurement. Press again to stop the measurement and deflate the cuff.

D Trend Press this button to enter trend table review dialog box.E Freeze In normal mode, press this button to freeze all the waveforms on the screen. In

Freeze mode, press this button to restore the waveform refreshing.F Recording Press this button to start a real-time recording. Press again to stop recording. G Menu Press this button to open the main menu when there is no menu open. Press it

again to exit.H Rotary knob The user can turn the rotary knob clockwise or counter-clockwise to highlight the

desired item. Press the rotary knob to select the item.I Mains/Battery

indicatorRefer to chapter “Battery power indicator” for details.

J On/Off When connected to the AC power supply, press the key to turn the monitor on. Press the key again to turn the monitor off.

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Overview

30 Instructions for use Vista 120/Vista 120S SW 3.n

Side view

Vista 120

A ECG port B BIS port (Optional)C Dräger SpO2 portD T1 and T2 portE IBP1, IBP2 and IBP3 ports (Optional)F NIBP port G Nellcor SpO2 port (Optional)H etCO2 port (Optional)I C.O. port (Optional)J Recorder (Optional)K Battery compartment doorL Dräger G2 module holder (Optional)

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Instructions for use Vista 120/Vista 120S SW 3.n 31

Overview

Vista 120S

A NIBP portB ECG portC T1 and T2 portsD SpO2 portE IBP1, IBP2 and IBP3 ports (Optional)F etCO2 port (Optional)G C.O. port (Optional)H Recorder (Optional)I Battery compartment doorJ Dräger G2 module holder (Optional)

NOTE The side view above is for demonstration. The port distribution on the monitor depends on the monitor configuration and on the options purchased and may deviate from the side view.

NOTE To avoid blocking and affecting NIBP measurement, the user can open the battery compartment door to clean the dustproof vent periodically. Do not use wet cotton swab to clean the vent. If NIBP measurement is still affected after cleaning, contact DrägerService.

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Overview

32 Instructions for use Vista 120/Vista 120S SW 3.n

Back view

Vista 120

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Overview

Vista 120S

A SpeakerB Equipotential grounding terminal. If the monitor is used with other devices, connect this terminal to

eliminate potential ground differences between devices.C Power cord safety latch. Used to prevent the power cord from detaching. Place the latch on the

power cord and press it down firmly to ensure that it secures the power cord.D Ventilation gridE Anti-theft lockF Medibus/X interfaceG RJ45 network interfaceH Nurse call port/ analog output/ defibrillator synchronization.

Nurse call port: it connects the monitor to the hospital’s nurse call system. Alarms indications are alerted through the nurse call system if configured to do so.Analog output: the monitor outputs the waveform through the port. Defibrillator synchronization: the monitor outputs the defibrillator synchronization signal through the port.

I USB interfaces. They are used to connect the USB device.J VGA outputK AG Scio module interface

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Overview

34 Instructions for use Vista 120/Vista 120S SW 3.n

Abbreviations

Abbreviation ExplanationAC Alternating currentAdu AdultAG Anaesthesia gasAHA American Heart AssociationArt ArterialaVF Left foot augmented leadaVL Left arm augmented leadaVR Right arm augmented leadawRR Airway respiration rateBP Blood pressureBTPS Body temperature and pressure,

saturatedC.O. Cardiac outputCI Cardiac indexCISPR International Special Committee

on Radio InterferenceCO2 Carbon dioxideCOHb CarboxyhemoglobinCVP Central venous pressureDC Direct currentDDoS Distributed Denial of ServiceDia DiastolicDoS Denial of ServiceECG ElectrocardiogramEEC European Economic CommunityEMC Electromagnetic compatibilityEMI Electromagnetic interferenceESU Electrosurgical unitet End-tidaletCO2 End-tidal carbon dioxideFCC Federal Communication

Commission

FiCO2 Fraction of inspired carbon dioxide

Hb HemoglobinHb-CO CarboxyhemoglobinHR Heart rateIBP Invasive blood pressureICP Intracranial pressureICU Intensive care unitID IdentificationIEC International Electrotechnical

CommissionIEEE Institute of Electrical and

Electronic EngineersLA Left armLAP Left atrial pressureLCD Liquid crystal displayLED Light emitting diodeLL Left legMAP Mean arterial pressureMDD Medical Device DirectiveMetHb MethemoglobinN/A Not applicableNeo NeonateNIBP Non-invasive blood pressureO2 OxygenOxyCRG Oxygen cardio-respirogramPA Pulmonary arteryPAWP Pulmonary artery wedge pressurePed PediatricPleth PlethysmogramPR Pulse ratePVC Premature ventricular complex

Abbreviation Explanation

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Instructions for use Vista 120/Vista 120S SW 3.n 35

Overview

Symbols

R RightRA Right armRAP Right atrial pressureRESP RespirationRHb Reduced hemoglobinRL Right legRR Respiration rateSYS Systolic pressureTB Blood TemperatureTD Temperature differenceTEMP TemperatureUSB Universal serial bus

Abbreviation Explanation

Audio Pause USB port

NIBP measurement RS232 port

Trend graph VGA output, external monitor

Freeze Signal output port

Recording Defibrillator synchronization port

Menu Nurse call port

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Overview

36 Instructions for use Vista 120/Vista 120S SW 3.n

Anti-theft lock Protection class type CF (defibrillation-protected)

Battery indicator Defibrillation-proof type BF applied part

Mains indicator Alternating current

Power supply switch Serial number

Equipotential bonding Disposal instructions

Caution Recycle

Network port Part number

Manufacturer Date of manufacture

Consult Instructions for Use Follow Instructions for Use

Ingress Protection: IPX1 (protected against vertically falling water drops)

Do not reuse

Batch code Quantity

Temperature limitation Non-sterile

Relative humidity Atmospheric pressure

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Instructions for use Vista 120/Vista 120S SW 3.n 37

Overview

This way up Fragile, handle with care

Keep dry Stacking limit by number

Handle with care Do not step on

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Instructions for use Vista 120/Vista 120S SW 3.n 39

Getting started

Getting started

Initial inspection . . . . . . . . . . . . . . . . . . . . . . . 40

Installing the monitor . . . . . . . . . . . . . . . . . . . 40Installing the monitor on a flat surface . . . . . . . 40Installing the monitor on a wall . . . . . . . . . . . . . 40Installing the monitor on a roll stand/trolley . . . 40

Connecting the power cord. . . . . . . . . . . . . . 40

Checking the monitor. . . . . . . . . . . . . . . . . . . 41

Checking the strip recorder. . . . . . . . . . . . . . 41

Setting the date and time. . . . . . . . . . . . . . . . 41

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Getting started

40 Instructions for use Vista 120/Vista 120S SW 3.n

Initial inspection

Before unpacking, check the packaging and check that there are no signs of mishandling or damage. If the shipping cartons are damaged, contact the local supplier for assistance.

Open the package carefully and remove the monitor and accessories. Check that all correct options and accessories are included.

If the user has any question, contact the local supplier.

Installing the monitor

Installing the monitor on a flat surface

Place the monitor on a flat surface. Make sure the surface does not vibrate and is free of corrosive medicine and dust.

Installing the monitor on a wall

Refer to Wall-Mounting Bracket Assembly Instruction.

Installing the monitor on a roll stand/trolley

An Assembling Instruction will be delivered with the roll stand/trolley. Refer to that Assembly Instruction for details of installing the monitor on a roll stand/trolley.

Connecting the power cord

1 Make sure the AC power supply complies with the following specifications: 100 V to 240 V~, 50 Hz/60 Hz.

2 Connect the power cord provided with the monitor to the power input of the monitor. Connect the other end of the power cord to a grounded 3-pin power output.

WARNING Introduce regular checks of the mounting integrity depending on the local environment.

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Instructions for use Vista 120/Vista 120S SW 3.n 41

Getting started

Checking the monitor

Make sure there is no damage to the measurement accessories and cables. Turn on the monitor and verify that the monitor starts normally. Make sure all alarm lamps light up and the alarm sound is heard when turning on the monitor. Refer to the chapter “Testing alarms”.

Checking the strip recorder

If the monitor is equipped with a strip recorder, verify that paper is properly installed in the strip recorder by opening the strip recorder's door. Refer to the chapter “Recording” for details regarding installing paper.

Setting the date and time

To set the date and time:

1 Select Menu > Maintenance > User Maintain > Date/Time Setup.

2 Adjust the date display format as desired.

3 Set the correct time of Year, Month, Day, Hour, Min and Sec

WARNING Do not use the device if any damage is detected or if the monitor displays error messages. Contact the hospital technical personnel or Customer Service Center immediately.

NOTE Check that all monitor functions are operating correctly.

NOTE If rechargeable batteries were provided, charge them each time before using the device to ensure adequate power.

NOTE After long-time continuous running, please restart the monitor to ensure the monitor’s steady performance and long lifespan.

NOTE If the system is not used for a long period of time, its system time may be inaccurate. In this case, readjust the system time after powering on.

NOTE If the system time cannot be saved and resumes the default value after restart, contact DrägerService to replace the button cell in main board.

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Instructions for use Vista 120/Vista 120S SW 3.n 43

System configuration

System configuration

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Opening User Maintain Menu . . . . . . . . . . . . 44

Entering Demo mode . . . . . . . . . . . . . . . . . . . 44

Entering Standby mode . . . . . . . . . . . . . . . . . 44

Entering Night mode . . . . . . . . . . . . . . . . . . . 45

Entering Privacy mode. . . . . . . . . . . . . . . . . . 45

Entering NFC mode*. . . . . . . . . . . . . . . . . . . . 46

Selecting lead placement. . . . . . . . . . . . . . . . 46

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System configuration

44 Instructions for use Vista 120/Vista 120S SW 3.n

Overview

The user can not change the system configuration of the monitor. After the monitor is installed and checked properly, a service engineer needs to change the system configuration.

Opening User Maintain Menu

1 Select the Menu item on the main interface.

2 Select Maintenance > User Maintain.

3 Type the password into the displayed dialog box and press OK to enter the User Maintain menu.

Entering Demo mode

To change from operating mode to demo mode:

1 Select Menu > Common Function > Demo Mode from the pop-up dialog box.

2 Type the password into the displayed dialog box.

After entering the Demo Mode, the monitor will perform the following:

Stops detecting alarms and generating alarm signals.

Stops storing data and clears previously stored data from memory.

All real-time data and historical data are simulated rather than actual patient data.

To exit the Demo Mode, select Menu > Common Function > Demo Mode.

Entering Standby mode

To enter into standby mode, select Menu > Common Function > Standby, or press the shortcut key on the screen directly, the monitor enters into standby mode after user’s confirmation.

WARNING The Demo Mode is for demonstration purposes only. The user must not change to Demo Mode during patient monitoring. In Demo Mode, all stored trend information is deleted from the monitor's memory.

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Instructions for use Vista 120/Vista 120S SW 3.n 45

System configuration

In standby mode:

1 The monitor stops monitoring patients and stores previous monitoring data.

2 The monitor won’t respond to all alarms and prompts, except Battery Low alarm.

3 Audio alarm paused status discontinues. Audio alarm off, alarm off, alarm reset and alarm latch status are not influenced.

4 All recording and printing tasks will stop.

5 CMS won’t update monitoring data, and will display monitor's standby mode. If network is disconnected, monitor will make request for connection.

The monitor exits standby mode in any of the conditions:

1 The user clicks anywhere on the screen or presses any key (except Power ON/OFF key).

2 Battery Low alarm occurs.

3 The monitor is connected to Vista 120 CMS.

After exiting standby mode, the monitor resumes monitoring, including parameter monitoring, storage and alarm; users need to press Record button to restart recording.

Entering Night mode

To switch to night mode, you may:

1 Select the shortcut key on the main screen, or

2 Select Menu > Common Function > Night Mode.

Entering Privacy mode

Only if the monitor is connected and admitted by Vista 120 CMS, the privacy mode can be activated. To enter into privacy mode, you can select Menu > Maintenance > User Maintain > Shortcut Setup > Privacy Mode (off by default). Press the shortcut key on the screen, the monitor enters into privacy mode after user’s confirmation.

In privacy mode:

1 The screen displays message: Privacy mode and Patient monitored without audio and visual alarms. Please click on screen or hard key to exit.

2 Monitoring data, alarm information, stored data and monitor status are transmitted to Vista 120 CMS.

3 Audio alarm paused status discontinues. Audio alarm off, alarm off, alarm reset and alarm latch status are not influenced.

NOTE The monitor is unable to enter into standby mode when exporting data.

NOTE In night mode, the sound of key, heart beat and pulse is muted; the alarm volume, reminder volume and screen brightness are down to their minimum; the settings including key volume, beat volume, PR volume, alarm volume, reminder volume and screen brightness are unavailable.

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System configuration

46 Instructions for use Vista 120/Vista 120S SW 3.n

The monitor exits privacy mode under any of the conditions:

1 The user clicks anywhere on the screen or presses any key (except Power ON/OFF key).

2 Battery Low alarm occurs.

3 The monitor is disconnected with Vista 120 CMS.

Entering NFC mode*

* This is for French users only and NFC has nothing to do with "Near Field Communication".

NFC mode means HR physiological alarms can't be turned off. To configure NFC mode, select Menu > Maintenance > User Maintain > Alarm Setup and choose NFC Mode which can be set to On or Off. NFC mode is off by default.In NFC mode:

1 The HR physiological alarms are always on and can't be set to off by the user.

2 The user can't turn off the audio alarm permanently.

3 The audio alarm off status will be finished and the monitor enters normal alarm response status. Pause Time will automatically switch to 120 s, which can be set to 60 s, 120 s, or 180 s manually.

4 The audio alarm paused status before entering NFC mode is not affected.

5 Symbol is displayed in the HR parameter area.

6 Monitoring data, alarm information, stored data and monitor status are transmitted to Vista 120 CMS.

After exiting NFC mode:

1 The HR physiological alarms are still on and can be set to off by the user.

2 Pause Time keeps no change and the user can set it to Permanent.

3 Symbol gets disappeared.

Selecting lead placement

ECG lead names have two styles: American standard (AHA) and European standard (IEC).

To set the correct style:

1 Select User Maintain > Electrode setup.

2 Select AHA or IEC from the list and press the knob to confirm the selection.

NOTE The monitor is unable to enter into privacy mode when exporting data.

NOTE NFC mode and standby mode can't coexist. When the monitor enters the standby mode, the NFC mode will automatically pause. After exiting the standby mode, the monitor will automatically resume the NFC mode.

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Instructions for use Vista 120/Vista 120S SW 3.n 47

Operation

Operation

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

Using keys. . . . . . . . . . . . . . . . . . . . . . . . . . . . 49Permanent keys . . . . . . . . . . . . . . . . . . . . . . . . 49Shortcut keys . . . . . . . . . . . . . . . . . . . . . . . . . . 49Hardkeys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50Pop-up keys . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Changing monitor settings . . . . . . . . . . . . . . 51Adjusting screen brightness . . . . . . . . . . . . . . . 51Changing date and time . . . . . . . . . . . . . . . . . . 51

Adjusting volume . . . . . . . . . . . . . . . . . . . . . . 51Adjusting key volume . . . . . . . . . . . . . . . . . . . . 51Adjusting alarm volume . . . . . . . . . . . . . . . . . . 51Adjusting beat volume . . . . . . . . . . . . . . . . . . . 51

Checking the monitor version. . . . . . . . . . . . 52

Networked monitoring . . . . . . . . . . . . . . . . . . 52

Setting languages. . . . . . . . . . . . . . . . . . . . . . 52

Setting keyboard languages . . . . . . . . . . . . . 52

Understanding screens . . . . . . . . . . . . . . . . . 53

Calibrating screens . . . . . . . . . . . . . . . . . . . . 53

Disabling the touch screen . . . . . . . . . . . . . . 53

Using the barcode scanner . . . . . . . . . . . . . . 53

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Operation

48 Instructions for use Vista 120/Vista 120S SW 3.n

Overview

The user may frequently use the follow functions:

• ECG monitoring (Refer to chapter “Monitoring ECG” for more information.)

• SpO2 monitoring (Refer to chapter “Monitoring SpO2” for more information)

• PR monitoring (Refer to chapter “Monitoring PR” for more information.)

• NIBP monitoring (Refer to chapter “Monitoring NIBP” for more information.)

• Alarm (Refer to chapter “Alarms” for more information.)

Everything the user needs to operate the monitor is displayed on its screen. Nearly every element on the screen is interactive. Screen elements include measurement numerics, waveforms, screen keys, information fields, alarms fields and menus. The monitor can be configured in a number of different ways. For example, the user can access an item through the on-screen setup menu, via a hard key, or via a shortcut key. This Instructions for Use describes how to access items via an on-screen menu.

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Instructions for use Vista 120/Vista 120S SW 3.n 49

Operation

Using keys

The monitor has four different types of keys. If the key sound is enabled, the monitor gives a normal key sound when the operation is valid.

Permanent keys

A permanent key is a graphical key that is permanently located at the bottom of the main screen allowing fast, direct access to functions.

Shortcut keys

A shortcut key is a configurable graphical key located at the bottom of the main screen. It gives the user direct access to functions. The selection of shortcut keys available on the monitor depends on the monitor configuration and options purchased. You can adjust the shortcut key sequence as need. The following functions are available:

A Department J Date and timeB Bed number K Network statusC Patient name L Battery status symbolD Patient type M AC power supply symbolE Alarm status area N Shortcut key areaF Alarm off O Scroll left to display more shortcut keysG Measurement value P Alarm reset keyH Menu Q Parameter waveformI Scroll right to display more shortcut keys

Menu Display the main setup menu

Alarm resetCease alarm signal for which no associated alarm condition currently exists

Admit a patient

Review the trend table

Access the NIBP review

Switch to the standard screen

Switch to the OxyCRG screen

Set the module switch

Adjust the screen brightness

Zero the IBP sensor

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Operation

50 Instructions for use Vista 120/Vista 120S SW 3.n

Hardkeys

Hardkeys are the physical keys on the front panel of the monitor. The monitor has the following hardkeys: Mute, NIBP, Trend, Freeze, Recording, and Menu. Refer also to the chapter “Front view”.

Pop-up keys

Pop-up keys are task-related graphical keys that appear automatically on the screen when required. For example, the confirmation pop-up key appears only when the user needs to confirm a change.

Change the beat volume

View Medibus/X window

Review the trend graph

Review the alarm event

Access the ARR review

Switch to the trend screen

Switch to the large font screen

Change the key volume

Enter standby mode

Alarm setup

Enter night mode

Bed View

Enter privacy mode

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Instructions for use Vista 120/Vista 120S SW 3.n 51

Operation

Changing monitor settings

Adjusting screen brightness

To change the screen brightness:

1 Select the shortcut key on the screen directly, or.

2 Select Menu > Common Function > Brightness, and select the appropriate setting for the screen brightness. 10 is the brightest, 1 is the least bright.

The monitor can be configured with lower brightness in standby mode and also for transport to conserve battery power.

Changing date and time

To change the date and time, refer to chapter “Setting the date and time”.

Adjusting volume

Adjusting key volume

The key volume is audible when the user selects any field on the monitor screen or when the user turns the knob. To adjust the key volume:

1 Select the shortcut key on the screen directly or

2 Select Menu > System Setup > Key Volume, then select the appropriate setting: five bars represent the maximum volume and one bar represents the minimum volume. If none of bars are selected, the key volume will be off.

Adjusting alarm volume

The monitor provides five levels of alarm volume: five bars represent the maximum volume and one bar represents the minimum volume.

To change the alarm volume:

1 Select the shortcut key on the screen directly, or

2 Select Menu > Alarm Setup > AlarmVolume, and select the desired setting.

Adjusting beat volume

Beat volume is from HR or PR, depending on the setting of the beat source. To change the beat volume:

1 Select the shortcut key on the screen directly, or

2 Select ECG Setup > Beat Volume, then select the appropriate setting for the beat volume: five bars represent the maximum volume and one bar represents the minimum volume. If none of bars are selected, the beat volume will be off. Beat frequency has positive correlation with measurement value.

WARNING Changing date and time will affect the storage of trend data.

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Operation

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Checking the monitor version

To check the monitor version, select Menu > Common Function > About to check the monitor revision menu.

Networked monitoring

Your monitor can be connected to the wired network and the wireless network. If the monitor is networked, a network symbol is displayed on the screen.

Setting languages

To change the language:

1 Select Menu > Maintenance > User Maintain, then type the maintenance password into the displayed dialog box.

2 Select the Language option on the pop-up dialog box to display the language list.

3 Select the desired language from the list. To make the change permanent, restart the monitor.

Setting keyboard languages

The monitor is equipped with Chinese keyboard, English keyboard and Russian keyboard. To change the keyboard language, select Menu > Maintenance > User Maintain > Keyboard Language, then select the desired language from the list. To make the change permanent, restart the monitor.

NOTE Be aware that some network-based functions may be limited for monitors on wireless networks in comparison to those on wired networks.

NOTE When selecting dynamic IP mode, please check the IP address from Vista 120 CMS.

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Instructions for use Vista 120/Vista 120S SW 3.n 53

Operation

Understanding screens

The monitor has a set of preconfigured screens, which are optimized for common monitoring scenarios such as OR adult or ICU neonatal. A screen defines the overall selection, size and position of waveforms, numerics and shortcut keys displayed when the user starts the monitor. The user can switch between different screens during

monitoring. Screens do not affect alarm settings, patient category etc. If the user changes from a complex to a less complex screen layout, some measurements may not be visible but are still monitored in the background. For detailed information, refer to chapter “User Interface”.

Calibrating screens

To calibrate the screen:

1 Select Menu > Maintenance > User Maintain, then type the maintenance password into the displayed dialog box, then select TouchScr Calibration from the pop-up dialog box.

2 The symbol appears on the screen.

3 Click the center of the symbol .

Disabling the touch screen

The user can disable touch screen operation by

selecting and holding the permanent key for 3 s. A message of Screen Locked and the symbol

will be displayed at the bottom of screen. To enable the touch screen operation, select the

symbol by using the knob.

Using the barcode scanner

To enter the barcode setup menu, please select Menu > Maintenance > User Maintain. After entering the required password, select Other Setups > BarCode Setup. Then the user can set MRN, last name, first name and so on.

User can also check relevant scanner device information in User Maintain > Scanner Management.

NOTE If calibration file is lost or damaged, the monitor will automatically enter into screen calibration interface.

NOTE In the screen calibration interface, the screen turns gray and no measurement data can be displayed.

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Operation

54 Instructions for use Vista 120/Vista 120S SW 3.n

If the scanner is connected for the first time, the monitor will pop up a confirmation message to ask user whether the new USB device is added as scanner. Choose Yes to add as scanner, choose No to add as USB device.

NOTE Read the user manual of barcode scanner carefully prior to use.

NOTE The start and end code should be set before using scanner to update patient, otherwise the barcode can’t be recognized correctly. After setting start and end code, user should also set male code and female code to distinguish the gender.

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Alarms

Alarms

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Alarm categories . . . . . . . . . . . . . . . . . . . . . . 56Physiological alarms. . . . . . . . . . . . . . . . . . . . . 56Technical alarms. . . . . . . . . . . . . . . . . . . . . . . . 56Prompts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Selecting alarm tone type . . . . . . . . . . . . . . . 56

Alarm levels . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Controlling alarm . . . . . . . . . . . . . . . . . . . . . . 58Switching the individual alarm off . . . . . . . . . . . 58Audio alarm paused . . . . . . . . . . . . . . . . . . . . . 58Audio alarm off . . . . . . . . . . . . . . . . . . . . . . . . . 59Alarm reset . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59Setting alarm limits . . . . . . . . . . . . . . . . . . . . . . 59Latching alarms . . . . . . . . . . . . . . . . . . . . . . . . 60Disabling Sensor Off Alarms . . . . . . . . . . . . . . 60Network Disconnected Alarms . . . . . . . . . . . . . 61Testing alarms . . . . . . . . . . . . . . . . . . . . . . . . . 61

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Overview

Alarm categories

The monitor has physiological, technical, and prompt alarms.

Physiological alarms

If one or more physiological parameters monitoring the patient exceed the predefined alarm limit (for example: APNEA and SpO2 value exceed the alarm limit), the monitor alarms. For more information, refer to chapter “Physiological alarm information”.

Technical alarms

If, for example, the device has a low battery or defective lead the monitor will initiate a technical alarm. Technical alarms cannot be disabled. For more information, refer to chapter “Technical Alarm Information”.

Prompts

The device monitors processes and other functions, such as: ARR Relearning. For more information, refer to chapter “Prompts”.

Selecting alarm tone type

The user can select the alarm tone type as desired.

1 Select Menu > Maintenance > User Maintain, and enter the required password.

2 Select Alarm Setup, and set Alarm Tone to Standard or Mode 1.

Standard: Standard alarm sound according to IEC 60601-1-8.

Mode 1: User customized alarm sound according to clinical applications.

WARNING A potential hazard can exist if different alarm presets are used for the same or similar equipment in different areas, e.g., an intensive care unit or a cardiac operating room.

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Alarms

Alarm levels

There are three alarm levels consisting of high, medium, and low.

1 High level alarms A high level alarm intensively warns the operator of a high priority alarm condition which requires immediate operator response. Failure to respond to the cause of the alarm condition is likely to result in death or irreversible injury of the patient.

2 Medium level alarms A medium level alarm warns the operator of a medium priority alarm condition which requires prompt operator response. Failure to respond to the cause of the alarm condition is likely to result in reversible injury of the patient.

3 Low level alarms A low level alarm reminds the operator of a low priority alarm condition which requires response. And the response time for a low priority alarm condition can be greater than that for a medium priority alarm condition. Failure to respond to the cause of the alarm condition is likely to result in discomfort or reversible minor injury of the patient.

The high/medium/low-level alarms have the following audible characteristics:

Standard

Alarm level Prompt Physiological alarms Technical alarmsHigh Mode is “DO-DO-DO------

DO-DO, DO-DO-DO------DO-DO”, which is triggered once every 10 s.

The alarm indicator flashes in red, with a frequency of 1.4Hz ~ 2.8Hz.The alarm message flashes with red background, and the symbol *** is displayed at the alarm area.

The alarm indicator flashes in red. The alarm message flashes with red background, and the symbol *** is displayed at the alarm area.

Medium Mode is “DO-DO-DO”, which is triggered once every 25 s.

The alarm indicator flashes in yellow, with a frequency of 0.4Hz ~ 0.8Hz. The alarm message flashes with yellow background, and the symbol ** is displayed at the alarm area.

The alarm indicator flashes in yellow. The alarm message flashes with yellow background, and the symbol ** is displayed at the alarm area.

Low Mode is “DO-”, which is triggered once every 30 s.

The alarm indicator is constantly yellow. The alarm message flashes with yellow background, and the symbol * is displayed at the alarm area.

The alarm indicator is constantly blue. The alarm message flashes with yellow background, and the symbol * is displayed at the alarm area.

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Mode 1

The sound pressure range for standard audible alarm signals is from 45 dB to 85 dB, and for Mode 1 is from 30 dB to 85 dB.

When different level alarms occur at the same time, alarm sound and alarm indicator prompt the highest level alarm, alarm messages display in turn.

The parameter area has two flash methods to prompt alarms: background flash and text flash. User can select one method from Menu > Alarm Setup > Visual Effect:

1 Text Flash: text flashes with frequency of 1 Hz.

2 Background Flash: background flashes with frequency of 1 Hz.

Controlling alarm

Switching the individual alarm off

To switch the alarm off,

1 Select the parameter area, open the XX Setup menu (XX stands for parameter name). Select Alarm Setup > Switch to toggle between On or Off, or

2 Use the shortcut key or select Menu > Alarm Setup, and then click Alarm Options > Switch to toggle between On or Off.

When alarm switch is off, the parameter alarm off

icon will be displayed in the corresponding parameter area.

Audio alarm paused

If the monitor is in audio alarm paused status, the monitor will:

Not generate an auditory alarm signal.

Visually display alarm information.

The audio alarm paused symbol is displayed and the remaining pause time is displayed on a red colored background. The user can set the pause time as desired. The default pause time is 120 s.

Alarm level PromptHigh Mode is “Di-Di-Di------Di-Di”, which is triggered once every 10 s. The alarm indicator

flashes in red, with frequency of 1.4 Hz ~ 2.8 Hz. The alarm message flashes with red background, and the symbol *** is displayed at the alarm area.

Medium Mode is “Di-Di-Di”, which is triggered once every 25 s. The alarm indicator flashes in yellow, with frequency of 0.4 Hz ~ 0.8 Hz. The alarm message flashes with yellow background, and the symbol ** is displayed at the alarm area.

Low Mode is “Di-”, which is triggered once every 30 s. When physiological alarm is triggered, the alarm indicator is constantly yellow. While for technical alarm, the alarm indicator is constantly blue. The alarm message flashes with yellow background, and the symbol * is displayed at the alarm area.

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Alarms

1 Select Menu > Maintenance > User Maintain, and enter the required password.

2 Select Alarm Setup, and set Pause Time to 60 s, 120 s, or 180 s.

Press the hardkey to pause the audio alarm. If the user presses the button again or if the pause time ends, the system will resume normal monitoring status and the Audio Alarm Paused **s and icon will clear.

Pressing or holding the button again resumes the alarm.

Audio alarm off

Set Pause Time to Permanent, press hardkey

, the monitor displays information: please confirm whether to activate audio alarm off function? Click Yes, the monitor will enter into audio alarm off status. Click No, the monitor will keep current status.

The audio alarm is turned off, and no alarms are sounding.

The visual alarm indications are still displayed.

Remind signal: Audio alarm off symbol and Audio Alarm off on a red colored background are displayed with an interval of 2 s when the monitor is in audio alarm off status.

Pressing the hardkey again can resume the audio alarm.

Alarm reset

Select the shortcut key Alarm Reset on the screen directly. When the alarm is reset.

No alarms are sounding until a new alarm occurs.

As for the active alarms, the visual alarm indications are still displayed.

All latching alarms are cleared. If the alarm condition is no longer present, all alarm indications stop and the alarm is reset.

It will not influence the configuration of physiological alarm off, audio paused, and audio off status.

Setting alarm limits

To change individual measurement alarm limits:

1 Select the parameter area, and open the XX Setup menu (XX stands for parameter name). Select Alarm Setup to set the alarm limit to the desired value from the pop-up dialog box, or

2 Use the shortcut key or select Menu > Alarm Setup, and then click Alarm Options to set the alarm limit to the desired value from the pop-up dialog box.

WARNING If a new alarm occurs during the audio alarm paused period, the new alarm will not be sounding.

WARNING If a new alarm occurs during the audio alarm off period, the new alarm will not be sounding.

WARNING If a new alarm occurs after the alarm is reset, the new alarm will be sounding.

WARNING Prior to monitoring, make sure that the alarm limit settings are appropriate for the patient.

WARNING Setting alarm limits to extreme values may cause the alarm system to become ineffective. It is recommended to use the default settings.

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Latching alarms

To configure the alarm latching setting, select Menu > Maintenance > User Maintain > Alarm Setup and choose Alarm Latch which can be set to On or Off. When it is set to Off, alarm indications end when the alarm condition ends. When it is set to On, the visual and audio alarm indications are still displayed after the alarm condition ends; meanwhile, the alarm time is also displayed for the latched alarm for reference. The indication lasts until the alarm is acknowledged.

The user can use the permanent key on the screen to acknowledge the lated alarm.

Disabling Sensor Off Alarms

To set sensor off alarm, select Menu > Maintenance > User Maintain and enter the required password. Then select Alarm Setup and set Sensor Off Alm from the pull-down list. If it is set to On, and a sensor off alarm occurs, after

pressing the hardkey or permanent key

the user can disable the audio alarm signal, however, the visual alarm indications are still displayed. If it is set to Off, and a sensor off

alarm occurs, after pressing the hardkey or

permanent key , sensor-off status will be announced with a prompt message. It means there’s no audio alarm signal and alarm indicator, but prompt information displayed.

In Menu > Maintenance > User Maintain > Alarm Setup, SpO2 Sensor Off and ECG Lead Off alarm level can be adjusted as High, Med. or Low. These alarm levels are set to Low by default.

Upper arrow or lower arrow to increase or decrease the alarm limit

Setting value of high alarm limit

Low Alarm LimitSetting value

of low alarm limit

High Alarm Limit

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Alarms

Network Disconnected Alarms

To configure the network disconnected alarms, select Menu > Maintenance > User Maintain > Alarm Setup and choose Disconnect Alarm which can be set to On or Off. The alarm is off by default.

Testing alarms

When the user switches the monitor on, the monitor will prompt a “Di” tone that means the audio in selftest is normal. Meantime, you must check that the alarm indicator lights are normal. This indicates that the visible and auditory alarm indicators are functioning correctly. For further testing of individual measurement alarms, perform the measurement on a subject or use a simulator. If necessary, adjust the alarm limits and check that the system is operating correctly.

NOTE When the monitor is connected with the central monitoring system, the user must set Disconnect Alarm to On.

NOTE If Disconnect Alarm occurs during audio alarm paused or audio alarm off status, the monitor will prompt a sounding alarm with information of NetWork Disconnect. During the network disconnected status, activating audio alarm paused or audio alarm off function can disable the audio alarm signal of Disconnect Alarm.

NOTE The patient monitor will reboot in 3 s due to self-test failure.

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Alarm information

Alarm information

Physiological alarm information. . . . . . . . . . 64

Technical alarm information . . . . . . . . . . . . . 68

Prompts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Adjustable range of alarm limits . . . . . . . . . 82

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Physiological alarm information

WARNING The physiological alarms including Asystole, RESP APNEA, SpO2 No Pulse, CO2 APNEA, AG FiO2 Low, and AG APNEA cannot be turned off.

Message Cause Alarm level

ECG

HR High HR value is above the upper alarm limit. User-selectable

HR Low HR value is below the lower alarm limit. User-selectable

ST-X high ST measuring value is above the upper alarm limit. (X stands for I, II, III, aVR, aVL, aVF, V)

User-selectable

ST-X low ST measuring value is below the lower alarm limit.(X stands for I, II, III, aVR, aVL, aVF, V)

User-selectable

PVCs High The measurement value of PVCs is greater than high alarm limit that has been set. User-selectable

Asystole No QRS is detected for 4 consecutive seconds. High

V-Fib/V-Tach 4 consecutive seconds' fibrillation wave occurs; Or 5 consecutive ventricular beats, and ventricular HR ≥ 100 bpm.

High

Run PVCs 3 ≤ the number of consecutive PVCs < 5 User-selectable

Couplet 2 consecutive PVCs User-selectable

PVC Bigeminy A dominant rhythm of N, V, N, V (N = supraventricular beat, V = ventricular beat) was detected.

User-selectable

PVC Trigeminy A dominant rhythm of N, N, V, N, N,V User-selectable

R on T A type of single PVC under the condition that HR<100, R-R interval is less than 1/3 the average interval, followed by a compensating pause of 1.25X the average R-R interval (the next R wave advances onto the previous T wave).

User-selectable

PVC Single PVC detected in normal heartbeats, and the number of single PVC ≥ 4 within 30 s.

User-selectable

Tachy Adult: RR interval for 5 consecutive QRS complex ≤ 0.5 s. Pediatric/neonatal: RR interval for 5 consecutive QRS complex ≤ 0.375 s.

User-selectable

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Alarm information

Brady Adult: RR interval for 5 consecutive QRS complex ≥ 1.5 s.Pediatric/neonatal: RR interval for 5 consecutive QRS complex ≥ 1 s.

User-selectable

Missed Beat If HR < 120 bpm, no beats are detected for 1.75 times average RR interval; or if HR ≥ 120 bpm, no beats are detected for one second; or no valid QRS wave is detected within 3 s or longer.

User-selectable

Irr Rhythm Consistently irregular heart rhythm. User-selectable

Pacer not Capture

No QRS complex detected in 300ms after a pace pulse. User-selectable

Pacer not Pacing

No pace pulse detected in 1.75 times RR interval after a QRS complex.

User-selectable

Vent Brady 5 consecutive ventricular beats, and ventricular HR < 40 bpm. High

Vent Rhythm 5 consecutive ventricular beats, and 40 bpm ≤ ventricular HR < 100 bpm.

User-selectable

RESPRESP APNEA RESP waveform can not be detected within the set apnea

alarm delay time.High

RR High RR value is above upper alarm limit. User-selectable

RR Low RR value is below lower alarm limit. User-selectable

SpO2

SpO2 High SpO2 value is above upper alarm limit. User-selectable

SpO2 Low SpO2 value is below lower alarm limit. User-selectable

SpO2 No Pulse The signal of the measurement site is too weak due to insufficient blood supply and environmental factors, so the monitor can not detect the pulse signal.

High

SpO2 Desat SpO2 measuring value is below the SpO2 Desat Limit. High

PR

PR High PR value is above upper alarm limit. User-selectable

PR Low PR value is below lower alarm limit. User-selectable

TEMP

T1 High Value of T1 channel is above upper alarm limit. User-selectable

T1 low Value of T1 channel is below lower alarm limit. User-selectable

T2 High Value of T2 channel is above upper alarm limit. User-selectable

Message Cause Alarm level

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T2 Low Value of T2 channel is below lower alarm limit. User-selectable

TD High Value of TD channel is above upper alarm limit. User-selectable

NIBP

SYS High SYS value is above upper alarm limit. User-selectable

SYS Low SYS value is below lower alarm limit. User-selectable

DIA High DIA value is above upper alarm limit. User-selectable

DIA Low DIA value is below lower alarm limit. User-selectable

MAP High MAP value is above upper alarm limit. User-selectable

MAP Low MAP value is below lower alarm limit. User-selectable

PR (NIBP) HighPR measuring value from the NIBP module is above upper alarm limit. User-selectable

PR (NIBP) LowPR measuring value from the NIBP module is below lower alarm limit. User-selectable

IBP

Art SYS High Art SYS value is above upper alarm limit. User-selectable

Art SYS Low Art SYS value is below lower alarm limit. User-selectable

Art DIA High Art DIA value is above upper alarm limit. User-selectable

Art DIA Low Art DIA value is below lower alarm limit. User-selectable

Art MAP High Art MAP value is above upper alarm limit. User-selectable

Art MAP Low Art MAP value is below lower alarm limit. User-selectable

PA SYS High PA SYS value is above upper alarm limit. User-selectable

PA SYS Low PA SYS value is below lower alarm limit. User-selectable

PA DIA High PA DIA value is above upper alarm limit. User-selectable

PA DIA Low PA DIA value is below lower alarm limit. User-selectable

PA MAP High PA MAP value is above upper alarm limit. User-selectable

PA MAP Low PA MAP value is below lower alarm limit. User-selectable

CVP MAP High CVP MAP value is above upper alarm limit. User-selectable

CVP MAP Low CVP MAP value is below lower alarm limit. User-selectable

ICP MAP High ICP MAP value is above upper alarm limit. User-selectable

Message Cause Alarm level

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Alarm information

ICP MAP Low ICP MAP value is below lower alarm limit. User-selectable

LAP MAP High LAP MAP value is above upper alarm limit. User-selectable

LAP MAP Low LAP MAP value is below lower alarm limit. User-selectable

RAP MAP High RAP MAP value is above upper alarm limit. User-selectable

RAP MAP Low RAP MAP value is below lower alarm limit. User-selectable

P1 SYS High P1 SYS value is above upper alarm limit. User-selectable

P1 SYS Low P1 SYS value is below lower alarm limit. User-selectable

P1 DIA High P1 DIA value is above upper alarm limit. User-selectable

P1 DIA Low P1 DIA value is below lower alarm limit. User-selectable

P1 MAP High P1 MAP value is above upper alarm limit. User-selectable

P1 MAP Low P1 MAP value is below lower alarm limit. User-selectable

P2 SYS High P2 SYS value is above upper alarm limit. User-selectable

P2 SYS Low P2 SYS value is below lower alarm limit. User-selectable

P2 DIA High P2 DIA value is above upper alarm limit. User-selectable

P2 DIA Low P2 DIA value is below lower alarm limit. User-selectable

P2 MAP High P2 MAP value is above upper alarm limit. User-selectable

P2 MAP Low P2 MAP value is below lower alarm limit. User-selectable

CO2

etCO2 High etCO2 value is above upper alarm limit. User-selectable

etCO2 Low etCO2 value is below lower alarm limit. User-selectable

FiCO2 High FiCO2 value is above alarm limits. User-selectable

AWRR High AwRR value is above upper alarm limit. User-selectable

AWRR Low AwRR value is below lower alarm limit. User-selectable

CO2 APNEA In a specific time interval, no RESP were detected by the CO2 module.

High

Message Cause Alarm level

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Technical alarm information

AG

XX High(XX stands for CO2, O2, N2O, SEV/DES/HAL/ ENF/ISO)

XX value is above upper alarm limit. User-selectable

XX Low(XX stands for CO2, O2, N2O, SEV/DES/HAL/ ENF/ISO)

XX value is below lower alarm limit. User-selectable

AwRR (AG) High

AwRR (AG) value is above upper alarm limit. User-selectable

AwRR (AG) Low

AwRR (AG) value is below lower alarm limit. User-selectable

AG FiO2 Low FiO2 value is extremely low. High

AG APNEA In a specific time interval, no breath was detected by the AG module.

High

C.O.

TB High TB measuring value is above upper alarm. User-selectable

TB Low TB measuring value is below lower alarm. User-selectable

BIS

BIS High BIS measuring value is above upper alarm. User-selectable

BIS Low BIS measuring value is below lower alarm. User-selectable

Message Cause Alarm level

NOTE The lead names in the table below use the AHA (American Heart Association) denomination. For the corresponding IEC lead names, refer to chapter “Installing Electrodes”.

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Alarm information

Message Cause Alarm Level Action Taken

ECG

ECG Lead Off

1 The drive electrode or more than one ECG limb electrode falls off the skin;2 ECG cables fall off the monitor.

Low

Make sure that all electrodes, lead wires and patient cables are properly connected.

ECG LL Lead OffECG electrode LL falls off the skin or the ECG cable LL falls off the monitor.

Low

ECG LA Lead OffECG electrode LA falls off the skin or the ECG cable LA falls off the monitor.

Low

ECG RA Lead OffECG electrode RA falls off the skin or the ECG cable RA falls off the monitor.

Low

ECG V Lead OffECG electrode V falls off the skin or the ECG cable V falls off the monitor.

Low

ECG Signal Exceed ECG measuring signal is beyond measuring range. High Check lead connection

and patient condition.

ECG Comm Fail ECG module failure or communication failure. High

Stop monitoring ECG and notify hospital technical personnel or customer support.

ECG Noise ECG measuring signal is greatly interrupted. Low Check lead connection

and patient condition.

RESP

RESP Comm Fail RESP module failure or communication failure. High

Stop monitoring RESP, and notify hospital technical personnel or customer support.

RR Exceed Respiration signal is beyond the specified range. Medium

Confirm whether RESP signal is interfered and observe patient’s breath.

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RESP Cardiac Artifact

No RESP waveform can be detected due to apnea or shallow breathing of the patient.

High

If patients’ breath is normal, adjust the electrode measurement site.

If patients’ breath is abnormal, take some measures to make patients breath normal.

RESP Noise RR cannot be measured due to patient movement. Low Check lead connection

and keep patient quiet.

SpO2

SpO2 Sensor OffSpO2 sensor may be disconnected from the patient or the monitor.

Low

Make sure the sensor is well connected to the patient’s finger or other parts.

Make sure the monitor and cables are well connected.

SpO2 No Sensor

SpO2 sensor was not connected well or connected to the monitor, or the connection is loose.

Low

Ensure the monitor and sensor are properly connected. Reconnect the sensor.

SpO2 Sensor ErrMalfunction in the SpO2 sensor or in the extension cable.

LowReplace the SpO2 sensor or the extension cable.

SpO2 Low Perfusion

(Dräger SpO2)

The pulse signal is too weak or the perfusion of the measurement site is too low.

Low

Reconnect the SpO2 sensor and change the measurement site. If the problem continues, notify hospital technical personnel or customer support.

SpO2 Noisy Signal

(Dräger SpO2)

There is interference with SpO2 measurement signals due to patient movement, ambient light, electrical interference or else.

Low

Check the condition of patient and avoid patient movement; make sure the cable is well connected.

Message Cause Alarm Level Action Taken

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Alarm information

SpO2 Light Interference

(Dräger SpO2)

Ambient light around the sensor is too strong. Low

Reduce interference of the ambient light and avoid sensor’s exposure to strong light.

SpO2 Comm Fail SpO2 module failure or communication failure. High

Stop monitoring SpO2 and notify hospital technical personnel or customer support.

NIBP

NIBP Comm Fail NIBP module failure or communication failure. High

Stop monitoring NIBP and notify hospital technical personnel or customer support.

NIBP Leak NIBP pump, valve, cuff or tube has a leakage. Low

Check the connections and the wrapped cuff to see whether they are all prepared well.If failure persists, please notify biomedical engineer or manufacturer’s service staff.

NIBP Excessive Pressure

Pressure has exceeded the specified upper safety limit. Low

Measure again, if failure persists, stop monitoring NIBP and notify hospital technical personnel or customer support.

NIBP Init Pressure High

The initial pressure is too high during measuring. Low

Measure again, if failure persists, stop monitoring NIBP and notify hospital technical personnel or customer support.

NIBP Aux Excessive Pressure

Pressure has exceeded the second safety limit as specified.

High

Notify biomedical engineer or manufacturer’s service staff.

Message Cause Alarm Level Action Taken

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NIBP Time Out Measuring time has exceeded the specified time. Low

Measure again or use other measuring method.

NIBP Self Test Error Sensor or other hardware errors. High

Measure again, if failure persists, stop monitoring NIBP and notify hospital technical personnel or customer support.

NIBP Cuff type ErrorThe cuff type used is inconsistent with the patient type.

Low Confirm the patient type and change the cuff.

NIBP System Pressure Abnormality

Atmospheric pressure or system pressure is abnormal. The valve is occluded so that deflation is failed.

Low

Check whether the airway is occluded or pressure sensor works properly. If the problem still exists, contact service personnel.

NIBP System Failure NIBP is not calibrated. High Contact service

personnel.

NIBP Weak Signal Cuff is too loose or patient pulse is too weak. Low

Use a different method to measure blood pressure.

NIBP Range Exceeded

The patient’s blood pressure is beyond the measurement range.

HighThe patient’s blood pressure is beyond the measurement range.

NIBP Loose Cuff Cuff is no properly wrapped or no cuff exists. Low Rewrap the cuff.

NIBP Interference Signal noise is too large or pulse rate is not regular. Low

Make sure that the patient under monitoring is motionless.

NIBP Leak Test Error

Fail to deflate normally during the leak test, so NIBP leak test cannot be finished.

Low

Test again. If the problem still exists, contact service personnel.

Message Cause Alarm Level Action Taken

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Alarm information

TEMP

TEMP T1 Sensor OffTemperature cable of TEMP channel 1 may be disconnected.

Low Make sure that the cable is properly connected.

TEMP T2 Sensor OffTemperature cable of TEMP channel 2 may be disconnected.

Low Make sure that the cable is properly connected.

Excessive T1 TEMP1 measuring value is beyond measuring range. High

Check sensor connection and patient condition.

Excessive T2 TEMP2 measuring value is beyond measuring range. High

Check sensor connection and patient condition.

TEMP Comm Fail TEMP module failure or communication failure. High

Stop monitoring TEMP and notify hospital technical personnel or customer support.

T1 Calibration Failed T1 calibration failed. High Check whether the

module works properly.

T2 Calibration Failed T2 calibration failed. High Check whether the

module works properly.

IBP

YY Sensor Off(YY stands for the IBP label name)

IBP sensor falls off monitor. Medium Make sure that cable is properly connected.

YY Comm Fail(YY stands for the label name)

IBP module failure or communication failure. High

Stop monitoring IBP and notify hospital technical personnel or customer support.

IBP Catheter Off IBP catheter falls off due to patient movement. High

Check the catheter connection and reconnect it.

IBP Sensor Error Malfunction in the IBP sensor or in the extension cable. Medium Replace the IBP sensor

or the extension cable.

Message Cause Alarm Level Action Taken

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C.O.

C.O. Comm Fail C.O. module failure or communication failure. High

Stop measuring of C.O. module, or notify biomedical engineer or Manufacturer’s service staff.

C.O. TI No Sensor C.O. TI sensor not connected. Low Insert injective temperature sensor.

C.O. TB No Sensor C.O. TB sensor not connected. Low Insert TB sensor.

C.O. TEMP Out Of Range

TI/TB measuring value is beyond measuring range. High Check TI/TB sensor.

CO2

CO2 Out Of RangeThe CO2 concentration exceeds the accuracy range of CO2 module.

High Reduce CO2 concentration.

CO2 Sensor Faulty CO2 module failure. High

Stop monitoring CO2 and notify hospital technical personnel or customer support.

CO2 Sensor Over Temp

CO2 sensor temperature exceeds +40 °C. High

CO2 Comm Fail CO2 module failure or communication failure. High

CO2 Zero Required(Respironics CO2) Zero calibration failure. Low

CO2 Check Adapter

1 For the Respironics CO2 module: The cannula is off or disconnected.2 For G2 module: The water trap is disconnected or not properly connected.

Low

1 For the Respironics CO2 module: Check whether the adapter is properly connected or replace the adapter.2 For G2 module: Properly connect the water trap.

CO2 Occlude

Water trap of sidestream module is occluded, or airway adapter of mainstream module is occluded.

High Make sure the gas exhaust works well.

Message Cause Alarm Level Action Taken

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Alarm information

CO2 Power Error(Dräger MCable mainstream)

CO2 module power failure. High

Stop monitoring CO2 and notify hospital technical personnel or customer support.

AG

AG Comm Fail AG module failure or communication failure. High

Stop measuring function of AG module, and notify biomedical engineer or Manufacturer’s service staff.

Check Watertrap/Sample Line

Watertrap or sample line falls off. Low

1 Check whether water trap is installed normally.

2 Check whether sample line is installed normally.

AG Change Watertrap Malfunction in watertap. Medium Replace the watertrap.

Watertrap will be full Watertrap will be full. Medium Replace the watertrap.

AG Software Error AG module software failure. High

1 Unplug and plug the communication cable.

2 Restart AG module.

3 Call manufacturer.

AG Hardware Error AG module hardware failure. High

1 Check connection.

2 Restart AG module.

3 Call manufacturer.

XX Out Of Range(XX stands for CO2, O2, N2O, AA)

The XX concentration exceeds the accuracy range of the gas module.

High

1 Check whether measured gas is beyond measurement range.

2 Restart AG module.

AG Mixed Agents (MAC<3) Mixture agents less than 3. Low

If mixture agents are detected, there is no need to take measures.

Message Cause Alarm Level Action Taken

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AG Mixed Agents (MAC>=3)

Mixture agents more than or equal to 3. Medium

If mixture agents are detected, there is no need to take measures.

AG OcclusionScio module sample line occluded Watertrap full, defective, or not installed.

High

1 Check sample line and replace if necessary.

2 Check watertrap, replace or install, if necessary.

AG Agent Mixture

Mixture agents are detected, but the monitor cannot calculate MAC because of low concentration.

MediumCheck agents’ concentration ratio.

BIS

BIS Comm Fail1 Disconnection between the BISx device and the monitor. 2 BISx device stops operating.

HighProperly connect cables and well connect the module.

BIS Sensor Not Connected

1 The sensor is not properly connected. 2 PIC is not properly connected.

Low Reconnect the sensor or PIC.

BIS Sensor Type Error

1 Wrong sensor type.2 Use the sensor on neonatal patients.

Low Replace the sensor.

BIS Sensor Usage > 24hrs

The sensor was attached to the monitor for more than 24 hours.

Low Replace the sensor.

BIS Sensor Error

Sensor malfunction including sensor over current, sensor ground element (positive and negative) failure.

Low

Examine sensor connection or replace the sensor. And then click Continue in the BIS Sensor Fault window which appears on the screen or reconnect the BISx device.

Message Cause Alarm Level Action Taken

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Alarm information

BIS Sensor Invalid

1 The BIS sensor is invalid or not supported by the BISx device.2 The sensor is not properly connected.

Low1 Replace the sensor.2 Connect the sensor properly.

BIS Sensor Expired The sensor expired. Low

The sensor can be used as long as it passes the impedance check, which, however, may affect the measurements. Replace the sensor if necessary.

BIS No More Uses For This Sensor

The sensor has been used too many times and cannot be used any more.

Low Replace the sensor.

BIS High Impedance

The impedance is above the limit. Low Check the senor-to-skin

contact.

BIS Lead Off Electrode has no skin contact. Low Check the senor-to-skin contact.

BIS Noise There is electrical interference. Low Check the senor-to-skin contact.

Bad BIS SQI SQI < 15 Medium

1 Check the senor-to-skin contact. 2 The SQI value will be influenced by impedance check for the ground electrode and sensor check.

Poor BIS SQI 15 ≤ SQI < 50 Low

1 Check the senor-to-skin contact. 2 The SQI value will be influenced by impedance check for the ground electrode and sensor check.

BIS ArtifactArtifact, such as those generated by motion or eye blinks.

Low Attempt to identify and eliminate artifact source.

Message Cause Alarm Level Action Taken

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Others

Battery Low Battery low. High Change the battery or recharge it.

Battery1 Error Malfunction in Battery 1. Low

Replace the battery and restart the monitor. If the problem persists, notify the manufacturer’s service staff.

Recorder Out Of Paper Recorder out of paper. Low Insert new paper.

Recorder Probe Overheated

The probe of recorder is overheated. Low Stop recording and retry

after the probe cools.

Insufficient storage space

Less than 10M space is left in the storage device. Low

Delete some data in the storage device or use another storage device.

Read-only storage device

The storage device is read-only. Low

Repair the storage device or replace it with a new one.

Network Disconnect

In distributed alarm system, the monitor’s network is disconnected.

Low

1 Check if the network cable is well connected.2 Check if the Vista 120 CMS is turned on.3 Check if the IP of bedside monitor and Vista 120 CMS are on the same network segment.

Network traffic anomaly

Abnormal network traffic has been detected. The data traffic exceeds the limit.

High

Disconnect the network to make the monitor work properly, and then contact the professionals authorized by manufacturer to check the network problem.

Message Cause Alarm Level Action Taken

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Alarm information

Prompts

Message Cause

ECG ARR Learning The QRS template building required for Arr. Analysis is in process.

V-Fib/V-Tach Off V-Fib/V-Tach alarm is set to Off.

Vent Brady Off Vent Brady alarm is set to Off.

Key ARR Alarm Off One of Key ARR alarms is set to Off.

SpO2 Search Pulse When the sensor is connected to the patient, the SpO2 is analyzing the patient signal and searching for the pulse to compute the saturation.

SpO2 Noisy Signal

(Nellcor SpO2)

There is interference with SpO2 measurement signals due to patient movement, ambient light, electrical interference or else.

Manual Measuring In manual measuring mode.

Continual Measuring In continuous measuring mode.

Auto Measuring In automatic measuring mode.

Measurem. Canceled Measurement over.

Calibrating During calibrating.

Calibrat. Canceled Calibration over.

Leak. Test Running During pneumatic test.

Leak.Test Canceled Pneumatic test over.

Resetting NIBP module in resetting.

Please Start NIBP module is in idle status.

Done NIBP measurement successfully done.

Venipuncture Starting Start the assisting venipuncture and the cuff begins to inflate.

In venipuncture process Venipuncture in process.

Venipuncture Ending Finish the assisting venipuncture and the cuff begins to deflate.

CO2 Standby Changing from measuring to standby mode places the module in energy-saving status.

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CO2 Sensor Warms Up The CO2 module is in warm-up state.

CO2 Zero Failed CO2 module zero is failed.

CO2 Calibrating CO2 module is calibrating.

CO2 Calibration Failed CO2 module calibration is failed.

CO2 Calibration Reset The entered test gas is out of range. Reset the calibration.

Please Press 'Zero'. Enter the IBP zeroing menu, and zeroing is not performed yet.

Zero OK IBP completes zeroing.

Pulsatile Pressure Zero Fail. During the zeroing process, pressure fluctuation is excessive.

Pressure out of normal range,Fail.

During the zeroing process, pressure value is beyond the zeroing range.

Sensor Off, Fail! Perform zeroing when the sensor is off.

Invalid Time,Zero Fail. Time is not set up prior zeroing.

Unable to Calibrate in Demo Mode Perform zeroing in Demo Mode.

Zeroing... Zeroing is in progress.

Please Press 'Calibrate'. Enter the Calibration menu, and Calibration is not performed yet.

Calibration OK Calibration is completed.

Pulse Pressure Calibration Failed During the Calibration process, pressure fluctuation is excessive.

Pressure out of range During the Calibration process, pressure value is beyond the Calibration range.

Zeroing and Calibration Failed Zeroing is not performed prior calibration.

Sensor Off,Fail. Perform calibration when the sensor is off.

Invalid Time,Calibration Fail. Time is not set up prior calibration.

Unable to Calibrate in Demo Mode Perform calibration in Demo Mode.

Calibrating... Calibration is in progress.

Message Cause

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Alarm information

IBP alias collision The same IBP label appears.

C.O. Lack Param Parameter is not configured for C.O. measurement.

AG Is Starting Scio module is starting.

AG Standby User sets Work Mode to Standby.

AG Zero In Progress Scio module zero in progress.

AG Is Warming Up Scio module is warming up and is operating at reduced accuracy.

AG Changing to Standby Work Mode is switching to Standby from Measure.

AG Changing to Meas. Work Mode is switching to Measure from Standby.

AG Agent Low Concentration

Measured agent concentration is low.

AG Agent Calculate Usually it comes up if no single agent history is available and a mixture situation occurs.

AG Agent Estimated The AG module cannot identify the present agent(s) but only give an estimation of one of the present agents. The reason is the presence of either a mixture of too many anesthetic.

AG Agent Overflow The gas concentration has increased above the maximum threshold.

BIS Sensor Check - Not Pass Yet

A sensor check is in progress.

BIS Ground Check Impedance check for the ground electrode is in progress.

Reconnect BIS Device The module has stopped or the BISx device is not connected.

Recorder Setup Needed The user presses the RECORD button or shortcut key Record when Recorder is not configured.

NIBP Simul NIBP Simul function is turned on.

Message Cause

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Adjustable range of alarm limits

ECG alarm limits are listed as follows (unit bpm):

ST analysis alarm limits are listed as follows (unit mV):

RESP alarm limits are listed as follows (unit rpm):

SpO2 alarm limits are listed as follows (unit %):

SpO2 Desat Limits are listed as follows (unit %):

PR alarm limit is listed as follows (unit bpm):

NIBP alarm limits are listed as follows (unit mmHg):

TEMP alarm limits are listed as follows:

IBP alarm limits are listed as follows (unit mmHg):

CO2 alarm limits are listed as follows:

Patient Type Adjustable Range

HRADU 15 to 300PED/NEO 15 to 350

Adjustable RangeST -2.0 to 2.0

Patient Type Adjustable Range

RESPADU 6 to 120PED/NEO 6 to 150

Adjustable RangeSpO2 20 to 100

Adjustable RangeSpO2 Desat Limit 20 to 99

NOTE User can set the range through User Maintain > Alarm Setup > SpO2 Desat Limit, SpO2 Desat Limit should be less than or equal to SpO2 alarm low limit.

Adjustable Range

PR (SpO2)Dräger 30 to 300Nellcor 30 to 300

PR (NIBP) Dräger 40 to 240PR (IBP) Dräger 30 to 300

Adjustable Range

ADUSYS 40 to 270DIA 10 to 215MAP 20 to 235

PEDSYS 40 to 230DIA 10 to 180MAP 20 to 195

NEOSYS 40 to 135DIA 10 to 100MAP 20 to 110

Adjustable RangeT1 0 °C (+32 ºF) to +50 °C (+122 ºF)T2 0 °C (+32 ºF) to +50 °C (+122 ºF)

TD High limit: +0.1 °C (+32.18 ºF) to +50 °C (+122 ºF)

Adjustable RangeArt 0 to 300RAP/LAP/CVP/ICP -10 to 40PA -6 to 120P1/P2 -50 to 300

Adjustable RangeDräger G2 & Respironics Dräger MCable

etCO20 mmHg to 150 mmHg

0 mmHg to 100 mmHg

FiCO2High limit: 3 mmHg to 50 mmHg

High limit: 3 mmHg to 50 mmHg

AwRR

2 rpm to 150 rpm0 rpm to 150 rpm (Respironics mainstream)

3rpm to 150 rpm

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Alarm information

AG alarm limits are listed as follows:

BIS alarm limits are listed as follows:

Adjustable Range

FiCO2High limit: 0% to 10.0%

etCO2 0% to 10.0%FiO2 18.0% to 100.0%EtO2/FiN2O/EtN2O 0% to 100.0%EtDES/FiDES 0% to 20.0%EtISO/FiISO/EtHAL/FiHAL 0% to 8.5%EtSEV/FiSEV/EtENF/FiENF 0% to 10.0%AwRR 0 rpm to 100 rpmApnea Time 20 s to 40 s

Adjustable RangeBIS 0 to 100

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Managing patients

Managing patients

Confirming a patient. . . . . . . . . . . . . . . . . . . . 86

Admitting a patient . . . . . . . . . . . . . . . . . . . . . 86Patient category and paced status . . . . . . . . . . 87

Quick admit . . . . . . . . . . . . . . . . . . . . . . . . . . . 87

Barcode admit. . . . . . . . . . . . . . . . . . . . . . . . . 87

Managing patient information . . . . . . . . . . . . 88Editing patient information . . . . . . . . . . . . . . . . 88Obtaining patient information from the network server . . . . . . . . . . . . . . . . . . . . . . 88

Central monitoring system . . . . . . . . . . . . . . 89

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Managing patients

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Confirming a patient

The pre-selected configuration may not be appropriate for the newly admitted patient. Therefore, the monitor allows the user to load a desired configuration to ensure that all the settings are appropriate for the patient.

After the user switches the monitor on, the monitor will prompt “Continue current patient or admit new patient?”. Select Current Patient to use the current configuration; Select New Patient to admit new patient.

Admitting a patient

The monitor displays patient physiological data and records the information in trends. This allows the user to monitor unadmitted patients. It is recommended, however, that the user admit patients to record their information in reports.

During admission, the patient category setting determines the algorithm that the monitor uses to process and calculate measurements. These include safety limits that are applied for specific measurements and alarm limit ranges.

To admit a patient:

1 Select the Admission shortcut key on the screen or

2 Select Menu > Patient Setup > New Patient, then a message is displayed to ask the user to confirm to update patient.

3 Click No to cancel this operation; click Yes, the Patient Info window is displayed.

4 Enter the patient information:

MRN: Enter the patient's medical record number (MRN), for example 12345678.

Last name: Enter the patient’s last name (family name), for example Smith.

First name: Enter the patient’s first name, for example Joseph.

Bed No.: supports up to 8 characters. Chinese, English, Russian, number and special characters can be input.

Doctor: Enter the attending doctor for the patient.

Gender: Choose Male or Female.

Type: Choose the patient type, Adult, Pediat, or Neonat.

BloodType: Choose the patient type N/A, A, B, AB, or O.

Pace: Choose On or Off (The user must use On if the patient has a pacemaker).

Date of Birth: Enter the patient’s date of birth.

Date of Admission: Enter the patient’s date of admission.

Height: Enter the patient’s height.

Weight: Enter the patient’s weight.

Height unit: cm or inch.

Weight unit: kg or lb.

NOTE If the user does not make a selection within 3 minutes, Current Patient is selected by default.

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Managing patients

Patient category and paced status

The patient category setting determines which algorithm the monitor uses for specific measurements, the safety limits that are applied for specific measurements, and the alarm limit range.

The paced setting determines whether the monitor shows pacemaker pulses. When Pace is set to Off, pace pulses are filtered and do not show in the ECG waveform. Refer to chapter “Setting Pace Status”.

Quick admit

If the user does not have the time or information to fully admit a patient, fill in the rest of the patient information later.

The user can quickly admit a patient as follows:

1 Select the shortcut key on the screen directly, or

2 Select Menu > Patient Setup > Quick Admit, a message is displayed requesting that the user confirm the patient update.

3 Click No to cancel this operation; click Yes to continue and the Quick Admit window is displayed, choose Type and Pace and set them to the correct mode.

Barcode admit

Barcode scanner can recognize patient information directly and quickly, which can provide convenience and reduce mistakes for users.

To admit a patient by barcode:

1 The user can scan the barcode through scanner, then a message is displayed to ask the user to confirm the patient update.

NOTE Admitting new patient will clear the history data in the monitor associated with the patient.

NOTE For Bed No., user can select English, Chinese, Russian by switching keyboard language, and

select special characters through .

WARNING Changing the patient category may change the arrhythmia and NIBP alarm limits. Always check alarm limits to make sure that they are appropriate for the patient.

WARNING For paced patients, the user must set Pace to On. If it is incorrectly set to Off, the monitor could mistake a pace pulse for a QRS and fail to alarm during asystole.

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Managing patients

88 Instructions for use Vista 120/Vista 120S SW 3.n

2 Click No to cancel this operation; click Yes, the Patient Info window is displayed and the corresponding patient information is updated according to the identified MRN. If the monitor is connected with the network server through the gateway, the monitor will automatically inquire for patient information from the network server via MRN. As soon as the MRN is successfully found on the network server, the corresponding patient information will be updated to the monitor. Otherwise, prompt information will be displayed to notify the user that network is not available or no patient information is matched. If patient information is modified on the network server, prompt information will also be sent to inform the user of the update.

Managing patient information

Editing patient information

To edit the patient information after a patient has been admitted, select Menu > Patient Setup > Patient Info, and make the desired changes through the pop-up dialog box.

If the monitor is equipped with a barcode scanner, the user can scan the patient’s barcode to enter the patient’s medical record number (MRN).

When patient’s MRN is modified, the user can click

on to obtain the patient information from network server. Otherwise, only MRN is updated.

Obtaining patient information from the network server

The user can obtain patient information from the network server to the monitor.

To obtain patient information from the network server,

1 Select Menu > Patient Setup > Network Admit.

2 Input the query conditions (Department, Date

of Admission), and then click . A list including all the patients that meet the query conditions is displayed.

3 Select a patient from the patient list, and click Admit. The corresponding patient information in the monitor will be updated after user’s confirmation. Click View to display the detailed patient information.

NOTE Caps Lock is unavailable, user can input capitals and symbols through switching Shift key.

NOTE Patient information obtained from network server cannot be edited.

NOTE Switching patient type will change the current configuration.

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Managing patients

Central monitoring system

The monitor can be connected to the central monitoring system. Through the network:

1 The monitor sends patient information, real-time monitoring or measurement data to the central monitoring system.

2 The real-time monitoring information is displayed on the central monitoring system as the same to the monitor, and the central monitoring system can perform some bilateral control. For example: changing patient information, receiving patient, discharging patient and so forth.

For detailed information, please refer to Vista 120 CMS Central Monitoring System User Manual.

And the monitor supports HL 7 protocol.

NOTE The user can load patient information from the network server only when ADT Query is enabled. Default setting is off. Setting path: Maintenance > User Maintain > Network Maintain > ADT Query.

NOTE Use wired instead of wireless networking when connecting the monitor to central monitoring system in the operating room because the ESU will interfere with a wireless network, which may cause networking failure.

NOTE Make sure the network connection between the monitor and the central monitoring system is in good condition when the time synchronization function on the monitor is active (Default setting is off. Route: Maintenance > User Maintain > Date/Time Setup > Sync Time). If the setting is on, the monitor will accept time synchronization from Vista 120 CMS.

NOTE The time synchronization function might not be available to all software versions of Vista 120 CMS. Consult our technical service department or your local distributor for more information.

NOTE When deploying the network of the monitor and Vista 120 CMS, it is recommended to isolate the network and the Intranet system of the hospital by using VLAN so as to ensure the network security. Only trusted devices are allowed to join the VLAN network.

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User interface

User interface

Setting interface style . . . . . . . . . . . . . . . . . . 92

Selecting display parameters . . . . . . . . . . . . 92

Changing waveform position . . . . . . . . . . . . 92

Changing interface layout . . . . . . . . . . . . . . . 93

Viewing short trend screen . . . . . . . . . . . . . . 93

Viewing OxyCRG screen . . . . . . . . . . . . . . . . 93

Viewing large font screen . . . . . . . . . . . . . . . 94

Viewing the Bed View Window . . . . . . . . . . . 94

Opening the Bed View Window. . . . . . . . . . . 95

Settings of the Bed View Window. . . . . . . . . 95

Changing Parameter and Waveform Colors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95

Displaying the timer . . . . . . . . . . . . . . . . . . . . 95

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Setting interface style

The user can set the interface style. The following options are available:

Waveform sweep

Monitored parameters

Only authorized personnel should set the interface style.

Selecting display parameters

The user can select the display parameters based on specific monitoring and measurement requirements. To select the parameter:

1 Select the shortcut key on the screen directly, or

2 Select Menu > System Setup > Module Switch.

3 Select the required parameters from the popup interface.

4 Exit the menu and the screen will adjust the parameters automatically.

Changing waveform position

The user can exchange the waveform positions of parameter A and parameter B as follows:

1 Select waveform A and display the setup menu of waveform A.

2 Select Change from the pop-up menu and select the desired label name of waveform B from the pull-down list.

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User interface

Changing interface layout

Select Menu > Display Setup to open the Display Setup menu on which the user can

Select a function screen based on the clinical requirements by configuring View Selection.

Select the maximum number of waveforms displayed on the screen by configuring Wave. Num.

Decide whether the control bar is displayed or not displayed on the screen by setting Control Bar to On or Off.

Viewing short trend screen

To view the trend screen, the user can press the

shortcut key on the screen directly or select Menu > Display Setup > View Selection > TrendScreen.

Select short trend to open Short Trend Setup menu, the user can set:

1 Parameter.

2 Interval: set the interval to 30 min, 1 h and 2 h.

Viewing OxyCRG screen

To view the oxyCRG screen, the user can press the

shortcut key on the screen directly or select Menu > Display Setup > View Selection > oxyCRG.

This is a NICU only feature. Monitoring of SpO2, HR and Resp of the neonate are different from those of adults. OxyCRG is in the bottom half part of wave area; it consists of HR trend, SpO2 trend and RR trend or compressed respiration waveform.

Select oxyCRG waveform to open OxyCRG Setup menu, the user can set:

1 Interval: set the interval to 1 min, 2 min and 4 min.

2 Parameter: to select RESP or RR.

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Viewing large font screen

To display the large font screen:

1 Select the shortcut key on the screen directly or

2 Select Menu > Display Setup > View Selection > Large Font to select this display mode.

To view the large font dialog box of specific parameter, select the parameter pull-down dialog on the dialog box (the red rectangle shown in the following figure).

Viewing the Bed View Window

The Bed View window allows to view one waveform, numeric information of all parameters and alarm information from another bed on the same network. The monitor enables a maximum of eight beds to be viewed.

NOTE The IP addresses of the monitors configured with bed view function should share the same network segment. The IP addresses of the monitors on the same LAN should be unique from each other; the user cannot use the bed view function in the monitors in which an IP address conflict exists.

NOTE In order to use the bed view function without impediment, the monitor needs to be restarted after changing its IP address.

NOTE To use the bed view function smoothly, make sure the network connection is in good condition.

NOTE In the Bed View window, the over-limit alarms of physiological parameters occurring on other beds cannot be viewed. Besides, arrhythmia alarms and vital alarms will be indicated only by alarm icons.

NOTE The bed view results are for reference only.

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User interface

Opening the Bed View Window

Before opening the Bed View window, make sure the bed view function is configured on the monitor. To open the Bed View window, select Menu >

Display Setup and choose Bed View in the View

Selection list, or select the shortcut key on the screen directly.

Settings of the Bed View Window

Click on the Bed View window to open the ViewBed Setup menu on which the user can

Assign a bed to be viewed by selecting the bed No. in the Bed No. list.

Select the waveform to be displayed on the window in the Wave Type list.

Use the buttons and to view more numeric information of parameters in the window.

Changing Parameter and Waveform Colors

The user can set the display colors of parameter and waveform as desire. To change the display color, select Menu > Maintenance > User

Maintain, enter the required password. Then select Color Setup to make color changes on parameter and waveform.

Displaying the timer

The monitor has the timer function to notify you when a preset time period is expired. To display the timer on the main interface,

1 Select the shortcut key on the screen directly, or

2 Select Menu > System Setup > Module Switch.

3 Select Timer from the popup interface. Exit the menu and the screen will adjust the parameters automatically.

In the timer displaying area, the user can set the timer counting direction. Select Timer Setup > Timing Direction.

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Count Down: to display the remaining time. When the user selects Count Down, Timing Duration shall be set simultaneously. The timing duration can be set between 0 and 120 hours. Default setting is 5 min. When the remaining time is 30 s, the time turns red, prompting you that the timing duration is to expire. When the timing duration expires, the monitor issues a reminder tone. To set the reminder tone volume, select Menu > System Setup > Reminder Volume.

Count Up: to display the elapsed time.

When the Timing Direction is Count Down, the user can select Start/Pause/Resume or Cancel to start/pause/resume or end the timer; When the Timing Direction is Count Up, the user can select Start or Cancel to start or clear the timer.

To turn off the timer displaying, the user can remove the timer in the module switch menu.

NOTE The user cannot change timer settings when a timer is running.

NOTE Do not use the timer to schedule critical patient-related tasks.

NOTE The timer function is not available in privacy mode and standby mode.

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Monitoring ECG

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98

ECG safety information . . . . . . . . . . . . . . . . . 98

ECG display . . . . . . . . . . . . . . . . . . . . . . . . . . 100Changing the size of the ECG waveform . . . . . 100Changing the ECG filter settings . . . . . . . . . . . 100

Selecting calculation lead . . . . . . . . . . . . . . . 101

Monitoring procedure . . . . . . . . . . . . . . . . . . 102Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102Connecting ECG cables . . . . . . . . . . . . . . . . . . 102

Selecting lead type. . . . . . . . . . . . . . . . . . . . . 102

Installing electrodes. . . . . . . . . . . . . . . . . . . . 102Electrode placement for 3-lead. . . . . . . . . . . . . 103Electrode placement for 5-lead. . . . . . . . . . . . . 103Recommended ECG lead placement for surgical patients . . . . . . . . . . . . . . . . . . . . . 104

ECG menu setup. . . . . . . . . . . . . . . . . . . . . . . 105Setting alarm source. . . . . . . . . . . . . . . . . . . . . 105Setting beat source. . . . . . . . . . . . . . . . . . . . . . 105Smart lead off . . . . . . . . . . . . . . . . . . . . . . . . . . 105ECG display . . . . . . . . . . . . . . . . . . . . . . . . . . . 105Setting pace status . . . . . . . . . . . . . . . . . . . . . . 106ECG calibration . . . . . . . . . . . . . . . . . . . . . . . . 106ECG waveform settings . . . . . . . . . . . . . . . . . . 106

ST segment monitoring . . . . . . . . . . . . . . . . 107Setting ST analysis. . . . . . . . . . . . . . . . . . . . . . 108ST display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108About ST measurement points . . . . . . . . . . . . . 108Adjusting ST and ISO measurement points . . . 108

Arrhythmia monitoring. . . . . . . . . . . . . . . . . . 108Arrhythmia analysis . . . . . . . . . . . . . . . . . . . . . 108ARR Analysis menu . . . . . . . . . . . . . . . . . . . . . 110

ECG leadwires and trunk cables (New added) . . . . . . . . . . . . . . . . . . . . . . . . . . 112Order list . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

Definition of target group . . . . . . . . . . . . . . . . . 113Users . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113For your safety and that of your patients . . . . . 113Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . 113Installation and operation . . . . . . . . . . . . . . . . 113Cleaning and disinfection . . . . . . . . . . . . . . . . 114Testing of procedures and agents . . . . . . . . . . 114Manual disinfection and simultaneous cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114Visual inspection . . . . . . . . . . . . . . . . . . . . . . . 114Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115

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Overview

The electrocardiogram (ECG) measures electrical activity in the heart and displays it both numerically and as a waveform. This chapter also describes arrhythmia and ST segment monitoring.

ECG safety information

WARNING Use only compatible ECG cables for monitoring.

WARNING When connecting the cables and electrodes, make sure no conductive part is in contact with the ground. Verify that all ECG electrodes, including the neutral electrode, are securely attached to the patient but not a conductive part or ground.

WARNING Place the electrode carefully and ensure a good contact. Check every day whether there is skin irritation resulted from the ECG electrodes. If yes, replace electrodes every 24 hours or change their sites.

WARNING Store the electrodes in room temperature. Open the electrode package immediately prior to use. Never mix electrode types or brands. This may lead to problem due to impedance difference. When applying the electrodes, avoid bones close to skin, obvious layers of fat, and major muscles. Muscle movement can result in electrical interference. Applying electrodes on major muscles, for example on muscles of thorax, may lead to erroneous arrhythmia alarm due to excessive muscle movement.

WARNING Check if the lead connection is correct before monitoring. If the ECG cable is unplugged from the socket, the screen will display the error message “ECG LEAD OFF” and an audible alarm sounds.

WARNING If the ECG signal exceeds the measuring range, the monitor will indicates it by a message “ECG Signal Exceed”.

WARNING In order to avoid being burnt, please keep the electrodes far away from the radio knife while using electrosurgical equipment.

WARNING ECG cables can be damaged when connected to a patient during defibrillation or using other high frequency equipment. Check cables for functionality before using them again. It is recommended to use defibrillator-proof ECG lead to avoid burn.

WARNING When using electrosurgery (ES) equipment, do not place an electrode near the grounding plate of the electrosurgery device: otherwise, more interference will be evident on the ECG waveform.

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WARNING The electrodes should be made of the same metal materials.

WARNING According to AAMI specifications the peak of the synchronized defibrillator discharge should be delivered within 60 ms of the peak of the R wave. The synchronization pulse output on the patient monitors is delayed by a maximum of 35 ms from the R wave peak. The biomedical engineer should verify that the ECG/Defibrillator combination does not exceed the recommended maximum delay of 60 ms.

WARNING Before outputting signals with defibrillator synchronization or ECG, check if the output is functioning normally.

WARNING ECG accessories are not suitable for DIRECT CARDIAC APPLICATION. (Refer to IEC60601-1 for more information about the definition of DIRECT CARDIAC APPLICATION.)

WARNING Line isolation monitor transients may resemble actual cardiac waveforms and thus inhibit heart rate alarms. When the electrode or lead is loose or fallen, the monitor is easily affected by the transient response of certain types of insulation monitors. The transient monitor signal produced by poor insulation of the line may be very similar to the actual heart waveform, which will prevent the monitor from prompting a heart rate alarm. In order to avoid this, user should check lead wires for damage and ensure good skin contact prior to and during use. Always use fresh electrodes and follow proper skin preparation techniques.

WARNING The monitor can only be used on one patient at a time. Monitoring more than one patient simultaneously may result in hazards to the patient.

WARNING Pacemaker Failure: During a complete cardiac block or when pacemaker is unable to pacing/capture, high P-wave (greater than 1/5 of the average height of the R-wave) may be incorrectly counted by the monitor, which leads to a missing asystole.

NOTE Interference from a non-grounded instrument near the patient and ESU interference can cause inaccuracy of the waveform.

NOTE IEC/EN60601-1-2 (protection against radiation is 3 V/m) specifies that the electrical field density exceeding 3 V/m may cause measurement error in various frequencies. It is accordingly suggested to not use equipment generating electrical radiation near ECG/RESP monitoring devices.

NOTE The simultaneous use of cardiac pacemaker and other patient-connected equipment may cause a safety hazard.

NOTE If the pacemaker signals are beyond the claimed range, the heart rate may be calculated incorrectly.

NOTE In the default settings of the monitor, the ECG waveforms are the first two waveforms from the top in the waveform area.

NOTE For measurements in or near the heart connect the monitor to the potential equalization system.

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ECG display

The figure below is for reference only.

The symbol 1 indicates the lead name of the displayed waveform; refer to chapter “Selecting calculation lead”.

The symbol 2 indicates waveform gain; refer to chapter “Changing the size of the ECG waveform”.

The symbol 3 indicates Filter setting; refer to chapter “Changing the ECG filter settings”.

Changing the size of the ECG waveform

If any of the displayed ECG waveforms are too small or clipped, the size can be changed. Select ECG Waveform Setup > ECG Gain, then select an appropriate factor from the pop-up box to adjust the ECG waveform.

X0.125 to make the size of 1 mV ECG waveform signal become 1.25 mm;

X0.25 to make the size of 1 mV ECG waveform signal become 2.5 mm;

X0.5 to make the size of 1 mV ECG waveform signal become 5 mm;

X1 to make the size of 1 mV ECG waveform signal become 10 mm;

X2 to make the size of 1 mV ECG waveform signal become 20 mm;

X4 to make the size of 1 mV ECG waveform signal become 40 mm;

AUTO let the monitor choose the optimal adjustment factor for all the ECG waveforms.

Changing the ECG filter settings

The ECG filter setting defines how ECG waveforms are smoothed. An abbreviation indicating the filter type is shown under the lead label on the monitor display. Filter settings do not affect ST measurement.

NOTE For protecting the environment, the used electrodes must be recycled or disposed of properly.

NOTE The effect of ECG wave gain is subject to the size of the wave area. Whichever wave gain is chosen, the ECG wave has to be displayed within the wave area, the exceeded part is clipped.

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To change the filter setting, in the ECG Setup menu, select Filter and then select the appropriate setting.

Monitor: Use this mode under normal measurement conditions.

Surgery: The filter reduces interference to the signal. It should be used if the signal is distorted by high- or low-frequency interference. High frequency interference usually results in large amplitude spikes making the ECG signal look irregular. Low-frequency interference usually leads to a wandering or rough baseline. In the operating room, the Filter reduces artifacts and interference from HF surgical equipment. Under normal measurement conditions, selecting Surgery may distort the QRS complexes too much and thus interfere with the clinical evaluation of the ECG displayed on the monitor.

Diagnos: Use when undistorted quality is required and its own characteristics can be maintained. The waveform filtered by the bandwidth of 0.05 Hz~150 Hz is displayed so that the actual changes such as R-wave notching or discrete elevation or depression of the ST segments are visible.

Selecting calculation lead

To set the calculation lead, select ECG Setup > Calc. Lead, or on the Normal display interface, click on the calculation lead waveform area, select Calc. Lead from the popup interface to make the appropriate setting. For 3 Leads, II, I, and III are selectable; For 5 Leads, II, I, III, aVR, aVL, aVF, and V are selectable. Normal QRS complex is defined as:

The normal QRS should be either completely above or below the baseline and it should not be biphasic. For paced patients, the QRS complexes should be at least twice the height of pace pulses.

The QRS should be tall and narrow.

The P-waves and the T-waves should be less than 0.2 mV.

NOTE Make sure you have selected the best lead with the best waveform amplitude and highest signal-to-noise ratio. Choosing the best lead is important for heart beat test, heart beat classification and ventricular fibrillation detection.

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Monitoring procedure

Preparation

Skin is a poor conductor of electricity. Prepare the patient's skin to facilitate good electrode conductivity.

Select sites with intact skin, without impairment of any kind.

Shave hair from sites, if necessary.

Wash sites thoroughly with soap and water. (Never use ether or pure alcohol, because this increases skin impedance).

Rub the skin briskly to increase capillary blood flow in the tissues and remove skin scurf and grease.

Connecting ECG cables

1 Attach a clip or snap to the electrodes prior to placement.

2 Place the electrodes on the patient. Before attaching, apply some conductive jelly on the electrodes if the electrodes are not electrolyte self-supplied.

3 Connect the electrode lead to the patient's cable.

4 Plug the patient cable into the ECG connector on the monitor.

Selecting lead type

To change the lead type:

1 Select the ECG parameter area, display the ECG Setup menu;

2 Set Lead Type to 3 Leads or 5 Leads based on the lead used.

Installing electrodes

CAUTION To protect the monitor from damage during defibrillation, for accurate ECG information and to protect against noise and other interference, use only ECG electrodes and cables specified by Dräger.

NOTE The following table gives the corresponding lead names according to IEC (used in Europe) and the AHA (USA) respectively.

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Electrode placement for 3-lead

Take the AHA standard for example, see the following figure:

RA: Directly below the clavicle and near the right shoulder.

LA: Directly below the clavicle and near the left shoulder.

LL: On the left hypogastrium.

Electrode placement for 5-lead

Take the AHA standard for example, see the following figure:

RA: Directly below the clavicle and near the right shoulder.

LA: Directly below the clavicle and near the left shoulder.

RL: On the right hypogastrium.

LL: On the left hypogastrium.

V: On the chest, the position depends on the desired lead selection.

For 5-lead, attach the V electrode to one of the indicated positions as below:

V1: On the 4th intercostal space at the right sterna margin.

V2: On the 4th intercostal space at the left sterna margin.

V3: Midway between V2 and V4 electrodes.

V4: On the 5th intercostal space at the left clavicular line.

AHA (American Standard)

IEC (Europe Standard)

Electrode Labels

Color Electrode Labels

Color

RA White R Red

LA Black L Yellow

LL Red F Green

RL Green N Black

V Brown C White

RA

Lewis LA

LL

RESP

NOTE To ensure safety, all leads must be attached to the patient.

LLRL

V

RA

LewisLA

RESP

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V5: On the left anterior axillary line, horizontal with V4 electrode.

V6: On the left middle axillary line, horizontal with V4 electrode.

V3R-V6R: On the right side of the chest in positions corresponding to those on the left.

VE: Over the xiphoid position.

V7: On the 5th intercostal space at the left posterior axillary line of back.

V7R: On the 5th intercostal space at the right posterior axillary line of back.

Recommended ECG lead placement for surgical patients

ECG leads are used mainly for monitoring patient vital signs. When using the patient monitor with other HF surgical equipment, use defibrillator-proof ECG leads.

The placement of the ECG leads depends on the type of surgery. For example, during open heart surgery the electrodes can be placed laterally on the chest or back. In the operating room, artifacts may affect the ECG waveform due to the use of ES (electrosurgery) equipment. To help reduce this interference, the electrodes can be placed on the right and left shoulders, the right and left sides near the abdomen and the chest lead on the left side at mid-chest. Avoid placing the electrodes on the upper arms, which might result in a small waveform.

WARNING When using HF surgical equipment, leads should be placed in a position in equal distance from the Electrosurgery electrotome and the electrosurgery grounding plate to avoid cautery. HF surgical equipment wires and ECG cable must not be tangled up.

WARNING ECG cables can be damaged when connected to a patient during defibrillation or using other high frequency equipment. Check cables for functionality before using them again. It is recommended to use defibrillator-proof ECG lead to avoid burn.

NOTE If an ECG waveform is not accurate (with electrodes are tightly attached), change the leads displayed on the screen.

NOTE Interference from a non-grounded instrument near the patient and ESU interference can cause inaccurate waveforms.

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ECG menu setup

Setting alarm source

To change the alarm source, select ECG Setup > Alarm Source. Select from the following options:

– HR: HR is HR/PR alarm source;

– PR: PR is HR/PR alarm source;

– AUTO: If the alarm source is set to AUTO, the monitor will use the heart rate from the ECG measurement as the alarm source whenever the ECG measurement is switched on and at least one ECG lead can be measured without a technical condition. The monitor will automatically switch to PR as the alarm source if:

a valid ECG lead can no longer be measured and

a PR source is switched on and available.

The monitor uses the pulse rate from the currently active measurement as system pulse. While PR is the alarm source, all arrhythmia and ECG HR alarms are switched off. If an ECG lead becomes available again, the monitor automatically uses HR as alarm source.

Setting beat source

To change the beat source, select either ECG Setup > Beat Source or PR Setup > Beat Source. Select from the following options:

HR: HR is HR/PR beat source;

PR: PR is HR/PR beat source;

AUTO: If the Beat Source is set to AUTO, the monitor will use HR as the beat source whenever the ECG measurement is switched on, and at least one ECG lead can be measured. The monitor will automatically switch to PR as the beat source if:

a valid ECG lead can no longer be measured and

a PR source is switched on and available.

If an ECG lead becomes available again, the monitor automatically uses HR as beat source and the monitor gives a “Di” tone with a blinking heart

displaying in the HR parameter box when one heartbeat is detected. While a pulse is detected, the monitor gives a “Da” tone.

Smart lead off

When Lead Type is 5 Leads and Smart LeadOff is set to On, if the selected ECG waveform cannot be measured because of lead-off or other reasons, it will automatically switch to another available lead channel via which a waveform can be measured. And the lead name above the display ECG waveform also automatically turns into the current one.

To change the smart lead off setting, select ECG Setup > Smart Leadoff. Select options from the pop-up menu.

ECG display

The ECG display varies with the Lead Type. When Lead Type is set to 3 Leads, Display can be set to Normal, and displays one ECG waveform on the main screen.

When Lead Type is set to 5 Leads, Display can be set to Normal, Full-Scr and Half-Scr. Select Normal to display two ECG waveforms on the main screen. Select Full-Scr to display seven ECG waveforms. Half-Scr displays seven ECG waveforms on the screen in an area of four waveforms.

NOTE If 3 Leads is selected in the ECG Setup menu, only Normal can be selected for Display in the sub-menu.

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Setting pace status

Set the paced status correctly when starting ECG monitoring. To change the paced status in the ECG Setup menu, select Pace to toggle between On or Off. When Pace is set to On:

– Pace Pulse Rejection is switched on. This means that pacemaker pulses are not counted as extra QRS complexes.

– Paced symbol is displayed as | on the main screen. At this time, the artifact is displayed on the screen instead of the actual pacemaker crest. All pacemaker crests are the same, so do not give a diagnostic explanation about the size and shape of the pacemaker crest.

ECG calibration

Selecting this item from the ECG Setup menu inserts a square wave into the ECG waveform that can be used to estimate the amplitude accuracy of that waveform. Select the item again to turn off the square wave.

ECG waveform settings

To change the speed, select ECG Waveform Setup > Sweep, then select from the pop-up list. The bigger the value, the wider the waveform.

Select ECG Waveform Setup > Cascade: Turn on or off ECG cascade. Cascade means the ECG waveforms displayed on the screen all occupy the area of two waveforms. This function is valid only when Display is set to Normal.

NOTE When monitoring a patient with a pacemaker, set Pace to On. If monitoring a patient without a pacemaker, set Pace to Off.

WARNING Some pace pulses can be difficult to reject. When this happens, the pulses are counted as a QRS complex, and could result in an incorrect HR and failure to detect cardiac arrest or some arrhythmias. Be sure to check the paced symbol on the display screen has correctly detected the pacing pulse. Keep pacemaker patients under close observation.

WARNING For patients with pacemakers, the pace must be switched ON. Otherwise, the pacing impulse may be counted as regular QRS complexes, which could prevent an asystole event from being detected. When changing settings and admitting patients, please make sure the pace mode is always correct.

WARNING External pacing electrodes: When using pacemakers with external pacing electrodes on the patient, the quality of arrhythmia is severely degraded due to the high energy level in the pacemaker pulse. This can cause arrhythmia algorithms can not detect the pacemaker without capturing or asystole.

WARNING Pacemaker spike detection is inoperative when using the blue ESU trunk cables.

WARNING Do not use the blue ESU trunk cables except during electrosurgery.

NOTE The patients can’t be monitored during ECG calibration.

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ST segment monitoring

The monitor performs ST segment analysis on normal and atrially paced beats and calculates ST segment elevations and depressions. This information can be displayed in the form of ST numerics and ST templates on the monitor.

ST segment monitoring function is shut off by default. It can be switched to On when necessary. When using the ST analysis function, the result is displayed on the main screen.

NOTE ST-segment analysis is intended for use with adult and pediatric patients and is not clinically validated for use with neonatal patients.

NOTE In ST analysis, the obtained ST value and ST template are all unaffected by the selected filter mode. ST algorithm itself uses a dedicated linear filter to ensure the signal is not distorted, and to better ensure the consistent and accurate measurement value and ST template can be obtained in different filter modes. If the doctor wants to observe the waveform to evaluate ST segment result, it is recommended to use the ST template for observation, as it is not affected by the filter mode. If the real-time waveform displayed on the interface is used to evaluate ST segment result, it is recommended to select Diagnosis mode.

NOTE Reliable ST monitoring may be influenced in following situations: You are unable to get a lead with low noise. If there is arrhythmia such as atrial

fibrillation/flutter, the ECG baseline may be irregular.

The patient is continually performing ventricular paced.

The dominant template cannot be obtained for a long time.

The patient has left bundle branch block.

When any of above situations happens, ST monitoring should be switched off.

NOTE The ST algorithm has been tested for accuracy of the ST segment data. The significance of the ST segment changes need to be determined by a clinician.

NOTE If ST analysis is used, the user must adjust the ST measurement point when starting the monitor. If the patient's heart rate or ECG waveform changes significantly, this will affect the size of the QT interval, so the ST point must be placed. If the equipotential or ST points are not set correctly, the ST fragments of the artifacts may be depressed or raised. Always ensure that the ST measurement point is suitable for the patient.

NOTE ST values may be affected by such factors as some drugs or metabolic and conduction disturbances.

NOTE ST is calculated with a fixed delay from the R position. Changes in heart rate or the width of QRS may affect ST.

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Setting ST analysis

To change ST analysis, select ECG Setup > ST Analysis, then select On or Off from the pop-up list.

ST display

The screen may look different from the illustrations.

About ST measurement points

The ST value for each beat complex is the vertical difference between the isoelectric (ISO) point and the ST point, as shown in the diagram below. The ISO point provides the baseline, and the ST point is at the midpoint of the ST segment. The J point is where the QRS complex changes its slope. It is a fixed distance away from the ST point and can be useful during positioning.

The ST and ISO measurement points need to be adjusted when monitoring is started, and if the patient's heart rate or ECG morphology changes significantly. Always ensure that ST measurement points are appropriate for the patient. Abnormal QRS complexes are not considered in ST segment analysis.

Adjusting ST and ISO measurement points

Depending on the monitor's configuration, the ST point can be positioned as well.

These two points can be adjusted by turning the knob. When adjusting ST measurement point, the system shows the ST measurement point window. The system displays the QRS complex template in the window and can be adjusted using the highlight bar. The user can select ISO or ST by switching the knob left or right to move the cursor line. When the cursor is at the desired position, the base point or the measurement point can be selected.

Arrhythmia monitoring

Arrhythmia analysis

The arrhythmia algorithm is used to monitor ECG of adult and pediatric patients in clinics, and detect the changes of heart rate and ventricular rhythm, and

also save arrhythmia events and generate alarming information. The arrhythmia analysis is not clinically validated for use with neonatal patients. Arrhythmia algorithm can monitor paced and non-paced patients. Qualified personnel can use arrhythmia

NOTE If the algorithm triggers self-learning (either manually or automatically), the calculation of ST segment will be reinitialized.

ISO: -180ms ST: +180ms

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analysis to evaluate patient’s condition (such as heart rate, PVCs frequency, rhythm and ectopic beat) and decide the treatment. Besides detecting

change of ECG, arrhythmia algorithm can also monitor patients and give proper alarm for arrhythmia.

The monitor can support up to 16 different arrhythmia analyses.

Selecting an ECG lead for Arrhythmia:

In arrhythmia monitoring, it is important to select the appropriate lead.

For non-paced patients, the guidelines are:

– QRS should be tall and narrow (recommended amplitude > 0.5 mV)

ARR Alarms Occurring Condition

Asystole No QRS is detected for 4 consecutive seconds.

V-Fib/V-Tach 4 consecutive seconds' fibrillation wave occurs; Or 5 consecutive ventricular beats, and ventricular HR ≥ 100 bpm.

Run PVCs 3 ≤ the number of consecutive PVCs < 5.

Couplet 2 consecutive PVCs.

PVC Bigeminy A dominant rhythm of N, V, N, V (N = supraventricular beat, V = ventricular beat) was detected.

PVC Trigeminy A dominant rhythm of N, N, V, N, N,V.

R on T A type of single PVC under the condition that HR<100, R-R interval is less than 1/3 the average interval, followed by a compensating pause of 1.25X the average R-R interval (the next R wave advances onto the previous T wave).

PVC Single PVC detected in normal heartbeats, and the number of single PVC ≥4 within 30 s.

Tachy Adult: RR interval for 5 consecutive QRS complex ≤ 0.5 s.

Pediatric/neonatal: RR interval for 5 consecutive QRS complex ≤ 0.375 s.

Brady Adult: RR interval for 5 consecutive QRS complex ≥ 1.5 s.

Pediatric/neonatal: RR interval for 5 consecutive QRS complex ≥ 1 s.

Missed Beat If HR < 120 bpm, no beats are detected for 1.75 times average RR interval; or if HR ≥ 120 bpm, no beats are detected for one second; or no valid QRS wave is detected within 3 s or longer.

Irr Rhythm Consistently irregular heart rhythm.

Pacer not Capture No QRS complex detected in 300 ms after a pace pulse.

Pacer not Pacing No pace pulse detected in 1.75 times RR interval after a QRS complex.

Vent Brady 5 consecutive ventricular beats, and ventricular HR < 40 bpm.

Vent Rhythm 5 consecutive ventricular beats, and 40 bpm ≤ ventricular HR < 100 bpm.

PVCs High The measurement value of PVCs is greater than high alarm limit that has been set.

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– R wave should be above or below the baseline (but not biphasic)

– T wave should be smaller than 1/3 of the R wave height.

– P wave should be smaller than 1/5 of the R wave height.

For paced patients, in addition to above guidelines, the pacemaker signal should also:

– not wider than normal QRS

– The QRS complexes should be at least twice the height of the pacing pulse

– large enough to be detected, without repolarization signal.

According to Standard ISO60601-2-27, the minimum detection level of the QRS complex is set to 0.15 mV, to prevent the detection of P-wave or baseline noise as QRS complexes. Adjusting ECG displayed waveform size (gain adjustment) won’t influence ECG signals which are used for arrhythmia analysis. If the ECG signal is too small, a false asystole alarm may occur.

Aberrantly-Conducted Beats:

As not recognizing the P waves, the monitoring system is difficult to distinguish between aberrantly-conducted beats and ventricular heartbeat. If the aberrantly-conducted beat is similar to ventricular tachycardia, it may be classified as ventricular. Make sure to select such a lead, the aberrantly-conducted beats have an R wave that is as narrow as possible to minimize the incorrect calls. The ventricular should have a different appearance from “normal heartbeat”. Physicians should be more alert to these patients.

Intermittent bundle branch block: bundle branch block or other bundle obstruction phenomenon is a challenge for arrhythmia algorithm. If the QRS wave during the block has a considerable change in morphology compared to the normal QRS of learning, the blocked heartbeat may be misclassified as ventricular tachycardia, resulting in an incorrect chamber alarm. Make sure to select such a lead, which blocks the heartbeat of the R wave as narrow as possible to minimize the wrong

classification. Ventricular heartbeat should have a different appearance from “normal heartbeat”. Physicians should be more alert to these patients.

ARR Analysis menu

Switching ARR analysis on and off

To switch ARR Analysis on or off, in the ECG Setup menu, select ARR Analysis to toggle between On and Off.

NOTE Heart rate reading may be affected by cardiac arrhythmias. Do not rely entirely on heart rate alarms when monitoring patients with arrhythmia. Always keep these patients under close surveillance.

NOTE Since the arrhythmia detection algorithm sensitivity and specificity is less than 100%, sometimes there may be some false arrhythmias detected and also some true arrhythmia events may not be detected. This is especially true when the signal is noisy.

NOTE The ventricular HR mentioned above refers to: when the consecutive PVCs number ≥ 5, the algorithm calculates ventricular HR with the average of 4-8 RR intervals.

The methods are different from the HR Averaging Method of the monitor. Therefore, the ventricular HR values calculated by the ARR algorithm may be different from the HR values calculated by HR Averaging Method. The ventricular HR is for judging arrhythmias and is not exactly equal to the HR displayed on the interface.

NOTE The ARR analysis results and HR values obtained during ARR analysis and HR calculation are not affected by the selected filter mode. The algorithm itself has independent data-flow processing, which can better ensure the consistent and accurate results in different filter modes.

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ARR Alarm Setup

Select ECG Setup > ARR Analysis > ARR Alarm Setup to change the following ARR alarm settings: Separately switch on or off each arrhythmia

alarm and set the alarm level/record. Select All Alarms On/All Alarms Off to switch

on or off all arrhythmia alarms. Set the threshold of certain arrhythmia alarms.

When an arrhythmia exceeds its threshold, an alarm will be triggered.

Select Default to restore the ARR alarm settings to factory defaults.

Confirm the changes to make the settings effective.

V-Fib/V-Tach and Vent Brady are key ARR alarms and they are preset to be on. The user can switch on/off those key ARR alarms only when Key ARR Alarm Switch Authority is enabled. To enable the authority,

1 Select Menu > Maintenance > User Maintain, and enter the required password.

2 Select Alarm Setup and set Key ARR Alarm Switch Authority to On. If any of key ARR alarms is switched off, the bottom information area will prompt Key ARR Alarm Off. Clicking the prompts can view the details.

Asystole alarm is preset to be on and cannot be turned off.

Pacer not Capture and Pacer not Pacing alarms are available only when Pace is set to On.

Adjustable Range of ARR Alarm Threshold

ARR Selflearning

Select this item ARR Selflearn to start a learning procedure. ECG ARR Learning is displayed on the screen. The ARR selflearning will start automatically in the following status: Connecting or switching calculation leads; Admitting a patient; Changing patient type or lead type; Changing pacemaker status; Exiting demo or standby mode; Switching calibration mode into normal

measurement mode; Switching the ECG parameter on.

WARNING When the ARR alarm is set to Off, the monitor won’t give an alarm prompt even if an alarm occurs. In order to avoid endangering the patient’s life, the user should use this function cautiously.

ARR Alarm RangePVCs High 1/min to 99/min

NOTE Both the ARR alarm information and threshold value are displayed when the above ARR alarms are triggered.

NOTE During the relearning phase of the algorithm, arrhythmia detection may not be available. So you should closely monitor the patient condition during and for several minutes after the learning phase to allow the algorithm to reach optimal detection performance.

NOTE Take care to initiate ARR selflearning only during periods of predominantly normal rhythm and when ECG signal is relatively noise-free. If ARR selflearning takes place during arrhythmia, the ectopics may be incorrectly learned as normal QRS complex. This may result in missed detection of subsequent events of arrhythmia.

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ECG leadwires and trunk cables (New added)

The following chapter refers to ECG leadwires and trunk cables in the following order list.

Order list

NOTE If ARR selflearning is performed during ventricular rhythm, ventricular heartbeats may be erroneously identified as normal QRS complexes. This may lead to missed ventricular tachycardia and ventricular fibrillation events.

Due to this reason, you should:

1 Take care that ARR selflearning may start automatically;

2 Response to lead off information;

3 Always check the correctness of arrhythmia alarm.

Description Part No.ECG leadwiresECG leadwire, 3-lead single-pin, IEC, 1m 2612000ECG leadwire, 3-lead single-pin, AHA, 1m 2612001ECG leadwire, 5-lead single-pin, IEC, 1.5m 2612002ECG leadwire, 5-lead single-pin, AHA, 1.5m 2612003ECG trunk cables

ECG defib trunk cable, 3/5-lead single-pin, 1.5m 2612020ECG defib trunk cable, 3/5-lead single-pin, 2.5m 2612021ECG defib trunk cable, Neonate, single-pin, 1.5m 2612026ECG defib trunk cable, Neonate, single-pin, 2.5m 2612027ECG blue trunk cables with ESUECG ESU trunk cable, 3/5-lead single-pin, 1.5m 2612024ECG ESU trunk cable, 3/5-lead single-pin, 2.5m 2612025ECG ESU trunk cable, Neonate, single-pin, 1.5m 2612028ECG ESU trunk cable, Neonate, single-pin, 2.5m 2612029

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Definition of target group

For the ECG leadwires and trunk cables, users are defined as target group.

This target group must have received instruction in the use of the product and must have the necessary training and knowledge to use the product.

The product must be used exclusively by the defined target group.

Users

See chapter “Intended user” on page 26.

For your safety and that of your patients

Intended use

Dräger ECG leadwire sets, reusable, for acquisition and transmission of ECG signals from patient electrodes to patient monitors.

Dräger ECG trunkcables, for transmission of ECG signals from ECG leadwires to patient monitors.

These ECG leadwire sets and trunkcables are approved for Vista 120 patient monitoring systems.

Installation and operation

For installation of the ECG leadwires and trunkcables, refer to the chapter Monitoring procedure in this instruction for use. Pay special attention to all WARNING and -CAUTION statements relating to the use of ECG equipment.

WARNING The medical device must not be modified.

Modifications to the medical device may lead to malfunction.

WARNING Risk of patient injury

Do not use damaged or broken items. Otherwise, the correct functioning of the medical device may be impaired.

CAUTION Strictly observe the instructions for use of the basic device on which this medical device is used.

WARNING Risk of patient injury

Do not operate the medical device in magnetic resonance imaging environments.

ECG leadwires and Trunkcables are not to be used in X-Ray environment.

During electro surgery the applicable precautions stated in the instructions for use of the basic device must be observed.

To minimize the risk of patient strangulation, carefully position and secure ECG cables.

CAUTION ECG leadwires and trunkcables are intended to be used with Vista 120 series models only.

Before first use inspect the primary packaging. Do not use the ECG leadwire in case the primary packaging is damaged.

WARNING Impedance respiration monitoring and pacemaker spike detection are inoperative when using the blue ESU trunk cables.

Do not use the blue ESU trunk cables except during electrosurgery.

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Cleaning and disinfection

Observe the hygiene regulations of the hospital.

Testing of procedures and agents

Cleaning and disinfection of ECG lead wires and trunk cables have been tested with the following procedures and agents. At the time of testing, the following procedures and agents showed good material compatibility and effectiveness:

Manual disinfection and simultaneous cleaning:

– Incidin® Extra N by Ecolab

– Incidin® Plus by Ecolab

– Sani-Cloth Active® by Ecolab

– Optim 33 TB® by Virox

– mikrozid® PAA wipes by Schülke

– Klorsept 17 by Medentech

– Green soap, green soap tincture (U.S.Pharmacopoeia), or alcohol-free hand soap;

– 2% glutaraldehyde solution;

– Sodium hypochlorite (bleach) solution 10% in water

For choosing the appropriate disinfectant, observe country-specific lists of disinfectants.

Strictly observe the manufacturer’s instructions for using disinfectants. The composition of disinfectants may change.

Manual disinfection and simultaneous cleaning

1 Carefully and completely remove all visible dirt immediately with a cloth soaked in disinfectant. Make sure that the surfaces to be disinfected are completely and sufficiently wetted with disinfectant.

2 Perform surface disinfection (scrub-and-wipe disinfection).

3 After the contact time has elapsed, remove disinfectant residues.

Visual inspection

Check all items for damage and external signs of wear, such as cracking, embrittlement, or pronounced hardening, and residual dirt.

WARNING The ECG leadwires and ECG trunk cable are reusable.

Before using, clean and/or disinfect ECG leadwires and trunk cables.

Do not autoclave ECG leadwires and trunk cables.

WARNING Risk of electric shock or device malfunction

Penetrating liquid may cause malfunction of or damage to the reusable ECG cables, which may endanger the patient.

Only scrub-and-wipe-disinfect ECG cables and make sure no -liquids penetrate into the ECG cables.

WARNING Risk due to faulty accessories

Even reusable accessories have a limited service life. If there are external signs of wear, e.g., cracks, deformations, or peeling, exchange affected accessories.

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Disposal

After use, the medical device must be disposed of according to the applicable hospital, hygiene and waste disposal regulations.

The ECG equipment in this chapter meets the requirements of the standard, ECG TRUNK CABLES and PATIENT LEADWIRES ANSI/AAMIEC53.

Ambient conditionsDuring operationTemperature 0 °C to 40 °CAtmospheric pressure 860 to 1060 hPa Relative humidity 5 % to 95 %, non-

condensingDuring storage/transportTemperature –20 °C to 55 °C Atmospheric pressure 500 to 1100 hPa Relative humidity 5 % to 95 %, non-

condensing

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Monitoring RESP

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118

RESP safety information . . . . . . . . . . . . . . . . 118

Electrode placement for monitoring resp . . 119

Cardiac overlay. . . . . . . . . . . . . . . . . . . . . . . . 120

Chest expansion. . . . . . . . . . . . . . . . . . . . . . . 120

Abdominal breathing . . . . . . . . . . . . . . . . . . . 120

Selecting RESP lead. . . . . . . . . . . . . . . . . . . . 120

Changing hold type . . . . . . . . . . . . . . . . . . . . 121

Changing the size of the respiration waveform. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

Changing the apnea alarm time . . . . . . . . . . 121

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Overview

The monitor measures respiration from the amount of thoracic impedance between two ECG electrodes. The change of impedance between the two electrodes, (due to the thoracic movement), produces a respiratory waveform on the screen.

RESP safety information

WARNING If the user does not set the Hold High and Hold Low for the respiration correctly in manual detection mode, it may not be possible for the monitor to detect apnea. If the user sets the Hold High and Hold Low too low, the monitor is more likely to detect cardiac overlay, and to falsely interpret cardiac overlay as respiratory activity in the case of apnea.

WARNING Respiration measurements can not detect all underexposure sudden events, nor can they distinguish between central, obstructive and mixed respiratory asphyxial events. It only prompts alarm in a predetermined time if the last breath is detected and the next breath is not detected, so it can not be used for diagnostic purposes.

WARNING If operating under conditions according to the EMC Standard EN 60601-1-2 (Radiated Immunity 3 V/m), field strengths above 3 V/m may cause erroneous measurements at various frequencies. Therefore it is recommended to avoid the use of electrically radiating equipment in close proximity to the respiration measurement unit.

WARNING Cardiogenic artifact in impedance respiration monitoring may make it difficult to detect breaths or may otherwise be counted as breaths. In some instances, the breath rate may also correspond to the heart rate making it difficult to determine if the signal is due to breathing or the cardiac cycle. Do not rely on RESP monitoring as the sole method for detecting cessation of breathing. Follow hospital guidelines and best clinical practices for apnea detection including monitoring additional parameters that indicate the patient’s oxygenation status, such as etCO2 and SpO2.

WARNING For the diagnosis of apnea, especially in premature infants and infants, the safety and effectiveness of respiration measurements have not been validated.

WARNING To monitor the respiration, only non-ESU-proof accessories can be used. This is because the internal impedance of the ESU-proof accessories required to be used for electrosurgical operation is too large.

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Electrode placement for monitoring resp

Correct patient skin preparation for electrode placement is important for RESP measurement. Refer to the chapter on ECG for more information.

The RESP signal is always measured between two of the ECG electrodes. There are two standard ECG leads for selection: I lead (RA and LA) and II lead (RA and LL).

WARNING Some implantable pacemakers can adjust their triggering frequency according to the "minute ventilation rate." Impedance respiration measurements may cause these pacemakers to react incorrectly. To prevent this, turn off the respiration measurement.

WARNING In manual detection mode, after changing the gain of the respiration wave, be sure to check the setting of Hold High and Hold Low.

WARNING When ECG electrode is placed on patient’s limb, the impedance respiration may be unreliable.

WARNING Respiration measurement cannot be performed when ESU is used.

WARNING Impedance respiration monitoring is inoperative when using the blue ESU trunk cables.

NOTE The RESP monitoring is not recommended to be used on patients who are very active, as this can cause false alarms.

LLRL

RALA

RESP

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Cardiac overlay

Cardiac activity that affects the RESP waveform is called cardiac overlay. This occurs when RESP electrodes detect impedance changes caused by rhythmic blood flow. Correct electrode placement

can reduce cardiac overlay: avoid the liver area and the ventricles of the heart in the line between the respiratory electrodes. This is particularly important for neonates.

Chest expansion

Some patients, especially neonates, expand their chests laterally. In this case, place the two respiratory electrodes in the right midaxillary and

left lateral chest areas at the maximum expansion point. This placement optimizes respiratory waveform results.

Abdominal breathing

Some patients with restricted chest movement breathe mainly abdominally. In this case, place the LL electrode on the left abdomen at the point of maximum abdominal expansion. This placement optimizes respiratory waveform results.

Selecting RESP lead

To change RESP lead: From the RESP Setup menu, select RESP Lead, then choose the appropriate lead from the pop-up list.

NOTE Place the red and green electrodes diagonally to optimize the respiration waveform. Do not position electrodes over the liver or the heart’s ventricles. This is an especially important safety procedure for neonates.

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Changing hold type

To change the calculation mode: From the RESP Setup menu, set Hold Type to Manual or AUTO. When set to AUTO mode, Hold High and Hold Low are unavailable, and the monitor calculates the respiration rate automatically. When set to Manual mode, the broken lines in RESP area can be adjusted by using Hold High and Hold Low.

Changing the size of the respiration waveform

Select the RESP waveform area to display the Resp waveform menu:

Select AMP and select the desired value. Larger values increase the waveform amplitude.

Select Sweep: Select an appropriate setting from the pop-up list.

Changing the apnea alarm time

The apnea alarm is a high priority red alarm used to detect apneas. The apnea alarm delay time defines the time period between the point where the monitor cannot detect any respiration activity and the indication of the apnea alarm. Users should set it cautiously.

1 In the RESP Setup menu, select Apnea Alm.

2 Select the desired setting from the pop-up list.

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Monitoring SpO2

Monitoring SpO2

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124

SpO2 safety information . . . . . . . . . . . . . . . . 124

Measuring SpO2 . . . . . . . . . . . . . . . . . . . . . . . 125Measurement procedure . . . . . . . . . . . . . . . . . 125

Measurement limitations . . . . . . . . . . . . . . . . 128

Perfusion Index (PI)* . . . . . . . . . . . . . . . . . . . 129

SpO2 Alarm Delays. . . . . . . . . . . . . . . . . . . . . 129

SatSeconds Alarm Management* . . . . . . . . . 129Describing SatSeconds . . . . . . . . . . . . . . . . . . 129SatSeconds "Safety Net" . . . . . . . . . . . . . . . . . 130Setting SatSeconds Duration . . . . . . . . . . . . . . 130

Measuring SpO2 and NIBP Simultaneously . . . . . . . . . . . . . . . . . . . . . . . . 131

Setting pitch tone . . . . . . . . . . . . . . . . . . . . . . 131

Setting sensitivity. . . . . . . . . . . . . . . . . . . . . . 131

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Overview

SpO2 is used to measure arterial blood oxygen saturation, which is the percentage of oxyhemoglobin in the arterial blood. The SpO2 parameter can also provide a pulse rate (PR) and a plethysmogram waveform (Pleth).

SpO2 safety information

WARNING Do not use the SpO2 sensors if the packaging or the sensor is damaged and return them to the vendor.

WARNING If the SpO2 sensor does not work properly, reconnect the sensor or use a new one.

WARNING Correct and proper sensor application: if the sensor is too loose, it might compromise the optical alignment, and even cause the sensor to fall off. If the sensor is too tight, (such as the application site is too large or becomes too large due to edema), excessive pressure and local tissue ischemia, hypoxia and lack of nutrition may occur on the application site. Prolonged and continuous monitoring may increase the risk of skin irritations or lacerations. To avoid these damages, users should periodically check surrounding skin of application site according to the patient's condition and pressure sensor, inspect the if there is sign of stress-related damage in surrounding tissue, and regularly change the application site. For the patients whose fluid is easy to transfer and/or the patients with systemic or localized edema, users should inspect the skin and change application site more frequently.

WARNING Neonate SpO2 sensor can only be used when required, no more than 20 min at a time.

WARNING Use only Dräger permitted sensors and extension cables with the oximeter. Other sensors or extension cables may cause improper monitor performance and/or minor personal injury.

WARNING High oxygen levels may predispose a premature infant to retrolental fibroplasia. If this is a consideration do NOT set the high alarm limit to 100%, which is equivalent to switching the high limit alarm off.

WARNING When serious arrhythmia is present, the SpO2 pulse rate may differ from ECG heart rate but this does not indicate an inaccurate PR (SpO2) value.

WARNING Misapplied sensor or sensor that becomes partially dislodged may cause either over or under reading of actual arterial oxygen saturation.

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Measuring SpO2

1 Select the correct patient category setting (adult/pediatric and neonatal). This is used to optimize the calculation of the SpO2 and pulse numerics.

2 During measurement, ensure that the application site:

– has a pulsatile flow, ideally with a good circulation perfusion.

– has not changed in its thickness, causing an improper fit of the sensor.

Measurement procedure

1 Switch on the monitor.

2 Attach the sensor to the appropriate site of the patient.

Before Applying the Sensor

Be sure to understand all warnings listed in the previous section before applying any sensor to a patient. Also,check the sensor as follows:

Check the sensor outside and inside. To inspect the inside, gently open the sensor cavity and check splits on or next to the transparent silicone that covers the optical elements.

Any sensor showing signs of damage or alteration must not be used for further patient monitoring; instead, dispose of it using proper disposal procedures.

NOTE Avoid placing the sensor on extremities with an arterial catheter, or intravascular venous infusion line, or inflated NIBP cuff. When measuring SpO2 on the limb with inflated NIBP cuff, please turn on the NIBP Simul function.

NOTE When a trend toward patient deoxygenation is indicated, analyze the blood samples with a laboratory co-oximeter to completely understand the patient’s condition.

NOTE If the surrounding temperature increases, the operator should pay attention to the site of poor perfusion, and increase the frequency of checking the skin and changing the measurement site to prevent burns. If the initial skin temperature is less than 35 °C (95 °F), the temperature of all the listed sensors on the skin will not exceed 41 °C (105.8 °F) during working.

NOTE SpO2 waveform is not directly proportional to the pulse volume.

NOTE The device is calibrated to display functional oxygen saturation.

NOTE Functional tester or simulator can not be used to assess the SpO2 accuracy. However, it can be used to demonstrate that a particular monitor reproduces a calibration curve that has been independently demonstrated to meet a particular accuracy.

NOTE The cumulative use time for the SpO2 sensor in a single patient should be less than 30 days.

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Applying Finger/Soft-tip Sensors:

Nip the clamp, and choose a site that is well perfused and minimally restricts a conscious patient’s movements. The ring finger of the non-dominant hand is preferred. Alternatively, the other fingers on the non-dominant hand may be used.

The big toe or long toe (next to the big toe) may be used on restrained patients or patients whose hands are unavailable.

Place the finger into the sensor according to the direction of the symbol on the sensor. Adjust the finger to ensure that the pad of the finger completely covers the sensor detection window.

Orient the sensor so that the cable will be running towards the top of the patient’s hand.

Connect the sensor with the monitor (or with the extension cable if needed).

Applying Neonatal Finger (or Toe) Wrap Sensors:

When you perform the measurement, position the sensor over the hand or foot with optical components opposite each other.

Hold the sensor, and insert stretched strap into slot, hold it there while threading end through latch. If strap is too long, thread it through second latch.

Connect the sensor with the monitor (or with the extension cable if needed).

Applying Adult/Pediatric Ear Clip Sensor:

When you perform the measurement, clip the plastic fixing part on top of the ear; reinforce it to prevent falling off or getting loose.

Clip the probe onto fleshy part of the lobe with optical components opposite to each other.

Connect the sensor with the monitor (or with the extension cable if needed).

3 Plug the sensor extension cable connector into the SpO2 socket.

WARNING Inspect the application site every two to three hours to ensure skin quality and correct optical alignment. If the skin quality changes, move the sensor to another site. Change the application site at least every four hours. For neonatal patients, change the measuring site every 20 minutes.

WARNING Assessing the Validity of a SpO2 Reading

The user can check the quality of the pleth wave and the stability of the SpO2 values to assess whether the sensor functions properly and whether the SpO2 readings are valid. Always use these two indications simultaneously to assess the validity of a SpO2 reading.

Generally, the quality of the SpO2 pleth wave reflects the quality of the light signals obtained by the sensor. A wave of poor quality manifests a decline of the signal validity. On the other hand, the stability of the SpO2 values also reflects the signal quality. Different from varying SpO2 readings caused by physiological factors, unstable SpO2 readings are resulted from the sensor's receiving signals with interference. The problems mentioned above may be caused by patient movement, wrong sensor placement or sensor malfunction. To obtain valid SpO2 readings, try to limit patient movement, check the placement of the sensor, measure another site or replace the sensor.

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NOTE The SpO2 accuracy has been validated in controlled human studies against arterial blood sample reference measured with a CO-oximeter. SpO2 measurements are statistically distributed, only about two-thirds of the measurements can be expected to fall within the specified accuracy compared to CO-oximeter measurements. The volunteer population in the studies are composed of healthy men and women from age 19 to 37 (for Dräger SpO2 module), from 18 to 50 (for Nellcor SpO2 module), with variations of skin pigmentations. Note that the study population was healthy adults and not in the actual intended use population.

NOTE The pulse rate accuracy is obtained by comparison to the pulse rate generated with an arterial oxygen simulator (also an electronic pulse simulator).

NOTE During monitoring, if the monitor's reading differs significantly from the patient's physiological condition, it indicates that the signal may be disturbed, resulting in an inaccurate reading. In this case, the artifact can disguise as a similar reading, causing the monitor to fail to send an alarm. In order to ensure reliable monitoring, it is necessary to regularly check whether the sensor is wearing properly and the signal quality is good.

NOTE Injected dyes such as methylene blue or intravascular dyshemoglobins such as methemoglobin and carboxyhemoglobin may lead to inaccurate measurements.

NOTE Inspect the sensor to ensure that the light emitter and receiver are aligned with each other and there is no gap between the sensor and the finger. All the light emitted by the light emitter must pass through the patient's tissue. The sensor cable should be placed on the back of the hand.

NOTE Clean and remove any substances such as nail polish from the application site. Periodically check to ensure that the sensor remains properly positioned on the patient.

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Measurement limitations

Certain patient conditions can affect the measurements or cause the loss of the pulse signal.

Inaccurate measurements can be caused but not limited by:

incorrect sensor application

high ambient light sources, such as surgical lights (especially those with a xenon light source), bilirubin lamps, fluorescent lights, infrared heating lamps, and direct sunlight

failure to cover the sensor with opaque material in high ambient light conditions

dysfunctional hemoglobins

low peripheral perfusion

excessive or violent patient movement

venous pulsations

intravascular dyes, such as indocyanine green or methylene blue

externally applied coloring agents (nail polish, dye, pigmented cream)

defibrillation

placement of the sensor on an extremity with a blood pressure cuff, arterial catheter, or intravascular line

electromagnetic interference.

Loss-of-pulse signal can occur for the following reasons:

the sensor is applied too tightly

a blood pressure cuff is inflated on the same extremity as the one with the sensor attached

there is arterial occlusion proximal to the sensor

low peripheral profusion.

NOTE To prevent interference from ambient light, ensure that the sensor is properly applied, and cover the sensor site with opaque material.

NOTE Adjacent SpO2 sensors may interfere with each other (eg, multiple SpO2 measurements in the same patient). Be sure to cover the sensor with opaque material to reduce cross-interference.

NOTE Move the sensor to a less active site, and keep the patient still, if possible.

NOTE For Nellcor SpO2 module, the algorithm automatically extends the amount of data required for measuring SpO2 and PR depending on the measurement conditions. During normal measurement conditions the averaging time is 6 to 7 s. During conditions such as those caused by low perfusion, interference (e.g., external interference such as ambient light or patient movement), or a combination of these, the algorithm automatically extends the amount of data required beyond 7 s. If the resulting dynamic averaging time exceeds 20 s, the screen will display prompt message “SpO2 Search Pulse” and SpO2 and PR will continue to be updated every second. As these conditions extend, the amount of data required continues to increase. If the dynamic averaging time reaches 40 s, the screen will display high-level alarm message “SpO2 No Pulse” indicating a loss-of-pulse condition.

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Perfusion Index (PI)*

* Only applicable to the Dräger SpO2 module.

PI is a numeric value indicating perfusion level. It reflects the perfusion level at the monitoring site.

As the measurement of SpO2 is based on the pulsation caused by the blood flow through the vessel, PI is in relation to the strength of the pulse. Also, the user can use PI as a signal quality indicator for the measurement of SpO2.

PI is indicated by a value ranging from 0 to 10. The bigger the value is, the better the perfusion and the signal quality will be. The perfusion level and the signal quality are at their maximum when the value reaches 10. When PI is below 2, it indicates the low perfusion and the poor signal quality at the monitoring site; the user needs to reposition the sensor or find a better site.

The PI value is displayed in the SpO2 parameter area.

SpO2 Alarm Delays

There is a delay between a physiological event at the measurement site and the corresponding alarm at the monitor. This delay has two components:

1 The time between the occurrence of the physiological event and when this event is represented by the displayed numerical values. This delay depends on the algorithmic processing time and the sensitivity. The lower the sensitivity configured, the longer the time needed until the numerical values reflect the physiological event.

2 The time between the displayed numerical values exceeding an alarm limit and the alarm indication on the monitor. This delay is the combination of the configured alarm delay time plus the general system delay time.

SatSeconds Alarm Management*

* Only applicable to the Nellcor SpO2 module.

* Not applicable to Vista 120 CMS.

Describing SatSeconds

With traditional alarm management, upper and lower alarm limits are set for monitoring oxygen saturation. During monitoring, as soon as an alarm limit is violated by as little as one percentage point, an alarm is immediately triggered. When the SpO2

level fluctuates near an alarm limit, the alarm is triggered each time the limit is violated. Such frequent alarms can be distracting.

With the SatSeconds technique, upper and lower SpO2 alarm limits are set in the same way as traditional alarm management. However, the user can also set a SatSeconds limit that allows monitoring of SpO2 below the selected lower alarm limit and above the selected upper alarm limit for a period of time before an alarm is triggered.

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The method of calculation is as follows:

The number of percentage points that the SpO2 falls outside the alarm limit is multiplied by the number of seconds that the SpO2 level remains outside that limit. This can be stated as an equation:

Points × Seconds = SatSeconds

Where:

Points = SpO2 percentage points outside of the limit

Seconds = number of seconds that SpO2 remains at that point outside of the limit

The alarm response time, assuming a SatSeconds limit set at 50 and a lower alarm limit set at 90, is described and illustrated below.

In this example, the SpO2 level drops to 88 (2 points below the limit) and remains there for a period of 2 seconds (2 points × 2 seconds = 4 SatSeconds). The SpO2 then drops to 86 for 3 seconds and then to 84 for 6 seconds. The resulting SatSeconds values are shown below:

After approximately 10.7 seconds, a SatSeconds alarm will be triggered, because the limit of 50 SatSeconds has been exceeded. See arrow () in the following figure.

Saturation levels may fluctuate rather than remaining steady for a period of several seconds. Often, the patient SpO2 may fluctuate above and below the alarm limit, re-entering the non-alarm range several times. During such fluctuation, the monitor integrates the number of SpO2 points, both positive and negative, until either the SatSeconds limit is reached, or the patient SpO2 returns within a normal range and remains there.

SatSeconds "Safety Net"

The SatSeconds "Safety Net" is for patients whose saturation makes frequent excursions below or above the SpO2 limit but does not remain in violation long enough for the SatSeconds limit to be reached. If three or more SpO2 alarm limit violations occur within a 60-second period, an alarm will be triggered even if the SatSeconds limit has not been reached.

Setting SatSeconds Duration

The user can set SatSeconds to Off or to the duration among 10, 25, 50 and 100. To configure the SatSeconds settings, enter the SpO2 Setup menu and select the desired SatSeconds setting from the SatSeconds list.

SpO2 Seconds SatSeconds

2 x 2 = 4

4 x 3 = 12

6 x 6 = 36

Total SatSeconds = 52

50 SatSecondsAlarm Point

SECONDS

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Measuring SpO2 and NIBP Simultaneously

While measuring SpO2 and NIBP on the same limb simultaneously, the user can set NIBP Simul to On in SpO2 Setup menu to lock the SpO2 alarm status until the NIBP measurement ends. If NIBP Simul is

set to Off, low perfusion caused by NIBP measurement may lead to inaccurate SpO2 readings and therefore cause false physiological alarms.

Setting pitch tone

If tone modulation is on, the PR sound lowers when the SpO2 level drops. In SpO2 Setup menu, select Pitch Tone to toggle between On and Off.

Setting sensitivity

Sensitivity allows the user to set the refresh frequency. High is the highest SpO2 refresh frequency value. To change the sensitivity:

1 Select the SpO2 Setup menu;

2 Select Sensitivity and set the desired sensitivity from the pop-up list.

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Monitoring PR

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

Setting PR Source . . . . . . . . . . . . . . . . . . . . . 134

Setting PR volume . . . . . . . . . . . . . . . . . . . . . 134

Selecting the active alarm source. . . . . . . . . 134

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Overview

The pulse numeric counts the arterial pulsations that result from heart mechanical activity of the heart in beats per minute (bpm). A pulse can be obtained from any measured SpO2 signal or any arterial pressure.

Setting PR Source

The monitor provides PR source options. You can select SpO2 or arterial pressure labels as the PR source in the PR Source list on the PR Setup menu.

Setting PR volume

Select PR Setup > PR Volume, then select the appropriate setting for the PR volume: five bars represent the maximum volume and one bar represents the minimum volume. If none of bars are

selected, the PR volume will be off. Beat frequency of pulse has positive correlation with measurement value.

Selecting the active alarm source

In most cases, the HR and PR numerics are identical. To avoid simultaneous alarms on HR and PR, the monitor uses either ECG or PR as its active alarm source. To change the alarm source, select either ECG Setup > Alarm Source or PR Setup > Alarm Source, then select:

HR: HR is HR/PR alarm source;

PR: PR is HR/PR alarm source. Be aware that if you select PR as the alarm source, ECG HR alarms are switched off;

AUTO: If the alarm source is set to AUTO, the monitor will use the heart rate from the ECG measurement as the alarm source whenever the ECG measurement is switched on and at least one ECG lead can be measured without a technical alarm condition. The monitor will automatically switch to PR for the alarm source if:

a valid ECG lead can no longer be measured and

a PR source is switched on and available.

NOTE In the PR Source list, an arterial pressure label accompanied with a label with brackets indicates this label is in conflict. Do not select a conflicting label as the PR source.

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The monitor uses the pulse rate from the currently active measurement as system pulse. While PR is the alarm source, all arrhythmia and ECG HR alarms are switched off. If an ECG lead becomes available again, the monitor automatically uses HR as alarm source.

NOTE Pulse alarms are generated only when the active alarm source is set to PR, a pulse source is set as system pulse and pulse alarms are switched on.

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Monitoring NIBP

Monitoring NIBP

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

NIBP safety information. . . . . . . . . . . . . . . . . 138

Measurement limitations . . . . . . . . . . . . . . . . 140Measurement methods. . . . . . . . . . . . . . . . . . . 140

Measurement procedures . . . . . . . . . . . . . . . 141

Operation prompts . . . . . . . . . . . . . . . . . . . . . 142

Correcting the measurement if limb is not at heart Level . . . . . . . . . . . . . . . . . . . . 142

NIBP Multi-Review Window . . . . . . . . . . . . . . 143

Resetting NIBP . . . . . . . . . . . . . . . . . . . . . . . . 143

Calibrating NIBP . . . . . . . . . . . . . . . . . . . . . . . 143

Leak test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143Procedure for leak testing. . . . . . . . . . . . . . . . . 144

Setting inflation mode . . . . . . . . . . . . . . . . . . 144

Assisting Venipuncture . . . . . . . . . . . . . . . . . 145

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Overview

This monitor uses the oscillometric method for measuring NIBP. It can be used for adult, pediatric and neonatal patients. It is also intended for use with pregnant, including pre-eclamptic patients.

Oscillometric devices measure the amplitude of pressure changes in the occluding cuff as the cuff deflates from above systolic pressure. The amplitude suddenly increases as the pulse breaks through the occlusion in the artery. As the cuff pressure decreases further, the pulsations increase in amplitude, reach a maximum (which approximates to the mean pressure), and then diminish.

The blood pressure measurements determined with this device comply with the American National Standard for Electronic or Automated Sphygmomanometers (ISO 81060-2:2013) in relation to mean error and standard deviation. In clinical investigation method with a reference sphygmomanometer, the fifth Korotkoff sound was used to determine adult diastolic pressure, and the fourth Korotkoff sound was used to determine pediatric diastolic pressure. The invasive blood pressure is used to determine the neonate pressure in clinical investigation, and the arterial reference sites include umbilical artery, arteria cruralis, axillary artery, brachial artery, dorsalis pedis, and radial artery.

NIBP safety information

The monitor and peripheral devices are protected against high-frequency interference from defibrillators and electrosurgical units and against 50- and 60-Hz power line interference.

WARNING Do not measure NIBP on patients with sickle-cell disease or any condition where skin damage has occurred or is expected.

WARNING Do not measure NIBP on the arm of the same side with a mastectomy.

WARNING Use clinical judgment to decide whether to perform frequent blood pressure measurements on patients with severe blood clotting disorders because of the risk of hematoma in the limb fitted with the cuff.

WARNING Do not apply the cuff to a limb that has an intravenous infusion or catheter in place. This could cause tissue damage around the catheter when infusion is slowed or blocked during cuff inflation.

WARNING Do not attach the cuff to a limb being used for IV infusions as the cuff inflation can block the infusion, potentially causing harm to patient.

WARNING Do not apply the cuff to a limb where intravascular access or therapy, or an arterio-venous (A-V) shunt is present, otherwise, it may result in injury to the patient.

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WARNING Ensure that the correct patient type is selected before performing measurements. Do not apply the higher adult inflation, overpressure limits and measurement duration for neonatal patients. Not using the neonate mode on a neonatal patient can block the blood flow, potentially causing harm to the patient.

WARNING Make sure that the air tubing connecting the blood pressure cuff and the monitor is neither blocked nor tangled.

WARNING Measuring of blood pressure can temporarily cause malfunctioning of other medical monitoring devices on the same limb.

WARNING NIBP readings can be affected by the measurement site, the position of the patient, exercise, or the patient's physiologic conditions.

WARNING Continuous cuff pressure due to connection tubing kinking can block the blood flow, and may result in injury to the patient.

WARNING Verifying the calibration is only applicable for adults, and it cannot be operated in automatic measuring interval. Continuous measuring cannot be operated in automatic measuring interval either.

NOTE Do not start NIBP measurements during low battery conditions (the monitor may turn off automatically).

NOTE If an alarm occurs or measurement fails, discontinue the measurement.

NOTE If the user spills liquid onto the equipment or accessories, particularly if there is a chance that it can get inside the tubing or the measurement device, contact service personnel.

NOTE Continuous use of the automatic measuring mode for short intervals may lead to the discomfort of the patient. Continuous measuring and automatic measuring in neonatal or pediatric mode may result in tissue damage or ischemia to the patient.

NOTE NIBP measurement can be affected by extremes of temperature, humidity and altitude.

NOTE NIBP measurement value should be explained by qualified professionals.

NOTE The pulse rate based on the NIBP measurement may differ from the heart rate based on the ECG waveform. NIBP measures the number of peripheral pulse pulsations, and the heart rate is measured by the electrical signal of the heart. When the electrical signals of the heart occasionally fail to cause the peripheral blood vessels to pulse or the patient's peripheral perfusion is poor, the difference happens.

NOTE The cumulative use time for the NIBP cuff in a single patient should be less than 30 days.

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Measurement limitations

Measurements are impossible with pulse rate extremes of less than 40 bpm or greater than 240 bpm, or if the patient is on a heart-lung machine.

The measurement may be inaccurate or impossible in the following situations:

A regular arterial pressure pulse is hard to detect.

Patients with cardiac arrhythmias.

Patients with excessive and continuous movement such as shivering or convulsions.

Patients with rapid blood pressure changes.

Patients with severe shock or hypothermia that reduces blood flow to the periphery.

Obese patients, where a thick layer of fat surrounding a limb dampens the oscillations coming from the artery.

Patients with an edematous extremity.

Measurement methods

There are three methods of measuring NIBP:

Manual - measurement on demand.

Auto - continually repeated measurements (between 1 and 480 minute adjustable interval). After the first measurement ends, the monitor will automatically measure NIBP as preset interval. When the measurement interval is set to the value between 5 and 480 minutes, the system will automatically adjust the next measurement time. Here’s an example.

Continuous - NIBP measurements run consecutively in five minutes, and then the monitor switches to manual mode.

Auto Measurement

Interval

Current Time

Next Measurement Time

5 min 12:02 12:05, 12:10, 12:15, 12:20, and so forth.

10 min 12:02 12:10, 12:20, 12:30, 12:40, and so forth.

15 min 12:0212:15, 12:30, 12: 45, 13:00, and so forth.

30 min 12:02 12:30, 13:00, 13:30, 14:00, and so forth.

60 min 12:02 13:00, 14:00, 15:00, 16:00, and so forth.

90 min 12:02 13:00, 14:30, 16:00, 17:30, and so forth.

120 min 12:02 13:00, 15:00, 17:00, 19:00, and so forth.

180 min 12:02 13:00, 16:00, 19:00, 22:00, and so forth.

240 min 12:02 13:00, 17:00, 21:00, 1:00, and so forth.

360 min 12:02 13:00, 19:00, 1:00, 7:00, and so forth.

480 min 12:02 13:00, 21:00, 5:00, 13:00, and so forth.

WARNING Prolonged non-invasive blood pressure measurements in Auto mode may be associated with purpura, ischemia and neuropathy in the limb wearing the cuff. When monitoring a patient, examine the extremities of the limb frequently for normal color, warmth and sensitivity. If any abnormality is observed, stop the blood pressure measurements.

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Measurement procedures

To obtain accurate measurements, the following operating steps need to be observed:

1 Ensure the patient position in normal use, including:

Comfortably seated (or lie flat on back)

Legs uncrossed

Feet flat on the floor

Back and arm supported

2 Make sure the patient relaxes as much as possible and neither talking nor applying external pressure against the cuff. Rest for five minutes in a quiet environment.

3 Connect the air hose and switch on the monitor.

4 Attach the blood pressure cuff to the patient's arm or leg and follow the following instructions.

– Ensure that the cuff is completely deflated.

– Attach the appropriate size cuff to the patient (For information about cuff size selection, refer to the chapter "NIBP accessories"), and ensure the symbol "Φ" is over the artery. Ensure that middle of the cuff is at the level of the right atrium of the heart and the cuff is not wrapped too tightly around the limb. Excessive tightness can cause discoloration and ischemia of the extremity.

5 Check if the patient type is appropriate. Access the Patient Setup menu from Menu. Turn the knob to select the desired patient Type in the Patient Info. menu.

6 Select a measurement mode and NIBP Unit (mmHg, kPa or cmH2O, 1 mmHg=0.133 kPa, 1 mmHg=1.36 cmH2O) in the NIBP Setup menu. Refer to chapter “Operation prompts” for information.

7 Press the button on the front panel or shortcut key on the main screen to start a measurement.

8 Wait until the first reading is taken.

NOTE The width of the cuff is either approximately 40% of the limb circumference or 2/3 of the upper arm length. The inflatable part of the cuff should be long enough to encircle 80-100% of the limb. The wrong size of cuff can cause erroneous readings. If the cuff size is in question, use another cuff with suitable size to avoid errors.

NOTE If an NIBP measurement is suspect, repeat the measurement. If you are still uncertain about the reading, use another method to measure the blood pressure.

NOTE Please make sure the cuff is well connected. A leak of air may cause measurement error.

NOTE Please select the cuff with the suitable size. An unsuitable cuff may cause incorrect measurements.

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Operation prompts

1 Manual measurement

Access the NIBP Setup menu and set the Measure Mode item to Manual. Press the button on the front panel or shortcut key on the main screen to start a manual measurement.

2 Automatic Measurement

Access the NIBP Setup menu and set the Measure Mode item to Auto.

Select the time interval as need, then press the button on the front panel or shortcut key on the main screen.

3 Continuous measurement

Access the NIBP Setup menu and select the Continuous item to start a continuous measurement. The continuous measurement will last 5 minutes.

4 Stopping continuous measurement

During continuous measurement, press the button on the front panel or shortcut key on the main screen at any time to stop.

Correcting the measurement if limb is not at heart Level

The following measurement corrections should be applied if the limb is not at heart level:

NOTE Avoid incursion of liquid into the cuff. If this happens, please desiccate the cuff completely.

Add 0.75 mmHg (0.10 kPa) for each cm higher or

Subtract 0.75 mmHg (0.10 kPa) for each cm lower or

Add 1.9 mmHg (0.25 kPa) for each inch higher

Subtract 1.9 mmHg (0.25 kPa) for each inch lower

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NIBP Multi-Review Window

To set the display of NIBP measurements, select NIBP Setup > Review:

When it is set to On, a window for NIBP measurements will be displayed at the waveform area on the main interface, and the size of this window varies depending on the numbers of displayed waveforms.

When it is set to Off, the window is unavailable on the screen.

Resetting NIBP

When NIBP does not work properly and the system does not generate an error message, select Reset in the User Maintain > NIBP Maintain menu to activate the self-test procedure. This function restores the system.

Calibrating NIBP

NIBP is not user-calibrated. Cuff-pressure transducers must be verified and calibrated, if necessary, at least once every two years by a qualified service professional. See the Service Guide for details.

Leak test

Leak test is used to detect the air tightness of the NIBP pump, valve, and trachea. If not, the system will display NIBP leakage. NIBP leak detection should be performed at least once every two years or when you think the measurement is inaccurate.

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Monitoring NIBP

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Procedure for leak testing

1 Connect the cuff securely with the socket for NIBP air hole.

2 Wrap the cuff around the cylinder of an appropriate size, don’t wrap the cuff around limbs.

3 Make sure the patient type has been set to Adult.

4 Access User Maintain > NIBP Maintain.

5 Turn the knob to the Leakage Test item and press the item. Then the prompt of Leak. Test Running will appear indicating that the system has started performing the leak test.

6 The system will automatically inflate the pneumatic system to about 180 mmHg.

7 After 20 to 40 s, if system leakage has detected, the system will automatically open the deflating valve to stop the leakage test and indicates NIBP Leak. If no system leakage is detected when the pneumatic system is inflated to 180mmHg, the system will perform a deflation to an approximate value of 40mmHg and subsequently perform the second phase leakage test. After 20 to 40 s, the system will automatically open the deflating valve and provide corresponding indication based on the test result.

If the prompt of Leakage Test Ok appears, it indicates that the airway is in good condition and no air leaks exist. However if the alarm information of NIBP Leak appears, it indicates that the airway might have air leaks. In this case, the user should check for loose connections. After confirming secure connections, the user should re-perform the pneumatic test. If the failure prompt still appears, contact DrägerService.

Setting inflation mode

To change the inflation mode:

1 Select NIBP Setup > Inflation Mode;

2 Choose Manual or AUTO from the pull-down list.

If Manual is chosen, the preset value by users will be adopted as the inflation value when measuring blood pressure.

If AUTO is chosen, the default value will be adopted as the inflation value when measuring blood pressure.

WARNING This pneumatic test, other than being specified in the ISO 81060-1 standard, is to be used by the user to simply determine whether there are air leaks in the NIBP airway. If, at the end of the test, the system gives the prompt that the NIBP airway has air leaks, contact the manufacturer for repair.

Monitor

NIBP

Hose

Cuff

Cylinder

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Monitoring NIBP

Assisting Venipuncture

The user can use the NIBP cuff to cause a pressure close to diastolic pressure, so as to block the venous blood vessel and therefore help venipuncture. To assist venipuncture:

1 Select NIBP Setup > Venipuncture;

2 Select the appropriate Cuff Pressure according to the patient type;

3 Select Start.

4 Wait until the monitor prompts In venipuncture process. If an abnormal alarm occurs before it, no follow-up operation can be carried out. Restart the procedure after checking if necessary;

5 Puncture vein and draw blood sample;

6 Select Stop to deflate the cuff. If you do not deflate the cuff, the cuff automatically deflates when the venipuncture time expires (170 s for adult and pediatric patient, 85 s for neonatal patient).

During venipuncture, pay attention to the cuff pressure and the countdown displayd in the NIBP numerics area. When the remaining time is 30 s, the monitor issues a reminder tone and the countdown displays in red, prompting the user that the venipuncture time is to expire.

NOTE Only when the monitor exits Assisting Venipuncture Setup menu, the user can do other operations.

NOTE When the monitor is in DEMO mode, continuous measurement process, or auto measurement process, Assisting Venipuncture function is not available.

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Monitoring TEMP

Monitoring TEMP

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148

TEMP safety information . . . . . . . . . . . . . . . . 148

Selecting TEMP sensor type . . . . . . . . . . . . . 149

Switching T1/T2 On/Off . . . . . . . . . . . . . . . . . 149

TEMP monitoring setup . . . . . . . . . . . . . . . . . 149Selecting a Temperature for Monitoring . . . . . . 149

Calculating temp difference . . . . . . . . . . . . . 149

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Monitoring TEMP

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Overview

Body temperature is measured using a thermistor probe (a semiconductor whose resistance changes with temperature) placed appropriately on the patient.

Two TEMP probes can be used simultaneously to measure two TEMP values. The monitor automatically calculates the temperature difference. The default configuration is skin sensor for adult.

TEMP safety information

CAUTION Place a protective rubber sheath over the probe to prevent the possibility of burns during electrosurgery or defibrillation. Do not use surface probes during electrosurgery.

WARNING Verify probe cables fault detection before using the probe to monitor the patient. If the temperature probe cable of channel 1 is unplugged from the socket, the screen will display the error message TEMP1 SENSOR OFF and the audible alarm is activated. It is the same for the other channel.

WARNING Handle the TEMP probe and cable carefully. When they are not in use, the probe and cable should be coiled into a loose circle. Pulling the wire inside the cable may mechanically damage the probe and the cable.

WARNING Remember to disinfect the reusable TEMP probe after each use on a patient.

WARNING Risk of patient injury. Do not operate the device in magnetic resonance imaging environments.

WARNING Prior to use, make sure that the temperature probe is not damaged and that it is correctly applied to the patient. Otherwise, the correct functioning of the medical device may be impaired.

NOTE Disposable TEMP probe can only be used once per patient.

NOTE The reference body site temperature is the same as the temperature of the measuring site.

NOTE The cumulative use time for the oral or rectal temperature probe in a single patient should be less than 24 hours.

NOTE Cover internally placed reusable temperature sensors with temperature probe sheaths.

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Monitoring TEMP

Selecting TEMP sensor type

The user can choose the TEMP sensor type as the temperature signal source.

To configure the TEMP sensor type, select Menu > Maintenance > User Maintain > Other Setups, and set TEMP Sensor to YSI-10K or YSI-2.252K.

Switching T1/T2 On/Off

In Menu > System Setup > Module Switch, T1 or T2 can be switched on/off separately and won’t be affected by each other.

TEMP monitoring setup

If disposable TEMP probes are used, connect the TEMP cable to the monitor and then connect the probe to the cable. With a reusable TEMP probe the probe can be connected directly to the monitor.

Apply the TEMP probes securely to the patient.

Switch on the monitor.

It takes 5 minutes for the body temperature to stabilize.

Selecting a Temperature for Monitoring

Select the temperature label according to the measurement site. The label is a unique identifier for each type of temperature.

To select the label,

1 Click the TEMP parameter area to enter TEMP Setup menu.

2 Select the appropriate label from the list for T1 and T2.

Label Description

Tskin Skin temperature

Trect Rectal temperature

Tcore Core temperature

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Monitoring TEMP

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Calculating temp difference

The monitor can calculate and display the difference between two temperature values by subtracting the second value from the first. The difference is labeled TD.

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Monitoring IBP (optional)

Monitoring IBP (optional)

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152

IBP safety information . . . . . . . . . . . . . . . . . . 152

Monitoring procedures . . . . . . . . . . . . . . . . . 153

Selecting a pressure for monitoring. . . . . . . 153

Zeroing the pressure transducer . . . . . . . . . 154

Troubleshooting the pressure zeroing (taking Art for example) . . . . . . . . . . . . . . . . . 154

IBP calibration . . . . . . . . . . . . . . . . . . . . . . . . 154

Changing the IBP Waveform Ruler . . . . . . . . 155

IBP Waveform Overlapping . . . . . . . . . . . . . . 155

Measuring PAWP . . . . . . . . . . . . . . . . . . . . . . 155Measurement Procedures . . . . . . . . . . . . . . . . 155

Calculating PPV . . . . . . . . . . . . . . . . . . . . . . . 157

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Monitoring IBP (optional)

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Overview

IBP is measured by means of a catheter inserted into the circulatory system. A pressure transducer connected to the catheter converts the mechanical force exerted by the blood into an electrical signal. This is displayed graphically as pressure versus time and as numerics on the monitor screen.

The monitor measures direct blood pressure of one selected blood vessel and displays waveforms and numerics for the measured direct blood pressure (SYS, DIA and MAP).

For further information on the IBP Kit, refer to the accompanying Instructions for Use of the manufacturer.

IBP safety information

WARNING The operator should avoid contact with the conductive parts of the device when it is connected to the patient.

WARNING When the monitor is used with HF surgical equipment, the transducer and the cables must be avoided from conductive connection to the HF equipment. This is to protect against burns to the patient.

WARNING Disposable IBP transducer or domes should not be reused.

WARNING If any kind of liquid, other than solution to be infused in pressure line or transducer, is splashed on the equipment or its accessories, or enters the transducer or the monitor, contact service personnel immediately.

WARNING The longest duration of IBP arterial catheterization is 7 days.

WARNING All invasive procedures have risks to the patient. Use aseptic technique and follow catheter manufacturer's instructions.

WARNING Mechanical shock to the invasive blood pressure transducer may cause severe shifts in zero and calibration, and then cause erroneous readings.

NOTE Use only the pressure transducer listed in the IBP accessories.

NOTE If measuring intracranial pressure (ICP) on a sitting patient, adjust the transducer on the same level with the top of the patient’s ear. Incorrect leveling may lead incorrect values.

NOTE Confirm you set correct alarm limit for labels, the alarm limit you set are stored for its label only. Changing label may change the alarm limit.

NOTE Don’t perform IBP calibration when a patient is being monitored.

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Monitoring IBP (optional)

Monitoring procedures

Preparatory steps for IBP measurement:

1 Connect the pressure cable to the corresponding socket and switch on the monitor.

2 Prepare the flush solution.

3 Flush through the system, exhaust all air from the tube, ensure that the transducer and stopcocks are free of air bubbles.

4 Connect the patient catheter to the pressure line, making sure that there is no air present in the catheter or pressure line.

5 Position the transducer so that it is at the same level as the patient’s heart, approximately mid-axillary line.

6 For the label name selection, refer to chapter “Selecting a pressure for monitoring”.

7 To zero the transducer, refer to chapter “Zeroing the pressure transducer”.

Selecting a pressure for monitoring

The user can assign a pressure label to uniquely identify each pressure. The monitor then uses that label's stored settings (i.e., for color, scale and alarm settings) and selects which algorithm is used to process the pressure signal. An incorrect label can lead to incorrect pressure values. To select the label, refer to the following table:

NOTE When using high frequency ventilation, make sure that the ventilator catheter is not connected to or indirectly connected to the arterial catheter at zero pressure. This can lead to less pressure variations, thus interfere the zeroing process.

WARNING If there are air bubbles in the tube system, you should flush the system with the solution again. The bubbles may cause erroneous pressure readings.

Label DescriptionART Arterial blood pressure

PA Pulmonary artery pressure

CVP Central venous pressure

ICP Intracranial pressure

LAP Left atrial pressure

RAP Right atrial pressure

P1-P2 Alternative non-specific pressure labels

NOTE The pressure option is only valid when the label is P1/P2 and does not take effect under other labels.

Label Description

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Monitoring IBP (optional)

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Zeroing the pressure transducer

To avoid inaccurate pressure readings, the monitor requires a valid zero. Zero the transducer in accordance with the hospital’s policy (at least once per day).

Zeroing must be performed:

When a new transducer or tubing is used;

Every time the transducer cable is reconnected to the monitor;

If the monitor’s pressure readings seem to be incorrect.

When using a pressure module, the zero information is stored in the module.

To zero a pressure measurement:

1 Turn off the stopcock to the patient.

2 Vent the transducer to atmospheric pressure. This compensates for the static and atmospheric pressure exerted on the transducer.

3 In the setup menu for pressure, select Zero Channel: XX or Zero All. (XX stands for the IBP label name). After confirmation, the user can zero the pressure of certain channel or pressure of all channels.

4 When the message Zero Ok is displayed, close the stopcock to atmospheric pressure and open the stopcock to the patient.

Troubleshooting the pressure zeroing (taking Art for example)

The status message lists the probable cause of an unsuccessful calibration.

IBP calibration

IBP is not user-calibrated. Calibration should be performed by a qualified service professional as frequently as dictated by the Hospital Procedures Policy.

Message Corrective Action

Art ZERO FAIL Make sure that the transducer is not attached to the patient.

Art SENSOR OFF, FAIL Make sure that transducer is not off, and then proceed zeroing.

IN DEMO, FAIL Make sure that the monitor is not in DEMO mode. Contact service technician if necessary.

PRESSURE OVER RANGE, FAIL Make sure that the stopcock is vented to atmosphere. If the problem persists, contact service technician.

PULSATILE PRESSURE ZERO FAIL

Make sure that the transducer is vented to air, not connected to a patient, and try again.

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Monitoring IBP (optional)

Changing the IBP Waveform Ruler

The top, middle and bottom rulers are available for each channel of IBP waveform. Users can adjust the top, middle or bottom rulers manually:

1 Open the menu Wave Setup of IBP by clicking on the IBP waveform area.

2 Select a suitable ruler from the options TopRuler, MidRuler and BotRuler.

IBP Waveform Overlapping

The monitor can display IBP overlapped waveforms. To set IBP waveform overlapping:

1 Select Menu > Maintenance > User Maintain > Other Setups, and set IBP Wave Overlapping to On or Off.

2 Click the IBP waveform area to show the IBP Wave Setup menu.

3 Select Add IBP Waves and then select the IBP waves for overlapping from the pop-up list. A maximum of four overlapping waveforms can be displayed.

4 After exiting the interface, the main screen will display the overlapped IBP waves. The flashing label is the main label of the waveform area.

Click the IBP overlapping waveform area on the main screen, and then select Setup Rulers. The user can select a suitable ruler for the overlapped waveforms from the options TopRuler and BotRuler.

Measuring PAWP

PAWP, Pulmonary Artery Wedge Pressure, used to assess the cardiac function, is obtained by introducing a balloon-tipped pulmonary artery flotation catheter into the pulmonary artery. When the catheter is in one of the smaller pulmonary arteries, the inflated balloon occludes the artery allowing the monitor to record changes in the intrathoracic pressures that occur throughout the respiration cycle. The user can view the PAWP measurement result via connected Vista 120 CMS.

Measurement Procedures

Pulmonary Artery Wedge Pressure (PAWP) values are affected by fluid status, myocardial contractility, valve and pulmonary circulation integrity. The most accurate PAWP values are obtained at the end of the respiration cycle when the intrathoracic pressure is fairly constant. You can use the respiration waveform as a reference when assessing the PAWP waveform, to ensure constant measurement timing relative to the respiratory cycle.

To start the measurement:

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Monitoring IBP (optional)

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1 On the standard screen interface, select the PA parameter window to enter its setup menu. Then, select Setup > PAWP Activate to open the PAWP measurement window.

2 Prepare and check the accessories according to your hospital policy.

3 Wedge the flotation catheter into the pulmonary artery. Then inflate the balloon and pay attention to PA waveform changes on the screen.

4 After obtaining a stable PAWP waveform, press Freeze to freeze the waveform. In freeze status, you can adjust the PAWP scale to an appropriate position by selecting Measure and moving the cursors up and down according to the clinical experience. Select Confirm to store the PAWP, CVP, HR values. To review the frozen waveform, press s Browse and rotate the rotary knob clockwise or counter-clockwise as desired. If you need to review the stored PAWP, CVP, HR values, select PAWP Review.

5 Deflate the balloon when the monitor prompts you “Please deflate the balloon!”.

6 If you need to start a new measurement, select Remeasure.

7 Click on Exit or select Setup > PAWP Exit to exit.

WARNING Prolonged inflation can cause pulmonary hemorrhage, infarction or both. Inflate the balloon for the minimum time necessary to get an accurate measurement.

WARNING If the PAWP (mean) is greater than the PA (systolic), deflate the balloon and report the incident in accordance with hospital policy, because the pulmonary artery could be accidently ruptured, and the PAWP value derived will not reflect the patient’s hemodynamic state, but will merely reflect the pressure in the catheter or balloon.

WARNING The pressure receiver in the catheter records the pressure change that occurs only at the front of the obstruction.

WARNING Due to the short measurement delay, do not use sidestream CO2 as a direct reference to determine the end point of the breath in the pressure curve.

WARNING If the balloon is not inflated but the pulmonary artery floating catheter enters the wedge position, the pulmonary artery pressure waveform becomes wedge-shaped. Follow the standard steps to take appropriate action to correct this situation.

WARNING PAWP measurement is not applicable to pediatric and neonate patients.

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Monitoring IBP (optional)

Calculating PPV

Pulse Pressure Variation (PPV) is calculated from the specific arterial pressure values, which reflects the variation between the maximal pulse pressure and the minimum pulse pressure in 30 s. Pulse pressure is affected by left ventricular-stroke volume, arterial resistance and arterial compliance.

PPV is calculated according to the following equation:

PPV= (PPmax – PPmin)/(PPmax + PPmin)/2) * 100%

To select an arterial pressure as PPV source:

1 Click the PPV parameter area to enter PPV Setup menu.

2 Select Art, P1, P2, or AUTO as PPV Source.

Only when P1 and P2 are arterial pressure can they be selected as PPV source. When it is set to AUTO and if there is more than one arterial pressure at the same time, the priority level should be: Art > P1 > P2.

WARNING The clinical value of the derived PPV information must be determined by a physician. According to recent scientific literature, the PPV information is restricted to sedated patients who receive controlled mechanical ventilation and without arrhythmia. Whether the calculation results in other situations are clinically significant, applicable and reliable must be determined by a physician.

WARNING In below situations, the calculated PPV value may be inaccurate:

– the respiration rate is lower than 8 rpm

– the tidal volume during ventilation is lower than 8 ml/kg

– patients have acute right ventricular functional disorder (pulmonary heart disease)

WARNING PPV measurement has been validated only for adult patients.

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Monitoring CO2 (optional)

Monitoring CO2 (optional)

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160

CO2 safety information . . . . . . . . . . . . . . . . . 160

Monitoring procedures . . . . . . . . . . . . . . . . . 161Zeroing the sensor . . . . . . . . . . . . . . . . . . . . . . 161Sidestream CO2 Module. . . . . . . . . . . . . . . . . . 162Mainstream CO2 Module . . . . . . . . . . . . . . . . . 164

Setting CO2 waveform setup. . . . . . . . . . . . . 166

Setting CO2 corrections. . . . . . . . . . . . . . . . . 166

Setting Apnea Alarm Time. . . . . . . . . . . . . . . 167

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Monitoring CO2 (optional)

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Overview

The monitor provides the sidestream and mainstream methods for CO2 monitoring. Dräger G2 module and Respironics Sidestream CO2 module are used for sidestream measuring, and Respironics Mainstream CO2 module and Dräger Mainstream CO2 module M11.1 are used for mainstream measuring. Respironics CO2 module is plug-and-play and the monitor can automatically identify sidestream and mainstream modules.

The principle of CO2 measurement is primarily based on the fact that CO2 molecule can absorb 4.3 μm infrared ray. Absorption intensity is proportional to CO2 concentration of patient sample, the CO2

concentration will compute according to the detecting CO2 absorption intensity of patient sample.

Sidestream measurement takes a sample of the respiratory gas with a constant sample flow from the patient’s airway and analyzes it with a remote CO2 sensor. The user can measure Sidestream CO2 using the monitor’s built-in CO2 measurement. Respiration rate is calculated by measuring the time interval between detected breaths.

Mainstream measurement uses a CO2 sensor attached to an airway adapter directly inserted into the patient’s breathing system.

CO2 safety information

WARNING Do not use the device in the environment with flammable anesthetic gas.

WARNING The device should be used by trained and qualified medical personnel.

WARNING Nitrous oxide, elevated levels of oxygen, helium, xenon, halogenated hydrocarbons, and barometric pressure can influence the CO2 measurement.

WARNING The monitor will be damaged if any pipeline from the CO2 module’s air tube/the air inlet/the air outlet are plugged by water or other materials.

WARNING The accuracy of the CO2 measurement will be affected by the following reasons: the airway was highly obstructed; a leaky airway connection or quick variation of environment temperature.

WARNING Follow precautions for electrostatic discharge (ESD) and electromagnetic interference (EMI) to and from other equipment.

WARNING Do not place the sensor cables or tubing in a way that may cause tangling or strangulation.

WARNING When using mechanical ventilation, gas compensation should be well set. Inappropriate setting may cause incorrect measurement result.

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Monitoring CO2 (optional)

Monitoring procedures

Zeroing the sensor

For the Dräger G2 module:

Dräger G2 module itself has automatic zero function, only when the measurement is abnormal or measurement results are doubtful, the user can perform manual zero as following steps:

1 Wait until the monitor’s warm-up message disappears; keep the monitor away from CO2 source.

2 In the CO2 Setup menu, set Work Mode to Measure.

3 Select Zero Calibration in CO2 Setup menu.

WARNING Respironics module is not equipped with automatic air pressure compensation, before you start the CO2 measurement for the first time, you must set the correct altitude. Incorrect altitude settings can cause incorrect CO2 readings. Dräger G2 module is equipped with automatic air pressure compensation, and manual setting is not required.

WARNING Leakage in the respiratory system or sampling system may result in a significant low display of the etCO2 value. Always keep all components connected firmly and check for leaks according to standard clinical procedures.

WARNING The etCO2 reading is not always closely related to the paCO2 value, especially in neonatal patients, and patients with pulmonary disease, with pulmonary embolism or inappropriate ventilation.

WARNING Don’t measure CO2 while nebulized medications are being delivered.

WARNING The CO2 module temporally stops measuring during zeroing.

NOTE After the low battery alarm appears, do not start the CO2 measurement. The monitor may turn off from lack of battery power.

NOTE For disposal of hospital waste such as accumulated fluids, calibration gases, sampled gases, where not otherwise specified, follow local regulations regarding disposal of hospital waste.

NOTE If the measurement or sensor fails, stop measurement before the qualified service personnel solves the problem.

NOTE The cumulative use time for the sampling line in a single patient should be less than 30 days.

NOTE Disconnect the water trap from the holder or set Work Mode to Standby when the module is not in use. Setting path: CO2 Setup > Work Mode > Standby.

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4 After the zeroing calibration is completed, the zeroing message disappears, and the CO2 monitoring can be performed.

For the Respironics Sidestream CO2 Module:

1 Connect the sample line to the module correctly, wait until the monitor’s warm-up message disappears, keep the inlet of sample line away from CO2 source.

2 In the CO2 Setup menu, set Work Mode to Measure.

3 Select Zero Calibration in CO2 Setup menu.

4 After the zeroing calibration is completed, the zeroing message disappears, and the CO2 monitoring can be performed. If the monitor displays Breath Detected or Zero Required, zeroing has failed. Zero calibration must be performed again.

For the Respironics Mainstream CO2 Module:

1 Wait until the monitor’s warm-up message disappears; correctly install the mainstream CO2 sensor to airway adaptor and remove it from breathing circuit, keep the monitor away from CO2 source.

2 In the CO2 Setup menu, set Work Mode to Measure.

3 Select Zero Calibration in CO2 Setup menu.

4 After the zeroing calibration is completed, the zeroing message disappears, and the CO2 monitoring can be performed. If the monitor displays Breath Detected or Zero Required, zeroing has failed. Zero calibration must be performed again.

Sidestream CO2 Module

Measurement Steps

Dräger G2 Module

1 Fix the water trap to the water trap holder on the left side of the monitor, and confirm it is well fixed.

2 Connect the sampling cannula or the sampling line to the water trap.

3 Set Work Mode to Measure.

4 For intubated patients, an airway adapter is required. For non-intubated patients, place the nasal cannula or the sampling mask onto the patient.

NOTE CO2 source includes ventilator, patient’s and operator’s breath.

CAUTION The water trap collects water drops condensed in the sampling line and therefore prevents them from entering the module. If the water trap is nearly filled, the user should replace it to avoid blocking the airway.

CAUTION Based on a sample gas temperature of +37 °C (+98.6 °F), a room temperature of +23 °C (+73.4 °F) and sample relative humidity of 100%, the water trap will be filled after approximately 90 hours with the flowrate of 100 ml/min and approximately 130 hours with the flowrate of 70 ml/min. In clinical practice, the water trap can be used for a longer time before it is filled. It is recommended to replace the water trap once every month.

CAUTION When replacing the water trap or suspecting the measurement value, check if the O-rings of the water trap holder are normal and well installed. If the O-rings get damaged or loose, contact DrägerService.

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Monitoring CO2 (optional)

Respironics Sidestream Module

1 Plug the sensor cable into the monitor’s CO2 input connector. Allow the sensor two minutes for warm-up.

2 Appropriately connect the cannula, airway adapter or sample line to the sensor. It will click into place when seated correctly.

3 To zero the sensor, refer to zeroing the sensor.

4 For intubated patients, an airway adapter is required;

For non-intubated patients: Place the nasal cannula onto the patient.

CAUTION To prevent the module from abnormal work, please ensure the water trap detection button is not mistakenly touched.

CAUTION Replace and discard the water trap when blocking. Don’t reuse it, otherwise the reading is not accurate and even the device may be damaged.

NOTE To avoid patient cross infection, do not connect the exhaust tube to the ventilator circuit. If the sampled gas is returned to the breathing system, always use the bacterial filter of the sample gas return kit.

NOTE The user must perform a zero calibration as described in this procedure each time the ambient temperature changes more than 10 °C (50 °F) (for example during transport).

NOTE Always connect the airway adapter to the sensor before inserting the airway adapter into the breathing circuit. In reverse, always remove the airway adapter from the breathing circuit before removing the sensor.

NOTE Always disconnect the cannula, airway adapter or sample line from the sensor when the sensor is not in use.

NOTE To extend the lifetime of the module, set Work Mode to Standby when the module is not in use.

NOTE The sidestream CO2 module continuously extracts a quantity of gas from the patient's airway per minute. Please do not use this module in any patient who will be affected by this sampling rate.

NOTE If the catheter falls off during the measurement, it is necessary to re-zero after the catheter is well connected, and then measurement can be performed.

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Removing Exhaust Gases from the System

Use an exhaust tube to remove the sample gas to a scavenging system. Attach it to the sidestream sensor at the outlet connector.

Mainstream CO2 Module

Measurement steps

Respironics Mainstream CO2 Module

1 Attach the sensor connector to the CO2 connector on the monitor.

2 Wait two minutes, allowing the sensor to reach its operating temperature and a stable thermal condition.

3 Choose the appropriate airway adapter and connect it to the sensor head. The airway adapter clicks into place when seated correctly.

4 To zero the sensor, refer to zeroing the sensor;

5 Install the airway adapter at the proximal end of the circuit between the elbow and the ventilator Y-section.

WARNING Do not connect the exhaust tube to the ventilator circuit, connect the outlet to a scavenging system, cross infection can occur if sampling gas is returned to the breathing system. When using the sidestream CO2 measurement on patients who are receiving or have recently received anesthetics, avoid exposing medical staff to anesthetics.

NOTE The user must perform a zero calibration as described in this procedure each time a new airway adapter is used.

WARNING Accuracy is affected by temperature and barometric pressure.

WARNING No routine user calibration is required.

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Dräger MCable Mainstream CO2

Selecting the adapter type

The following airway adapters can be used:

- Reusable adapters

- Disposable adapters

To change the adapter type, select CO2 Setup > Other Setups > Adapter Type, and set Adapter Type to Reusable or Disposable based on the adapter used. If the selected adapter type does not correspond to the adapter used, the prompt information Ensure the adapter type is fit is displayed.

To start CO2 measurement,

1 Attach the sensor connector to the CO2 connector on the monitor.

2 Wait two minutes, allowing the sensor to reach its operating temperature and a stable thermal condition.

3 Choose the appropriate airway adapter and connect it to the sensor head. The airway adapter clicks into place when seated correctly.

NOTE If the catheter falls off during the measurement, it is necessary to re-zero after the catheter is well connected, and then measurement can be performed.

NOTE Replace the airway adapter if excessive moisture or secretions are observed in the tubing or if the CO2 waveform changes unexpectedly without a change in patient status.

NOTE To avoid cross infection, use only sterilized, disinfected, or disposable airway adapters.

NOTE Inspect the airway adapters prior to use. Do not use if airway adapter appears to have been damaged or broken. Observe airway adapter color coding for patient population.

NOTE Periodically check the flow sensor and tubing for excessive moisture or secretion buildup.

NOTE Always connect the airway adapter to the sensor before inserting the airway adapter into the breathing circuit. In reverse, always remove the airway adapter from the breathing circuit before removing the sensor.

NOTE To avoid dead space, place the sensor as close to the patient as possible.

CAUTION Make sure that used type of airway adapter (reusable or disposable) is correctly selected.

CAUTION Prior to use check sensor housing and airway adapter for mechanical integrity.

CAUTION Since zero has proven rather stable so far, it may be checked on other occasion if checking is inconvenient right at the beginning of use. However is it recommended to check zero regularly.

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4 To zero the sensor, refer to zeroing the sensor. Zeroing must be done without any airway adapter in room air.

5 Insert the airway adapter with vertically positioned windows between endotracheal tube and ventilator circuit (Y-piece).

Checking the calibration of the CO2 sensor with a test filter

Perform the calibration check of the CO2 sensor with a test filter at intervals of one month.

Setting CO2 waveform setup

Open the menu CO2 Waveform Setup by clicking on the CO2 waveform area:

1 Set Mode to Curve or Filled as desired.

2 Set Sweep to an appropriate value from the pop-up list. The larger the value, the faster the speed.

Setting CO2 corrections

Temperature, water vapor in the patient’s breath, barometric pressure, and the proportions of O2, N2O and Helium in the mixture all influence CO2 absorption. If values seem inaccurately high or low, check that the monitor is using the appropriate corrections.

For Dräger G2 module, the following items are available in the CO2 Other Setup menu: N2O Compen., O2 Compens., Anest. Agent, Vapor Compen. and Pump Rate. The concentration of compensated gas should be set based on the current gas concentration which is supplied for patient. As for O2 and N2O, Make the supplied gas concentration multiply to its volume to get the concentration. For instance, supply 100% O2, and its volume is 60%, then O2 compensation is: 100%*60%=60%. AG concentration is decided by anaesthesia apparatus.

For the Respironics CO2 modules, there are Baro Press, O2 Compens, Anes Agent and Balance Gas in the CO2 Other Setup menu. For Dräger MCable Mainstream CO2 module, there are Baro Press, O2 Compens., N2O Compen., He Compens. and Xe Compens. in the CO2 Other Setup menu.The concentration of compensated gas (including O2 and AG) should be set based on the current gas concentration which is supplied for patient. The selection of balance gas depends on actual situation. For instance, N2O should be selected as balance gas if the real balance gas is N2O.

After settings, the interface will display a dialog box: Confirm to change the settings? And the detailed settings are displayed under the warning. Click Yes to confirm, and click No to cancel the settings.

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Monitoring CO2 (optional)

Setting Apnea Alarm Time

This determines the time when the monitor gives an alarm if the patient stops breathing.

1 Select the CO2 Setup menu.

2 Select Apnea Alm.

3 Choose the apnea alarm time from the pop-up list.

NOTE Make sure compensation value is correctly set, otherwise the measurement accuracy may be affected.

WARNING Safety and effectiveness of the respiration measurement method in the detection of apnea, particularly the apnea of prematurity and apnea of infancy, has not been established.

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Monitoring C.O. (optional)

Monitoring C.O. (optional)

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170

C.O. Safety Information . . . . . . . . . . . . . . . . . 170

C.O. Monitoring. . . . . . . . . . . . . . . . . . . . . . . . 171Preparing Measurement . . . . . . . . . . . . . . . . . . 171

Performing C.O. Measurement . . . . . . . . . . . 172

Blood Temperature Monitoring . . . . . . . . . . . 174

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Overview

The cardiac output (C.O.) measurement invasively measures cardiac output and other hemodynamic parameters by using the Thermodilution method. The Thermodilution method is to inject a cold solution into the blood circulation system and measure the temperature changes caused by the cold solution through the thermistor of the

pulmonary artery floating catheter, and the C.O. value is calculated by using the temperature dilution curve.

As C.O. is a variable value, a series of measurements must be carried out to obtain a reliable and average C.O. value. Always use the average of multiple measurements for thereapy decisions. The monitor can save a maximum of 6 measurement results.

C.O. Safety Information

WARNING Make sure that the C.O. accessories conform with the applicable medical device safety requirements and regulations and are applied in correspondence with the C.O. accessories' instructions for use.

WARNING C.O. accessories should be avoided from contact with conductive metal body when being connected or applied.

WARNING All invasive procedures involve risks to the patient. Use aseptic technique and follow catheter manufacturer's instructions.

WARNING The C.O. measurement results may be incorrect during electrosurgery.

WARNING C.O. floating catheter shall be removed or reinserted after 3 days.

NOTE To replace the catheter thermistor, enter the catheter computation coefficient into the Constant item according to the instruction.

NOTE Please set injection switch well. The calculation of the cardiac output is based on the state of the injection switch at the end of the measurement. Therefore, after the selection of the injection switch is completed, don’t change until the measurement is completed.

NOTE Start C.O. measurement after blood temperature is stable, otherwise the measurement may fail.

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C.O. Monitoring

Preparing Measurement

1 Plug the C.O. interface cable into the C.O. socket and turn on the monitor.

2 Attach the injective probe connector and catheter thermistor connector to the appropriate parts of the cardiac output interface cable.

1 Monitor

2 Thermodilution Catheter

3 Cardiac Output Cable

4 Injectate Sensor Housing

5 Injectate

6 Delivery System

7 In-line injectate Temperature probe

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3 Open the patient information window to confirm the patients’ height and weight.

4 In C.O. Setup menu, set:

C.O. Constant: The computation constant is associated with catheter and injectate volume. When the catheter is changed, adjust Constant in the C.O. Setup menu based on product description provided by the manufacturer. After user’s confirmation, the setup takes effect.

INJ. TEMP Source: Select Auto or Manual from the list, when set as Manual, the system directly displays the injectate temperature from INJ. TEMP. Ensure INJ. TEMP is correct, otherwise the C.O. measurement may be affected. When set as Auto, the system obtains the injectate temperature through sampling.

Performing C.O. Measurement

1 Pick the C.O. Measure item in the C.O. Option menu. The C.O. Measure menu displays as below:

The functional keys on the C.O. measure window are explained in the following table:1 Measurement curve

2 Prompt message area3 Cardiac Output4 Cardiac Index5 Body Surface Area6 Blood Temperature7 Injectate Temperature8 Start time of the measurement9 Function keys

1

2

345678

91110

10 X axis: Change the Scale X (time) value. Two modes are available: 0 s to 30 s, 0 s to 60 s. If you start measurement in the 0 s to 30 s mode, it will be switched to 0 s to 60 s mode automatically if the measurement can not finish within 30 s. After the switch, no further adjustment can be made to the Scale X.

11 Y axis: Change the scale Y (temperature) value. Three modes are available: 0 °C (+32 °F) to +0.5 °C (+32.9 °F), 0 °C (+32 °F) to +1 °C (+33.8 °F), 0 °C (+32 °F) to +2.0 °C (+35.6 °F). Adjust the scale by the temperature differences. A smaller scale results in a larger curve.

Start Start a measurement.Stop If the blood temperature cannot

resume in a considerably long time, the measurement could not stop automatically. Use this button to stop the measurement and display the C.O., CI calculation result.

Cancel Cancel the processing measurement or cancel the result after measurement.

Record Print out the curve.Review Enter the Review window.

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Monitoring C.O. (optional)

2 Measurement should be taken when the message "Ready for new measurement" appears on the screen. Press the Start button, and then start injection. The thermodilution curve, current blood temperature and the injective temperature are displayed during the measurement. Curve drawing will stop automatically when the measurement finishes, and the C.O. and CI (3 and 4 in the above figure) will be calculated and displayed on the screen. The monitor will display C.O. in the parameter area and the start measurement time (8 in the above figure).

To ensure the accuracy of the measurement, it is suggested that a reasonable interval should take place between two consecutive measurements. The length of the interval can be set in the C.O. Setup menu (Time unit: second). The interval time counter is displayed on the screen. The next measurement cannot be performed until the time reduces to zero and a message Ready for new measurement appears. The adjustable range of Interval is: 5 to 300 s.

Repeat this procedure until the measurements are completed as desired.

A maximum of six measurements can be saved. If the user performs additional measurements, the earliest measurement will be automatically deleted when a seventh curve is saved.

In C.O. review window, select required curves from the 6 measurement curves, and the monitor will automatically calculate and respectively display the average values of C.O. and CI as following:

Contents displayed in the window:

1

2 3

1 Six curves of the six measurements and C.O. value

2 Average value of C.O.3 Average value of CI

WARNING Make sure that the computational constant for the measurement is appropriate to the catheter used.

WARNING Before a C.O. measurement is initiated, check the accuracy of patient setup. The calculation of C.O. is related to the patient height, weight, and catheter computation coefficient; therefore, incorrect input will lead to error in calculation.

NOTE The blood temperature alarm will not function during C.O. measurement. It will resume automatically when the measurement is over.

NOTE It is strongly recommended that the user must push the injector within four seconds after pressing the Start button.

NOTE It is strongly recommended that wait at least 1 minute (or longer depending on the patient’s clinical condition) before starting the next measurement.

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Blood Temperature Monitoring

Blood temperature monitoring can function when C.O. measurement is not taken. The blood temperature is measured by the thermistor situated in the distal end of the flotation catheter in the pulmonary artery.

The blood temperature alarm function will not work during the C.O. measurement. When the measurement ends, the function will automatically resume.

The current blood temperature is displayed in the C.O. parameter area.

Flotation catheter

Right atrium

Right ventricle

Pulmonary artery

Air cell

Thermal resistance

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Gas monitoring (optional)

Gas monitoring (optional)

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176

Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . 176

Getting started . . . . . . . . . . . . . . . . . . . . . . . . 176Switch on the gas analyzer. . . . . . . . . . . . . . . . 176

Operation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177Safety information. . . . . . . . . . . . . . . . . . . . . . . 177Multigas monitoring setup. . . . . . . . . . . . . . . . . 178

Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . 186

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Overview

Refer to the general precautions section for etCO2 and to the safety considerations section for safe device operation.

Intended use

The Scio Four module samples gas from the breathing gas of pediatric patients and adults. It continuously measures the concentration of CO2, N2O, and anesthetic agents (Halothane, Isoflurane, Enflurane, Sevoflurane, and Desflurane) in the breathing gas as well as the O2 concentration (optional). All measured values as well as derived values are communicated to a patient monitor.

Getting started

Switch on the gas analyzer

To prevent condensation and resulting failure of electrical components, do not switch on the device after abrupt temperature changes for 1 to 2 hours (e.g., after storage in unheated rooms).

1 Connect the mains plug if necessary and set the device switch on the back to the ON position.

2 Check the external power indicator on the front of the gas analyzer.

WARNING Risk of delayed essential therapy changes.

Dräger recommends the user to remain in the vicinity of the patient monitor, i.e. within a distance of up to 4 meters (12 feet). This facilitates fast recognition and response in the event of an alarm.

NOTE The Scio Four modules are hereafter referred to as “gas analyzer”.

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Gas monitoring (optional)

Upon start-up, the gas analyzer passes through an initialization (status message MultiGas Initialization appears) and warm-up period (status message MultiGas Warming Up appears). During this time, concentrations for certain gases may no be available and the anesthetic agent may not be identified. After the warm-up period, the gas analyzer will have achieved full ISO-accuracy.

Operation

Safety information

WARNING Risk of inaccurate gas measurement values.

During warm-up, reported values may not be accurate. Refer to the Technical Data appendix in the gas analyzer supplement for further information regarding gas analyzer accuracy.

WARNING Risk due to defective sensors.

If the gas sensors are not ready for operation, the patient will not be adequately monitored.

Before using the medical device, ensure a suitable substitute monitoring.

WARNING Risk of inaccurate gas measurement values.

When the monitor is used with a gas analyzer, it meets the Class A limits of CISPR11. The system is not intended for connection to public mains due to possible line-conducted disturbances.

WARNING Risk of patient injury

The multigas information displayed is intended to be used by trained and authorized health care professionals only.

WARNING Risk of misinterpretation

Misdiagnosis or misinterpretation of the measured values or other parameters can endanger the patient.

Do not make therapeutic decisions based solely on individual measured values and monitoring parameters. Therapeutic decisions must be made solely by qualified users.

WARNING Risk due to incorrect settings

For patient monitors within the same care area, different standard alarm limits or therapy settings might be configured. The user must observe the following:

– Ensure that the values set for new patients are appropriate.

– Ensure that the alarm system is neither rendered useless by setting extreme values for the alarm limits nor deactivated by switching off the alarms.

WARNING Risk of inaccurate gas measurement

When using three anesthetic agents the oxygen measurement may be inaccurate.

Only use two agents at a time.

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Multigas monitoring setup

The gas analyzer parameters are displayed in the CO2 (AG), O2 (in some models only), N2O and anesthetic agent parameter boxes. Each has its own setup menu, described on the following pages.

Monitoring of CO2 (AG)

The CO2 (AG) waveform indicates the instantaneous CO2 concentration. The CO2 (AG) parameter box displays the following parameters:

Inspired CO2 (FiCO2) - The level of CO2 in the airway during the inspiration phase.

End-tidal CO2 (etCO2) - The level of CO2 in the airway at the end of expiration phase.

Respiration Rate (AwRR) - The patient's respiration rate, derived from the etCO2* signal by calculating an average rate over the two most recent breaths.

The gas analyzer automatically serves as the etCO2 source, regardless of previous source selections. The source selection item on the etCO2 Setup menu is only displayed in the OR mode.

Typical CO2 (AG) parameter box displays are shown below

To access the CO2 (AG) setup menu, click on the CO2 (AG) parameter box.

To execute CO2 (AG) setup functions, click on the following items:

WARNING Risk of inaccurate gas measurement waveforms

Under extreme monitoring conditions (and if network functionality is in use), intermittent spikes may be present on the gas analyzer waveform display. Parameter box data is not affected.

NOTE For disposal of hospital waste such as accumulated fluids, calibration gases, sampled gases, where not otherwise specified, follow local regulations regarding disposal of hospital waste.

NOTE If O2 is detected from the connected SCIO module, the monitor will turn off the O2 measurement function on the Fabius and Atlan series anesthetic machines. Otherwise, the monitor will retain the O2 measurement on the anesthetic machine if applicable.

NOTE Disconnect the water trap from the holder or set Work Mode to Standby when the module is not in use. Setting path: AG Setup > Work Mode > Standby.

NOTE If alarms are disabled, crossed-out bell icons appear next to the corresponding parameter values.

The monitor does not alarm for CO2 (AG) limit violations until it has established a valid respiratory rate.

CO2 (AG) Setup menu

Menu item Description Settings

Work Mode Sets the Scio status to Measure or Standby Measure, Standby

Unit Sets the units for the concentration %, mmHg, kPa

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Gas monitoring (optional)

To access the CO2 (AG) waveform setup menu, click on the CO2 (AG) waveform area.

To execute CO2 (AG) waveform setup functions, click on the following items:

Monitoring of O2

The O2 waveform indicates the instantaneous O2 concentrations. The O2 parameter box displays the following parameters:

Inspired O2 (FiO2) - The level of O2 in the airway during the inspiration phase.

Expired O2 (EtO2) - The level of O2 in the airway during the expiration phase.

Typical O2 parameter box displays are shown below

Apnea Alarm Sets the time that the monitor waits before reporting a cessation of breathing as an apnea event

20s, 25s, 30s, 35s, 40s

Zero Calibration Manually zeroes the Scio module Not applicable

etCO2 Alarm Setup Sets the Alarm switch, Record switch, Level, and Alarm limits

Alarm switch: ON, OFF Record switch: ON, OFF Level: High, Med., Low Alarm limits: digitals

FiCO2 Alarm Setup

AwRR Alarm Setup

Default Restores all menu setup to factory default Not applicable

CO2 (AG) Setup menu

Menu item Description Settings

The CO2 (AG) waveform Setup menu

Menu item Description Settings

Mode Sets the waveform drawing mode Curve, filled

AMP Sets the waveform scale 1, 2, 3, 4, 5

Sweep (mm/s) Sets the waveform sweep speed on screen display

6.25, 12.5, 25.0, 50.0

Change Changes the current channel to another waveform

All the available waveforms

CO2 (AG) setup Links to the CO2 (AG) setup menu Not applicable

NOTE The O2 monitoring function is only available with Scio Four Oxi and Scio Four Oxi plus.

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To access the O2 setup menu, click on the O2 parameter box.

To execute O2 setup functions, click on the following items:

NOTE The monitor does not alarm for inspiratory and expiratory oxygen limit violations until it has established a valid respiratory rate.

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Gas monitoring (optional)

To access the O2 waveform setup menu, click on the O2 waveform area.

To execute O2 waveform setup functions, click on the following items:

Monitoring of N2O

The N2O waveform indicates the instantaneous N2O concentrations. The N2O parameter box displays the following parameters:

Inspired N2O (FiN2O) - The level of N2O in the airway during the inspiration phase.

Expired N2O (etN2O) - The level of N2O in the airway during the expiration phase.

Typical N2O parameter box displays are shown below

To access the N2O setup menu, click on the N2O parameter box.

O2 Setup menu

Menu item Description Settings

Work Mode Sets the Scio status to Measure or Standby Measure, Standby

Unit Sets the units for the concentration %, mmHg, kPa

Zero Calibration Manually zeroes the Scio module Not applicable

EtO2 Alarm setup Sets the Alarm switch, Record switch, Level, and Alarm limits

Alarm switch: ON, OFF

Record switch: ON, OFF

Level: High, Med., Low

Alarm limits: digitals

FiO2 Alarm Setup

Default Restores all menu setup to factory default Not applicable

The O2 waveform Setup menu

Menu item Description Settings

AMP Sets the waveform scale 1, 2, 3, 4, 5

Sweep (mm/s) Sets the waveform sweep speed on screen display

6.25, 12.5, 25.0, 50.0

Change Changes the current channel to another waveform

All the available waveforms

O2 setup Links to the O2 setup menu Not applicable

NOTE The monitor does not alarm for inspiratory and expiratory N2O limit violations until it has established a valid respiratory rate.

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To execute N2O setup functions, click on the following items:

To access the N2O waveform setup menu, click on the N2O waveform area.

To execute N2O waveform setup functions, click on the following items:

Monitoring of anesthetic agents

The agent waveform indicates the instantaneous agent concentrations. The agent parameter box displays the following parameters:

Inspired agent (e.g., FiHAL) - The level of anesthetic agent in the airway during the inspiration phase.

Expired agent (e.g., etHAL) - The level of anesthetic agent in the airway during the expiration phase.

The agent waveforms and parameters can be identified by color as follows:

Halothane = red

Desflurane = light blue

Enflurane = orange

Sevoflurane = yellow

Isoflurane = purple

The appearance of the agent parameter box varies depending on the number of identified agents. Typical agent parameter box displays are shown below

N2O Setup menu

Menu item Description Settings

Work Mode Sets the Scio status to Measure or Standby Measure, Standby

Unit Sets the units for the concentration %, mmHg, kPa

Zero Calibration Manually zeroes the Scio module Not applicable

EtN2O Alarm setup Sets the Alarm switch, Record switch, Level, and Alarm limits

Alarm switch: ON, OFF Record switch: ON, OFF Level: High, Med., Low Alarm limits: digitals

FiN2O Alarm Setup

Default Restores all menu setup to factory default Not applicable

The N2O waveform Setup menu

Menu item Description Settings

AMP Sets the waveform scale 1, 2, 3, 4, 5

Sweep (mm/s) Sets the waveform sweep speed on screen display

6.25, 12.5, 25.0, 50.0

Change Changes the current channel to another waveform

All the available waveforms

N2O setup Links to the N2O setup menu Not applicable

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Gas monitoring (optional)

To access the anesthetic agent setup menu, click on the agent parameter box (if displayed).

To execute anesthetic agent setup functions, click on the following items:

To access the anesthetic agent waveform setup menu, click on the anesthetic agent waveform area.To execute the anesthetic agent waveform setup functions, click on the following items:

NOTE If two agents are detected, the one with the higher expired MAC value is regarded as the primary agent.

The monitor does not alarm for Inspiratory and expiratory agent limit violations until it has established a valid respiratory rate.

Anesthetic agent (AA) Setup menu

Menu item Description Settings

Work Mode Sets the Scio status to Measure or Standby Measure, Standby

Agent Configures Scio module to identify Agent ID automatically or use a user-specified agent ID

Auto, HAL, ISO, ENF, SEV, DES

Mac Setup Sets the MAC calculate method None, Standard, Age-based

Zero Calibration Manually zeroes the Scio module Not applicable

EtAA Alarm setup Sets the Alarm switch, Record switch, Level, and Alarm limits

Alarm switch: ON, OFF Record switch: ON, OFF Level: High, Med., Low Alarm limits: digitals

FiAA Alarm Setup

Default Restores all menu setup to factory default Not applicable

Anesthetic agent (AA) waveform Setup menu

Menu item Description Settings

AMP Sets the waveform scale 1, 2, 3, 4, 5

Sweep (mm/s) Sets the waveform sweep speed on screen display 6.25, 12.5, 25.0, 50.0

Change Changes the current channel to another waveform All the available waveforms

AA setup Links to the AA setup menu Not applicable

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Manual agent ID

If no anesthetic agent has been selected or the gas analyzer is not in operation, the message AA is displayed in the parameter box.

To set the agent ID:

1 Click on the agent parameter box (if displayed)

2 Click on the drop-down list of Agent

3 Click and select the desired agent ID.

Automatic agent ID

These gas analyzers are able to automatically identify up to two anesthetic agents, even in mixtures. Then the specific agent (e.g. HAL) will be show in the parameter box.

If the gas analyzer has not yet identified or cannot identify an agent (e.g. due to too low agent concentrations, a leaking vaporizer, or traces of disinfectants), the agent parameter box displays the message AA or AA1.

Mixed agent

When the gas analyzer detects a mix of two or more anesthetic agents, the displayed agent waveform reflects the agent with the highest level of concentration.

The color of the waveform represents the agent with the highest level of concentration. If there is a change of the anesthetic agent during monitoring, the parameter box displays the message AG Agent Mixture and replaces the concentration values with -?-. The mixed label in waveform area indicates only the agent that has the highest level of concentration. This label will switch to that of the second administered agent when its concentration exceeds that of the first agent.

Standard MAC values

The minimum alveolar concentration (MAC) value of the agent is a simple navigation aid for anesthetic agent delivery.

1 standard MAC is equal to the alveolar anesthetic concentration at one atmosphere (760 mmHg) at which 50 % of all patients no longer respond to noxious stimuli. The integrated MAC algorithm is based on the MAC values shown in the following table. The values specified in the table apply to a

NOTE The manual agent ID setup is only relevant for gas analyzers without automatic agent recognition - Scio Four and Scio Four Oxi.

WARNING Risk due to inaccurate gas measurement values

Use care when setting agent ID manually. Measurements will be inaccurate if the wrong agent ID is selected.

WARNING Risk due to inaccurate gas measurement values

Measurements using a gas analyzer without automatic agent recognition will be inaccurate if anesthetic gases are mixed.

NOTE The agent ID resets to blank upon a power cycle or patient discharge.

NOTE The automatic agent ID setup is only relevant for gas analyzers with automatic agent recognition - Scio Four plus and Scio Four Oxi plus.

NOTE The measurement of mixed agent is only relevant for gas analyzers with automatic agent recognition - Scio Four plus and Scio Four Oxi plus.

NOTE When the gas analyzer is connected to the monitor, users need to access the MAC Setup menu to determine if Standard MAC, Age-based MAC or no MAC is displayed.

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Gas monitoring (optional)

patient age of 40 years and are guiding values only. The binding values are specified on the package information leaflet of the anesthetic agent.

Once the monitor has detected an agent, the parameter box shows a MAC value.

For gas mixtures, the respective multiples for N2O and anesthetic agents are added according to the following equation.

Age-corrected MAC values

The age-corrected MAC values are calculated using an equation developed by W.W. Mapleson (British Journal of Anaesthesia 1996, pp. 179-185). The equation applies to patients older than 1 year.

For gas mixtures, the respective multiples for N2O and anesthetic agents are added according to the following equation.

Once the monitor has detected an agent, the parameter box shows a MAC value.

1 MAC corresponds to: (in 100 % O2)

Halothane 0.77 Vol%

Enflurane 1.7 Vol%

Isoflurane 1.15 Vol%

Desflurane 6.65 Vol%

Sevoflurane 2.10 Vol%

N2O 105 Vol%

NOTE Age and other factors are not taken into account for standard MAC value calculation.

NOTE When the gas analyzer is connected to the monitor, users need to access MAC Setup menu to determine if Standard MAC, Age-based MAC or no MAC is displayed.

CAUTION Risk due to incorrect setting for patient age

The patient's age is derived from the birth date entered in the Patient Admit menu. Incorrect settings can lead to inappropriate MAC values and therefore to inappropriate anesthetic gas delivery.

Always set patient age correctly.

CAUTION Age-based MAC values only apply if the patient’s age is ≥ 1 year. An aged-based MAC of 1 year is used if the patient’s age is < 1 year.

CAUTION If patient age is not entered, the default age-based MAC of 40 years is used.

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Zeroing

The gas analyzer purges and zeroes itself and does not need any interaction by the user. Waveforms flatline and parameter box values blank from the screen during this cycle. Status messages are as follows:

For further technical details on the zeroing process refer to the gas analyzer's supplement.

Troubleshooting

Alarm - Cause - Remedy

Alarm messages are displayed in hierarchal form in the alarm message field of the header bar.

The priority of the alarm messages is indicated by different background colors.

Warning = High-priority alarm message (red)

Caution = Medium-priority alarm message (yellow)

Advisory= Low-priority alarm message (blue)

The following table lists the alarm messages in alphabetical order. If an alarm occurs, the table helps to quickly identify causes and remedies. The possible causes and remedial measures should be looked through in the order they are listed until the alarm is resolved.

AG Zero In Progress appears The zeroing cycle is in progress.

AG Zero In Progress disappears The zeroing cycle was successful.

AG Zero In Progress keeps displayed in the display

The zeroing cycle failed and restarted automatically. Causes might be occlusions or leaks, polluted ambient air, hardware or communication problems.

WARNING Risk due to inaccurate gas measurement values

Delaying zeroing may compromise the accuracy of gas values.

CAUTION Risk due to gas measurement failure

If gas measurement fails, the patient can no longer be adequately monitored.– Ensure corresponding substitute monitoring.– Check sample line and water trap for damage

or blockage and resolve these as needed.– Observe the prescribed exchange intervals.

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Alarm priority Alarm Cause Remedy

Configurable FiCO2 Too High Soda lime is depleted Check soda lime

Increase fresh-gas flow

Check fresh-gas settings

Exchange soda lime

Leakage in breathing system Exchange breathing system

Gas measurement is inaccurate due to high respiratory rate

Adjust alarm limits if necessary

Large dead space Check ventilation settings

Configurable etCO2 Too High End-tidal CO2 concentration has exceeded the upper alarm limit

Check ventilation

Configurable etCO2 Too Low End-tidal CO2 concentration has fallen below the lower alarm limit

Check ventilation

Configurable AwRR Too High The patient is breathing at a high respiratory rate

Check patient condition

Check ventilation settings or spontaneous respiratory rate

AwRR has exceeded the upper alarm limit

Check ventilation settings

Configurable AwRR Too Low AwRR has fallen below the lower alarm limit

Check patient condition and ventilation settings

High AG APNEA No breathing or ventilation Start manual ventilation!

Check ventilation settings

Check spontaneous breathing ability of the patient

Sample line is not connected Connect sample line to breathing circuit or gas analyzer

Configurable FiO2 Too High Inspiratory O2 concentration has exceeded the upper alarm limit

Check O2 concentration and fresh-gas settings

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Configurable FiO2 Too Low Inspiratory O2 concentration has fallen below the lower alarm limit

Check O2 concentration and fresh-gas settings

Check breathing system for large leaks

Check O2 supply

Configurable FiHAL Too High FiISO Too High FiENF Too High FiSEV Too High FiDES Too High

Inspiratory anesthetic gas concentration has exceeded the upper alarm limit

Check vaporizer and fresh-gas settings

Configurable FiHAL Too Low FiISO Too Low FiENF Too Low FiSEV Too Low FiDES Too Low

Inspiratory anesthetic gas concentration has fallen below the lower alarm limit

Check vaporizer and fresh-gas settings

Check breathing system for large leaks

Soda lime is dried out Exchange soda lime

Configurable EtHAL Too High EtISO Too High EtENF Too High EtSEV Too High EtDES Too High

Expiratory anesthetic gas concentration has exceeded the upper alarm limit

Check vaporizer and fresh-gas settings

Configurable EtHAL Too Low EtISO Too Low EtENF Too Low EtSEV Too Low EtDES Too Low

Expiratory anesthetic gas concentration has fallen below the lower alarm limit

Check vaporizer and fresh-gas settings

Check breathing system for large leaks

Soda lime is dried out Exchange soda lime

High CO2 Out Of Range O2 Out Of Range N2O Out Of Range AA Out Of Range

The inspired concentration of the parameter is outside the monitor’s measuring range

Check the patient and treat, if necessary

High AG Occlusion Sample line, water trap or patient-side filter is occluded

Check sample line and patient-side filter

Water trap is defective or full. Check water trap.

Low Check Watertrap/Sample Line

Sample line is blocked or not connected

Check sample line

Water trap is full or not installed Check water trap

Alarm priority Alarm Cause Remedy

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High AG Comm Fail Gas analyzer has become disconnected

Check cable connections

If the problem persists, call DrägerService

High AG Hardware Error Loss of communication Check cable connections

Unplug and re-plug the gas analyzer

If the problem persists, call DrägerService

Failure of the entire gas analyzer

Call DrägerService

Alarm priority Alarm Cause Remedy

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Monitoring BIS (optional)

Monitoring BIS (optional)

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192

BIS safety information . . . . . . . . . . . . . . . . . . 193

BIS monitoring setup . . . . . . . . . . . . . . . . . . . 195

BIS continuous impedance check . . . . . . . . 195

BIS sensor check . . . . . . . . . . . . . . . . . . . . . . 196Starting a sensor check . . . . . . . . . . . . . . . . . . 196Stopping a sensor check . . . . . . . . . . . . . . . . . 196

BIS sensor window. . . . . . . . . . . . . . . . . . . . . 196BIS Impedance Indicators . . . . . . . . . . . . . . . . 197

Changing the BIS smoothing rate. . . . . . . . . 197

Switching secondary parameters on and off . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197

Changing the scale of the EEG wave . . . . . . 198

Setting the trend length . . . . . . . . . . . . . . . . . 198

Switching BIS filters on or off . . . . . . . . . . . . 198

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Overview

Bispectral Index monitoring helps to monitor the hypnotic state of the brain based on acquisition and processing of EEG signals. The monitor processes raw EEG signals to produce a single number, namely BIS, which correlates with the patient's level of hypnosis. The user can view the BIS measurement result via connected CMS.

The BISx device provides the monitor with the display consisting of:

BIS EEG waveform

BIS trend

Measure values of BIS, SQI, SR, SEF, TP and BC

– BIS: The BIS numeric reflects the patient’s level of consciousness. It ranges from 100 (fully awake) to 0 (absence of electrical brain activity). The BIS range guidelines are illustrated in the following chart.

– SQI: The SQI numeric reflects the signal quality for the EEG channel source and provides information about the reliability of the BIS, SR, SEF, TP and BC numerics during the last minute. It ranges from 0% to 100%:

0% to15%: the numerics cannot be derived.

15% to 50%: the numerics cannot be reliably derived.

50% to 100%: the numerics are reliable.

– SR: The SR is the percentage of time over the last 63-second period that the signal is considered to be in the suppressed state.

– SEF: The SEF is a frequency below which 95% of the total power is measured.

– TP: The TP numeric indicates the power in the frequency band 0.5 Hz to 30 Hz. The useful range is 40 dB to 100 dB.

– BC: (BISx device used with Extend Sensor only) The BC numeric helps to quantify suppression, reported as the number of EEG bursts per minute, where an EEG burst is defined as a period of activity followed and preceded by inactivity (at least 0.5 s). The BC numeric is valid when SQI ≥ 15% and SR ≥ 5%.

BIS Range and Clinical State

BIS

Inde

x R

ange

100 Awake Responds to normal voice

80 Light/ Moderate Sedation May respond to loud commands or

mild prodding/shaking

60 General Anesthesia Low probability of explicit recall

Unresponsive to verbal stimulus

40 Deep Hypnotic State

20 Burst Suppression

0 Flat Line EEG

Note: This chart reflects a general association between clinical state and BIS values. Ranges are based on results from a multi-center study of the BIS involving the administration of specific anesthetic agents. BIS values and ranges assume that the EEG is free of artifacts that can affect its performance. Titration of anesthetics to BIS range should be dependent upon the individual goals established for each patient. These goals and associated BIS ranges may vary over time and in the context of patient status and treatment plan.

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Monitoring BIS (optional)

EMG bar graph: The EMG bar graph displays the power (in decibels) in the frequency range 70 Hz -110 Hz. This frequency range contains power from muscle activity (i.e., electromyography or “EMG”) as well as power from other high-frequency artifacts. When the indicator is low, it indicates that EMG activity is low. BIS monitoring conditions are optimal when the bar is empty.

No bar represents power less than 30.

1 bar represents power in the 30-38 range.

2 bars represent power in the 39-47 range.

3 bars represent power in the 48-55 range.

4 bars represent power greater than 55.

BIS safety information

WARNING Explosion hazard: Do not use the BISx device in a flammable atmosphere or where concentrations of flammable anesthetics may occur.

WARNING The BISx device is not designed for use in MRI environment.

WARNING The use of accessory equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include: use of the accessory in the patient vicinity; evidence that the safety certification of the accessory has been performed in accordance to the appropriate IEC 60601-1 harmonized national standard.

WARNING Due to elevated surface temperature, do not place the BISx device in prolonged direct contact with patient’s skin, as it may cause discomfort.

WARNING To reduce the hazard of burns during use of high- frequency surgical equipment, the sensor or electrodes should not be located between the surgical site and the electro-surgical unit return electrode.

WARNING The conductive parts of electrodes or sensor and connectors should not contact other conductive parts, including earth.

WARNING To reduce the hazard of burns during use of brain-stimulating devices (e.g., transcranial electrical motor evoked potential), place stimulating electrodes as far as possible from the BIS sensor and make certain that sensor is placed according to package instructions.

WARNING The sensor must not be located between defibrillator pads when a defibrillator is used on a patient connected to the BISx device.

WARNING To minimize the risk of patient strangulation, the patient interface cable (PIC) must be carefully placed and secured.

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WARNING Universal precautions shall be observed to prevent contact with blood or other potentially infectious materials. Place contaminated materials in regulated waste container.

WARNING Whenever an event such as spillage of blood or solutions occurs, re-test ground leakage current before further use.

WARNING Do not reuse the BIS sensor.

CAUTION Do not autoclave the BISx device. Autoclaving will seriously damage the components.

CAUTION Do not open the BISx device for any reason.

CAUTION The BISx device has been designed to operate with a BIS sensor. The sensor is a silver/silver chloride electrode array that utilizes Aspect's patented Zipprep™ technology and uses a proprietary connector. Use of other electrodes is not recommended.

CAUTION Considerations when using Electro-Convulsive Therapy (ECT) equipment during BIS monitoring: Place ECT electrodes as far as possible from the BIS sensor to minimize the effect of interference. Certain ECT equipment may interfere with the proper function of the BISx device. Check for compatibility of equipment during patient setup.

CAUTION Avoid liquid ingress to the Patient Interface Cable. Contact of fluids with the PIC sensor connector can interfere with PIC performance.

CAUTION When connecting or disconnecting the BISx device, take care not to touch the exposed contacts of either connector. Damage due to electrostatic discharge may result.

CAUTION Using accessories other than those specified may result in increased electromagnetic emissions or decreased electromagnetic immunity of the BISx device.

CAUTION The BISx device should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the BISx device should be observed to verify normal operation in the configuration in which it will be used.

NOTE The BIS measurements are very sensitive measurements that measure very small signals. Technological limitations don't allow higher immunity levels than 1 V/m for radiated RF electromagnetic fields and 1 Vrms for conducted disturbances induced by RF fields. Electromagnetic fields with field strengths above 1 V/m and conducted disturbances above 1 Vrms may cause erroneous measurements. Therefore Dräger recommends that you avoid using electrically radiating equipment in the close proximity of these measurements.

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BIS monitoring setup

1 Connect the BISx device to the monitor with the adapter cable.

2 Using the attachment clip, secure the BISx device to a convenient location near the patient's head.

3 Prepare sensor site and place the BIS sensor on the patient in accordance with the instructions included on the sensor packaging. Make sure that the patient’s skin is dry. Be aware that a wet sensor or a salt bridge may cause erroneous BIS and impedance values.

4 Attach the BIS sensor to the PIC. To insert the sensor into the PIC, line up as shown and insert the sensor tab into the PIC sensor connector until an audible “click” is heard. The blank side of the sensor tab (i.e. the side without the computer chip) should be facing up.

BIS continuous impedance check

The continuous impedance check is always active to enable you to understand the sensor condition in real time. It checks:

The combined impedance of the signal electrodes and the reference electrode

This is done continuously and does not affect the EEG wave. As long as the impedances are within the valid range, no prompt message of this check or its results will be announced

The impedance of the ground electrode

Patient interface cable (PIC)

BISx device

Adapter cable

CAUTION Ensure that the BISx device does not come into prolonged contact with your patient’s skin, as it may generate heat and cause discomfort.

CAUTION The BISx device may remain connected to a patient during defibrillation as long as the sensor is not located between the defibrillator pads.

NOTE After you switch the operating mode of the monitor into monitoring mode from demo mode, you need to reconnect the BIS device to the monitor before starting BIS measurement.

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This is done every ten minutes and takes approximately four seconds. It causes an artifact in the EEG wave, and the monitor will announce BIS Ground Check on the screen during the check. If

the ground electrode does not pass the check, another check will be performed. This continues until the ground electrode passes the check.

BIS sensor check

This measures the exact impedance of each individual electrode. It causes a disturbed EEG wave.

Starting a sensor check

The sensor check is automatically started when a sensor is connected. To manually start a sensor check, select BIS Setup > Sensor States and click Start Sensor Check.

Stopping a sensor check

The sensor check stops automatically if the impedances of all electrodes are within the valid range. To manually stop a sensor check, select BIS Setup > Sensor States and click Stop Sensor Check.

BIS sensor window

To open the BIS sensor window, select Sensor States on the BIS Setup menu.

The window may look slightly different on your monitor. The graphic in the BIS sensor window automatically adapts to show the type of sensor in use. Each symbol in the graphic represents an electrode and illustrates the most recently-measured impedance status of the electrodes. Although BIS may still be measured when the electrode is in Noise or High status, for best performance, all electrodes should be in Pass status.

1 The time at which the last sensor check was completed.

2 Click this button to open a window in which information of the sensor in use is displayed.

12

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BIS Impedance Indicators

Changing the BIS smoothing rate

The smoothing rate defines how the monitor averages the BIS value. With the decline in smoothing rate, the monitor provides increased responsiveness to changes in the patient’s state.

Contrarily, the monitor provides a smoother BIS trend with decreased variability and sensitivity to artifacts.

To change the smoothing rate, open the BIS Setup menu and set Smoothing Rate to 10 sec, 15 sec or 30 sec.

Switching secondary parameters on and off

A maximum of four secondary parameters can be added to display on the BIS parameter area.

Select BIS Setup > Secondary Parameter Select and select four secondary parameter maximum.

Color Status Electrode-to-skin impedance Action

Green Pass The impedance is within the acceptable range.

No action necessary.

Red Noise The electrode impedance cannot be determined due to electrical interference (noise) from another source.

Check the senor-to-skin contact. Press the edges of the sensor to ensure adhesion and proper contact. If the problem persists, remove sensor, clean skin thoroughly, and reapply sensor or apply new sensor in accordance with instructions on the sensor packaging.

High The impedance is above the limit.

Lead Off Electrode has no skin contact. Reconnect electrode, or check the sensor-to-skin contact. If necessary, clean and dry skin.

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Changing the scale of the EEG wave

1 Open the BIS Wave Setup menu;

2 Select the appropriate setting from the Scale list.

Setting the trend length

1 Open the BIS Wave Setup menu;

2 Select the appropriate length of time for BIS trend from the Trend Length list.

Switching BIS filters on or off

1 Open the BIS Wave Setup menu;

2 Set Filters to On or Off.

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Connecting Ventilators/Anesthesia Machines

Connecting Ventilators/Anesthesia Machines

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 200

Setting the baud rate . . . . . . . . . . . . . . . . . . . 200

Opening the Medibus/X Window. . . . . . . . . . 200

Ventilator/Anesthesia Machine Monitoring Interface. . . . . . . . . . . . . . . . . . . . 201

Respiratory Loop Interface . . . . . . . . . . . . . . 202

Viewing Loops . . . . . . . . . . . . . . . . . . . . . . . . 202

Storing and Reviewing Loops . . . . . . . . . . . . 202

Changing Loops Type . . . . . . . . . . . . . . . . . . 203

Showing/Hiding the Reference Loop . . . . . . 203

Resizing the Loops. . . . . . . . . . . . . . . . . . . . . 203

Alarms from Ventilator/Anesthesia Machine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203

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Connecting Ventilators/Anesthesia Machines

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Overview

A ventilator/anesthesia machine can be connected to the monitor via RS232 serial port, which transmits data to the monitor. Data imported from the ventilator/anesthesia machine, for example waveforms, measurement numerics, settings and alarms, can be displayed on the monitor. The ventilator/anesthesia machine may show more information than is available on the monitor.

Setting the baud rate

Ensure the ventilator/anesthesia machine and the monitor share the same baud rate, thus they can be well communicated. To set the baud rate, the user

can select Menu > Maintenance > User Maintain > Medibus Maintain > Baud Rate and choose 9600 or 19200 from the drop-down list.

Opening the Medibus/X Window

To open the Medibus/X window, the user can press

the shortcut key on the screen directly or select Menu > Display Setup > View Selection > Medibus/X.

Depending on the device connected, the Medibus/X window varies. There’re three kinds of user interfaces: ventilator monitoring interface, anesthesia machine monitoring interface, and respiratory loop interface. When the device is

NOTE The monitor does not perform measurement, but only display the measurement result from the ventilator/anesthesia machine.

NOTE Settings on the ventilator/anesthesia machine are independent of those on the monitor. Settings on the monitor will not influence ventilator/anesthesia machine’s setting.

NOTE Installation and debugging should be executed by service personnel or authorized technician of the manufacturer.

NOTE If the value of the ventilator/anesthesia machine is inconsistent with that of the monitor, the ventilator/anesthesia machine shall prevail.

NOTE Displayed Medibus data are for information only and must not been used as basis for diagnostic and therapeutic purpose. Always refer to the external device before making diagnostic or therapeutic decisions.

NOTE Displayed alarm information is not intended to supplement the alarms of the external device. Remain within hearing range of the alarms issued by the external device.

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Connecting Ventilators/Anesthesia Machines

connected successfully, the currently-used source device name is shown in the Medibus/X window title.

Supported ventilators: Evita V500, Evita V300, Savina 300, Savina, Babylog 8000, Babylog VN500, Oxylog 3000+;

Supported anesthesia machines: Perseus A500, Zeus Infinity Empowered, Primus Infinity Empowered, Apollo, Fabius GS Premium, Fabius Tiro, Fabius MRI, Fabius plus, Fabius plus XL, Primus, Atlan.

Ventilator/Anesthesia Machine Monitoring Interface

1 External device name

2 Waveform

3 Measurement value

Click on the Medibus/X window to open the setup menu for the connected device on which the user can

Select the parameter to be displayed on the window in the Parameter list.

Select a suitable ruler for the waveform from the options TopRuler, MidRuler and BotRuler. MidRuler is not available when anesthesia machine is connected.

Select an appropriate sweep for the waveform in the Sweep list. The bigger the value is, the wider the waveform is.

Choose Mode and set it to Curve or Filled from the pop-up list.

Select Color Setup to make color changes on parameter and waveform.

Select Default to restore factory default for all setups in this menu.

Select Enter Full-param Interface to display all the sub-parameters’ measurement values, without waveforms displayed.

Select Respiratory Loop to enter respiratory loop interface. (Only applicable to anesthesia machine monitoring interface).

NOTE Ensure that the unit of external device is consistent with that of the monitor.

NOTE VT low alarm generated by Evita V300 is not displayed on the monitor.

NOTE When connecting to Savina 300, it is recommended to use the Medibus/X protocol. Otherwise, VT value will not be uploaded to the monitor.

Waveform area

Waveform area

Waveform area

Parameter area

Parameter area

Parameter area

Savina300

NOTE When switching between different devices, the trend data of the previous device is cleared.

NOTE If the patient type on ventilator/anesthesia machine is inconsistent with that on the monitor, there will be a prompt Inconsistent patient type (Anes/Vent) on the monitor.

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Respiratory Loop Interface

Respiratory loops can indicate a fault in the airway tubing and help physicians to detect respiratory problems of patients.

The two types of loops are available in real time:

F-V (flow-volume) loops: it illustrates the dynamic relation between flow and volume during respiration and provides information about condition of the airway tubing.

P-V (pressure-volume) loops: it reflects the dynamic relation between pressure and volume as well as compliance of the respiratory system.

Viewing Loops

To view respiratory loop interface,

1 Click on the Medibus/X window to open the setup menu;

2 Select Loop in the Parameter list.

3 Click on Large Loop on anesthesia machine interface or select Respiratory Loop on the setup interface for the connected device.

1 Respiratory loop

2 Timestamp of the saved respiratory loop

3 Measurement value

Storing and Reviewing Loops

Up to four loops of each kind can be stored for reference. When the number of stored loops is over four, the latest stored loops will replace the previously stored loops.

To save the current loop, click on Save in the respiratory loop interface. When it is successfully stored, a timestamp will be displayed in the rectangle box.

Selecting the timestamp of a currently hidden loop can review the loop. The color-coded loops tell whether the loop is currently displayed or not. If there is no whole respiratory loop detected within 15 s, the loop cannot be saved.

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Connecting Ventilators/Anesthesia Machines

Changing Loops Type

To change the loop type, select Setup > Display Loop and choose a loop type from the drop-down list.

Showing/Hiding the Reference Loop

To show/hide the reference loop, select Setup > Reference Loop and choose On/Off from the drop-down list.

Resizing the Loops

To resize the loop, select Setup > Paw Top Ruler or Vol Top Ruler or Flow Top Ruler in which the user can set up the top ruler for Paw, Vol and Flow.

Alarms from Ventilator/Anesthesia Machine

Physiological alarm limits and alarms from the ventilator/anesthesia machine are transmitted to the monitor. If external device generates physiological alarms about exceeding the alarm limits, the monitor prompts visual alarms to notify users. The alarms are always non-latching on the monitor, and announced as a flashing numeric with

parameter alarm off icon while the alarm condition persists.

When the external device has communication failure, the monitor will trigger XX Comm. Failed alarm (XX represents one of the external devices connected.). To configure Clear Comm Fail Alarm (V/A) function, select Menu > Maintenance > User Maintain > Alarm Setup and choose Clear Comm Fail Alarm (V/A) which can be set to On or Off.

When it is set to On and the user selects the the

permanent key , the XX Comm. Failed alarm (including visual and audio alarm indications) will be cleared, even if the alarm condition still exists, the monitor won’t generate this technical alarm. If a new alarm occurs after the alarm is reset, the new alarm will be sounding.

NOTE The physiological alarm limits are non-adjustable on the monitor; the users can adjust them on ventilator/anesthesia machine if necessary.

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Freeze

Freeze

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206

Entering/exiting freeze status . . . . . . . . . . . . 206Entering freeze status. . . . . . . . . . . . . . . . . . . . 206Exiting freeze status . . . . . . . . . . . . . . . . . . . . . 206

Setting freeze duration. . . . . . . . . . . . . . . . . . 207

Reviewing frozen waveform . . . . . . . . . . . . . 207

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Freeze

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Overview

When monitoring a patient, the user can freeze waveforms and examine them. The Freeze function has the following features:

Freeze status can be activated on any operating screen.

Upon freezing, the system exits all other operating menus. The system freezes all waveforms in the Waveform area of the Basic Screen, the Full Lead ECG waveforms and extra waveforms on the Full Lead ECG interface (if any). The Parameter area refreshes normally.

The frozen waveforms can be reviewed and recorded.

Entering/exiting freeze status

Entering freeze status

In the non-Freeze status, press the hardkey on the monitor control panel to exit the current menu. Press the button again, freeze status is entered and the popup Freeze menu is displayed. In Freeze status, all waveforms are frozen and will not be refreshed.

Exiting freeze status

Executing any of the following operations will exit Freeze status:

1 Exit the Freeze menu;

2 Press hardkey on the control panel again;

3 When the freeze time expires;

4 Execute any operation that triggers the adjustment of the screen or displays a new menu.

After exiting Freeze status, the system will clear screen waveforms and resume displaying real-time waveforms. In the Screen Refresh mode, the system will sweep the waveforms from left to right in the Waveform Area.

Press the hardkey on the control panel, and the Freeze menu will appear on the bottom part of the screen. At the same time, the system freezes the waveforms.

NOTE

Pressing the hardkey repeatedly over a short period of time may result in discontinuous waveforms on the screen.

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Freeze

Setting freeze duration

By setting the freeze duration, the monitor can exit freeze status automatically after certain period. To set the freeze duration:

1 On the Freeze menu, select Freeze Duration.

2 Select the desired setting from the pop-up list. None/1/2/3/4/5/10/15/20/30/60 min are optional. When None is selected, the user can exit freeze status manually based on the actual situation.

Reviewing frozen waveform

By moving the waveform, the user can review 120 s of the waveform before it was frozen. For a waveform of less than 120 s, the remaining part is displayed as a straight line. Select Time on the Freeze menu and use the up/down arrow keys to move the frozen waves so that the user can review the other parts of the frozen waves not displayed on the current screen.

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Review

Review

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 210

Trend graph review. . . . . . . . . . . . . . . . . . . . . 210

Trend table review . . . . . . . . . . . . . . . . . . . . . 211

NIBP review. . . . . . . . . . . . . . . . . . . . . . . . . . . 211

Alarm review . . . . . . . . . . . . . . . . . . . . . . . . . . 211

ARR review . . . . . . . . . . . . . . . . . . . . . . . . . . . 212

Full disclosure waveform review . . . . . . . . . 213Selecting waveform . . . . . . . . . . . . . . . . . . . . . 213

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Review

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Overview

The monitor provides 150-hour trend data of all parameters, storage of 1200 NIBP measurement results, 200 alarm events and 200 arrhythmia events. This chapter gives detailed instruction for review of all data.

Trend graph review

To review the trend Graph, press the shortcut key

on the screen or select Menu > Review > Trend Graph.

In the trend graph, the y-axis is the measurement value and x-axis represents time. With the exception of NIBP, other trends are displayed as continuous curves.

In the trend graph review window:

Select Parameter and you can choose the required parameters to be displayed in the trend graph.

To display a different parameter’s trend, you can either:

Select beside the parameter name and choose the desired parameter from the pop-up list (as shown in red circle above).

Press the symbols and to switch parameters in batch.

Select Zoom to adjust the trend scale. Once the trend scale on the trend graph review interface is adjusted, the trend scale of the corresponding parameter in TrendScreen of the main interface will also change.

Select Scale to change the length of trend data displayed on the current screen. 6 min, 12 min, 30 min, 1 h, 2 h, 4 h, 6 h, 12 h, 24 h, 36 h and 48 h are optional.

Select beside Cursor to move the cursor left or right.

Select and to scroll the screen left and right manually to browse the trend graph.

Select Trend Table to switch to the trend table interface.

NOTE Parameter labels from external devices (ventilators/anesthesia machines) are suffixed with (V/A).

1 Trend curve area2 Trend data: displays measurement values

at the cursor indicated time.3 Cursor4 Cursor time

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Review

Select Record to print out the currently displayed trends by the recorder.

Trend table review

To review the trend table, press the shortcut key

on the screen or select Menu > Review > Trend Table.

In the trend table review window:

Select Parameter and you can choose the required parameters to be displayed in the trend table.

Select Interval to change the interval of the trend data. 1 s, 5 s, 30 s, 1 min, 3 min, 5 min, 10 min, 15 min, 30 min, 60 min and NIBP are optional. Select NIBP to view the trend data according to the NIBP measurement time.

Select , , and to scroll the screen manually to browse the trend table.

Select Trend Graph to switch to the trend graph interface.

Select Record to print out the currently displayed trends by the recorder.

Select Record All to enter the setup menu. Click Record All after setting Start Time and End Time, then all the trends for that period will be printed out by the recorder.

NIBP review

To review the NIBP measurement data, press the

shortcut key on the screen or select Menu > Review > NIBP Review. The NIBP Review.

In the NIBP review window:

Select Unit to change the pressure unit.

Select and to browse more NIBP measurement data.

Select Record to print out the NIBP measurement data by the recorder.

Alarm review

To review the alarm event, press the shortcut key

on the screen or select Menu > Review > Alarm Review.

In the alarm review window:

Select Event Type to choose the required parameter from the popup list and the user can review alarm event of the specific parameters.

Select Time Index to set end time of alarm review.

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Review

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Current Time: the alarm events occurring before the current time are displayed on the alarm event review interface.

User Define: the user can define the review time by setting time box displayed on the interface. The alarm events occurring before the User Define option are displayed on the alarm event review interface.

Select and to browse more alarm events.

Select Record to print out the alarm events by the recorder.

When an alarm event occurs, all the measurement numerics and related waveform 4 (8 or 16) s before and after the event are stored. To set the waveform length, select Menu > Alarm Setup > Alarm Rec. Time. 8 s, 16 s and 32 s are optional.

ARR review

To review the ARR alarm event, press the shortcut

key on the screen or select ECG Setup > ARR Analysis > ARR Review or Menu > Review > ARR Review.

In the ARR review window, the latest arrhythmia

events are displayed. Select and to browse more ARR alarm events. You may select an alarm event and access the alarm review interface to get more information. On the alarm review interface, you can:

Right or left shift the waveform to review the complete 8-second waveform.

Select Record and output the arrhythmia waveform by the recorder.

According to the actual clinical needs, select another name from the pull-down list of Rename for the arrhythmia event. Confirm the changes to make the settings take effect.

Select Delete to remove a specific arrhythmia event.

Select Alarm List or exit to get back to the arrhythmia review interface.

NOTE The monitor can store a maximum of 200 alarm events. As soon as the alarm event storage is full, the earliest alarm event will be replaced by the latest one.

NOTE If there are more than 200 arrhythmia events, the monitor will only keep the recent ones.

NOTE The name of arrhythmia event will be shown on the alarm status area.

NOTE The renaming is only available for the ARR alarm event of the current patient, not for that of the history patient.

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Review

Full disclosure waveform review

Select Menu > Review > History Patient > Full Wave. to enter the full disclosure review interface. Depending on the configuation, the user can review up to 48-hour or 96-hour waveform data.

Selecting waveform

Before reviewing the waveform, you must select waveform you want to display. To display the desired waveforms,

1 Enter the full disclosure review interface;

2 Select Wave Setup to set the desired waveform (Maximum: 1) to be displayed on the full disclosure review interface.

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Calculation and titration table

Calculation and titration table

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216

Drug Calculation. . . . . . . . . . . . . . . . . . . . . . . 216Calculation Procedures . . . . . . . . . . . . . . . . . . 216Calculation Unit . . . . . . . . . . . . . . . . . . . . . . . . 217

Titration Table . . . . . . . . . . . . . . . . . . . . . . . . . 217

Hemodynamic Calculation. . . . . . . . . . . . . . . 218Calculation Procedure . . . . . . . . . . . . . . . . . . . 218Input Parameters . . . . . . . . . . . . . . . . . . . . . . . 218Output Parameters . . . . . . . . . . . . . . . . . . . . . 218

Oxygenation Calculation . . . . . . . . . . . . . . . . 219Calculation Procedure . . . . . . . . . . . . . . . . . . . 219Input Parameters . . . . . . . . . . . . . . . . . . . . . . . 219Output Parameters . . . . . . . . . . . . . . . . . . . . . . 220

Ventilation Calculation. . . . . . . . . . . . . . . . . . 221Calculation Procedure . . . . . . . . . . . . . . . . . . . 221Input Parameters . . . . . . . . . . . . . . . . . . . . . . . 221Output Parameters . . . . . . . . . . . . . . . . . . . . . . 221

Renal Function Calculation . . . . . . . . . . . . . . 222Calculation Procedure . . . . . . . . . . . . . . . . . . . 222Input Parameters . . . . . . . . . . . . . . . . . . . . . . . 222Output Parameters . . . . . . . . . . . . . . . . . . . . . . 223

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Overview

The monitor provides a calculation function and titration table. Calculations are patient data that are not directly measured but calculated by the monitor.

The monitor can perform drug calculation, hemodynamic calculation, oxygenation calculation, ventilation calculation and renal function calculation, and also support record function.

Drug Calculation

Calculation Procedures

1 The drug calculation window is displayed by selecting Menu > Common Function > Drug Dose.

2 Select the right pull-down box of the Drug option and select the required drug name among the 15 drugs which are listed as follows. And the drug name of Drug A, Drug B, Drug C, Drug D and Drug E can be defined by the user.

Drug A, Drug B, Drug C, Drug D and Drug E

Aminophylline

Dobutamine

Dopamine

Epinephrine

Heparin

Isuprel

Lidocaine

Nipride

Nitroglycerin

Pitocin

3 The system generates values that can not be treated the calculation results. The user must enter the correct parameter value based on the doctor’s instruction.

4 Manually enter the value of patient weight or directly obtain the value from the monitor by selecting Get Info.

5 Enter the correct parameter value.

6 Confirm whether the calculation result is correct.

The following formulas are applied to dose calculation:

Concentrate = Amount / Volume

NOTE The drug calculation function acts only as a calculator. The patient weights in Drug Dose menu and in Patient Information menu are independent of each other. Therefore changing the Weight in Drug Dose menu will not change the weight in the Patient Information menu.

NOTE The calculation results are for reference only and the calculation significance must be determined by the physician.

WARNING The correctness of the input parameters and the suitability of the calculated results should be carefully verified. The manufacturer is not liable for any consequences arising from input or operation errors.

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Calculation and titration table

INF Rate = DOSE / Concentrate

Duration = Amount / Dose

Dose = Rate × Concentrate

DRIP Rate = INF Rate / 60 × DROP Size

Calculation Unit

Each drug has the fixed unit or unit series to calculate. Among the same unit series, the unit binary varies with the entered parameter value.

The calculation units of the drugs are listed as follows:

When defining a drug, select Drug A, Drug B, Drug C, Drug D, and Drug E based on the unit series.

Titration Table

After completing the drug calculation, the user can open the Titration on the Drug Dose interface.

The user can change the following items in the titration table:

Basic

Step

Dose Type

The data in the titration table will vary with the changes above. And the user can perform the following:

Select and to observe more data.

Record the data displayed in the current window by selecting Record.

Drug Unit Drug A, Drug B, Drug C, Aminophylline, Dobutamine, DopaminE, Epinephrine, IsupreL, Lidocaine, Nipride, Nitroglycerin

g, mg, mcg

Drug D, Pitocin, Heparin Ku, mu, UnitDrug E mEq

NOTE The drug calculation is displayed as invalid value before the user edits the drug name and patient weight, and the user can not enter any value.

NOTE Drip Rate and Drop Size are invalid in the neonatal mode.

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Hemodynamic Calculation

Calculation Procedure

1 The hemodynamic calculation interface is displayed by selecting Menu > Common Function > Calculation > Hemodynamics.

2 Manually enter the values required on this interface. The user can also directly obtain the values of HR, C.O., PA MAP, CVP, and PAWP if they are available from the monitor by selecting Get Info.

3 Select Calculate to output parameter value.

Input Parameters

Output Parameters

Items Unit English Full Name/Description

PAWP mmHg Pulmonary artery wedge pressure

CVP mmHg Central venous pressure

C.O. L/min Cardiac output

HR bpm Heart rate

EDV ml End-diastolic volume

AP MAP mmHg Mean Artery Pressure

PA MAP mmHg Pulmonary artery mean pressure

PAP mmHg Pulmonary artery pressure

Height cm /

Weight kg /

Items Unit English Full Name/Description Formula

CI L/min/m2 Cardiac index C.O. / BSA

SV ml Stroke volume C.O. / HR × 1000

SVR DS/cm5 Systemic vascular resistance 80 × (AP MAP – CVP) / C.O.

PVR DS/cm5 Pulmonary vascular resistance 80 × (PA MAP – PAWP) / C.O.

LCW kg·m Left cardiac work 0.0136 × AP MAP × C.O.

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Calculation and titration table

Oxygenation Calculation

Calculation Procedure1 Select Menu > Common Function >

Calculation > Oxygenation.

2 Manually enter the values required on this interface. The user can also directly obtain the values of patient height, patient weight, C.O. and FiO2 if they are available from the monitor by selecting Get Info.

3 Select Calculate to output parameter value.

Input Parameters

LVSW g·m Left ventricular stroke work 0.136 × (AP MAP – PAWP) × SV

EF % Ejection fraction SV / EDV × 100%

SVI ml/m2 Stroke volume index SV / BSA

SVRI DS·m2/cm5 Systemic vascular resistance index SVR × BSA

PVRI DS·m2/cm5 Pulmonary vascular resistance index PVR × BSA

LCWI kg·m/m2 Left cardiac work index LCW / BSA

LVSWI g·m/m2 Left ventricular stroke work index LVSW / BSA

RCW kg·m Right cardiac work 0.0136 × PA MAP × C.O.

RVSW g·m Right ventricular stroke work 0.0136 × (PAP-PAWP) × SV

BSA m2 Body surface area Weight0.425 × Height0.725 × 0.007184

RCWI kg·m/m2 Right cardiac work index RCW / BSA

RVSWI g·m/m2 Right ventricular stroke work index RVSW / BSA

Items Unit English Full Name/Description

FiO2 % Percentage fraction of inspired oxygen

PaO2 mmHg Partial pressure of oxygen in the arteries

PaCO2 mmHg Partial pressure of carbon dioxide in the arteries

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Output Parameters

PiO2 mmHg Partial pressure of oxygen in inspired gas

SaO2 % Arterial oxygen saturation

PvO2 mmHg Partial pressure of oxygen in venous blood

SvO2 % Venous oxygen saturation

Hb g/L Hemoglobin

RQ / Respiratory quotient

Height cm /

Weight kg /

CI l/min/m2 Cardiac index

Items Unit English Full Name/Description Formula

BSA m2 Body surface area Weight0.425 × Height0.725 × 0.007184VO2 ml/(min.m2) Oxygen consumption Ca-v O2 × CICaO2 ml/L Arterial oxygen content Hb × 1.34 × SaO2/100% + (0.0031 × PaO2)CvO2 ml/L Venous oxygen content Hb × 1.34 × SvO2/100% + (0.0031 × PvO2)

Ca-v O2 ml/L Arterial venous oxygen content difference CaO2 – CvO2

O2ER / Oxygen extraction ratio (VO2 / DO2) × 100%

DO2 ml/(min.m2) Oxygen transport CaO2 × CI

PAO2 mmHg Partial pressure of oxygen in the alveoli

PiO2-PACO2 × [FiO2/100% + (1-FiO2/100%) / RQ]

AaDO2 mmHg Alveolar-arterial oxygen difference PAO2 – PaO2

CC’O2 ml/L Capillary oxygen content PAO2 × 0.003 + 1.34 × SaO2/100% × Hb

Qs/Qt / Venous admixture (CC’O2 – CaO2) / (CC’O2 – CvO2) × 100%

C.O. L/min Cardiac output VO2 /( Ca-v O2 × BSA)

AaDO2/PaO2 / Spiro-index (PAO2 – PaO2) / PaO2× 100%

DO2I ml/(min.m2) Oxygen delivery index DO2/BSA

VO2I ml/(min.m2)Oxygen consumption index VO2/BSA

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Calculation and titration table

Ventilation Calculation

Calculation Procedure1 Select Menu > Common Function >

Calculation > Ventilation.

2 Manually enter the values required on this interface. The user can also directly obtain the values of FiO2, RR, PIP and PEEP if they are available from the monitor by selecting Get Info.

3 Select Calculate to output parameter value.

Input Parameters

Output Parameters

Items Unit English Full Name/Description

FiO2 % Percentage fraction of inspired oxygen

RR rpm Respiration rate

VT ml Tidal volume

PaCO2 mmHg Partial pressure of carbon dioxide in the arteries

PaO2 mmHg Partial pressure of oxygen in the arteries

RQ / Respiratory quotient

PEEP cmH2O Positive end-expiratory pressure

PEEPi cmH2O Intrinsic PEEP

PeCO2 mmHg Partial pressure of mixed expiratory CO2

PiO2 mmHg Partial pressure of oxygen in inspired gas

Ppeak cmH2O The peak inspiratory pressure

Items Unit English Full Name/Description Formula

PAO2 mmHg Partial pressure of oxygen in the alveoli PiO2-PaCO2 × [FiO2/100% + (1-FiO2/100%)/RQ]

AaDO2 mmHg Alveolar-arterial oxygen difference PAO2 – PaO2

MV L/min Minute volume VT × RR/1000

AaDO2/PaO2 / Spiro-index (PAO2 – PaO2) / PaO2× 100%

VA L/min Alveolar volume (VT – VD) × RR/1000

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Renal Function Calculation

Calculation Procedure1 Select Menu > Common Function >

Calculation > Renal Function.

2 Manually enter the values required on this interface.

3 Select Calculate to output parameter value.

Input Parameters

VD ml Volume of physiological dead space [(PaCO2 – PeCO2) × VT] / PaCO2

VD/VT / Physiological dead space in percent of tidal volume

(PaCO2 – PeCO2) / PaCO2 × 100%

Cdyn ml/cmH2O Compliance dynamic VT / (Ppeak – PEEP – PEEPi)

Items Unit English Full Name/Description

URK mmol/L Urine potassium

URNa mmol/L Urinary sodium

Urine ml/24h Urine

Posm mOsm/kgH2O Plasm osmolality

Uosm mOsm/kgH2O Urine osmolality

SerNa mmol/L Serum sodium

SCr umol/L Serum creatinine

UCr umol/L Urine creatinine

BUN mmol/L Blood urea nitrogen

UUN mmol/L Urine urea nitrogen

Height cm /

Weight kg /

Type / Patient type: Adult, Pediat, Neonat

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Calculation and titration table

Output Parameters

Gender / Male, Female, N/A.

Items Unit English Full Name/Description Formula

URNaEx mmol/24h Urine sodium excretion URNa × Urine / 1000

URKEx mmol/24h Urine potassium excretion URK × Urine / 1000

CUUN ml/min Urine urea nitrogen clearance rate UUN × Urine / (BUN × 24 × 60)

CNa ml/24h Clearance of sodium URNa × Urine / (SerNa)

CCr ml/min Creatinine clearance rate (UCr × Urine) / (SCr × 24 × 60)

Cosm ml/min Osmolar clearance (Uosm × Urine) / (Posm × 24 × 60)

FENa % Fractional excretion of sodium (URNa × SCr) / (UCr × SerNa) × 100%

FEUr % Fractional Excretion of Urea (SCr × UUN) / (UCr × BUN) × 100%

BUN/SCr / Blood urea nitrogen creatinine ratio (BUN / SCr) × 1000

CH2O ml/24h Free water clearance Urine – Uosm ×Urine / Posm

U/P osm / Urine to plasma osmolality ratio Uosm / Posm

U/SCr / Urine-serum creatinine ratio UCr / SCr

Na/K % Sodium potassium ratio URNa / URK × 100%

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Strip recording

Strip recording

General information . . . . . . . . . . . . . . . . . . . . 226

Performance of the recorder . . . . . . . . . . . . . 226

Starting and stopping strip recording . . . . . 227

Recorder operations and status messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . 228Record paper requirement . . . . . . . . . . . . . . . . 228Proper operation. . . . . . . . . . . . . . . . . . . . . . . . 228Paper out . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 228Installling paper . . . . . . . . . . . . . . . . . . . . . . . . 229Removing paper jam . . . . . . . . . . . . . . . . . . . . 229

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General information

A thermal dot matrix recorder is used for the monitor and can support a number of recording types and output patient information, measurement data, and review data waveforms.

Performance of the recorder

Waveform record printed at the rate of 12.5 mm/s, 25 mm/s or 50 mm/s.

48 mm wide printout paper.

Record up to three waveforms.

User-selectable real-time recording time and waveform.

Auto recording interval is set by the user and the waveform displays in real time.

1 Start/Stop key. Press this key to start or stop recording task.

2 Recorder door3 Paper outlet4 Recording indicator

NOTE Do not use the strip recorder with a low battery as recorder usage will more quickly deplete the battery.

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Strip recording

Starting and stopping strip recording

The monitor provides several types of stripe recording. The strip recording can be started and stopped in the following ways:

Recording Type Description/ProcedureContinual real-time recording

Select at least one Rec waveform in Recorder Setup (A maximum of three waveforms can be selected), select Continual in R-T Rec Time. Press the Record button on the front panel to start the recording. Press the button again to stop recording.

8-second/20-second real-time recording

Select at least one Rec waveform in Recorder Setup (A maximum of three waveforms can be selected), select 8 s or 20 s in R-T Rec Time, set Record Interval as needed, press the Record button on the front panel to start the recording. Press the button again to stop recording or when R-T Rec time ends, the monitor stops recording automatically. The runtime for each wave is 8 s or 20 s. The record Interval can be set as: Off, 10 min, 20 min, 30 min, 40 min, 50 min, 1 h, 2 h, 3 h, 4 h. The default recording time is 8 s.

Trend graph recording Select Menu > Review > Trend Graph, click Record to start recording.

Trend table recording Select Menu > Review > Trend Table, click Record to start recording.

NIBP review recording Select Menu > Review > NIBP Review, click Record to start recording.

Arrhythmia review recording Select Menu > Review > ARR Review, select one arrhythmia alarm and click Record to start recording.

Alarm review recording Select Menu > Review > Alarm Review, select one alarm and click Record to start recording.

Drug calculation titration recording

Select Menu > Common Function > Calculation > Drug Dose > Titration, click Record to start recording.

Hemodynamic Calculation result recording

Select Menu > Common Function > Calculation > Hemodynamics, click Record to start recording.

Oxygenation Calculation result recording

Select Menu > Common Function > Calculation > Oxygenation, click Record to start recording.

Ventilation Calculation result recording

Select Menu > Common Function > Calculation > Ventilation, click Record to start recording.

Renal Function Calculation result recording

Select Menu > Common Function > Calculation > Renal Function, click Record to start recording.

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The recorder will stop recording in the following situations:

The strip recording task is finished.

When the Start/Stop button on the front panel of the printer is pressed while the printer is printing.

No paper in the recorder.

Because of malfunction.

Recorder operations and status messages

Record paper requirement

Proper operation

When the strip recorder is operating, do not pull the paper.

Do not operate the strip recorder without record paper.

Paper out

When the Recorder Out Of Paper alarm is displayed, the strip recorder will not start.

C.O. measurement recording

Select C.O. Option > C.O. Measure, click Record to start recording.

Frozen waveform recording In the Freeze window, click Record to start recording.

Recording Type Description/Procedure

NOTE

The button on the front panel enables users to manually start or stop recording.

NOTE For waveforms with sweep of 6.25 mm/s, after entering freeze status, the recording speed will automatically be adjusted to 12.5 mm/s. Users can modify the recording speed according to their actual needs. The options are 12.5 mm/s, 25 mm/s and 50 mm/s.

CAUTION Only use standard thermo-sensitive record paper. If non-standard record paper is used, the recorder might not function, the recording quality may be poor, and the thermo-sensitive printhead could be damaged.

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Strip recording

Installling paper

1 Pull out the upper arc of the strip recorder casing as shown in the following figure.

2 Insert a new roll of paper into the paper cassette, printing side facing upwards.

3 Position the paper correctly.

4 Pull 2 cm of paper out and close the strip recorder casing.

Removing paper jam

When the strip recorder malfunctions, open the strip recorder door to check for a paper jam. Remove the paper jam in the following way:

Cut the record paper from the feeding edge.

Open the strip recorder door.

Re-install the paper.

NOTE Be careful when inserting paper. Avoid damaging the thermo-sensitive print head. Do not leave the strip recorder door open except to insert paper or troubleshoot printing problems.

NOTE If the monitor is not installed with a strip recorder, it will indicate Recorder Setup Needed after pressing the Record button in the dialog box.

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NOTE Do not touch the thermo-sensitive print head when performing continuous recording.

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Other Functions

Other Functions

Nurse call . . . . . . . . . . . . . . . . . . . . . . . . . . . . 232

Analog Output and Defibrillator Synchronization . . . . . . . . . . . . . . . . . . . . . . . 232

Wi-Fi (optional) . . . . . . . . . . . . . . . . . . . . . . . . 232

Storing Data in the Storage Device. . . . . . . . 234Data Stored in the Storage Device . . . . . . . . . . 234Activating/ Deactivating Data Storing . . . . . . . . 234Selecting a Storage Device . . . . . . . . . . . . . . . 234Reviewing Data Stored in the Storage Device . . . . . . . . . . . . . . . . . . . . . . . . . 235Deleting Data Stored in the Storage Device . . . . . . . . . . . . . . . . . . . . . . . . . 235Exporting data stored in the internal storage device . . . . . . . . . . . . . . . . . . . . . . . . . 235Formatting the internal storage device . . . . . . . 235Ejecting a Removable Device. . . . . . . . . . . . . . 236

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Other Functions

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Nurse call

The monitor provides a dedicated nurse call port which can be connected to the hospital’s nurse call system. The user should activate the function following the steps below:

1 Select Menu > Maintenance > User Maintain, and input the password;

2 Select Other Setups > Aux Output;

3 Choose On in the Nurse Call list.

Analog Output and Defibrillator Synchronization

The monitor provides analog output signals to accessory equipment. Also, if a defibrillator is connected to the monitor, a defibrillator synchronization pulse can be output. The user should activate the function following the steps below:

1 Select Menu > Maintenance > User Maintain, and input the password;

2 Select Other Setups > Aux Output;

3 Choose Analog Output or Defibrillation in the Aux Output list.

Wi-Fi (optional)

Wi-Fi modules are optional to be configured in the monitors. And The user should configure the settings on the monitor following the steps below before connecting the monitor to a wireless network:

1 Select Menu > Maintenance > User Maintain, and input the password.

2 In the User Maintain menu, select Network Maintain.

3 In the Network Maintain menu, select Wi-Fi from the Network Type list. And click Config to open the Wi-Fi Setup window. The available networks will be listed in this window.

4 Choose a network from the window, in which the user can check the network’s encryption information (Security). The user will be prompted to enter the password of that network if a password is required. After entering the password and setting the IPv4 address, the

user can click to connect the network.

5 Or select to connect the hidden networks. After entering Network Name, Security, password and setting the IPv4 address, the

user can click to connect the hidden network.

NOTE Before using nurse call function, check whether it is working normally.

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Other Functions

If the monitor is successfully connected to the selected network, it will be indicated by the message Connected, and the local IP address of the monitor will be displayed in the Wi-Fi Setup window. Also, a symbol indicating the networking state will be displayed on the lower portion of the main screen. The meanings of the networking state symbols are explained below:

Click to review the historically connected networks. After choosing certain network, the user can select Forget This Network or Join This Network.

If the encryption information of the currently connected network is modified, the network will automatically disconnect and attempt to reconnect.

At this time, click first to ignore this network and then connect manually.

The following symbols may appear when configuring Wi-Fi:

Wi-Fi signal intensity: Level 4

Wi-Fi signal intensity: Level 3

Wi-Fi signal intensity: Level 2

Wi-Fi signal intensity: Level 1

Symbol Description

Connect to hidden networks

View historically connected networks

Refresh network list

Turn the page left and right. to view more networks

Secure network

Insecure network (not recommended). Icon color is red.

Hide password

Show password

Connect the network

Disconnect the network

NOTE Be aware that some network-based functions may be limited for monitors on wireless networks in comparison with those on wired networks.

NOTE The obstacle may interfere with data transmission and even cause data loss.

NOTE If the monitor fails to connect to any wireless network or no available wireless network is in the Wi-Fi Setup window, switch the Network Type from Wi-Fi to Wired and then to Wi-Fi again. Then retry to connect to a wireless network. If the wireless network still fails to be connected, please try to restart the monitor and connect again.

NOTE Use the wireless device recommended by Dräger, otherwise some exceptional situations such as frequent network disconnection may occur on the monitor.

NOTE The wireless driver is compatible with channels 1-11 only.

NOTE When signal intensity is level 2 or less, signal may be unstable and quality of the signal transmission may be degraded.

NOTE When the monitor is connected to Vista 120 CMS via the wireless network, the user should set the router to a secure encryption/authentication mode (Recommended option: WPA2-PSK, with a high complexity, non-dictionary password).

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Storing Data in the Storage Device

Data Stored in the Storage Device

Refer to Section Data management for more information about single patient data volume.

When the single patient data reach the maximum, the user can choose to Keep Storing or Stop Storing by selecting Menu > Common Function > Data Store > if one patient data full.

If Keep Storing is selected, as soon as the single patient data is full, the earliest data will be replaced by the latest one. When the remaining storage space is less than 15 M, the earliest patient data in the storage space will be deleted in order to store the latest data.

If Stop Storing is selected, the monitor will stop data storing and the latest data cannot be stored when the single patient data reach the maximum. For instance, if all the patient data (such as the trend graph, trend table, NIBP measurements, arrhythmia event, and alarm event ) except waveforms reach the maximum, the monitor will stop storing, while only the waveforms keep storing until they are full. When the remaining storage space is less than 10 M, the monitor will stop storing new data, prompting insufficient storage space.

The monitor can detect the storage space threshold. Select Menu > Common Function > Data Store and set Threshold Detection to On. When the removable device is newly inserted and its remaining storage space is less than 300 M, the monitor will stop storing data, prompting The space in U disk is less than 300 M. Please clean it up.. The user needs to clean up the space manually till the remaining space is more than 300 M, thus the monitor will keep storing data.

Activating/ Deactivating Data Storing

To activate/ deactivate the data storing function, select Menu > Maintenance > User Maintain > Other Setups, and set Data Store to On or Off.

The monitor will stop storing data in the storage device under the following circumstances:

No storage devices are selected.

There is no enough space in the storage device for storing data.

The removable device is read-only.

The data storing function is deactivated.

The monitor is switched off.

The power supply is off.

Selecting a Storage Device

To configure the storage device, select Menu > Common Function > Data Store > Storage Medium, and choose the storage medium from the pop-up list as desired. Internal Storage Device and Removable Device can be selected.

When Internal Storage Device is selected as the storage medium, if configured, the storage device name will automatically become Internal Storage Device. When Removable Device is selected as

NOTE The storage time varies according to the patient's parameter data volume. When the single patient data store reaches 240 hours, the monitor will automatically create a new folder for continuous data store.

NOTE Threshold Detection is only applicable to the removable devices.

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Other Functions

the storage medium, the user may plug several removable devices into the monitor at the same time, but only one is operative. The user can select a removable device as a working one among the plugging devices by selecting Menu > Common Function > Data Store > Storage Device and choosing the device name from the list. By default, the first plugged removable device is the working one.

After configuring the appropriate storage device, click exit. If the storage device is successfully starting data storing, the monitor will be indicated

by the symbol . If there is no enough space in storage device, or the storage device is read-

only/damaged, the symbol will be displayed.

Reviewing Data Stored in the Storage Device

To review data stored in the storage device, select Menu > Review > History Patient. The user can choose to review the storage device as desired from the pop-up list. Choose a patient from the list to review the data including patient information, trend graph, trend table, NIBP measurements, arrhythmia event, alarm event, and full disclosure waveform. The user can choose to record trend graph, trend table, NIBP measurements, and full disclosure waveform via recorder.

Deleting Data Stored in the Storage Device

To delete data of one patient, choose the patient from the list after selecting Menu > Review > History Patient, and then click Delete Data on the Review menu. Further confirmation of deletion is required.

To delete data of all patients, select Menu > Review > History Patient and click Delete all data on the History Patient Review menu. Further confirmation is required.

Exporting data stored in the internal storage device

To export data of one patient from the internal storage device to the removable device, choose the patient from the list after selecting Menu > Review > History Patient, and then click Export Current Data on the Review menu.

To export data of all patients, select Menu > Review > History Patient and click Export all data on the History Patient Review menu.

Formatting the internal storage device

To format the internal storage device, select Menu > Maintenance > User Maintain > Other Setups > Format internal storage device. Further confirmation is required.

CAUTION Not all the removable devices are compatible with the monitor. Use the removable devices recommended by Dräger.

CAUTION DO not set the read-only switch on the removable device to on when the removable device is inserted in the monitor.

CAUTION It is recommended to format the USB flash drive to the FAT file type via PC prior to use.

NOTE As soon as the internal storage device is formatted, all the data will be cleared.

NOTE You have no need to restart the monitor after formatting is successful. The internal storage device can be identified and loaded automatically.

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Other Functions

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Ejecting a Removable Device

Before unplugging a removable device from the monitor, the user needs to select Menu > Removable Device and click Eject to uninstall the removable device. In this menu, the user can also check the remaining capacity of the storage device.

NOTE If formatting is failed, try again. Restart the monitor and retry the formatting, or contact the service personnel of the manufacturer if formatting is failed repeatedly.

CAUTION Do not remove the removable device without ejecting it during data storing, or the removable device might be damaged.

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Using battery

Using battery

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 238

Battery power indicator . . . . . . . . . . . . . . . . . 238

Battery status on the main screen . . . . . . . . 238

Checking battery performance . . . . . . . . . . . 239

Replacing the battery . . . . . . . . . . . . . . . . . . . 240

Recycling the battery . . . . . . . . . . . . . . . . . . . 241

Maintaining the battery . . . . . . . . . . . . . . . . . 241

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Overview

This monitor can run on battery, which ensures the uninterrupted operation even when AC power supply is interrupted. The battery recharges whenever the monitor is connected to the AC power source. During monitoring, if the AC power is

interrupted, the monitor will take power from the internal battery. If the monitor is powered by battery, the monitor will switch off automatically before the battery is completely depleted.

Battery power indicator

The indicator labeled Battery on the front panel of the monitor illuminates green when the monitor is battery powered and yellow when being charged. The indicator is not illuminated when the monitor is not powered or when using AC power.

Battery status on the main screen

The Battery Status shows the status of each battery detected and the combined battery power remaining. It also includes an estimate of the monitoring time remaining.

When the monitor is battery powered, the monitor switches off automatically if there is no power.

Icon is shown when the monitor is not equipped with a battery.

Remaining battery power: 100%.

Remaining battery power: 75%.

Remaining battery power: 50%.

Remaining battery power: 25%.

Batteries are almost depleted and need to recharge immediately.

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Instructions for use Vista 120/Vista 120S SW 3.n 239

Using battery

Checking battery performance

The performance of rechargeable batteries may deteriorate over time. The battery should be conditioned regularly as follows:

1 Disconnect the patient from the monitor and stop all monitoring and measurement.

2 Switch the monitor power on and charge the battery for more than 6 hours continuously.

3 Disconnect the monitor and let it run until there is no battery power remaining and the monitor shuts off.

4 Reconnect the monitor to mains.

This should improve the battery running time. If the running time is less than listed in the specification, change the battery or contact the customer service.

NOTE Remove the battery from the monitor when the monitor is not used for a long period of time.

WARNING Before using the rechargeable lithium-ion battery (hereinafter called battery), be sure to read these Instructions for Use and follow all safety precautions.

WARNING The service life of the battery depends on the service interval. The service life of the battery is about three years if the battery is well maintained and stored. The service life of the battery may shorten if it is used inappropriately. If the battery life is exhausted and not replaced in time, it may cause damage or heat to the device.

WARNING Periodic checks on the battery performance are required. Change the battery if necessary.

WARNING Do not connect the positive (+) and negative (-) terminals with metal objects, and do not put the battery together with metal objects, which can result in short circuits.

WARNING Do not destroy, disassemble or modify the battery in any way. Do not short circuit the battery, or its terminals, to a metal object.

WARNING Do not unplug the battery while the monitor is working.

WARNING Do not heat or throw battery into a fire.

WARNING Do not use, leave the battery close to fire or other places where temperature may be above +60 °C.

WARNING Do not immerse, throw, or wet battery in water/seawater.

WARNING Do not destroy the battery: do not pierce the battery with a sharp object such as a needle; do not hit with a hammer, step on or throw or drop to cause strong shock; do not disassemble or modify the battery.

WARNING The recommended battery can only be used for this monitor. Do not connect battery directly to an electric outlet or cigarette lighter charger.

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Replacing the battery

To install or replace the battery: 1 Pull the battery door downwards to open it.

2 Pull the metal retainer until the battery can be removed.

3 Insert the new battery into the battery compartment.

4 Pull the metal retainer downward to fix the battery and close the battery door.

WARNING Do not solder the leading wire and the battery terminal directly.

WARNING If liquid leaking from the battery gets into eyes, do not rub eyes. Wash them well with clean water and go to see a doctor immediately. If liquid leaks of the battery splash onto skin or clothes, wash well with fresh water immediately.

WARNING If leakage or foul odor is detected, ensure that there’s no fire around.

WARNING Stop using the battery if abnormal heat, odor, discoloration, damage, deformation, or abnormal condition is detected during use, charge, or storage. Keep it away from the monitor.

WARNING Do not use a battery with serious scratch or deformation.

WARNING When the monitor is running on battery power, do not replace the battery during monitoring patients; or the monitor will be powered off, which may result in patient injury.

WARNING Do not place battery in the monitor with the (+) and (-) in the wrong way.

WARNING Replacement of lithium batteries or fuel cells by inadequately trained personnel would result in an unacceptable risk (e.g., excessive temperatures, fire or explosion).

Battery door

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Using battery

Recycling the battery

When the battery no longer holds a charge, it should be replaced. Remove the old battery from the monitor and recycle it properly.

Maintaining the battery

Batteries should be conditioned regularly to maintain their useful life.

Remove the batteries from the monitor if they are not used for a longer period of time. And recharge the batteries at a minimum of every 6 months when they are stored.

Discharge the battery completely once every month.

NOTE To prolong the life of rechargeable battery, charge it at least once every six months for a charging time of about five hours.

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Care and cleaning

Care and cleaning

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 244

General points . . . . . . . . . . . . . . . . . . . . . . . . 244

Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 244Cleaning the monitor . . . . . . . . . . . . . . . . . . . . 245Cleaning the Reusable Accessories. . . . . . . . . 245

Disinfection. . . . . . . . . . . . . . . . . . . . . . . . . . . 246Disinfecting the Monitor . . . . . . . . . . . . . . . . . . 246Disinfecting the Reusable Accessories . . . . . . 247

Cleaning and Disinfecting Other Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . 248

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Overview

Use only the Dräger-approved substances and methods listed in this chapter to clean or disinfect the equipment. The warranty does not cover damage caused by using unapproved substances or methods.

Dräger has validated the cleaning and disinfection instructions included in this User Manual. It is the responsibility of the healthcare professional to ensure that the instructions are followed so as to ensure adequate cleaning and disinfection.

Dräger makes no claims regarding the efficacy of the listed chemicals or methods as a means for controlling infection. Contact infectious disease experts in the hospital for details.

General points

Keep the monitor, cables and accessories free of dust and dirt. To prevent the device from damage, follow the procedure:

Use only recommended cleaning substances and disinfectants listed in this manual. Others may cause damage (not covered by warranty), reduce product lifetime or cause safety hazards.

Always dilute according to the manufacturer’s instructions.

Unless otherwise specified, do not immerse any part of the equipment or any accessories in liquid.

Do not pour liquid onto the system.

Do not allow liquid to enter the case.

Never use abrasive material (such as steel wool or silver polish).

Inspect the monitor and reusable accessories after they are cleaned and disinfected.

Cleaning

If the device or accessory has been in contact with the patient, then cleaning and disinfection is required after every use. If there has been no patient contact and there is no visible contamination then daily cleaning and disinfection is appropriate.

The validated cleaning agents for cleaning the monitor and reusable accessories are:

Mild near neutral detergent

Ethanol (75%)

Isopropanol (70%)

Cleaning agents should be applied and removed using a clean, soft, non-abrasive cloth or paper towel.

CAUTION If the user spills liquid on the equipment, battery, or accessories, or they are accidentally immersed in liquid, contact service personnel or Dräger service engineer.

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Care and cleaning

Cleaning the monitor

To surface-clean the monitor, follow these steps:

1 Switch off the monitor and disconnect it from the power line.

2 Wipe the entire exterior surface, including the screen, of the equipment using a soft cloth dampened with the cleaning solution thoroughly until no visible contaminants remain.

3 After cleaning, wipe off the cleaning solution with a fresh cloth or towel dampened with tap water until no visible cleaning agent remains.

4 Dry the monitor in a ventilated and cool place.

Cleaning the Reusable Accessories

Cleaning the ECG Cable Assembly

1 Wipe the cable assembly with a soft cloth dampened with the cleaning solution until no visible contaminants remain.

2 After cleaning, wipe off the cleaning solution with a fresh cloth or towel dampened with tap water until no visible cleaning agent remains.

3 Wipe off residual moisture with a dry cloth.

4 Leave the cable assembly to air dry.

Cleaning the Blood Pressure Cuff

Cleaning the Cuff:

1 Take out the air bladder before cleaning.

2 Hand wash the cuff with the cleaning solution; clean the air bladder with a soft cloth dampened with the cleaning solution until no visible contaminants remain.

3 Rinse the cuff and after cleaning, wipe off the cleaning solution with a fresh cloth or towel dampened with tap water until no visible cleaning agent remains.

4 Wipe off residual moisture with a dry cloth.

5 Air dry the cuff thoroughly after cleaning.

Replacing the Air Bladder:

After cleaning, replace the air bladder into the cuff following the steps below:

1 Roll the bladder lengthwise and insert it into the cuff from the large opening at one end of the cuff.

2 Thread the hose from within the cuff and out through the small hole at the top of the cuff.

3 Adjust the bladder until it is in position.

Cleaning the SpO2 Sensor

1 Wipe the surfaces of the sensor and cable using a soft cloth dampened with the cleaning solution until no visible contaminants remain.

2 Wipe the patient contact area of the sensor with the cotton swab dampened with the cleaning solution. until no visible contaminants remain.

3 After cleaning, wipe off the cleaning solution with a fresh cloth or towel dampened with tap water until no visible cleaning agent remains.

4 Wipe off residual moisture with a dry cloth.

5 Leave the sensor to air dry.

Cleaning the IBP/C.O. cables/BIS patient interface cable

1 Wipe the cables with a soft cloth dampened with the cleaning solution until no visible contaminants remain.

2 After cleaning, wipe off the cleaning solution with a fresh cloth or towel dampened with tap water until no visible cleaning agent remains.

3 Wipe off residual moisture with a dry cloth.

4 Leave the cables to air dry.

CAUTION Before cleaning the monitor, make sure that the monitor is switched off and disconnected from the power line.

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Care and cleaning

246 Instructions for use Vista 120/Vista 120S SW 3.n

Cleaning the TEMP Sensor

1 Wipe the patient contact area with a soft cloth dampened with the cleaning solution until no visible contaminants remain.

2 After cleaning, wipe off the cleaning solution with a fresh cloth or towel dampened with tap water until no visible cleaning agent remains.

3 Wipe off residual moisture with a dry cloth.

4 Leave the sensor/probe to air dry.

Disinfection

For devices or accessories that have been in contact mucosal surface, High Level disinfection must occur, for all other accessories, low level disinfection is appropriate. Clean the monitor and reusable accessories before they are disinfected. The validated disinfectants for cleaning the monitor and reusable accessories are:

Ethanol (75%)

Isopropanol (70%)

Cidex OPA (High level disinfection of intracavitary temperature probe only)

If Ethanol or Isopropanol is used for both cleaning and disinfecting, then a new cloth is required to be used for the disinfection step.

Disinfecting the Monitor

To disinfect the monitor, follow these steps:

1 Switch off the monitor and disconnect it from the power line.

2 Wipe the display screen using a soft, clean cloth dampened with the disinfectant solution.

3 Wipe the exterior surface of the equipment using a soft cloth dampened with the disinfectant solution.

4 Wipe off the disinfectant solution with a dry cloth after disinfection if necessary.

5 Dry the monitor for at least 30 minutes in a ventilated and cool place.

CAUTION Do not use any disinfectant containing additional active ingredients other than those listed, such as disinfectant didecyl dimethyl ammonium bromide which contains quanternary ammonium salt.

CAUTION Although the monitor is chemically resistant to most common hospital cleaners, disinfectants and non-caustic detergents, unvalidated cleaners or disinfectants are not recommended and may stain the monitor, such as disinfectant didecyl dimethyl ammonium bromide which contains quanternary ammonium salt.

WARNING The monitor and reusable accessories shall be disinfected to avoid patient cross infection.

WARNING Before disinfecting the monitor, make sure that the monitor is switched off and disconnected from the power line.

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Instructions for use Vista 120/Vista 120S SW 3.n 247

Care and cleaning

Disinfecting the Reusable Accessories

Disinfecting the ECG Cable Assembly

1 Wipe the cable assembly with a soft cloth dampened with the disinfectant solution.

2 Wipe off the disinfectant solution with a dry cloth after disinfection.

3 Leave the cable assembly to air dry for at least 30 minutes.

Disinfecting the Blood Pressure Cuff

Disinfecting the Cuff:

1 Take out the air bladder before disinfection.

2 Wipe the cuff and the air bladder with a soft cloth dampened with the disinfectant solution.

3 Leave the cuff and air bladder to air dry for at least 30 minutes.

Replacing the Air Bladder:

After disinfection, replace the air bladder into the cuff. Refer to Section Cleaning the blood pressure cuff for more information.

Disinfecting the SpO2 Sensor

1 Wipe the surfaces of the sensor and cable using a soft cloth dampened with the disinfection solution.

2 Wipe the patient contact area of the sensor with the cotton swab dampened with the disinfection solution.

3 Wipe off the disinfection solution with a dry cloth after disinfection.

4 Leave the sensor to air dry for at least 30 minutes.

Disinfecting the IBP/C.O. cables/BIS patient interface cable

1 Wipe the cables with a soft cloth dampened with the disinfectant solution.

2 Wipe off the disinfectant solution with a dry cloth after disinfection.

3 Leave the cables to air dry for at least 30 minutes.

Disinfecting the TEMP sensor

The intracavitary TEMP sensors should be reprocessed by high-level disinfection before and after use on each new patient. Cidex OPA is the validated agent for high level disinfection. Refer to the instructions of the disinfectant for the methods of disinfection. High level disinfection has been validated with a 12 minute soak. Rinse and dry according to the labeled instructions of Cidex OPA. Do not dampen the sensor connector.

For the skin TEMP sensors, disinfect them as follows using ethanol or isopropanol only:

1 Wipe the patient contact area with a soft cloth dampened with the disinfectant solution (ethanol or isopropanol).

2 Wipe off the disinfectant solution with a dry cloth after disinfection.

3 Leave the sensor to air dry.

NOTE Prolonged use of disinfectant may cause discoloration of the cuff.

NOTE Do not use phenol disinfectants because vinyl absorbs them. Do not use strong aromatic, chlorinated, ketone, ether or ester solvents. Do not immerse the cables for any prolonged period in alcohol, mild organic solvents, or highly alkaline solutions. Never boil or autoclave the cable. Vinyl withstands temperatures up to 100 °C but begins to soften at around 90 °C. Handle gently when hot and wipe away from the tip toward the cable.

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Care and cleaning

248 Instructions for use Vista 120/Vista 120S SW 3.n

Cleaning and Disinfecting Other Accessories

For cleaning and disinfecting other accessories, refer to the instructions delivered with the accessories. If the accessories are not accompanied by instructions, refer to this manual for the methods of cleaning and disinfecting the monitor.

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Instructions for use Vista 120/Vista 120S SW 3.n 249

Maintenance

Maintenance

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250

Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250

Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251

Replacing fuse . . . . . . . . . . . . . . . . . . . . . . . . 251

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Maintenance

250 Instructions for use Vista 120/Vista 120S SW 3.n

Overview

Inspection

The overall check of the monitor, including the safety check, should be performed by trained service personnel every 24 months, and following repair.

The following items should be checked:

If the environmental condition and power supply meet requirements.

If the power supply cord is damaged and the insulation is not cut.

If the device and accessories are damaged.

Specified accessories.

If the alarm system works properly.

If the recorder works properly and there is sufficient paper.

Battery performance

If all monitoring functions are in good condition.

If grounding resistance and leakage function properly.

If any damage or abnormality is found, do not use the monitor and contact customer support.

Maintenance shall be carried out at least once every two years, or as specified by local regulations. The following tasks are for Dräger-qualified service professionals only. Contact an Dräger-qualified service provider if the monitor needs a safety or performance test. Clean and disinfect equipment to decontaminate it before testing or maintaining it.

WARNING Failure on the part of the responsible institution to implement a satisfactory maintenance schedule may cause undue equipment failure and possible health hazards.

WARNING If the monitor is mechanically damaged, or if it is not working properly, do not use it. Contact technical personnel.

WARNING If the user finds any problems with the equipment, contact service personnel or authorized supplier.

WARNING The maintenance operations such as software upgrade of the device shall only be conducted by Dräger-qualified service professionals.

WARNING Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

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Instructions for use Vista 120/Vista 120S SW 3.n 251

Maintenance

Repair

Dräger recommends that all repairs are carried out by DrägerService and that only authentic Dräger repair parts are used.

Replacing fuse

Only applicable to Vista 120.

To replace the blown fuse:

1 Switch off the monitor and unplug the power cable.

2 Carefully place the monitor upside down on a flat surface covered with cloth or other protecting pad.

3 Pull out the fuse box from the groove and the user will see the fuse.

4 1.Remove the old fuse. Take out a new fuse with the following specifications: ø 5 mm x 20 mm: Model: T3.15AH250VP.

5 Place the new fuse in the fuse socket and push the box back into position.

Maintenance and Test Schedule Frequency

Safety checks. Selected tests on the basis of IEC60601-1

At least once every two years, or as needed, after any repairs where the power supply is removed or replaced, or if the monitor has been dropped.

Check all monitoring functions and measuring functions

At least once every two years, or as needed.

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Disposal

Disposal

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 254

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Disposal

254 Instructions for use Vista 120/Vista 120S SW 3.n

Overview

For countries subject to EU Directive 2002/96/EC:

This device is subject to EU directive 2002/96/EC (WEEE). In order to comply with its registration according to this directive, it may not be disposed of at municipal collection points for waste electrical and electronic equipment. Dräger has authorized a company to collect and dispose of this device. To initiate take-back or for further information, visit us on the Internet at www.draeger.com and navigate to the DrägerService area where the user will find a link to “WEEE”. If the user has no access to our website, contact the local Dräger organization.

CAUTION The device and its components must be disinfected and cleaned before disposal!

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Instructions for use Vista 120/Vista 120S SW 3.n 255

Accessories

Accessories

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 256

ECG accessories . . . . . . . . . . . . . . . . . . . . . . 256

SpO2 accessories . . . . . . . . . . . . . . . . . . . . . . 258

NIBP accessories . . . . . . . . . . . . . . . . . . . . . . 258

Temp accessories. . . . . . . . . . . . . . . . . . . . . . 259

IBP accessories . . . . . . . . . . . . . . . . . . . . . . . 260

CO2 accessories. . . . . . . . . . . . . . . . . . . . . . . 260

C.O. Accessories . . . . . . . . . . . . . . . . . . . . . . 261

BIS Accessories . . . . . . . . . . . . . . . . . . . . . . . 262

Anesthesia gas accessories . . . . . . . . . . . . . 262

Device accessories . . . . . . . . . . . . . . . . . . . . 262

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Accessories

256 Instructions for use Vista 120/Vista 120S SW 3.n

Overview

Accessories can be ordered from the local Dräger representative.

The following cables may not all be available in all countries. Check availability with the local Dräger supplier.

ECG accessories

The following table lists the optional configuration for the monitor:

WARNING Never reuse disposable transducers, sensors or other accessories that are intended for single-use or single patient use only. Reuse may compromise device functionality and system performance and cause a potential hazard.

WARNING Only use accessories that are approved by Dräger. Using accessories that are not approved by Dräger may compromise device functionality and system performance and cause a potential hazard.

WARNING IBP and C.O. sterilized accessories are already sterilized, refer to the package labeling for detailed method. Do not use a sterilized accessory if its packaging is damaged.

NOTE Transducers and sensors have a limited shelf life. Refer to the package labeling.

Part Number Accessory

2606495 ECG trunk cable, 3-lead, IEC/AHA

2606496 ECG trunk cable, 5-lead, IEC/AHA

2606492 ECG trunk cable, 3-lead, for Neonates, IEC & AHA*

2606493 ECG limb wires, 3-lead, Grabber, IEC

2606494 ECG limb wires, 5-lead, Grabber, IEC

2606497 ECG limb wires, 3-lead, Grabber, AHA

2606498 ECG limb wires, 5-lead, Grabber, AHA

2612000 ECG leadwire, 3-lead single-pin, IEC, 1m

2612001 ECG leadwire, 3-lead single-pin, AHA, 1m

2612002 ECG leadwire, 5-lead single-pin, IEC, 1.5m

2612003 ECG leadwire, 5-lead single-pin, AHA, 1.5m

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Instructions for use Vista 120/Vista 120S SW 3.n 257

Accessories

* Note: For use with the following part numbers: 2612020, 2612021, 2612024, 2612025.

2612020 ECG defib trunk cable, 3/5-lead single-pin, 1.5m

2612021 ECG defib trunk cable, 3/5-lead single-pin, 2.5m

2612026 ECG defib trunk cable, Neonate, single-pin, 1.5m

2612027 ECG defib trunk cable, Neonate, single-pin, 2.5m

2612024 ECG ESU trunk cable, 3/5-lead single-pin, 1.5m

2612025 ECG ESU trunk cable, 3/5-lead single-pin, 2.5m

2612028 ECG ESU trunk cable, Neonate, single-pin, 1.5m

2612029 ECG ESU trunk cable, Neonate, single-pin, 2.5m

MS14555 MonoLead 3, EURO, 2m *

MS14556 MonoLead 3, AHA/US, 2m *

MS28561 ECG cable MonoLead 3, EURO, 4.1m *

MS28557 ECG cable MonoLead 3 AHA/US 4.1m *

MS14559 MonoLead 5, EURO, 2.5m *

MS14560 MonoLead 5, AHA/US, 2.5m *

MS28559 ECG cable MonoLead 5, EURO, 5.3m *

MS28558 ECG cable MonoLead 5 AHA/US 5.3m *

MP03401 ECG 3-Lead single-pin EURO, 1m *

MP03402 ECG 3-Lead single-pin AHA, 1m *

MP03403 ECG 5-Lead single-p EURO, 1.5m *

MP03404 ECG 5-Lead single-p AHA, 1.5m *

MP00875 Single Patient Use ECG 3-Lead IEC1 *

MP00877 Single_Patient_Use_ECG_3_Lead_IEC2 *

MP00879 Single_Patient_Use_ECG_5_Lead_IEC1 *

MP00881 Single_Patient_Use_ECG_5_Lead_IEC2 *

MS25951 ECG Neo Adapter cable, 2m *

5195024 Neonatal electrodes with attached lead wire, 100 packages of 3 electrodes

2606247 Adhesive ECG Electrodes, Adult, Disposable, 300 pcs

2606248 Adhesive ECG Electrodes, Children/Neonatal, Disposable, 500 pcs

2606249 Adhesive ECG Electrodes, Adult, Disposable, 1000 pcs

Part Number Accessory

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258 Instructions for use Vista 120/Vista 120S SW 3.n

SpO2 accessories

NIBP accessories

Part Number Accessory

2606483 SpO2 Finger Sensor, adult, 2.5 m, reusable

2606484 SpO2 Finger Sensor, adult, 1 m, reusable

2606485 SpO2 Silicone Soft-tip Sensor, adult, 1 m, reusable

2606486 SpO2 Silicone Soft-tip Sensor, pediatric, 1 m, reusable

2606487 SpO2 Extension cable, 2m, reusable

2606208 SpO2 Sensor, adult, 0.5 m, disposable, 25 pieces

2606209 SpO2 Sensor, pediatric, 0.5 m, disposable, 25 pieces

2606210 SpO2 Sensor, Infant, 0.5 m, disposable, 25 pieces

2606211 SpO2 Sensor, Neonate, 0.5 m, disposable, 25 pieces

7262764 Nellcor Reusable Adult SpO2 Sensor (DS-100A OxiMax)

MS20979 Nellcor SpO2 Extension cable (Compatible with Nellcor OXI-Max SpO2 module and Nellcor sensor) 3 meter

MP00748 Nellcor SpO2 Extension cable (Compatible with Nellcor OXI-Max SpO2 module and Nellcor sensor) 1.2 meter

MX01004 SpO2 Multipurpose sensor Nellcor Dura-Y reusable

MX01005 Earclip for Nellcor Dura-Y

MX50070 SpO2- Sensor Nellcor Oximax Max-Fast

Part Number Accessory

2606151 NIBP Cuff, E5, Infant, 10 cm - 15 cm, reusable

2606152 NIBP Cuff, E6, Small child, 13 cm - 17 cm, reusable

2606153 NIBP Cuff, E7, Child, 16 cm - 21.5 cm, reusable

2606154 NIBP Cuff, E8, Small adult, 20.5 cm - 28 cm, reusable

2606155 NIBP Cuff, E9,Adult, 27 cm - 35 cm, reusable

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Instructions for use Vista 120/Vista 120S SW 3.n 259

Accessories

Temp accessories

2606156 NIBP Cuff, E10,Larger Adult, 34 cm - 43 cm, reusable

2607034 NIBP Cuff, Neonatal #1, 3 cm – 6 cm, disposable

2607035 NIBP Cuff, Neonatal #2, 4 cm – 8 cm, disposable

2607036 NIBP Cuff, Neonatal #3, 6 cm – 11 cm, disposable

2607037 NIBP Cuff, Neonatal #4, 7 cm – 13 cm, disposable

2607038 NIBP Cuff, Neonatal #5, 8 cm – 15 cm, disposable

2601195 NIBP Tube, 3m

Part Number Accessory

Part Number Accessory

2601197 Temperature Probe Skin, adult, 3m, reusable

2601198 Temperature Probe, rectal/oral, adult, 3m, reusable

2601199 Temperature probe, rectal/oral, neonatal/infant, 3m, reusable

2601200 Temperature probe, skin, neonatal/infant, 3m, reusable

MP00943 TEMP adapter, jack connector

7014616 Protective cover for general-purpose temp probe, contains latex

MP00991 General-purpose temp probe, single-pat. use, adult, 7-pin connector, 1.6 m

MP00992 General-purpose temp probe, single-pat. use, adult, 7-pin connector, 3 m

MP00993 General-purpose temp probe, single-pat. use, child, 7-pin connector, 1.6 m

MP00994 General-purpose temp probe, single-pat. use, child, 7-pin connector, 3 m

MP00995 Skin temp probe, single-pat. use, adult, 7-pin connector, 1.6 m

MP00996 Skin temp probe, single-pat. use, adult, 7-pin connector, 3 m

MP00997 Skin temp probe, single-pat. use, child/neonatal, 7-pin connector, 1.6 m

MP00998 Skin temp probe, single-pat. use, child/neonatal, 7-pin connector, 3 m

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Accessories

260 Instructions for use Vista 120/Vista 120S SW 3.n

IBP accessories

CO2 accessories

Part Number Accessory

2606488 IBP cable Becton Dickinson

2606489 IBP cable Edwards

2606490 IBP cable Abbot, Medex, Hospira

2606491 IBP cable Utah

2607558 IBP cable 7-Pin

2607559 IBP cable 10-Pin

2606225 Disposable pressure transducer kit, BD

Part Number Accessory

CO2 Respironics Mainstream

2606226 etCO2 Module with disp. Adult airway adapter

2606227 CO2 Airway Adapter, Adult, disposable, 10 pieces

2606228 CO2 Airway Adapter, Neonatal (infant/pediatric), 10 pcs.

CO2 Sidestream Respironics LoFlow

2605125 Respironics etCO2 module/(Side-stream)

2605126 LoFloTM Module Mounting Bracket

2605127 Disposable CO2 Nasal Cannula - Adult

2605128 Adult/Pediatric Airway adapter kit with dehumidification tubing

2605129 Disposable Sampling Line Kit with Dehumidification Tubing

2605130 Adult Nasal CO2 with O2 delivery sampling cannula(Respironics 3469ADU-00)

2605081 Pediatric Nasal CO2 with O2 delivery sampling cannula

2605082 Infant Nasal CO2 with O2 delivery sampling cannula

2605083 Adult Nasal/Oral CO2 sampling cannula

2605084 Pediatric Nasal/Oral CO2 sampling cannula

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Instructions for use Vista 120/Vista 120S SW 3.n 261

Accessories

C.O. Accessories

2605085 Adult Nasal/Oral CO2 with O2 delivery sampling cannula

2605086 Adult/Pediatric Airway adapter kit

2605087 Disposable CO2 Nasal Cannula - Pediatric

2605088 Disposable CO2 Nasal Cannula - Infant

2605089 Pediatric/Infant Airway adapter kit with dehumidification tubing

CO2 Dräger G2 Sidestream

2605115 1 x Dräger G2 CO2 Module Kit 1 x Dräger G2 CO2 Module Mounting Bracket

2607550 Disposable CO2 Sampling line with male luer lock

2607551 Adult Nasal CO2 sampling cannula

2607552 Child Nasal CO2 sampling cannula

2607553 Infant Nasal CO2 sampling cannula

2607554 Adult Nasal CO2 with O2 delivery sampling cannula

2607555 Child Nasal CO2 with O2 delivery sampling cannula

2605124 Water Trap

CO2 Dräger MCable Mainstream

6871950 Dräger MCable Mainstream CO2

2607032 CO2 interface cable for Dräger CO2

MP01062 CO2 cuvette, adult, disp, 10 pcs

MP01063 CO2 cuvette, pedi., disp, 10 pcs

6870279 CO2 cuvette, adult, reusable

6870280 CO2 cuvette, pediatric, reusable

8416352 Parking Holder for Dräger Mcable CO2 Sensor

Part Number Accessory

Part Number Accessories

2601190 In-line Injection temperature probe (BD 684056-SP4042)

2601191 In-line Injection temperature probe housing (BD 680006-SP5045)

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Accessories

262 Instructions for use Vista 120/Vista 120S SW 3.n

BIS Accessories

Anesthesia gas accessories

Device accessories

2601192 Control Syringe (Medex MX387)

2601201 Cardiac output cable

Part Number Accessories

NOTE The Thermodilution Catheter is required when measuring C.O.. Swan-Ganz catheter (Type 131HF7 and 741HF7), manufactured by Edwards Lifesciences Corporation, has been validated to be compatible with the monitor. Refer to Edwards for more details.

Part Number Accessories

2607560 BISx adapter cable Vista120

2607561 BISx Pod Vista120

MP00005 BIS 4 Electrode Sensor (box of 25)

MP00003 BIS Pediatric Sensor (box of 25)

Part Number Accessory

8601473 SCIO direct connect cable to Vista 120

Part Number Accessory

2606229 Vista 120 Rechargeable Lithium-Ion Battery, 5000 mAh

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Instructions for use Vista 120/Vista 120S SW 3.n 263

Accessories

2606231 Vista 120 Printing paper, 4 rolls

2606232 Vista 120 Ground Cable

2607062 Vista 120 Mounting adaptor 2

2601146 Vista 120 New mounting adaptor

2601147 Vista 120 Mounting arm

2601148 Vista 120 Mounting Arm, with basket

2601149 Vista 120 Rolling stand

2607115 RS232 cable for Savina

2603244 RS232 cable for Zeus/IE

2603245 RS232 cable for VN500/V300/V500/A500/Atlan

NOTE The part description may vary depending on context, but the part number is constant.

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Technical data

Technical data

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 266

Classification . . . . . . . . . . . . . . . . . . . . . . . . . 266

Device specifications. . . . . . . . . . . . . . . . . . . 266

Function configuration . . . . . . . . . . . . . . . . . 267

Ambient conditions . . . . . . . . . . . . . . . . . . . . 268

Leakage current . . . . . . . . . . . . . . . . . . . . . . . 268

Power supply . . . . . . . . . . . . . . . . . . . . . . . . . 269

Display. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 270

Recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 270

Data management. . . . . . . . . . . . . . . . . . . . . . 271Data review. . . . . . . . . . . . . . . . . . . . . . . . . . . . 271Data storage . . . . . . . . . . . . . . . . . . . . . . . . . . . 271

Wi-Fi. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 272

ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2723-, 5-lead monitoring . . . . . . . . . . . . . . . . . . . . 272

RESP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 277

NIBP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 278

SpO2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 279

PR. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 281

TEMP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 281

IBP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 282

CO2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 283

C.O. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 291

AG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 292

BIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 293

Interfaces. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 293

Analog Output . . . . . . . . . . . . . . . . . . . . . . . . . 293Defibrillator Synchronization . . . . . . . . . . . . . . 294Nurse Call . . . . . . . . . . . . . . . . . . . . . . . . . . . . 295USB Interfaces . . . . . . . . . . . . . . . . . . . . . . . . 295VGA Interface . . . . . . . . . . . . . . . . . . . . . . . . . 295SCIO Interface/ Medibus/X Interface. . . . . . . . 296Network Interface . . . . . . . . . . . . . . . . . . . . . . 296

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Overview

Classification

Device specifications

NOTE The performance of the equipment with ☆ mark is determined to be essential performance.

Protection class Class I equipment and internal powered equipment

Degree of protection against electric shock

CF: ECG (RESP), TEMP, IBP, C.O.

BF: SpO2, NIBP, CO2, AG, BIS

Defibrillation protection Yes

Liquid ingress protection IPX1

Disinfection/sterilization method Refer to chapter “Care and Cleaning” for details.

Mode of operation Continuous

Compliant with Standards IEC 60601-1: 2005+A1 :2012; IEC 60601-1-2: 2014;

EN 60601-1: 2006+A1 :2013; EN 60601-1-2: 2015;

IEC 60601-2-49: 2011

Model Size (W × H × D) Weight (standard configuration, without battery and accessories)

Vista 120 (408±3) mm × (316±2) mm × (157±2) mm < 7 kg

Vista 120S (344±3) mm × (266±2) mm × (145±2) mm < 5 kg

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Function configuration

Product Model Configuration

Vista 120

A ECG, RESP, TEMP, SpO2 (Dräger), NIBP, AG

Wired network, Wi-Fi

A+ ECG, RESP, TEMP, SpO2 (Nellcor), NIBP, AG

Wired network, Wi-Fi, recorder

C

ECG, RESP, TEMP, SpO2(Dräger), NIBP, AG, IBP, C.O., CO2(Dräger G2), CO2(Respironics C5, LoFlo), CO2 (Dräger MCable), BISx

Wired network, Wi-Fi, recorder

C+

ECG, RESP, TEMP, SpO2(Nellcor), NIBP, AG, IBP, C.O., CO2(Dräger G2), CO2(Respironics C5, LoFlo), CO2 (Dräger MCable), BISx

Wired network, Wi-Fi, recorder

Vista 120S

A ECG, RESP, TEMP, SpO2 (Dräger), NIBP, AG

Wired network

A+ ECG, RESP, TEMP, SpO2(Nellcor), NIBP, AG

Wired network, Wi-Fi, recorder

C ECG, RESP, TEMP, SpO2 (Dräger), NIBP, AG, IBP, C.O., CO2

(Dräger G2), CO2(Respironics C5, LoFlo), CO2 (Dräger MCable)

Wired network, Wi-Fi, recorder

C+ ECG, RESP, TEMP, SpO2(Nellcor), NIBP, AG, IBP, C.O., CO2

(Dräger G2), CO2 (Respironics C5, LoFlo), CO2 (Dräger MCable)

Wired network, Wi-Fi, recorder

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Ambient conditions

Leakage current

WARNING The monitor may not meet the performance specifications given here if stored or used outside the specified temperature, humidity and altitude ranges.

Temperature

Operating +0 °C to +40 °C (+32 °F to +104 °F)

Transport and storage -20 °C to +55 °C (-4 °F to +131 °F)

Relative humidity

Operating 15%RH to 95%RH (non-condensing)

Transport and storage 15%RH to 95%RH (non-condensing)

Ambient pressure

Operating 86 kPa to 106 kPa

Transport and storage 70 kPa to 106 kPa

Applied part Normal condition Single fault condition

Earth leakage current < 0.5 mA < 1 mA

Enclosure leakage current < 0.1 mA < 0.5 mA

Patient leakage current CF AC: < 0.01 mA DC: < 0.01 mA

AC: < 0.05 mA DC: < 0.05 mA

BF AC: < 0.1 mA DC: < 0.01 mA

AC: < 0.5 mA DC: < 0.05 mA

Patient leakage current (Mains on applied parts)

CF < 0.05 mA

BF < 5 mA

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Power supply

Patient auxiliary current CF AC: <0.01 mA DC: <0.01 mA

AC: <0.05 mA DC: <0.05 mA

BF AC: <0.1 mA DC: <0.01 mA

AC: <0.5 mA DC: <0.05 mA

Power supply 100 V to 240 V~, 50 Hz/60 Hz

Current =1.4 A-0.7 A

FUSE T 3.15 AH, 250 VP

Battery (optional)

Quantity 1

Capacity 5000 mAh

Battery life Vista 120 ≥ 300 min (At 25±2 °C, with (a) new fully charged battery/batteries, continuous SpO2 measurement and NIBP automatic measurement mode at interval of 15 minutes, Dräger ECG/TEMP module connected, recording at interval of 10 minutes, brightness set to “1”)

Vista 120S ≥ 350 min (At 25±2 °C, with (a) new fully charged battery/batteries, continuous SpO2 measurement and NIBP automatic measurement mode at interval of 15 minutes, Dräger ECG/TEMP module connected, recording at interval of 10 minutes, brightness set to “1”)

Battery charge time Vista 120 ≤ 390 min, 100% charge

≤ 351 min, 90% charge (Monitor is on or in standby mode.)

Vista 120S ≤ 390 min, 100% charge

≤ 351 min, 90% charge (Monitor is off.)

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Display

Recorder

Product Display Messages

Vista 120 Display screen: 15” color TFT

Resolution: 1024 × 768

A maximum of 13 waveforms One power LED Two alarm LEDs One charge LED

Vista 120S Display screen: 12.1” color TFT

Resolution: 800 × 600

A maximum of 11 waveforms One power LED Two alarm LEDs One charge LED

Record width 48 mm

Paper speed 12.5 mm/s, 25 mm/s, 50 mm/s

Trace Up to 3

Recording types Continual real-time recording8-second/20-second real-time recordingTrend graph recordingTrend table recordingNIBP review recordingArrhythmia review recordingAlarm review recordingC.O. measurement recordingFrozen waveform recording Drug calculation titration recordingHemodynamic Calculation result recording Oxygenation Calculation result recordingVentilation Calculation result recordingRenal Function Calculation result recording

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Data management

Data review

Refer to Chapter Review for more information about data review.

Data storage

A single piece of patient data maximally contains the following information:

The following storage capacity for 1G extended space is for reference:

Trend Data Short: 3 hours, resolution: 1 sLong: 150 hours, resolution: 1 min

Alarm Events Up to 200 sets

NIBP Measurement Data 1200 sets

Arrhythmia Events Up to 200 sets

Patient information MRN, name, date of birth, date of admission, gender, type, height, weight, blood type, pace, doctor, bed No., department

Trend graph and trend table 240 hours, resolution: 1 min

NIBP measurement review 1200 sets

Alarm review 200 sets

Arrhythmia event 200 sets

Full disclosure waveforms

Vista 120S: 48 hours Vista 120: 96 hours The specific storage time depends on the waveforms stored and the number of stored waveforms.

Continuous parameter data 720 hours, resolution: 1 minNIBP data At least 68000 setsPhysiological alarm event At least 4500 setsArrhythmia event At least 4500 setsFull disclosure waveforms 30 hours

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Refer to Section Storing data in the storage device for more information about storing data in the storage medium.

Wi-Fi

ECG

3-, 5-lead monitoring

Complies with IEC 60601-2-27: 2011.

IEEE 802.11b/g/n

Frequency Band 2.4 GHz ISM band

Modulation OFDM with BPSK, QPSK, 16-QAM, and 64-QAM802.11b with CCK and DSSS

Typical Transmit Power (±2 dBm) 17 dBm for 802.11b DSSS17 dBm for 802.11b CCK15 dBm for 802.11g/n OFDM

Lead Mode 3-Lead: I, II, III 5-Lead: I, II, III, aVR, aVL, aVF, V

Lead Naming Style AHA, IEC

☆ Display Sensitivity (Gain Selection)

1.25 mm/mV (×0.125), 2.5 mm/mV (×0.25), 5 mm/mV (×0.5), 10 mm/mV (×1), 20 mm/mV (×2), 40 mm/mV (×4), AUTO gain

☆ Sweep 6.25 mm/s, 12.5 mm/s, 25 mm/s, 50 mm/s

Bandwidth (-3dB) Diagnosis: 0.05 Hz to 150 HzMonitor: 0.5 Hz to 40 HzSurgery: 1 Hz to 20 Hz

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☆ CMRR (Common Mode Rejection Ratio)

Diagnosis: >95 dBMonitor: >105 dBSurgery: >105 dB

Notch In diagnosis, monitor and surgery modes: 50 Hz/60 Hz (Notch filter can be turned on or off manually)

☆ Differential Input Impedance >5 MΩ

☆ Input Signal Range ±10 mV PP

☆ Accuracy of Signal Reproduction

An error of ≤ ±20 % of the nominal value of the output or ±100 μV, whichever is greater. The total error and frequency response comply with IEC 60601-2-27: 2011, Sect. 201.12.1.101.1.

☆ Electrode Offset Potential Tolerance

±800 mV

Auxiliary Current (Leads off detection)

Active electrode: <100 nA Reference electrode: <900 nA

☆ Recovery Time After Defibrillation

< 5 s (measured without electrodes as IEC60601-2-27:2011, Sect. 201.8.5.5.1 requires.)

Leakage Current of Patient < 10 μA

Scale Signal 1 mV PP, accuracy is ±5%

☆ System Noise < 30 μVPP

☆ Multichannel Crosstalk ≤ 5% of the input signal Complied with IEC 60601-2-27: 2011, Sect. 201.12.1.101.5.

☆ Frequency and Impulse Response

Frequency response: Input a 5 Hz, 1 mV sine wave signal, and the output signal amplitude remains within the range of 71 % to 110 % at 0.67 Hz and 40 Hz. Input a 1 Hz, 1.5 mV 200 ms triangular wave input signal, and the output shall be within 11.25 mm~15 mm. Impulse response: Displacement value: ≤ 0.1 mV Slope: ≤ 0.3 mV/s following the end of the pulse. Complied with IEC 60601-2-27: 2011, Sect. 201.12.1.101.8.

Sampling Frequency 1000 Hz

Sampling Channel Switch Time < 80 μS

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A/D Precision 24 Bits (Minimum resolution: 0.077uV/LSB)

☆ ESU Protection Cut mode: 300 WCoagulation mode: 100 WRestore time: ≤10 s

Electrosurgical Interference Suppression

Test according to ANSI/AAMI EC13:2002, Sect. 5.2.9.14. Complied with ANSI/AAMI EC13:2002, Sect. 4.2.9.14.

Minimum Input Slew Rate (Lead II)

> 2.5 V/s

☆ Baseline Reset Time < 3 s

Pace Pulse

☆ Pulse Indicator Pulse is marked if the requirements of IEC 60601-2-27: 2011, Sect. 201.12.1.101.12 are met:Amplitude: ±2 mV to ±700 mVWidth: 0.1 ms to2.0 msAscending time: 10 μs to 100 μs

☆ Pulse Rejection Pulse is rejected if the requirements of IEC 60601-2-27: 2011, Sect. 201.12.1.101.13 are met:Amplitude: ±2 mV to ±700 mVWidth: 0.1 ms to 2.0 msAscending time: 10 μs to 100 μs

Pace Pulse Detecting Lead: one among I, II, III, AVR, AVL, AVF, V

Heart Rate

HR Calculation

☆ Range ADU: 15 bpm to 300 bpmPED/NEO: 15 bpm to 350 bpm

☆ Accuracy ±1% or 1 bpm, whichever is greater

Resolution 1 bpm

Sensitivity ≥ 300 μVPP

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☆ QRS Detection Range The detection range has exceeded the requirement described in the standard: Width: 70 ms~120 ms for adult, 40 ms~120 ms for Pediatric/neonate. Amplitude: 0.5 mv~5 mv In adult mode, these two signals are not responded: 1 when QRS amplitude of 0.15 mV or less is applied; 2 when QRS duration of 10 ms and QRS amplitude of 1 mV or

less is applied.Complied with IEC 60601-2-27: 2011, Sect. 201.12.1.101.15.

PVC

Range ADU: (0 to 300) PVCs/ minPED/NEO: (0 to 350) PVCs/ min

Resolution 1 PVCs/min

ST value

Range -2.0 mV to +2.0 mV

Accuracy -0.8 mV to +0.8 mV: ±0.02 mV or 10%, whichever is greater.Beyond this range: not specified.

Resolution 0.01 mV

HR Averaging Method

Method 1 Heart rate is computed by excluding the minimum and maximum values from the 12 most recent RR intervals and averaging the residual 10 RR intervals.

Method 2 If each of three consecutive RR intervals is greater than 1200 ms, then the four most recent RR intervals are averaged to compute the HR.

Range of Sinus and SV Rhythm

Tachy Adult: RR interval for 5 consecutive QRS complex ≤ 0.5 s. Pediatric/neonatal: RR interval for 5 consecutive QRS complex ≤ 0.375 s.

Normal Adult: 0.5 s < RR interval for 5 consecutive QRS complex < 1.5 s. Pediatric/neonatal: 0.375 s < RR interval for 5 consecutive QRS complex < 1 s.

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Brady Adult: RR interval for 5 consecutive QRS complex ≥ 1.5 s.Pediatric/neonatal: RR interval for 5 consecutive QRS complex ≥ 1 s.

Range of Ventricular Rhythm

Ventricular Tachycardia The interval of 5 consecutive ventricular beats is less than 600 ms

Ventricular Rhythm The interval of 5 consecutive ventricular beats ranges from 600 ms to 1000 ms

Ventricular Bradycardia The interval of 5 consecutive ventricular beats is more than 1000 ms

Maximum Start-up Alarm Time for Tachycardia

Ventricular Tachycardia1 mV 206 bpm

Gain 0.5: 10 sGain 1.0: 10 sGain 2.0: 10 s

Ventricular Tachycardia2 mV 195 bpm

Gain 0.5: 10 sGain 1.0: 10 sGain 2.0: 10 s

Response Time of Heart Rate Meter to Change in HR

HR range: 80 bpm to 120 bpmRange : Within 11 sHR range: 80 bpm to 40 bpmRange : Within 11 s

☆ Tall T-wave Rejection Complied with IEC 60601-2-27: 2011, Sect. 201.12.1.101.17 minimum recommended 1.2 mV T-Wave amplitude

Accuracy of Heart Rate Meter and Response to Irregular Rhythm

Complied with IEC 60601-2-27: 2011, Sect. 201.7.9.2.9.101 b) 4), the HR value after 20 s of stabilization is displayed as follows:Ventricular bigeminy: 80 bpm±1 bpmSlow alternating ventricular bigeminy: 60 bpm±1 bpmRapid alternating ventricular bigeminy: 120 bpm±1 bpmBidirectional systoles: 91 bpm±1 bpm

Time to Alarm for Heart Rate alarm conditions

Asystole alarm: ≤ 10 sHR low alarm: ≤ 10 sHR high alarm: ≤ 10 s

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RESP

Arrhythmia analyses Asystole V-Fib/V-Tach Couplet

Run PVCs PVC Bigeminy PVC Trigeminy

Vent Rhythm R on T PVC

Tachy Brady MISSED BEATS

IRR Brady Pacer not Capture

Pacer not Pacing

Method Impedance between RA-LL, RA-LA

Measurement lead Options are lead I and II. The default is lead II.

Calculation Type Manual, Automatic

Baseline Impedance Range 200 Ω to 2500 Ω(with ECG cables of 1 KΩ resistance)

Measuring Sensitivity Within the baseline impedance range: 0.3 Ω

Waveform Bandwidth 0.2 Hz to 2.5 Hz (-3 dB)

Respiration Excitation Waveform

Sinusoid, 45.6 kHz(±10%), < 350 μA

☆ RR Measuring Range

☆ Adult 0 rpm to120 rpm

☆ Neo/Ped 0 rpm to150 rpm

Resolution 1 rpm

☆ Accuracy

☆ Adult 6 rpm to 120 rpm: ±2 rpm0 rpm to 5 rpm: not specified

☆ Neo/Ped 6 rpm to 150 rpm: ±2 rpm0 rpm to 5 rpm: not specified

☆ Gain Selection ×0.25, ×0.5, ×1, ×2, ×3, ×4, ×5

☆ Sweep 6.25 mm/s, 12.5 mm/s, 25 mm/s, 50 mm/s

☆ Apnea Alarm Time Setup 10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s; default value is 20 s.

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NIBP

Complies with IEC 80601-2-30: 2009+A1: 2013.

Method Oscillometric

Mode Manual, Auto, Continuous

Measuring interval in AUTO mode (unit: minutes)

1/2/2.5/3/4/5/10/15/30/60/90/120/180/240/360/480

Continuous 5 min, interval is 5 s

Measuring type SYS, DIA, MAP

☆ Alarm type SYS, DIA, MAP

☆ Measuring range

☆ Adult mode SYS: 40 to 270 mmHgDIA: 10 to 215 mmHgMAP: 20 to 235 mmHg

☆ Pediatric mode SYS: 40 to 230 mmHg DIA: 10 to 180 mmHgMAP: 20 to 195 mmHg

☆ Neonatal mode SYS: 40 to 135 mmHgDIA: 10 to 100 mmHgMAP: 20 to 110 mmHg

☆ Cuff pressure measuring range

0 to 300 mmHg

Pressure resolution 1 mmHg

☆ Maximum mean error ±5mmHg

☆ Maximum standard deviation

8 mmHg

Maximum measuring period

Adult/Pediatric 120 s

Neonate 90 s

Typical measuring period 20 to 35 s (depend on HR/motion disturbance)

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SpO2

Complies with ISO 80601-2-61: 2011.

Dual independent channel overpressure protection

Adult 297 ±3 mmHg

Pediatric 245 ±3 mmHg

Neonatal 147 ±3 mmHg

Pre-inflation pressure

Adult Default: 160 mmHgRange: 80/100/120/140/150/160/180/200/220/240 mmHg

Pediatric Default: 140 mmHgRange: 80/100/120/140/150/160/180/200 mmHg

Neonatal Default: 100 mmHgRange: 60/70/80/100/120 mmHg

Venipuncture pressure

Adult Default: 60 mmHgOptions: 20 mmHg, 30 mmHg, 40 mmHg, 50 mmHg, 60 mmHg, 70 mmHg, 80 mmHg, 90 mmHg, 100 mmHg, 110 mmHg, 120 mmHg

Pediatric Default: 40 mmHgOptions: 20 mmHg, 30 mmHg, 40 mmHg, 50 mmHg, 60 mmHg, 70 mmHg, 80 mmHg

Neonatal Default: 30 mmHgOptions: 20 mmHg, 30 mmHg, 40 mmHg, 50 mmHg

Measuring Range 0% to 100%

Resolution 1%

☆ Data Update Period 1 s

☆ Accuracy

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Nellcor Module

☆ Adult /Pediatric ±2% (70% to 100% SpO2)

Undefined (0% to 69% SpO2)

☆ Neonate ±3% (70% to 100% SpO2)

Undefined (0% to 69% SpO2)

Sensor

Red Light (660±3) nm

Infrared Light (905±10) nm

Emitted Light Energy < 15 mW

PI (Perfusion Index)

Measuring Range 0-10, invalid PI value is 0.

Resolution 1

Measuring Range 1% to 100%

☆ Adjustable Range of Alarm Limits

20% to 100%

Resolution 1%

☆ Data update period 1s

☆ Accuracy (70% to 100% SpO2)

DS-100A, OXI-A/N(Adult): ± 3% OXI-A/N(Neonate): ± 4% D-YS (Infant to Adult): ± 3%D-YS (Neonate): ± 4% D-YS with D-YSE Ear Clip: ± 3.5%MAX-FAST: ± 2%

Sensor Wave length: approximately 660 and 900nm

Emitted light energy: <15mW

NOTE Information about the wave length range can be especially useful to clinicians (for instance, when photodynamic therapy is performed).

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PR

TEMP

Complies with ISO 80601-2-56: 2009.

Measuring range Accuracy Resolution

☆ PR (SpO2)Dräger 25 bpm to 300 bpm ±2 bpm 1 bpm

Nellcor 20 bpm to 300 bpm ± 3 bpm (20 bpm to 250 bpm) 1 bpm

☆ PR (NIBP) Dräger 40 bpm to 240 bpm ±3 bpm or 3.5%, whichever is greater 1 bpm

☆ PR (IBP) Dräger 20 bpm to 300 bpm30 bpm to 300 bpm: ±2 bpm or ±2%,whichever is greater;

20 bpm to 29 bpm: undefined1 bpm

Technique Thermal resistance

Position Skin, oral, rectum

Channel 2

Sensor Type YSI-10K, YSI-2.252K

Unit °C, °F

Measuring range 0 °C to +50 °C (+32 ºF to +122 ºF)

Resolution +0.1 °C (+0.1 ºF)

☆ Accuracy1 ±0.3 °C (±32.54 ºF)

Accuracy (without sensor) ±0.1 °C (±32.18 ºF)

Refresh time Every 1 to 2 s

Self-test At an interval of 5-10 minutes

Measuring Mode Direct Mode

Transient Response Time ≤ 30 s

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IBP

Complies with IEC 60601-2-34: 2011.

NOTE The accuracy consists of two parts, as following:

Accuracy (not including sensor): ± 0.1 °C (± 32.18 ºF)

Sensor accuracy: ≤ ±0.2 °C (± 32.36 ºF)

NOTE The claimed response time is valid without probe covers.

Technique Direct invasive measurement

Channel 3 channels

IBP Measure ☆ Measuring Range

Art (0 to +300) mmHg

PA/PAWP (-6 to +120) mmHg

CVP/RAP/LAP/ICP (-10 to +40) mmHg

P1/P2 (-50 to +300) mmHg

Resolution 1 mmHg

☆ Accuracy (not including sensor) ± 2% or ±1 mmHg, whichever is greaterICP: 0 mmHg to 40 mmHg: ± 2% or ±1 mmHg, whichever is greater; -10 mmHg to 0 mmHg: undefined

Pressure Unit kPa, mmHg, cmH2O

Pressure sensor

Sensitivity 5 μV/V/mmHg

Impedance Range 300 Ω to 3000 Ω

Filter DC~ 12.5 Hz; DC~ 40 Hz

Zero Range: ±200 mmHg

Pressure Calibration Range

IBP (excluding ICP) 80 mmHg to 300 mmHg

ICP 10 mmHg to 40 mmHg

Volume Displacement 7.4 x 104 mm3 / 100mmHg

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CO2

Complies with ISO 80601-2-55: 2011.

G2 Module.

Intended Patient Adult, pediatric, neonatal

Measure Parameters etCO2, FiCO2, AwRR

Unit mmHg, %, kPa

☆ Measuring Range

CO2 0 mmHg to 150 mmHg (0% to 20%)

AwRR 2 rpm to 150 rpm

Resolution

etCO2 1 mmHg

FiCO2 1 mmHg

AwRR 1 rpm

☆ AccuracyetCO2

± 2 mmHg, 0 mmHg to 40 mmHgTypical conditions:Ambient temperature: (25± 3) °C (77±37.4) °FBarometric pressure: (760±10) mmHgBalance gas: N2Sample gas flowrate: 100 ml/min

± 5% of reading, 41 mmHg to 70 mmHg

± 8% of reading, 71 mmHg to 100 mmHg

± 10% of reading, 101 mmHg to 150 mmHg

±12% of reading or ± 4 mmHg, whichever is greater

All conditions

AwRR ± 1 rpm

Drift of Measure Accuracy Meets the requirements of the measure accuracy

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Sample Gas Flowrate 70 ml/min or 100 ml/min(default), accuracy: ±15 ml/min

Warm-upTime Display reading within 20 s; reach to the designed accuracy within 2 minutes.

Rise Time< 400 ms (with 2 m gas sampling tube, sample gas flowrate: 100 ml/min)

<500 ms (with 2 m gas sampling tube, sample gas flowrate: 70 ml/min)

Response Time< 4 s (water trap with 2 m gas sampling tube, sample gas flowrate: 100 ml/min)

<4 s (with 2 m gas sampling tube, sample gas flowrate: 70 ml/min)

Work Mode Standby, measure

O2 CompensationRange: 0% to 100%Resolution: 1%Default: 16%

N2O Compensation

Range: 0% to 100%Resolution: 1%Default: 0%

AG Compensation

Range: 0% to 20%Resolution: 0.1%Default: 0%

Humidity Compensation Method

ATPD(default), BTPS

Barometric Pressure Compensation

Automatic (The change of barometric pressure will not add additional errors to the measurement values.)

Zero Calibration Support

Calibration Support (It is recommend to be operated by trained personal.)

☆ Alarm etCO2, FiCO2, AwRR

☆ Apnea Alarm Delay

10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s, 60s; default value is 20 s.

Data Sample Rate 100 Hz

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Technical data

Interfering Gas Effects:

etCO2 Change1 AwRR ≤ 80 rpm, meet the accuracy mentioned above;AwRR >80 rpm, etCO2 descending 8%AwRR >120 rpm, etCO2 descending 10%

with 2 m gas sampling tube, sample gas flowrate: 100 ml/min)

AwRR ≤ 60 rpm, meet the accuracy mentioned above; AwRR > 60 rpm, EtCO2 descends 8%;AwRR > 90 rpm, EtCO2 descends 10%;AwRR > 120 rpm, EtCO2 descends 15%;

with 2 m gas sampling tube, sample gas flowrate: 70 ml/min)

NOTE Use a test device equivalent to EN ISO 80601-2-55 fig 201.101 to measure at 1:2 I/E ratio. Respiration rate accuracy is determined by frequency of device, and end-tidal gas reading change refers to the nominal value.

Gas Gas Level (%) Quantitative Effect/Comments

Nitrous oxide Halothane Enflurane Isoflurane SevofluraneDesflurane

60455515

The interfering gas will have no effect on the measurement value if compensation of O2, N2O, anesthetic agents has been correctly set.

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286 Instructions for use Vista 120/Vista 120S SW 3.n

Respironics Module (Mainstream and Sidestream)

Applicable Patient Type Adult, pediatric and neonatal patients

Technique Infra-red Absorption Technique

Measure Parameters etCO2, FiCO2, AwRR

Unit mmHg, %, Kpa

☆ Measuring Range

☆ etCO2 0 mmHg to 150 mmHg

☆ FiCO2 3 mmHg to 50 mmHg

☆ AwRR 0 rpm to 150 rpm (Mainstream)2 rpm to 150 rpm (Sidestream)

Resolution etCO2 1 mmHg

FiCO2 1 mmHg

AwRR 1 rpm

☆ etCO2 Accuracy ± 2 mmHg, 0 mmHg to 40 mmHg

± 5 % of reading, 41 mmHg to 70 mmHg

± 8 % of reading, 71 mmHg to 100 mmHg

± 10 % of reading, 101 mmHg to 150 mmHg

± 12% of reading, RR is over 80 rpm (sidestream)There will be no degradation in performance due to Respiration Rate. (mainstream)

☆ AwRR Accuracy ± 1 rpm

Operation Mode Measure, standby

Sample Gas Flowrate (sidestream) (50 ±10) ml/min

O2 Compensation

Range 0% to 100%

Resolution 1%

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Default 16%

Barometric Pressure Compensation User setup

Anesthetic Gas Compensation

Range 0% to 20%

Resolution 0.1%

Default 0.0%

Balance Gas Compensation Room air, N2O, helium

Stability

Short Term Drift Drift over 4 hours < 0.8 mmHg

Long Term Drift 120 hours

Zero Calibration Support

☆ Alarm Type etCO2, FiCO2, AwRR

☆ Apnea Alarm Delay 10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s; default value is 20 s.

Data Sample Rate 100 Hz

CO2 Rise Time/Response Time (mainstream)

Less than 60 ms

Sensor Response Time (sidestream)

< 3 s, including transport time and rise time

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Interfering Gas and Vapor Effects on etCO2 Measurement Values:

Barometric Pressure on etCO2 Measurement Values:

Gas or Vapor Gas Level (%) Quantitative Effect/Comments

Nitrous oxide Halothane Enflurane Isoflurane SevofluraneXenon Helium Desflurane

604555805015

Dry and Saturated Gas(0 to 40) mmHg: ± 1 mmHg additional error(41 to 70) mmHg: ± 2.5% additional error(71 to 100) mmHg: ± 4% additional error(101 to 150) mmHg: ± 5% additional error*Additional worst case error when compensation for PB, O2, N2O, anesthetic agents, or helium is correctly selected for the actual fractional gas constituents present. Desflurane:The presence of desflurane in the exhaled breath at concentrations greater than 5% will positively bias Carbon Dioxide values by up to an additional 3 mmHg at 38 mmHg.Xenon:The presence of Xenon in the exhaled breath will negatively bias Carbon Dioxide values by up to an additional 5 mmHg at 38 mmHg.

Quantitative Effect

Ambient Barometric, Operational(0 to 40) mmHg: ± 1 mmHg additional error(41 to 70) mmHg: ± 2.5% additional error(71 to 100) mmHg: ± 4% additional error(101 to 150) mmHg: ± 5% additional error*Additional worst case error when compensation for PB, O2, N2O, anesthetic agents, or helium is correctly selected for the actual fractional gas constituents present.

NOTE Respiration Rate accuracy was verified by using a solenoid test setup to deliver a square wave of known CO2 concentration to the device. 5% and 10% CO2 concentrations were used. Respiration rate was varied over the range of the device. Pass/Fail criteria was comparison of the respiratory rate output from the sensor to the frequency of the square wave.

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Technical data

Dräger MCable Mainstream CO2 Module.

Measure Parameters etCO2, FiCO2, AwRR

Unit mmHg, %, Kpa

☆ Measuring Range

☆ etCO2 0 mmHg to 100 mmHg

☆ FiCO2 0 mmHg to 100 mmHg

☆ AwRR 3 rpm to 150 rpm (PGM algorithm)

Resolution etCO2 1 mmHg

FiCO2 1 mmHg

AwRR 1 rpm

☆ etCO2 Accuracy < 0.5 mmHg rms, 0 mmHg to 40 mmHg

< 1 mmHg rms, 40.1 mmHg to 100 mmHg

Operation Mode Measure, standby

Local Barometric Pressure 57 kPa to 110 kPa

O2 Compensation

Range 0% to 100%

Resolution 1%

Default 16%

N2O Compensation

Range 0% to 100%

Resolution 1%

Default 0%

He Compensation

Range 0% to 100%

Resolution 1%

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Default 0%

Xe Compensation

Range 0% to 100%

Resolution 1%

Default 0%

Zero Calibration Support

☆ Alarm Type etCO2, FiCO2, AwRR

☆ Apnea Alarm Delay 10 s, 15 s, 20 s, 25 s, 30 s, 35 s, 40 s; default value is 20 s.

Data Reporting Rate Every 10 msec or 20 msec

Response Time Rise Time: t10-90 = 24 msec Delay Time: 150 msec

Warm Up The sensor meets the specified operating performance within 2 minutes typical from power on or reset at ambient temperatures from 20 °C to 40 °C. At 10 °C ambient temperature, time from power on to reach the specified operating performance is 10 min approximately.

Interfering Gases and Vapours

N2O 100 Vol.% 0.00 Vol.%

Halothane 5 Vol.% 0.02 Vol.%

Enflurane 5 Vol.% 0.03 Vol.%

Isoflurane 5 Vol.% 0.02 Vol.%

Sevoflurane 5 Vol.% 0.02 Vol.%

Desflurane 20 Vol.% 0.00 Vol.%

Ethanol 4 %o * 0.00 Vol.%

Acetone 1 %o * 0.00 Vol.%

Isopropanol 1 % 0.00 Vol.%

Methane 3 Vol.% <0.02 Vol.%

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Technical data

*blood concentration equivalent

Effects of Humidity or Condensate:

The airway adapter windows are indirectly heated via the sensor to prevent moisture condensation. While by sensor design the effect of water droplets

spilled onto the airway adapter windows and of contamination, as long as still some measurement light passes the airway adapter windows, is largely compensated for, water droplets and other window contamination may slightly influence measurement bias, up to 0.3 Vol.% approximately at 5 Vol.% CO2 (normally much less). Precision, of course, worsens if less light passes (i.e., noise of reading gets higher). After some time, water droplets are heated away.

If measurement light is blocked such that noise of reading gets unacceptably high, an error message is sent from the CO2 sensor indicating that the airway adapter has to be checked (cleaned or replaced).

C.O.

NO 100 ppm 0.01 Vol.%

NO2 50 ppm 0.00 Vol.%

CO 4 Vol.% 0.00 Vol.%

Freon R21 100 Vol.% 0.07 Vol.%

Freon R134a 100 Vol.% 0.19 Vol.%

Heptafluorpropane 0.7 Vol.% 0.00 Vol.%

Water vapour 37 °C (98.6 °F) saturated 0.01 Vol.%

NOTE The numbers given at the end of each line are typical CO2 readings of the sensor for the pure interfering gas or vapour, balance N2 (if applicable), without CO2 content. CO2 reading of common mixtures like CO2, O2, N2O, anaesthetic agent (in physiological concentration) or CO2, O2, N2, water vapour is within specified bias, provided that the major foreign gases (see above: O2, N2O, He, Xe) are entered to the sensor.

Technique Thermodilution Technique

Measure Parameters C.O., TB, TI

Measuring Range

C.O. 0.1 L/min to 20 L/min

TB +23 °C to +43 °C (+73.4 ºF to +109.4 ºF)

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AG

TI -1 °C to +27 °C (+30.2 ºF to +80.6 ºF)

Resolution

C.O. 0.01 L/min

TB, TI +0.1 °C (+0.1 ºF)

Accuracy

C.O. ±5% or ± 0.2 L/min, whichever is greater

TB ±0.1 °C (±32.18 ºF) (not including sensor)

TI ±0.1 °C (±32.18 ºF) (not including sensor)

NOTE At least 90% of the C.O. data should reside inside the bounded region, and the lower 95% confidence interval should not exceed 85%.

NOTE Regarding the AG specifications, refer to the Supplement Scio Four modules.

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Technical data

BIS

Complies with IEC 60601-2-26: 2012.

Interfaces

Analog Output

Technique Bispectral index, power spectrum analysis

☆ MeasureParameters

Primary Parameter BIS 0 to 100

Secondary Parameters

SQI 0% to 100%

SR 0% to 100%

EMG 30 dB to 80 dB

SEF 0.5 Hz to 30.0 Hz

TP 40 dB to 100 dB

BC (only applicable to BIS™ Extend Sensor)

0 to 30

Sweep Speed 6.25 mm/s, 12.5 mm/s, 25 mm/s, 50 mm/s

Wave Scale 50 μv, 100 μv, 200 μv, 500 μv

BIS Trend Length of BIS trend: 6 min, 12 min, 30 min, 60 min

Smoothing Rate 10 s, 15 s, 30 s

Noise (EEG Waveform)

< 0.3 μV (0.25 Hz to 50 Hz)

EEG Bandwidth 0.25 Hz to 100 Hz

☆ BIS Alarm Range 0 to 100

Bandwidth (-3dB; reference frequency: 10Hz)

Diagnosis/Monitor: 0.5 Hz to 40 HzSurgery: 1 Hz to 20 Hz

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Defibrillator Synchronization

Maximum Transmission Delay (Diagnosis Mode)

500 ms

Sensitivity 1 V/1 mV ±10%

PACE Rejection/ Enhancement Not applicable.

Compliant with Standard and Directive

Complies with the requirements in terms of short circuit protection and leakage current in EN60601-1.

Output Impedance < 500Ω

Interface Type PS2 connector

NOTE While using analog output, set the calculation lead as following:

1 In 3-lead mode, set to Lead I, Lead II, or Lead III.

2 In 5-lead mode, set to Lead I, Lead II, Lead III or Lead V.

Output Impedance <500Ω

Maximum Time Delay 35mS (R-wave peak to leading edge of pulse)

Waveform Rectangular wave

Amplitude High level: 3.5 V to 5.5 V, providing a maximum of 1 mA output current;Low level: < 0.5V, receiving a maximum of 5 mA input current

Minimum Required R-wave Amplitude

0.3 mV

Pulse Width 100 mS ±10%

Limited Current 15 mA rating

Rising and Falling Time < 1mS

Interface Type PS2 connector

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Nurse Call

PS2 connector Definition for Analog Output/Defibrillator Synchronization/Nurse Call

USB Interfaces

VGA Interface

Drive Mode Voltage output

Power Supply ≤ 12VDC, 200 mA Max.

Interface Signal 12 V power supply and PWM waveform

Interface Type PS2 connector

PIN.NO. Signal name Signal Description

1 ANALOG_OUT Analog out signal

2 GND Ground

3 SYS_OUT Defibrillator Synchronization signal

4 +12V Nurse call power

5 GND Ground

6 NURSE_OUT Nurse call control signal

Number of USB Interfaces 2

Drive Mode HOST interface, USB1.0/2.0 protocol

Power Supply 5VDC±5%, 500mA Max.

Interface Type USB A-type port

Number of VGA Interface 1

Horizontal Refreshing Rate 30-94 KHZ

Video Signal 0.7 Vpp @ 75 Ohm, HSYNC/VSYNC signal TTL

Interface Type DB-15 female receptacle

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SCIO Interface/ Medibus/X Interface

Network Interface

Level RS232

Interface Type DB-9 female receptacle

Bandwidth 10M

Interface Type Standard RJ-45 network interface

HL7 XML formatThe data transmission will be finished within 8 s. The actual transmission time cost will depend on the XML file size.

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EMC Declaration

EMC Declaration

General information . . . . . . . . . . . . . . . . . . . . 298

Electromagnetic emissions. . . . . . . . . . . . . . 298

Electromagnetic environment . . . . . . . . . . . . 299

Electromagnetic immunity. . . . . . . . . . . . . . . 299

Recommended separation distances to portable and mobile RF telecommunication devices. . . . . . . . . . . . . . 305

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General information

The EMC compliance of the Vista 120 series patient monitors (Vista 120, Vista 120S) is also applicable to the external cables, transducers, and accessories specified in the list of accessories. In addition, accessories which do not affect EMC compliance may be used if no other reasons forbid their use (see other sections of the Instructions for Use). The use of non-compliant accessories may result in increased emissions or decreased immunity of the Vista 120 series patient monitors (Vista 120, Vista 120S).

The Vista 120 series patient monitors (Vista 120, Vista 120S) may only be used adjacent to or stacked with other devices when the configuration is approved by Dräger. If adjacent or stacked use of non-approved configurations is inevitable, the Vista 120 series patient monitors (Vista 120, Vista 120S) must be observed to verify normal operation in the said configuration. In any case, strictly observe the Instructions for Use of the other devices.

Electromagnetic emissions

When selecting wireless systems (wireless communication devices, pager systems, etc.) for use in installations where wireless networking is used, ensure that operating frequencies are compatible. Low-level signals such as ECG are particularly susceptible to interference from electromagnetic energy. While the equipment meets the testing described below, it will not ensure perfect operation. The ‘quieter’ the electrical environment the better. In general, increasing the distance between electrical devices decreases the likelihood of interference.

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Electromagnetic environment

The Vista 120 series patient monitors (Vista 120, Vista 120S) are intended for use in an electromagnetic environment as specified below. The user must ensure its use in such an environment.

Electromagnetic immunity

The Vista 120 series patient monitors (Vista 120, Vista 120S) are intended for use in an electromagnetic environment as specified below. The user must ensure its use in such an environment.

Emissions Compliance according to Electromagnetic environment

Radio frequency emissions

(CISPR 11)

Group 1 The Vista 120 series patient monitors (Vista 120, Vista 120S) use RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

Class A The Vista 120 series patient monitors (Vista 120, Vista 120S) are suitable for use in all establishments other than domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Harmonic emissions (IEC 61000-3-2)

Class A

Voltage fluctuations/flicker emissions (IEC 61000-3-3)

Complies

NOTE The EMISSIONS characteristics of the Vista 120 series patient monitors (Vista 120, Vista 120S) make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) the Vista 120 series patient monitors (Vista 120, Vista 120S) might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment.

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Immunity against Test level (IEC 60601-1-2)

Compliance level Electromagnetic environment

Electrostatic discharge (ESD) (IEC 61000-4-2)

Contact discharge: ±8 kV

Contact discharge: ±8 kV

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.

Air discharge: ±15 kV

Air discharge: ±15 kV

Electrical fast transients/ bursts (IEC 61000-4-4)

Power supply lines: ±2 kV

Power supply lines: ±2 kV

Mains power quality should be that of a typical commercial or hospital environment.Longer input / output

lines: ±1 kVLonger input / output lines: ±1 kV

Surge on AC mains lines (IEC 61000-4-5)

Common mode: ±2 kV

Common mode: ±2 kV

Mains power quality should be that of a typical commercial or hospital environment.Differential mode:

±1 kVDifferential mode: ±1 kV

Power frequency magnetic field (50/60 Hz) (IEC 61000-4-8)

30 A/m 30 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

Voltage dips and short interruptions on AC mains input lines (IEC 61000-4-11)

0 % UT; 0.5 cycle At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°

0 % UT; 0.5 cycle At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315°

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Vista 120 series patient monitors (Vista 120, Vista 120S) requires continued operation during mains power supply interruptions, it is recommended that the Vista 120 series patient monitors (Vista 120, Vista 120S) be powered from an uninterruptible power supply or a battery.

0 % UT; 1 cycle and 70 % UT; 25/30 cycles ) Single phase: at 0°

0 % UT; 1 cycle and 70 % UT; 25/30 cycles ) Single phase: at 0°

0 % UT; 250/300 cycle 0 % UT; 250/300 cycle

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Radiated RF (IEC 61000-4-3)

80 MHz to 2.7 GHz:

3 V/m

3 V/m (1 V/m when using the BIS module)

80 MHz to 2.7 GHz

Portable and mobile RF communications equipment should be used no closer to any part of the Vista 120 series patient monitors (Vista 120, Vista 120S), including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance

150 KHz to 80 MHz

( 150 KHz to 80 MHz)

80 MHz to 800 MHz

( 80 MHz to 800 MHz)

800 MHz to 2.7 GHz

( 800 MHz to 2.5 GHz)

Conducted RF (IEC 61000-4-6)

150 kHz to 80 MHz: 3 VRMS

6 Vrms3 in ISM bands between 0.15 MHz and 80 MHz

3 VRMS (1 VRMS when using the BIS module)

150 kHz to 80 MHz

6 Vrms3 in ISM bands between 0.15 MHz and 80 MHz

Immunity against Test level (IEC 60601-1-2)

Compliance level Electromagnetic environment

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See Table 1 Comply with Table 1

at RF wireless communications equipment bands (Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the monitor, including cables specified by the manufacturer).

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey1, should be less than the compliance level in each frequency range2.

Interference may occur in the vicinity of equipment marked with the following symbol:

NOTE

At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

Immunity against Test level (IEC 60601-1-2)

Compliance level Electromagnetic environment

6

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Table 1 Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment

1 Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Vista 120 series patient monitors (Vista 120, Vista 120S) are used exceeds the applicable RF compliance level above, the Vista 120 series patient monitors (Vista 120, Vista 120S) should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Vista 120 series patient monitors (Vista 120, Vista 120S).

2 Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.3 The ISM (industrial, scientific and medical) bands between 0.15 MHz and 80 MHz are 6.765 MHz to

6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz. The amateur radio bands between 0.15 MHz and 80 MHz are 1.8 MHz to 2.0 MHz, 3.5 MHz to 4.0 MHz, 5.3 MHz to 5.4 MHz, 7 MHz to 7.3 MHz, 10.1 MHz to 10.15 MHz, 14 MHz to 14.2 MHz, 18.07 MHz to 18.17 MHz, 21.0 MHz to 21.4 MHz, 24.89 MHz to 24.99 MHz, 28.0 MHz to 29.7 MHz and 50.0 MHz to 54.0 MHz.

Immunity against Test level (IEC 60601-1-2)

Compliance level Electromagnetic environment

Test frequency

(MHz)

Band a) (MHz) Service a) Modulation b) Maximum

power (W)Distance

(m)

Immunity test level

(V/m)

385 380-390 TETRA 400Pulse

modulation b) 18 Hz

1.8 0.3 27

450 430-470 GMRS 460, FRS 460

FM c)

± 5 kHz deviation

1 kHz sine

2 0.3 28

710

704-787 LTE Band 13, 17

Pulse modulation b)

217 Hz0.2 0.3 9745

780

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810

800-960

GSM 800/900, TETRA

800, iDEN 820, CDMA

850, LTE Band 5

Pulse modulation b)

18 Hz2 0.3 28

870

930

1720

1700-1990

GSM 1800; CDMA

1900; GSM 1900;

DECT; LTE Band 1, 3,

4, 25; UMTS

Pulse modulation b)

217 Hz2 0.3 28

1845

1970

2450 2400-2570

Bluetooth, WLAN, 802.11

b/g/n, RFID 2450, LTE

Band 7

Pulse modulation b)

217 Hz2 0.3 28

5240

5100-5800 WLAN 802.11 a/n

Pulse modulation b)

217 Hz0.2 0.3 95500

5785

NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3.

a) For some services, only the uplink frequencies are included. b) The carrier shall be modulated using a 50 % duty cycle square wave signal. c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.

Test frequency

(MHz)

Band a) (MHz) Service a) Modulation b) Maximum

power (W)Distance

(m)

Immunity test level

(V/m)

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Recommended separation distances to portable and mobile RF telecommunication devices

The separation distances below are in accordance with IEC 60601-1-2.

Rated maximum output power of

transmitter

(W)

Separation distance according to frequency of transmitter(m)

150 kHz to 80 MHz

( )

80 MHz to 800 MHz

( )

800 MHz to 2.7 GHz

( 800 kHz to 2.5 GHz)

The separation distance values in the brackets are specific to the occasion when the BIS module is used.

0.01 0.12 (0.35) 0.12 (0.35) 0.23 (0.70)

0.1 0.38 (1.1) 0.38 (1.1) 0.73 (2.2)

1 1.2 (3.5) 1.2 (3.5) 2.3 (7.0)

10 3.8 (11) 3.8 (11) 7.3 (22)

100 12 (35) 12 (35) 23 (70)

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE

At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE

These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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Default settings

Default settings

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 308

Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 308

User Configuration. . . . . . . . . . . . . . . . . . . . . 308

Patient information default settings . . . . . . . 308

Alarm default settings . . . . . . . . . . . . . . . . . . 309

ECG default settings . . . . . . . . . . . . . . . . . . . 309

RESP default settings . . . . . . . . . . . . . . . . . . 311

SpO2 default settings . . . . . . . . . . . . . . . . . . . 311

PR default settings. . . . . . . . . . . . . . . . . . . . . 312

NIBP default settings . . . . . . . . . . . . . . . . . . . 312

TEMP default settings . . . . . . . . . . . . . . . . . . 313

IBP default settings . . . . . . . . . . . . . . . . . . . . 313

CO2 default settings. . . . . . . . . . . . . . . . . . . . 314

C.O. default settings. . . . . . . . . . . . . . . . . . . . 314

C.O. default settings. . . . . . . . . . . . . . . . . . . . 315

Ventilator/Anesthesia Machine Monitoring default settings . . . . . . . . . . . . . . 315

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Default settings

308 Instructions for use Vista 120/Vista 120S SW 3.n

Overview

This appendix documents the most important default settings of the monitor as it is delivered from the factory.

Profile

To set default configuration, select Menu > Profile. On the Profile menu, users can choose a factory configuration (adult, pediatric or neonate) based on the patient category. Also, users can choose a user configuration saved in the monitor if it is available. For more information about user configuration, refer to User configuration.

To check the configuration currently used, select Menu > Profile. The one labeled with (√) is current configuration. If there's no labeled configuration, it means the currently used configuration is not one of them.

User Configuration

Select Menu > Maintenance > User Maintain, enter the required password, users can save the current monitor's configuration, delete the saved user configuration and rename it. Three pieces of user

configuration can be saved in the monitor. User can select as desire. The one labeled with (√) is current configuration.

Patient information default settings

NOTE If the monitor has been preconfigured according to the requirements, the settings at delivery will be different from the default settings listed below.

Patient information settings

Patient type Adult

Pace Off

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Instructions for use Vista 120/Vista 120S SW 3.n 309

Default settings

Alarm default settings

ECG default settings

Alarm settings

Pause time 120 s

Sensor off alarm On

Alarm latch Off

ECG settings ADU PED NEO

Alarm switch On

Alarm record Off

Alarm level Medium

Alarm high limit 120 160 200

Alarm low limit 50 75 100

ARR Analysis ThresholdValue

PVCs High 10/min

Pace Off

Lead type 5 Leads

Display Normal

Filter Monitor

Smart lead off Off

Heart volume 3

ST analysis Off

Alarm switch Off

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Default settings

310 Instructions for use Vista 120/Vista 120S SW 3.n

Alarm level Medium

Alarm record Off

Alarm high limit (ST-X) 0.2

Alarm low limit (ST-X) -0.2

X stands for I, II, III, aVR, aVL, aVF, V.

ARR analysis

ARR analysis On

ARR alarm settings Alarm switch Alarm level Alarm record

Asystole On (non-adjustable) High (non-adjustable) Off

V-Fib/V-Tach On High (non-adjustable) Off

R on T On Medium Off

Run PVCs On Medium Off

Couplet On Medium Off

PVC On Medium Off

PVC Bigeminy On Medium Off

PVC Trigeminy On Medium Off

Tachy On Medium Off

Brady On Medium Off

Missed Beat On Medium Off

Irr Rhythm On Medium Off

Pacer not Capture On Medium Off

Pacer not Pacing On Medium Off

Vent Brady On High (non-adjustable) Off

Vent Rhythm On Medium Off

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Default settings

RESP default settings

SpO2 default settings

RESP settings ADU PED NEO

Alarm switch On

Alarm record Off

Alarm level Medium

Alarm high limit 30 30 100

Alarm low limit 8 8 30

Apnea time 20 s

Calculation type Auto

Resp hold type Auto

Sweep 12.5 mm/s

Amplitude 1

SpO2 settings ADU PED NEO

Alarm switch On

Alarm record Off

Alarm level Medium

Alarm high limit 100 100 95

Alarm low limit 90 90 88

Pitch tone Off

SatSeconds (Nellcor Module)

Off

Sweep 12.5 mm/s

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PR default settings

NIBP default settings

PR settings ADU PED NEO

PR source SpO2

Alarm switch On

Alarm record Off

Alarm level Medium

Alarm high limit 120 160 200

Alarm low limit 50 75 100

Pulse volume 3

Alarm source Auto

NIBP settings ADU PED NEO

Alarm switch On

Alarm record Off

Alarm level Medium

Alarm high limit (SYS) 160 120 90

Alarm low limit (SYS) 90 75 40

Alarm high limit (Mean) 110 90 70

Alarm low limit (Mean) 60 50 30

Alarm high limit (Dia) 90 70 60

Alarm low limit (Dia) 50 40 20

Inflation value 160 140 100

Venipuncture pressure 60 40 30

Unit mmHg

Interval Manual

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Default settings

TEMP default settings

IBP default settings

TEMP settings ADU PED NEO

Alarm switch On

Alarm record Off

Alarm level Medium

Alarm high limit (T1) 39.0 39.0 39.0

Alarm low limit (T1) 36.0 36.0 36.0

Alarm high limit (T2) 39.0 39.0 39.0

Alarm low limit (T2) 36.0 36.0 36.0

Alarm high limit (TD) 2.0 2.0 2.0

Unit °C

IBP settings ADU PED NEO

Alarm switch On

Alarm record Off

Alarm level Medium

Unit mmHg

Filter 12.5 Hz

SYS, DIA, MEAN SYS, DIA, MEAN SYS, DIA, MEAN

Alarm high limit (ART, P1, P2)

160, 90, 110 120, 70, 90 90, 60, 70

Alarm low limit (ART, P1, P2)

90, 50, 70 70, 40, 50 55, 20, 35

Alarm high limit (PA) 35, 16, 20 60, 4, 26 60, 4, 26

Alarm low limit (PA) 10, 0, 0 24, -4, 12 24, -4, 12

MEAN MEAN MEAN

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314 Instructions for use Vista 120/Vista 120S SW 3.n

CO2 default settings

C.O. default settings

Alarm high limit (CVP, RAP, LAP, ICP)

10 4 4

Alarm low limit (CVP, RAP, LAP, ICP)

0 0 0

CO2 settings ADU PED NEO

Alarm switch On

Alarm record Off

Alarm level Medium

Work mode Standby

Unit mmHg

Apnea time 20 s

O2 compensate 16 %

Anes agent 0 %

Alarm high limit (etCO2) 50 50 45

Alarm low limit (etCO2) 25 25 30

Alarm high limit (FiCO2) 4 4 4

Alarm high limit (AWRR) 30 30 100

Alarm low limit (AWRR) 8 8 30

Sweep 6.25 mm/s

Amplitude Low

BIS Settings ADU/PED

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Instructions for use Vista 120/Vista 120S SW 3.n 315

Default settings

C.O. default settings

Ventilator/Anesthesia Machine Monitoring default settings

Alarm Switch On

Alarm Record Off

Alarm Level Medium

Unit /

BIS Alarm High Limit 70

BIS Alarm Low Limit 20

C.O. Settings ADU PED NEO

Alarm Switch On

Alarm Record Off

Alarm Level Medium

Alarm High Limit (TB) 43.0 43.0 43.0

Alarm Low Limit (TB) 23.0 23.0 23.0

Injective Temperature Source Auto

Temperature Unit °C

Interval 30

Constant 0.542

Ventilator/Anesthesia Machine Monitoring Settings ADU PED NEO

Paw Ruler Top Ruler: 40Bottom Ruler: 0

Top Ruler: 40Bottom Ruler: 0

Top Ruler: 40Bottom Ruler: 0

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316 Instructions for use Vista 120/Vista 120S SW 3.n

Flow Ruler Top Ruler: 80Bottom Ruler: -80

Top Ruler: 80Bottom Ruler: -80

Top Ruler: 80Bottom Ruler: -80

Vol Ruler Top Ruler: 800Bottom Ruler: 0

Top Ruler: 800Bottom Ruler: 0

Top Ruler: 800Bottom Ruler: 0

CO2 Ruler Top Ruler: 80Bottom Ruler: 0

Top Ruler: 80Bottom Ruler: 0

Top Ruler: 80Bottom Ruler: 0

O2 Ruler Top Ruler: 100Bottom Ruler: 0

Top Ruler: 100Bottom Ruler: 0

Top Ruler: 100Bottom Ruler: 0

HAL/ISO/ENF/SEV Ruler Top Ruler: 5Bottom Ruler: 0

Top Ruler: 5Bottom Ruler: 0

Top Ruler: 5Bottom Ruler: 0

DES Ruler Top Ruler: 15Bottom Ruler: 0

Top Ruler: 15Bottom Ruler: 0

Top Ruler: 15Bottom Ruler: 0

Sweep 6.25 mm/s

Mode Filled

Loop Type P-V

Reference Loop On

P-V Paw: 40 Vol: 800

F-V Vol: 800 Flow: 150

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Instructions for use Vista 120/Vista 120S SW 3.n 317

Passwords

Passwords

The following dialog boxes are protected by a password to prevent unauthorized changes:

User Maintain

Demo Mode

The password can be found on this page of these Instructions for Use. Cut out this section and store it in a safe place to keep it from unauthorized persons.

If the section with the password has been removed, ask the person responsible for the device about the possibility of making changes in the above mentioned dialog boxes.

If the password is lost, contact DrägerService.

Passwords for the Vista 120 series patient monitors (Vista 120, Vista 120S)

Cut out this section and store it in a safe place to keep it from unauthorized persons.

The following dialog boxes are protected by a password to prevent unauthorized changes:

Dialog box Password

Menu > Maintenance > User Maintain ABC (default initial password)

Menu > Common Function > Demo Mode 3045

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Instructions for use

Vista 120 CMS

WARNING To properly use this medical device, read and comply with these instructionsfor use.

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2 Instructions for use Vista 120 CMS SW 1.n

Screen images

Schematic renderings of screen images are used, which may differ in appearance or in configuration from the actual screen images.

Definition of safety information

Abbreviations and symbols

For explanations refer to sections “Abbreviations” and “Symbols” in chapter “Overview”.

WARNING A WARNING statement provides important information about a potentially hazardous situation which, if not avoided, could result in death or serious injury.

CAUTION A CAUTION statement provides important information about a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient or in damage to the medical device or other property.

NOTE A NOTE provides additional information intended to avoid inconvenience during operation.

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Contents

Contents

Intended use and safety guidance . . . . . . . . 7Intended use/Indications for Use . . . . . . . . . . . 8Components . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Application scope . . . . . . . . . . . . . . . . . . . . . . . 8Safety guidance . . . . . . . . . . . . . . . . . . . . . . . . 9

Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . 13General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14System functions . . . . . . . . . . . . . . . . . . . . . . . 15Mouse Operation . . . . . . . . . . . . . . . . . . . . . . . 15

Display screens of Vista 120 CMS . . . . . . . . 17Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Main Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

System Information Area . . . . . . . . . . . . . . 18Patient Sectors . . . . . . . . . . . . . . . . . . . . . . 18Quick Control Area . . . . . . . . . . . . . . . . . . . 19

Auxiliary Screen . . . . . . . . . . . . . . . . . . . . . . . . 22Large Font Display . . . . . . . . . . . . . . . . . . . . . . 23Layout of Patient Sectors . . . . . . . . . . . . . . . . . 23

Switching Vista 120 CMS on and off. . . . . . . 25Starting monitoring . . . . . . . . . . . . . . . . . . . . . . 26Shutting down the System . . . . . . . . . . . . . . . . 27

Patient Management. . . . . . . . . . . . . . . . . . . . 29Admitting a Patient . . . . . . . . . . . . . . . . . . . . . . 30Obtaining patient information . . . . . . . . . . . . . . 30Synchronizing patient information* . . . . . . . . . . 31Changing Patient Information. . . . . . . . . . . . . . 31Switching Patient sector . . . . . . . . . . . . . . . . . . 32Discharging a Patient . . . . . . . . . . . . . . . . . . . . 32Setting Idle Bed . . . . . . . . . . . . . . . . . . . . . . . . 32Transferring a Patient . . . . . . . . . . . . . . . . . . . . 33Monitoring Statistics . . . . . . . . . . . . . . . . . . . . . 33

Patient Sector . . . . . . . . . . . . . . . . . . . . . . . . . 35Networked Monitoring Display . . . . . . . . . . . . . 36Menu in the Patient Sector . . . . . . . . . . . . . . . . 37Parameter/ Waveform Setup . . . . . . . . . . . . . . 37

Setting Waveforms . . . . . . . . . . . . . . . . . . . 37Setting Parameters . . . . . . . . . . . . . . . . . . . 37

Freeze . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Real-Time Printing. . . . . . . . . . . . . . . . . . . . . . 39Alarm Reset. . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Viewing Single Bed . . . . . . . . . . . . . . . . . . . . 41Display of Single Bed . . . . . . . . . . . . . . . . . . . 42Hiding/Showing Multi-Lead Waveform . . . . . . 43Short Trend Review. . . . . . . . . . . . . . . . . . . . . 43OxyCRG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43Freeze . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Viewing bedside monitor’s work status . . . 45Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46Standby Mode . . . . . . . . . . . . . . . . . . . . . . . . . 46NFC Mode* . . . . . . . . . . . . . . . . . . . . . . . . . . . 46Privacy Mode. . . . . . . . . . . . . . . . . . . . . . . . . . 47

Setting Monitors via Vista 120 CMS. . . . . . . 49Changing Patient Information . . . . . . . . . . . . . 50Setting Parameters . . . . . . . . . . . . . . . . . . . . . 50

Configuring NIBP Measurement Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . 50Parameters Alarm Setting . . . . . . . . . . . . . 50

Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54Patient List. . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Patient Review. . . . . . . . . . . . . . . . . . . . . . 54History Patient Review. . . . . . . . . . . . . . . . 54Backup Patient Review . . . . . . . . . . . . . . . 55

Wave Review. . . . . . . . . . . . . . . . . . . . . . . . . . 55Reviewing Normal Waveforms. . . . . . . . . . 55Reviewing ECG Compressed Waveforms. . . . . . . . . . . . . . . . . . . . . . . . . 55Setting Wave Speed . . . . . . . . . . . . . . . . . 55Refreshing Waveform . . . . . . . . . . . . . . . . 55Selecting Waveform. . . . . . . . . . . . . . . . . . 55Time Setup . . . . . . . . . . . . . . . . . . . . . . . . 56Print . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Alarm Review . . . . . . . . . . . . . . . . . . . . . . . . . 56Locking and Unlocking Alarm Information. . . . . . . . . . . . . . . . . . . . . . . . . 56Printing Alarm Information . . . . . . . . . . . . . 56Sequencing the Alarm List. . . . . . . . . . . . . 56

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4 Instructions for use Vista 120 CMS SW 1.n

Annotating Alarm . . . . . . . . . . . . . . . . . . . . 57Filtering Alarm Events. . . . . . . . . . . . . . . . . 57

Trend Review . . . . . . . . . . . . . . . . . . . . . . . . . . 57Setting Resolution. . . . . . . . . . . . . . . . . . . . 57Viewing Parameters selectively . . . . . . . . . 57Refreshing Data . . . . . . . . . . . . . . . . . . . . . 57Printing Trend Review. . . . . . . . . . . . . . . . . 58Selecting Trend Table, trend Graph . . . . . . 58

NIBP Review . . . . . . . . . . . . . . . . . . . . . . . . . . 58C.O. Measure Review . . . . . . . . . . . . . . . . . . . 58Quick Temp review . . . . . . . . . . . . . . . . . . . . . . 59PAWP review . . . . . . . . . . . . . . . . . . . . . . . . . . 59

System Setup . . . . . . . . . . . . . . . . . . . . . . . . . 61Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62Common Setup . . . . . . . . . . . . . . . . . . . . . . . . 62

Parameter Unit Setup . . . . . . . . . . . . . . . . . 62Color Setup. . . . . . . . . . . . . . . . . . . . . . . . . 62Display Setup . . . . . . . . . . . . . . . . . . . . . . . 62Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

User Maintain . . . . . . . . . . . . . . . . . . . . . . . . . . 63Monitor Batch Settings . . . . . . . . . . . . . . . . 63Date/Time Setup. . . . . . . . . . . . . . . . . . . . . 63Alarm Setup for Vista 120 CMS . . . . . . . . . 64Changing Language . . . . . . . . . . . . . . . . . . 64HL7 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64Database Maintain . . . . . . . . . . . . . . . . . . . 64EMR database maintenance . . . . . . . . . . . 64Other Setups. . . . . . . . . . . . . . . . . . . . . . . . 65User Password Setting . . . . . . . . . . . . . . . . 65Operation Log . . . . . . . . . . . . . . . . . . . . . . . 65Certificate Management . . . . . . . . . . . . . . . 65About . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

Alarm Management . . . . . . . . . . . . . . . . . . . . 67Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68

Physiological Alarm . . . . . . . . . . . . . . . . . . 68Technical Alarm . . . . . . . . . . . . . . . . . . . . . 68

Alarm Level of the Monitors . . . . . . . . . . . . . . . 68Alarm Mute . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69Audio Pause . . . . . . . . . . . . . . . . . . . . . . . . . . . 69Alarm Prompt/Response . . . . . . . . . . . . . . . . . 69Alarms for Networking Status . . . . . . . . . . . . . . 70

Printing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71Printing Report with a Printer . . . . . . . . . . . . . . 72Printing Preview/ Printing Settings . . . . . . . . . . 72

Printing Preview. . . . . . . . . . . . . . . . . . . . . 72Printing Settings . . . . . . . . . . . . . . . . . . . . 72

Exporting the PDF File . . . . . . . . . . . . . . . . . . 72

Database Management . . . . . . . . . . . . . . . . . 75Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76Database backup . . . . . . . . . . . . . . . . . . . . . . 76Reviewing backup database . . . . . . . . . . . . . . 76

Calculation and Titration Table . . . . . . . . . . 77General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78Drug Calculation . . . . . . . . . . . . . . . . . . . . . . . 78

Drug Calculation Formula . . . . . . . . . . . . . 79Calculation of Titration Table . . . . . . . . . . . 79

Hemodynamic Calculation. . . . . . . . . . . . . . . . 80Input Parameters . . . . . . . . . . . . . . . . . . . . 80Output Parameters . . . . . . . . . . . . . . . . . . 80

Renal Function Calculation . . . . . . . . . . . . . . . 81Input Parameters . . . . . . . . . . . . . . . . . . . 81Output Parameters . . . . . . . . . . . . . . . . . . 81

Oxygenation Calculation . . . . . . . . . . . . . . . . . 82Input Parameters . . . . . . . . . . . . . . . . . . . . 82Output Parameters . . . . . . . . . . . . . . . . . . 82

Ventilation Calculation . . . . . . . . . . . . . . . . . . . 83Input Parameters . . . . . . . . . . . . . . . . . . . . 83Output Parameters . . . . . . . . . . . . . . . . . . 84

CMS-WEB Observer . . . . . . . . . . . . . . . . . . . 85General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86Typical Screens of the CMS-WEB. . . . . . . . . . 86Starting/ Shutting Down the System . . . . . . . . 88

Starting the System . . . . . . . . . . . . . . . . . . 88Shutting Down the System . . . . . . . . . . . . 89

System Setup . . . . . . . . . . . . . . . . . . . . . . . . . 89Common Setup . . . . . . . . . . . . . . . . . . . . . 89Administrator Setup . . . . . . . . . . . . . . . . . . 90

Viewing Single Bed . . . . . . . . . . . . . . . . . . . . . 91Patient Information . . . . . . . . . . . . . . . . . . 91Single Bed View. . . . . . . . . . . . . . . . . . . . . 91Waveform Review . . . . . . . . . . . . . . . . . . . 91Alarm Review . . . . . . . . . . . . . . . . . . . . . . 92Trend Review. . . . . . . . . . . . . . . . . . . . . . . 92NIBP Review . . . . . . . . . . . . . . . . . . . . . . . 92

Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93Control and safety index . . . . . . . . . . . . . . . . . 94Characteristics. . . . . . . . . . . . . . . . . . . . . . . . . 94

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Contents

Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . 95Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96Cleaning the filter mat. . . . . . . . . . . . . . . . . . . . 96

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . 99Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . 100

Specifications . . . . . . . . . . . . . . . . . . . . . . . . . 101Recommended Hardware Configuration . . . . . 102Software Performance . . . . . . . . . . . . . . . . . . . 104

Vista 120 CMS System Alarms and Prompts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106Prompts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

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Intended use and safety guidance

Intended use and safety guidance

Intended use/Indications for Use . . . . . . . . . 8

Components . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Application scope. . . . . . . . . . . . . . . . . . . . . . 8

Safety guidance . . . . . . . . . . . . . . . . . . . . . . . 9

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Intended use and safety guidance

8 Instructions for use Vista 120 CMS SW 1.n

Intended use/Indications for Use

Vista 120 CMS Central Station provides centralized monitoring and critical care management for bedside Vista 120 monitored patients. From the Vista 120 CMS Central Station, clinicians can gain access to patient information for patients on the Network. The Vista 120 CMS Central Station displays waveforms, parameters, and alarm status of Vista 120 bedside monitors for up to 32 patients on a single screen or up to 64 patients using two screens.

Vista120 CMS is just the secondary monitor for all bedside monitors displayed on the Main screen, so it is not intended to be the only one approach relied on by users to make therapeutic and diagnostic decisions for monitoring patient. Clinical decision making based on the output of the Vista120 CMS is left to the discretion of the provider.

Components

Vista 120 CMS Central Monitoring System (abbreviated to Vista 120 CMS) consists of:

Vista 120 central monitoring software (watchdog included)

Vista 120 central monitoring PC workstation (abbreviated to PC workstation)

Mouse/keyboard

Uninterruptible power supply (UPS, optional)

Loudspeaker

Laser printer (optional)

Bedside Vista 120 series patient monitors (supplied separately)

Application scope

Vista 120 CMS is intended to monitor patients’ ECG, respiration, non-invasive and invasive blood pressure, pulse oxygen saturation, pulse rate, body temperature, and cardiac output.

The physiological waveforms, parameters and alarm information displayed on Vista 120 CMS can only be used for reference for the doctor, not as the basis for carrying out clinical treatment. Prior to intervening based on this data, check the displayed results on the corresponding bedside monitor.

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Instructions for use Vista 120 CMS SW 1.n 9

Intended use and safety guidance

Safety guidance

WARNING The system should be installed by a qualified service engineer. Do not switch on power until all cables have been properly connected and verified.

WARNING The user of this system should get professional training and read this manual thoroughly before using it.

WARNING Do not use the PC workstation in the presence of flammable anesthetic due to explosion risk.

WARNING To avoid the risk of electric shock, do not open the case of the PC workstation.

WARNING Do not move the main unit and monitor while powering on the central monitoring PC workstation.

WARNING Only the accessories supplied or recommended by the manufacturer can be connected to the PC workstation.

WARNING Ensure that the environment in which the system is operated is not subject to any sources of strong electromagnetic interference, such as radio transmitters, mobile telephones, etc. Keep them far away.

WARNING This equipment must be used by or under the guide of medical professional. This equipment is not intended for home use.

WARNING Vista 120 CMS system can only collect, supervise, record, store and display the information from patient monitor but can not replace the monitoring function of the patient monitor.

WARNING The wireless monitors and Vista 120 CMS form a wireless local area network (WLAN), and bidirectional data transmission between them is achieved by radio. Its RF emissions may cause interference in nearby electronic equipment. So the RF device must comply with the local standards and certification requirements. Data transmission loss between them may occur due to interference caused by other RF signals.

WARNING Ensure that the system can meet the requirements of standard IEC/EN 60601-1 before other devices are connected to the system. Other equipments connected to the interfaces of PC station must comply with the respective IEC/EN standards (e.g. IEC/EN 60950 for data processing equipment and IEC/EN 60601-1 for medical equipment). Furthermore, all configurations should comply with the valid version of the system standard IEC/EN 60601-1. Everybody who connects additional equipment to the signal input connector or signal output connector configures a medical system, and is therefore responsible for the system complying with the requirements of the valid version of the system standard IEC/EN 60601-1. If in doubt, consult our technical service department or local distributor.

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Intended use and safety guidance

10 Instructions for use Vista 120 CMS SW 1.n

WARNING The Vista 120 central monitoring software can only be installed on the device recommended by Dräger.

WARNING Only use operating systems that are approved by Dräger, such as Window 7. Using operating systems that are not approved by Dräger may compromise the system performance and cause a potential hazard.

WARNING Refer to Vista 120 CMS Central Monitoring System Installation Instructions for detailed information of installation and uninstallation.

WARNING Restart Vista 120 CMS host once the prompt “System running time is too long, please restart” appears. According to the practical situation, restart cycle is 3 to 6 months.

WARNING When Network Encryption is turned on, only monitors with AES or TLS encryption can be connected to Vista 120 CMS. Contact DrägerService for Network Encryption settings.

CAUTION Read this manual prior to using the Vista 120 CMS.

CAUTION Keep the environment clean. Avoid vibration. Keep it far from corrosive reagents, dust areas, high-temperature and humid environment.

CAUTION The user must check that the equipment, cables and transducers do not have visible evidence of damage that may affect patient safety or monitoring capability before using it. The recommended inspection interval is once per week or less. If damage is evident, replacement is recommended before using it.

CAUTION Turn off the system power before connecting or disconnecting any accessory.

CAUTION Do not operate the system if it is not operating normally or requires service.

CAUTION Turn off the system power and remove the power cable before maintaining the system.

CAUTION Preventive maintenance of the system including periodic cleaning and appearance check can be finished by the user.

CAUTION Avoid using attrite material to clean the PC workstation. Remove all dust from the exterior surface of the equipment with a soft brush or cloth, slightly dampened with a mild detergent solution or cool disinfector. Especially the tie-in and panel edge should be noticed.

CAUTION Avoid pouring liquids on the equipment while cleaning, and do not immerse any parts of the equipment into any liquids.

CAUTION The system data will be delayed for no more than 5 s.

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Instructions for use Vista 120 CMS SW 1.n 11

Intended use and safety guidance

CAUTION Additional multi-socket outlet or extension cord can’t be connected to the system.

CAUTION The maintenance operations like software upgrade of the system can only be completed by qualified service professionals of the manufacturer.

NOTE Clinical decision making based on the output of the device is left to the discretion of the provider.

NOTE Prior to intervening based on data displayed on the Central Monitoring System, providers must verify this data with the corresponding bedside monitor.

NOTE The illustrations in this manual are for reference only.

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Instructions for use Vista 120 CMS SW 1.n 13

Introduction

Introduction

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

System functions . . . . . . . . . . . . . . . . . . . . . . 15

Mouse Operation . . . . . . . . . . . . . . . . . . . . . . 15

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Introduction

14 Instructions for use Vista 120 CMS SW 1.n

General

Vista 120 CMS connects bedside monitors via cable network and displays physiological information of the patients being monitored by bedside monitors. This system can simultaneously display the information from up to 64 bedside monitors.

Physiological waveforms of each bedside monitor that can be displayed on Vista 120 CMS include:

2 ECG waveforms (Up to 7 ECG waveforms in multi-lead interface of Single Bed View sub-window)

1 RESP waveform

1 PLETH waveform

3 IBP waveforms (Only IBP waveforms supported by the monitor will be displayed)

1 CO2 waveform

4 AG waveforms for CO2, O2, N2O and AA

3 waveforms from ventilator/anesthesia machine

1 BIS waveform

Physiological parameters of each bedside monitor that can be displayed on the Vista 120 CMS include:

ECG: HR, ST value, PVCs

RESP: RR

NIBP: SYS, DIA, MAP

SpO2: SpO2, PR, PI, SpO2 bar graph

TEMP: T1, T2, TD

Quick TEMP

IBP: ART, PA, CVP, RAP, ICP, LAP, P1, P2, PPV, PAWP

CO2: etCO2, FiCO2, AwRR

AG: etCO2, FiCO2, AwRR; EtO2, FiO2; EtN2O, FiN2O; HAL/ISO/ENF/SEV/DES: Et, Fi, MAC

C.O.: C.O., TB

Parameters from ventilator/anesthesia machine: PEEP, PIP, Pmean, AwRR, MV, MVi, VT, VTi, etCO2, FiCO2, EtN2O, FiN2O, EtO2, FiO2, EtAA, FiAA, EtHal, FiHal, EtEnf, FiEnf, EtIso, FiIns, EtDes, FiDes, EtSev, FiSev, Mac

BIS: BIS, EMG, SQI, SR, SEF, TP, BC

Vista 120 CMS can also generate both audio and visual alarms from bedside monitor in order to attract the doctor's attention, thus the alarm event can be dealt with in time.Vista 120 CMS supports various kinds of peripheral devices such as printer that can output monitoring report. The typical central monitoring system network is shown in the following figure:

HIS/EMR System

Wireless Network

Mirth Connect

Vista 120 CMS CMS-WEB observer

Monitors with Wi-Fi module

Monitors without Wi-Fi module

Wired Network

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Instructions for use Vista 120 CMS SW 1.n 15

Introduction

System functions

The standard Vista 120 CMS Central Station includes a PC and one display, mouse and keyboard, instructions for use, and the following features:

Internal speaker

Patient data from bedside Vista 120 collected and displayed including ECG (3-lead or 5-lead), Respiration (ECG), ST, ARR, SpO2, TEMP, Quick TEMP, NIBP, IBP, etCO2 C.O., anesthesia gas monitoring data via Dräger SCIO 4 module, data from Dräger ventilator or anesthesia machine, and BIS measurement data via BISx device.

Audio alarm annunciation

96 or 240 hour full disclosure waveform

Store and review 240-hour alarm events (up to 20000 pieces) for each bedside monitor

Export of waveforms

240 hour graphical and tabular trends

12-hour short trend per patient

Review 240-hour NIBP measurements (up to 20000 pieces)

Review 240-hour C.O. measurements (up to 20000 pieces)

Review 240-hour Quick TEMP measurements (up to 20000 pieces)

Review 240-hour PAWP measurements (up to 20000 pieces)

Comprehensive system help information

Power off data storage function

Drug calculation and titration table

Hemodynamic calculation

Oxygenation calculation

Renal Function calculation

Ventilation calculation

Bidirectional alarms configuration and NIBP setting

Supporting wired connected and wireless connected monitor

Web observation in the hospital local area network

Perform information interaction with HIS system or EMR system

HL7

Mouse Operation

Usually, we use the following terms to describe mouse operation:

Left-key:

1 Click: move mouse to the target, then quickly press left-key once and release it.

2 Double-click: move mouse to the target, then quickly press left-key twice and release it.

3 Drag: move mouse to the target, press left-key and move to the destination and then release it.

Right-key:

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Introduction

16 Instructions for use Vista 120 CMS SW 1.n

1 Click: move mouse to the target, then quickly press right-key once and release it.

2 Double-click: move mouse to the target, then quickly press right-key twice and release it.

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Instructions for use Vista 120 CMS SW 1.n 17

Display screens of Vista 120 CMS

Display screens of Vista 120 CMS

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Main Screen . . . . . . . . . . . . . . . . . . . . . . . . . . 18System Information Area . . . . . . . . . . . . . . . . . 18Patient Sectors . . . . . . . . . . . . . . . . . . . . . . . . . 18Quick Control Area . . . . . . . . . . . . . . . . . . . . . . 19

Auxiliary Screen . . . . . . . . . . . . . . . . . . . . . . . 22

Large Font Display . . . . . . . . . . . . . . . . . . . . . 23

Layout of Patient Sectors . . . . . . . . . . . . . . . 23

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18 Instructions for use Vista 120 CMS SW 1.n

Overview

Vista 120 CMS can display the monitoring data using a single display or using dual displays. The main screen and the auxiliary screen are the main operation screens. The main screen and auxiliary screen on a single display are different from those on dual displays.

The patient sectors can be displayed in two modes: the general display mode with waveforms and physiological parameter values displaying on the screen and the large font display mode with only parameter values displaying on the screen. The number of patient sectors which the user can simultaneously view on the main screen and the size of the patient sectors depend on the layout of the patient sectors.

Main Screen

If a single display is used, Vista 120 CMS system will enter the main screen for the single display after the system starts up. If dual displays are used, it will enter the main screen for dual displays.

1 System information area 2 Patient sectors 3 Quick control area

System Information Area

The following information will be displayed in this area:

The hospital and department information.

Alarm sound pause indicator and alarm mute indicator .

Alarm information and prompts of Vista 120 CMS. If more than one piece of message occurs, they will be displayed circularly.

The system time.

EMR (Electronic Medical Record) indicator. Please refer to section Synchronizing patient information.

Patient Sectors

A patient is monitored by a monitor. This monitor will occupy a patient sector when it is connected to Vista 120 CMS; meanwhile, the monitoring data will be displayed in this patient sector. Vista 120 CMS supports 64 monitors connected to the system; therefore, a total of 64 patient sectors are available in Vista 120 CMS. The layout of patient sectors may cause some patient sectors temporarily invisible, refer to Section Layout of Patient Sectors.

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Instructions for use Vista 120 CMS SW 1.n 19

Display screens of Vista 120 CMS

The patient sector has four types of state:

Network Disconnected: The black background with the white font Disconnected in a patient sector indicates no device is assigned to this patient sector or this patient sector has been set to idle status (refer to Section Setting Idle Bed).

Patient discharged: The black background with bed No. at top left corner in patient sector indicates patient has been discharged.

Improper Offline: Patient information and the message Monitor is offline with yellow background are displayed in the patient sector and accompany with low level alarm sound. Improper Offline indicates the patient in this sector has been admitted but is offline. The alarm sound for improper offline will be given out only once.

Networked Monitoring: Display of patient information, waveforms, trend data and alarm information indicates the patient in this sector has been admitted and is properly networked and under observation.

Refer to Chapter Patient Sector for more information about the patient sectors in networked monitoring state.

Quick Control Area

Function Buttons

The quick control area contains the following function buttons:

Button Button Label Function

Main Screen Click on it to return to the main screen.

Audio Pause

Click on this symbol to make the alarm pause and the

symbol appears in place of the symbol . And

click on the symbol to disable the pause function

and the symbol appears in place of the symbol

. When the alarm sound pauses, the symbol as well as the related prompt will be displayed in the system information area.

Review

Click on it to enter the review interface, including patient information review, waveform review, alarm review, trend review, NIBP review, C.O. measurement review, Quick TEMP review and PAWP review.

System Setup Click on it to enter the system setup menu.

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Display screens of Vista 120 CMS

20 Instructions for use Vista 120 CMS SW 1.n

Shut Down Click on it to shut down Vista 120 CMS and the operating system.

Admission Click on it to open the patient admission window.

System Volume Adjustor

Click on it, and the volume adjustor icon appears. Select the Mute check box, and then enter the password ABC in the text box on the pop-up window;

the entire system become mute, and the symbol appears. To disable the silence function, tick the Mute

check box again and the symbol appears. Additionally, the user can drag the volume adjustor to the desired volume.

NOTE:Vista 120 CMS will keep mute as soon as mute check box is ticked. If a new alarm occurs, the system will not break mute status and will keep mute until mute check box is ticked again. Use it with caution.

Button Button Label Function

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Instructions for use Vista 120 CMS SW 1.n 21

Display screens of Vista 120 CMS

Networked State

The networked state window has 64 panes representing the 64 monitors that can be supported and connected to the Vista 120 CMS. The pane only displays the bed number. The user can access the single bed interface by clicking on the pane.

The pane has the several types of state:

Blank: Network disconnected.

With grey background: Improper offline or patient discharged.

With green background: Networked monitoring, without physiological alarm.

With yellow background: Networked monitoring, with medium or low level physiological alarm.

With red background: Networked monitoring, with high level physiological alarm.

Events Review

Review physiological alarms for all patients online.Events Review interface includes:

Bed No.

Events, name of the events

Events level, same as alarm level

Time, when the event is triggered

Length, the event timeline duration. 30 min, 60min, 120 min and 240 min are optional. Default value is 30 min.

Refresh, for data refreshing.

The user can sequence the events ascendingly or descendingly by clicking on the heading of any column: Bed No., Events, or Time. Chronological order is the default.

To exit events review, the user can click the exit button in the top right corner, or double-click any events to enter into alarm review interface for single patient.

NOTE:Events review interface will be blank if there are no patients online.

Button Button Label Function

1 2 3 …

4

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Display screens of Vista 120 CMS

22 Instructions for use Vista 120 CMS SW 1.n

Auxiliary Screen

If the patient sector is either in improper offline status or networked monitoring status, the user can access the auxiliary screen by clicking the waveform area or parameter area (except for NIBP parameter area) on the patient sector. The auxiliary screen on a single display and dual displays are as shown below.

1 System information area2 Patient sectors3 Switch and setup area for sub-window4 Sub-window of auxiliary screen5 Quick control area

1 System information area2 Patient sectors 3 Quick control area 4 Switch and setup area for sub-window5 Sub-window of auxiliary screen

The auxiliary screen contains a group of sub-windows including Single Bed View, Patient Mgmt, Wave Review, Alarm Review, Trend Review, NIBP Review, Parameter/Waveform Setup, C.O. measure review, Quick TEMP Review, PAWP Review and Calculation. The sub-window of Single Bed View will be displayed by default when the user enters the auxiliary screen.

In the switch and setup area for the sub-window, the user can:

Click a tag to switch the current sub-window to another sub-window.

Click to scroll leftward and click to scroll rightward in the tag bar.

Click to open the drop-down list in which the user can set the tags to show/hide.

Click to exit the auxiliary screen and enter the main screen.

Drag a tag to adjust its location.

Click or to switch between full screen display mode and half screen display mode for the auxiliary screen when using a single display.

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Instructions for use Vista 120 CMS SW 1.n 23

Display screens of Vista 120 CMS

Large Font Display

Choose Display the window in large font from the menu in the patient sector, and this sector will be displayed in the large font display mode. Choose Display the window in large font again, and the sector will be displayed in the general display mode. In the large font display mode, parameter values are displayed in the patient sector, but no waveform is shown.

1: Large font display mode

2-8: General Display Mode

Choose Display all windows in large font from the menu in the patient sector, and all sectors will be displayed in the large font display mode. Choose Display all windows in large font again, and all sectors will be displayed in the general display mode.

Layout of Patient Sectors

The number of patients the user can view on the screen and the size of each patient sector depend on the layout of the patient sectors. If 64 monitors are connected to the Vista 120 CMS and the number of patient sectors displayed on the main screen is set to 32, the screen will only display 32 patient sectors and the other 32 sectors are invisible. The user may:

Switch between the visible and invisible patient sectors, refer to Section Switching Patient sector.

Click bed number to view the 64 patient sectors in the networked state window.

Refer to Section Display Setup for more information about setting the layout of the patient sectors.

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Instructions for use Vista 120 CMS SW 1.n 25

Switching Vista 120 CMS on and off

Switching Vista 120 CMS on and off

Starting monitoring . . . . . . . . . . . . . . . . . . . . 26

Shutting down the System . . . . . . . . . . . . . . 27

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26 Instructions for use Vista 120 CMS SW 1.n

Starting monitoring

When all of its components are correctly connected, press the power button on the front panel of the device. The power indicator on the front panel lights up and the device performs hardware self-test. If the device works normally, the main screen appears. If the device detects abnormity during self-test, it beeps to show alarm and displays error information on the screen. In this case, the user should record the error information, shut down the device and contact DrägerService representative. After the system self-test is completed, the user will access the Vista 120 CMS system interface and the system will also finish the environment self-test automatically. Meanwhile, the system will sound Do-Do-Do, a test sound. The user should set the volume system and confirm that the volume of the system can be heard clearly.

NOTE Before starting the system, verify that the dongle has been installed. Otherwise, the user may fail to access the system.

NOTE Dongle will give out alarm sound if system gets blocked till resuming normal status.

CAUTION Ensure that the audio adapter of the PC is activated and the loudspeaker is on.

CAUTION The audio adapter and network adapter should be correctly installed, or the user may not access Vista 120 CMS.

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Instructions for use Vista 120 CMS SW 1.n 27

Switching Vista 120 CMS on and off

Shutting down the System

It is important to shut down the system properly. Follow this simple procedure to properly shut down the system. This prevents inadvertent errors from occurring during system shut down.

Vista 120 CMS can work continuously for a long time. The user does not need to shut it down in order to achieve a longer working life.

The user should follow the procedure to shut down Vista 120 CMS.

Method 1:

Select Shut Down on the main menu and enter the password of user maintain. Confirm the password by clicking OK, and the Vista 120 CMS as well as the operating system will be shut down.

Method 2:

Select System Setup > User Maintain, and enter the password of user maintain; select Other Setup.

Select Shut Down: Vista 120 CMS as well as the operating system will be shut down.

Select Return to Windows: the user will exit from Vista 120 CMS, but the operating system will not be shut down.

WARNING Shut down the system by strictly observing the shutdown procedure to avoid losing the central monitoring of bedside patients.

WARNING When using an UPS (optional) do not switch off the UPS by force. Otherwise it can result in a system failure and can affect the future operation of the system.

WARNING If power cut-off occurs, turn off the system before the UPS exhausts its electricity.

CAUTION Hospitals without a stable power source should use a UPS to provide power to Vista 120 CMS. The UPS must not be turned off. When there is a power failure, the system should be shut down by following the specified shutdown procedure before the UPS is exhausted. If the system has a sudden power failure, system failure may occur and consequently the system might not work properly next time.

NOTE If the user forgets the password, contact Dräger service engineer.

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Instructions for use Vista 120 CMS SW 1.n 29

Patient Management

Patient Management

Admitting a Patient. . . . . . . . . . . . . . . . . . . . . 30

Obtaining patient information . . . . . . . . . . . . 30

Synchronizing patient information* . . . . . . . 31

Changing Patient Information . . . . . . . . . . . . 31

Switching Patient sector . . . . . . . . . . . . . . . . 32

Discharging a Patient. . . . . . . . . . . . . . . . . . . 32

Setting Idle Bed . . . . . . . . . . . . . . . . . . . . . . . 32

Transferring a Patient. . . . . . . . . . . . . . . . . . . 33

Monitoring Statistics . . . . . . . . . . . . . . . . . . . 33

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Patient Management

30 Instructions for use Vista 120 CMS SW 1.n

Admitting a Patient

Once Vista 120 CMS starts up and the monitor is properly connected with Vista 120 CMS, the system will prompt the user to admit patients by displaying the number of pending patients at the information area.

Click Admission in the quick control area to display a window of Pending patient list. Select the patients the user wants to admit from the left list in the window, and enter the patient information in the right area of the window. Click the Admission button at the bottom of the window to complete patient admission.

After being admitted, a patient will occupy a patient sector. Vista 120 CMS displays the real-time monitoring data which will also be stored in the database.

For the monitor that has been offline due to network problems and is networked with Vista 120 CMS later, the user needs not readmit the patient of this monitor. This monitor will be automatically online in the patient sector which it has occupied.

Obtaining patient information

If configured, patient information from a Hospital Information System (HIS) or Electronic Medical Record (EMR) system can be obtained through Mirth Connect (MC) and will display on Vista 120 CMS.

There are two routes to obtain patient information:

Route 1:

1 Click Admission in the quick control area > EMR Patient List or click on the patient sector and select Patient Mgmt > EMR Patient List, and the EMR patient list is displayed.

2 Input a query condition for ALL, MRN, Last Name or First Name, and then click Query button. The required patient information is displayed. The user also can select Display all patients or Display pending patients to show the required patient information.

3 Select a patient from the patient information list. Click Confirm and then Admission, or click Confirm and then Update Monitor. The corresponding patient information in Vista 120 CMS and the monitor will be updated.

WARNING For those bedside monitors that have been networked with Vista 120 CMS for the first time, the user has to complete patient admission by using the methods mentioned above, which enables the monitors to be online and observed by Vista 120 CMS. Otherwise, the monitors will not be online on Vista 120 CMS, and the monitoring data will not be saved by Vista 120 CMS.

WARNING Before accepting a new patient, no matter the former one on patient sector is in networked monitoring status or improper offline status, the operation of discharging the former one is needed.

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Patient Management

Route 2:

Select User Maintain > HL7 and tick Auto Admitting via MRN. When the monitor is networked with Vista 120 CMS and gets online for the first time, Vista 120 CMS will automatically search for the patient’s MRN in EMR patient list. If the patient is found, the patient information will automatically be updated to Vista 120 CMS and the monitor.

Synchronizing patient information*

*Only applicable to patients admitted from EMR patient list.

When Vista 120 CMS is associated with a HIS/EMR system, Vista 120 CMS will be informed to synchronize and update the patient information with the HIS/EMR system. For instance, whenever the patient is updated/discharged/transferred in

HIS/EMR system, will be displayed in Vista

120 CMS to prompt the user. Click , and a list of EMR handling messages (Bed ** Updated/Bed

**Discharged/Bed ** Transferred) is displayed in EMR Message List. In this case, the user needs to confirm whether to synchronize the patient information with HIS/EMR system or ignore the message.

Likewise, if patient information is modified in Vista 120 CMS, prompt information will also be sent to inform HIS/EMR system of the update. Meanwhile, the patient’s physiological data will also be sent to HIS/EMR system.

Changing Patient Information

The user can change the patient information on Vista 120 CMS when the information is incorrect. To modify the patient information, click on the patient sector and select Patient Mgmt, enter the correct information in the appropriate fields and click Update Monitor.

There are two ways to modify the patient information:

Modify the patient information via the monitor. For more information, refer to the user manual of the monitor.

Modify patient information via Vista 120 CMS.

NOTE EMR Patient List button is available only when Mirth Connect function is enabled. For Mirth Connect settings, contact DrägerService.

NOTE If patient’s MRN is modified during monitoring, Vista 120 CMS will not perform automatical query.

NOTE If the patient type is changed via Vista 120 CMS, the patient type on the monitor will be changed accordingly.

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Patient Management

32 Instructions for use Vista 120 CMS SW 1.n

Switching Patient sector

For a disconnected patient sector (refer to Section Patient Sectors), click anywhere in it and choose a patient to be assigned to this sector from the patient list.

For a patient sector which is in patient discharged status or improper offline status or networked monitoring status (refer to Section Patient Sectors), select Show from the list on the patient sector, and select another bedside monitor from the patient list; the selected bedside monitor will be displayed in this patient sector.

Discharging a Patient

When the monitoring on a patient is completed, the user needs to discharge this patient by any of the following methods:

Choose Discharge Patient from the menu in the patient sector.

Choose Patient Mgmt > Discharge Patient on the auxiliary screen.

Discharge the patient via the Review window.

The operation of discharging a patient will cause the patient offline from Vista 120 CMS, and there will be no patient admitted in the related patient sector. The discharged patient will be shown in the history patient list.

After discharging patient, open patient sector menu by clicking on patient information area. The user can set this patient sector to idle status by clicking Set Idle Bed and switch patient sector by clicking Show.

Setting Idle Bed

A patient sector displays monitoring information for one monitoring device only. Setting idle bed will discharge monitoring device from the patient sector.

The user can set idle bed by following methods:

Method 1: After discharging patient, click Set Idle Bed in patient sector menu;

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Instructions for use Vista 120 CMS SW 1.n 33

Patient Management

Method 2: Select System Setup > Common Setup > Display Setup, and click the area which displays bed No., and then click Set Idle Bed. Or the user can drag the area to change monitoring device’s position on patient sector.

Transferring a Patient

Select Patient Mgmt >Transfer on the auxiliary screen, and the user will see a list of online patients. From this list, select a patient whose bed will be considered as the destination bed and click OK, and then the current patient will be transferred to the destination bed.

Monitoring Statistics

The monitoring statistics of the selected patients will be shown in the patient management window. The monitoring statistics covers the total monitoring time for waveforms and trends, the number of alarm events, the number of NIBP measuring, the number of C.O. measuring, the number of Quick TEMP measuring and the number of PAWP measuring.

Click Analysis, the system will:

Analyze the number of high and low limit alarms for each physiological parameter and analyze the percentage of the limit alarms of the parameter in all limit alarms.

Analyze the number of arrhythmia events for each type of arrhythmia and analyze the percentage of a certain type of arrhythmia.

Analyze the average value, maximum/minimum value, and measure time of the maximum/minimum value for the trend values.

NOTE Because the number of beds to be viewed on the screen is optional (refer to Section Display Setup), the monitoring device’s position on patient sector is in a relatively fixed order, that is, from top to bottom and then left to right.

NOTE Switching patient sector is not equal to setting idle bed. They are mutual independent and will not influence each other.

NOTE Transferring a patient to the destination bed will at the same time discharge the selected patient on the destination bed.

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Patient Sector

Patient Sector

Networked Monitoring Display . . . . . . . . . . . 36

Menu in the Patient Sector . . . . . . . . . . . . . . 37

Parameter/ Waveform Setup . . . . . . . . . . . . . 37Setting Waveforms . . . . . . . . . . . . . . . . . . . . . . 37Setting Parameters. . . . . . . . . . . . . . . . . . . . . . 37

Freeze . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Real-Time Printing . . . . . . . . . . . . . . . . . . . . . 39

Alarm Reset. . . . . . . . . . . . . . . . . . . . . . . . . . . 39

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Patient Sector

36 Instructions for use Vista 120 CMS SW 1.n

Networked Monitoring Display

1 Waveform area

2 Parameter area

3 Patient information area

4 Technical alarm/ Prompts/ indicator area

5 Physiological alarm area

Waveform area and parameter area: It displays some of real-time monitoring waveforms and parameter values.

Patient information area: It displays the bed number and patient name.

Technical alarm/ Prompts/ Indicator area: It displays the technical alarm messages when a technical alarm occurs. Click on the technical alarm message, and the list for the current technical alarms will be displayed. When no technical alarms and no prompts occur, it displays the indicators indicating the state of the monitors:

Physiological alarm area: It displays the physiological alarm messages. Click on the physiological alarm message, and the list for the current physiological alarms will be displayed.

Indicator Description

Pace on

Pace off

Alarm mute of the monitor

Alarm pause of the monitor

NOTE Due to the delay of network transmission, data viewed on Vista 120 CMS has a delay of 5 s compared with data generated at the corresponding bedside monitor.

NOTE Due to the operating system schedule, the waveform scan of Vista 120 CMS might be suspended for about 20 ms in very few occasions. After the suspension, waveform scan will go back to normal status. The quality of patient monitoring during the suspension will not be affected.

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Instructions for use Vista 120 CMS SW 1.n 37

Patient Sector

Menu in the Patient Sector

When the patient sector is in the improper offline state or in the networked monitoring state, the user can open a menu by clicking on the patient information area. The available items in this menu are:

Display the window in large font: Switch between the large font display mode and the general display mode for the current patient sector.

Display all windows in large font: Switch between the large font display mode and the general display mode for all patient sectors.

Parameter/Waveform Setup: Switch to the Parameter/Waveform Setup window on the auxiliary screen.

Monitor Parameter Setup: Switch to Monitor Parameter Setup window on the auxiliary screen.

NIBP MEASURE: Start a NIBP measurement.

Discharge Patient: Discharge the patient in the current patient sector.

Freeze: Freeze/ unfreeze the waveform in the current patient sector.

Print: Print the monitoring data in the current patient sector.

Show: Switch between patient sectors.

Alarm Reset: Activate alarm reset function.

Parameter/ Waveform Setup

Due to the limited display space of the patient sector, the numbers of waveforms and parameters to be displayed depends on the numbers of monitors displayed on patient sector. Six waveforms and four parameters to be displayed on patient sector are the maximum. The user can set the displayed waveforms and parameters by setting configuration in the Parameter/Waveform Setup window. The user may access this window by either of the two methods below:

Choose Parameter/ Waveform Setup from the menu on the patient sector.

Click the tag Parameter/ Waveform Setup on the auxiliary screen.

Setting Waveforms

Select or deselect the check box before a Wave Name to display or not display the waveform. Click Update Wave Setup to confirm the configuration. The patient sector will only display the selected waveforms.

Choose Speed and set the desired sweep speed for the waveform. Click Update Wave Setup to confirm the configuration. The waveform will be displayed according to the speed the user has set.

Setting Parameters

Adding a parameter to be displayed

To add a new parameter to be displayed, select the desired parameter name in Available Params and click on Add to add it into Current Params, and then click on Refresh ParamGroup to update the parameters displayed on the patient sector.

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Patient Sector

38 Instructions for use Vista 120 CMS SW 1.n

Removing a parameter displayed

To remove a parameter displayed, select the parameter in the Current Params box, and click on Remove and Refresh ParamGroup.

Setting Parameter Order for Display

To adjust the display position of the parameter, select the parameter name in the Current Params box, and click on Move UP or Move Down. To make the change valid, click on Refresh ParamGroup.

Freeze

Choose Freeze from the menu in the patient sector, the user can freeze the waveform displayed in this patient sector. And the item name Freeze is changed into Unfreeze. The user can unfreeze the waveform by choosing Unfreeze. And then the item name will resume Freeze.

The waves stop scanning during freeze. The freeze time and a timeline will also be displayed in the

window. The user can use the arrow buttons

and beside the timeline or drag the pointer on the freeze wave to review more details.

The user can review 3-minute frozen waveform in this menu.

NOTE Due to the limited display space, the displayed waveforms and parameters of each patient sector will decrease as the displayed patient sectors increase. If the user wants more waveforms and parameters to be displayed in one patient sector, modify the display layout by reducing the patient sectors displayed on the main screen.

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Instructions for use Vista 120 CMS SW 1.n 39

Patient Sector

Real-Time Printing

To print real-time data from Vista 120 CMS, click Print from the menu in the patient sector or click the Print button in the single bed window.

After Print is selected, Vista 120 CMS starts to collect data for printing and the system will indicate Collecting Data… at the top of the main screen. After the system completes 11-second data

collecting, a dialog box for printing setup will appear. The printout includes the 11-second waveform data at the point of starting printing, data of all physiological parameters at the time the user selects Print and the latest NIBP measurement before finishing collecting.

Alarm Reset

Choose Alarm Reset from the menu in the patient sector to activate the alarm reset function. During the alarm reset status:

The audio alarm is turned off, and no alarms are sounding.

The visual alarm indications are still displayed.

Clear all the latched alarms.

Alarm reset on Vista 120 CMS will also influence alarm status on bedside monitors. The on-going alarms are reset both on bedside monitors and on the corresponding patient sector on Vista 120 CMS.

NOTE If a new alarm occurs during the alarm reset period, the new alarm on Vista 120 CMS will recover normal. That is, the new alarm will be sounded and displayed.

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Viewing Single Bed

Viewing Single Bed

Display of Single Bed. . . . . . . . . . . . . . . . . . . 42

Hiding/Showing Multi-Lead Waveform . . . . . 43

Short Trend Review . . . . . . . . . . . . . . . . . . . . 43

OxyCRG. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Freeze . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

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Viewing Single Bed

42 Instructions for use Vista 120 CMS SW 1.n

Display of Single Bed

The Single Bed View sub-window will be displayed by default when the user enters the auxiliary screen.

1 Patient information area

2 Toolbar

3 Indicator area

4 Technical alarm area/ Prompts area

5 Physiological alarm area

6 Short trend area

7 Waveform area

8 Parameter area

9 Scroll bar

Patient information area: It displays the bed No., patient name, gender and patient type.

The user can perform the following functions via the toolbar: – Freezing or unfreezing the waveforms

displayed in the Single Bed View sub-window.

– Real-time printing.– Display setup: choosing the multi-lead

waveform of ECG to be hidden or shown; setting the short trend display to on or off; choosing the OxyCRG window to be opened or closed.

Indicator area: It displays indicators indicating the state of the monitors.

Technical alarm area/ Prompts area: It displays technical alarm messages consistent with the messages displayed in the patient sector. The mouse operation here of technical alarm is the same as the one in patient sector.

Physiological alarm area: It displays physiological alarm messages consistent with the messages displayed in the patient sector. The mouse operation here of physiological alarm is the same as the one in patient sector.

Short trend area: When the short trend display is on, the short trend will be displayed in this area. When the short trend display is off, waveforms will be displayed in this area.

Waveform area: It displays all waveforms from the networked monitor.

Parameter area: It displays all parameters from the networked monitor.

Scroll bar: The user can drag the scroll bar to view more waveforms and parameters in this window.

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Instructions for use Vista 120 CMS SW 1.n 43

Viewing Single Bed

Hiding/Showing Multi-Lead Waveform

Choose View Selection > Multi-lead on the toolbar in the Single Bed View sub-window. The waveform area can display multi-lead waveforms for ECG. Choose View Selection > Multi-lead again, and the multi-lead waveform display for ECG will become unavailable. When 3-lead is used, multi-lead waveform display is unavailable.

Short Trend Review

After entering the single bed view interface, choose View Selection > Trend Screen on the toolbar and the short trend will be displayed on the left of the interface. Click short trend area and a dialog box of short trend settings will pop up. The user can set the display mode of the short trend by configuring

Param Select and Interval. The user may select the desired parameters to be displayed from the drop-down list of Param Select. Also, the user can choose Interval on the interface to open the list and select an appropriate interval among 1h, 2h, 4h, 8h and 12h.

OxyCRG

In the Single Bed View window, choose View Selection > OxyCRG on the toolbar, and the OxyCRG window will be open. The user can switch the display between respiratory rate and respiratory

waveform by clicking RR and RESP. The user can also set the interval of the OxyCRG to 1 minute, 2 minutes or 4 minutes.

xxx

xxx

xxx

xxx

xxx

xxx

xxx

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Viewing Single Bed

44 Instructions for use Vista 120 CMS SW 1.n

Freeze

The user can freeze the waveform displayed in this window by choosing Freeze on the toolbar and unfreeze the waveform by choosing Unfreeze.

The display of freezing waveform in the Single Bed View sub-window is consistent with the one in the patient sector.

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Instructions for use Vista 120 CMS SW 1.n 45

Viewing bedside monitor’s work status

Viewing bedside monitor’s work status

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Standby Mode . . . . . . . . . . . . . . . . . . . . . . . . . 46

NFC Mode* . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Privacy Mode . . . . . . . . . . . . . . . . . . . . . . . . . 47

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Viewing bedside monitor’s work status

46 Instructions for use Vista 120 CMS SW 1.n

Overview

When the bedside monitor is connected to Vista 120 CMS, its real-time work status will be transmitted to Vista 120 CMS.

Standby Mode

When the monitor is in standby mode,

1 Vista 120 CMS won’t update monitoring data, and will display monitor's standby mode.

2 Vista 120 CMS will neither store data transmitted from the monitor, nor display waveforms/parameters/alarms.

3 Vista 120 CMS cannot transfer or discharge the patient. Printing and freezing functions are disabled. The patient information cannot be modified.

4 Vista 120 CMS can normally review the history data.

The monitor exits standby mode in any of the conditions:

1 The user clicks Exit Standby Mode in the specific patient sector’ menu.

2 Vista 120 CMS admits a new patient.

NFC Mode*

* This is for French users only and NFC has nothing to do with "Near Field Communication".

When the monitor is in NFC mode,

1 The HR physiological alarms on Vista 120 CMS are always on and can't be set to off by the user.

2 Prompt information NFC: On is displayed in HR parameter area.

3 The user can't turn off the audio alarm permanently.

4 HR audio alarms can be turned off via Alarm Reset in the specific patient sector’s menu.

5 The audio alarm off status will be finished and Vista 120 CMS enters normal alarm response status. Audio Pause will automatically switch to 2 minute, which can be set to 1 minute, 2 minute, 3 minute manually.

NOTE NFC mode and standby mode can't coexist. When the monitor enters the standby mode, the NFC mode will automatically pause. After exiting the standby mode, the monitor will automatically resume the NFC mode.

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Instructions for use Vista 120 CMS SW 1.n 47

Viewing bedside monitor’s work status

Privacy Mode

When the monitor is in privacy mode, Vista 120 CMS normally updates and displays monitoring data, and displays monitor's privacy mode in technical alarm area of patient sector.

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Setting Monitors via Vista 120 CMS

Setting Monitors via Vista 120 CMS

Changing Patient Information . . . . . . . . . . . . 50

Setting Parameters. . . . . . . . . . . . . . . . . . . . . 50Configuring NIBP Measurement Settings. . . . . 50Parameters Alarm Setting . . . . . . . . . . . . . . . . 50

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Setting Monitors via Vista 120 CMS

50 Instructions for use Vista 120 CMS SW 1.n

Changing Patient Information

Refer to Chapter Patient Management Section Changing Patient Information for more information.

Setting Parameters

The user can open the parameter setup window by two methods:

Method 1: Choose Monitor Parameter Setup in the patient sector.

Method 2: Select the parameter area in the single bed interface, and click on the chosen parameter area.

1 Physiological parameter list;

2 Alarm display and configuration list;

3 Physiological parameter attribute and configuration;

4 Update Monitor button;

5 Button for closing the window

The physiological parameter list shows all the available physiological parameter module of the networked monitor. Choose a parameter, the relevant alarm settings and parameter attribute will be respectively displayed in Area 2 and Area 3. The user can configure the alarm settings and modify

parameter attributes, after which the user clicks Update Monitor to update the relevant settings of the monitor.

Clicking button 5 can close parameter setup window.

Configuring NIBP Measurement Settings

Choose NIBP in the parameter list on the parameter setup window, and the user can configure the NIBP measurement settings on the physiological parameter attribute and configuration area. The user can modify the measurement mode and measurement interval of NIBP. The operation steps are shown as follows:

1 Choose a measurement mode.

2 If automatic measurement mode is chosen, the user also needs to set the measurement interval.

3 Click Update Monitor to make the change valid.

4 For a continual measurement, click Continual.

Parameters Alarm Setting

The user can configure the alarm setting via the alarm display and configuration list on the parameter setup window. The user can configure the alarm threshold, alarm switch, alarm level, alarm upper and lower limits. The operation steps are shown as follows:

1

2

3 4

5

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Instructions for use Vista 120 CMS SW 1.n 51

Setting Monitors via Vista 120 CMS

1 Choose a parameter from the physiological parameter list.

2 Configure the alarm settings in the alarm display and configuration list.

3 Click Update Monitor to make the change valid.

ECG ARR alarm setting

Set the threshold of certain arrhythmia alarms. When an arrhythmia exceeds its threshold, an alarm will be triggered.

V-Fib/V-Tach and Vent Brady are key ARR alarms and they are preset to be on. The user can switch on/off those key ARR alarms only when Key ARR Alarm Switch Authority is enabled. To enable the authority, the user should input the required user maintain password. If any of key ARR alarms is switched off, the technical alarm area will prompt Key ARR Alarm Off. Clicking the prompts can view the details.

Asystole is preset to On and cannot be turned off.

If Key ARR Alarm Switch Authority on the monitor is Off, the switch setting on Vista 120 CMS fails. Meanwhile, Vista 120 CMS will prompt the setting failures.

WARNING Prior to monitoring, make sure that the alarm limit settings are appropriate for the patient.

WARNING When the alarm is set to OFF, Vista 120 CMS will not give an alarm even if an alarm occurs. In order to avoid endangering the patient’s life, the user should use this function cautiously.

WARNING Setting alarm limits to extreme values may cause alarm system to become ineffective. It is recommended to use the default settings.

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Instructions for use Vista 120 CMS SW 1.n 53

Review

Review

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

Patient List . . . . . . . . . . . . . . . . . . . . . . . . . . . 54Patient Review . . . . . . . . . . . . . . . . . . . . . . . . . 54History Patient Review . . . . . . . . . . . . . . . . . . . 54Backup Patient Review. . . . . . . . . . . . . . . . . . . 55

Wave Review. . . . . . . . . . . . . . . . . . . . . . . . . . 55Reviewing Normal Waveforms . . . . . . . . . . . . . 55Reviewing ECG Compressed Waveforms . . . . 55Setting Wave Speed . . . . . . . . . . . . . . . . . . . . . 55Refreshing Waveform. . . . . . . . . . . . . . . . . . . . 55Selecting Waveform . . . . . . . . . . . . . . . . . . . . . 55Time Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56Print . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56

Alarm Review . . . . . . . . . . . . . . . . . . . . . . . . . 56Locking and Unlocking Alarm Information . . . . 56Printing Alarm Information . . . . . . . . . . . . . . . . 56Sequencing the Alarm List . . . . . . . . . . . . . . . . 56Annotating Alarm . . . . . . . . . . . . . . . . . . . . . . . 57Filtering Alarm Events . . . . . . . . . . . . . . . . . . . 57

Trend Review . . . . . . . . . . . . . . . . . . . . . . . . . 57Setting Resolution . . . . . . . . . . . . . . . . . . . . . . 57Viewing Parameters selectively . . . . . . . . . . . . 57Refreshing Data . . . . . . . . . . . . . . . . . . . . . . . . 57Printing Trend Review . . . . . . . . . . . . . . . . . . . 58Selecting Trend Table, trend Graph . . . . . . . . . 58

NIBP Review . . . . . . . . . . . . . . . . . . . . . . . . . . 58

C.O. Measure Review . . . . . . . . . . . . . . . . . . . 58

Quick Temp review. . . . . . . . . . . . . . . . . . . . . 59

PAWP review. . . . . . . . . . . . . . . . . . . . . . . . . . 59

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Review

54 Instructions for use Vista 120 CMS SW 1.n

Overview

Via Vista 120 CMS, The user can review the history data of patients, which includes the list containing all patients, patient management, trend, alarm, wave, NIBP, C.O. measure, Quick TEMP and

PAWP. By clicking on the review button in quick control area of main screen, the user can enter the review interface.

Patient List

Clicking review button in quick control area of main screen and the user will access the review interface. It displays the Patient List by default. By respectively selecting the items from the drop-down list shown at the top left corner, the user can review the list of patients who have been admitted by Vista 120 CMS, the list of patients who have been discharged, and the list of patients saved in the backup database.

The user can select a patient from the list and click the Patient Mgmt tab to review detailed information of this patient. Also, the user can double click the patient name in the list to open the patient management window. Choose Trend Review, Alarm Review, Wave Review, NIBP Review, C.O. measure review, Quick TEMP Review, PAWP Review, the user can review relevant monitoring data of the patient.

There is a query column and a small inverted triangular black indicator in the rightmost column. To search a patient’s information, click the inverted triangular black indicator and choose among the items (such as MRN, patient’s first name, patient’s family name and doctor). Input patient’s information related with the items and click on Query. If the patient information is saved, the corresponding information is displayed on the screen.

Patient Review

By default, the Patient List displays the patients who have been admitted by Vista 120 CMS after entering the review interface. And also, the default items from the drop-down lists shown at the top left corner will be Online Database Source and Patient Review.

Select a patient and click Discharge Patient, and this patient will be discharged. The discharged patients will be transferred to the History Patient Review list.

History Patient Review

Respectively select Online Database Source and History Patient Review from the drop-down lists shown at the top left corner, and the user can review the list of patients who have been discharged.

To delete patients, Select a patient > click Delete > input default User Maintain password ABC in popup window > click OK to finish deleting. The patients deleted will be completely deleted from Vista 120 CMS.

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Review

Backup Patient Review

Select Offline Database Source from the drop-down list shown at the top left corner, and the user can review the backup patient data.

Wave Review

The Vista 120 CMS can review the change process of the physiological waveform of one patient in the latest 240 hours. Select User Maintain > Database Maintain > Waveform Storage, and there are 96 hours and 240 hours for selection. 96 hours is the default selection.

To use waveform review, click on Main Screen > Review > Wave Review or access the auxiliary screen and choose Wave Review. On this screen, the user can:

Review normal waveforms or ECG compressed waveforms

Set wave speed

Select waveform

Set start time and end time

Refresh waveform

Print

Reviewing Normal Waveforms

Normal waveform review is available to all waveforms. In the normal waveform review window, the waveform is displayed with the same altitude and speed of the real-time waveform.

The user can select Show parameters/Hide parameters. If Show parameters is chosen, the related parameter value will also be displayed accompanying the waveform.

In this window, waveforms can also be dynamically displayed.

Reviewing ECG Compressed Waveforms

Compressed waveform review is only available to ECG waveforms. In the compressed waveform review window, the altitude of the ECG waveform will be compressed so that the user can review the waveform containing longer time of data.

Setting Wave Speed

By clicking on the Sweep button, a list of available wave speed (i.e. 6.25 mm/s, 12.5 mm/s, 25 mm/s and 50 mm/s) will be displayed, from which the user can set the width of waveforms displayed in the waveform area. Changing wave speed will affect the time length of the waveform area.

Refreshing Waveform

Waveform will not update automatically. Therefore, if the user wants to view up-to-date waveform, refresh them manually. Clicking on the Refresh button will refresh the waveform.

Selecting Waveform

Click on the Select Wave button, and a list of

CAUTION If a patient is deleted from the History Patient Review list, his or her data will be completely removed from the system. Before deleting, the backup operation is recommended. Please refer to section Database backup for details.

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56 Instructions for use Vista 120 CMS SW 1.n

available waveforms will be shown. By default, all waveforms are selected. The user can deselect a waveform by ticking its check box.

Time Setup

Click Time Setup button, set Start Time in pop-up dialog box, and click OK to finish.

Print

To print the waveform displayed on the current screen, select Print on the screen to print it by the laser printer.

Alarm Review

Alarm table and waveform will be generated when Vista 120 CMS makes physiological alarm notification. Alarm review helps the clinician observe the details of the monitoring information. Alarm information can be stored by the user and thus become important alarm event.

The alarm strip in alarm review is a 16-second waveform. User can also switch alarms by using keyboard arrow keys.

Locking and Unlocking Alarm Information

When the user thinks that an alarm is very important, he/she can save it by locking the alarm information with a symbol √ on the alarm review interface. The symbol √ will appear to its right on this interface when the alarm is locked. The locked alarm cannot be deleted automatically. The user can click on the symbol √ to unlock the locked alarm, the symbol √ will disappear.

Printing Alarm Information

If the user wants to print alarm table, he/ she can click on Print on the interface to print it by a laser printer.

Sequencing the Alarm List

The user can sequence all alarms ascendingly or descendingly by clicking on the heading of any column:

Alarm Time: Clicking on it will sequence all alarms ascendingly or descendingly by time.

Alarm Level: Clicking on it will sequence all alarms ascendingly or descendingly by level.

At the same time, one of the following symbols will appear on the bottom of the heading:

NOTE The 240-hour full disclosure waveform storage will occupy a lot of hard disc. Therefore, the user shall be cautious to add the useless waveform information to the waveform setup.

NOTE A maximum of 20000 alarm information (within 240 hours) can be stored. If the storage space is full and there are new alarms occurring, the earliest alarm information will disappear.

NOTE The important alarm events can be deleted but not automatically .The unimportant alarm events can be automatically replaced by new alarm events when they have accumulated to a certain amount.

NOTE The alarm stripe displays the physiological waveform at 25mm/s when an alarm takes place.

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Review

The symbol ▲ indicates ascending sequence, and

The symbol ▼ indicates descending sequence.

Annotating Alarm

The user can add notes to illuminate an alarm. To annotate an alarm, select a certain alarm stripe and the user will see the title Alarm Note on the bottom of the alarm review interface. Move the cursor 1cm left to the title Alarm Note and a pop-up input box in which the user can input detailed information for the alarm will appear. After completing the notes,

move the cursor out of the area of the input box, and Vista 120 CMS will automatically save the input information.

Filtering Alarm Events

The user can filter alarm events by selecting or clearing the check boxes before the items in the Alarm Level list, in the Event Type list and in the Param Select list. The Alarm Review window will only display the alarm events whose alarm level /levels has/have be selected and the alarm events of selected parameters.

Trend Review

Choose Main Screen > Review > Trend Review or choose Trend Review on the auxiliary screen, and the user will enter the trend review interface, through which up to 240 hours of trend data can be stored and reviewed. Change of trends can be observed through trend table and trend graph. On this interface, the user can:

set the resolution

view parameters selectively

refresh the data

print

set the starting and ending time for review.

Setting Resolution

The user can select a time period as the resolution for viewing the graph and table as required. Options are 1 s, 5 s, 1 min, 5 min, 15 min, 30 min, 60 min, 2 Hours, 3 Hours, 4 Hours, Display Time Points for NIBP Measurements and Display Time Points for Quick TEMP Measurements. To

change the resolution, select Resolution Setting on the interface and select the desired option from the list.

Viewing Parameters selectively

In the parameter list of Param Select, the user can select modules or parameters by ticking their check boxes as required. Only the selected parameters are displayed in the graph or table.

When a parameter module is selected or unselected, all of its parameters will be selected or unselected accordingly.

Refreshing Data

Trend data will not update automatically. Therefore, if the user wants to view up-to-date trend data, refresh them manually. Click on the Refresh button to refresh the data to up-to date. After refreshing them, the status selected and order of parameters remain unchanged.

NOTE Input characters are limited to 256.

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Printing Trend Review

Clicking on Trend Review > Print > Print Trend Table/ Print Trend Graph, the trend table and trend graph can be printed. By default, the system will print the latest data.

Selecting Trend Table, trend Graph

Select Trend table to review the trend table only. Select Trend Graph to review the trend graph only. Select Trend Table, Trend Graph to review the trend table and trend graph at the same time.

Trend data in trend table is displayed according to the selected resolution. If NIBP or Quick TEMP is selected in Param Select, NIBP data or Quick TEMP and other parameters’ data within the resolution will also be displayed.

The y-axis scale in trend graph will automatically adjust according to the x-axis time, in order to achieve the optimum display effect.

NIBP Review

Results of four latest NIBP measurements are displayed in the NIBP area in the Single Bed View window.

To review earlier NIBP measurement results, choose Main Screen > Review > NIBP Review or choose NIBP Review on the auxiliary screen to enter the NIBP review interface, through which up to 20000 groups of NIBP measurements of a patient (within 240 hours) can be viewed.

The NIBP review window displays Serial No., Measure Time, SYS, DIA, MAP and PR for each measurement. Additionally, in this window the user can:

Click Show parameters, and the measurement values of all physiological parameters at the measure time specified in the selected item will be shown in the lower portion of the window. Click Hide parameters, and these measurements values will not be displayed.

Refresh

Print out the current page

Print out all pages

C.O. Measure Review

Choose Main Screen > Review > C.O. Measure Review or choose C.O. Measure Review on the auxiliary screen, and up to 20000 groups of C.O. measurement of the current patient in this window (within 240 hours) can be reviewed.

In the C.O. Measure Review window, measure results are arranged chronologically on the left. Select a measure result and the measure value as well as the curve will be displayed on the right. A maximum of six groups of measure results can be displayed simultaneously.

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Review

At the lower part of the window, the average values of C.O and CI of the selected measure results are displayed.

The user can print the selected measure results.

Quick Temp review

Choose Main Screen > Review > Quick TEMP Review or choose Quick TEMP Review on the auxiliary screen, and up to 20000 groups of Quick TEMP measurement (within 240 hours) in this

window can be reviewed. The Quick TEMP measure result and measure time are available. The user can print the Quick TEMP measurement list.

PAWP review

Choose Main Screen > Review > PAWP Review or choose PAWP Review on the auxiliary screen, and up to 20000 groups of PAWP measurement (within 240 hours) in this window can be reviewed. The user can print the PAWP measurement list.

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System Setup

System Setup

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62

Common Setup. . . . . . . . . . . . . . . . . . . . . . . . 62Parameter Unit Setup. . . . . . . . . . . . . . . . . . . . 62Color Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . 62Display Setup . . . . . . . . . . . . . . . . . . . . . . . . . . 62Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63

User Maintain . . . . . . . . . . . . . . . . . . . . . . . . . 63Monitor Batch Settings . . . . . . . . . . . . . . . . . . . 63Date/Time Setup. . . . . . . . . . . . . . . . . . . . . . . . 63Alarm Setup for Vista 120 CMS . . . . . . . . . . . . 64Changing Language . . . . . . . . . . . . . . . . . . . . . 64HL7. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64Database Maintain . . . . . . . . . . . . . . . . . . . . . . 64EMR database maintenance . . . . . . . . . . . . . . 64Other Setups . . . . . . . . . . . . . . . . . . . . . . . . . . 65User Password Setting . . . . . . . . . . . . . . . . . . . 65Operation Log. . . . . . . . . . . . . . . . . . . . . . . . . . 65Certificate Management . . . . . . . . . . . . . . . . . . 65About . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65

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Overview

The System Setup function is used to modify the display information at the patient sector according to the real requirements. By using this function, the user can observe the waveform, parameter, and

the parameter list as desired. There are Common Setup, User Maintain, and Factory Maintain to be set.

Common Setup

It is mainly used to make some conventional monitoring settings, such as Param Unit Setup, Color Settings, Display Setup, and Help.

Parameter Unit Setup

The user can change the unit of IBP, NIBP, CO2, (AG) CO2, (AG) O2, C.O. (TB), (RM) CO2 and TEMP. For example, to change the unit of IBP, select Main Screen > System Setup > Common Setup > Param Unit Setup, and select the desired unit among mmHg, kpa and cmH2O from the pull-down list at the right of IBP.

Color Setup

The user can change the display color of all parameters and the other information of the parameter is displayed as the same color. And the information includes waveform name, gain and filter, real-time value (upper limit and lower limit), review waveform and so on. To change the color of the parameter:

1 Select Main Screen > System Setup > Common Setup > Color Setup. Click on the Param Select to choose desired parameter, then choose desired color from the left color area or input desired RGB values of red, green, blue directly.

2 After this, click on OK to confirm.

After setting, the color displayed on Color Setup column is the successfully chosen color. The color on Initial Color column is set by default.

To get the default color, choose desired parameter from Param Select and click Default Settings, and then click OK to confirm.

Display Setup

The user can set the number of beds to be viewed on the screen. To change the display to be viewed, select Main Screen > System Setup > Common Setup > Display Setup > Display Bed Number and choose the desired bed number 3, 4, 6, 8, 10, 12, 14, 16, 32, 64 from the drop-down list of display bed.

The user can also click the area which displays bed No., and then click Set Idle Bed.

There’re two routes to change the monitor’s position:

Route 1: Drag the area which displays bed No. to any position you want.

Route 2: Select Main Screen > System Setup > Common Setup > Display Setup > Sequence, the monitor’s position will be sequenced according to the Bed No..

The monitor is assigned to the patient sector according to the sequence of left to right and top to bottom.

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System Setup

Help

Help information is available on this interface.

User Maintain

To access the settings interface of user maintain, input a user password. The default password is ABC.

Monitor Batch Settings

The user can configure the alarm limit, alarm switch and alarm level for a group of monitors. The user needs to choose a patient type from Adult, Pediat or Neonat before configuring the alarm settings in Templet of Alarm Limit Adjusting Range. Choose the monitors to be configured in the right pane in which the user may see a list of monitors, and click Config. The configuration in the left templet pane will be applied to the chosen monitors.

Besides, from the right pane, the user can choose a monitor whose alarm settings will serve as the source of batch settings for other monitors. Select one monitor in the right pane and click Obtain Monitor Configuration to obtain its parameter alarm settings. The obtained configuration will be displayed in the left templet pane. Choose the monitors to be configured in the right pane and click Config to complete batch settings.

Date/Time Setup

The user can set the correct date and time and their desired format. There are three kinds of date format: yyyy-MM-dd, dd-MM-yyyy, MM-dd-yyyy, two kinds of time format: HH-mm-ss (24 hours) and hh-mm-ss tt (12 hours), and three date separator: /, - and. To change the date and time setup, select Main Screen > System Setup > User Maintain > Date /Time Setup, and select the desired settings from the menu. The time and date displayed on the main screen will also change after change the date and time setup and their format.

NOTE Two screens are needed if the user wants to simultaneously display the information of 64 bedside monitors.

NOTE The function of batch setting is not available for all monitors. If the monitor is labeled as Not Supported in the Compatibility column in the right pane, this function is not available for this monitor.

NOTE If the patient type set in Templet of Alarm Limit Adjusting Range is different from the one set on the bedside monitor to be configured, the system may fail to set the configuration for the monitor.

NOTE The prompt message Success only indicates success in setting the configuration for current activated parameters on the monitor.

NOTE The user must restart the system to make the change effective.

WARNING During patient monitoring, a change in date and time will influence the storage of trend data.

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64 Instructions for use Vista 120 CMS SW 1.n

Alarm Setup for Vista 120 CMS

Choose Main Screen > System Setup > User Maintain > Alarm Setup

The user can configure the alarm setting for Vista 120 CMS.

The user can set the duration in drop-down list of Audio Pause to 1 minute, 2 minute, 3 minute or Permanent.

When the option is 1 minute, 2 minute or 3 minute, the user can click audio pause symbol in main interface to activate Audio Pause. System can exit the audio pause status automatically when the duration time is out, or user can click audio pause symbol again to exit.

When the option is Permanent, the user can click audio pause symbol in main interface to activate

Alarm Mute. The icon is displayed at the top area of the screen. Clicking audio pause symbol again can be used to exit alarm mute status only.

The user can set alarm sound intervals for Vista 120 CMS.

The user can set alarm sound intervals by choosing the desired intervals from the drop-down list of High Alarm Interval (s), Med Alarm Interval (s) and Low Alarm Interval(s).

The user can set alarm ringtone for Vista 120 CMS.

The user can choose different alarm ringtone as desired from the drop-down list of Alarm Tone. Click Play to confirm. Standard and Mode 1 are optional. The default option is Standard.

Changing Language

To change the display language, select Main Screen > System Setup > User Maintain, and input the correct password. Select Language Setup and select the desired language from the drop-down list.

HL7

In User Maintain window, users can set the interval for HL7 data to be sent and set the format of HL7 data package sent by Vista 120 CMS. The interval can be set to 30 s (default) to 7200 s. HL7 data is sent in the format of MLLP (HL7 Mini Lower Layer Protocol) by default. If XML is selected, the data sent by Vista 120 CMS will be packed in XML format. NIBP uploading method can be set to Upload for First Time or Upload for Every Time (default).

Database Maintain

Refer to Section Database Backup for more information about database backup.

EMR database maintenance

To delete the unnecessary HIS/EMR patient information, select Main Screen > System Setup > User Maintain > EMR Database Maintenance. The patients are sorted according to the status. The user can choose Admitted in CMS/Wait for admitting/Discharged in CMS/All to delete the unused information.

NOTE In audio pause or alarm mute status, though a new alarm occurs, system will not give out alarm sound.

NOTE The system will restart automatically to make the change effective.

NOTE HL7 data is sent via the port 9100 by default.

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System Setup

Other Setups

On this interface, the user can:

Set Hospital Info. and Department. The hospital information and department will be displayed at the top left corner on the main screen.

Choose to display or conceal the grid in the View window by selecting or clearing the check box of Display Grid on View.

Return to Windows.

Switch off the system.

User Password Setting

To modify the password, enter the old password in the Old Password field and a new one in the New Password field, after which the user has to Confirm new password to complete the modification.

Operation Log

In User Maintain window, user can scan All operation contents which include Modify Patient Info. (The modifications finished on monitoring device, Vista 120 CMS and EMR system can be scanned), Clear Database, Delete Patient Info., Discharge, Transfer, Backup, Enter Standby Mode, Exit Standby Mode and related ADT operations. The user also can select one of operation contents to scan. Clicking Export can export operation contents.

Certificate Management

To set TLS bidirectional authentication communication, select User Maintain > Certificate Management.

After successfully imporing CA Certificate (.cer), Server Certificate (.cer) and Private Key Certificate (.key.pem), and confirming the Private Key Password, TLS commnunication can be built.

About

It offers information about the software compiling time and software version.

NOTE If the password is forgotten, contact the technical representative of Dräger. If the Factory Maintain password is used to enter the Other Setups menu, the user can directly reset the user password without inputting the old password.

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Alarm Management

Alarm Management

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 68Physiological Alarm . . . . . . . . . . . . . . . . . . . . . 68Technical Alarm . . . . . . . . . . . . . . . . . . . . . . . . 68

Alarm Level of the Monitors . . . . . . . . . . . . . 68

Alarm Mute . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Audio Pause . . . . . . . . . . . . . . . . . . . . . . . . . . 69

Alarm Prompt/Response . . . . . . . . . . . . . . . . 69

Alarms for Networking Status . . . . . . . . . . . . 70

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Overview

Alarms, triggered by a physiological sign that appears abnormal or by technical problems of the monitor, are sent to Vista 120 CMS by the monitors and then indicated to the users by Vista 120 CMS. Alarms coming from the monitors are displayed in the patient sectors and in the single bed view window.

The alarm and prompts coming from Vista 120 CMS system are displayed in the system information area on the upper screen.

Physiological Alarm

It includes parameter alarm and arrhythmia alarm.

Physiological alarm arouses the doctors’ attention by means of visual and audible methods specified in harmonized international standard. Visual method is realized basically by the way of lightening or flicking of the color light. Audible method is realized by the sound for different levels.

Physiological alarms are implemented by alarm limits, which define a range in which a certain physiological parameter is considered to be in the normal status. When a parameter value is beyond the range, the system will consider it to be in an abnormal status and consequently give an alarm.

Technical Alarm

Technical alarms refer to the technical alarms of bedside monitor. Technical alarms of bedside monitor refer to alarms other than physiological alarms, including hardware failure, communication error, lead off, etc. For these technical alarms, the system presents four different types of audible and visual prompts.

When a group of technical alarms (for example, transducer falls off) produced by multi-parameter monitors, a piece of alarm prompt information in scrolling mode will appear on the main screen of Vista 120 CMS. In addition, Vista 120 CMS will sound corresponding alarm (high, medium or low level alarm). The corresponding bedside monitor status indicator will also show corresponding signal color (high, medium or low level alarm signal color).

Alarm Level of the Monitors

Alarm level reflects the severity of an alarm. The alarms have three groups regarding the alarm levels.

High level alarm

Medium level alarm

Low level alarm

NOTE The alarm signal will be delayed for no more than 5 s.

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Alarm Management

Alarm Mute

For information about how to set alarm mute, refer to Section Alarm Setup for Vista 120 CMS. Alarm mute means that when an alarm occurs, the system will not give an alarm sound but only maintain a visual prompt.

Audio Pause

Audio Pause means that during a period of time, when an alarm occurs, the system will not give alarm announcement. The duration setting is introduced in Section Alarm Setup for Vista 120 CMS. By click the Audio Pause button on the main screen, the audio pause function can be activated or deactivated.

When the duration of alarm pause has lasted for the preset-time, the system will stop the status of alarm pause and resume normal alarm automatically.

Alarm Prompt/Response

Alarm information can be prompted by means of visual and audible methods. Because the alarm information is very important and timely response to the alarm information is highly required, Vista 120 CMS provides the following methods to indicate to the user the occurrence of the alarm.

The alarm message will be displayed in the technical area or physiological area of the patient sector and of the single bed view window.

High level alarm: displayed with red background

Medium level alarm: displayed with yellow background

Low level alarm: displayed with yellow background

An asterisk or more will be displayed before the physiological alarm message to indicate the alarm level.

High level alarm: ***

Medium level alarm: **

Low level alarm: *

For limit alarms of the parameter, the relevant parameter value and parameter alarm limit will be respectively displayed with the color alternating between the parameter color and the alarm color.

Alarm tone

If the system mute, alarm mute or alarm pause setup is deactivated, the system will warn the user about the alarm with the alarm tone.

NOTE The alarm mute function is only valid for Vista 120 CMS itself. Vista 120 CMS cannot silence the bedside monitor’s audible alarm.

NOTE The alarm pause function is only valid for Vista 120 CMS itself. Vista 120 CMS cannot pause the bedside monitor’s audible alarm.

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70 Instructions for use Vista 120 CMS SW 1.n

The alarm tone can be set to Standard or Mode 1:

Standard:

High level alarm: sound "DO-DO-DO DO-DO DO-DO-DO DO-DO";

Medium level alarm: sound "DO-DO-DO";

Low level alarm: sound "DO- ".

Mode 1:

High level alarm: sound "Ding-Ding-Ding-Ding-Ding-Ding";

Medium level alarm: sound "Ding-Ding-Ding";

Low level alarm: sound "Ding-".

The sound pressure range for standard audible alarm signals is from 45 dB to 85 dB, and for Mode 1 is from 30 dB to 85 dB.

Alarms for Networking Status

When the monitor is online, the system will indicate it with low level alarm sound.

If the monitor is offline without being discharged (that is improper offline), system will indicate it respectively with low level/medium level alarm sound. The alarm sound for improper offline will be given out only once.

NOTE In good network status, if there are no patients online, Vista 120 CMS will give out a high level alarm sound with intervals of 20 s.

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Printing

Printing

Printing Report with a Printer . . . . . . . . . . . . 72

Printing Preview/ Printing Settings. . . . . . . . 72Printing Preview . . . . . . . . . . . . . . . . . . . . . . . . 72Printing Settings . . . . . . . . . . . . . . . . . . . . . . . . 72

Exporting the PDF File . . . . . . . . . . . . . . . . . . 72

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Printing Report with a Printer

Vista 120 CMS can output the reports by equipped with a laser printer. HP LaserJet Series printers are recommended. The laser printer working with Vista 120 CMS is independent of the mainframe. The printer has its independent power supply. It is connected to the mainframe via a USB interface or a network (wired or wireless).

The laser printer generates the following types of printing:

Waveform review printing

Alarm wave printing

Alarm table printing

Trend graph printing

Trend table printing

NIBP review printing

Printing for drug calculation, hemodynamic calculation, oxygenation calculation, renal function calculation and ventilation calculation

Patient information printing

C.O. review printing

Quick TEMP review printing

PAWP review printing

Printing Preview/ Printing Settings

Printing Preview

Before the reports are printed, the user can preview them on the screen. The user will access the preview interface after selecting the function of printing. If a report consists of more than one page, the user may select a certain page to preview by turning to the page as desired. Besides, the user can adjust the zoom setting by choosing a certain option from the drop-down list of the SIZE.

Printing Settings

Click on Print on the preview interface, and in the Print setup menu select the printer, the print range and the number of copies in demand and then click on OK to confirm it.

Exporting the PDF File

Vista 120 CMS can export the PDF file by installing a PDF printer software. The software PDFCreator is recommended. The user can obtain the installation version of PDFCreator in the Vista 120

CMS installation disk. Also, the user may download it from the website http://www.pdfforge.org/pdfcreator.

NOTE Vista 120 CMS only supports printing on A4 paper.

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Printing

To export the PDF file, choose a PDF printer (for instance, PDFCreator) from the drop-down list when the user selects the printers, and then confirm it by clicking on OK.

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Database Management

Database Management

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76

Database backup . . . . . . . . . . . . . . . . . . . . . . 76

Reviewing backup database . . . . . . . . . . . . . 76

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Database Management

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Overview

Vista 120 CMS provides database backup and review, which allows the user to conveniently manage and maintain data.

Database backup

To backup database, select Main Screen > System Setup > User Maintain, and input the correct password. Select Database Maintain and click on the button Browse to choose a directory for backup file storage. Then click on Backup Database to start database backup.

Reviewing backup database

Vista 120 CMS allows the user to review the backup data at any time.

To review backup data, select Main Screen > Review > Patient List, and select the directory for storing backup file from the drop-down list of Offline Database Source. For more information about review, refer to Chapter Review.

NOTE During database backup, Vista 120 CMS automatically stops its patient monitoring.

NOTE If the check box indicating “Empty local database after backup is completed” is ticked, Vista 120 CMS will empty the local database after database backup is completed; whether this check box is ticked or not, Vista 120 CMS will restart automatically after backup is completed.

NOTE Regular data backup operations are recommended.

NOTE The system will prompt when there is excessive amount of history patient data. Clean the history patient data manually in time. The user can clean the data by item (refer to chapter History patient review for detailed operations), or clean the data all at once in batches by ticking the check box mentioned above. It is recommended to perform backup operation before cleaning up the data.

NOTE It takes about 3 to 10 s for Vista 120 CMS to load the backup data.

NOTE During reviewing backup data, discharging or deleting patients is unavailable.

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Calculation and Titration Table

Calculation and Titration Table

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

Drug Calculation. . . . . . . . . . . . . . . . . . . . . . . 78Drug Calculation Formula. . . . . . . . . . . . . . . . . 79Calculation of Titration Table . . . . . . . . . . . . . . 79

Hemodynamic Calculation. . . . . . . . . . . . . . . 80Input Parameters . . . . . . . . . . . . . . . . . . . . . . . 80Output Parameters . . . . . . . . . . . . . . . . . . . . . . 80

Renal Function Calculation . . . . . . . . . . . . . . 81Input Parameters . . . . . . . . . . . . . . . . . . . . . . . 81Output Parameters . . . . . . . . . . . . . . . . . . . . . . 81

Oxygenation Calculation . . . . . . . . . . . . . . . . 82Input Parameters . . . . . . . . . . . . . . . . . . . . . . . 82Output Parameters . . . . . . . . . . . . . . . . . . . . . . 82

Ventilation Calculation. . . . . . . . . . . . . . . . . . 83Input Parameters . . . . . . . . . . . . . . . . . . . . . . . 83Output Parameters . . . . . . . . . . . . . . . . . . . . . . 84

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General

Vista 120 CMS provides functions including drug calculation and titration table, hemodynamic calculation, oxygenation calculation, renal function calculation and ventilation calculation; the calculation results can be printed out. Click on Calculation in the status of single bed view to access the drug calculation screen.

Vista 120 CMS is able to save a maximum of 100 groups of results for every type of calculation. In the calculation window, the user can use the Save button to save the calculation results and use Calculation Result List to review each calculation result.

Drug Calculation

From the Drug drop-down list, the user can select one to calculate its amount, liquid volume, concentration, etc.

Drug A

Drug B

Drug C

Drug D

Drug E

AMINOPHYLLINE

DOBUTAMINE

DOPAMINE

EPINEPHRINE

HEPARIN

ISUPREL

LIDOCAINE

NIPRIDE

NITROGLYCERIN

PITOCIN

The calculation procedure is listed below:

1 Confirm whether the patient type is correct and the weight is entered.

2 Select a drug to be calculated from the drug list.

3 Input correct parameter values under the direction of a doctor.

4 Select Basic, Dose Type and Step for titration table.

5 Click on the Calc button, the calculation result will be displayed in the drug parameter area and titration table.

NOTE Drug A, Drug B, Drug C, Drug D and Drug E are user-defined drugs.

WARNING Be sure to input correct parameter values. The user must verify the correctness of the calculations displayed on the screen before using them.

WARNING The calculations in the titration table are subject to the drug calculations, therefore, the correctness of the drug calculations must be ensured. Besides, the basic, step and dose type should be ensured correct.

WARNING We assume no responsibility for the results arising from incorrect inputs and operations.

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Calculation and Titration Table

Drug Calculation Formula

Formulas for drug calculation are:

Concentration = amount / volume

Flow rate = dose / concentration

Total dose = dose × duration

Total volume = flow rate × duration

Relationship between calculation units:

1 g = 1000 mg

1 mg = 1000 mcg

1 K unit = 1000 units

1 M unit = 1000 K units

Calculation of Titration Table

Calculation of titration table is included on the screen of drug calculation. The titration table is located at the lower part of the drug calculation screen. The method for calculation of titration table is:

1 The core method for the calculation of titration table is: concentration = dose / flow rate. The calculating method of titration table is to keep the fixed concentration, change the dose to calculate the flow rate or change the flow rate to calculate the dose. Concentration here is obtained from drug calculation.

2 The titration table can be displayed by way of dose and rate. The user can enter the rate step from 1-10. There are four options available for dose unit: mg/hour, mg/min, mg/Kg/hour and mg/Kg/min, among which mg will vary with the unit changes in drug calculation.

3 The calculating result of titration table is displayed in the list. The user can click on the scroll bar to browse more calculating results.

WARNING Prior to performing drug calculation, the above formulas must be confirmed. Our company will not be liable for any consequence resulted from using inappropriate formulas.

WARNING Correct drug unit must be entered. Our company will not be liable for any consequence resulted from incorrect input.

WARNING The calculating result of titration table depends on the calculating result of drug. First of all, the calculating result of drug should be accurate. And then, the calculating result of titration is concerned with the input titration control parameters and the calculating formula. Therefore, the user must ensure the correctness of all these mentioned operations. Our company will not be liable for any consequence resulted from improper operations.

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Hemodynamic Calculation

Input Parameters

Output Parameters

Items Unit English Full Name/Description

PAWP mmHg Pulmonary artery wedge pressureCVP mmHg Central venous pressureC.O. L/min Cardiac outputHR bpm Heart rateEDV ml End-diastolic volumeAP MAP mmHg Mean Artery PressurePA MAP mmHg Pulmonary artery mean pressurePAP mmHg Pulmonary artery pressureHeight cm /Weight kg /

Items Unit English Full Name/Description FormulaCI L/min/m2 Cardiac index C.O. / BSASV ml Stroke volume C.O. / HR × 1000SVR DS/cm5 Systemic vascular resistance 80 × (AP MAP – CVP) / C.O.PVR DS/cm5 Pulmonary vascular resistance 80 × (PA MAP – PAWP) / C.O.LCW kg·m Left cardiac work 0.0136 × AP MAP × C.O.LVSW g·m Left ventricular stroke work 0.136 × (AP MAP – PAWP) × SVEF / Ejection fraction SV / EDV × 100%SVI ml/m2 Stroke volume index SV / BSASVRI DS·m2/cm5 Systemic vascular resistance index SVR / BSAPVRI DS·m2/cm5 Pulmonary vascular resistance index PVR / BSALCWI kg·m/m2 Left cardiac work index LCW / BSALVSWI g·m/m2 Left ventricular stroke work index LVSW / BSARCW kg·m Right cardiac work 0.0136 × PA MAP × C.O.RVSW g·m Right ventricular stroke work 0.0136 × (PAP – PAWP) × SVBSA m2 Body surface area Weight0.425 × Height0.725 × 0.007184RCWI kg·m/m2 Right cardiac work index RCW / BSARVSWI g·m/m2 Right ventricular stroke work index RVSW / BSA

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Calculation and Titration Table

Renal Function Calculation

Input Parameters

Output Parameters

Items Unit English Full Name/DescriptionURK mmol/L Urine potassiumURNa mmol/L Urinary sodiumUrine ml/24h UrinePosm mOsm/kgH2O Plasm osmolalityUosm mOsm/kgH2O Urine osmolalitySerNa mmol/L Serum sodiumSCr umol/L Serum creatinineUCr umol/L Urine creatinineBUN mmol/L Blood urea nitrogenUUN mmol/L Urine urea nitrogenHeight cm /Weight kg /Type / Patient type: Adult, Pediat, NeonatGender / Male, Female, N/A.

Items Unit English Full Name/Description FormulaURNaEx mmol/24h Urine sodium excretion URNa × Urine / 1000URKEx mmol/24h Urine potassium excretion URK × Urine / 1000CUUN ml/min Urine urea nitrogen clearance rate UUN × Urine / (BUN × 24 × 60)CNa ml/24h Clearance of sodium URNa × Urine / (SerNa)CCr ml/min Creatinine clearance rate (UCr × Urine) / (SCr × 24 × 60)Cosm ml/min Osmolar clearance (Uosm × Urine) / (Posm × 24 × 60)FENa % Fractional excretion of sodium (URNa × SCr) / (UCr × SerNa) × 100%FEUr % Fractional Excretion of Urea (SCr × UUN) / (UCr × BUN) × 100%BUN/SCr / Blood urea nitrogen creatinine ratio (BUN / SCr) × 1000CH2O ml/24h Free water clearance Urine – Uosm × Urine / PosmU/P osm / Urine to plasma osmolality ratio Uosm / PosmU/SCr / Urine-serum creatinine ratio UCr / SCrNa/K % Sodium potassium ratio URNa / URK × 100%

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Oxygenation Calculation

Input Parameters

Output Parameters

Items Unit English Full Name/DescriptionFiO2 % Percentage fraction of inspired oxygenPaO2 mmHg Partial pressure of oxygen in the arteriesPaCO2 mmHg Partial pressure of carbon dioxide in the arteriesPiO2 mmHg Partial pressure of oxygen in inspired gasSaO2 % Arterial oxygen saturationPvO2 mmHg Partial pressure of oxygen in venous bloodSvO2 % Venous oxygen saturationHb g/L HemoglobinRQ / Respiratory quotientHeight cm /Weight kg /CI l/min/m2 Cardiac index

Items Unit English Full Name/Description Formula

BSA m2 Body surface area Weight0.425 × Height0.725 × 0.007184

VO2 ml/(min.m2) Oxygen consumption Ca-v O2 × CI

CaO2 ml/L Arterial oxygen content Hb × 1.34 × SaO2/100% + (0.0031 × PaO2)

CvO2 ml/L Venous oxygen content Hb × 1.34 × SvO2/100% + (0.0031 × PvO2)

Ca-v O2 ml/L Arterial venous oxygen content difference CaO2 – CvO2

O2ER / Oxygen extraction ratio (VO2 / DO2) × 100%

DO2 ml/(min.m2) Oxygen transport CaO2 × CI

PAO2 mmHg Partial pressure of oxygen in the alveoli

PiO2-PACO2 × [FiO2/100% + (1-FiO2/100%) / RQ]

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Calculation and Titration Table

Ventilation Calculation

Input Parameters

AaDO2 mmHg Alveolar-arterial oxygen difference PAO2 – PaO2

CC’O2 ml/L Capillary oxygen content PAO2 × 0.003 + 1.34 × SaO2/100% × Hb

Qs/Qt / Venous admixture (CC’O2 – CaO2) / (CC’O2 – CvO2) × 100%

C.O. L/min Cardiac output VO2 /( Ca-v O2 × BSA)

AaDO2/PaO2 / Spiro-index (PAO2 – PaO2) / PaO2× 100%

DO2I ml/(min.m2) Oxygen delivery index DO2/BSA

VO2I ml/(min.m2)Oxygen consumption index VO2/BSA

Items Unit English Full Name/DescriptionFiO2 % Percentage fraction of inspired oxygenRR rpm Respiration rateVT ml Tidal volumePaCO2 mmHg Partial pressure of carbon dioxide in the arteriesPaO2 mmHg Partial pressure of oxygen in the arteriesRQ / Respiratory quotientPEEP cmH2O Positive end-expiratory pressurePEEPi cmH2O Intrinsic PEEPPeCO2 mmHg Partial pressure of mixed expiratory CO2

PiO2 mmHg Partial pressure of oxygen in inspired gasPpeak cmH2O The peak inspiratory pressure

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Output Parameters

Items Unit English Full Name/Description Formula

PAO2 mmHg Partial pressure of oxygen in the alveoli

PiO2-PaCO2 × [FiO2/100% + (1-FiO2/100%)/RQ]

AaDO2 mmHg Alveolar-arterial oxygen difference PAO2 – PaO2

MV L/min Minute volume VT × RR/1000AaDO2/PaO2 / Spiro-index (PAO2 – PaO2) / PaO2 × 100%VA L/min Alveolar volume (VT – VD) × RR/1000

VD ml Volume of physiological dead space [(PaCO2 – PeCO2) × VT] / PaCO2

VD/VT / Physiological dead space in percent of tidal volume (PaCO2 – PeCO2) / PaCO2 × 100%

Cdyn ml/cmH2O Compliance dynamic VT / (Ppeak – PEEP – PEEPi)

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CMS-WEB Observer

CMS-WEB Observer

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 86

Typical Screens of the CMS-WEB. . . . . . . . . 86

Starting/ Shutting Down the System. . . . . . . 88Starting the System . . . . . . . . . . . . . . . . . . . . . 88Shutting Down the System . . . . . . . . . . . . . . . . 89

System Setup . . . . . . . . . . . . . . . . . . . . . . . . . 89Common Setup. . . . . . . . . . . . . . . . . . . . . . . . . 89Administrator Setup . . . . . . . . . . . . . . . . . . . . . 90

Viewing Single Bed . . . . . . . . . . . . . . . . . . . . 91Patient Information . . . . . . . . . . . . . . . . . . . . . . 91Single Bed View . . . . . . . . . . . . . . . . . . . . . . . . 91Waveform Review . . . . . . . . . . . . . . . . . . . . . . 91Alarm Review . . . . . . . . . . . . . . . . . . . . . . . . . . 92Trend Review . . . . . . . . . . . . . . . . . . . . . . . . . . 92NIBP Review . . . . . . . . . . . . . . . . . . . . . . . . . . 92

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General

The CMS-WEB Observer system is a medical information device applied in clinical monitoring field. It realizes remote monitoring by reviewing real-time and history data from central monitoring system through web page. A CMS-WEB network system is constructed by connecting multiple monitors and Vista 120 CMS central monitoring systems. Being the center of the monitoring network, the system realizes remote monitoring by collecting, processing, and analyzing the physiological information from the central monitoring systems. Medical staff can obtain patient information by visiting the server of Vista 120 CMS via the browser.

The CMS-WEB Observer displays patients’ physiological information collected by Vista 120 CMS central monitoring system. The system displays information of up to 32 bedside monitors from Vista 120 CMS.

Typical Screens of the CMS-WEB

The CMS-WEB shares similar screen features with Vista 120 CMS. The main screen of the CMS-WEB has three areas. At the top of the screen is the area

displaying the system prompt information. The middle part is the main monitoring area. The bottom part is the system menu area.

NOTE The CMS-WEB Observer is only available via the hospital local area network.

NOTE Vista 120 CMS supports the maximum of 6 accounts at the same time.

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CMS-WEB Observer

Structure of the main screen:

1 Information area

Displaying the hospital name and current system time.

2 Main monitoring screen

Indicating the current status of each bedside monitor:

The onscreen bedside monitors are networked.

The red color in the alarm area of the patient sector indicates the bedside monitor has high priority alarm.

The yellow color in the alarm area of the patient sector indicates the bedside monitor has a medium or low priority alarm.

When four or less than four bedside monitors are networked, the layout of patient sectors will be of single row.

When over four bedside monitors are networked, the screen displays patient sectors with a maximum of eight bedside monitors.

NOTE The number of displayed waveforms on each patient sector will vary with the resolution of the computer monitor. The maximum number of waveforms displayed on each patient sector is four. It is recommended to use computer monitors with the resolution of 1028 × 1024 or 1440 × 900.

NOTE The alarms on CMS-WEB may be delayed, and the delay time depends on the actual network environment. Refer to the displaying on Vista 120 CMS for alarms.

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3 Main menu

The main menu is at the bottom of the screen. Click on it to access corresponding windows or perform corresponding functions.

If one patient sector is selected for single bed reviewing, the button Return Main Screen will appear at the bottom left corner, selecting which can return to the main screen.

4 Control iconsControl icon area includes the following icons:

Starting/ Shutting Down the System

Starting the System

Before starting the system, make sure the computer in which the CMS-WEB Observer server is installed has been installed with the IIS (Internet Information System) groupware as well. Assume that the IP address of the server is 192.168.11.138; to start the CMS-WEB, the user should enter

Icons Operating method

Click on it to return to the main screen.

Click on it to enter the system setup menu.

Click on it to log out of the system.

Click on it, the volume adjustor icon appears. Tick the Mute check box, the entire system become mute until a new alarm occurs. To deselect the silence function, tick the Mute check box again. Additionally, the user can drag the volume adjustor to the desired volume.

NOTE Before starting the system, make sure Vista 120 CMS has been installed in the computer. Otherwise, the user cannot use the CMS-WEB.

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CMS-WEB Observer

http://192.168.11.138/MFM-CMS/ into the address bar of the browser and input user name as well as password in the login window to access the system.

Shutting Down the System

The user can shut down the system via either of the following two methods:Method 1: Click on the Logout button at the bottom right corner onscreen.

Method 2: Click on the button at the top right corner onscreen.

System Setup

The user can access the system setup menu by clicking on System Setup and configure the following items: Common Setup and Administrators Setup.

Common Setup

Setting User Information

Select System Setup > Common Setup > Personal Infor., and the user can change the user name, name, gender, department, and so on.

Setting Password

Select System Setup > Common Setup > Password Change; the user can change the login password.

Setting Parameter Unit

Select System Setup > Common Setup > Unit Setup; the user can change the units of IBP, NIBP, CO2, AG CO2, AG O2, C.O.TB and TEMP.

Setting Multi-Bed Waveform

Select System Setup > Common Setup > Wave In Multi-bed; the user can set the physiological waveforms displayed on the patient sectors. In this window, the left column displays the waveform names; the right column displays the waveform names which have been selected.

Adding a waveform to be displayed:

To add a displayed waveform, choose one from the left column and click on Add so that it can be added to the right column.

Deleting a displayed waveform

To delete a displayed waveform, choose one from the right column and click on Remove so that it can be deleted from the waveform display area.

NOTE The default user name for administrator is “admin”; default password is “test”. The user can change the user name and password after accessing the system.

NOTE The administrator is able to create other administrators and users. The default password for creating new users is “123456”.

NOTE The available setup items may vary with different users due to different users’ access authority. Both Common Setup and Administrators Setup are available for the administrator while only Common Setup is available for general users.

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Setting Multi-Bed Parameter

Select System Setup > Common Setup > Para In Multi-bed; the user can set the physiological parameters displayed onscreen. In this window, the left column displays the parameter names; the right column displays the parameter names which have been selected.

Adding a parameter to be displayed

To add a displayed parameter, choose one from the left column and click on Add so that it can be added to the right column.

Deleting a displayed parameter

To delete a displayed parameter, choose one from the right column and click on Remove so that it can be deleted from the screen.

Setting Wave Speed

Select System Setup > Common Setup > WaveSpeed; the user can set the speed for a selected waveform. Choose one waveform from

the Wave Name list and the chosen one will be highlighted; then select a speed from the drop-down list of New Speed.

Setting Language

Select System Setup > Common Setup >

Language, click on and select a language from the drop-down list.

Administrator Setup

User Management

Select System Setup > Administrators Setup > User Manage; the administrator can set the user access authority.

Creating a userIn the User Manage window, input the User Name, Name, User Type, Gender, Department and so on, click on Insert and a new user will be created. The default password for creating users is 123456.

NOTE The user can only select a maximum of 6 waveforms to be displayed on each patient sector. Also, the number of displayed waveforms is subject to the computer resolution.

NOTE The user can only add or delete one waveform one time.

NOTE The paced symbol won’t be displayed on the CMS-WEB observer.

NOTE The user can only select a maximum of four parameters to be displayed on each patient sector.

NOTE The user can only add or delete one parameter one time.

NOTE To ensure the normal display of CMS-WEB, restart the system after finishing the language configuration.

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CMS-WEB Observer

Deleting a userSelect a user to be deleted from the user list, click on Delete and the user will be removed.

Modifying user informationSelect a user whose information is to be modified and enter new information for the user; then click on Modify to complete the modification.

Resetting user passwordSelect a user whose password is to be reset and click on Reset password; confirm it by clicking on Confirm on the pop-up dialog box. The password will be reset to the default password.

Setting Date/Time Format

Select System Setup > Administrators Setup >

TimeFormat, click on the button beside Date Format or Time Format and select a format from the drop-down lists.

Setting Waveform Refresh Type

Select System Setup > Administrators Setup > Refresh Type; the user can set the refresh type of the real-time waveforms. Two options are available: Pen Mode and Move Mode. Click on the button

and select one mode from the drop-down list.

Viewing Single Bed

Via the function of viewing single bed, the user can check information of a patient. Click on any area of the patient sector and the user will access the single bed window. Available items including Patient Infor, Single Bed View, Wave Review, Alarm Review, Trend Review and NIBP Review will be displayed onscreen.

Patient Information

The user may check patient information via Patient Infor window. CMS-WEB Observer displays the patient information collected by Vista 120 CMS. The user can only view the patient information via CMS-WEB but not modify them. The readings of Height and Weight will vary with the unit selection. Click on Print if the patient information is needed to output.

Single Bed View

Multi-waveform display

Click on Multi-lead in the window so that the user can view multiple channels of waveforms displayed onscreen. Click on it again to switch to single waveform display mode.

Freezing waveform

Click on Freeze in the window so that the user can freeze the waveform displayed onscreen, which may help analyze the waveform of interest. Click on Freeze again to unfreeze the waveform.

Waveform Review

In the Wave Review window, the user can:

Select waveforms;

Set wave speed;

Refresh waveforms;

Set the starting time for printing;

Print waveforms.

NOTE The administrator cannot modify his/her information here.

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The system allows to print the waveform with a maximum time of two minutes. If the starting time is not set, the system will output the latest data by default. If the starting time is set, the system will start to output data at the point of the set time.

For more details about waveform review, refer to relevant content for Vista 120 CMS in Section Wave Review.

Alarm Review

In the Alarm Review window, the user can:

Refresh alarm information;

Print alarm list;

Print alarm strip.

For more details about alarm review, refer to relevant content for Vista 120 CMS in Chapter Review Section Alarm Review.

Trend Review

In the Trend Review window, the user can:

Review trend data;

Set resolution;

Select parameters to be reviewed;

Refresh data;

Print trend graph and trend list;

Set the display mode of the trend review window;

Set the starting time for printing.

Printing trend graph: If the starting time is not set, the system will output the latest data by default. If the starting time is set, the system will start to output data at the point of the set time. The system allows to output a maximum of 600 pieces of data.

Printing trend list: If the starting time is not set, the system will output the latest data by default. If the starting time is set, the system will start to output data at the point of the set time. The system allows to output a maximum of 20000 pieces of data within 240 hours.

For more details about trend review, refer to relevant content for Vista 120 CMS in Chapter Review Section Trend Review.

NIBP Review

In the NIBP Review window, up to 20000 groups of NIBP measurements within 240 hours of an online patient can be viewed.

The NIBP review window displays Serial No., Measure Time, SYS, DIA, MAP and PR for each measurement. Additionally, the user can:

Refresh;

Print.

NOTE The set starting time for printing will be invalid after the data is output. NOTE

The set starting time for printing will be invalid after the data is output.

NOTE Make sure a PDF reader has been installed in thecomputer, which enables the user to preview and open the printing document.

NOTE CMS-WEB only supports printing on A4 paper. Make sure the paper size is set to A4 in the printing setup.

NOTE If the main menu is not displayed onscreen after clicking on the print button and return to the CMS-WEB screen, check the browser setup. For Firefox browser, select Tools > Options > Tabs, and tick the check box of Always show the tab bar.

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Instructions for use Vista 120 CMS SW 1.n 93

Safety

Safety

Control and safety index . . . . . . . . . . . . . . . . 94

Characteristics . . . . . . . . . . . . . . . . . . . . . . . . 94

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Control and safety index

Windows 8/ Windows XP/Windows 7 workstation, printer, UPS (optional), Keyboard, display and mouse should accord with the corresponding safety requirements. They are not suitable for installation in the patients’ environment.

Characteristics

The standard Vista 120 CMS includes the following characteristics:

Up to 240 hours of trend data storage and review

Storage of patients’ history data

96 or 240 hour full disclosure waveforms

3 or 5-lead ECG display

12-hour short trend data

Printing report

Monitoring 64 patients simultaneously with two displays

Transfer waveforms, parameters, alarms, etc.

NOTE The configuration above is for reference only.

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Maintenance

Maintenance

Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96

Cleaning the filter mat . . . . . . . . . . . . . . . . . . 96

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Maintenance

96 Instructions for use Vista 120 CMS SW 1.n

Overview

Every 24 months a regular inspection (functional and safety check) according to IEC 60950 for the PC is recommended to be performed by trained service personnel, in addition to national regulations and laws (for example, accident prevention regulations).

Dräger recommends that all repairs are carried out by DrägerService and that only authentic Dräger repair parts are used. Using non-Dräger repair parts may adversely affect the operation of the device.

If the product fails to function properly, or if assistance is needed, for service and for spare parts, contact Dräger's service center. A representative will assist in troubleshooting the problem and will make every effort to solve it over the phone or e-mail, avoiding potential unnecessary returns.

If the user has any questions about maintenance, technical specifications, or malfunctions of devices, contact the local distributor.

Cleaning the filter mat

Regular maintenance (dust cleaning) is recommended by users at least every four months.

The filter mat is inserted in the filter mat holder at the front of the fan slide-in module. The soiling of the filter mat is caused by the pollution of the operating environment. A heavily soiled filter mat can cause excessive heating in the device. For this reason it is recommended to clean the filter mat as often as necessary. The filter mat can be changed while the system is in operation.

A Front side of the KISS 4U V2 platform

B Filter mat

C Filter mat holder with knurled screw

D Fan slide-in module

E Front access door

To replace the filter mat, proceed as follows:

1 Open the front access door.

2 Loosen the knurled screw that secures the filter mat holder to the fan slide-in module.

3 Pull the filter mat holder out of the positioning holes into the marked direction and lift it off.

4 Remove the soiled filter mat.

5 Clean the filter mat as follows:

Rinse in water (up to approx. 40 °C; possibly with the addition of a standard mild detergent).

It is also possible to beat the filter mat, to vacuum it, or to blow it with compressed air.

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Maintenance

For dirt that contains grease or oil, rinse the filter mat with warm water with the addition of a degreaser. Filter mats should not be cleaned with powerful water jets or be wrung out.

6 After cleaning and drying the filter mat, place it in the filter mat holder.

7 Reattach the filter mat holder to the front side of the fan slide-in module by inserting the positioning plates into the positioning holes.

8 Fix the filter mat holder by tightening the knurled screw to the bolt with the tapped hole at the fan slide-in module.

NOTE Defective components may only be replaced by Dräger original spare parts.

NOTE The chapter of cleaning filter mat is only applicable for the Hardware provided by Dräger.

NOTE The UPS battery needs exchanging every two years.

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Accessories

Accessories

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . 100

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Accessories

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Accessories

Description SpecificationVista 120 CMS Host With Windows 7 embedded, central monitoring software, USB

key, industrial computer KTQ67/Flex

Vista 120 CMS Display 2 19" Check with Dräger for details.

Vista 120 CMS Display 3 22" Check with Dräger for details.

LAN switch Cisco 2960-24TC

LAN switch Cisco 2960-48TC (optional)

Printer 115 V/230 V (optional)

Extension cable mouse and keyboard 20 m (optional)

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Specifications

Specifications

Recommended Hardware Configuration . . . 102

Software Performance . . . . . . . . . . . . . . . . . . 104

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Specifications

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Recommended Hardware Configuration

Components Requirements

System Meet the IEC/EN control requirements for ITE device

PC workstation CPU: Intel Core i3 Duo 3.0GHz or aboveMemory: 4G or aboveHard disk: 500GB or aboveDisplay interface: 2LAN port: 1 or aboveUSB port: more than oneOS: Windows 7 Pro 32/64 bit

Windows 8 Pro 32/64 bitWindows 10 Pro 32/64 bit

Keyboard PS/2 or USB keyboard with CE mark

Mouse PS/2 or USB mouse with CE mark

Display Specifications:Dimensions (inch) Resolution (pixel)22 1920X108019 (widescreen) 1440X900*19 (regular-screen) 1280X102417 (regular-screen) 1280X1024*Recommended

Quantity:For 1 to32 bedside monitors one displayFor 33 to 64 bedside monitors two displays

Printer LaserJet

UPS 1000 W

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Specifications

Network device specifications

Structure Ethernet 802.3

Device Network switch

Transmission rate 10M, 100M

Transmitted information Waveforms, parameters and alarms of all networked bedside monitors

Compatible monitors Patient monitors complying with Dräger network protocol

Maximum number of networked monitors

64

Speaker Built-in speaker is recommended.

Kontron system Compatible

Components Requirements

CAUTION Ensure that the computer hardware can meet the requirements of the software installation and running. Also, the video adapter, the audio adapter, the network adapter and their respective drivers should been installed well in the computer; otherwise, the software may not run normally.

NOTE The hardware specifications require the use of PC that complies with IEC/EN requirements for ITE equipment.

NOTE The configuration mentioned above is for reference and not permanent. Dräger preserves the right to change and upgrade system settings.

NOTE It is recommended to install the antivirus software (recommend Kaspersky software) on the computer which is used for Vista 120 CMS, and also keep it updated in time.

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Specifications

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Software Performance

Trend 240-hour trend review for each bedside monitor;12-hour short trend dynamic display for each bedside monitor;

Alarm events 240-hour alarm events for each bedside monitor (up to 20000 pieces)

Alarm type Physiological AlarmTechnical Alarm

Alarm mode 3 levels of audible and visual alarms

Waveform storage and review Up to 240-hour waveform for each bedside monitor 96-hour is the default selection.

NIBP measurement storage and review

240-hour NIBP measurement for each bedside monitor (up to 20000 pieces)

C.O. measurements 240-hour C.O. measurement for each bedside monitor (up to 20000 pieces)

Quick TEMP measurements 240-hour Quick TEMP measurement for each bedside monitor (up to 20000 pieces)

PAWP measurements 240-hour PAWP measurement for each bedside monitor (up to 20000 pieces)

CAUTION Network configuration should strictly comply with the recommended requirements.

CAUTION Vista 120/Vista 120S is the only officially appointed monitor for the CMS.

CAUTION Some bedside monitors may not appear on the CMS screen when the number of monitors exceeds 64 monitors.

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Vista 120 CMS System Alarms and Prompts

Vista 120 CMS System Alarms and Prompts

Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106

Prompts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

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106 Instructions for use Vista 120 CMS SW 1.n

Alarms

Alarms Display Color Cause Solution

Database is full, it can't store new data, please discharge or delete patient.

Red

Less than 2 G space is left in the disk for data store.

Refer to Section History Patient Review and delete the out-of-date patient data. Or refer to Section Database Backup to back up the data in another disk and delete the data in the current database.

Network is disconnected!

The host in which Vista 120 CMS software is installed is not connected with the network cable.

Check the connection of the network cable and ensure the cable is well connected to the host.

Alarm Mute Vista 120 CMS is in the status of alarm mute.

Refer to Section Alarm Mute for information about alarm mute.

No Audio card! The audio adapter driver is not installed in the host.

Log out of Vista 120 CMS and install the audio adapter driver.

No Video card! The video adapter driver is not installed in the host.

Log out of Vista 120 CMS and install the video adapter driver.

Audio Pause Vista 120 CMS is in the status of alarm pause.

Refer to Section Audio Pause for information about alarm pause.

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Vista 120 CMS System Alarms and Prompts

Prompts

Prompts Display Color Cause Solution

Database is full, please discharge or delete patient.

White

Less than 10 G space is left in the disk for data store.

Refer to Section History Patient Review and delete the out-of-date patient data. Or refer to Section Database Backup to back up the data in another disk and delete the data in the current database.

Collecting Data… Real-time printing /

Number of pending patients:

Remind the user to admit the patients who has been connected to Vista 120 CMS but has not been admitted.

Refer to Section Admitting a Patient for information about admitting patients.

No bed is online. Please check the network connecting

No monitor is connected to the Vista 120 CMS because no monitor is connected to the network or the network setup is incorrect.

Check if the cable is well connected with the monitor and with the switch.

Please clear history patient White

The system will display a prompt when there is excessive amount of history patient data.

Please clean the history patient data manually in time. (please refer to chapter Database Backup for detailed operations)

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These instructions for use only apply to Vista 120/Vista 120S SW 3.nwith the Serial No.:If no Serial No. has been filled in by Dräger, these instructions for use are provided for general information only and are not intended for use with any specific machine or unit.This document is provided for customer information only, and will not be updated or exchanged without customer request.

Directive 93/42/EEC concerning Medical Devices

Manufacturer:

Drägerwerk AG & Co. KGaAMoislinger Allee 53 – 55D-23542 LübeckGermany+49 451 8 82-0

FAX +49 451 8 82-20 80http://www.draeger.com

26 80 051 – GA 6498.020 en © Drägerwerk AG & Co. KGaA Edition: 8 – 2019-07 (Edition: 1 – 2012-12)Dräger reserves the right to make modificationsto the equipment without prior notice.