BiPAP AVAPS and BiPAP S/T Service & Technical Reference Manual€¦ · The BiPAP AVAPS and BiPAP S/T devices are intended to provide noninvasive ventilatory (NIV) support to treat

BiPAP AVAPS and BiPAP S/TService & Technical Reference Manual

PAGE I1118824, VER. 00

© 2014 Koninklijke Philips N.V. All rights reserved

PAGE II 1118824, VER. 00

LIMITED WARRANTYRespironics, Inc. warrants that the system shall be free from defects of workmanship and materials and willperform in accordance with the product specifications for a period of two (2) years from the date of sale byRespironics, Inc. to the dealer. If the product fails to perform in accordance with the product specifications,Respironics, Inc. will repair or replace – at its option – the defective material or part. Respironics, Inc. will paycustomary freight charges from Respironics, Inc. to the dealer location only. This warranty does not coverdamage caused by accident, misuse, abuse, alteration, water ingress, and other defects not related to materialor workmanship. The Respironics, Inc. Service department shall examine any devices returned for service, andRespironics, Inc. reserves the right to charge an evaluation fee for any returned device as to which no problemis found after investigation by Respironics, Inc. Service.

Respironics, Inc. disclaims all liability for economic loss, loss of profits, overhead, or consequential damageswhich may be claimed to arise from any sale or use of this product. Some states do not allow the exclusion orlimitation of incidental or consequential damages, so the above limitation or exclusion may not apply to you.

This warranty is given in lieu of all other express warranties. In addition, any implied warranties – including anywarranty of merchantability or fitness for the particular purpose – are limited to two years. Some states do notallow limitations on how long an implied warranty lasts, so the above limitation may not apply to you. Thiswarranty gives you specific legal rights, and you may also have other rights which vary from state to state.

To exercise your rights under this warranty, contact your local authorized Respironics, Inc. dealer or contactRespironics, Inc. at:

Respironics, Inc.1001 Murry Ridge Lane

Murrysville, Pennsylvania15668-8550

DeutschlandGewerbestrasse 17

82211 Herrsching Germany+49 8152 93060

1118824 VER. 00

CHAPTER 1: INTRODUCTION1.0 PRODUCT OVERVIEW ..................................................................................................... 1-1

1.0.1 BiPAP AVAPS & BiPAP S/T ................................................................................................. 1-1

1.1 “2.XX” AND BIPAP AVAPS AND S/T DESIGN CHANGES .............................................. 1-3

1.2 THEORY OF OPERATION DIAGRAMS................................................................................ 1-5

1.3 PRODUCT OPERATING SOFTWARE UPGRADES ................................................................ 1-7

1.4 SERVICE NOTICE.......................................................................................................... 1-10

1.5 SERVICE TRAINING....................................................................................................... 1-11

1.6 PRODUCT SUPPORT STATEMENT .................................................................................. 1-11

CHAPTER 2: WARNINGS, CAUTIONS, & NOTES2.0 WARNINGS..................................................................................................................... 2-2

2.1 CAUTIONS...................................................................................................................... 2-3

2.2 NOTES........................................................................................................................... 2-3

CHAPTER 3: SPECIFICATIONS & CLASSIFICATIONS3.0 BIPAP AVAPS AND BIPAP S/T SPECIFICATIONS.......................................................... 3-2

3.1 SYSTEM ONE HEATED HUMIDIFIER SPECIFICATIONS........................................................ 3-4

3.2 ELECTROMAGNETIC EMISSIONS ...................................................................................... 3-5

3.3 ELECTROMAGNETIC IMMUNITY ........................................................................................ 3-6

3.4 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE & MOBILE RF COMMUNICA-TIONS AND TH3 DEVICE ............................................................................................... 3-8

CHAPTER 4: SETUP4.0 SUPPLYING POWER TO THE DEVICE................................................................................ 4-1

4.0.1 Supplying AC Power to the Device ..................................................................................... 4-1

4.0.2 Supplying DC Power to the Device ..................................................................................... 4-2

4.1 STARTING THE DEVICE ................................................................................................... 4-3

4.2 NAVIGATING THE DEVICE SCREENS ................................................................................ 4-4

4.3 USER AND PROVIDER MODES......................................................................................... 4-4

4.3.1 User Mode.............................................................................................................................. 4-5

4.3.2 Provider Mode ....................................................................................................................... 4-6

4.3.3 Measured Parameters......................................................................................................... 4-10

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CHAPTER 5: TROUBLESHOOTING AND ERROR CODES5.0 INTRODUCTION................................................................................................................5-1

5.1 READING THE DEVICE’S ERROR LOG...............................................................................5-1

5.2 CLEARING THE DEVICE’S ERROR LOG .............................................................................5-2

5.3 ERROR CODES ...............................................................................................................5-3

5.4 BENCH CHECKOUT .......................................................................................................5-11

CHAPTER 6: NIV DEVICE REPAIR & REPLACE6.0 REPLACEMENT PART (RP) KITS FOR PR SYSTEM ONE NIV DEVICES ..............................6-3

6.1 REPLACEMENT INSTRUCTIONS.........................................................................................6-5

6.1.1 Replacing the SD Card Slot Cover ...................................................................................... 6-5

6.1.2 Replacing the User Interface (UI) Knob .............................................................................. 6-6

6.1.3 Replacing the Right Side Cover .......................................................................................... 6-7

6.1.4 Replacing the Top Cover ..................................................................................................... 6-8

6.1.5 Replacing the UI Panel ......................................................................................................... 6-9

6.1.6 Replacing the Keypad ........................................................................................................ 6-10

6.1.7 Replacing the End Panel.................................................................................................... 6-11

6.1.8 Replacing the Main PCA .................................................................................................... 6-12

6.1.9 Replacing the Blower Cap ................................................................................................. 6-14

6.1.10 Replacing the Blower Assembly and/or the Blower Outlet Bellows............................ 6-16

6.1.11 Replacing the Flow Manifold ........................................................................................... 6-18

6.1.12 Replacing the Right Panel Assembly ............................................................................. 6-19

6.1.13 Replacing the Humidifier Cable....................................................................................... 6-20

6.1.14 Replacing the Blower Housing........................................................................................ 6-21

6.1.15 Replacing the Alarm Assembly and/or Alarm Holder ................................................... 6-22

6.1.16 Replacing the Sound Abatement Foam.......................................................................... 6-24

6.1.17 Replacing the Air Inlet Seal ............................................................................................. 6-25

6.1.18 Replacing the Bottom Enclosure .................................................................................... 6-26

6.2 CLEANING THE DEVICE .................................................................................................6-27

6.3 CLEANING AND REPLACING THE FILTERS.......................................................................6-27

6.4 CLEANING THE PATIENT TUBING ...................................................................................6-28

6.5 CLEANING THE HUMIDIFIER TANK ..................................................................................6-28

6.6 SYSTEM RUN-IN............................................................................................................6-29

CHAPTER 7: HUMIDIFIER REPAIR AND REPLACEMENT7.0 HUMIDIFIER REPLACEMENT PART (RP) KITS ...................................................................7-1

1118824 VER. 00

7.1 BENCH CHECKOUT......................................................................................................... 7-1

7.2 REPLACEMENT INSTRUCTIONS ........................................................................................ 7-2

7.2.1 Replacing the Water Chamber Assembly........................................................................... 7-3

7.2.2 Replacing the Tank Top Seal ............................................................................................... 7-4

7.2.3 Replacing the Dry Box Seal ................................................................................................. 7-5

7.2.4 Replacing the Dry Box Assembly/Humidifier Inlet Seal .................................................... 7-7

7.2.5 Replacing the Flip Lid Assembly......................................................................................... 7-9

7.2.6 Replacing the Humidifier Top Housing............................................................................. 7-11

7.2.7 Replacing the Humidifier Outside Cover .......................................................................... 7-12

7.2.8 Replacing the Humidifier Bottom Housing....................................................................... 7-13

7.2.9 Replacing the Heater Plate Assembly............................................................................... 7-15

7.2.10 Replacing the Slider Docking Latch................................................................................7-18

CHAPTER 8: TESTING8.0 SECTION OVERVIEW....................................................................................................... 8-1

8.1 REQUIRED EQUIPMENT................................................................................................... 8-1

8.2 SYSTEM VERIFICATION ................................................................................................... 8-1

8.3 MANUAL SOFTWARE TESTING ........................................................................................ 8-4

8.4 HEATER PLATE TEST ................................................................................................... 8-13

8.5 READING/VERIFYING THE DEVICE’S SERIAL NUMBER AND MODEL NUMBER ................... 8-14

CHAPTER 9: SCHEMATICS9.0 PROPRIETARY STATEMENT............................................................................................. 9-1

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PAGE 1-11118824, VER. 00

CHAPTER 1: INTRODUCTION

1.0 PRODUCT OVERVIEW

The BiPAP AVAPS and BiPAP S/T devices are intended to provide noninvasive ventilatory (NIV) support totreat adult patients weighing over 30 kg (66 lbs) and pediatric patients 7 years or older and weighing over 18 kg(40 lbs) with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. These devices may be used in thehospital or home.

1.0.1 BIPAP AVAPS & BIPAP S/T

The BiPAP AVAPS responds reliably to patient flow rates that indicate movement to inhalation or exhalation,even in the presence of most normal leaks in the patient circuit. Automatic adjustment of this trigger thresholdin the presence of leaks makes the system ideal for mask-applied ventilation assistance. The patientcontrollable Rise Time and Bi-Flex features may enhance patient-ventilator AVAPS and patient comfort.

The BiPAP AVAPS operates in the following modes: Continuous Positive Airway Pressure (CPAP),Spontaneous (S), Spontaneous/Timed (S/T), Timed (T), and Pressure Control (PC). In the Continuous PositiveAirway Pressure (CPAP) mode, the BiPAP AVAPS delivers continuous pressure support ventilation at onepressure level. The BiPAP S/T operates in CPAP, S and S/T modes.

In the Spontaneous (S) mode, bi-level pressure support is delivered. The device triggers to Inspiratory PositiveAirway Pressure (IPAP) in response to spontaneous inspiratory effort and cycles to Expiratory Positive AirwayPressure (EPAP) during exhalation. The level of pressure support delivered is determined by the differencebetween the IPAP and EPAP settings.

The Spontaneous/Timed (S/T) mode is similar to the S mode, except that it also can deliver a machine-triggered breath if the patient does not spontaneously breathe within a set time. The S/T mode ensures thatpatients receive a minimum number of breaths per minute based on the Rate setting. If the patient fails toinitiate an inspiration within the interval determined by the Rate control, the unit triggers a timed (or machine-triggered) breath resulting in a pressure-control (pressure-limited, time-cycled) breath at the set IPAP level.The rate of timed breaths is adjustable. The duration of each timed breath is controlled by an Inspiratory Timecontrol.

The Timed mode provides mandatory pressure assist. All breaths are machine triggered and machine cycled.The patient breathing has no affect on this machine. The triggering is determined by the Breath Rate control.The cycle time is determined by the Inspiratory Control.

The PC mode is equivalent to the S/T mode except that all breaths are machine cycled and, therefore, have afixed inspiratory time. This mode is a pressure limited, machine or patient triggered, time cycled mode. Thepatient may initiate a breath, but all breaths are pressure limited (IPAP) and time-cycled. The cycle time isdetermined by the Inspiratory Time control setting.

AVAPS is available in the S, S/T, Timed, and PC modes. AVAPS provides dynamic IPAP control. The IPAPpressure is dynamically controlled so that exhaled tidal volumes approach the Vte control value. AVAPSprovides gradual pressure changes to compensate for the tidal volume error observed over several precedingbreaths.

CAUTION

U.S. federal law restricts this device to sale by or onthe order of a physician.

PAGE 1-2 1118824, VER. 00

NOTE

The BiPAP AVAPS and S/T have experienced significant design changes. Philips Respironics beganmanufacturing a “2.XX” and “3.XX” version of the devices. These versions are manufactured withhardware components that are not compatible with the previously-designed version. “2.XX/3.XX”refers to the firmware version of the device. Devices that are not marked “2.XX/3.XX” require the use of thepreviously-designed components (refer to the Repair and Replacement section of this manual for furtherclarification.) To differentiate these devices from the previously-designed version, note the “2.XX” or “3.XX”annotation on the serial number label located on the bottom of the device, as follows:

If the “2.XX” annotation is present on the device’s serial number label, then the following components aredifferent from the previously-designed version of the device and are not backwards compatible.

• PCA,

• Blower,

• Blower Cap,

• Air Inlet Seal,

• Sound Abatement Foam, and

• Top Cover.

If the “3.XX” annotation is present on the device’s serial number label, then the components listed in theRP Kit Listing section 6.0 of Repair and Replace Chapter showing (3.XX) follow the “3.XX” format. Thesecomponents are not backwards compatible.

RP kits for both the previous design and the “2.XX/3.XX” version of the device will be available as long asparts are available from Philips Respironics suppliers.

PAGE 1-31118824, VER. 00

1.1 “2.XX” AND BIPAP AVAPS AND S/T DESIGN CHANGES

This section provides images of the physical differences between the components that were used in BiPAPAVAPS and BiPAP S/T devices that were originally manufactured and the devices that are marked with “2.XX”on the serial number/model number label of the device. Also note that the components used in the “2.XX”variation of the BiPAP AVAPS and BiPAP S/T devices are also used in the BiPAP autoSV Advanced.

“2.XX” BiPAP AVAPS and S/T Devices Components Original BiPAP AVAPS and S/T Device Components

“2.XX” device Blower bottom portion is blue

Original design Blower is all black

“2.XX” device Blower Cap has two

protruding grooves

Protruding grooves not present on original design

PAGE 1-4 1118824, VER. 00

PAGE 1-51118824, VER. 00

1.2 THEORY OF OPERATION DIAGRAMS

FIGURE 1-1: VENTILATOR EXTERNAL INTERFACES

PAGE 1-6 1118824, VER. 00

FIGURE 1-2: SYSTEM BLOCK DIAGRAM

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1.3 PRODUCT OPERATING SOFTWARE UPGRADES

Most Respironics products can be upgraded with the latest available software via an Internet connection. Toconnect the device to a PC with an internet connection, refer to the following illustration.

FIGURE 1-3: LINK MODULE

You must be a registered user to download software. If you are not a registered user, go to http://my.respironics.com and complete the on-line registration process.

Once you have access to download the software, perform the following:

1. Log into http://my.respironics.com.

NOTE

The Link Module and DB9F-DB9M cable are available in RP kit #1074113.

NOTE

Respironics service software is now available at http://my.respironics.com. In the eventthat you are unable to access this site, log onto http://servicesoftware.respironics.comto download Respironics service software.

Connect a DB9F-DB9M Cable between here and

COM1 of the PC.

2 31 4

Link Module

PAGE 1-8 1118824, VER. 00

2. Click on the Service Software and Documentation Software link.

FIGURE 1-4: DOWNLOADING OPERATING SOFTWARE

Login Here

http://my.respironics.com

Service Software and Documentation Link

PAGE 1-91118824, VER. 00

3. Select “Product Operating Updates” from the drop-down menu.

FIGURE 1-5: SERVICE SOFTWARE MENU

PAGE 1-10 1118824, VER. 00

4. Click on the “Download” button adjacent to the software you wish to download.

FIGURE 1-6: DOWNLOAD SOFTWARE

5. The installation wizard will guide you through the upgrade process. Follow the on-screen prompts to complete the upgrade process.

1.4 SERVICE NOTICE

The device is designed so that trained Service Technicians can perform repair and testing procedures. Onlytrained and qualified personnel should repair these products.

NOTE

• Respironics recommends that you use the Service Center Tools software to Clearthe device’s error log. Refer to the “Testing” section of this Service Manual foradditional information.

• Remember to periodically log onto http://my.respironics.com and check forsoftware upgrades.

PAGE 1-111118824, VER. 00

1.5 SERVICE TRAINING

Respironics offers service training for the device. Training includes complete disassembly of the device,troubleshooting sub-assemblies and components, and necessary safety testing. For more information, contactthe Service Marketing department at:

E-mail: [email protected]: (724) 755-8225

Fax: (724) 755-8230Or your Philips Respironics regional service location

1.6 PRODUCT SUPPORT STATEMENT

For product support, please contact Respironics Customer Satisfaction.

U.S.A. and CanadaPhone:1-800-345-6443Fax: 1-800-886-0245

InternationalPhone: 1-724-387-4000

Fax: 1-724-387-5012

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PAGE 2-11118824, VER. 00

CHAPTER 2: WARNINGS, CAUTIONS, & NOTES

Warnings, cautions, and notes are used throughout this manual to identify possible safety hazards, conditionsthat may result in equipment or property damage, and important information that must be considered whenperforming service and testing procedures on the Philips Respironics NIV devices. Please read this sectioncarefully before servicing the device.

WARNING

Warnings indicate the possibility of injury to people.

CAUTION

Cautions indicate the possibility of damage to equipment.

NOTE

Notes are used to emphasize a characteristic orimportant consideration.

PAGE 2-2 1118824, VER. 00

2.0 WARNINGS

WARNINGS

• To avoid electrical shock, disconnect the electrical supply before servicing this device.

• Do not service this device in the presence of flammable mixtures, gases, anesthetics,or liquids.

• Electronic components used in this device are subject to damage from static electricity.Repairs made to this device must be performed only in an antistatic, ElectrostaticDischarge (ESD) protected environment.

• To assure the safety of the service technician and the specified performance of thedevice, Respironics recommends that only technicians having prior training orexperience servicing NIV devices perform any repairs or adjustments to the device.

• Do not immerse this device in water, solvents, or cleaning solutions.

• This device is not intended for life support.

• Do not use extension cords with this device.

• Do not service the device near a source of toxic or harmful vapors.

• Do not service this device if the room temperature is warmer than 35° C (95° F). If thedevice is used at room temperatures warmer than 35° C (95° F), the temperature ofthe airflow may exceed 41° C (106° F). This could cause irritation or injury to thepatient’s airway.

• Repairs and adjustments must be performed by authorized service personnel only.Unauthorized service could cause injury, invalidate the warranty, or result in costlydamage.

• Inspect electrical cords and cables for damage or signs of wear. Replace if damaged.

• Using or servicing this device at an incorrect altitude setting could result in airflowpressures higher or lower than the prescribed setting. Always verify the altitude settingwhen traveling or relocating, and adjust the system accordingly.

• Pins of connectors identified with the ESD warning symbol should not be touched.Connections should not be made to these connectors unless ESD precautionaryprocedures are used. Precautionary procedures include methods to prevent build-upof electrostatic discharge (e.g., air conditioning, humidification, conductive floorcoverings, non-synthetic clothing), discharging one’s body to the frame of theequipment or system or to earth or a large metal object, and bonding oneself by meansof a wrist strap to the equipment or system or to earth.

PAGE 2-31118824, VER. 00

2.1 CAUTIONS

2.2 NOTES

CAUTIONS

• Perform the Performance Verification at regular intervals.Refer to the Testing section of this manual for additionalinformation.

• The device may only be operated at temperatures between5° C (41° F) and 35° C (95° F).

• Do not place liquids on or near the device.

• If this device has been exposed to either very hot or very coldtemperatures, allow it to adjust to room temperature beforeusing or servicing it.

• A properly installed, undamaged reusable foam inlet filter isrequired for proper operation.

NOTE

Refer to the device’s User Manual for additionalWarnings, Cautions, Notes, and Operating Instructions.

PAGE 2-4 1118824, VER. 00


PAGE 3-11118824, VER. 00

CHAPTER 3: SPECIFICATIONS & CLASSIFICATIONS

This chapter includes specifications and EMC compliance for the Philips Respironics NIV devices.

NOTE

1 hPa = 1 cm H2O

PAGE 3-2 1118824, VER. 00

3.0 BIPAP AVAPS AND BIPAP S/T SPECIFICATIONS

PAGE 3-31118824, VER. 00

PAGE 3-4 1118824, VER. 00

3.1 SYSTEM ONE HEATED HUMIDIFIER SPECIFICATIONS

Environmental

Operating Temperature: 5° to 35° C (41° to 95° F)

Storage Temperature: -20° to 60° C (-4° F to 140° F)

Relative Humidity (operating & storage): 15 to 95% (non-condensing)

Atmospheric Pressure: 77 to 101 kPa (0 - 2286 m / 0 - 7500 ft)

Physical

Dimensions: 18 x 14 x 10 cm (7” L x 5.5” W x 4” H)

Weight: Approximately 0.89 kg (1.95 lbs.)

Water Capacity

325 ml (11 oz.) at recommended water level

Standards Compliance - This device is designed to conform to the following standards:

IEC 60601-1 General Requirements for Safety of Medical Electrical Equipment

EN ISO 8185:2007 General Requirements for Humidification Systems

Electrical (When the System One Heated Humidifier is used with the device)

AC Power Consumption: 100 – 240 VAC, 50/60 Hz, 2.1 A

DC Power Consumption: 12 VDC, 5.0 A

Type of Protection Against Electric Shock: Class II Equipment

Degree of Protection Against Electric Shock: Type BF Applied Part

Degree of Protection against Ingress of Water: Drip Proof, IPX1

Mode of Operation: Continuous

Electromagnetic Compatibility: The device meets the requirements of EN 60601-1-2, 2nd edition.

Heater Plate

Max Temperature: 70° C (158° F)

Pressure Drop with Humidifier

Max.: 0.3 cm H2O at 60 LPM flow

Humidity

Humidity min Output: 10 mg H2O/L - Measured @ max flow, 35° C, 15% RH.

PAGE 3-51118824, VER. 00

3.2 ELECTROMAGNETIC EMISSIONS

This device is intended for use in the electromagnetic environment specified below. Use, service, and testing ofthe device should be performed in such an environment.

GUIDANCE & MANUFACTURER’S DECLARATION - ELECTROMAGNETIC EMISSIONS

EMISSIONS TEST COMPLIANCEELECTROMAGNETIC ENVIRONMENT

GUIDANCE

RF emissionsCISPR 11

Group 1 The device uses RF energy only for its internalfunction. Therefore, its RF emissions are very lowand are not likely to cause any interference innearby electronic equipment.

RF emissionsCISPR 11

Class B The device is suitable for use in all establishments,including domestic establishments and thosedirectly connected to the public low voltage powersupply network.Harmonic emissions

IEC 61000-3-2Class A

Voltage fluctuations/flicker emissions IEC 61000-3-3

Complies

PAGE 3-6 1118824, VER. 00

3.3 ELECTROMAGNETIC IMMUNITY

This device is intended for use in the electromagnetic environment specified below. Use, service, and testing ofthe device should be performed in such an environment.

GUIDANCE & MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY

IMMUNITY TESTIEC 60601 TEST

LEVELCOMPLIANCE

EMC ENVIRONMENT GUIDANCE

ElectrostaticDischarge (ESD)

IEC 61000-4-2

±6 kV contact±8 kV air

±6 kV contact±8 kV air

Floors should be wood,concrete, or ceramic tile. Iffloors are covered withsynthetic material, therelative humidity should beat least 30%.

Electrical fast Transient/burst

IEC 61000-4-4

±2 kV for power supply lines±1 kV for I/O lines

±2 kV for supply mains

±1 kV for I/O lines

Mains power quality should be that of a typical home or hospital environment.

Surge

IEC 61000-4-5

±1 kV Differential Mode±2 kV Common Mode

±1 kV differential mode±2 kV common mode

Mains power quality should be that of a typical home or hospital environment.

Voltage dips, short interruptions, and voltage variations on power supply input lines

IEC 61000-4-11

<5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles70% UT (30% dip in UT) for 25 cycles<5% UT (>95% dip in UT) for 5 sec

<5% UT

(>95% dip in UT) for 0.5 cycle 40% UT

(60% dip in UT) for 5 cycles70% UT (30% dip in UT) for 25 cycles<5% UT (>95% dip in UT) for 5 sec

Mains power quality should be that of a typical home or hospital environment. If the user of the device requires continued operation during power mains interruptions, it is recommended that the device be powered from an uninterruptible power supply or a battery.

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical hospital or home environment.

NOTE: UT is the AC mains voltage prior to application of the test level.

PAGE 3-71118824, VER. 00

GUIDANCE & MANUFACTURER’S DECLARATION - ELECTROMAGNETIC IMMUNITY

IMMUNITY TESTIEC 60601 TEST LEVEL

COMPLIANCE EMC ENVIRONMENT GUIDANCE

Conducted RF IEC 61000-4-6

Radiated RFIEC 61000-4-3

3Vrms150 kHz to 80 MHz

3 V/m80 MHz to 2.5 GHz

3 Vrms

3 V/m

Portable and mobile RF communicationsequipment should be used no closer to any part ofthe device, including cables, than therecommended separation distance calculated fromthe equation applicable to the frequency of thetransmitter. Recommended separation distance:

P = maximum output power rating of thetransmitter in watts (W) according to thetransmitter manufacturer and d = therecommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as

determined by an electromagnetic site survey,a

should be less than the compliance level in each

frequency range.b

Interference may occur in the vicinity of equipmentmarked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection fromstructures, objects, and people.a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateurradio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagneticenvironment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in thelocation in which the device is used exceeds the applicable RF compliance level above, the device should be observed to verify normaloperation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the device.b Over the frequency range 150 kHz to 80 MHz, the field strengths should be less than 3 V/m.

d 1.2 P=

d 1.2 P=

d 2.3 P=

PAGE 3-8 1118824, VER. 00

3.4 RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE & MOBILE RF COMMUNICATIONS AND TH3 DEVICE

This device is intended for use in an electromagnetic environment in which radiated RF disturbances arecontrolled. Electromagnetic interference may be prevented by maintaining a minimum distance betweenportable and mobile RF communications equipment (transmitters) and this device as recommended in thetable below, according to the maximum output power of the communications equipment.

RATED MAXIMUM POWER OUTPUT OF TRANSMITTER (W)

SEPARATION DISTANCE ACCORDING TO FREQUENCY OF TRANSMITTER

(m)

150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5GHz

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separationdistance d in meters (m) can be estimated using the equation applicable to the frequency of thetransmitter, where P is the maximum output power rating of the transmitter in watts (W) accordingto the transmitter manufacturer.

Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affectedby absorption and reflection from structures, objects, and people.

d 1.2 P= d 1.2 P= d 2.3 P=

PAGE 4-11118824, VER. 00

CHAPTER 4: SETUP

This chapter provides an overview of the system setup including introductory information on the User andProvider modes and menus.

4.0 SUPPLYING POWER TO THE DEVICE

4.0.1 SUPPLYING AC POWER TO THE DEVICE

Complete the following steps to operate the device using AC power.

1. Plug the socket end of the AC power cord (included) into the power supply (also included).

2. Plug the pronged end of the AC power cord into an electrical outlet that is not controlled by a wall switch.

3. Plug the power supply cord’s connector into the power inlet on the back of the device.

4. Ensure that all connections are secure.

WARNING

• Inspect the power cord often for any signs of damage.Replace a damaged power cord immediately.

• Do not use extension cords with this device.

• Be sure to route the power cord to the outlet in a way thatwill prevent the cord from being tripped over or interferedwith by chairs or other furniture.

• This device is activated when the power cord is connected.

CAUTION

If the device has been exposed to either very hot or very coldtemperatures, allow it to adjust to room temperature(approximately two hours) before beginning setup.

NOTE

• Please refer to the User Manual for additional information.

• If you are servicing the device with a System One Heated Humidifier,refer to the instructions included with the humidifier for details on howto supply power to the device and humidifier.

NOTE

To remove AC power, disconnect the powersupply cord from the electrical outlet.

PAGE 4-2 1118824, VER. 00

4.0.2 SUPPLYING DC POWER TO THE DEVICE

The Respironics DC Power Cord can be used to operate this device in a stationary recreational vehicle, boat,or motor home. The Respironics DC Battery Adapter Cable, when used with the DC Power Cord, enables thedevice to be operated from a 12 VDC free-standing battery.

Refer to the instructions supplied with the DC Power Cord and adapter cable for information on how to operatethe device using DC power.

CAUTION

• When DC power is obtained from a vehicle battery, thedevice should not be used while the vehicle’s engine isrunning. Damage to the vehicle or the device may occur.

• Only use a Respironics DC Power Cord and Battery AdapterCable. Use of any other system may cause damage to thedevice or vehicle.

PAGE 4-31118824, VER. 00

4.1 STARTING THE DEVICE

FIGURE 4-1: DEVICE CHARACTERISTICS

Display Screen Shows therapy settings, patient data, and error messages. The opening screen isshown temporarily when the unit is first plugged in before changing to the main menu.

Humidifier Icon This LED lights up when the optional System One Heated Humidifier is attached. Thehumidifier number settings are only visible when the System One Heated humidifier isattached and therapy is active. Please refer to the System One Heated humidifier usermanual for more information.

UI Knob Turn the UI Knob to toggle between options on the screen. Press the UI Knob tochoose an option.

Ramp Button When the airflow is on, this button allows you to activate or restart the ramp function.This LED lights up when therapy is active or during specific alerts.

Alarm Silence/Indicator Button

Silences the audible portion of the alarm for a period of time and indicates an alarmcondition.

Air Outlet Port

Side Cover

Power Inlet

Filter Area

SD Card Cover/Slot

UI Knob

LCD Screen

Ramp ButtonAlarm Silence/Indicator Button

Humidifier Icon and Number Settings

PAGE 4-4 1118824, VER. 00

1. Plug the device into an AC power source. The RAMP button lights up and the opening screen momentarily appears.

2. The next screen to appear is the Home screen, shown below.

FIGURE 4-2: HOME SCREEN

3. Turn the UI Knob to toggle between the four options. Highlight “Therapy” or the Therapy icon. Press the UI Knob to turn on the airflow and begin therapy.

4. Press the UI Knob again to turn off therapy and return to the Home screen.

4.2 NAVIGATING THE DEVICE SCREENS

In either User Mode or Provider Mode, turn the UI Knob to toggle between options and settings on the screen.Press the UI Knob to choose an option or setting that is highlighted. If you choose “Back” on any screen, it willtake you back to the previous screen.

4.3 USER AND PROVIDER MODES

The devices are equipped with the following control modes:

• User Mode - The parameters that can be modified by the patient are limited.

• Provider Mode - used by homecare Professionals to set the device’s parameters for the patient’s needs.

NOTE

• The screens shown throughout this manual are examplesonly. Actual screens may vary slightly.

• Your device will either display in text mode (English only) oricon mode.

Therapy

Info

Comfort

Setup

Text View Icon View - Blower Off Icon Mode - Blower On

PAGE 4-51118824, VER. 00

4.3.1 USER MODE

From the Home screen, highlight the “Comfort” option and press the UI Knob. The following Setup screen willappear:

FIGURE 4-3: COMFORT OPTIONS SCREEN

From the Home screen, highlight the “Setup” option and press the UI Knob. The following Setup screen willappear:

FIGURE 4-4: USER SETUP SCREENS

NOTE

Bi-Flex Setting Flex pressure relief - This setting can be enabled or disabled in Provider Mode.

Ramp Start Ramp Start Pressure - This setting can be enabled or disabled in Provider Mode.

Rise Time Rise Time Setting - This setting can be enabled or disabled in Provider Mode.

Backlight Enable or disable the button LED backlight on the device.

hPa/cmH2O Select either hPa or cm H2O as the default unit of measure on the device.

Humidifier View and adjust the humidifier setting. This setting displays when a humidifier is attached.

Setup=

Com

fort

Back Bi-Flex 2 Ramp start 4

Rise time 3

FLEX 2

4 3

Icon View Text ViewSe

tup

Back

Back light on

hPa/cmH2O cmH2O

Humidier 3

cmH2O

3

Icon View Text View

PAGE 4-6 1118824, VER. 00

From the Home screen, highlight the “Info” option and press the UI Knob. The following Setup screen willappear:

FIGURE 4-5: USER INFO SCREENS

4.3.2 PROVIDER MODE

When in Provider Mode, full access to all parameters is granted. To access Provider Mode, refer to Figure 4-6.

FIGURE 4-6: ACCESSING PROVIDER MODE

Blower Hours Displays the total number of hours that the Blower has been on.

Machine Hours Displays the total number of hours that the Blower has been on.

NOTE

• The screen will only show four (4) lines at a time. As you rotate the UI Knob to toggle overdifferent options the screen will slide up and down accordingly.

• For additional information on User Mode, refer to the device’s User Manual.

Info

Back

Blower Hours 890.1

Machine Hours 902.0

890.1

902.0

Icon View Text View

Therap y

Info

Fle x

Setu p

To access Provider Mode, 1. With power applied to the device, use the Control Wheel and toggle to “Setup”.

2. Press down and hold the Control Wheel and Ramp Button for at least five seconds.

PAGE 4-71118824, VER. 00

TO NAVIGATE THE PROVIDER MODE SCREENS:

Turn the UI Knob to toggle between options and settings on the screen. Press the UI Knob to choose an optionor setting that is highlighted. Choose “Back” to return to the previous screen.

FIGURE 4-7: BIPAP AVAPS PROVIDER MENU

NOTE

Provider mode will time out after one minute of inactivity. Thedevice will automatically return to the Home Screen in the UserMode.

PAGE 4-8 1118824, VER. 00

FIGURE 4-8: BIPAP S/T PROVIDER MENU

Mode CPAP, S, S/T, T, or PC. The default setting is S/T. PC mode is only available on the BiPAPAVAPS device.

Flex Control ““no” Allows the user to adjust the Bi-Flex setting if in “S” mode. “Yes” locks the Bi-Flexsetting so users cannot adjust it by selecting “yes”.

Bi-Flex(FLEX)

The setting of Off, 1, 2, or 3 is the level of air pressure relief that the patient feels whenexhaling during therapy. The default setting is Off.

CPAP CPAP pressure setting from 4-20 in 1.0 increments. The default setting is 10.

AVAPS Enable or disable AVAPS when in S, S/T, T, or PC mode by selecting “yes” or “no”. Thedefault setting is “no”. This setting is available only on the BiPAP AVAPS device.

PAGE 4-91118824, VER. 00

Vte If AVAPS is enabled, the target tidal volume can be set from 200-1500 ml in 10 mlincrements. The default setting is 200. This setting is available only on the BiPAP AVAPSdevice.

IPAP Max If AVAPS is enabled, the IPAP Max can be set from 4-25 in 1.0 increments. The defaultsetting is 12. This setting is available only on the BiPAP AVAPS device.

IPAP Min If AVAPS is enabled, IPAP Min setting from 4-25 in 1.0 increments. The default setting is12. This setting is available only on the BiPAP AVAPS device.

IPAP When AVAPS is not enabled, IPAP can be set to 4-25 in 1.0 increments. The defaultsetting is 12.

EPAP In any mode except CPAP, EPAP can be set from 4-IPAP in 1.0 increments. The defaultsetting is 4.

BPM In S/T or PC mode, Breaths Per Minute setting is from 0-30 in 1.0 BPM increments. In Tmode, the minimum BPM setting is 4. The default is 10.

Ti In S/T, T, or PC mode, the Inspiratory Time can be set from 0.5 to 3 seconds in 0.1increments. The default setting is 1.0.

Rise TimeControl

If set to “Yes,” users can not adjust the Rise Time. If set to “no,” users can adjust the RiseTime.

Rise Time Rise time is the time it takes for the device to change from EPAP to IPAP. The defaultsetting is 1.

Ramp Time Ramp Time can be set from 0 (off) - 45 minutes in 5-minute increments. The default settingis 0.

Ramp StartPressure

Ramp Start Pressure can be set from 4 to the CPAP or EPAP setting (depending on yourtherapy mode) in increments of 1. The default is 4.

Apnea The Apnea alarm detects the cessation of spontaneous breathing. Enable or disable theApnea alarm by choosing 0 (off), 10, 20, or 30 seconds. The alarm will sound when thetime between patient-triggered breaths is greater or equal to the specified apnea alarmsetting. The default is 0.

PatientDisconnect

Enable or disable the Patient Disconnect alarm by choosing 0, 15, or 60 seconds. Thealarm will sound when a large, continuous air leak is detected in the circuit for more thanthe specified alarm setting. The default is 0.

MinVent Enable or disable the Low Minute Ventilation alarm by choosing 0 (off) to 99 lpm in 1.0increments. The alarm will sound when the calculated minute ventilation is less than orequal to the specified setting. The default is 0 (off).

Low Vte When AVAPS is enabled, enable or disable the Low Tidal Volume alarm by choosing 0(off) or 1 (on). If enabled, the alarm will sound when the measured patient pressure hasreached the IPAP max setting and the estimated exhaled tidal volume is less than or equalto 90% of the target tidal volume. The default is 0 (off). BiPAP AVAPS device only.

Backlight Enable or disable the button backlights with this setting.

Language Select the language to display on-screen, or select “Icon” to display icons on-screen.

hPa/cmH2O Select the units of pressure that are displayed on-screen, “hPa” or “cmH2O”.

PAGE 4-10 1118824, VER. 00

4.3.3 MEASURED PARAMETERS

The following table describes each measured parameter. The measured parameters that display on theMonitor Pressure screen only appear one at a time. The Setup Parameter Display setting on the Setup screenallows you to choose which measured parameters you want displayed. The parameters below appear on boththe Monitor Pressure and the Monitor Parameters screens.

SetupParameterDisplay

Select which measured parameters will display on the Monitor Pressure screen. Choosefrom Leak, RR (Respiratory Rate), Min vent, or Vte.

Humidifier If the humidifier is attached to the device, you can select from 0 (off) to 5 in increments of 1to enable or disable the humidifier setting. The default is 0 (off). This setting only displays ifa humidifier is attached to the device.

ResetBlowerHours

Select “yes” to reset the blower hours (e.g., to track device usage between patients).

ProviderMode

Enable or disable provider mode. Selecting “on” will put the device in provider mode (andthe device will not automatically return to patient mode when the screen times out or youselect the Back option). Selecting “no” keeps the device in patient mode.

Pressure Displays the current patient pressure.

Leak The estimated leak is the average leak value for the last 6 breaths. Thedisplay is updated at the end of each breath.

Respiratory Rate (RR) This is the average of the previous 6 breaths. If the mode supportsmachine-triggered breaths, this display will be the total breathing rate(spontaneous breaths + machine breaths). The display is updated at theend of each breath.

Minute Ventilation (MinVent) The estimated Exhaled Minute Ventilation is based on the average of thelast 6 breaths. The display is updated at the end of each breath.

Exhaled Tidal Volume (Vte) The estimated Exhaled Tidal Volume is obtained by the integration ofpatient flow. The display is updated at the end of each breath.

PAGE 5-11118824, VER. 00

CHAPTER 5: TROUBLESHOOTING AND ERROR CODES

5.0 INTRODUCTION

This section provides instructions for viewing and clearing the devices’ error log, a description of the errorcodes and bench checkout procedure.

5.1 READING THE DEVICE’S ERROR LOG

Error codes can be viewed on a PC using Service Center Tools or on the device’s display. Refer to Chapter 1of this Service Manual for additional information on obtaining the Service Center Tools software andconnecting the device to a PC.

To read the device’s error log, perform the following:

1. Connect the device to a PC. Refer to Chapter 1 for information on connecting the device to a PC.

2. Apply power to the device.

3. Open Service Center Tools from the Windows Start menu.

FIGURE 5-1: START MENU

PAGE 5-2 1118824, VER. 00

4. Select Read Error Log from the drop-down menu.

FIGURE 5-2: SERVICE CENTER TOOLS

5. The device’s stored error codes will be displayed on the PC monitor.

5.2 CLEARING THE DEVICE’S ERROR LOG

To clear the device’s error log, perform the following:



3. Open Service Center Tools from the Windows Start menu.

4. Select Clear Error Codes from the drop-down menu.

PAGE 5-31118824, VER. 00


5. Verify that a “Error Log Cleared” confirmation window appears.

5.3 ERROR CODES

The four Error Types are described as follows:

ERROR TYPE DESCRIPTION

Vent Inop The error information is recorded in NVRAM and the unit is placed into Safe State. Theonly functionality available to the user is serial communication, turning off the audiblealarm via a key press and removing power.

Reboot The error information is recorded in NVRAM and the unit is Rebooted.

High Priority These alarms require immediate operator response. The alarm signal consists of a redLED and a high priority sound. The display has the message ALARM at the top of thescreen.

Medium Priority These alarms require prompt operator response. The alarm signal consists of a yellowLED and a medium priority sound. The display has the message ALARM at the top ofthe screen.

Low Priority These alarms require operator awareness. The alarm signal consists of a yellow LEDand a low priority sound. The display has the message ALARM at the top of the screen.

Log Only The error information is recorded in NVRAM and the unit continues to operate withoutnoticeable alteration.

PAGE 5-4 1118824, VER. 00

The following tables list the error codes for the Philips Respironics NIV devices.

CODE DESCRIPTION TYPE ACTION

E-0 No Error - you should only see this code in theerror log when the log entry is empty - never inthe middle of an otherwise full log.

N/A None

E-1 Software entered state that causes Device In-operative

Stop Replace the Therapy PCA

E-2 Failed the destructive power on self test of in-ternal RAM

Reboot Replace the Therapy PCA

E-3 Reserved for future use. Log Only None



E-6 Software Failure Log Only Replace the Therapy PCA

E-7 Failed the power on self test of the watchdogtimer


E-8 Failed the power on self test of the watchdogtimer.


E-9 One of the tasks in the background thread ispreventing the remaining tasks from executing.


E-10 During RASP operation response exceededtime limit

Log Only Replace the Therapy PCA

E-11 During Power-On tests, an error occurred whiletesting the watchdog timer.


E-12 Reserved for future use Log Only None


E-14 Processor not able to establish communicationwith the Flow Sensor

Vent Inop Replace the Therapy PCA





E-19 During spinup of the Blower, the drive detectedthat the rotor was not spinning or wires werebroken.

Reboot In the following order:

• Reseat Blower Con-nectors

• Replace Blower Assy

• Replace Therapy PCA

E-20 Processor is unable to communicate withPressure Sensor

Vent Inop Replace Therapy PCA

E-21 Processor not able to establish communicationwith the Flow Sensor

Reboot Clear error log and retest. If re-peats, replace Therapy PCA

PAGE 5-51118824, VER. 00

E-22 Humidifier plate is not making heat Log Only In the following order:

• Replace Heater Plate

• Orientation/Replace Base Humidifier Cable


E-23 Humidifier plate temperature is at maximum(183 degrees F)

Log Only • Replace Heater Plate


E-24 Flow offset error for 5 minutes consecutively. Vent Inop Replace Therapy PCA

E-25 Pressure Offset error (offset exceeded +/- 3cmH2O range for 5 minutes consecutively)


E-26 Flow Sensor Table is corrupt Vent Inop Replace Therapy PCA

E-27 During acquisition of the 12C bus to communi-cate with the EEPROM, there was a failure


E-28 Program execution error. Reboot Replace Therapy PCA

E-29 Processor is unable to communicate with Am-bient Sensor

Log Only Replace Therapy PCA

E-30 Program execution error Log Only Replace Therapy PCA


E-32 V bus has risen above 17.3 VDC for 25 ms. Vent Inop Replace Therapy PCA

E-33 Blower cannot be controlled: Not spinning, bro-ken wires, broken Blower drive, wrong Blowercalibration





E-34 Blower cannot be controlled (speed detectedas too high): Blower Control, broken wires, bro-ken Blower drive, wrong Blower calibration.





E-35 Blower cannot be controlled (speed detectedas negative)






PAGE 5-6 1118824, VER. 00

E-36 Blower thermistor is open circuit. Could be abroken wire or bad or missing connector.

Log Only In the following order:




E-37 Blower thermistor is shorted. Could be causedby the Blower being very high temperature.

Log Only In the following order:




E-38 Measurement of Blower parameters could notbe found within 18s. Could be defective Blowerdrive, broken wires.

Vent Inop In the following order:




E-39 Ramp Key is stuck on Log Only Check the operation/alignmentof the Ramp button. If OK, re-place Therapy PCA

E-40 Knob Stuck in the pressed position Log Only In the following order:

• Reposition or replace the UI knob/top enclosure neces-sary


E-41 Humidifier’s thermistor may be shorted. Log Only In the following order:

• Replace Heater Plate



E-43 Program execution error. Reboot Replace Therapy PCA

E-44 During communication with the EEPROM, thetransfer was never completed

Reboot Replace Therapy PCA

E-45 During rotation of the rotary encoder, the en-coder signal B is changing but encoder signalA is not


E-46 During rotation of the rotary encoder, the en-coder signal A is changing but encoder signalB is not


E-47 The number of bytes transferred was incorrectduring NVRAM operation



PAGE 5-71118824, VER. 00

E-48 The blower S/W 16 kHz periodic loop has ex-ceeded 62.4 µs.


E-49 Indicates that the sensor PCA battery may bedead. Could also indicate that the RTC hasnever been set.


E-50 The RTC has not incremented within one min-ute - should increment every second.


E-51 Blower Calibration storage unit in NVRAM con-tains all zeros



E-53 The present therapy software does not supportthis hardware version.


E-54 Program Execution Error Reboot Replace Therapy PCA

E-55 Process Phase Lock Loop (PLL) is not locked Reboot Replace Therapy PCA

E-56 The flow sensor tubing may be occluded withwater resulting in a constant near zero output.Error is persistent through power cycles.



E-58 One of the tasks in the background thread hassomehow gotten stuck preventing the remain-ing tasks from executing.



E-60 Program Error - Exception stack end locationmemory overrun.


E-61 Exception stack has written into reserve. Log Only None

E-62 Program Error - Exception stack starting loca-tion memory overrun.


E-63 Program Error - FIQ stack end location memo-ry overrun.


E-64 FIQ stack has written into reserve. Log Only None

E-65 Program Error - FIQ stack starting locationmemory overrun.


E-66 Program Error - IRQ stack end location memo-ry overrun.


E-67 IRQ stack has written into reserve Log Only None

E-68 Program Error - IRQ stack starting locationmemory overrun.


E-69 Program Error - Service Stack end locationmemory overrun.


E-70 Service Stack has written into reserve Log Only None

E-71 Program Error - Service stack starting locationmemory overrun.



PAGE 5-8 1118824, VER. 00

E-72 Program Error - Data written to an illegal ad-dress.


E-73 Program Error - Jump to an illegal address. Reboot Replace Therapy PCA

E-74 Program Error - Illegal instruction detected. Reboot Replace Therapy PCA

E-75 During the computation of VqSquared, it wasdetermined that the value would be negative,generating this error.

Reboot • Reseat Blower Con-nectors






E-79 During spinup of the motor the drive detectedthat the rotor was not spinning or wires werebroken.

Reboot • Reseat Blower Con-nectors



E-80 Parameter settings corrupted. Vent Inop Replace Therapy PCA

E-81 Parameter settings corrupted. Vent Inop Replace Therapy PCA

E-82 Program execution error or defective EE-PROM.


E-83 Defective EEPROM. Vent Inop Replace Therapy PCA

E-84 Defective EEPROM. Vent Inop Replace Therapy PCA


E-86 Program execution error Reboot Replace Therapy PCA


E-88 3 reboots within 24 hours. Vent Inop Replace Therapy PCA


E-90 Software rebooted since it wa initiated by theuser.

Reboot None

E-91 Spontaneous breathing has not been detectedwithin the alarm time.

High Alarm None

E-92 High flow condition has been detected. High Alarm None

E-93 The measured Minute Ventilation is less thanor equal to the alarm setting.

High Alarm None

E-94 High pressure condition. High Alarm Replace Therapy PCA

E-95 Excessive high pressure condition. Vent Inop Replace Therapy PCA

E-96 Low pressure condition High Alarm Replace Therapy PCA

E-97 Reserved for engineering Log Only None

E-98 Silence Key is stuck on. Log Only • Check the silence button op-eration.• Replace THerapy PCA.


PAGE 5-91118824, VER. 00

E-99 Input voltage is low. Medium Alarm None

E-100 Processor is unable to communicate with Baro-metric Sensor.


E-101 Indicates that the prescription on the SD cardhas been accepted.

Info Alarm None

E-102 Indicates that the prescription on the SD cardhas been rejected.

Info Alarm None

E-103 Program Execution Error. Vent Inop Replace Therapy PCA


E-105 Indicates that the SD card has become corrupt-ed

Low Alarm Install a new SD Card

E-106 Indicates that the SD card is full of data. Low Alarm Install a new SD Card

E-107 Indicates that the SD card has been removed. Info Alarm None

E-108 Indicates that the SD card has been inserted Info Alarm None

E-109 Indicates that a SD card error occurred Low Alarm Reinsert SD card

E-110 The desired tidal volume cannot be deliveredwithin the limits of the IPAP Min and Max set-tings.

High Alarm None


E-112 Unable to open BiPAP .S on the SD card. Info Alarm Install a new SD Card

E-113 Unable to read BiPAP .S on the SD card. Info Alarm Install a new SD Card

E-114 The used tried to upgrade to an older version ofa software.

Info Alarm Install a new SD Card

E-115 The user tried to upgrade to version of softwarethat is anot intended for this device.

Info Alarm Install a new SD Card

E-116 BiPAP .S file on the card is corrupt. Info Alarm Install a new SD Card


E-118 Therapy queue is full. Program execution error. Log Only Replace Therapy PCA

E-119 Pulse oximeter is reading high quality data. Info Alarm None

E-120 Pulse oximeter is reading poor quality data. Info Alarm None

E-121 Ventilator has collected enough pulse oximetrydata.

Info Alarm None

E-122 No SD card present to store the collected pulseoximetry data.

Low Alarm Insert SD Card


E-124 Pulse Oximetry queue is full. Program execu-tion error.


E-125 Reserved for future use. Log Only Insert Card

E-126 Program Error. Reboot Replace Therapy PCA

E-127 A Thread Stack has written into reserve Log Only None

E-128 A queue has written into reserve Log Only None


PAGE 5-10 1118824, VER. 00



Low Alarm None


Low Alarm None

E-132 Indicates that a SD card error occurred Low Alarm None

E-133 Indicates that a SD card error occurred Low Alarm None

E-134 Reserved for engineering use Log Only None

E-135 Indicates that a SD card error occurred Log Only None

E-136 Indicates that a SW upgrade was started Log Only None




Low Alarm None

E-140 Indicates that 60W power supply was used withheated tube humidifier

Log Only None


E-142 Heated tube temperature is at maximum (41deg C). Could be shorted thermistor.




Low Alarm None


Low Alarm None


E-147 Unable to create a file in the EEPROM Log Only None

E-148 Indicates that the device has started copyinglogs to SD card

Info Alarm None

E-149 Indicates that the device has finished copyinglogs to SD card

Info Alarm None

E-150 Indicates that the device has started copyinglogs from EEPROM

Log Only None

E-151 Indicates that SD card was prematurely re-moved during copying of logs

Log Only None

E-152 Indicates that pressure sensor may be unreli-able



E-154 Indicates that the clearing of patient data failed Info Alarm None

E-155 Indicates that the clearing of patient data is inprogress

Info Alarm None

E-156 Indicates that the clearing of patient data wassuccessful

Info Alarm None


PAGE 5-111118824, VER. 00

5.4 BENCH CHECKOUT

1. Visually inspect the outside of the device for physical damage and broken or missing parts.

2. Apply power to the device and verify the buttons are properly backlit and the LCD is working.

3. Turn on the device and verify proper operation of the unit. Listen to the device for noisy operation or loose components.

4. Run the device for at least eighteen minutes.

5. Perform repairs to the device as necessary.

E-157 Invalid access to the EEPROM Log Only None

E-158 Unable to enqueue messages to the Log Man-ager

Log Only None

E-159 Indicates that device could not copy logs to SDcard due to an error

Low Alarm None


Low Alarm None

E-161 Indicates that the serial number is not valid forlogging purposes

Log Only None


NOTE

BiPAP autoSV Advanced Errors not listed are Rebooterror types and require PCA replacement.


PAGE 5-12 1118824, VER. 00


PAGE 6-11118824, VER. 00

CHAPTER 6: NIV DEVICE REPAIR & REPLACE

This Chapter illustrates the names and locations of the replaceable components in the Philips RespironicsBiPAP AVAPS and BiPAP S/T devices. If repair or replacement procedures are performed, the device must berun-in for a minimum of eighteen (18) minutes, and tested to verify its proper operation. Refer to Chapter 8 forTesting Procedures.

WARNING

To prevent electrical shock, disconnect the electrical supply beforeattempting to make any repairs to these devices.

CAUTION

Components used in this device are subject to damage from static electricity. Repairs made to this devicemust be performed only in an antistatic, Electro-Static Discharge (ESD) protected environment.

PAGE 6-2 1118824, VER. 00

NOTE

The BiPAP AVAPS and S/T have experienced significant design changes. Philips Respironics beganmanufacturing a “2.XX” and “3.XX” version of the devices. These versions are manufactured withhardware components that are not compatible with the previously-designed version. “2.XX/3.XX”refers to the firmware version of the device. Devices that are not marked “2.XX/3.XX” require the use of thepreviously-designed components (refer to the Repair and Replacement section of this manual for furtherclarification.) To differentiate these devices from the previously-designed version, note the “2.XX” or “3.XX”annotation on the serial number label located on the bottom of the device, as follows:

If the “2.XX” annotation is present on the device’s serial number label, then the following components aredifferent from the previously-designed version of the device and are not backwards compatible.

• PCA,

• Blower,

• Blower Cap,

• Air Inlet Seal,

• Sound Abatement Foam, and

• Top Cover.

If the “3.XX” annotation is present on the device’s serial number label, then the components listed in theRP Kit Listing section 6.0 of Repair and Replace Chapter showing (3.XX) follow the “3.XX” format. Thesecomponents are not backwards compatible.

RP kits for both the previous design and the “2.XX/3.XX” version of the device will be available as long asparts are available from Philips Respironics suppliers.

PAGE 6-31118824, VER. 00

6.0 REPLACEMENT PART (RP) KITS FOR PR SYSTEM ONE NIV DEVICES

BiPAP AVAPS BiPAP S/T

1/4” Test Adapter (for run-in) 332353 332353

Air Inlet Seal 1064732 1064732

Alarm Assembly 1071730 1071730

Alarm Holder 1071728 1071728

Alarm/Ramp Button (Keypad) 1071732 1071732

Blower Assembly 1064734 1064734

Blower Assembly 3.XX 1118688 1118688

Blower Cap 1064735 1064735

Blower Housing 1064736 1064736

Blower Outlet Bellows 1064747 1064747

Bottom Enclosure 1071731 1071731

ST/AVAPS Bottom Enclosure 3.XX 1118695 1118695

Flow Manifold 1064751 1064751

Humidifier Base Cable 1064733 1064733

Link Module 1074113 1074113

Main PCA (non-Heated Tube) 1068961 1068963

S/T PCA,US / IN / BR / FR 3.XX 1117459

S/T PCA, INTL 25 3.XX 1117460

S/T PCA, China 3.XX 1117461

AVAPS PCA, US/ IN/ BR/ FR 3.XX 1117462

AVAPS PCA, INTL 25 1117463

AVAPS PCA, China 1117464

O2 Enrichment Attachment(for testing)

312710 312710

Outside Cover 1064808 1064808

Power Supply 1058190 1058190

Right Panel Assembly 1064750 1064750

SD Card Slot Cover 1064765 1064765

Top Enclosure 1071733 1071727

Top Enclosure 3.XX 1109987 1109987

PAGE 6-4 1118824, VER. 00

BiPAP AVAPS BiPAP S/T

Sound Abatement Foam 1064766 1064766

UI Knob 1064787 1064787

AVAPS UI Panel 3.XX 1118689

S/T UI Panel 3.XX 1118690

AVAPS INTL UI Panel 3.XX 1118691

S/T Device Label-China 3.XX 1118692

AVAPS Device Lbl-China 3.XX 1118693

Warning Label1071729

(Dom. U.S.)1071596 (Int’l)

1071729 (Dom. U.S.)

1071596 (Int’l)

S/T, AVAPS Warning Label-CN, 3.XX

1118694 1118694

PR REMstar/BiPAP Air Inlet Seal 2.XX

1080757 1080757

PR REMstar/BiPAP Blower Kit 2.XX

1080758 1080758

PR REMstar/BiPAP Blower Cap 2.XX

1080759 1080759

PR REMstar/BiPAP Sound Abatement Foam 2.XX

1080760 1080760

BiPAP AVAPS C Series Top Enclosure 2.XX

1082723

BiPAP S/T C Series Top Enclosure 2.XX

1082722

PAGE 6-51118824, VER. 00

6.1 REPLACEMENT INSTRUCTIONS

6.1.1 REPLACING THE SD CARD SLOT COVER

FIGURE 6-1: SD CARD SLOT COVER LOCATION

TO REMOVE THE SD CARD SLOT COVER:

• Refer to Figure 6-2.

FIGURE 6-2: SD CARD SLOT COVER REMOVAL

TO INSTALL THE SD CARD SLOT COVER:

• Snap the SD Card Slot Cover into place on the back of the device.

Included in Kit Tools Required

• SD Card Slot Cover Small flat blade screwdriver

SD Card Slot

Power Inlet

Filter Area

Air Outlet Port

PAGE 6-6 1118824, VER. 00

6.1.2 REPLACING THE USER INTERFACE (UI) KNOB

FIGURE 6-3: UI KNOB LOCATION

To remove the UI Knob:

• Pull the UI Knob straight up from the UI stem. A small flat blade screwdriver may be used to care-fully pry the UI Knob from the device.

To Install the UI Knob:

1. Verify that the “D” clip is installed in UI Knob.

2. Align the flat side of “D” clip with the flat side of the UI stem.

3. Press the UI Knob onto the UI stem.

4. Rotate the UI knob and verify that it is secure and rotates freely.

FIGURE 6-4: “D” CLIP IN UI KNOB


• UI Knob Small flat blade screwdriver

NOTE

A “D” clip is installed in the UI Knob.

UI Knob

Keypad

“D” clip installed

PAGE 6-71118824, VER. 00

6.1.3 REPLACING THE RIGHT SIDE COVER

FIGURE 6-5: RIGHT SIDE COVER

TO REMOVE THE RIGHT SIDE COVER

1. Push the locking tab on the end of the Right Side Cover towards the device’s Outlet Port.

2. Lift the Cover away from the device.

FIGURE 6-6: RIGHT SIDE COVER LOCKING TAB

TO REMOVE THE RIGHT SIDE COVER

1. Insert the Right Side Cover, support tabs at the front of the device first, into it’s mounting location.

2. Press the Right Side cover fully into place. Verify that the locking tab snaps and secures the cover.


Right Side Cover None

NOTE

The Right Side Cover is used when there is noHumidifier present.

PAGE 6-8 1118824, VER. 00

6.1.4 REPLACING THE TOP COVER

FIGURE 6-7: TOP COVER (BIPAP AVAPS SHOWN)

TO REMOVE THE TOP COVER

1. Remove the UI Knob. Refer to Replacing the User Interface (UI) Knob.

2. Place the device on a protected work surface and carefully turn it over to expose its bottom.

3. Using a Torx T15 screwdriver, remove the two #6 x 1-3/4” screws that secure the Top Cover to the Bottom Enclosure. Refer to Figure 6-8.

4. While securely holding the device together, carefully return it to its upright position.

5. Lift the Top Cover away from the Bottom Enclosure. The SD Card Slot Cover is loosely installed in the Top Cover.

6. The Keypad has a tendency to remain in the Top Cover. If necessary, remove the Keypad from the Top Cover and maintain it for installation in the replacement Top Cover.


Top Cover T15 Torx screwdriver

PAGE 6-91118824, VER. 00

FIGURE 6-8: SCREW LOCATION

To install the Top Cover:

1. Place the Top Cover onto the Bottom Enclosure.

2. Hold the device together and turn it over to expose its bottom.

3. Secure the Top Cover to the Bottom Enclosure using the two #6 X 1-3/4” screws. Torque screws to 10 in-lbs.

4. Assemble the remainder of the device as instructed in previous sections.

6.1.5 REPLACING THE UI PANEL

TO REMOVE THE USER INTERFACE PANEL

1. Remove the UI Knob. Refer to the Replacing the UI Knob section.

2. Gently peel back the User Interface Panel from the Top Cover

3. Remove any residual adhesive from the Top Cover.

TO INSTALL THE USER INTERFACE PANEL

1. Remove the protective backing from the new User Interface Panel

2. Install the User Interface Panel to the Top Cover ensuring the Panel fits within the recessed area.

NOTE

The SD Card Slot Cover is loosely installed in the TopCover. Use care when removing the Top Cover so asnot to lose the SD Card Slot Cover.

Torque screws to 10 in-lbs during installation.

PAGE 6-10 1118824, VER. 00

6.1.6 REPLACING THE KEYPAD

FIGURE 6-9: KEYPAD

To remove the Keypad:


2. Remove the Top Cover. Refer to Replacing the Top Cover.

3. Remove the Keypad from the Top Cover.

To install the Keypad:

1. Place the Keypad in the Top Cover.



Keypad T15 Torx screwdriver

UI Knob

Keypad

PAGE 6-111118824, VER. 00

6.1.7 REPLACING THE END PANEL

FIGURE 6-10: OUTSIDE COVER

To remove the Outside Cover:

1. Remove the UI Knob. Refer to 6.1.2.


3. Slide the Outside Cover out of the Bottom Enclosure.

To Install the Outside Cover:

1. Slide the Outside Cover into the Bottom Enclosure.



End Panel T15 Torx screwdriver

PAGE 6-12 1118824, VER. 00

6.1.8 REPLACING THE MAIN PCA

FIGURE 6-11: MAIN PCA

To remove the Main PCA:



3. Disconnect the wiring harnesses from the Main PCA. The wiring harnesses are indicated by red arrows in Figure 6-11.

4. Squeeze the standoffs, indicated by blue arrows in Figure 6-11, to release the Main PCA from its mounting location in the Bottom Enclosure.

5. Lift the PCA out of the Bottom Enclosure.


Main PCA T15 Torx screwdriver

PAGE 6-131118824, VER. 00

To Install the Main PCA:

1. Place the PCA in the Bottom Enclosure. Be sure that the Flow and Pressure (if applicable) Sen-sors properly align with the Flow Manifold.

FIGURE 6-12: FLOW MANIFOLD

2. Connect the wiring harnesses to the PCA.

3. Install the #4 x 1/2” screw.


CAUTION

The PCA’s Flow and Pressure Sensors must be in proper alignment withthe Flow Manifold. Otherwise, the device will not operate properly.

NOTE

Verify that the standoffs secure the PCA.

The PCA’s Flow and Pressure Sensors align here.

PAGE 6-14 1118824, VER. 00

6.1.9 REPLACING THE BLOWER CAP

FIGURE 6-13: BLOWER CAP

To remove the Blower Cap:

1. Remove the UI Knob. Refer to section 6.1.2.


3. Remove the Main PCA. Refer to Replacing the Main PCA.


• Blower Cap

• #4 x 1/2” screw (x7)

• T8 Torx screwdriver


Torque screws to 7 in-lbs during installation.

PAGE 6-151118824, VER. 00

4. Using a T8 Torx screwdriver, remove the seven #4 x 1/2” screws that secure the Blower Cap to the Bottom Enclosure. The screws are indicated by the white arrows in Figure 6-13.

5. Push the grommet and the Blower wiring harness through its mounting hole in the Blower Cap.

6. Remove the Blower Cap from the Bottom Enclosure.

To install the Blower Cap:

1. Insert the Blower wiring harness and grommet through its mounting hole in the Blower Cap. Verify that the grommet seats properly in the hole.

2. Align the Blower Cap with the Blower Housing in the Bottom Enclosure.

3. Secure the Blower Cap to the Blower Housing using the seven #4 x 1/2” screws.


PAGE 6-16 1118824, VER. 00

6.1.10 REPLACING THE BLOWER ASSEMBLY AND/OR THE BLOWER OUTLET BELLOWS

FIGURE 6-14: BLOWER ASSEMBLY AND BLOWER OUTLET BELLOWS

TO REMOVE THE BLOWER ASSEMBLY/OUTLET BELLOWS:




4. Remove the Blower Cap.Refer to Replacing the Blower Cap

5. Lift the Blower Assembly out of the Blower Housing. Remove the Blower Outlet Bellows from the Blower Assembly.

To install the Blower Assembly/Outlet Bellows:

1. Place the Outlet Bellows onto the Blower Assembly.


• Blower Assembly

• Blower Outlet Bellows



Blower and Blower Outlet Bellows

Removed from Device

PAGE 6-171118824, VER. 00

2. Align the stands located on the bottom of the Blower Assembly with the holes in the Blower Hous-ing.

FIGURE 6-15: BLOWER INSTALLATION

3. Gently push the Blower Assembly into the Blower Housing.

4. Properly seat the Blower Outlet Bellows in the Blower Housing.


PAGE 6-18 1118824, VER. 00

6.1.11 REPLACING THE FLOW MANIFOLD

FIGURE 6-16: FLOW MANIFOLD

To remove the Flow Manifold:




4. Lift the Flow Manifold off of the Right Side Assembly.

To install the Flow Manifold:

1. Place the Flow Manifold onto the Right Side Assembly as shown in Figure 6-16.



• Flow Manifold • T15 Torx screwdriver

NOTE

The other type is for devices that have a Pressure Sensor.

Flow Manifold

PAGE 6-191118824, VER. 00

6.1.12 REPLACING THE RIGHT PANEL ASSEMBLY

FIGURE 6-17: RIGHT PANEL ASSEMBLY

To remove the Right Panel Assembly:




4. Remove the Blower Cap. Refer to Replacing the Blower Cap.

5. Remove the Flow Manifold. Refer to Replacing the Flow Manifold.

6. Lift the Right Panel Assembly out of the Bottom Enclosure.

To install the Right Panel Assembly:

1. Slide the Right Panel Assembly into the Bottom Enclosure.

2. Place the Flow Manifold onto the Right Panel Assembly as shown in Figure 6-17.



• Right Side Assembly • T8 Torx screwdriver


PAGE 6-20 1118824, VER. 00

6.1.13 REPLACING THE HUMIDIFIER CABLE

FIGURE 6-18: HUMIDIFIER CABLE

To remove the Humidifier Cable:





5. Remove the Right Panel Assembly. Refer to Replacing the Right Panel Assembly.

To install the Humidifier Cable:

1. Place the Humidifier Cable into the Bottom Enclosure. Be sure the Humidifier Cable is properly seated in its mounting location.



• Humidifier Cable • T8 Torx screwdriver


Verify that key is facing upwards

during installation.

PAGE 6-211118824, VER. 00

6.1.14 REPLACING THE BLOWER HOUSING

FIGURE 6-19: BLOWER HOUSING

To remove the Blower Housing:





5. Remove the Blower Assembly. Refer to Replacing the Blower Assembly and/or the Blower Outlet Bellows.


7. Remove the Humidifier Cable. Refer to Replacing the Humidifier Cable.

8. Release the four latches that secure the Blower Housing inside the Bottom Enclosure.

9. Lift the Blower Housing out of the Bottom Enclosure.

To install the Blower Housing:

1. Place the Humidifier Cable into the Bottom Enclosure. Be sure the Humidifier Cable is properly seated in its mounting location.

2. Press the Blower Housing into its mounting location in the Bottom Enclosure. Be sure that all four locking tabs secure the Housing.



Blower Housing • T8 Torx screwdriver


PAGE 6-22 1118824, VER. 00

6.1.15 REPLACING THE ALARM ASSEMBLY AND/OR ALARM HOLDER

FIGURE 6-20: ALARM ASSEMBLY AND ALARM HOLDER

To remove the Alarm Assembly and Alarm Holder:








8. Remove the Blower Housing. Refer to Replacing the Blower Housing.

9. Lift the Alarm Assembly and Housing out of the Bottom Enclosure.

10. Remove the Alarm Assembly from the Alarm Holder.

To install the Alarm Assembly and Alarm Holder:

1. Place the Alarm Assembly into the Alarm Holder as shown in Figure 6-20.

2. Route the Alarm Assembly Wires through the loop in the Alarm Holder as shown in Figure 6-20.

3. Place the Alarm Assembly and Alarm Holder into the Bottom Enclosure as shown in Figure 6-20.


• Alarm Assembly • T8 Torx screwdriver



• Alarm Holder • T8 Torx screwdriver


PAGE 6-231118824, VER. 00


PAGE 6-24 1118824, VER. 00

6.1.16 REPLACING THE SOUND ABATEMENT FOAM

FIGURE 6-21: SOUND ABATEMENT FOAM

TO REMOVE THE SOUND ABATEMENT FOAM:1. Remove the UI Knob. Refer to Replacing the User Interface (UI) Knob.








9. Lift the Foam out of the Bottom Enclosure.

TO INSTALL THE SOUND ABATEMENT FOAM:

1. Place the Foam in the Bottom Enclosure as shown in Figure 6-21.



• Sound Abatement Foam • T8 Torx screwdriver


PAGE 6-251118824, VER. 00

6.1.17 REPLACING THE AIR INLET SEAL

FIGURE 6-22: AIR INLET SEAL

TO REMOVE THE AIR INLET SEAL:1. Remove the UI Knob. Refer to Replacing the User Interface (UI) Knob.








TO INSTALL THE AIR INLET SEAL:

1. Install the Air Inlet Seal in the Bottom Enclosure. Verify that it is flush with the Bottom Enclosure and fully seated on the two prongs as shown in Figure 6-22.



Air Inlet Seal • T8 Torx screwdriver


PAGE 6-26 1118824, VER. 00

6.1.18 REPLACING THE BOTTOM ENCLOSURE

FIGURE 6-23: BOTTOM ENCLOSURE

TO REPLACE THE BOTTOM ENCLOSURE:1. Remove the UI Knob. Refer to Replacing the User Interface (UI) Knob.








9. Remove the Sound Abatement Foam. Refer to Replacing the Sound Abatement Foam.

10. Remove the Air inlet Seal. Refer to Replacing the Air Inlet Seal.

11. Install all the components into the new Bottom Enclosure and assemble the device as instructed in previous sections.


• Bottom Enclosure • T8 Torx screwdriver


PAGE 6-271118824, VER. 00

6.2 CLEANING THE DEVICE

1. Unplug the device, and wipe the outside of it with a cloth slightly dampened with water and a mild detergent. Let the device dry completely before plugging in the power cord.

2. Inspect the device and all circuit parts for damage after cleaning. Replace any damaged parts.

6.3 CLEANING AND REPLACING THE FILTERS

Under normal usage, you should clean the gray foam filter at least once every two weeks and replace it with anew one every six months. The white ultra-fine filter is disposable and should be replaced after 30 nights of useor sooner if it appears dirty. DO NOT clean the ultra-fine filter.

1. Disconnect the device from the power source.

2. Remove the filter(s) from the enclosure by gently squeezing the filter in the center and pulling it away from the device.

3. Examine the filter(s) for cleanliness and integrity.

4. Wash the gray foam filter in warm water with a mild detergent. Rinse thoroughly to remove all detergent residue. Allow the filter to air dry completely before reinstalling it. If the foam filter is torn, replace it. Only Respironics-supplied filters should be used as replacement filters.

5. If the white ultra-fine filter is dirty or torn, replace it.

6. Reinstall the filters, inserting the white ultra-fine filter first if applicable.

WARNING

To avoid electrical shock, always unplug the powercord from the wall outlet before cleaning the device.

CAUTION

Do not immerse the device in liquid or allow any liquidto enter the enclosure, inlet filter, or any opening.

CAUTION

Operating the device with a dirty filter may keep the systemfrom working properly and may damage the device.

CAUTION

Dirty inlet filters may cause high operating temperatures that may affect deviceperformance. Regularly examine the inlet filters as needed for integrity and cleanliness.

CAUTION

Never install a wet filter into the device. You mustensure sufficient drying time for the cleaned filter.

PAGE 6-28 1118824, VER. 00

6.4 CLEANING THE PATIENT TUBING

Disconnect the flexible tubing from the device. Gently wash the tubing in a solution of warm water and a milddetergent. Rinse thoroughly and allow the tubing to air dry. The patient tubing should be cleaned daily.

6.5 CLEANING THE HUMIDIFIER TANK

1. Turn the therapy device off and allow approximately 15 minutes for the heater plate and water to cool.

2. Disconnect the Patient Tubing from the device.

3. Remove the Humidifier Tank Assembly. Empty any remaining water.

4. Separate the Humidifier Tank Lid from the Humidifier Tank Base. Refer to Figure 6-24.

FIGURE 6-24: SEPARATING THE HUMIDIFIER TANK LID FROM THE TANK BASE

5. Wash the Humidifier Tank Lid and Tank Base by hand in a solution of warm water and mild dish-washing soap.

6. Inspect all parts for damage prior to reassembly.

7. Reassemble the Humidifier Tank.

8. Fill the Humidifier Tank to the fill line. Inspect the Humidifier Tank for any leaks or damage. Replace the entire Humidifier Tank Assembly if damaged.

NOTE

Hand washing The Humidifier Tank can be performed daily.

WARNING

• Empty and clean the Humidifier Tank daily to prevent mold and bacteria growth.

• Allow the water in the Humidifier Tank to cool to room temperature beforeremoving the chamber from the humidifier.

Middle Seal

Hinge s

Tab

Water ChamberBase

Water ChamberLid

Hinge s

PAGE 6-291118824, VER. 00

6.6 SYSTEM RUN-IN1. Connect the 0.25” Test Orifice to the Outlet Coupler of the device.

2. Enter the Provider Setup Mode and set the device’s output pressure to its maximum setting.

3. Turn on the device’s Blower and allow it to run-in for a minimum of eighteen (18) minutes.

PAGE 6-30 1118824, VER. 00


PAGE 7-11118824, VER. 00

CHAPTER 7: HUMIDIFIER REPAIR AND REPLACEMENT

This section illustrates the names and locations of the replaceable components in the System One Humidifier.

7.0 HUMIDIFIER REPLACEMENT PART (RP) KITS

7.1 BENCH CHECKOUT

Prior to performing repair and replacement procedures on the device:

1. Visually inspect the outside of the device for physical damage and broken or missing parts.

2. Connect the Humidifier to the NIV device and verify that the Heater Plate works (i.e., does it get warm?)

3. Perform repairs to the device as necessary.

WARNING

To prevent electrical shock, disconnect the Humidifier from theNIV device before attempting to make any repairs.

CAUTION

Components used in this device are subject to damage from static electricity.Repairs made to this device must be performed only in an antistatic, Electro-Static Discharge (ESD) protected environment.

RP KIT NAME PART NO. RP KIT NAME PART NO.

Dry Box Assembly 1064803 Inlet Seal (included w/Dry Box Seal) 1064804

Dry Box Seal (included w/Inlet Seal) 1064804 Outside Cover 1064808

Flip Lid Assembly 1064805 Slider Docking Latch 1064797

Heater Plate 1064806 Top Seal 1064798

Heater Plate Spring 1064807 Torx Screwdriver Kit 1040889

Humidifier Bottom Housing 1064799 Water Chamber (Dom. U.S.) 1063785

Humidifier Lower Base 1064800 Water Chamber (Int’l) 1066737

Humidifier Top Housing 1064801 Humidifier Tank Top Seal 1064798

PAGE 7-2 1118824, VER. 00

7.2 REPLACEMENT INSTRUCTIONS

Refer to the flow chart provided below to help you to determine which components must be removed whenperforming repairs.

PAGE 7-31118824, VER. 00

7.2.1 REPLACING THE WATER CHAMBER ASSEMBLY

FIGURE 7-1: WATER CHAMBER ASSEMBLY

To remove the Water Chamber Assembly:

1. Gently squeeze the latch on the Flip Lid Assembly to release it and lift the Flip Lid Assembly.

2. Pull the Humidifier Tank Assembly out of the Humidifier.

To Install the Humidifier Tank Assembly:

1. With the Flip Lid Assembly in the up position, push the Tank Assembly into the Humidifier.

2. Be sure the Tank assembly is fully seated with the Dry Box Seal.

3. Close the Flip Lid Assembly.


• Tank Assembly None

PAGE 7-4 1118824, VER. 00

7.2.2 REPLACING THE TANK TOP SEAL

FIGURE 7-2: TANK TOP SEAL

TO REMOVE THE TANK TOP SEAL:

1. Remove the Humidifier Tank Assembly. Refer to Replacing the Water Chamber Assembly.

2. Remove the Tank Top Seal from the Flip Lid Assembly.

TO INSTALL THE TANK TOP SEAL:1. Lift the Flip Lid Assembly.

2. Press the Tank Top Seal onto the Patient Outlet Swivel Clip.


• Tank Top Seal None

PAGE 7-51118824, VER. 00

7.2.3 REPLACING THE DRY BOX SEAL

FIGURE 7-3: DRY BOX SEAL

TO REMOVE THE DRY BOX SEAL:1. Remove the Humidifier Tank Assembly. Refer to Replacing the Water Chamber Assembly.

2. Remove the Dry Box Seal.


• Dry Box Seal

• Inlet Seal

None

PAGE 7-6 1118824, VER. 00

FIGURE 7-4: DRY BOX SEAL REMOVAL

TO INSTALL THE DRY BOX SEAL:

1. Insert the narrow side of the Dry Box Seal into the Dry Box Assembly.

2. Verify that the Dry Box Seal is fully Seated in the Dry Box Assembly.

FIGURE 7-5: DRY BOX SEAL INSTALLATION

It is not necessary to remove the Flip Lid

Assembly.

Narrow Side of the Seal

PAGE 7-71118824, VER. 00

7.2.4 REPLACING THE DRY BOX ASSEMBLY/HUMIDIFIER INLET SEAL

FIGURE 7-6: BLOWER CAP

TO REMOVE THE DRY BOX ASSEMBLY/HUMIDIFIER INLET SEAL:

1. Remove the Humidifier Tank Assembly. Refer to .

2. Insert a flat blade screwdriver into the hole located on the back of the Humidifier and lightly press inward to release the Dry Box Assembly. Refer to Figure 7-7.

3. Remove the Dry Box Assembly with Inlet Seal.


• Dry Box Assembly

• Inlet Seal

• Dry Box Seal

Flathead Screwdriver

CAUTION

Do not press firmly on the screwdriver as damage tothe Humidifier may occur.

Dry Box Assembly

Inlet Seal

PAGE 7-8 1118824, VER. 00

4. Remove the Inlet Seal from the Dry Box Assembly.

FIGURE 7-7: DRY BOX SEAL REMOVAL

TO INSTALL THE DRY BOX ASSEMBLY/HUMIDIFIER INLET SEAL:

1. Install The Inlet Seal onto the Dry Box Assembly if necessary.

2. Slide the Dry Box Assembly with Inlet Seal into its mounting location in the Humidifier Bottom Housing. Verify that the Dry Box Assembly with Inlet Seal are secured and do not fall out of the Housing.

Do not press firmly on the screwdriver handle. Very light

pressure is needed to release the Dry Box Assembly.

PAGE 7-91118824, VER. 00

7.2.5 REPLACING THE FLIP LID ASSEMBLY

FIGURE 7-8: FLIP LID ASSEMBLY

TO REMOVE THE FLIP LID ASSEMBLY :1. Remove the Humidifier Tank Assembly. Refer to Replacing the Water Chamber Assembly.

2. Using a screwdriver or similar probing tool, push in on the latches that secure the Flip Lid Assem-bly to the Humidifier Top Housing. Refer to Figure 7-9.

FIGURE 7-9: FLIP LID ASSEMBLY REMOVAL


• Flip Lid Assembly

• Tank Top Seal

None

PAGE 7-10 1118824, VER. 00

Continue to bend the Flip Lid Assembly completely backwards until it is completely removed.

For Heated Tube devices, remove the wire harness from the base.

PAGE 7-111118824, VER. 00

7.2.6 REPLACING THE HUMIDIFIER TOP HOUSING

FIGURE 7-10: HUMIDIFIER TOP HOUSING

TO REMOVE THE HUMIDIFIER TOP HOUSING:


2. Using a T8 Torx screwdriver, remove the four #4 x 1/2” screws that secure the Top Housing to the Humidifier Bottom Housing.

3. Lift the Top Housing off of the Bottom Housing.

TO INSTALL THE HUMIDIFIER TOP HOUSING:

1. Place the Top Housing onto the Bottom Housing.

2. Secure the Top Housing to the Bottom Housing using the four #4 x 1/2” screws.


• Top Housing

• #4 X 1/2” screw (x4)

T8 Torx Screwdriver

PAGE 7-12 1118824, VER. 00

7.2.7 REPLACING THE HUMIDIFIER OUTSIDE COVER

FIGURE 7-11: OUTSIDE COVER

TO REMOVE THE HUMIDIFIER TOP HOUSING:


2. Remove the Flip Lid Assembly. Refer to Replacing the Flip Lid Assembly.

3. Remove the Top Housing. Refer to Replacing the Humidifier Top Housing.

4. Slide the Outside Cover out of the Bottom Housing.

TO INSTALL THE OUTSIDE COVER:

• Slide the Outside Cover into the Bottom Housing.


• Outside Cover T8 Torx Screwdriver

PAGE 7-131118824, VER. 00

7.2.8 REPLACING THE HUMIDIFIER BOTTOM HOUSING

FIGURE 7-12: HUMIDIFIER BOTTOM HOUSING

TO REMOVE THE HUMIDIFIER BOTTOM HOUSING:1. Remove the Humidifier Tank Assembly. Refer to Replacing the Water Chamber Assembly.


3. Remove the Dry Box Assembly with Inlet Seal. Refer to Replacing the Dry Box Assembly/Humidi-fier Inlet Seal.


5. Remove the Outside Cover. Refer to Replacing the Humidifier Outside Cover.

6. Remove the Left Side Panel.

7. Using a T15 Torx screwdriver, remove the four #6 x 1/4” screws that secure the Bottom Housing to the Lower Base Assembly.

TO INSTALL THE HUMIDIFIER BOTTOM HOUSING:


• Bottom Housing (with Left Side Panel)

• #6 X 1/4” screw (x4)

• T8 Torx Screwdriver


Torque screws to 5 in.-lbs. (x4)

PAGE 7-14 1118824, VER. 00

1. Place the Bottom Housing onto the Lower Base Assembly.

2. Verify that the Heater Plate Wiring Harness is properly routed in the Lower Base Assembly and not at risk of being pinched or damaged.

3. Using the four #6 x 1/4” screws, secure the Bottom Housing to the Lower Base Assembly. Torque the screws to 5 in.-lbs.

CAUTION

Route the Heater Plate wiring harness so as not to causedamage during installation of the Humidifier Bottom Housing.

PAGE 7-151118824, VER. 00

7.2.9 REPLACING THE HEATER PLATE ASSEMBLY

FIGURE 7-13: HEATER PLATE ASSEMBLY

To remove the Heater Plate Assembly:






6. Remove the Humidifier Bottom Housing. Refer to Replacing the Humidifier Bottom Housing.

7. Remove the Heater Plate Assembly.

To install the Heater Plate Assembly:



• #6 X 1/4” screw (x4)



PAGE 7-16 1118824, VER. 00

1. Place the Heater Plate Assembly into the Humidifier Lower Base as shown in Figure 7-14. Be sure that the Heater Plate Spring is properly seated under the Heater Plate.

FIGURE 7-14: HEATER PLATE INSTALLATION

2. Secure the Bottom Housing to the Lower Base using the four #6 x 1/4” screws and assemble the remainder of the device as necessary.

The Heater Plate Assembly is secured by two small tabs.

PAGE 7-171118824, VER. 00

FIGURE 7-15 HEATER PLATE ASSY HEATED TUBE

PAGE 7-18 1118824, VER. 00

7.2.10 REPLACING THE SLIDER DOCKING LATCH

FIGURE 7-16: HEATER PLATE ASSEMBLY

To remove the Heater Plate Assembly:






6. Remove the Humidifier Bottom Housing. Refer to Replacing the Humidifier Bottom Housing.

7. Remove the Heater Plate Assembly.

To install the Heater Plate Assembly:



• #6 X 1/4” screw (x4)



PAGE 7-191118824, VER. 00

1. Place the Heater Plate Assembly into the Humidifier Lower Base as shown in Figure 7-14. Be sure that the Heater Plate Spring is properly seated under the Heater Plate.

FIGURE 7-17: HEATER PLATE INSTALLATION

2. Secure the Bottom Housing to the Lower Base using the four #6 x 1/4” screws and assemble the remainder of the device as necessary.

The Heater Plate Assembly is secured by two small tabs.

PAGE 7-20 1118824, VER. 00


PAGE 8-11118824, VER. 00

CHAPTER 8: TESTING

8.0 SECTION OVERVIEW

This section provides run-in, performance verification, and manual software testing procedures for the NIVdevices. Calibration is necessary when a repair has been made to the device. However, these procedures maybe used in conjunction with the performance verification to determine that the device is functioning properly.Verification shall be performed at periodic intervals commensurate with hospital or Home Care Providerguidelines for preventive maintenance, between rentals, after the device has been repaired, or during normalpatient usage.

Calibration and testing requires the use of Respironics Utility Software. Before proceeding, log on to http://my.respironics.com and download the Utility Software onto your PC.

8.1 REQUIRED EQUIPMENT

• Link Module (RI p/n 1074113) with DB9F-DB9M Cable

• Respironics Utility Tools Software (download from: http://my.respironics.com)

• Digital Manometer (RI p/n 302227, or equivalent) with Pressure Tubing

• Windows®-compatible personal computer (PC) running Windows XP or 7 version software

• Printer

• Flow meter (range: +180 to -180 lpm, 3% accuracy, 1 lpm resolution)

• Flow control valve (RI p/n 1037985)

• O2 Enrichment Attachment (312710)

• Negative flow source (any CPAP capable of delivering 20 cm H2O)

• Smooth-Bor Patient Tubing (RI p/n 301016)

• System One Heated Humidifier

• Whisper Swivel® II (RI p/n 332113)

• End Cap (not available from Respironics), or similar device

• Any commercially available Barometer that displays atmospheric pressure in inches of mercury (Hg)

8.2 SYSTEM VERIFICATION

Perform the following:

1. Record the Serial Number and Model Number of the device on the data sheet.

2. Connect the device to a System One Humidifier. Ensure that gray foam filter is installed in the device.

NOTE

• Make photocopies of the Test Data Sheet located on page 15.

• When testing is complete, and before patient use, adjust the device to theappropriate patient settings.

PAGE 8-2 1118824, VER. 00

3. Connect the device to the proper line voltage (depending on the model of the device; Domestic U.S. or International) and record the line voltage used for testing.

4. Record the blower hours of the device on the test data sheet.

5. Connect the patient tubing to the Humidifier’s outlet port. Refer to Figure 8-1.

6. Connect the Whisper Swivel II to the end of the patient tubing. Refer to Figure 8-1.

7. Place the O2 Enrichment Attachment on the end of the Whisper Swivel. Refer to Figure 8-1.

8. Place the end cap on the end of the O2 Enrichment Attachment. Refer to Figure 8-1.

9. Connect a Digital Manometer to the pressure pick-off on the O2 Enrichment Attachment.

10. Enter the device’s Provider Menu. Refer to Chapter 4 (Setup) if necessary.

FIGURE 8-1: PRESSURE VERIFICATION SETUP

11. Set the device to CPAP Mode and the pressure value to four (4) cm H2O.

12. Exit the therapy menu and turn on the device’s airflow.

13. Record the manometer reading on the test data sheet.

14. Enter the device’s Provider Menu and set the CPAP pressure value to 20 cm H2O.

15. Set the device to the S mode and set the IPAP pressure to ten (10) cm H2O and EPAP pressure to 5 cm H2O.

16. Remove the end cap.

17. Occlude then open the outlet repeatedly and verify that the device switches between IPAP and EPAP mode on the display screen. Record results on the test data sheet.

End Cap

O2 Enrichment Attachment

Whisper Swivel II

PAGE 8-31118824, VER. 00

18. Set the device to the S/T mode and set the IPAP pressure to ten (10) cm H2O, the EPAP pressure to five (5) cm H2O, BPM to 10, and Ti to 2.0.

19. Verify that the device switches between IPAP and EPAP mode on the display screen and record the results on the test data sheet.

20. While still in the provider menu, activate the ramp mode.

21. Once the device has achieved the set IPAP and EPAP pressure, press the ramp button.

22. Enter the device’s Provider Menu and set the output pressure to ten (10) cm H2O.

23. Set the Ramp Time to 5 and the Ramp Start to four (4) cm H2O.

24. Turn on the device’s air flow then press the ramp button.

25. Observe the display on the manometer until the pressure increases at least one (1) cm H2O. Record the results on the data sheet.

ALARM VERIFICATION

Maintain the testing configuration as used at the end of system verification.

• Patient Disconnect Alarm Test

a. Set the device to S mode.

b. Set the Apnea Alarm setting to 0 (Off).

c. Set the Patient Disconnect Alarm setting to 15 sec.

d. Exit Provider Mode and remove the test orifice.

e. Verify that the Patient Disconnect Alarm occurs in approximately 15 seconds.

f. Press the Alarm Silence button to silence the alarm, and wait for one minute until the alarm sounds again.

g. Press the UI Knob button to clear the alarm.

h. Replace the test orifice.

i. Simulate a breathing pattern by occluding and opening the outlet port to correct the alarm con-dition.

j. Set the Patient Disconnect Alarm setting to 0 (Off).

• Apnea Alarm Test

a. Set the Apnea Alarm setting to 10 sec.

b. Simulate breathing by alternately occluding and opening the outlet port.

c. Occlude the outlet port and verify that the Apnea alarm occurs in approximately 10 seconds.

d. Press the UI Knob to clear the alarm.

e. Set the Apnea Alarm setting to 0 (Off).

• Minute Ventilation Alarm Test

a. Simulate six breaths by alternately occluding and opening the outlet port for 2 seconds each.

b. Set the Minute Ventilation Alarm setting to 10.0 LPM.

c. Simulate one or two breaths by occluding and opening the outlet port.

NOTE

The red high priority alarm indicator light flashes when the alarm condition has subsided, or ifthe alarm has been silenced. The light will continue to flash until the alarm has been cleared.

PAGE 8-4 1118824, VER. 00

d. Verify that the Minute Ventilation alarm occurs.

e. Press the UI Knob to clear the alarm.

f. Set the Minute Ventilation Alarm setting to Off.

• Loss of Input Power Alarm Test

a. While the device is still operating, disconnect the power cord from the device.

b. Verify that a Loss of Input Power alarm sounds.

c. Reconnect power to stop the alarm.

8.3 MANUAL SOFTWARE TESTING

This procedure must be performed after:

• The device has been repaired and

• The Real-time Clock has been calibrated.

NOTE

When testing is complete, and before patient use, adjust the device to theappropriate patient settings.

Item # Description Item # Description

1 Link Module 6 18” patient Tubing (x3)

2 DB9F-DB9M Cable 7 Any CPAP Device (for Neg. Flow)

3 Whisper Swivel II (Not used in Manual Testing) 8 Flow Valve

4 O2 Enrichment Attachment w/End Cap 9 Flow Meter

5 Digital Manometer Personal Computer (not shown)

2

3

4

7

1

8

9

5

6

PAGE 8-51118824, VER. 00

DOWNLOADING SOFTWARE

You must be a registered user to download Respironics Service Software. If you are not a registered user, goto http://my.respironics.com and complete the on-line registration process. For testing the NIV Devices, youmust download both the Service Center Tools Suite (version 3.0, at the time of publication of this manual) andthe appropriate manual test software.

Once you have access to download the software, perform the following:

1. Log into http://my.respironics.com.

2. Click on the Service Software and Documentation link.

FIGURE 8-2: DOWNLOADING OPERATING SOFTWARE

NOTE

• This procedures requires the use of the Respironics Service Center Tools Suite, and Service CenterManual Test software. The software can be obtained from http://my.respironics.com.

• You must be a registered user to download Respironics Service Software. If you are not a registereduser, go to http://my.respironics.com and complete the on-line registration process.

NOTE

In the event that you are unable to access http://my.respironics.com, log onto http://servicesoftware.respironics.com to download Respironics service software.

Login Here

http://my.respironics.com

Service Software and Documentation Link

PAGE 8-6 1118824, VER. 00

3. Click on “Utility Tools”.

FIGURE 8-3: SERVICE SOFTWARE MENU

4. Click on the “Download” button adjacent to the software you wish to download.

FIGURE 8-4: DOWNLOAD SOFTWARE

Click Here

PAGE 8-71118824, VER. 00

5. The installation wizard will guide you through the upgrade process. Follow the on-screen prompts to complete the upgrade process.

FIGURE 8-5: SECURITY

9. Click on Run to install the software onto your PC, or click on Save to download the software and save it to a specific location on your PC. Click Save if you wish to copy the software to a CD ROM and install it on other PCs.

FIGURE 8-6: RUN OR SAVE?

NOTE

• Respironics recommends that you use the Service Center Tools Suite software toClear the device’s error log.

• Remember to periodically log onto http://my.respironics.com and check forsoftware upgrades.

NOTE

Clicking on “Run” installs the software onto your PC. The programwill be accessible from the Start menu in your Windows Task bar.

If this Appears, Right-click Here and Select “Download File...”

PAGE 8-8 1118824, VER. 00

REAL-TIME CLOCK CALIBRATION

The devices record and track, in real-time, several different parameters (e.g. patient pressures, apnea events,when and how the device is used, error codes, etc.) You must calibrate the device’s Real-time Clock (RTC)prior to performing any testing, otherwise the device will fail.

TO CALIBRATE THE DEVICE’S RTC:

1. Ensure AC power is connected to the device.

2. Connect the device to com port 1 (COM1) of your computer via the Link Module and DB9F-DB9M Cable. Refer to Section 1.3 for information on connecting the device to a PC.

3. Open Service Center Tools from the Start menu.


PAGE 8-91118824, VER. 00

4. When you open the Service Center Tools Suite software, select “Real Time Clock Calibration” from the drop-down menu, then click on the “Execute Tool” button.

FIGURE 8-8: EXECUTE “REAL TIME CLOCK CALIBRATION” TOOL

5. Once the Real-Time Clock Calibration tool has been launched, click on “Set RT Clock” button to calibrate the Real-time Clock. A dialog box appears once the RTC has been successfully cali-brated.

FIGURE 8-9: RTC CALIBRATION

PAGE 8-10 1118824, VER. 00

PERFORMING TESTING USING THE SERVICE CENTER MANUAL TEST SOFTWARE

The Final Manual Test must be performed after repairs have been made to the device, the RTC has beencalibrated, and the device has been run in for two hours.

1. Before starting the test, perform the following (refer to Figure 8-10):

• Connect the device to com port 1 (COM1) of your computer via the Link Module and DB9F-DB9M Cable (if not already connected). Refer to Section 1.3 for information on connecting the device to a PC.

• Connect the O2 Enrichment Attachment (occluded) to the Outlet Port of the Device.

• Attach the Pressure Tubing to the O2 Enrichment Attachment and the manometer.

FIGURE 8-10: MANUAL CALIBRATION INITIAL SETUP

2. Turn on the manometer and verify that it is functioning properly.

3. Launch the Service Center Manual Test from the Windows Start menu. Refer to Figure 8-11.

NOTE

You must clear the device’s error log before and after testing is performed.

Device Connected to Computer via Link Module and DBPF-DB9M Cable

PAGE 8-111118824, VER. 00


4. Follow the on-screen prompts to continue with the test. When prompted, connect the Flow Control Valve and Flow Meter to the device, as shown in Figure 8-12.

FIGURE 8-12: FLOW METER AND FLOW VALVE

NOTE

At the beginning of the test, a prompt to conduct a Humidifier testappears. Respironics suggests conducting the Humidifier test if thedevice is expected to be used with a Humidifier.

To PC

Flow Meter

Valve

PAGE 8-12 1118824, VER. 00

5. Continue following the on-screen prompts.

FIGURE 8-13: INCREASE/DECREASE FLOW

6. When prompted, connect any CPAP device capable of delivering 20 cm H2O to the Flow Meter using 18” patient tubing. The program will now calibrate negative flow.

FIGURE 8-14: APPLY NEGATIVE FLOW SOURCE

NOTE

Be sure the CPAP device being used for negative flow is set to20 cm H2O and turned on.

Click Here

PAGE 8-131118824, VER. 00

FIGURE 8-15: SYSTEM CALIBRATION WITH NEGATIVE FLOW SOURCE

Once testing is complete, a test data sheet will appear. Click on the “Print” button to print the test results andfile the test data sheet accordingly.

8.4 HEATER PLATE TEST

Perform the following:

1. Connect the Patient Tubing with Whisper Swivel II and Test Orifice with End Cap to the Humidi-fier’s Outlet Port.

2. Remove the Humidifier Tank from the device’s Heater Plate (if necessary).

FIGURE 8-16: HUMIDIFIER ICON

IMPORTANT NOTE

During the negative flow portion of testing, the flow meter may display a positive value.However, you must enter a negative sign (-) when prompted by the software.

To PC

Humidifier Icon is Displayed Here if

Setting is not “0” (Off)

PAGE 8-14 1118824, VER. 00

3. Turn the Blower “On”.

4. Turn the UI Knob to any setting other than “0” and verify the following:

• The Humidifier Icon is displayed, and

• The Heater Plate gets warm.

5. Record the result on the test data sheet on page 15.

8.5 READING/VERIFYING THE DEVICE’S SERIAL NUMBER AND MODEL NUMBER

To read or verify the serial number and model number of the device, perform the following:



3. Open the Service Center Tools Suite from the Windows Start Menu.

4. Select Read Serial Number & Model Number from the drop-down menu.

5. Click on the Execute Tool button.

6. The serial number and model number of the device will be displayed.

NOTE

The Read Serial Number & Model Number tool can be used only on the NIVdevices, not the System One Heated Humidifier.

PAGE 8-151118824, VER. 00

SYSTEM VERIFICATION DATA SHEET

Notification # (if applicable):

Model #/Serial #: /

Model Name:

Line Voltage:

Blower Hours

Pressure Verification Result (Circle one)

@ 4 cmH20 + 1 cmH20 PASS / FAIL

@ 20 cmH20 + 2 cmH20 PASS / FAIL

System Verification

Type Result (Circle one)

Trigger Performance PASS / FAIL

Ramp Performance PASS / FAIL

S Mode Trigger Performance PASS / FAIL

Alarm Verification

Alarm Type Result (Circle one)

Patient Disconnect PASS / FAIL

Apnea PASS / FAIL

Minute Ventilation PASS / FAIL

Loss of Input Power PASS / FAIL

Humidifier Test

Heater Plate warms when Heat setting is set to 1, 2, 3, 4, or 5 PASS / FAIL (circle one)

NOTE

If the device does not pass all tests, perform repairs as necessary and retest the device.

Tested By (Print / Sign): / Date: / /

PAGE 8-16 1118824, VER. 00


PAGE 9-11118824, VER. 00

CHAPTER 9: SCHEMATICS

9.0 PROPRIETARY STATEMENT

Schematics are supplied in direct support of the sale and purchase of this product.

The Schematics are proprietary and confidential. Do not copy the schematics or disclose them to third partiesbeyond the purpose for which they are intended.

The schematics are intended to satisfy administrative requirements only. They are not intended to be used forcomponent level testing and repair. Any changes of components could effect the reliability of the device,prohibit lot tracking of electronic components, and void warranties. Repairs and testing are supported only atthe complete board level.

The schematics are of the revision level in effect at the time this manual was last revised. New revisions may ormay not be distributed in the future.

PAGE 9-2 1118824, VER. 00

PAGE 9-31118824, VER. 00

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V

R413

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30

MB

RX

140

R40

6

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10.0

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HU

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RM

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AN

EM

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DD

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MC

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ICS

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12F6

15-I/

SN

PAGE 9-51118824, VER. 00

RE

VC

/N

AP

PR

BY

:

DR

N B

Y:

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106

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D

WHITECR11

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D

RA

MP

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ND

CR22

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GN

D

R101

10.0K

R102

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D

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10.0K

R135

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ND10pF C132

10pF C50GN

D

R104

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GN

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R137

10.0K

R138

10.0K

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D

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GN

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VR

EF

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GN

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0

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RE

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D

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D

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D

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T

R13

233

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R18

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R20

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R19

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PLA

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M_H

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M_P

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M_P

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IGH

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M_P

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IGH

SD

CA

RD

1000pF

C173

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E13

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OH

MS

@ 1

00 M

HZ

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J7:E

6J7

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R133

10.0K

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910

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130

100

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AC

CE

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010

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111

100

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SW

3*1

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ND

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D

WHITECR12

WHITECR13

WHITECR15

WHITECR17

PW

RG

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390

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MS

@ 1

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TER

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D

312

BA

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10.0K

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610

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MS

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1

23

NTR4003NT1GQ13

HU

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GN

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D

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V

R144

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110

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R14

210

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R19

033

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33.2

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D

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733

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33.2

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33.2

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D

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D

1

4

2

3

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MS

@ 1

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GN

D

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7

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D_B

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1

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HU

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TER

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R98

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HU

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LED

4

R46

433

.2R

434

33.2

R20

933

.2R

211

33.2

SS

P1_

MO

SI

UA

RT

TXD

R10

533

.2

R20

733

.2

R20

633

.2

R46

233

.2

R46

633

.2R

467

33.2

4V

SS

1C

S2

SO

5S

I

7H

OLD

8V

DD

3W

P6

SC

K

U15

*

1

2 3

NTR

4502

Q11

8VSSQ

56VSSQ

105VSSQ

103X2_CPU

41X2_RTC

16VSS

113VSS

17 VDD

112 VDD

23 VDDQ

73 VDDQ

120 VDDQ

40VSSQ

87VSSQ

72VSSQ

24VSSQ

121VSSQ

42X1_RTC

82VSS

48VSS81 VDD

49 VDD

57 VDDQ

43 VDDQ

39 VBATT

89R

ES

ET_

IN

75E

MI_

RD

13P

7.3

80P

5.7

70P

5.4

95U

SB

DN

126

P4.

5

1P

4.2

122

AV

DD

109

P1.

4

99P

1.1

118

P7.

6

93P

6.7

68P

3.7

59P

3.1

114

P1.

6

33P

2.2

62P

9.6

51P

9.3

46P

9.0

65P

3.5

27P

5.3

84P

6.5

19P

6.2

90P

0.7

78P

0.4

69P

0.1

115

JTD

I

22E

MI_

WR

H74

EM

I_A

LE

7P

7.2

79P

5.6

77P

5.5

60P

3.2

61P

3.3

18P

5.1

128

P4.

312

7P

4.4

4A

VS

S

101

P1.

2

119

P7.

7

106

P1.

3

14P

7.4

12P

5.0

55P

3.0

15P

7.5

35P

2.3

110

P1.

5

10P

2.0

11P

2.1

104X1_CPU

52P

9.4

58P

9.5

44P

8.7

32P

8.3

30P

8.2

28P

8.1

34P

8.4

36P

8.5

63P

3.4

66P

3.6

53P

2.6

45P

2.5

92P

6.6

20P

6.3

29P

6.0

31P

6.1

83P

6.4

85P

0.5

88P

0.6

67P

0.0

94M

II_M

DIO

6P

7.1

5P

7.0

125

P4.

6

3P

4.0

124

P4.

7

2P

4.1

123

AV

RE

F

96U

SB

DP

37P

2.4

64P

9.7

47P

9.1

50P

9.2

38P

8.6

26P

8.0

98P

1.0

71P

0.2

116

P1.

7

76P

0.3

9 VDDQ

102 VDDQ

86 VDDQ

21E

MI_

BW

R_W

RL

100

RE

SE

T_O

UT

54U

SB

CLK

_P2.

7

108

JTC

K

25P

HY

CLK

_P5.

2

97JR

TCK

107

JTR

ST

91TA

MP

ER

_IN

117

JTD

O11

1JT

MS

STR

911F

AW

44X

6U

9

HD

W_C

ON

FIG

_2

DIS

PLA

Y_C

S#

DIS

PLA

Y_R

ST#

SS

P1_

SC

LK

HE

AR

TBE

AT_

YH

EA

RTB

EA

T_R

HU

MID

IFIE

R_O

N_I

ND

ICA

TOR

HD

W_C

ON

FIG

_1

PAGE 9-6 1118824, VER. 00

AP

PR

BY

:

DR

N B

Y:

CH

K B

Y:

PR

OC

ES

S:

PR

OD

UC

T LI

NE

:

SIZ

E

SC

ALED

TITL

E:

DR

AW

ING

NO

.

1:1

SH

EE

TO

F5

5E

DM

SE

DM

SE

DM

SE

DM

S

D.R

ON

EY

5.14

.200

9

SC

HE

MA

TIC

YO

DA

PA

RT

NO

.

RE

V.

106

1413

S10

6141

311

+V

MO

TOR

_EN

GN

D

C15

6 *

R222

10.0K

R221

4.53K

+V

GN

D

R214

80.6K

GN

D

C163

.1uF

+3.3

VGN

D

R148

61.9K

RE

SE

T

.1uF

C115

82pF

C123

R167

20.0K

GN

D

R40

20.0K

2700

pf

C12

4

C11

2.1

uF50

V

PW

RG

ND

R166

20.0K

R46

*

R15

2

10

GN

D

PW

RG

ND

2 1

SMCJ16CA

CR23

GN

D

AG

ND

R156

5.1

AG

ND

VR

EF

GN

D

TP1

GN

DG

ND

10pF

C14

9

10pF

C14

8

10pF

C16

0

GN

DGN

D10uF

C415

AG

ND

AG

ND

GN

D

AG

ND

AG

ND

GN

DAG

ND

GN

D

PW

RG

ND

AG

ND

10uF

C420

GN

D

R460

3.24M

.1uF

C423

R213

4.53K

R4710

*R45

+3.3

V

GN

D

C15

8

*

10pF C139

+3.3

V_A

NA

GN

D

+V

R72

1.00K

C13

810

uF

1

3

2

FDD

4243

Q18

GN

D

R168

3.32K

C14

6

*

50V

.1uF

C15

1

C11

4

3300

pF

AG

ND

R150

0.050

220pF

C119 GN

D

GN

D

.1uF

C142

10uF

C120

10uF

C417

1uF

C418

GN

D

CR

35

MB

RX

140

GN

D

R461

1.02M

GN

D

R210

10.0K

R161

2.67K

10uF

C127

10uF

C128

.47uF

C125

C12

91u

F

GN

D

PW

RG

ND

R21

2

1.00

K

+V_B

US

PW

RG

ND

PW

RG

ND

R44

*

C15

7

*

PW

RG

ND

R157

7.87K

R153

1M35

V10

uFC

170

PW

RG

ND

1/4W

R16

0

0 O

HM

Del

taIp

p =

Vin

- V

out -

(Rl@

dc+

rDS

(on)

*Iou

t

Ioc

= V

Ilim

/RIli

m =

0.1

V/.0

5hm

= 2

A

R15

8

10.0

K

GN

D

GN

D

+V_B

US

35V

10uF

C11

3

R147

.0101W

PW

RG

ND

R22

0

ZER

O

VR

EF

C145

*

.33uF

C147

PW

RG

ND

390

OH

MS

@ 1

00 M

HZ

E15G

ND

+3.3

V

SY

STE

M_B

US

_CU

RR

EN

T

GN

D

C18

2

1000

pF

C17

9

1000

pF

C17

5

1000

pF

AG

ND

R15

9

10

+VC

OR

E

390

OH

MS

@ 1

00 M

HZ

E14

PW

RG

ND

PW

RG

ND

R45

7

1.21

K

.1uF

C416

R45

9

100

1/4W

C18

3

1000

pF

C17

7

1000

pF

GN

DG

ND

+C

419

5.5V

1.5F

THE

RA

PY

BO

AR

D

PO

WE

R S

UP

PLY

22PF

C422

10uF

C424

C16

9 *

CR1

MMSZ4678T1

10uF 35

VC16

2

+V_B

US

C15

9 *

4A

DJ

2V

OU

T

1V

IN7

VO

UT

6V

OU

T3

VO

UT

5N

C8

NC

U7

*

3S

H2

SL

1C

J8

220pF

C116

3300pF

C122

+V_B

US

C13

722

0pF

R20

1

20.0

K

R19

8

20.0

K

435

Q17

:AM

MD

T390

4

Fsw

=1/(R

rc x

Crc

x 0

.105

) = 3

60.7

5KH

z

4

3

86

2

7

1

Q16

FDFS

2P75

3Z

R15

1

1.00

K

10

R149

+V_B

US

R200

*

26 1

MM

DT3

904

Q17

:B

1R

EF

2GN

D54

6

3 V+

U11

INA

213

R21

9

ZER

O

C11

11u

F

1

3

2

FDD

4243

Q15

GN

D

C11

710

0uF

6.3V

.1uF

C69

C11

0.1

uF

C18

1

1000

pF

C17

8

1000

pF

+10

V

C13

310

uF

VR

EF

+V_B

US

4A

DJ

2V

OU

T

1V

IN7

VO

UT

6V

OU

T3

VO

UT

5N

C8

NC

U16

TL31

7CP

W

R45

8

100

1/4W

R456

3.24K

C18

0

1000

pF

C17

6

1000

pF

L2

10uH

.1uF

C421

GN

DG

ND

+5V

_BO

OS

T

CR20

BZX84B16LT1

Q21MMBT3906LT1

3GN

D

1V

IN2

VO

UT

U14

RE

F303

0

.1uF

C12

6

R21

5

100K

Vov

ersh

oot =

(.02

5V +

Vou

t^2)

^0.5

= 3

.308

79V

Vov

ersh

oot^

2 - V

out^

2 =

L *

Iout

^2 /

C =

.025

V

Tss

= R

c *

Css

* ln

(Vss

t / (V

sst -

1.4

V))

= 1

x 1

0^6

* .1

x 1

0^-6

* ln

(8/6

.6) =

19m

SIrm

s =

Dut

yCyc

le *

(Iou

t^2

+ (D

elta

Ipp^

2/12

))^0

.5

Vin

/ R

rc =

18V

/120

K =

150

uA <

= 75

0uA

(con

ditio

n sa

tisfie

d)

R15

4

261

OU

TO

UT

GN

DIN

U13

LM11

17M

PX

-1.8

L1

10uH

12V

DC

INP

UT

FRO

MA

C P

OW

ER

SU

PP

LY

5 67

U6:

B

(4=G

ND

,8=+

V)

LM39

3DG

KR

3 21

U6:

A LM39

3DG

KR

(4=G

ND

,8=+

V)

TIE

GR

OU

ND

S T

OG

ETH

ER

HE

RE

(L*

I^2

) / 2

< {C

* (V

over

shoo

t^2

- Vou

t^2)

}/ 2

Vou

t = 0

.696

(1 +

Rto

p/R

botto

m) =

0.6

96 *

(1 +

10.

0K/2

.67K

) = R

ough

ly 3

.3V

1R

C2

SS

3C

OM

P4

FB5

GN

D

6G

DR

V

7IS

NS

8V

DD

U12

TPS

4020

0D

CR

28

1N41

48X

PW

RG

ND

7AF1

7GND

5FB

6V

OU

T

2G

ND

3V

IN

1S

W

4S

HD

NU19

LTC

3526

L

Respironics Inc.1001 Murry Ridge LaneMurrysville, PA 15668 USA

Respironics DeutschlandGewerbestrasse 1782211 Herrsching, Germany 1118824, VER. 00

SJW 09/22/2014

Documents

BiPAP AVAPS and BiPAP S/T Service & Technical Reference Manual€¦ · The BiPAP AVAPS and BiPAP S/T devices are intended to provide noninvasive ventilatory (NIV) support to treat