Fluke ESA612 User's Manual
Contents
1. Press or to advance through each applied part grouping or the individual applied parts to ground These are selected and measured Electrical Safety Analyzer Performing Electrical Safety Tests The Lead to Ground Leakage test can be performed with a number of fault conditions on the test receptacle Press to switch the test receptacle between Normal Off Reverse and Off Press to open and close the neutral connection to the receptacle Press to open and close the receptacle s earth connection The following outlet conditions apply when performing this test e Normal Polarity e Normal Polarity Open Neutral e Normal Polarity Open Earth e Reversed Polarity e Reversed Polarity Open Neutral e Reversed Polarity Open Earth Note If there are more than five applied parts to connect to the Analyzer see Using the 1210 Adapter later in this manual 31 ESA612 Users Manual DEVICE UNDER TEST APPLIED PART CONDUCTIVE PART LEAD SELECT O I O O faw29 eps Figure 20 Lead to Ground Patient Leakage Current Test Schematic 32 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 applied part or lead and selected combination of lead connections all other or between two press the softkey labeled Lead to Lead from the2. em ee Power Cord Null Post Adapter 3326842 58 Electrical Safety Analyzer Replaceable Parts Table 6 Replaceable Parts cont Fluke Biomedical Part Number Carrying Case 2248650 Data Transfer Cable 1626219 EE AT20A 250V Fuse Time Lag 14 x Va 2183691 Fuse Australia Australia Switzerland AT10A 250V Fuse Time Lag 1 x Va 109298 Europe OR Taiana AEA 260V Fuse ime LAG ann 3321245 France Belgium Israel 15 20 A Adapter 2195732 ESA USA AUS ISR Accessory Kit Test Lead Set TP1 Test Probe Set AS AC285 Alligator Clip Set ESA EUR Accessory Kit Test Lead Set 3111024 TP74 Test Probe Set AC285 Alligator Clip Set 59 ESA612 Users Manual Accessories Table 7 lists the available accessories for the Analyzer Table 7 Accessories Test Leads with Retractable Sheath 1903307 Ground Pin Adapters 2242165 1210 Option 3392119 Universal Snap to Banana Adapter 2462072 60 Electrical Safety Analyzer Specifications Specifications Temperature ODS ge dae OE Ee OR N N tee 10 C to 40 C 50 F to 104 F oe eN EO HE EG 20 C to 60 C 4 F to 140 F Humidity RR ER OE N ER EE Ee ee 10 to 90 non condensing Altitude 120 V ac mains supply voltage 5000 m 230 V ac mains supply voltage 2000 m Bile eee EN LCD display Communications USB device port for compu
3. lead continuity Replace damaged leads before using the Analyzer When testing always be sure to keep your fingers behind the safety barriers on the test leads Never open the Analyzer s case Dangerous voltages are present There are no user replaceable parts in the Analyzer Have the Analyzer serviced only by qualified personnel The Analyzer must be properly earthed Only use a supply socket that has a protective earth contact If there is any doubt as to the effectiveness of the supply socket earth do not connect the Analyzer Do not use a two conductor adapter or extension cord this will break the protective ground connection Do not use the 15 20 A adapter to power devices rated in excess of 15 A Doing so may overload the installation Electrical Safety Analyzer Intended Use e Use extreme caution when working with voltages above 30 V e Use the proper terminals functions and ranges for the test being performed e Do not touch metal parts of the device under test DUT during analysis The DUT should be considered an electrical shock hazard when connected to the Analyzer as some tests involve high voltages high currents and or the removal of DUT earth bond Intended Use The Analyzer is intended for use by trained service technicians to perform periodic inspections on a wide range of medical equipment The testing procedures are menu driven and simple to operate ESA612 Users Manual Unpacking the
4. Analyzer Instrument Familiarization Carefully unpack all items from the box and check that Figure 1 and Table 2 describes the front panel controls you have the following items and connections of the Analyzer e ESA612 e Getting Started Manual e Users Manual CD e Carrying case e Power cord e 15 20 A Adapter USA only e ESA USA Accessory Kit USA Australia and Israel ony EO e ESA EUR Accessory Kit CE Ce FF C0 e Ansur demo CD e Null Post Adapter e 5 to 5 Banana to ECG Adapter BJ2ECG e Transfer cable mA SAVE ED a OL fis116 eps Figure 1 Front Panel Controls and Connections Electrical Safety Analyzer Instrument Familiarization Table 2 Top Panel Controls and Connections Conf um mme 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 mem meme enn Nulling Jack Connection for zeroing test lead resistance Equipment Outlet Configuration Buttons Keys F1 through F4 are used to select from a number of Function Softkeys selections that appear in the LCD display above each function softkey Indicates when high voltage is applied to the ECG Applied Parts posts or L1 and L2 of the Test High Voltage Indicator Receptacle Test Function Selects the various Analyzer 3 Buttons test functions Cursor control buttons for Navigation Buttons navigating menus
5. Leakage Test main menu shown in Figure 17 Figure 22 shows the electrical connections between the Analyzer and the DUT during a Lead to Lead Patient Auxiliary Leakage Current Test The Lead to Lead Patient Auxiliary Leakage test adds a diagram of the applied parts connection posts to the display as shown in Figure 21 In the figure the applied parts post RA R is shown above the other posts This indicates that the leakage measurement is being made from RA R to all others To move to the next applied part post press The first post will appear inline with the other posts while the LL F post appears above all others This indicates the second leakage measurement is being made from LL F to all others Continue pressing or to move from one connection post to another and noting the measured current in the display After each post is isolated individually the Lead to Lead Patient Auxiliary Leakage test measures current of three Electrical Safety Analyzer Performing Electrical Safety Tests different combinations of posts tied together RA R and LL F RA R and LA L or LL F and LA L fis107 eps Figure 21 Applied Parts Connection Posts Display Within the Lead to Lead Patient Auxiliary Leakage test a number of fault measurements can be made Pressing switches the polarity of the mains voltage applied to the Analyzer s test receptacle between Normal Off Reverse and Off Pressing opens and closes the neutral connect
6. OE eg ESA612 Users Manual Nor SJEL ME GE NN N Performing Electrical Safety Tests Setting the Test Standard asrrnrnnrrrnrnnnrnnrnnnrnrnnnnvnvnnnrnnnnnnrnvnnnsnnrnnnsnnnnsnrnsnnnsrnrnnsennnnn Performing Mains Voltage Testing Performing a Ground Wire Protective Earth Resistance Test Performing an Insulation Resistance Test Performing a Current Consumption Test Performing Leakage Current Tests Measuring Earth Leakage Current Performing a Chassis Enclosure Leakage Test Performing a Lead to Ground Patient Leakage Test Performing Lead to Lead Patient Auxiliary Leakage Tests Performing a Lead Isolation Mains on Applied Part Leakage Test Performing an Alternative Equipment Leakage Test Performing an Alternative Applied Part Leakage Test Performing a Direct Equipment Leakage Test Performing a Direct Applied Part Leakage Test Performing a Differential Leakage Current Test Using the 1210 Adapter N EG ed ee ee EEEE Making Point To Point Measurements sees sees se ee Re ee AR ee ee ee ee ee ee ee ee ee Meas ring Voltage is me SEG RE DRS titid irii DE ED De EG BE DR ea Measuring Resistance ss iss oes ek Se De se be Ge Ge ee ee ER ie Ke ki Ek eat Measuring Current esse ee ee EE Ee RR EE ee ee ee Ee ee RE ee ee EE ee ee Ee ee ee ee EE Ee ee Ee ee RE Ee ee Simulating ECG Waveforms ss USINO MENN sau Gesine Storing Data into Memory sise Viewing Memory Data sees see ss see Ee ke e
7. Press the softkey labeled Zero Leads The Analyzer zeroes out the measurement to cancel the test lead resistance 7 Connect the test lead coming from the Null jack to 14 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 ET 320 x 240 pixel Color LCD simulator 1 9 Ground Wire Resistance 0 002 Pep fis105 jpg Figure 8 DUT Ground Resistance Measurement AA Warning To avoid electric shock remove the null post adapter from the Null jack after a test lead zero is performed The Null jack becomes potentially hazardous during some of the test conditions A low resistance reading is required to confirm a good ground connection through the power cord Refer to the appropriate electrical safety standard for the specific limit value to be followed 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 15 ESA612 Users Manual To protective earth or any exposed conductive surface on the enclosure fis112 eps Figure 9 Ground Wire Protective Earth Resistance Measurement Connections 16 Electrical Safety Analyzer Performing Electrical Safety Tests Table 4 Schematic Abbreviations PS ST PS 17 ESA612 Users Manual
8. be done for equipment with F Type applied parts For equipment with multiple applied parts test each group of applied parts of a single function in turn with all others floating during the test All applied parts can be connected to the Analyzer s applied parts jacks and the lead selection will float those not selected 37 ESA612 Users Manual DEVICE UNDER TEST DUT_L1 7 APPLIED PART CONDUCTIVE PART TEST LEAD Figure 24 Alternative Equipment Leakage Current Test Schematic faw22 eps 38 To perform an alternative applied part leakage test 1 2 J Press Press the soft key labeled More Select the desired applied part groupings using and V Press the soft key labeled Select Press the soft key labeled Alternative A P Press to apply the test voltage and read the current in the display Press I or to advance to the next applied part group s of a single function if applicable Pressing to read leakage current for each group Figure 25 shows the electrical connections between the Analyzer and the DUT during an Alternative Applied Part Leakage current test Note If there are more than five applied parts to connect to the Analyzer see Using the 1210 Adapter later in this manual Performing a Direct Equipment Leakage Test Note The Direct Equipment Leakage test is available when the EN62353 standard is selected Electrical Safety Analyzer Performing Electrical Safety Test
9. interpreter has banana posts instead of snaps use the optional universal snap to banana adapter to connect to the Analyzer To access the ECG Simulation Waveform menu shown in Figure 32 press A From this menu a number of different waveforms are selected through F1 and the rate or frequency of the waveform is selected through F2 Pep KS 320 x 240 pixel Color LCD simulator 1 9 ECG Wave Simulation SN 123456799 60 bpm POWER ON ECG Complex 60 bpr fis109 jpg Figure 32 ECG Waveform Simulation Menu To select one of the predefined waveforms press the softkey labeled Wave Form A scroll box with next to it appears above the softkey label Use or to scroll through the different waveforms For all waveforms except VFIB and Triangle the rate or frequency of the waveform is adjusted through the softkey 51 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 next to it Use or 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 52 ECG Monitor OO Q ee Figure 33 ECG Monitor Connections Electrical Safety Analy
10. on biomedical equipment The following sections describe the various tests and how to perform them using the Analyzer 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 20 2 From the setup menu press the softkey labeled More to reveal additional menu selections 3 Press the softkey labeled Instrument to reveal the instrument setup selections 4 Press the softkey labeled Standard to open the scroll box above the softkey label 5 Press or to scroll through the standard selections 6 When the desired standard is displayed press the softkey labeled Done Some electrical tests may not be applicable for a specific standard In these cases the Analyzer s menu will not display the excluded test as a selection Performing Mains Voltage Testing The Mains Voltage test measures the voltage on the mains input through three separate measurements To access the Mains Voltage test press V J The Mains Voltage test menu is shown in Figure 7 Electrical Safety Analyzer Performing Electrical Safety Tests siel Mains Yoltage SH 123456789 230 5 Live to Neutral to Live to Neutral Earth Earth Figure 7 Mains Voltage Test Menu fis104 jpg Press each function softkey to perf
11. screw holding the fuse door with a 2 Phillips head screwdriver and lifting the fuse door from the Analyzer 4 Remove the fuses from the Analyzer Electrical Safety Analyzer Cleaning the Analyzer Cleaning the Analyzer AA Warning To avoid electric shock do not clean the Analyzer plugged into mains or attached to a UT N Caution Do not pour fluid onto the Analyzer surface fluid seepage into the electrical circuitry may cause the Analyzer to fail N Caution Do not use spray cleaners on the Analyzer such action may force cleaning fluid into the Analyzer and damage electronic components fis111 eps Clean the Analyzer occasionally utilizing a damp cloth and Figure 35 Fuse Access mild detergent Take care to prevent the entrance of Using a multimeter measure the continuity of each liquids fuse Wipe down the adapter cables with the same care Inspect them for damage to and deterioration of the insulation If one or both fuses do not show continuity replace Check the connections for integrity before each use the fuse s with fuses that have the same current and voltage rating Appropriate fuse ratings are posted on the case bottom label of the Analyzer Table 6 lists available fuses with Fluke Biomedical part numbers Reinstall the fuse door and secure it with the screw 57 ESA612 Users Manual Replaceable Parts Table 6 lists the replaceable parts for the Analyzer Table 6 Replaceable Parts
12. 0 1 EE RE sd ie 2 AMPIIUdE ii EE EER een eee 5 of 2 Hz square wave only fixed 1 mV Lead Il configuration Waveforms EGG COMPIEX een 30 60 120 180 and 240 BPM Ventricular Fibrillation Square wave 50 duty cycle 0 125 Hz and 2 Hz SINE WAVE has sie RE N OE AN 10 40 50 60 and 100 Hz Triangle wave EE Ee ee EE ee EE ee 2 Hz Pulse 63 ms pulse width 30 BPM and 60 BPM 64
13. DEVICE UNDER TEST APPLIED PART l l l l l l l l L CONDUCTIVE PART TEST LEAD faw26 eps Figure 10 Ground Wire Protective Earth Resistance Measurement Schematic 18 Performing an Insulation Resistance Test The five insulation resistance tests take measurements on mains L1 amp 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 accessible conductive points To access the Insulation Resistance Test menu press All Insulation Resistance Tests can be performed using 500 or 250 volts dc To change the test voltage from the Insulation Resistance Test menu press the softkey labeled More Pressing the softkey labeled Change Voltage will cause the test voltage to toggle between 250 and 500 volts dc Note Exiting and re entering the Insulation Resistance Test menu causes the test voltage to return to its default value of 500 volts dc As shown in Figure 11 three of the five tests are shown over function soft keys F1 through F3 To access the other two tests or test voltage selection press the softkey labeled More The softkey labeled Back will move the menu back up to the top level insulation resistance test menu Electrical Safety Analyzer Performing Electrical Safety Tests 320 x 240 pixel EF LCD simulator 1 9 Insulation Resistance Sh 1234 59 Push TEST 500 VDCA mm la MO
14. FLUKE sm Bjomedical 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 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 return the product shipping prepaid to Fluke Biomedical This warranty covers the original purchaser only and is not transferable The warranty does not apply if the product has been damaged by accident or misuse or has been serviced or modified by anyone other than an authorized Fluke Biomedical service facility NO OTHER WARRANTIES SUCH AS FITNESS FOR A PARTICULAR PURPOSE ARE EXPRESSED OR IMPLIED FLUKE SHALL NOT BE LIABLE FOR ANY SPECIAL INDIRECT INCIDENTAL OR CONSEQUENTIAL DAMAGES OR LOSSES INCLUDING LOSS OF DATA ARISING FROM ANY CAUSE OR THEORY This warranty covers only serialized products and their accessory items that bear a distinct serial number tag Recalibration of instruments is not covered under the warranty This warranty gives you specific legal rights and you may also have other rights that vary in different jurisdictions Since some jurisdictions do not allow the exclu
15. Normal Polarity e Normal Polarity Open Earth Electrical Safety Analyzer Performing Electrical Safety Tests e Normal Polarity Open Neutral e Reversed Polarity e Reversed Polarity Open Earth e Reversed Polarity Open Neutral IEC60601 1 specifies that the applied parts should be connected for this measurement Enable this measurement by pressing or b which grounds and ungrounds all applied parts connection posts 29 ESA612 Users Manual DEVICE UNDER TEST APPLIED PART CONDUCTIVE PART TEST LEAD aD PE APPLIED PART OPEN Figure 19 Enclosure Leakage Current Test Schematic Note Chassis leakage is the same schematic without the Applied Parts switch 30 faw28 eps 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 To perform a Lead to Ground Patient leakage test 1 Press 2 Press the soft key labeled More 3 Select one of the applied part groupings by pressing G orv Note Refer to the testing standard when deciding the type of the applied parts and how they should be grouped for testing Press the soft key labeled Select
16. Test Schematic 43 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 2 Press the soft key labeled Differential Figure 28 shows the electrical connections between the Analyzer and the DUT during a Differential Leakage Current test The following outlet conditions apply when performing this test e Normal Polarity Closed Earth e Normal Polarity Open Earth e Reversed Polarity Closed Earth e Reversed Polarity Open Earth 44 Note If there are more than five applied parts to connect to the Analyzer see Using the 1210 Adapter later in this manual Electrical Safety Analyzer Performing Electrical Safety Tests DEVICE UNDER TEST APPLIED PART CONDUCTIVE PART TEST LEAD faw32 eps Figure 28 Differential Leakage Current Test Schematic 45 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
17. To make a resistance measurement 1 Press the softkey labeled Resistance from the Point To Point menu 2 Insert test leads in the RED V Q A and BLACK jacks 3 Null lead resistance by shorting the leads together and pressing the softkey labeled Zero Leads 4 Place the probes across the unknown resistance and read the measurement in the Analyzer s display The Analyzer will measure resistances up to 2 0 Q Measuring Current The Analyzer can make dc only ac only and actdc 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 or select between ac only dc only or ac dc measurement mode 3 Insert test leads in the RED V Q 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 Simulating ECG Waveforms The Analyzer is capable of generating various waveforms on the applied parts connection posts These signals are used to test the performance characteristics of ECG monitors and ECG strip printers See Figure 33 for proper connections between the Analyzer and an ECG monitor For monitors using the snap style connectors insert the BJ2ECG adapter into the connectors at the top of the Analyzer and connect the monitor leads to the snap connectors on the adapter Electrical Safety Analyzer Simulating ECG Waveforms Note If the ECG monitor
18. ach in turn with all other floating during the test This test should only be done for equipment with F Type applied parts For Type B applied part see direct equipment leakage schematic in Figure 26 To perform a direct applied part leakage test 1 Press 2 Press the soft key labeled More 3 Select the desired applied part groupings using and V 4 Press the soft key labeled Select The Direct A P test should already be selected 5 Press or to select the applied part test configuration 6 Press to apply the test voltage and read the current in the display Electrical Safety Analyzer Performing Electrical Safety Tests 7 Press or to advance to the next group of applied parts if applicable Figure 27 shows the electrical connections between the Analyzer and the DUT during a Direct Applied Part Leakage Current Test The following outlet conditions apply when performing this test e Normal Polarity e Reversed Polarity Note If there are more than five applied parts to connect to the Analyzer see Using the 1210 Adapter later in this manual 41 ESA612 Users Manual DEVICE UNDER TEST APPLIED PART CONDUCTIVE PART TEST LEAD Figure 26 Direct Equipment Leakage Test Schematic 42 faw24 eps Electrical Safety Analyzer Performing Electrical Safety Tests DEVICE UNDER TEST APPLIED PART CONDUCTIVE PART OO faw25 eps Figure 27 Direct Applied Parts Leakage Current
19. and lists Test Button Initiates selected tests selected tests Gel the measurement or Save Button ECG waveform to memory EX Input Jacks Test lead connectors lead connectors Figure 2 and Table 3 describe the side and top panel connections of the Analyzer Users Manual ESA612 fis110 eps Figure 2 Side and Top Panel Connections Electrical Safety Analyzer Instrument Familiarization Table 3 Side and Top Panel Connections CE a U Equipment Outlet Equipment outlet specific to the version of the Analyzer which provides a DUT connection USB Device Port Digital connection for controlling the Analyzer from a PC or instrument B a connector controller 3 Fuse Access Door Access Door Covers the Covers the equipment outlet fuses outlet fuses EB Tilt Stand Support for holding the Analyzer in a tilted position 5 Jac Power Switch Turns ac power on and off Power Input Connector A grounded male three prong IEC 60320 C19 connector that accepts the line power cord Connection posts for Device Under Test DUT applied parts such as ECG ECG Applied Parts Jacks leads Used to test for leakage current through leads and to supply ECG signals and performance waveforms to a DUT Es Banana Jack to ECG Adapter Adapter for connecting ECG snap leads to the Analyzer ESA612 Users Manual Connecting to Line Power AAWarning To avoid shock hazard and for proper Analyzer operation connect the factory s
20. ates the selection is controlled by pressing amp or In this example the leakage current measurement is switched between AC DC AC only or DC only The applied parts indicator has on the left end and on the right end 10 These icons indicate the use of and b to select an applied part leg 0 085 NORMAL EEEE oo Patient Figure 5 Leakage Current Menu Leaka age SM 123456789 fis102 jpg The three buttons along the right side of the display PoLarny neurra _earTH control the wiring of the Analyzer s test receptacle for some electrical tests The present state of these three buttons is displayed along the right edge of the display whenever these controls are active Figure 5 shows polarity is settable between normal reversed and off Neutral is also settable to closed or open Earth condition is not displayed which indicates it can not be changed However earth is internally opened during this test 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 IB Mek HET x 240 pixel Color LCD simulator 1 9 Enter Test Record ID Figure 6 Setup Menu Note See the Using Memory section later in this manual for a description of how to enter a test record ID fis114 bmp The setup parameters have
21. ation Electrical Safety Analyzer Turning the Analyzer On To protective earth or any exposed conductive surface on the enclosure fis113 eps Figure 4 DUT Connections to the Analyzer 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 If the mains voltage is too high or too low the Analyzer displays this fault and does not continue until the supply voltage is corrected and the Analyzer power cycled off and then on again Accessing the Analyzer s Functions For each test and setup function the Analyzer uses a series of menus to access various Analyzer test and setup variables As shown in Figure 5 the Analyzer indicates various leakage current tests along the bottom of the display An Exit selection is also indicated as a way of backing out of the leakage current tests Pressing a softkey F1 through F4 under a specific test will cause the analyzer to setup for or perform the selected test In addition to the function softkeys the Analyzer test functions may require using the navigation buttons to select parameters as well In the example above the leakage selection has next to it This icon indic
22. be connected for this measurement Enable this measurement by pressing or b which grounds and ungrounds all applied parts connection posts Electrical Safety Analyzer Performing Electrical Safety Tests 27 ESA612 Users Manual DEVICE UNDER TEST APPLIED PART CONDUCTIVE PART 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 28 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 To perform a Chassis Enclosure Leakage Test 1 Connect a lead between the Analyzer s V Q A jack and the DUT s enclosure 2 Press the softkey labeled Chassis from the Leakage Current Test menu 3 The Analyzer displays the measured current The Chassis Leakage test can be performed with a number of fault conditions on the test receptacle Press to switch the test receptacle between Normal Off Reverse and Off Press to open and close the neutral connection to the receptacle Press to open and close the receptacle s earth connection The following outlet conditions apply when performing this test e
23. been grouped into six categories Instrument Display Sound Instrument Info Calibration and Diagnostics Electrical Safety Analyzer Setting Up the Analyzer Setting Polarity Switching Delay 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 From the setup menu press the softkey labeled More to reveal additional menu selections 2 Press the softkey labeled Instrument to reveal the instrument setup selections 3 Press the softkey labeled Polarity Delay to open the scroll box above the softkey label 4 Press or to adjust the delay from 0 to 5 seconds in 1 second steps 5 Press the softkey labeled Done to exit the switching polarity delay setup function Setting the Display Contrast There are two methods for setting the display contrast From the Select a Test menu or through the setup menu Whenever the Analyzer displays its start up menu Select a test pressing or will increase or decrease the display s contrast respectively Press the softkey labeled Done to exit contrast setup Another way to adjust the contrast is through the Analyzer s setup menu 11 ESA612 Users Manual 1 From the setup menu press the softkey labeled More twice to set F1 to the display contrast function Press the softkey labeled Display Contrast Press or to increase or decrease the display s contrast
24. 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 plugged into the V1 jack 5 jack of the Analyzer See Figure 30 This configuration allows for isolation of the RA LL LA and RL leads from each other and the remaining chest leads which are shorted together while performing leakage tests 48 Electrical Safety Analyzer Using the 1210 Adapter ECG Monitor ESA612 fis121 eps Figure 30 EGC Lead Connection with 1210 Adapter 49 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 257 Softkeys F1 through F3 are used to select the measurement function SM 123456759 File 115 8 fis108 jpg Figure 31 Point To Point Function Menu Measuring Voltage To make a voltage measurement 1 Press the softkey labeled Voltage from the Point To Point menu 2 Insert test leads in the RED V Q A and BLACK jacks 50 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 Measuring Resistance
25. e ee Ee ee ee EE ee ee ee Rek EE Re ee ee ee EE Re ke ee ee EE Deleting Data from Memory sisi Controlling the Analyzer Remotely ss li Contents continued Je TG CoV Fe an re EE OE ER EE ee eee Testing and Replacing the Fuses Cleaning the Analyzer cccccssccccssceccesseecceseeeceuseecseaececsueeeesseeesseeeesseeeeessgeeessgeeenas Replaceable Parts iii PENN Je ete LI ts OS ee ee ee Detailed Specifications iii il ESA612 Users Manual List of Tables Table Replaceable Parts AOC ei en ae area ea ee NOOR WDM ep O I D 3 QD O gt D lt eb Er O gt ep ESA612 Users Manual vi List of Figures Figure Title 1 Front Panel Controls and Connections VU 2 Side and Top Panel Connections ss 3 Analyzer Ready for Operation cccccccseceeeceeeeeeeeeeeeeeeeeeeeeeeesseeeesseeeeeseeeeesseeeeesaueeesseeeeesaees 4 DUT Connections to the Analyzer ns 5 Leakage Current Menu es ER een 6 SE eds EE EE EE ER AE N EE ON T Mains Voltage Test MenH ie sels aan 8 DUT Ground Resistance Measurement 9 Ground Wire Protective Earth Resistance Measurement Connections 10 Ground Wire Protective Earth Resistance Measurement Schematic 11 Insulation Resistance Measurement Vs 12 Mains to Protective Earth Insulation Resistance Test Schematic 13 A
26. ers to technical questions either email techservices flukebiomedical com or call 1 800 648 7952 or 1 425 446 6945 Claims Our routine method of shipment is via common carrier FOB origin Upon delivery if physical damage is found retain all packing materials in their original condition and contact the carrier immediately to file a claim If the instrument is delivered in good physical condition but does not operate within specifications or if there are any other problems not caused by shipping damage please contact Fluke Biomedical or your local sales representative 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 auxiliary modules etc are not eligible for return or refund Only products returned within 90 days from the date of original purchase are eligible for refund credit In order to receive a partial refund credit of a product purchase price on a serialized product the product must not have been damaged by the customer or by the carrier chosen by the customer to return the goods and the product must be returned complete meaning with all manuals cables accessories etc and in as new and resalable condition Products not returned within 90 days of purchase or products which are n
27. eventive maintenance e Work procedures e Performance tests e Safety tests Ansur software utilizes plug in modules to work with a wide array of Fluke Biomedical instruments The plug in module is a software interface to the Ansur test program The plug in modules are available for purchase as an optional accessory Plug ins provide test elements used by Ansur This has the benefit of using the same user interface for all analyzers and simulators supported by an Ansur plug in When a new Fluke Biomedical analyzer or simulator is purchased simply update your existing Ansur software by installing a new plug in Each plug in module works only 56 with the options and capabilities needed for the instrument being tested Maintenance The Analyzer needs little maintenance or special care However treat it as a calibrated measuring instrument Avoid dropping or other mechanical abuse that could cause a shift in the calibrated settings Testing and Replacing the Fuses AA Warning To prevent electric shock remove all power cords and test leads from the Analyzer before opening the fuse door For electrical protection of the equipment outlet the Analyzer uses two fuses one in the live L1 line and one in the neutral L2 line To test the fuses do the following while referring to Figure 35 1 Turn the Analyzer so the case bottom is facing up 2 Flip up the tilt stand 3 Remove the fuse door from the Analyzer by removing the
28. ion to the Analyzer s test receptacle Pressing ear opens and closes the earth or ground connection to the Analyzer s test receptacle Note If there are more than five applied parts to connect to the Analyzer see Using the 1210 Adapter later in this manual 33 ESA612 Users Manual CONDUCTIVE PART LEAD GROUND LEAD faw30 eps Figure 22 Lead to Lead Patient Auxiliary Leakage Current Test Schematic 34 The following outlet conditions apply when performing this test e Normal Polarity e Normal Polarity Open Neutral e Normal Polarity Open Earth e Reversed Polarity Open Neutral e 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 IEC60607 amp ANSI AAMI standard is selected The Lead Isolation Mains On Applied Parts Leakage Current test measures the current that flows in response to an isolated AC voltage applied between a selected applied part group of applied parts or ALL applied parts and Earth and any conductive part connected to the RED terminal Figure 23 shows the electrical connections between the Analyzer and the DUT during a Mains on Applied Part Leakage Current Test Note With 60601 standard selected the MAP test voltage is available in both Normal and Reverse 180 degrees out of phase with mains To perform a Lead Isolation Mains on Applied Pa
29. ions iii Ee ee EE ee ee ee RE Ee ee Ee ee ee ee ee 30 EGC Lead Connection with 1210 Adapter VV Ee ee ee ee ee ee ee ee ee ee ee ee 31 Point To Polint Function MENU iss SE eN EES EES NESER EER EE GERS NEE GREG EE Re EE Gee ERG Ee N EE Gee GR DE 32 ECG Waveform Simulation Menu ss 33 ECG Monitor Connections sessie in Se oe eg ee ee Se Se ee ee De ee 34 Test Record ID Entry SEEN su NR EG N se De os nn ENES viii Electrical Safety Analyzer Introduction e Insulation resistance The Fluke Biomedical ESA612 Electrical Safety Analyzer sore al eakage hereafter the Analyzer is a full featured compact e Chassis Enclosure leakage portable analyzer designed to verify the electrical safety e Lead to Ground Patient and Lead to Lead Patient of medical devices The Analyzer tests to domestic Auxiliary leakage ANSI AAMI ES1 NFPA 99 and international IEC62353 e Lead isolation Mains on applied parts leakage AN NZS 3551 and parts of IEC 60601 1 electrical safety e Differential leakage standards The integrated ANSI AAMI ES1 and IEC60601 1 patient loads are easily selectable e Direct equipment leakage e Direct applied part leakage The Analyzer performs the following tests e Alternative equipment leakage e Line Mains voltage e Alternative applied part patient leakage e Ground Wire or Protective Earth Resistance e Point to point leakage voltage and resistance e Equipment current e ECG simulation and performance wa
30. la x Debua Inf fis106 jpg Figure 11 Insulation Resistance Measurement After selecting one of the tests by pressing the appropriate softkey press to apply the selected voltage to the DUT and take the resistance measurement Figures 12 through 16 shows the electrical connections between the Analyzer and DUT for the five insulation resistance tests Note The DUT is powered off for this test 19 ESA612 Users Manual DEVICE UNDER TEST APPLIED PART l l l l l l l l L CONDUCTIVE PART faw17 eps Figure 12 Mains to Protective Earth Insulation Resistance Test Schematic 20 Electrical Safety Analyzer Performing Electrical Safety Tests DEVICE UNDER TEST APPLIED PART CONDUCTIVE PART faw18 eps Figure 13 Applied Parts to Protective Earth Insulation Test Schematic 21 ESA612 Users Manual DEVICE UNDER TEST DUT_L1 At APPLIED PART DUT_L2 I CONDUCTIVE PART faw19 eps Figure 14 Mains to Applied Parts Insulation Test Schematic 22 Electrical Safety Analyzer Performing Electrical Safety Tests DEVICE UNDER TEST APPLIED PART CONDUCTIVE PART faw20 eps Figure 15 Mains to Non Earth Accessible Conductive Points Schematic 23 ESA612 Users Manual DEVICE UNDER TEST DUT Hi A APPLIED PART DUT_L2 7 CONDUCTIVE PART TEST LEAD faw21 eps Figure 16 Applied Parts to Non Earth Conductive Points Schematic 24 Electrical Safet
31. ns 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 Biomedical for the use or reliability of software or equipment that is not supplied by Fluke Biomedical or by its affiliated dealers Manufacturing Location The ESA612 Electrical Safety Analyzer is manufactured at Fluke Biomedical 6920 Seaway Blvd Everett WA U S A Table of Contents INIKOQUCTIONI ARE EE EE TR EE Safety IHlormalion AA OO EA a al ei VCS d RA RE ER EE EO ER OE N ees Unpacking the ANalyZzer ae Ek AR RR RR Aare Instrument Familiarization sessies dk ge de N AR Ne ee neh le ete re Connecting to Line Power Re Re ee ee ee ee ee RR ee ee ee ee ee AR ee ee ee ee Ee ee Connecting a DUT to the Analyzer ees ee Ee RE EE RR EE Ee ee EE ee ee ee ee ee ee EE ee ee EE ee ee ee ee Turning the Analyzer ON ee RR Re ee ee Re ee ee ee ee ee ee ee ee ee ee ee ee ee Accessing the Analyzer s Functions Setting Up the Analyzer EE Ee EE RR EE Ee ee EE Ee ee EE ee ee ee ee Ee ee RE ee ee EE ee ee ee ee Ee ee Setting Polarity Switching Delay Setting the Display Contrast ee ee ee ee ee ee ee ee ee Setting up the Beeper iii Viewing Instrument Information ss NES ek EE EE EO OE aise
32. orm each of the three measurements Live to neutral neutral to earth and live to earth Note Power to the test receptacle is off during the Mains Voltage test Performing a Ground Wire Protective Earth Resistance Test The Ground Wire Protective Earth Resistance test measures the impedance between the Analyzer s test receptacle s PE terminal and the exposed conductive parts of the DUT that are connected to the DUT s Protective Earth 13 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 To access the Ground Wire Protective Earth Null Resistance Test menu press Note The DUT is powered off for this test To perform a ground wire resistance test 1 Ensure the power cord from the DUT is plugged into the Analyzer s test receptacle Press to reveal the resistance function menu Connect one end of a test lead to the V Q A jack as shown in Figure 9 4 If using an accessories probe connect it to the other end of the test lead and place the probe tip into the GINull jack If using an alligator clip accessory connect it to the other end of the test lead place the null post adapter in the Null jack and clamp the alligator clip to the null post adapter Connect the other end of the test lead to Null jack
33. ot in as new and resalable condition are not eligible for credit return and will be returned to the customer The Return Procedure see below must be followed to assure prompt refund credit Restocking Charges Products returned within 30 days of original purchase are subject to a minimum restocking fee of 15 Products returned in excess of 30 days after purchase but prior to 90 days are subject to a minimum restocking fee of 20 Additional charges for damage and or missing parts and accessories will be applied to all returns Return Procedure All items being returned including all warranty claim shipments must be sent freight prepaid to our factory location When you return an instrument to Fluke Biomedical we recommend using United Parcel Service Federal Express or Air Parcel Post We also recommend that you insure your shipment for its actual replacement cost Fluke Biomedical will not be responsible for lost shipments or instruments that are received in damaged condition due to improper packaging or handling Use the original carton and packaging material for shipment If they are not available we recommend the following guide for repackaging Use a double walled carton of sufficient strength for the weight being shipped Use heavy paper or cardboard to protect all instrument surfaces Use nonabrasive material around all projecting parts Use at least four inches of tightly packed industry approved shock absorbent mate
34. pplied Parts to Protective Earth Insulation Test Schematic ee ee 14 Mains to Applied Parts Insulation Test SchematiC esse see se ee Ee ee ee ee ee Ee ee ee ee ee 15 Mains to Non Earth Accessible Conductive Points SchematiC iese ss ees se ee ee ee ee ee ee Vil ESA612 Users Manual 16 Applied Parts to Non Earth Conductive Points Schematic ee ee ee ee ee 17 Leakage Current Main Menu is ee ee ee ee ee ee ee ee ee ee ee ee ee 18 Earth Leakage Current Test Schematic ss 19 Enclosure Leakage Current Test Schematic ee ee Ee ee Ee ee ee Ee ee ee ee ee ee ee 20 Lead to Ground Patient Leakage Current Test Schematic 21 Applied Parts Connection Posts Display 22 Lead to Lead Patient Auxiliary Leakage Current Test Schematic 23 Lead Isolation Mains On Applied Parts Leakage Test Schematic 24 Alternative Equipment Leakage Current Test Schematic ees ee ee ee ee ee 25 Alternative Applied Part Leakage Test Schematic esse see se ee ee ee ee Ee ee Ee ee ee 26 Direct Equipment Leakage Test Schematic ee ee ee ee Ee ee ee EE ee Ee ee ee ee ee 27 Direct Applied Parts Leakage Current Test Schematic see ee Ee ee ee ee ee ee ee Ge ee 28 Differential Leakage Current Test Schematic VV 29 1210 Adapter Connect
35. respectively 4 Press the softkey labeled Done to exit contrast setup Setting up the Beeper To enable or disable the beeper 1 From the setup menu press the softkey labeled More twice to set F2 to the beeper on off function Press the softkey labeled Beeper to switch the beeper on and off Press the softkey labeled Done to go back to the setup menu Viewing Instrument Information To view information about the Analyzer 1 12 From the setup menu press the softkey labeled More twice to set F3 to the instrument information function Press the softkey labeled Instrument Information After viewing the displayed information press the softkey labeled Done to exit the information screen 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 Setting the GFCI Limit To set the GFCI current limit 1 From the setup menu press the softkey labeled More to reveal additional menu selections 2 Press the softkey labeled Instrument to reveal the instrument setup selections 3 Press the softkey labeled GFCI Limit to open the scroll box above the softkey label 4 Press or to adjust the current limit from 5 to 25 MA 5 Press the softkey labeled Done to exit the GFCI Limit setup function Performing Electrical Safety Tests The Analyzer is designed to perform a number of different electrical and performance tests
36. rial around the instrument 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 go to www flukebiomedical com service or In the U S A Cleveland Calibration Lab Tel 1 800 850 4606 Email globalcal flukebiomedical com Everett Calibration Lab Tel 1 888 99 FLUKE 1 888 993 5853 Email service status fluke com In Europe Middle East and Africa Eindhoven Calibration Lab Tel 31 402 675300 Email ServiceDesk fluke com In Asia Everett Calibration Lab Tel 425 446 6945 Email service international fluke com Certification This instrument was thoroughly tested and inspected It was found to meet Fluke Biomedical s manufacturing specifications when it was shipped from the factory Calibration measurements are traceable to the National Institute of Standards and Technology NIST Devices for which there are no NIST calibration standards are measured against in house performance standards using accepted test procedures WARNING Unauthorized user modifications or application beyond the published specifications may result in electrical shock hazards or improper operation Fluke Biomedical will not be responsible for any injuries sustained due to unauthorized equipment modificatio
37. rt test Electrical Safety Analyzer Performing Electrical Safety Tests Press 2 Press the soft key labeled More 3 Select the desired applied part groupings using and V Note Refer to the testing standard when deciding the type of the applied parts and how they should be grouped for testing 4 Press the soft key labeled Select Press the soft key labeled Lead Isolation 6 Press or to select the desired applied part connection 7 Press to apply the voltage and read the leakage current in the display S Pressing and scrolls through the applied part connections or groupings Press for each connection configuration to thoroughly test the DUT The following outlet conditions apply when performing this test e Normal Polarity e Reverse Polarity Note If there are more than five applied parts to connect to the Analyzer see Using the 1210 Adapter later in this manual 35 ESA612 Users Manual DEVICE UNDER TEST APPLIED PART L2 OPEN EARTH OPEN OO CONDUCTIVE PART TEST LEAD D LEAD SELECT MAP ISOLATION l TRANSFORMER O faw31 eps Figure 23 Lead Isolation Mains On Applied Parts Leakage Test Schematic 36 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 equipmen
38. s The Direct Equipment Leakage Current test measures the leakage current between all applied parts and the exposed conductive surface on the housing to mains earth To perform a direct equipment test 1 Press HA The direct equipment test is the default test and should already be selected 2 Press to apply the voltage and read the leakage current in the display Figure 26 shows the electrical connections between the Analyzer and the DUT during a Direct Equipment Leakage Current Test The following outlet conditions apply when performing this test e Normal Polarity Closed Earth e Normal Polarity Open Earth e Reversed Polarity Closed Earth e Reversed Polarity Open Earth Note If there are more than five applied parts to connect to the Analyzer see Using the 1210 Adapter later in this manual 39 ESA612 Users Manual DEVICE UNDER TEST APPLIED PART DUT_L2 Q DUT PE Q CONDUCTIVE PART TEST LEAD faw23 eps Figure 25 Alternative Applied Part Leakage Test Schematic 40 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 For equipment with multiple applied parts each group of a single function should be tested e
39. sion or limitation of an implied warranty or of incidental or consequential damages this limitation of liability may not apply to you If any provision of this warranty is held invalid or unenforceable by a court or other decision maker of competent jurisdiction such holding will not affect the validity or enforceability of any other provision 7 07 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 Biomedical agrees to a limited copyright release that allows you to reproduce manuals and other printed materials for use in service training programs and other technical publications If you would like other reproductions or distributions submit a written request to Fluke Biomedical Unpacking and Inspection Follow standard receiving practices upon receipt of the instrument Check the shipping carton for damage If damage is found stop unpacking the instrument Notify the carrier and ask for an agent to be present while the instrument is unpacked There are no special unpacking instructions but be careful not to damage the instrument when unpacking it Inspect the instrument for physical damage such as bent or broken parts dents or scratches Technical Support For application support or answ
40. t ID of 0000000000000001 and a date of is assigned to the record LE eld 0 x 240 pixel Color LCD simulator 1 9 Enter Test Record ID Figure 34 Test Record ID Entry Screen fis114 bmp After selecting a function push to store the measurement or ECG signal under the Test Record ID 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 can only be stored under the most recently opened record Viewing Memory Data Previously stored data for any Test Record is recalled to the screen through the setup menus To recall data 1 Press 20 2 Press the softkey labeled More to reveal additional menu selections Press the softkey labeled View Memory Select the desired Test Record by pressing or to scroll through the records listed in the display 5 Press the softkey labeled View to view the data stored for the selected record If the stored data is more than can fit on one screen press the softkey labeled Next Page to view the additional data Deleting Data from Memory To delete a Test Record and its associated data from memory Electrical Safety Analyzer Controlling the Analyzer Remotely Press 2 Press the softkey labeled More to reveal additional menu selections 3 Press the softkey labeled Vie
41. t outlet mains live neutral and equipment outlet earth the exposed conductive surface on the housing and all applied parts short circuited together Equipment is separated from mains during the test The current which flows over the insulation of the DUT is measured This test is not applicable for equipment with internal electrical power source The switches in mains part shall be closed during measurement To perform an alternative equipment leakage test 1 Press 2 Press the softkey labeled Alternative Equipment 3 Press to apply the voltage and read the current in the display Figure 24 shows the electrical connections between the Analyzer and the DUT during an Alternative Equipment Leakage Test Electrical Safety Analyzer Performing Electrical Safety Tests The following outlet conditions apply when performing this test e Closed Earth e Open Earth Note If there are more than five applied parts to connect to the Analyzer see Using the 1210 Adapter later in this manual Performing an Alternative Applied Part Leakage Test Note The Alternative applied part leakage test is available when the EN62353 standard is selected During the Alternative Applied Part Leakage test the test voltage is applied between short circuited applied parts of a single function and the short circuited equipment outlet mains live neutral equipment outlet earth and exposed conductive surface on the housing This test should only
42. ter control Modes of Operation Manual and remote Power 120 Volt power Outlet iese ee EE ee EE ee ee 90 to 132 V ac rms 47 to 63 Hz 20 A maximum 230 Volt power Outlet ee see ee Ee ee EE ee ee ee 180 to 264 V ac rms 47 to 63 Hz 16 A maximum Veit 1 6 kg 3 5 Ib RE EE OE EE OE EE 28 5 cm x 17 6 cm x 8 4 cm 11 2 in x 6 9 in x 3 3 in Safety Standards LE IEC EN61010 1 2 Edition Pollution degree 2 ONE Rd ie AE CAN CSA C22 2 No 61010 1 UL61010 1 Electromagnetic Compatibility Standards EMC European EMC u EN61326 1 61 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 see Ee ooa D E De 2 of reading 0 2 V Earth Resistance MORE ae at EE tion Two terminal SSC UN SIA ce an gt 200 mA ac ee jie RE EN 0 000 to 2 000 Q PM 2 of reading 0 015 Q Equipment Current EL gt N AE HE RE en 0 0 to 20 0 A ac rms PAC GUI EN EE 5 of reading 2 counts or 0 2A whichever is greater EY Asie OO N OE N ON 15 A to 20 A 5 min on 5 min off 10 Ato 15A 7 min on 3 min off 0 Ato 10 A continuous Leakage Current Modes ee ER see ee AC DC True rms AC onl
43. tion Mains on Applied parts are displayed in one of three ways AC DC AC Only or DC only The initial result is displayed in the appropriate parameter based on the standard selected To change the displayed parameter press or The present measurement method is displayed to the right of the current measurement while leakage current tests are conducted 26 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 Within the Ground Wire Leakage Current test there are a few combination measurements that can be performed Pressing switches the polarity of the mains voltage applied to the Analyzer s test receptacle between Normal Off Reverse and Off Pressing opens and closes the neutral connection to the Analyzer s test receptacle There is no need to open up the test receptacle earth ground since this is done internally during the measurement The following outlet conditions apply when performing this test e Normal Polarity e Normal Polarity Open Neutral e Reversed Polarity e Reversed Polarity Open Neutral IEC60601 1 specifies that the applied parts should
44. 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 The Defibrillator Monitor in the example has ten ECG leads two pacer leads and two defibrillator paddles which need to be tested together and in groups if single function for current leakage per IEC62353 The example shows the ECG leads to be snap type connectors and two BJ2ECG adapters are shown plugged into the Adapter If the ECG leads did not have snap connectors then the Universal Snap to Banana Adapter can be used to make the connections to the Adapter The common lead from the Adapter is plugged into the RA jack 1 jack of the Analyzer Using four sheathed test leads with alligator clips connect the two defibrillator paddles into the LL and LA Analyzer jacks and the two pacer leads into the RL and V1 jacks Using the selection that ties all five Analyzer jacks together will test all fourteen leads for leakage current Using the selection of applied part group of 1 2 and 2 allows for testing of groups of applied parts of single function 46 Electrical Safety Analyzer Using the 1210 Adapter Defibrillator Pacer ESA612 fis120 eps Figure 29 1210 Adapter Connections 47 ESA612 Users Manual When performing an applied parts test using the AAMI NFPA 99 standard the normal
45. upplied 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 The Analyzer is intended for use with single phase grounded power lt is not intended for dual split phase or three phase power configurations But it can be used with any power system that supplies the correct voltages for single phase and is grounded or is an isolated power system Connecting a DUT to the Analyzer A Device Under Test DUT can be connected in a number of different ways depending on the device and the number of connections needed for a full electrical safety test Figure 4 shows a DUT connected to the test receptacle applied parts posts and a separate connection to the DUT s enclosure or protective earth ground 8 Turning the Analyzer On Note To ensure the high voltage indicator is working look for it to illuminate during the power up Self test Press the power switch on the left side panel so the I side of the ac power switch is depressed The Analyzer will perform a series of self tests and then display the message shown in Figure 3 when the self test has completed successfully la x Select a test or Pehun Infa fis101 jpg Figure 3 Analyzer Ready for Oper
46. veforms ESA612 Users Manual Table 1 Symbols Safety Information In this manual a Warning identifies hazardous conditions and actions that could cause bodily harm or death A Caution identifies conditions and actions that could damage the Analyzer the equipment under test or cause nu standards To avoid possible electrical shock or ne personal injury follow these guidelines e Use this Analyzer only in the manner Ed EG specified by the manufacturer or the Conforms to European Union directives protection provided may be impaired e Read the Users Manual before operating the Analyzer Do not dispose of this product as unsorted municipal waste Go to Fluke s website for recycling information e Do not connect the Analyzer to a patient or equipment connected to a patient The IEC Measurement Category II CAT Il Analyzer is intended for equipment equipment designed to protect against evaluation only and should never be used transients from energy consuming in diagnostics treatment or in any other equipment supplied from fixed capacity where the Analyzer would come installations in contact with a patient e Do not use the product in wet or damp locations around explosive gases or dust 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
47. w Memory Select the desired Test Record by pressing or to scroll through the records listed in the display 5 Press the softkey labeled Delete Note All Test Records can be deleted at this point by pressing the softkey labeled Delete All 6 When Delete appears in the display press the softkey labeled Delete to remove the record from memory Otherwise press the softkey labeled Cancel to return to the Test Record list and leave the selected record in memory Note Deleting the last or current record does not open the previous record for additional data storage Only a new Test Record can be opened for data recording after deleting the last record Controlling the Analyzer Remotely Fluke Biomedical Ansur test automation software allows a solutions based approach to complete testing of the medical device under test DUT Ansur helps create standard work using the test template sequence which is 55 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 The software works hand in hand with Fluke Biomedical analyzers and simulators creating a seamless integration for e Visual inspections e Pr
48. y DC only Modes AC DC AC only and DC only available for all leakages with exception of MAP that are available in True rms shown as AC DC Patient Load Selection AAMI ES1 1993 Fig 1 IEC 60601 Fig 15 Crest GOP ies EE ae s3 62 Electrical Safety Analyzer Detailed Specifications RANGES EG ee Dee ode 0 0 to 199 9 uA 200 to 1999 uA 2 00 to 10 00 mA Accuracy DE BI K nee 1 of reading 1 uA or 1 LSD whichever is greater to 100 KEES re Ga eg eg N De de 2 of reading 1 uA or 1 LSD whichever is greater 100 kHz to 1 MHz 5 of reading 1 uA or 1 LSD whichever is greater Mains on applied part test voltage 100 5 of Mains for AAMI current limited to 1 mA 25 per AAMI 100 5 of Mains for 62353 current limited to 3 5 mA 25 per 62353 100 5 of Mains for 60601 current limited to 7 5 mA 25 per 60601 Differential leakage Ranges 10 to 199 uA 200 to 2000 uA 2 00 to 20 00 mA ACO AO EE N 10 of reading 2 counts or 20 uA whichever is greater Insulation resistance Range EE ie be Ee 0 5 to 20 0 MQ 20 0 to 100 0 MQ Accuracy 20 MIG RINGE nee 2 of reading 0 2 MQ 100 MO Range Ha aaa 7 5 of reading 0 2 MQ Source test voltage cn rn 500 V dc 20 0 1 5 0 25 mA short circuit current or 250 V dc selectable Maximum load capacitance 1 UF 63 ESA612 Users Manual ECG Performance Waveforms Accuracy 21
49. y Analyzer Performing Electrical Safety Tests Performing a Current Consumption Test Which leakage tests are available depends on which standard is selected See the Selecting the Test Standard section earlier in this manual to change the standard the Analyzer is using To measure the current consumed by the DUT press LA The Analyzer displays the current flowing through the mains connections of the test receptacle Table 5 lists six leakage current tests that have different Performing Leakage Current Tests names based on which standard is selected The Analyzer measures leakage current for a number of different DUT configurations In addition to the leakage found on the enclosure and the earth connection the Analyzer can measure leakage on each connected applied part and combinations of connected applied parts Press to access the leakage current main menu shown in Figure 17 Table 5 Test Names Based on Selected Standard IEC60601 AAMI NFPA 99 Protective Earth Resistance Ground Wire Resistance Earth Leakage Current Ground Wire Leakage Current Mains on Applied Part MAP Leakage Current 25 ESA612 Users Manual Fil 0 085 4 NORMAL Leakage SM 123496759 CLOSED ep Leadto 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 fis117 jpg All leakage currents with the exception of Lead Isola
50. zer Simulating ECG Waveforms BJ2ECG Adapter fis115 eps 53 ESA612 Users Manual 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 flukebiomedical com ESA612 is required to upload memory data to a PC Installation and operator instructions are also located on the software web page Note It is recommended that memory data be uploaded daily or as often as possible to reduce upload time Storing Data into Memory Each of the six measurement functions allow data storage within the Analyzer The ECG function allows storage of the simulated waveforms only for reference of tests performed To store data a Test Record ID should be created first To input a new Test Record ID 1 Press to open the screen shown in Figure 34 2 Press or to set the first character Available characters are 0 9 A Z and space Press to move to the next character position Fill in up to 15 character positions to identify a test record 54 gt Press enter save button to store the Test Record ID Use b and to enter the date of the Test Record Press to store the date The Test Record ID is displayed in the upper left corner of the display Note If no record ID data is entered a defaul
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