Page 2 - Warranty and Product Support
Warranty and Product Support Fluke Biomedical warrants this instrument against defects in materials and workmanship for one year from the date of original purchase. During the warranty period, we will repair or at our option replace, at no charge, a product that proves to be defective, provided you ...
Page 3 - Notices; All Rights Reserved
Contents (continued) Notices All Rights Reserved © Copyright 2008, Fluke Biomedical. No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or translated into any language without the written permission of Fluke Biomedical. Copyright Release Fluke Biom...
Page 4 - Standard Terms and Conditions
Standard Terms and Conditions Refunds and Credits Please note that only serialized products and their accessory items (i.e., products and items bearing a distinct serial number tag) are eligible for partial refund and/or credit. Nonserialized parts and accessory items (e.g., cables, carrying cases, ...
Page 5 - Certification
Contents (continued) Returns for partial refund/credit: Every product returned for refund/credit must be accompanied by a Return Material Authorization (RMA) number, obtained from our Order Entry Group at 1-800-648-7952 or 1-425-446-6945. Repair and calibration: To find the nearest service center, g...
Page 7 - Table of Contents; Title
i Table of Contents Title Page Introduction .................................................................................................................... 1 Safety Information .......................................................................................................... 2 Intended ...
Page 9 - iii
Contents (continued) iii Maintenance................................................................................................................... 56 Testing and Replacing the Fuses ................................................................................... 56 Cleaning the Analyzer .......
Page 11 - List of Tables; Table Title
v List of Tables Table Title Page 1. Symbols................................................................................................................................. 2 2. Top-Panel Controls and Connections.................................................................................... 5 ...
Page 13 - vii; List of Figures; Figure; Controls
vii List of Figures Figure Title Page 1. Front-Panel Controls and Connections ................................................................................. 4 2. Side and Top-Panel Connections .......................................................................................... 6 3. Analyzer...
Page 14 - Current
ESA612 Users Manual viii 16. Applied Parts to Non-Earth Conductive Points Schematic .................................................... 24 17. Leakage Current Main Menu ................................................................................................ 26 18. Earth Leakage Current Test...
Page 15 - Electrical Safety Analyzer; Introduction
1 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 internati...
Page 16 - Users Manual; Symbol Description; Safety Information; XW; Warning
ESA612 Users Manual 2 Table 1. Symbols Symbol Description 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 unso...
Page 17 - Intended Use
Electrical Safety Analyzer Intended Use 3 • 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.) • Inspect the test leads for damaged insulation or exposed metal. Check test lead continuity. Replace d...
Page 18 - Unpacking the Analyzer; Figure 1. Front-Panel Controls and Connections
ESA612 Users Manual 4 Unpacking the Analyzer Carefully unpack all items from the box and check that you have the following items: • ESA612 • Getting Started Manual • Users Manual CD • Carrying case • Power cord • 15 – 20 A Adapter (USA only) • ESA USA Accessory Kit (USA, Australia, and Israel only) ...
Page 19 - Table 2. Top-Panel Controls and Connections
Electrical Safety Analyzer Instrument Familiarization 5 Table 2. Top-Panel Controls and Connections Item Name Description 1 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 n...
Page 20 - Figure 2. Side and Top-Panel Connections
ESA612 Users Manual 6 Figure 2 and Table 3 describe the side and top-panel connections of the Analyzer. TEST RA LL LA RL V1 R F L N C1 2 7 8 1 6 5 3 4 fis110.eps Figure 2. Side and Top-Panel Connections
Page 21 - Item Name
Electrical Safety Analyzer Instrument Familiarization 7 Table 3. Side and Top-Panel Connections Item Name Description 1 Equipment Outlet Equipment outlet, specific to the version of the Analyzer, which provides a DUT connection. 2 USB Device Port (B-style connector) Digital connection for controllin...
Page 22 - Connecting to Line Power; Connecting a DUT to the Analyzer; Note; Figure 3. Analyzer Ready for Operation
ESA612 Users Manual 8 Connecting to Line Power XW Warning 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 gr...
Page 23 - Figure 4. DUT Connections to the Analyzer
Electrical Safety Analyzer Turning the Analyzer On 9 TEST RA LL LA RL V1 R F L N C1 To protecti v e earth or any exposed cond u cti v e s u rface on the enclos u re fis113.eps Figure 4. DUT Connections to the Analyzer
Page 24 - Accessing the Analyzer’s Functions; Figure 5. Leakage Current Menu; PND
ESA612 Users Manual 10 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...
Page 25 - Setting Up the Analyzer; Setting Polarity Switching Delay
Electrical Safety Analyzer Setting Up the Analyzer 11 Setting Up the Analyzer 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 . fis114.bmp Figure 6. ...
Page 26 - Performing Electrical Safety Tests
ESA612 Users Manual 12 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 contr...
Page 27 - More; Performing Mains Voltage Testing; Figure 7. Mains Voltage Test Menu
Electrical Safety Analyzer Performing Electrical Safety Tests 13 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. T...
Page 31 - Table 4. Schematic Abbreviations
Electrical Safety Analyzer Performing Electrical Safety Tests 17 Table 4. Schematic Abbreviations Abbreviation Meaning MD Measuring Device (ESA612 Analyzer) FE Functional Earth PE Protective Earth Mains Mains Voltage Supply L1 Live Conductor L2 Neutral Conductor DUT Device Under Test DUT_L1 Device U...
Page 33 - . Pressing the softkey labeled
Electrical Safety Analyzer Performing Electrical Safety Tests 19 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 non-earthed accessible cond...
Page 36 - Figure 14. Mains to Applied Parts Insulation Test Schematic
ESA612 Users Manual 22 MD CO N DUCTI V E PART DUT_PE DUT_L2 DUT_L1 FE DE V ICE U N DER TEST APPLIED PART faw19.eps Figure 14. Mains to Applied Parts Insulation Test Schematic
Page 38 - Figure 16. Applied Parts to Non-Earth Conductive Points Schematic
ESA612 Users Manual 24 MD CO N DUCTI V E PART DUT_PE DUT_L2 DUT_L1 FE DE V ICE U N DER TEST APPLIED PART TESTLEAD faw21.eps Figure 16. Applied Parts to Non-Earth Conductive Points Schematic
Page 39 - Table 5. Test Names Based on Selected Standard
Electrical Safety Analyzer Performing Electrical Safety Tests 25 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 m...
Page 40 - Figure 17. Leakage Current Main Menu; Measuring Earth Leakage Current; Ground Wire
ESA612 Users Manual 26 fis117.jpg Figure 17. Leakage Current Main Menu Note The display shown in Figure 17 is the main leakage current menu when AAMI is the selected standard. All leakage currents, with the exception of Lead Isolation (Mains on Applied parts), are displayed in one of three ways: AC+...
Page 41 - or
Electrical Safety Analyzer Performing Electrical Safety Tests 27 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.
Page 42 - Figure 18. Earth Leakage Current Test Schematic
ESA612 Users Manual 28 CO N DUCTI V E PART DUT_PE APPLIED PART OPE N PE L2 DUT_L2 DUT_L1 MAI N S L1 EARTH OPE N L2 OPE N RE V POL MAI N S O N MD FE DE V ICE U N DER TEST APPLIED PART faw27.eps Figure 18. Earth Leakage Current Test Schematic Note Ground wire leakage is the same schematic without the ...
Page 43 - Chassis
Electrical Safety Analyzer Performing Electrical Safety Tests 29 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 bet...
Page 44 - Figure 19. Enclosure Leakage Current Test Schematic
ESA612 Users Manual 30 CO N DUCTI V E PART DUT_PE APPLIED PART OPE N TEST LEAD PE L2 DUT_L2 DUT_L1 MAI N S L1 EARTH OPE N MAI N S O N L2 OPE N MD FE DE V ICE U N DER TEST APPLIED PART faw28.eps Figure 19. Enclosure Leakage Current Test Schematic Note Chassis leakage is the same schematic without the...
Page 45 - Select
Electrical Safety Analyzer Performing Electrical Safety Tests 31 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 flowin...
Page 47 - Lead to
Electrical Safety Analyzer Performing Electrical Safety Tests 33 Performing Lead-to-Lead (Patient Auxiliary) Leakage Tests Note The Lead-to-Lead (Patient Auxiliary) leakage test is available when the IEC60601 or ANSI/AAMI ES1-1993 standard is selected. To measure the leakage current through each app...
Page 51 - Alternative Equipment
Electrical Safety Analyzer Performing Electrical Safety Tests 37 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...
Page 52 - Figure 24. Alternative Equipment Leakage Current Test Schematic
ESA612 Users Manual 38 CO N DUCTI V E PART DUT_PE DUT_L2 DUT_L1 FE DE V ICE U N DER TEST APPLIED PART PE OPE N TESTLEAD MD faw22.eps Figure 24. Alternative Equipment Leakage Current Test Schematic
Page 53 - Performing a Direct Equipment Leakage Test
Electrical Safety Analyzer Performing Electrical Safety Tests 39 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 Al...
Page 54 - Figure 25. Alternative Applied Part Leakage Test Schematic
ESA612 Users Manual 40 CO N DUCTI V E PART DUT_PE DUT_L2 DUT_L1 FE AP1 AP2 DE V ICE U N DER TEST APPLIED PART TESTLEAD MD faw23.eps Figure 25. Alternative Applied Part Leakage Test Schematic
Page 56 - Figure 26. Direct Equipment Leakage Test Schematic
ESA612 Users Manual 42 CO N DUCTI V E PART DUT_PE L2 DUT_L2 DUT_L1 MAI N S L1 L2 OPE N MAI N S O N RE V POL PE OPE N TEST LEAD FE DE V ICE U N DER TEST APPLIED PART MD faw24.eps Figure 26. Direct Equipment Leakage Test Schematic
Page 57 - Figure 27. Direct Applied Parts Leakage Current Test Schematic
Electrical Safety Analyzer Performing Electrical Safety Tests 43 AP1 AP2 CO N DUCTI V E PART DUT_PE L2 DUT_L2 DUT_L1 MAI N S L1 L2 OPE N MAI N S O N RE V POL FE DE V ICE U N DER TEST APPLIED PART MD faw25.eps Figure 27. Direct Applied Parts Leakage Current Test Schematic
Page 58 - Differential; Normal Polarity, Closed Earth
ESA612 Users Manual 44 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 neut...
Page 59 - Figure 28. Differential Leakage Current Test Schematic
Electrical Safety Analyzer Performing Electrical Safety Tests 45 CO N DUCTI V E PART DUT_PE PE L2 DUT_L2 DUT_L1 MAI N S L1 EARTH OPE N L2 OPE N TESTLEAD MAI N S O N RE V POL FE DE V ICE U N DER TEST APPLIED PART MD faw32.eps Figure 28. Differential Leakage Current Test Schematic
Page 63 - Figure 30. EGC Lead Connection with 1210 Adapter
Electrical Safety Analyzer Using the 1210 Adapter 49 ECG Monitor ESA612 1210 fis121.eps Figure 30. EGC Lead Connection with 1210 Adapter
Page 64 - Voltage; Measuring Resistance; Resistance
ESA612 Users Manual 50 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 fu...
Page 65 - Leakage; Simulating ECG Waveforms; Figure 32. ECG Waveform Simulation Menu
Electrical Safety Analyzer Simulating ECG Waveforms 51 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 on...
Page 67 - Figure 33. ECG Monitor Connections
Electrical Safety Analyzer Simulating ECG Waveforms 53 TEST RA LL LA RL V1 R F L N C1 RA LL LA RL V1 R F L N C1 ECG Monitor BJ2ECG Adapter fis115.eps Figure 33. ECG Monitor Connections
Page 68 - Using Memory; Storing Data into Memory; Figure 34. Test Record ID Entry Screen
ESA612 Users Manual 54 Using Memory 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.flukebi...
Page 69 - Viewing Memory Data; Controlling the Analyzer Remotely
Electrical Safety Analyzer Controlling the Analyzer Remotely 55 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. Note A previously closed record can not have measurements or ECG signals added to it. Data ca...
Page 70 - Maintenance
ESA612 Users Manual 56 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 ...
Page 71 - Figure 35. Fuse Access; Using a multimeter, measure the continuity of each; Cleaning the Analyzer
Electrical Safety Analyzer Cleaning the Analyzer 57 F1 - F2 fis111.eps Figure 35. Fuse Access 5. Using a multimeter, measure the continuity of each fuse. If one or both fuses do not show continuity, replace the fuse(s) with fuses that have the same current and voltage rating. Appropriate fuse rating...
Page 72 - Replaceable Parts; Table 6. Replaceable Parts
ESA612 Users Manual 58 Replaceable Parts Table 6 lists the replaceable parts for the Analyzer. Table 6. Replaceable Parts Item Fluke Biomedical Part Number ESA612 Getting Started Manual 3334511 ESA612 Users Manual CD 3334509 USA 2238680 UK 2238596 Australia 2238603 Europe 2238615 France/Belgium 2238...
Page 73 - Item
Electrical Safety Analyzer Replaceable Parts 59 Table 6. Replaceable Parts (cont.) Item Fluke Biomedical Part Number Carrying Case 2248650 Data Transfer Cable 1626219 USA W T20A 250V Fuse (Time Lag), 1¼ ″ x ¼ ″ 2183691 Australia, Switzerland W T10A 250V Fuse (Time Lag), 1¼ ″ x ¼ ″ 109298 Fuse Europe...
Page 74 - Accessories; Table 7 lists the available accessories for the Analyzer.; Table 7. Accessories; Test Leads with Retractable Sheath
ESA612 Users Manual 60 Accessories Table 7 lists the available accessories for the Analyzer. Table 7. Accessories Item Fluke Biomedical Part Number Test Leads with Retractable Sheath 1903307 Ground Pin Adapters 2242165 1210 - Option 3392119 Universal Snap to Banana Adapter 2462072
Page 75 - Specifications
Electrical Safety Analyzer Specifications 61 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 ...
Page 76 - Detailed Specifications
ESA612 Users Manual 62 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-...