Fluke ESA612 manual

March 2009, Rev. 1 © 2009 Fluke Corporation. All rights reserved. Spe c ifications a re subject to change w ithout notice. All product names are trademarks of their respectiv e companies. ESA612 Electrical Safety Analyzer Users Manual[...]

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 warrant y period, we will repai r or at our option replace, at no c harge, a product that proves to be defective, provided you ret urn the product, shipping prepaid, to F luk[...]

Contents (continued) Notices All Rights Reserve d © Copy right 2008, Fluke Biomedical. No part of this pu blication may be reproduced, trans mitted, transcribed , stored in a retriev al system, or translated into any language without the wr itten permission of Fluke Biom edical. Copyright Release Fluke Biomedical agrees to a limited copy ri ght re[...]

Standard Terms and Conditions Refunds and Credits Please note that only serialized products and their accessory item s (i.e., products an d 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, auxiliary mod ules, etc.) ar e n o t e l i g i [...]

Contents (continued) Returns for partial refund/credit: Every product returned for refund/credit must be accompanied by a Return Material Authorization (RMA) num ber, obtained from our Order Entry Group at 1- 800-648 -7952 or 1-425-446-6 945. Repair and calibration: To find the nearest service center, go to www.flukebiomedical.com/service or In the[...]

Restrictions and Liabilities Information in this document is subject to change and does not represent a commitment by Fluke Biomedical. Changes made to the information in this document will be incorporated in new editions of the publication. No responsibility is assumed by Fluke Bio medical for the use or reliability of software or equipment that i[...]

i Table of Contents Title Page Introduc tion ................................................................................................................... . 1 Safety Info rmation .......................................................................................................... 2 Intended Use ...........................................[...]

ESA612 Users Manual ii Setting the GFCI Limit ............................................................................................... 12 Performing Electrical Safety Te sts ................................................................................. 12 Setting the Test Standard ..........................................................[...]

Contents (continued) iii Maintenanc e ................................................................................................................... 56 Testing and Replaci ng the Fuse s ................................................................................... 56 Cleaning the A nalyzer .................................................[...]

ESA612 Users Manual iv[...]

v List of Tables Table Title Page 1. Symbols..................................................................................................................... ............ 2 2. Top-Panel Controls and Connect ions .................................................................................... 5 3. Side and Top-Pane l Connecti ons ...........[...]

ESA612 Users Manual vi[...]

vii List of Figures Figure Title Page 1. Front-Panel Controls and Connecti ons ................................................................................. 4 2. Side and Top-Pane l Connecti ons .......................................................................................... 6 3. Analyzer Ready for Operat ion .........................[...]

ESA612 Users Manual viii 16. Applied Parts to Non-Earth C onductive Points Schemat ic .................................................... 24 17. Leakage Current Main Menu ................................................................................................ 2 6 18. Earth Leakage Current T est Schem atic ..................................[...]

1 Electrical Safety Analyzer Introduction The Fluke Biomedical ESA612 Elec tric al Safety Analyzer (hereafter the Analyzer) is a full-featured, compact, portable analyzer, desig ned to verify the electrical safet y of medical devices. The Analyzer tests to domestic (ANSI/AAMI ES1, NFPA 99) and international (IEC62353, AN/NZS 3551, and parts of IEC [...]

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 unsorted municipal waste. Go to Fluke’s website for [...]

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 (suc h as a faulty display, broken case, etc.) • Inspect the test leads for damaged insulation or exposed metal. Check test lead continuity. Repl ace damaged leads before using the A nalyzer. •[...]

ESA612 Users Manual 4 Unpacking the Analyzer Carefully unpack all items fr om the bo x 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) • ESA EUR Accessory Kit • An[...]

Electrical Safety Analyzer Instrument Familiarization 5 Table 2. Top-Pa nel Controls and Conne ctions 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 neutral and hot connection. 2 High Voltage Indica[...]

ESA612 Users Manual 6 Figure 2 and Table 3 descri be the side and top-pane l connections of the Analyz er. TEST RA LL LA RL V1 R FLN C1 2 7 8 1 6 5 3 4 fis110.eps Figure 2. Side and T op-Panel Connect ions[...]

Electrical Safety Analyzer Instrument Familiarization 7 Table 3. Side a nd Top-Panel Connect ions Item Name Description 1 Equipment Outlet Equipment outlet, specific to the versi on of the Analyzer, which provides a DUT connection. 2 USB Device Port (B-style connector) Digital connection for controlling the Anal yzer from a PC or instrument control[...]

ESA612 Users Manual 8 Connecting to Line Power XW Warning To avoid s hock hazard and for proper Analyzer operation, con nect the factory supplied three-conduc tor line power cord to a properly grounded po w er outlet. Do not use a two-condu ctor adapter or extensio n cord; this will break the protective ground connection. Connect the Analyz er to a[...]

Electrical Safety Analyzer Turning the Analyzer On 9 TEST RA LL LA RL V1 R F L NC 1 T o 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 t o the Ana lyzer[...]

ESA612 Users Manual 10 During the self-test, the Analyzer checks its ac mains input for proper polarit y, ground integrity and voltage level. The high voltage indicat or illuminates briefl y during the self test. If the polarity is reversed, the Analyzer indicates this condition and a llows the polarity to be reversed internally. If the ground is o[...]

Electrical Safety Analyzer Setting Up the Analyzer 11 Setting Up the Analyzer There are a number of Anal yz er parameters that are adjusted through a setup func tion as well as the abilit y to save a record by ID and da te. To access the first Setup menu shown in Figure 6, press Q . fis114.bmp Figure 6. Setup Menu Note See the Using Memory section [...]

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 contrast setup. Setting up the Beeper To enable or di[...]

Electrical Safety Analyzer Performing Electrical Safety Tests 13 Setting the Test Standard The Analyzer is designe d 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 A nalyzer’s defau lt standard. To select another standard: 1. Press Q . 2. Fr[...]

ESA612 Users Manual 14 Prior to conducting any leak age tests with the Analyzer, it is best to test the integrity of the ground connection between the Analyz er’s test receptacle ground an d the DUT’s Protective earth ground or enclosure with this test. To access the Ground Wire (Protective Earth) ∅ /Null Resistance Test menu press O . Note T[...]

Electrical Safety Analyzer Performing Electrical Safety Tests 15 Figure 9 shows the electrical connectio ns between the Analyzer and the DUT . Table 4 lists the abbreviations used in the schematics and their descriptions .[...]

ESA612 Users Manual 16 TEST RA LL LA RL V1 RF L NC 1 T o protecti v e earth or any exposed cond u cti v e s u rface on the enclos u re fis112.eps Figure 9. Ground Wire (Protective Eart h) Resistance Measurement Connections[...]

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 Under Test Live conductor DUT_L2 Device Under Test [...]

ESA612 Users Manual 18 MD TEST LEAD CO N DUCTI V E PART DUT_PE FE PE DUT_L2 DUT_L1 DE V ICE U N DER TEST APPLIED PART EARTH OPE N faw26.eps Figure 10. Ground Wire (Protective Eart h) Resistance Measurement Schematic[...]

Electrical Safety Analyzer Performing Electrical Safety Tests 19 Performing an Insulation Resistance Test The five insulation resistance t ests take measurements on mains (L1 & L2) to Protective earth, applied parts to Protective earth, mains to applied parts, mains to non- earthed accessible conductive points, and applied parts to non-earthed [...]

ESA612 Users Manual 20 MD CO N DUCTI V E PART DUT_PE DUT_L2 DUT_L1 FE DE V ICE U N DER TEST APPLIED PART faw17.eps Figure 12. Mains to Prot ective-Earth Insulation Resistan ce Test Schematic[...]

Electrical Safety Analyzer Performing Electrical Safety Tests 21 MD CO N DUCTI V E PART DUT_PE DUT_L2 DUT_L1 FE DE V ICE U N DER TEST APPLIED PART faw18.eps Figure 13. Applied Parts to Protecti ve-Earth 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[...]

Electrical Safety Analyzer Performing Electrical Safety Tests 23 MD CO N DUCTI V E PART DUT_PE DUT_L2 DUT_L1 FE DE V ICE U N DER TEST APPLIED PART TEST LEAD faw20.eps Figure 15. Mains to Non -Earth Access ible Conductive Points Sc hematic[...]

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 TEST LEAD faw21.eps Figure 16. Applied Parts to Non-Earth Conductive Points Schematic[...]

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 curre nt flowing through the mains connections of the test receptacle. Performing Leakage Current Te sts The Analyzer measures leak age current for a number of differ[...]

ESA612 Users Manual 26 fis117.jpg Figure 17. Leakage Curr ent Main Menu Note The display shown in Figure 17 is the main leakage current men u when AAMI is the selected standard. All leakage currents, with t he exc eption of Lead Isolation (Mains on Applied parts), are displaye d in one of three ways: AC+DC, AC Only, or DC only. The initial result i[...]

Electrical Safety Analyzer Performing Electrical Safety Tests 27 IEC60601-1 specifies that the app lied parts should be connected for this measurement. Enable thi s measurement by pressing E or F which grounds and ungrounds all applie d parts connection post s.[...]

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 C urrent Test Schematic Note Ground wire leakage is the same sche mat ic without the Applied Parts switch.[...]

Electrical Safety Analyzer Performing Electrical Safety Tests 29 Performing a Chas sis (Enclosu re) Leakage Test Note The Chassis (Enclosure) Leak age test is only available for the IEC60601 or ANSI/AAMI ES1 1993 standard selections. The Chassis (Enclosure) Leak age Test measures the current flowing between the DUT ’s enclosure and protective ear[...]

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 Leak age Current Test Sch ematic Note Chassis leakage is the same s chematic without the Applied Parts switch.[...]

Electrical Safety Analyzer Performing Electrical Safety Tests 31 Performing a Lead-to-Gr ou nd (Patient) Leakage Test Note The Lead-to-Ground (Pat ie nt) Leakage Current Test is not available for IEC 62353 standard selections. The Lead-to-Ground (Patient ) Leakage Current test measures the current flowing bet ween a selected applied part, selected [...]

ESA612 Users Manual 32 CO N DUCTI V E PART DUT_PE 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 LEAD SELECT LEAD G N D FE DE V ICE U N DER TEST APPLIED PART faw29.eps Figure 20. Lead-to-Grou nd (Patient) Leakage Current Test Sch ematic[...]

Electrical Safety Analyzer Performing Electrical Safety Tests 33 Performing Lead-to-Lead (Patient Auxili ary) Leakage Tests Note The Lead-to-Lead (Patient Auxili ary) leakage test is available when the IEC60601 or ANSI/AAMI ES1-1993 standard is selected. To measure the leakage current throug h each applied part or lead and selected combination of l[...]

ESA612 Users Manual 34 CO N DUCTI V E PART DUT_PE PE L2 DUT_L2 DUT_L1 MAI N S L1 EARTH OPE N L2 OPE N MAI N S O N RE V POL GROU N D LEAD + LEAD - LEAD FE DE V ICE U N DER TEST APPLIED PART MD faw30.eps Figure 22. Lead-to-Lead (Patient Aux iliary) Leakage Curren t Test Schematic[...]

Electrical Safety Analyzer Performing Electrical Safety Tests 35 The following outlet conditions apply when performing this test: • Normal Polarity • Normal Polarity, Open Neutral • Normal Polarity, Open Earth • Reversed Polarit y, Open Neutral • Reversed Polarit y, Open Earth Performing a Lead Isolation (Mains on Applied Part) Leakage Te[...]

ESA612 Users Manual 36 CO N DUCTI V E PART DUT_PE PE L2 DUT_L2 DUT_L1 MAI N S L1 EARTH OPE N L2 OPE N MAI N S O N RE V POL MAP RE V LEAD SELECT TEST LEAD MD MAP (ISOLATIO N ) TRA N SFORMER FE DE V ICE U N DER TEST APPLIED PART faw31.eps Figure 23. Lead Isolatio n (Mains On Applied Parts) Leakage Test Sch ematic[...]

Electrical Safety Analyzer Performing Electrical Safety Tests 37 Performing an Alternative Equipment Leakage Test Note The alternative equipment lea kage test is available when the EN623 53 standard is selected. During the Alternative Equipment Leakag e test, the voltage source is applied bet ween short-circuited equipment outlet mains live, neutra[...]

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 TEST LEAD MD faw22.eps Figure 24. Alternative Equipment Leakag e Current Test Sch ematic[...]

Electrical Safety Analyzer Performing Electrical Safety Tests 39 To perform an alternative applied p art leakage test: 1. Press B . 2. Press the soft key labeled More . 3. Select the desired applied par t groupings usi ng G and H . 4. Press the soft key labeled Select . 5. Press the soft key labeled Alternati ve A .P. . 6. Press T to apply the test[...]

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 TEST LEAD MD faw23.eps Figure 25. Alternati ve Applied Part Leakage Test Schematic[...]

Electrical Safety Analyzer Performing Electrical Safety Tests 41 Performing a Direct Applied Part Leakage Te st Note The Direct Applied Part Leaka ge test is available when the EN62353 standard is selected. The Direct Applied Part Leaka ge Current test measures the leakage current bet ween all applied part s of a single function and the exposed con[...]

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 Equip ment Leakage 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 Leakag e Current Test Schematic[...]

ESA612 Users Manual 44 Performing a Differential Leakag e Current Test Note The Differential Leakage Current test is avail able when the EN62353 standard is selected. The differential leakage current test measures the magnitudes of the differentia l current flowing in the Equipment Outlet live and neu tral, with power applied to the equipment outle[...]

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 TEST LEAD MAI N S O N RE V POL FE DE V ICE U N DER TEST APPLIED PART MD faw32.eps Figure 28. Differential Leaka ge Current Test Schematic[...]

ESA612 Users Manual 46 Using the 1210 Adapter The 1210 Adapter, an optional access ory, is designed to increase the number of lead or applie d parts connections to the Analyzer from five to 14. The adapter it self ties up to ten leads together into a singl e lead that is plugged into one of the input jacks of the A nalyzer. The four remainin g Anal[...]

Electrical Safety Analyzer Using the 1210 Adapter 47 OFF DEFIB PACER Defibrillator/Pacer ESA612 1210 fis120.eps Figure 29. 1210 Adapter Connections[...]

ESA612 Users Manual 48 When performing an applie d 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 fr om the Universal Snap to Banana Adapter set will be requir ed for the first four connections. The remaining chest lea ds are connected to the [...]

Electrical Safety Analyzer Using the 1210 Adapter 49 ECG Monitor ESA612 1210 fis121.eps Figure 30. EGC Lead Conne ction with 1210 Adapter[...]

ESA612 Users Manual 50 Making Point-To-Point Measurements The Analyzer can make voltage, resistance, and lo w current measurements through its Point-to-P oint 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. fis108.jpg Figure 31. Point-To-Point Fun[...]

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 b etween ac on ly, dc only , or ac+dc measurement mode. 3. Insert test l[...]

ESA612 Users Manual 52 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 softke y label with K next to it. Use G or H to select the frequency or rate. For those waveforms that have only two frequen[...]

Electrical Safety Analyzer Simulating ECG Waveforms 53 TEST RA LL LA RL V1 RFL NC 1 RA LL LA RL V1 R FLN C1 ECG Monitor BJ2ECG Adapter fis115.eps Figure 33. ECG Monitor Connections[...]

ESA612 Users Manual 54 Using Memory The non-volatile memor y 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 exporte d to a PC. Data Viewer software, available at www.flukebiomedic al.com/ESA612 , is required to uploa d me[...]

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 ne w one. Note A previously closed record can not hav e measurements or ECG signals adde d to it. Data can only be stored under the most rece ntly opene[...]

ESA612 Users Manual 56 based on a user written test pr ocedure), an d 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 , indicati ng whether results are passing or failing. Ansur mana ges test procedures by allowing both manual an d [...]

Electrical Safety Analyzer Cleaning the Analyzer 57 F1 - F2 fis111.eps Figure 35. Fuse Access 5. Using a multimeter, meas ure t he 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 ratings are p osted on the case bottom label of the An[...]

ESA612 Users Manual 58 Replaceable Parts Table 6 lists the replaceabl e parts for the Analyzer. Table 6. Replaceable Part s 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 22386 15 Thailand 2238644 Israel 2434122 Power Cord [...]

Electrical Safety Analyzer Replaceable Parts 59 Table 6. Replaceable Part s (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 (T ime Lag), 1¼ ″ x ¼ ″ 109298 Fuse Europe, UK, Thailand, France/Belgium, Isra[...]

ESA612 Users Manual 60 Accessories Table 7 lists the available acc essories 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 Ad apter 2462072[...]

Electrical Safety Analyzer Specifications 61 Specifications Temperature Operating ............................................................ 10 ° C to 40 ° C (5 0 ° F to 104 ° F) Storage ................................................................ -20 ° C to 60 ° C (-4 ° F to 140 ° F) Humidity .........................................[...]

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-point voltage) ............................ 0.0 to[...]

Electrical Safety Analyzer Detailed Specifications 63 Ranges ................................................................ 0.0 to 199.9 μ A 200 to 1999 μ A 2.00 to 10.00 mA Accuracy DC to 1 kHz ..................................................... ± (1 % of reading + (1 μ A or 1 LSD, whichever is greater)) 1 to 100 kHz ......................[...]

ESA612 Users Manual 64 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,[...]