601PRO INTERNATIONAL

SAFETY ANALYZER

MAIN INDEX

PART (1) INTRODUCTION &

DESCRIPTION PART (2) OPERATING METHODS

PART (3) PRACTICAL PART (4) CIRCUITS DESCIRPTION

PART (1)

INTRODUCTION& DESCRIPTION

THIS PART INCLUDE1-GENERAL INTRODUCTION

2-INTRODUCTION TO 601PRO ANALYZER3 -WHAT TESTS CAN 601PRO ANALYZER DO?

4 -WARNINGS5-SYMBOLS DESCRIPTION

6-TOP PANEL FEATURES7 -FRONT PANEL FEATURES

8-BACK PANEL FEATURES

Difference and Risks of DC and AC .

Importance of Erath In (homes , medical devices ….etc) , and macro / micro shock

Difference between PE(protective earth) & FE (functional earth)

What is the quality assurance .

(1) GENERAL INTRODUCTION

(2) INTRODUCTION TO 601PRO ANALYZER

(2) INTRODUCTION TO 601PRO ANALYZER

The 601PRO SeriesXL (601PRO) is an automated electrical safety analyzer that meets stringent international standards for electrical safety testing of hospital and laboratory electro medical equipment

THIS ANALYZER PERFORMS INTERNATIONAL TESTS THAT BELONG INTERNATIONAL STANDARDS ON MEDICAL MACHINES (DUT) AND IT WILL CHECK IF DUT PASS OR FAIL IN THIS TESTS .

Ex: This analyzer can perform protective earth resistance test (international test) and this test belong IEC 601 or VDE 701 ………..etc (international standards )

Note: The 601PRO will accept device information that is input using an external keyboard, integrated

keypad, or barcode keyboard wedge.

(3) WHAT TESTS CAN 601PRO ANALYZER DO?

Available electrical safety tests include: Mains Voltage Dual Lead Voltage Dual Lead Leakage Current Consumption Insulation Resistance. Protective Earth Resistance/cal. Earth Leakage Current Enclosure Leakage Current Patient Leakage Current Mains on Applied Part

Leakage/cal. Patient Auxiliary Current Accessible Voltage Accessible Leakage Equivalent Device Leakage/cal. Equivalent Patient Leakage/cal.

Available ECG performance waveforms include: Square wave: 0.125, 2 Hz Sine wave: 10, 40, 50, 60, 100

Hz Triangle wave: 2 Hz ECG complex: 30, 60, 120, 180,

240 BPM Pulse: 30, 60 BPM AFib,AFlutter,Tach,Idioventricul

ar,PVC1, R-on-T, Run, V-Fib, V-Tach

Caution

This symbol means during this test

a shock hazard is present at theinstrument's measurement

terminals

(4) WARNINGS

☛ Do not discharge a defibrillator while it is plugged into the 601PRO. ☛ Only use Fluke Biomedical-supplied test leads or leads rated for 32

Amps/1000Volts with the Protective Earth Resistance Test. ☛ Inspect the lead ends for possible wear, cracks or breaks before each use. ☛ Take leakage current measurements only after earth resistance (protective

earth resistance) is measured and found to be compliant with the applied safety limit.

☛ External devices, such as printers and computers, attached to the 601PRO, may affect the 601PRO's ability to sense Open Earth conditions on the Mains input. If Mains voltage readings are in error, remove all external devices.

☛ If the DUT fails the Earth Resistance test, the operator must discontinue testing and label the DUT defective.

☛ If any single test fails, the test must be immediately discontinued and the DUT labeled defective.

☛ Prior to performing an ECG Simulation test, perform an Applied Part Leakage Test. If the Applied Part Leakage Test yields an instrument-under-test failure, then do not perform an ECG Simulation Test, as damage to the instrument may occur.

☛ If operating the 601PRO with a variable AC Supply (Variac), it is important to perform a calibration after changing the Mains Voltage level. Calibration can be performed from within the Mains On Applied Part, Equivalent Device Leakage, or Equivalent Patient Leakage tests.

(5) SYMBOLS DESCRIPTION

(6) TOP PANEL FEATURES

TOP PANEL FEATURES

TOP PANEL FEATURES

(7) FRONT PANEL FEATURES

FRONT PANEL FEATURES

(8) BACK PANEL FEATURES

PART (2)

OPERATING MODES (1)MANUAL MODE

( 2)STEP MODE( 3)AUTO MODE

THIS PART INCLUDE1- INTRODUCTION2-SELECT THE CLASS/TYPE OF DUT3-FUNCTIONS OF TOP PANEL KEYS (THE VIEW PRESENT SETTINGS ) KEY(ENTER/PRINT DATA/PREVIOUS /ESC/ STOP/PRINT HEADER KEYS 4- MANUAL MODEOPERATING METHODS (FIRST & SEC. METHOD) ECG OUTPUTSTESTS WITH BLACK & RED TERMINALS (DUAL LEAD LEAKAGE/VOLTAGE) 5- STEP/AUTO MODE(I) SELECTING AUTO OR STEP MODE TESTING(II) CREATING & EDITING A DEVICE RECORD OR TEMPLATE (III) EXECUTING AUTO AND STEP MODE TESTS

(1) INTRODUCTION

General Notes:

Inv (Invalid) will appear next to the reading if the selected test is not applicable to the test standard and class/type chosen, and outlet fault conditions are present.

When the MAIN MENU is displayed, the DUT outlet is OFF (L1, L2 and Earth

are open).

The current standard is displayed on the MAIN MENU and may be changed by selecting SYSTEM SETUP then TEST STANDARD , Or by pressing the VIEW PRESENT SETTINGS key .

The current class/type is displayed on the MAIN MENU and may be changed by selecting CLASS/TYPE , Or by pressing the VIEW PRESENT SETTINGS key.

(2) SELECT THE CLASS/TYPE FOR DUT BY USING THE FOLLOWING CHART

(3) FUNCTIONS OF TOP PANEL KEYSThe View Present Settings Key

FUNCTIONS OF TOP PANEL KEYS The View Present Settings Key

Using View Present Settings key: The view present settings key allows the

operator to inspect or alter the currently selected test standard, class/type, or current source. This is also the only way to edit the Lead selection (Applied Part Type).

To change test standard: press VIEW PRESENT SETTINGS key then press SELECT STANDARD

To change the class/type, press the view present settings key, and press CLASS/TYPE at the following menu:

To choose the current source to be used for the Protective Earth Resistance test, press the view present settings key, and press AMPERES then choose (1 , 10 Or 25 Amp).

To view or change the lead types, press the view present settings key while at the MAIN MENU , then press EDIT LEADS,

Then enter Number Of Applied Part Leads after that Define Lead and Select Type

FUNCTIONS OF TOP PANEL KEYS The View Present Settings Key

FUNCTIONS OF TOP PANEL KEYSEnter/Print Data/Previous /Esc/ Stop/Print Header Keys

The ENTER key advances to the next menu or saves/selects options.

The PRINT DATA key sends displayed test data to the printer.

The PREVIOUS key returns the operator to the previous screen.

The ESC/STOP key discontinues the current test and returns the operator to the MAIN MENU.

From the MAIN MENU or any manual test, press the PRINT HEADER key to print a test header to the selected printer.

Manual Operation: The 601PRO can be used to perform individual tests manually(Manual mode) without the need to perform an automatedsequence (Auto mode). That means we can perform one test or more than one as wewant or do tests one by one with possibility of repeat any testindividually. we have two methods: * By using test short cut key (0,1,2,3,4,5,6,7,8,9, /,-) * By using the MAIN MENU then TEST/AUTOMODES soft

key then choose MANUAL soft key option.

(4) MANUAL MODE

From MAIN MENU the analyzer will perform selected test when we

press the test-short cut keys as indicated in the following table

NOTE: When you perform manual mode tests using short cut test keys begin from MAIN MENU window

MANUAL MODEOperation Methods

(First Method )

Using test-short cut keys

MANUAL MODEOperation Methods

(First Method )

Using TEST /AUTO MODE to operate manual mode

The operator may perform any of the available tests by selecting MANUAL from the TESTS/AUTOMODES option.

The following will be displayed:

MANUAL MODEOperation Methods

(Second Method )

In This Mode We Can Change 601pro Out Put Configurations DuringEach Test As We Want : In tests where the condition of the DUT outlet can be changed, its status

is shown on the display and may be modified by pressing appropriate SOFT KEY on the 601PRO as The following window :

• SOFT KEY 1 cycles the polarity from Normal Polarity to DUT Off to Reverse Polarity, or from Reverse Polarity to DUT Off to Normal Polarity.

• SOFT KEY 2 changes the earth line from Earth (closed earth) to No Earth (open earth).

• SOFT KEY 3 changes the L2 line from L2 (closed L2) to No L2 (open L2).

MANUAL MODE

MANUAL MODE( ECG Output & Dual Lead Leakage )

Tests Can Not Be Accessible From Test Shortcut Keys

In addition to the above tests: Dual Lead Leakage and ECG Output can be accessed

through themanual test menus by pressing TESTS/AUTOMODES, thenMANUAL, then *MORE until the tests are displayed.

Thesetests are not accessible from the test shortcut keys.

ECG Output can ONLY be accessed from MAIN MENU. Dual Lead Leakage currents are measured between

the RED and BLACK test leads. Measurements may have either a true RMS or a DC-only response. The Dual Lead Leakage test can ONLY be accessed from the Manual menu. This test will measure leakage current between two points on DUT.

MANUAL MODE (ECG Output)

Tests That Not Be Accessible From Test Shortcut Keys The 601PRO generates a series of ECG, performance,

and arrhythmia waveforms to verify the accuracy of ECG machines/monitors.

ECG Output can ONLY be accessed from MAIN MENU. To generate waveforms:• From the MAIN MENU, or with the outlet unpowered, plug the

DUT into the 601PRO front panel outlet, and turn on the device.

• Attach the device’s ECG leads to the matching 601PRO applied part terminals.

• From the MAIN MENU, press TESTS/AUTOMODES, then MANUAL, then ECG OUTPUT.

• At the ECG/PERFORMANCE WAVEFORMS menu, press the SOFT KEY below the type of waveform/frequency to output. The outlet is powered on

MANUAL MODE(Dual Lead Leakage Test - Between RED & BLACK Input Jacks )

Tests Can Not Be Accessible From Test Shortcut Keys

To perform a Dual Lead Leakage test:• From the MAIN MENU, or with the outlet unpowered,

plug the DUT into the 601PRO front panel outlet, and turn on the device.

• Attach the RED test lead from the 601PRO to the device. A bare exposed metal area or an applied part should be selected.

• Attach the BLACK test lead from the 601PRO to the device. A bare exposed metal area should be selected.

• From the MAIN MENU, press TESTS/AUTOMODES, then MANUAL, then*MORE until DUAL LEAD LEAKAGE is displayed. Press Dual Lead Leakage, and the test begins immediately. And this window is displayed .

MANUAL MODE Dual Lead Voltage Test (Between RED & BLACK Input Jacks )

NOTE :We can perform this test with red and black input jacks: To initiate the Dual Lead Voltage test, select DUAL

LEAD from the Mains Voltage test ( short cut key no: 0 ) , or select the Dual Lead Voltage Test from the MAIN MENU

The Dual Lead Voltage Test measures the voltage between the RED and BLACK inputs

Introduction: At the beginning the operator have to select either Device

Record or Template as he wish . ( He can do that from SYSTEM SETUP ) If Device Record is selected during setup then control number

will be the first written data . If templates was selected during setup , then replace control number with template name.

The operator may either recall a Device Record based on its control number if Device Records were selected at setup, or a Template based on its name if Templates were selected at setup, or use the instrument present settings to execute a sequence.

If the operator dose not make previous Device Record or Template , he can create new device record /template

(5) STEP/AUTO MODE(i)Selecting Auto Or Step Mode Testing

When prompted for a control number or template name, the operator will haveseveral options:1. Enter a control number or template name, which will recall a file from memory.The Test Standard, Class, Type and other test information will be set from thisfile. The test result will be printed and stored in memory for printing or exportingat a later time. Note; We can using the SCROLLING1 feature or use the optional keyboard plugged

into ISA601PROXL2. Press the ENT key without entering a control number or template name, which will

use the present settings. The test result will be printed only and will not be stored. The present settings include the current Test Standard, Class, Type, and Lead definitions plus the following defaults:

• Power Off Delay of 5 seconds• Startup Delay of 5 seconds• Protective Earth Resistance Applied Current of 1 Amp3. Create/Edit a new device record/template.

STEP/AUTO MODE(i) Selecting Auto Or Step Mode Testing

(1) To enter a control number for a device record or a template name currently stored in the 601PRO’s database, use a combination of the SOFT KEYS for alphanumeric and special characters, and the TEST-SHORTCUT KEYS for numeric keys. Press ENT when the control number has been entered

SCROLL soft key to find stored control number after typing first number or second number and so on also to scroll through the list of existing device records or templates. When the preferred test is found, press ENT soft key to start the test.

CURSOR -> soft key to shift from first number to second number and so on The control number or template name, if entered, is displayed along with the Test Standard

and Class/Type designations that will determine the tests to perform and their limits. When the DUT is connected and ready for testing, press START TEST(SOFT KEY 1).

STEP/AUTO MODE(i) Selecting Auto Or Step Mode Testing

(2) If a control number or template name is not found in memory, create a device record or template as follows:

• From the 601PRO MAIN MENU, press TESTS/AUTOMODES, then select either AUTO mode or STEP mode and press ENT.

• Enter a control number or template name and press ENT

. Then press YES Then press STAR TEST

NOTE; The following instructions and displays are based on having device records selected during setup. If templates was selected during setup , then replace control number with template name in the following displays examples.

STEP/AUTO MODE(i) Selecting Auto Or Step Mode Testing

(3) We can perform STEP/AUTO test after CREATE / EDIT device record and store it in 601PRO memory as following :

MAIN MENU then UTILITIES then DEVICE RECORD then CREATE RECORD then Enter Control Number – Select test standard - class/type - applied current (for protective earth resistance test ;1/10/25A) - startup delay (power on delay time before next switch off) – power off delay (power off delay time before next switch on) – enter number of applied part leads – define leads and select type – enter serial number

(not required for templates) – enter device location- enter device type – enter device manufacture - enter procedure ID .

After this the analyzer will return to Device Record Utility menu then press PERVIOUS to return to MAIN MENU

Note: We can edit record ) change device record parameters ( , from MAIN MENU then UTILITIES then DEVICE RECORD then EDIT RECORD .

STEP/AUTO MODE (ii)Creating /Editing A Device Record Or Template

After choosing AUTO MODE press NEXT to advance analyzer to complete other tests .

press START TEST (if you want to repeat many readings of protective earth resistance ) after that you can press next to complete other tests .

Protective Earth Resistance during an Auto sequence:

STEP/AUTO MODE(iii)Executing Auto / Step Mode Tests

(Auto Mode)

During Step mode operation, the operator must press the NEXT-> key to advance to the next test in the sequence. At the time the NEXT-> key is pressed, the value displayed will be stored as the data for that test.

Pressing the NEXT-> key multiple times at the same screen is discouraged because some tests may be skipped. Examples of Step mode test sequence screens are shown below. Mains Voltage during Step mode 1:

Then press next to perform Insulation Resistance during Step mode 2 or press START TEST to repeat Mains voltage test (and so on):

STEP/AUTO MODEExecuting Auto / Step Mode Tests

(Step Mode)

When either Auto or Step mode is completed, the technician’s name must be entered. The name will be stored in the result record. The technician’s name will default to the previous name entered, if one exists. At the following screen, enter the Technician Name and press ENT.

☛ Note: Press the Esc key to discontinue an Auto/Step sequence at the Enter Technician Name and Test Comments screens.

Press the esc/stop key to abort the Auto or Step sequence at any time. Once the esc/stop key has been pressed, the unit may complete the test it is presently executing before aborting

STEP/AUTO MODEExecuting Auto / Step Mode Tests

(Final Stage)

PART (3)

PRACTICE & PRACTICAL

THIS PART INCLUDE1-INTRODUCTION

2 -PRACTIC TO DEFINE APPLIED PART OF DEFFIBRILATOR WITH TWO PADDELS

TYPE BF AND 3 ECG LEADS TYPE CF 3 -ACTION(A)

4-ACTION(B)5-ACTION(C)

6 -NOTES7 -OPERATING FLOW CHART

(1) INTRODUCTION

The CLASS/TYPE selection sets the Type of EQUIPMENT that is being tested. Thisaffects the limits for the Protective Earth Resistance, Insulation Resistance L1, L2Case, Earth Leakage, and Enclosure Leakage Tests. When Applied Part Types aredefined, this affects the limits as well as which tests are being performed on eachOf the individual leads. The operator should consider the following possible scenarioswhen defining Applied Part Types:CONDITION 1:If ALL of the Applied Parts are defined with the SAME Type as the EQUIPMENTType, then the leads will be tested TOGETHER.CONDITION 2:If ALL of the Applied Parts are defined with the SAME Type, but with a differenttype than the EQUIPMENT Type, then the Applied Parts will be testedINDIVIDUALLYCONDITION 3:If at least one Applied Part is defined with a DIFFERENT Type than any of the leads

orthe EQUIPMENT Type, then the Applied Parts will be tested INDIVIDUALLY.

Lead Type DefinitionUse the following procedure to test a defibrillator with two paddles, Type BF, andthree ECG leads, RA, LA and LL, all of which are Type CF.)This is an example of Condition 3( Assuming that the ECG leads will be connected to the 601PRO applied partTerminals with the identical names, the paddles would have to be connected to theRL and any V terminal. Define the lead types using the following steps:1- The first lead that appears for definition is RA. Since RA is Type CF, press TYPE CF:

Press enter to advance to the next lead )RL(.

(2) PRACTIC OF DEFFIBRILATOR WITH TWO PADDELS TYPE BF AND 3 ECG LEADS TYPE CF

Lead Type Definition2. Since RL is Type BF, press TYPE BF:

Press enter to advance to the next lead )LA(.3. Since LA is Type CF, press TYPE CFPress enter to advance to the next lead )LL(.4. Since LL is Type CF, press TYPE CF .Press enter to advance to the next lead )V1-V6(.5. Since the V lead is Type BF, press TYPE BF.

☛ Note: The applied parts are always assigned left to right, beginning with the top row

PRACTIC OF DEFFIBRILATOR WITH TWO PADDELS TYPE BF AND 3 ECG LEADS TYPE CF

Device under test (DUT) connection to 601PRO analyzer Using single lead (red input jack)

(3) ACTION (A)

Red input jack

(3) ACTION (A)

Perform manual mode test and some other test: Connecting the Device Under Test Before starting the test)s(, ensure that the

601PRO and the device being tested are connected properly. when connecting the Device Under Test )DUT( to the 601PRO. Applied Parts are optional, depending on the device being tested ,

When DUT and the 601PRO have been connected, power up both units.

1- change CLASS/TYPE using MAIN MENU 2- change CLASS/TYPE using VIEW SETTING KEY3- change international TEST STANDARD using VIEW SETTING KEY OR SYSTEM SET UP4- perform MANUAL MODE TEST using the SOFT KEYS 5- perform MANUAL MODE TEST using SHORT CUT KEYS to perform desired test as written above theses keys

As we know we have 3 deferent way to perform auto/step test :1- perform quick test with stored control number or template name. as a

following: MAIN MENU then TEST/AUTO modes then select either AUTO mode or STEP mode and enter control number then Press ENT then press START TEST

2- perform quick test If a control number or template name is not found in memory, create a device record or template as follows: From the 601PRO MAIN MENU, press TESTS/AUTOMODES, then select either AUTO mode or STEP mode and press ENT. then Enter a control number or template name and press ENT Then press YES Then press STAR TEST

(4) ACTION (B)

(4) ACTION (B)

3- Perform test after create/edit)change parameters( device record and store it in 601PRO memory as following :

MAIN MENU then UTILITIES then DEVICE RECORD then CREATERECORD then Enter Control Number – Select test standard - class/type –applied current for protective earth resistance test)1,10,25A( – startupdelay)time of power on delay – power off delay) time power of delay( – enternumber of applied part leads – define leads and select type )as describedbefore( – enter serial number)not required for templates( – enter devicelocation- enter device type – enter device manufacture - enter procedure ID– after this the analyzer will return to Device Record Utility menu then presspervious to return to Main Menu

perform )STEP MODE TEST( perform ) AUTO MODE TEST( print and discus all results .

(5) ACTION (C)

With previous and After create / edit device record 1- perform )STEP MODE TEST( 2- perform ) AUTO MODE TEST(3- print and discus all results .

(6) NOTES

USING RED AND GREEN AND RED INPUT JACKS :1- measure R between two points ( using protective earth resistance key )this is what we call it point to point resistance measurement 2- perform lead calibration ( when using new testing lead)When performs protective earth resistance test with new lead. 3- testing permanently devices .(perform measurements like protective earth resistance , enclosure leakage

current using manual operation keys)4- test IP devices.

USING BLACK AND RED INPUT JACKS: 1- perform dual lead voltage test ( voltage between 2 points)2- perform dual lead leakage test (current between two points ) or (conductive surface ) using dual lead leakage test

Note : We can using PRO601 to test detachable power cords ( like measuring R between 2 points) .

)7 (OPERATING FLOW CHART

PART (4)

CIRCUITS DESCRIPTION

THIS PART INCLUDE(1) PROTECTIVE EARTH RESISTANCE(2) EARTH LEAKAGE CURRENT(3) ENCLOSURE LEAKAGE CURRENT(4) MAINS INSULATION RESISTANCE(5) APPLIED PART INSULATION RESISTANCE(6) MAINS ON APPLIED PART(7) PATIENT AUXILIARY CURRENT(8) PATIENT LEAKAGE CURRENT(9) VDE, EQUIVALENT DEVICE LEAKAGE(10) VDE, EQUIVALENT PATIENT LEAKAGE(11) ACCESSIBLE VOLTAGE(12) ACCESSIBLE LEAKAGE CURRENT

(1) Protective Earth Resistance

(2) Earth Leakage Current

(3) Enclosure Leakage Current

(4) Mains Insulation Resistance

(5) Applied Part Insulation Resistance

(6) Mains On Applied Part

(7) Patient Auxiliary Current

(8) Patient Leakage Current

(9) VDE, Equivalent Device Leakage

(10) VDE, Equivalent Patient Leakage

(11) Accessible Voltage

(12) Accessible Leakage Current

Best luck