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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 INCLUDE. 1-GENERAL INTRODUCTION
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MAIN INDEX PART (1) INTRODUCTION & DESCRIPTION PART (2)OPERATING METHODS PART (3)PRACTICAL PART (4) CIRCUITS DESCIRPTION
PART (1) INTRODUCTION & DESCRIPTION
THIS PART INCLUDE 1-GENERAL INTRODUCTION 2-INTRODUCTION TO 601PRO ANALYZER 3-WHAT TESTS CAN 601PRO ANALYZER DO? 4- WARNINGS 5-SYMBOLS DESCRIPTION 6-TOP PANEL FEATURES 7- FRONT PANEL FEATURES 8-BACK PANEL FEATURES
(1) GENERAL INTRODUCTION • 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 .
(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,Idioventricular,PVC1, R-on-T, Run, V-Fib, V-Tach Caution This symbol means during this test a shock hazard is present at the instrument'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.
PART (2) OPERATING MODES (1)MANUAL MODE (2)STEP MODE (3)AUTO MODE
THIS PART INCLUDE 1- INTRODUCTION 2-SELECT THE CLASS/TYPE OF DUT 3-FUNCTIONS OF TOP PANEL KEYS • (THE VIEW PRESENT SETTINGS ) KEY • (ENTER/PRINT DATA/PREVIOUS /ESC/ STOP/PRINT HEADER KEYS 4- MANUAL MODE • OPERATING METHODS • (FIRST & SEC. METHOD) • ECG OUTPUTS • TESTS WITH BLACK & RED TERMINALS • (DUAL LEAD LEAKAGE/VOLTAGE) 5-STEP/AUTO MODE • 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 MENUis displayed, the DUT outlet is OFF (L1, L2 and Earth are open). • The current standard is displayed on the MAIN MENUand may be changed by selecting SYSTEM SETUPthen TESTSTANDARD, 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,Orby pressing the VIEW PRESENT SETTINGSkey.
(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 keythen pressSELECT STANDARD
FUNCTIONS OF TOP PANEL KEYS The View Present Settings Key • 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 ProtectiveEarth 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 Leadsafter thatDefine Lead and Select Type
FUNCTIONS OF TOP PANEL KEYSEnter/Print Data/Previous /Esc/ Stop/Print Header Keys • The ENTERkeyadvances to the next menu or saves/selects options. • The PRINT DATAkey sends displayed test data to the printer. • ThePREVIOUSkey 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.
(4) MANUAL MODE Manual Operation: The 601PRO can be used to perform individual tests manually (Manual mode) without the need to perform an automated sequence (Auto mode). That means we can perform one test or more than one as we want or do tests one by one with possibility of repeat any test individually. 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 thenTEST/AUTOMODESsoft key then choose MANUALsoft key option.
MANUAL MODE • Operation Methods • (First Method ) FromMAIN MENUtheanalyzer 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 fromMAIN MENU window
MANUAL MODE • Operation Methods • (First Method ) Usingtest-short cut keys
MANUAL MODE • Operation Methods • (Second Method ) Using TEST /AUTO MODE to operate manual mode • The operator may perform any of the available tests by selecting MANUALfrom the TESTS/AUTOMODESoption. • The following will be displayed:
MANUAL MODE In This Mode We Can Change 601pro Out Put Configurations During Each 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( 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 the manual test menus by pressing TESTS/AUTOMODES, then MANUAL, then *MORE until the tests are displayed. These tests 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 & BLACKInput 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 BLACKtest 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 MODEDual Lead Voltage Test (Between RED & BLACKInput 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
(5) STEP/AUTO MODE(i)Selecting Auto Or Step Mode Testing 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
STEP/AUTO MODE(i) Selecting Auto Or Step Mode Testing • When prompted for a control number or template name, the operator will have several 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 this file. The test result will be printed and stored in memory for printing or exporting at a later time. Note; We can using the SCROLLING1 feature or use the optional keyboard plugged into ISA601PROXL 2. 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 Amp 3. 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 • SCROLLsoft 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(ii)Creating /Editing A Device Record Or Template (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 Utilitymenu 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(iii)Executing Auto / Step Mode Tests (Auto Mode) • After choosing AUTO MODE press NEXTto 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 MODEExecuting Auto / Step Mode Tests(Step 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(Final Stage) • 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
PART (3) PRACTICE & PRACTICAL
THIS PART INCLUDE 1-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- NOTES 7- OPERATING FLOW CHART
(1) INTRODUCTION The CLASS/TYPE selection sets the Type of EQUIPMENT that is being tested. This affects the limits for the Protective Earth Resistance, Insulation Resistance L1, L2 Case, Earth Leakage, and Enclosure Leakage Tests. When Applied Part Types are defined, this affects the limits as well as which tests are being performed on each Of the individual leads. The operator should consider the following possible scenarios when defining Applied Part Types: CONDITION 1: If ALL of the Applied Parts are defined with the SAME Type as the EQUIPMENT Type, then the leads will be tested TOGETHER. CONDITION 2: If ALL of the Applied Parts are defined with the SAME Type, but with a different type than the EQUIPMENT Type, then the Applied Parts will be tested INDIVIDUALLY CONDITION 3: If at least one Applied Part is defined with a DIFFERENT Type than any of the leads or the EQUIPMENT Type, then the Applied Parts will be tested INDIVIDUALLY.
(2) PRACTIC OF DEFFIBRILATOR WITH TWO PADDELS TYPE BF AND 3 ECG LEADS TYPE CF Lead Type Definition Use the following procedure to test a defibrillator with two paddles, Type BF, and three 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 part Terminals with the identical names, the paddles would have to be connected to the RL 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).
PRACTIC OF DEFFIBRILATOR WITH TWO PADDELS TYPE BF AND 3 ECG LEADS TYPE CF Lead Type Definition 2. 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 CF Press 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
(3) ACTION (A) Device under test (DUT) connection to 601PRO analyzer Using single lead(redinput jack) 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 KEY 3- change international TEST STANDARD using VIEW SETTING KEY OR SYSTEM SET UP 4- 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
(4) ACTION (B) As we know we have 3 deferent way to perform auto/step test : 1- perform quick test with storedcontrol 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 testIf 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) 3- Perform testafter create/edit(change parameters) 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(time of power on delay– power off delay( time power of delay) – enter number of applied part leads – define leads and select type (as described before) – 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 • perform (STEP MODE TEST) • perform ( AUTO MODE TEST) • print and discus all results .