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Fluke Biomedical ESA612, User Manual

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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 international (IEC62353, 

AN/NZS 3551, and parts of IEC 60601-1) electrical-safety 

standards. The integrated ANSI/AAMI ES1 and 

IEC60601-1 patient loads are easily selectable. 
The Analyzer performs the following tests: 

•

  Line (Mains) voltage 

•

  Ground Wire (or Protective Earth) Resistance 

•

  Equipment current 

•

  Insulation resistance 

•

  Ground (Earth) leakage 

•

  Chassis (Enclosure) leakage 

•

  Lead to Ground (Patient) and Lead to Lead (Patient 

Auxiliary) leakage 

•

  Lead isolation (Mains on applied parts leakage) 

•

  Differential leakage 

•

  Direct equipment leakage 

•

  Direct applied part leakage 

•

  Alternative equipment leakage 

•

  Alternative applied part patient leakage 

•

  Point to point leakage, voltage, and resistance 

•

  ECG simulation and performance waveforms 

Summary of Contents for ESA612

Page 1: ... Rev 3 3 22 2009 2022 Fluke Corporation All rights reserved Specifications are subject to change without notice All product names are trademarks of their respective companies ESA612 Electrical Safety Analyzer User Manual ...

Page 2: ...uke 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 i...

Page 3: ...g 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 answers to technical questions either email techservic...

Page 4: ...king 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 cla...

Page 5: ...andards 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 unau...

Page 6: ......

Page 7: ...yzer 5 Instrument Familiarization 6 How to Hold the Product 10 Connecting to Line Power 10 Connecting a DUT to the Analyzer 11 Turning the Analyzer On 11 Accessing the Analyzer s Functions 13 Setting Up the Analyzer 14 Setting the GFCI Limit 14 Setting the Display Contrast 15 Setting up the Beeper 16 ...

Page 8: ...est 33 Performing a Lead to Ground Patient Leakage Test 35 Performing Lead to Lead Patient Auxiliary Leakage Tests 37 Performing a Lead Isolation Mains on Applied Part Leakage Test 39 Performing an Alternative Equipment Leakage Test 42 Performing an Alternative Applied Part Leakage Test 43 Performing a Direct Equipment Leakage Test 45 Performing a Direct Applied Part Leakage Test 48 Performing a D...

Page 9: ...i Deleting Data from Memory 63 Controlling the Analyzer Remotely 63 Maintenance 64 Testing and Replacing the Fuses 64 Cleaning the Analyzer 66 Replaceable Parts 67 Accessories 69 Specifications 70 Detailed Specifications 71 ...

Page 10: ...ESA612 Users Manual iv ...

Page 11: ...s Table Title Page 1 Symbols 2 2 Top Panel Controls and Connections 6 3 Side and Top Panel Connections 9 4 Schematic Abbreviations 21 5 Test Names Based on Selected Standard 29 6 Replaceable Parts 68 7 Accessories 70 ...

Page 12: ...ESA612 Users Manual vi ...

Page 13: ...enu 14 8 Mains Voltage Test Menu 17 9 DUT Ground Resistance Measurement 18 10 Ground Wire Protective Earth Resistance Measurement Connections 20 11 Ground Wire Protective Earth Resistance Measurement Schematic 22 12 Insulation Resistance Measurement 23 13 Mains to Protective Earth Insulation Resistance Test Schematic 24 14 Applied Parts to Protective Earth Insulation Test Schematic 25 15 Mains to ...

Page 14: ...liary Leakage Current Test Schematic 39 24 Lead Isolation Mains On Applied Parts Leakage Test Schematic 42 25 Alternative Equipment Leakage Current Test Schematic 45 26 Alternative Applied Part Leakage Test Schematic 48 27 Direct Equipment Leakage Test Schematic 50 28 Direct Applied Parts Leakage Current Test Schematic 51 29 Differential Leakage Current Test Schematic 53 30 1 to 10 Adapter Connect...

Page 15: ...AMI ES1 and IEC60601 1 patient loads are easily selectable The Analyzer performs the following tests Line Mains voltage Ground Wire or Protective Earth Resistance Equipment current Insulation resistance Ground Earth leakage Chassis Enclosure leakage Lead to Ground Patient and Lead to Lead Patient Auxiliary leakage Lead isolation Mains on applied parts leakage Differential leakage Direct equipment ...

Page 16: ...product in domestic household waste Product Category With reference to the equipment types in the WEEE Directive Annex I this product is classed as category 9 Monitoring and Control Instrumentation product Do not dispose of this product as unsorted municipal waste Go to Fluke s website for recycling information CAT II Measurement Category II is applicable to test and measuring circuits connected d...

Page 17: ...a patient The Analyzer is intended for equipment evaluation only and should never be used in diagnostics treatment or in any other capacity where the Analyzer would come in contact with a patient 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 di...

Page 18: ... Use the proper terminals functions and ranges for the test being performed 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 Product is an electronic signal source and measurement device f...

Page 19: ...t is intended to be used in the laboratory environment outside of the patient care area and is not intended for use on patients or to test devices while connected to patients This Product is not intended to be used to calibrate medical equipment It is intended for over the counter use Unpacking the Analyzer Carefully unpack all items from the box and check that you have the following items ESA612 ...

Page 20: ...ent Outlet Configuration Buttons Controls the configuration of the equipment outlet Opens and closes the neutral and ground connection and reverses the polarity of the neutral and hot connection 2 High Voltage Indicator Indicates when high voltage is applied to the ECG Applied Parts posts or L1 and L2 of the Test Receptacle 3 Test Function Buttons Selects the various Analyzer test functions 4 Navi...

Page 21: ...ed tests 6 Save Button Saves the measurement or ECG waveform to memory 7 Input Jacks Test lead connectors 8 Nulling Jack Connection for zeroing test lead resistance 9 Function Softkeys Keys F1 through F4 are used to select from a number of selections that appear in the LCD display above each function softkey ...

Page 22: ...ESA612 Users Manual 8 Figure 2 and Table 3 describe the side and top panel connections of the Analyzer fis110 png Figure 2 Side and Top Panel Connections ...

Page 23: ... Analyzer in a tilted position 5 AC Power Switch Turns ac power on and off 6 Power Input Connector A grounded male three prong IEC 60320 C19 connector that accepts the line power cord 7 ECG Applied Parts Jacks Connection posts for Device Under Test DUT applied parts such as ECG leads Used to test for leakage current through leads and to supply ECG signals and performance waveforms to a DUT 8 Banan...

Page 24: ...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 It is not intended for dual split phase or three ph...

Page 25: ... applied parts posts and a separate connection to the DUT s enclosure or protective earth ground 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 mess...

Page 26: ...ESA612 Users Manual 12 fis113 png Figure 5 DUT Connections to the Analyzer ...

Page 27: ...ent 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 exampl...

Page 28: ... the Using Memory section later in this manual for a description of how to enter a test record ID The setup parameters have been grouped into six categories Instrument Display Sound Instrument Info Calibration and Diagnostics Setting the GFCI Limit The GFCI Ground Fault Current Interrupter protects the excessive leakage current to earth when ti is connected to the test receptable of the Analyzer T...

Page 29: ...und dialysis and portable X ray machines If you think the DUT has a highly capacitive or inductive power supply increase the Polarity Switching Delay from 1 second default to at least 5 seconds This increase allows the DUT to self discharge safely To set the polarity delay 1 From the Setup menu push or until the Polarity Delay variable is highlighted 2 Push the Enter button 3 Push or to highlight ...

Page 30: ...abeled Instrument Information 3 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 me...

Page 31: ...y 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 excl...

Page 32: ...cord from the DUT is plugged into the Analyzer s test receptacle 2 Press to reveal the resistance function menu 3 Connect one end of a test lead to the V Ω 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 Null jack If using an alligator clip accessory connect it to the other end of the test lead place the null...

Page 33: ... 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 Figure 10 shows the electrical connections between the Analyzer and the DUT Table 4 lists the abbreviations used in the schematics and their descripti...

Page 34: ...ESA612 Users Manual 20 fis112 png Figure 10 Ground Wire Protective Earth Resistance Measurement Connections ...

Page 35: ...tage Supply L1 Live Conductor L2 Neutral Conductor DUT Device Under Test DUT_L1 Device Under Test Live conductor DUT_L2 Device Under Test neutral conductor DUT_PE Device Under Test protective earth REV POL Reversed mains supply polarity LEAD GND Lead to ground used in Patient leakage test MAP Mains on Applied Part MAP REV Reverse mains on applied part source voltage PE Open Open protective earth T...

Page 36: ...ESA612 Users Manual 22 faw26 png Figure 11 Ground Wire Protective Earth Resistance Measurement Schematic ...

Page 37: ...key 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 12 three of the five tests are shown over function soft keys F1 through F3 To access the other two tests or test volt...

Page 38: ...ESA612 Users Manual 24 faw17 png Figure 13 Mains to Protective Earth Insulation Resistance Test Schematic ...

Page 39: ...Electrical Safety Analyzer Performing Electrical Safety Tests 25 faw18 png Figure 14 Applied Parts to Protective Earth Insulation Test Schematic ...

Page 40: ...ESA612 Users Manual 26 faw19 png Figure 15 Mains to Applied Parts Insulation Test Schematic ...

Page 41: ...Electrical Safety Analyzer Performing Electrical Safety Tests 27 faw20 png Figure 16 Mains to Non Earth Accessible Conductive Points Schematic ...

Page 42: ...ESA612 Users Manual 28 faw21 png Figure 17 Applied Parts to Non Earth Conductive Points Schematic ...

Page 43: ...akage 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 Table 5 lists six leakage current tests that have different names based on which standard is selected Press to access the leakage current main menu shown in Figure 18 Table 5 Test Names Based on Selected Standard IEC60601 AA...

Page 44: ...rent 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 19 shows the electrical connections between the Analyzer and the DUT during a Ground Wire Leakage Current Test Within the Ground Wire Leaka...

Page 45: ...hen performing this test Normal Polarity Normal Polarity Open Neutral Reversed Polarity Reversed Polarity Open Neutral IEC60601 1 specifies that the applied parts should be connected for this measurement Enable this measurement by pressing or which grounds and ungrounds all applied parts connection posts ...

Page 46: ...ESA612 Users Manual 32 faw27 png Figure 19 Earth Leakage Current Test Schematic Note Ground wire leakage is the same schematic without the Applied Parts switch ...

Page 47: ...rom 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 conditi...

Page 48: ...ESA612 Users Manual 34 faw28 png Figure 20 Enclosure Leakage Current Test Schematic Note Chassis leakage is the same schematic without the Applied Parts switch ...

Page 49: ... type of the applied parts and how they should be grouped for testing 4 Press the soft key labeled Select 5 Press or to advance through each applied part grouping or the individual applied parts to ground These are selected and measured 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 Re...

Page 50: ...ESA612 Users Manual 36 gtv29 png Figure 21 Lead to Ground Patient Leakage Current Test Schematic ...

Page 51: ...e 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 Auxilia...

Page 52: ...ESA612 Users Manual 38 gtv30 png Figure 23 Lead to Lead Patient Auxiliary Leakage Current Test Schematic ...

Page 53: ...ted to the RED terminal Figure 24 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 Part test 1 Press 2 Press the soft key labeled More 3 Select the desired...

Page 54: ...0 The following outlet conditions apply when performing this test Normal Polarity Reverse Polarity Note If there are more than five applied parts to connect to the Analyzer see Using the 1 to 10 Adapter later in this manual ...

Page 55: ...AD GND SELECT RELAY REMOTE ONLY Leads not selected are open MD DUT_PE PE L2 DUT_L2 DUT_L1 Mains L1 Mains On REV POL MAP REV MAP ISOLATION TRANSFORMER FE APPLIED PART CONDUCTIVE PART DEVICE UNDER TEST TEST LEAD gtv31 png Figure 24 Lead Isolation Mains On Applied Parts Leakage Test Schematic ...

Page 56: ...ows 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 25 shows the electrical connecti...

Page 57: ...cuited 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 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 pa...

Page 58: ...ESA612 Users Manual 44 faw22 png Figure 25 Alternative Equipment Leakage Current Test Schematic ...

Page 59: ...UT 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 1 to 10 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 The Direct Equipment Leakage Current test measures the leakage current between all ...

Page 60: ...en performing this test Normal Polarity Closed Earth Normal Polarity Open Earth Reversed Polarity Closed Earth Reversed Polarity Open Earth Note If there are more than five applied parts to connect to the Analyzer see Using the 1 to 10 Adapter later in this manual ...

Page 61: ...Electrical Safety Analyzer Performing Electrical Safety Tests 47 gtv23 png Figure 26 Alternative Applied Part Leakage Test Schematic ...

Page 62: ...nt leakage schematic in Figure 27 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 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 7 Press or to ...

Page 63: ...Electrical Safety Analyzer Performing Electrical Safety Tests 49 faw24 png Figure 27 Direct Equipment Leakage Test Schematic ...

Page 64: ...ESA612 Users Manual 50 gtv25 png Figure 28 Direct Applied Parts Leakage Current Test Schematic ...

Page 65: ...rts 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 29 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 Normal Polarity Closed Earth Normal P...

Page 66: ...ESA612 Users Manual 52 gtv32 png Figure 29 Differential Leakage Current Test Schematic ...

Page 67: ...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 1st jac...

Page 68: ...ESA612 Users Manual 54 fis120 png Figure 30 1 to 10 Adapter Connections ...

Page 69: ...ers 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 5th jack of the Analyzer See Figure 31 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 w...

Page 70: ...ESA612 Users Manual 56 fis121 png Figure 31 ECG Lead Connection with 1 to 10 Adapter ...

Page 71: ...eled Voltage from the Point To Point menu 2 Insert test leads in the RED V Ω A and BLACK jacks 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 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 Ω A ...

Page 72: ...osts These signals are used to test the performance characteristics of ECG monitors and ECG strip printers See Figure 34 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 Note If the ECG monitor interp...

Page 73: ...uency of the waveform is adjusted through the softkey 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...

Page 74: ...ESA612 Users Manual 60 fis115 png Figure 34 ECG Monitor Connections ...

Page 75: ...emory 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 35 2 Press or to set the first character Available characters are 0 9 A Z and space 3 Press ...

Page 76: ... 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 2 Press the softkey labeled More to reveal additional menu selections 3 Press the softkey labeled View Memory 4 Select the desired Test Record by pressing or to scroll through the records listed in the disp...

Page 77: ...rn 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 ...

Page 78: ... or simulator is purchased simply update your existing Ansur software by installing a new plug in Each plug in module works only with the options and capabilities needed for the instrument being tested Fluke Biomedical recommends you download the latest Ansur Software and plug in module from www flukebiomedical com to make sure the software and Product are compatible Maintenance The Analyzer needs...

Page 79: ...s head screwdriver and lifting the fuse door from the Analyzer 4 Remove the fuses from the Analyzer fis111 png Figure 36 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 ratings are posted on the case bottom label of the Analyzer Table 6 lists...

Page 80: ...ause the Analyzer to fail Caution Do not use spray cleaners on the Analyzer such action may force cleaning fluid into the Analyzer and damage electronic components Clean the Analyzer occasionally utilizing a damp cloth and mild detergent Take care to prevent the entrance of liquids Wipe down the adapter cables with the same care Inspect them for damage to and deterioration of the insulation Check ...

Page 81: ...le 6 Replaceable Parts Item Fluke Biomedical Part Number ESA612 Getting Started Manual 3334511 ESA612 Users Manual CD 3334509 Power Cord USA 220V 2238644 UK 2238596 Australia 2238603 Europe 2238615 France Belgium 2238615 Thailand 2238644 Israel 2434122 Switzerland 3379149 Denmark 5277596 India 5261082 South Africa 4212623 ...

Page 82: ...Fuse Time Lag 1 in x in 2183691 Australia Switzerland Denmark China T10A 250V Fuse Time Lag 1 in x in 109298 Europe UK Thailand France Belgium Israel South Africa India T16A 250V Fuse Time Lag 6 3 mm x 32 mm 3321245 15 20 A Adapter 2195732 ESA USA AUS ISR Accessory Kit Test Lead Set TP1 Test Probe Set AC285 Alligator Clip Set 3111008 ESA EUR Accessory Kit Test Lead Set TP74 Test Probe Set AC285 Al...

Page 83: ...e available accessories for the Analyzer Table 7 Accessories Item Fluke Biomedical Part Number Test Leads with Retractable Sheath 1903307 Ground Pin Adapters 2242165 1 to 10 ECG Adapter 3392119 Universal Snap to Banana Adapter 2462072 Ansur ESA612 Plug In License 3454829 ...

Page 84: ...63 Hz 20 A maximum 230 Volt power outlet 180 to 264 V ac rms 47 to 63 Hz 16 A maximum Weight 1 6 kg 3 5 lb Size 28 5 cm x 17 6 cm x 8 4 cm 11 2 in x 6 9 in x 3 3 in Safety Standards General IEC 61010 1 Overvoltage Category II Pollution Degree 2 Measurement IEC 61010 2 030 CATII 300 V Electromagnetic Compatibility Standards EMC International IEC 61326 1 Basic Electromagnetic Environment IEC 61326 2...

Page 85: ...unication Equipment Class A Equipment meets requirements for industrial electromagnetic wave equipment and the seller or user should take notice of it This equipment is intended for use in business environments and not to be used in homes 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 ...

Page 86: ... is greater 100 kHz to 1 MHz 5 of reading 1 µA or 1 LSD whichever is greater Note Accuracy for Isolation MAP Direct AP Alternative AP and Alternative Equipment leakage tests all ranges are At 115 VAC 2 5 µA or 1 LSD whichever is greater At 230 VAC additional 3 0 and 2 5 µA or 1 LSD whichever is greater For Alternative and Direct AP leakage tests the leakage values are compensated for nominal mains...

Page 87: ... load capacitance 1 µF ECG Performance Waveforms Accuracy Frequency 2 Amplitude 5 of 2 Hz square wave only fixed 1 mV Lead II configuration Waveforms ECG Complex 30 60 120 180 and 240 BPM Ventricular Fibrillation Square wave 50 duty cycle 0 125 Hz and 2 Hz Sine wave 10 40 50 60 and 100 Hz Triangle wave 2 Hz Pulse 63 ms pulse width 30 BPM and 60 BPM 1 Add 6 to accuracy specification for Mains PE In...

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