ESA612 Electrical Safety Analyzer Users Manual March 2009, Rev. 1 © 2009 Fluke Corporation. All rights reserved. Specifications are subject to change without notice. All product names are trademarks of their respective companies.
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Table of Contents Title Page Introduction .................................................................................................................... Safety Information .......................................................................................................... Intended Use.................................................................................................................. Unpacking the Analyzer ..........................................................................
ESA612 Users Manual Setting the GFCI Limit............................................................................................... Performing Electrical Safety Tests................................................................................. Setting the Test Standard ......................................................................................... Performing Mains Voltage Testing ............................................................................
Contents (continued) Maintenance................................................................................................................... Testing and Replacing the Fuses ................................................................................... Cleaning the Analyzer .................................................................................................... Replaceable Parts ..........................................................................................................
ESA612 Users Manual iv
List of Tables Table 1. 2. 3. 4. 5. 6. 7. Title Page Symbols................................................................................................................................. Top-Panel Controls and Connections.................................................................................... Side and Top-Panel Connections.......................................................................................... Schematic Abbreviations ......................................................
ESA612 Users Manual vi
List of Figures Figure 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. Title Page Front-Panel Controls and Connections ................................................................................. Side and Top-Panel Connections.......................................................................................... Analyzer Ready for Operation ............................................................................................... DUT Connections to the Analyzer ..........................
ESA612 Users Manual 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34. 35. Applied Parts to Non-Earth Conductive Points Schematic.................................................... Leakage Current Main Menu ................................................................................................ Earth Leakage Current Test Schematic ................................................................................ Enclosure Leakage Current Test Schematic.......................
Electrical Safety Analyzer Introduction The Fluke Biomedical ESA612 Electrical Safety Analyzer (hereafter the Analyzer) is a full-featured, compact, portable analyzer, designed to verify the electrical safety of medical devices. The Analyzer tests to domestic (ANSI/AAMI ES1, NFPA 99) and international (IEC62353, AN/NZS 3551, and parts of IEC 60601-1) electrical-safety standards. The integrated ANSI/AAMI ES1 and IEC60601-1 patient loads are easily selectable.
ESA612 Users Manual Table 1. Symbols Symbol W Important information; refer to manual. X Hazardous voltage ) Conforms to relevant Canadian and US standards ; Conforms to relevant Australian EMC requirements P Conforms to European Union directives ~ Do not dispose of this product as unsorted municipal waste. Go to Fluke’s website for recycling information.
Electrical Safety Analyzer Intended Use • Inspect the Analyzer before using it. Do not use the Analyzer if abnormal conditions of any sort are noted (such as a faulty display, broken case, etc.) • Use extreme caution when working with voltages above 30 V. • Inspect the test leads for damaged insulation or exposed metal. Check test lead continuity. Replace damaged leads before using the Analyzer. • Do not touch metal parts of the device under test (DUT) during analysis.
ESA612 Users Manual Unpacking the Analyzer Instrument Familiarization Carefully unpack all items from the box and check that you have the following items: Figure 1 and Table 2 describes the front-panel controls and connections of the Analyzer.
Electrical Safety Analyzer Instrument Familiarization Table 2. Top-Panel Controls and Connections Item Name Description Equipment Outlet Configuration Buttons Controls the configuration of the equipment outlet. Opens and closes the neutral and ground connection and reverses the polarity of the neutral and hot connection. 2 High Voltage Indicator Indicates when high voltage is applied to the ECG/Applied Parts posts or L1 and L2 of the Test Receptacle.
ESA612 Users Manual Figure 2 and Table 3 describe the side and top-panel connections of the Analyzer. RA R LL F LA L RL N V1 C1 ST TE 7 2 4 1 3 8 5 6 fis110.eps Figure 2.
Electrical Safety Analyzer Instrument Familiarization Table 3. Side and Top-Panel Connections Item 1 Name Equipment Outlet Description Equipment outlet, specific to the version of the Analyzer, which provides a DUT connection. (B-style connector) Digital connection for controlling the Analyzer from a PC or instrument controller. 3 Fuse Access Door Covers the equipment outlet fuses. 4 Tilt Stand Support for holding the Analyzer in a tilted position. 5 AC Power Switch Turns ac power on and off.
ESA612 Users Manual Connecting to Line Power XWWarning To avoid shock hazard and for proper Analyzer operation, connect the factory supplied three-conductor line power cord to a properly grounded power outlet. Do not use a two-conductor adapter or extension cord; this will break the protective ground connection. Connect the Analyzer to a properly grounded three-prong outlet. The Analyzer will not properly test a DUT when the ground lead is open.
Electrical Safety Analyzer Turning the Analyzer On To protective earth or any exposed conductive surface on the enclosure RA R LL F LA L RL N V1 C1 ST TE fis113.eps Figure 4.
ESA612 Users Manual During the self-test, the Analyzer checks its ac mains input for proper polarity, ground integrity and voltage level. The high voltage indicator illuminates briefly during the self test. If the polarity is reversed, the Analyzer indicates this condition and allows the polarity to be reversed internally. If the ground is open, the Analyzer displays this fault.
Electrical Safety Analyzer Setting Up the Analyzer Setting Up the Analyzer Setting Polarity Switching Delay There are a number of Analyzer parameters that are adjusted through a setup function as well as the ability to save a record by ID and date. To access the first Setup menu shown in Figure 6, press Q. When switching the polarity of the Analyzer’s test receptacle, a delay can be set to control the actual switch time. To set the polarity delay: 1.
ESA612 Users Manual 1. From the setup menu, press the softkey labeled More twice to set F1 to the display contrast function. 2. Press the softkey labeled Display Contrast. 3. Press G or H to increase or decrease the display’s contrast respectively. 4. Press the softkey labeled Done to exit contrast setup. Setting up the Beeper To enable or disable the beeper: Viewing Memory Refer to the Using Memory section later in the manual to learn about viewing memory and how to store data in the Analyzer.
Electrical Safety Analyzer Performing Electrical Safety Tests Setting the Test Standard The Analyzer is designed to perform electrical safety testing based on a number of different safety standards: AAMI ES1/NFPA99, IEC62353, IEC60601-1, and AN/NZS 3551. AAMI is the Analyzer’s default standard. To select another standard: 1. Press Q. 2. From the setup menu, press the softkey labeled More to reveal additional menu selections. 3.
ESA612 Users Manual Prior to conducting any leakage tests with the Analyzer, it is best to test the integrity of the ground connection between the Analyzer’s test receptacle ground and the DUT’s Protective earth ground or enclosure with this test. the DUT enclosure or protective earth connection. 8. The measured resistance is displayed as shown in Figure 8 after the DUT connection(s) is/are made. To access the Ground Wire (Protective Earth) ∅/Null Resistance Test menu press O.
Electrical Safety Analyzer Performing Electrical Safety Tests Figure 9 shows the electrical connections between the Analyzer and the DUT. Table 4 lists the abbreviations used in the schematics and their descriptions.
ESA612 Users Manual To protective earth or any exposed conductive surface on the enclosure RA R LL F LA L RL N V1 C1 ST TE fis112.eps Figure 9.
Electrical Safety Analyzer Performing Electrical Safety Tests Table 4.
ESA612 Users Manual DEVICE UNDER TEST DUT_L1 APPLIED PART DUT_L2 EARTH OPEN FE DUT_PE PE CONDUCTIVE PART MD TEST LEAD faw26.eps Figure 10.
Electrical Safety Analyzer Performing Electrical Safety Tests Performing an Insulation Resistance Test The five insulation resistance tests take measurements on mains (L1 & L2) to Protective earth, applied parts to Protective earth, mains to applied parts, mains to nonearthed accessible conductive points, and applied parts to non-earthed accessible conductive points. To access the Insulation Resistance Test menu, press M. All Insulation Resistance Tests can be performed using 500 or 250 volts dc.
ESA612 Users Manual DEVICE UNDER TEST DUT_L1 APPLIED PART DUT_L2 MD DUT_PE FE CONDUCTIVE PART faw17.eps Figure 12.
Electrical Safety Analyzer Performing Electrical Safety Tests DEVICE UNDER TEST DUT_L1 APPLIED PART DUT_L2 DUT_PE MD FE CONDUCTIVE PART faw18.eps Figure 13.
ESA612 Users Manual DEVICE UNDER TEST DUT_L1 APPLIED PART DUT_L2 MD DUT_PE FE CONDUCTIVE PART faw19.eps Figure 14.
Electrical Safety Analyzer Performing Electrical Safety Tests DEVICE UNDER TEST DUT_L1 APPLIED PART DUT_L2 MD DUT_PE FE CONDUCTIVE PART TEST LEAD faw20.eps Figure 15.
ESA612 Users Manual DEVICE UNDER TEST DUT_L1 APPLIED PART DUT_L2 DUT_PE FE CONDUCTIVE PART TEST LEAD MD faw21.eps Figure 16.
Electrical Safety Analyzer Performing Electrical Safety Tests Performing a Current Consumption Test To measure the current consumed by the DUT, press A. The Analyzer displays the current flowing through the mains connections of the test receptacle. Performing Leakage Current Tests The Analyzer measures leakage current for a number of different DUT configurations.
ESA612 Users Manual Measuring Earth Leakage Current Note The Ground Wire (Earth) Leakage test is available for AAMI, 60601, and not IEC 62353. To measure the current flowing in the DUT’s protective earth circuit, press the softkey labeled Ground Wire (pending the standard) from the leakage current main menu. Figure 18 shows the electrical connections between the Analyzer and the DUT during a Ground Wire Leakage Current Test. fis117.jpg Figure 17.
Electrical Safety Analyzer Performing Electrical Safety Tests IEC60601-1 specifies that the applied parts should be connected for this measurement. Enable this measurement by pressing E or F which grounds and ungrounds all applied parts connection posts.
ESA612 Users Manual DEVICE UNDER TEST MAINS ON DUT_L1 L1 APPLIED PART MAINS L2 OPEN DUT_L2 L2 REV POL EARTH OPEN DUT_PE CONDUCTIVE PART MD PE FE APPLIED PART OPEN faw27.eps Figure 18. Earth Leakage Current Test Schematic Note Ground wire leakage is the same schematic without the Applied Parts switch.
Electrical Safety Analyzer Performing Electrical Safety Tests Performing a Chassis (Enclosure) Leakage Test Note The Chassis (Enclosure) Leakage test is only available for the IEC60601 or ANSI/AAMI ES1 1993 standard selections. The Chassis (Enclosure) Leakage Test measures the current flowing between the DUT’s enclosure and protective earth. Figure 19 shows the electrical connections between the Analyzer and the DUT.
ESA612 Users Manual DEVICE UNDER TEST MAINS ON DUT_L1 L1 APPLIED PART MAINS L2 OPEN DUT_L2 L2 EARTH OPEN DUT_PE FE CONDUCTIVE PART TEST LEAD MD PE APPLIED PART OPEN faw28.eps Figure 19. Enclosure Leakage Current Test Schematic Note Chassis leakage is the same schematic without the Applied Parts switch.
Electrical Safety Analyzer Performing Electrical Safety Tests Performing a Lead-to-Ground (Patient) Leakage Test Note The Lead-to-Ground (Patient) Leakage Current Test is not available for IEC 62353 standard selections. The Lead-to-Ground (Patient) Leakage Current test measures the current flowing between a selected applied part, selected group of applied parts, or ALL applied parts, and the Mains PE. Figure 20 shows the electrical connections between the Analyzer and the DUT.
ESA612 Users Manual DEVICE UNDER TEST MAINS ON DUT_L1 L1 APPLIED PART MAINS L2 OPEN DUT_L2 L2 REV POL EARTH OPEN DUT_PE FE CONDUCTIVE PART LEAD SELECT MD PE LEAD GND faw29.eps Figure 20.
Electrical Safety Analyzer Performing Electrical Safety Tests Performing Lead-to-Lead (Patient Auxiliary) Leakage Tests different combinations of posts tied together: RA/R and LL/F, RA/R and LA/L, or LL/F and LA/L. Note The Lead-to-Lead (Patient Auxiliary) leakage test is available when the IEC60601 or ANSI/AAMI ES1-1993 standard is selected.
ESA612 Users Manual MAINS ON DUT_L1 DEVICE UNDER TEST L1 APPLIED PART MAINS L2 OPEN DUT_L2 L2 EARTH OPEN REV POL DUT_PE FE CONDUCTIVE PART PE + LEAD MD - LEAD GROUND LEAD faw30.eps Figure 22.
Electrical Safety Analyzer Performing Electrical Safety Tests The following outlet conditions apply when performing this test: • • • • • Normal Polarity Normal Polarity, Open Neutral Normal Polarity, Open Earth Reversed Polarity, Open Neutral Reversed Polarity, Open Earth Performing a Lead Isolation (Mains on Applied Part) Leakage Test Note The Lead Isolation (Mains on Applied Part) leakage test is available when the IEC60601 & ANSI/AAMI standard is selected.
ESA612 Users Manual DEVICE UNDER TEST MAINS ON DUT_L1 L1 APPLIED PART MAINS L2 OPEN DUT_L2 L2 EARTH OPEN REV POL DUT_PE FE CONDUCTIVE PART TEST LEAD PE MD LEAD SELECT MAP (ISOLATION) TRANSFORMER MAP REV faw31.eps Figure 23.
Electrical Safety Analyzer Performing Electrical Safety Tests Performing an Alternative Equipment Leakage Test Note The alternative equipment leakage test is available when the EN62353 standard is selected. During the Alternative Equipment Leakage test, the voltage source is applied between short-circuited equipment outlet mains live, neutral, and equipment outlet earth, the exposed conductive surface on the housing, and all applied parts short-circuited together.
ESA612 Users Manual DEVICE UNDER TEST DUT_L1 APPLIED PART DUT_L2 DUT_PE FE CONDUCTIVE PART PE OPEN TEST LEAD MD faw22.eps Figure 24.
Electrical Safety Analyzer Performing Electrical Safety Tests To perform an alternative applied part leakage test: 1. Press B. 2. Press the soft key labeled More. 3. Select the desired applied part groupings using G and H. 4. Press the soft key labeled Select. 5. Press the soft key labeled Alternative A.P.. 6. Press T to apply the test voltage and read the current in the display. 7. Press F or E to advance to the next applied part group(s) of a single function if applicable.
ESA612 Users Manual DEVICE UNDER TEST DUT_L1 AP1 APPLIED PART AP2 DUT_L2 DUT_PE FE CONDUCTIVE PART TEST LEAD MD faw23.eps Figure 25.
Electrical Safety Analyzer Performing Electrical Safety Tests Performing a Direct Applied Part Leakage Test Note The Direct Applied Part Leakage test is available when the EN62353 standard is selected. The Direct Applied Part Leakage Current test measures the leakage current between all applied parts of a single function and the exposed conductive surface on the housing, to mains earth.
ESA612 Users Manual DEVICE UNDER TEST MAINS ON DUT_L1 L1 APPLIED PART MAINS L2 OPEN DUT_L2 L2 REV POL PE OPEN DUT_PE FE CONDUCTIVE PART MD TEST LEAD faw24.eps Figure 26.
Electrical Safety Analyzer Performing Electrical Safety Tests DEVICE UNDER TEST MAINS ON DUT_L1 AP1 L1 APPLIED PART MAINS L2 OPEN AP2 DUT_L2 L2 REV POL DUT_PE FE CONDUCTIVE PART MD faw25.eps Figure 27.
ESA612 Users Manual Performing a Differential Leakage Current Test Note The Differential Leakage Current test is available when the EN62353 standard is selected. The differential leakage current test measures the magnitudes of the differential current flowing in the Equipment Outlet live and neutral, with power applied to the equipment outlet. All applied parts should be connected during this test, if equipment has applicable applied parts. To perform a differential leakage current test: 1. Press B. 2.
Electrical Safety Analyzer Performing Electrical Safety Tests DEVICE UNDER TEST MAINS ON DUT_L1 L1 APPLIED PART MD L2 OPEN MAINS DUT_L2 L2 REV POL FE EARTH OPEN DUT_PE PE CONDUCTIVE PART TEST LEAD faw32.eps Figure 28.
ESA612 Users Manual Using the 1210 Adapter The 1210 Adapter, an optional accessory, is designed to increase the number of lead or applied parts connections to the Analyzer from five to 14. The adapter itself ties up to ten leads together into a single lead that is plugged into one of the input jacks of the Analyzer. The four remaining Analyzer input jacks can also be used in conjunction with the Adapter. Figure 29 shows one application of the Adapter.
Electrical Safety Analyzer Using the 1210 Adapter Defibrillator/Pacer ESA612 DEFIB OFF PACER 1210 fis120.eps Figure 29.
ESA612 Users Manual When performing an applied parts test using the AAMI/NFPA-99 standard, the normal connections of RA, LL, LA, and RL are made to their associated Analyzer input jacks. Four adapters from the Universal Snap to Banana Adapter set will be required for the first four connections. The remaining chest leads are connected to the Adapter and the common lead from the Adapter is th plugged into the V1 jack (5 jack) of the Analyzer. See Figure. 30.
Electrical Safety Analyzer Using the 1210 Adapter ECG Monitor ESA612 1210 fis121.eps Figure 30.
ESA612 Users Manual Making Point-To-Point Measurements The Analyzer can make voltage, resistance, and low current measurements through its Point-to-Point function. To access the Point-to-Point function menu shown in Figure 31, press R. Softkeys F1 through F3 are used to select the measurement function. 3. Place the probe tips across the unknown voltage and read the measurement in the Analyzer’s display. The Analyzer will measure up to 300 volts ac.
Electrical Safety Analyzer Simulating ECG Waveforms Measuring Current The Analyzer can make dc only, ac only, and ac+dc current measurements up to 10 mA. To make a current measurement: 1. Press the softkey labeled Leakage from the Point-To-Point menu. 2. Using G or H select between ac only, dc only, or ac+dc measurement mode. 3. Insert test leads in the RED (V/Ω/A ) and BLACK jacks. 4. Place the leads on the two points the unknown current may flow and read the measurement in the Analyzer’s display.
ESA612 Users Manual labeled Frequency or Rate. For some waveforms, there are more than two frequency or rate selections. For those waveforms, pressing the softkey labeled Frequency or Rate will open a scroll box above the softkey label with K next to it. Use G or H to select the frequency or rate. For those waveforms that have only two frequency or rate selections, the softkey labeled Frequency or Rate acts as a toggle, where each press of the softkey switches to the other value.
Electrical Safety Analyzer Simulating ECG Waveforms ECG Monitor RA R LL F LA L RL N RA R LL F V1 C1 LA L RL N V1 C1 ST TE BJ2ECG Adapter fis115.eps Figure 33.
ESA612 Users Manual Using Memory 5. Press (enter save button) to store the Test Record ID. The non-volatile memory of the Analyzer will store up to 500 measurements or ECG information for each of 100 different Test Records. Each test record can be recalled to the display of the Analyzer or exported to a PC. Data Viewer software, available at www.flukebiomedical.com/ESA612, is required to upload memory data to a PC. Installation and operator instructions are also located on the software web page. 6.
Electrical Safety Analyzer Controlling the Analyzer Remotely After performing and saving all the tests for one Test Record ID, enter a new Test Record ID to close the previous record and start a new one. 1. Press Q. 2. Press the softkey labeled More to reveal additional menu selections. Note A previously closed record can not have measurements or ECG signals added to it. Data can only be stored under the most recently opened record. 3. Press the softkey labeled View Memory. 4.
ESA612 Users Manual based on a user written test procedure), and integrates all test results into a single test report which can be printed or archived. Ansur allows for automatic comparisons to the limits of the standard selected, indicating whether results are passing or failing. Ansur manages test procedures by allowing both manual and visual automated test sequences.
Electrical Safety Analyzer Cleaning the Analyzer Cleaning the Analyzer XW Warning To avoid electric shock, do not clean the Analyzer plugged into mains or attached to a DUT. F1 - F2 W Caution Do not pour fluid onto the Analyzer surface; fluid seepage into the electrical circuitry may cause the Analyzer to fail. W Caution Do not use spray cleaners on the Analyzer; such action may force cleaning fluid into the Analyzer and damage electronic components. fis111.eps Figure 35. Fuse Access 5.
ESA612 Users Manual Replaceable Parts Table 6 lists the replaceable parts for the Analyzer. Table 6.
Electrical Safety Analyzer Replaceable Parts Table 6. Replaceable Parts (cont.) Item Fluke Biomedical Part Number Carrying Case 2248650 Data Transfer Cable 1626219 Fuse USA WT20A 250V Fuse (Time Lag), 1¼″ x ¼″ Australia, Switzerland WT10A 250V Fuse (Time Lag), 1¼″ x ¼″ Europe, UK, Thailand, WT16A 250V Fuse (Time Lag), 6.
ESA612 Users Manual Accessories Table 7 lists the available accessories for the Analyzer. Table 7.
Electrical Safety Analyzer Specifications Specifications Temperature Operating ............................................................10 °C to 40 °C (50 °F to 104 °F) Storage................................................................-20 °C to 60 °C (-4 °F to 140 °F) Humidity .................................................................10 % to 90 % non-condensing Altitude 120 V ac mains supply voltage ...........................5000 m 230 V ac mains supply voltage ...........................
ESA612 Users Manual Detailed Specifications Test Standard Selections........................................ ANSI/AAMI ES-1, IEC62353, IEC60601-1, and AN/NZS 3551 Voltage Ranges (Mains voltage)...................................... 90.0 to 132.0 V ac rms 180.0 to 264.0 V ac rms Range (Point-to-point voltage) ............................ 0.0 to 300.0 V ac rms Accuracy ............................................................. ±(2 % of reading + 0.2 V) Earth Resistance Modes ..............................
Electrical Safety Analyzer Detailed Specifications Ranges................................................................0.0 to 199.9 μA 200 to 1999 μA 2.00 to 10.00 mA Accuracy DC to 1 kHz .....................................................±(1 % of reading + (1 μA or 1 LSD, whichever is greater)) 1 to 100 kHz ....................................................±(2 % of reading + (1 μA or 1 LSD, whichever is greater)) 100 kHz to 1 MHz............................................
ESA612 Users Manual ECG Performance Waveforms Accuracy Frequency ....................................................... ±2 % Amplitude ........................................................ ±5 % of 2 Hz square wave only, fixed @ 1 mV Lead II configuration Waveforms ECG Complex ................................................. 30, 60, 120, 180, and 240 BPM Ventricular Fibrillation Square wave (50 % duty cycle) ...................... 0.125 Hz and 2 Hz Sine wave .............................................
