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SigmaPace 1000

 

External Pacemaker Analyzer 

Operators Manual 

PN 2243306 

July 2007

 

© 2007 Fluke Corporation, All rights reserved. Printed in USA 
All product names are trademarks of their respective companies. 

Summary of Contents for SigmaPace 1000

Page 1: ...igmaPace 1000 External Pacemaker Analyzer Operators Manual PN 2243306 July 2007 2007 Fluke Corporation All rights reserved Printed in USA All product names are trademarks of their respective companies...

Page 2: ...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 o...

Page 3: ...ent 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 sa...

Page 4: ...Authoriza tion 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...

Page 5: ...be incorpo rated in new editions of the publication No responsibility is assumed by Fluke Biomedi cal for the use or reliability of software or equipment that is not supplied by Fluke Bio medical or...

Page 6: ......

Page 7: ...ations 1 10 General Specifications 1 12 Instrument Specifications 1 12 Transcutaneous Pacemaker Tests 1 13 Transvenous Pacemaker Tests 1 17 Accessories 1 28 2 Setup Operation and Maintenance 2 1 Setti...

Page 8: ...ng 3 10 Output 3 12 Demand Mode Pacemaker s Interaction with ECG Signal 3 14 Continuous Mode Pacemaker s Interaction with ECG Signal 3 15 Demand Mode Pacemaker s Ability to Sense ECG Activity 3 17 Amp...

Page 9: ...s Ability to Sense ECG Activity 4 20 Amplitude of ECG Signal for a Demand Mode Pacemaker 4 23 Pacemaker s Ability to Filter Line Noise 4 28 DC Leak Test 4 31 DC Load Test 4 34 ECG Simulation Test 4 36...

Page 10: ...SigmaPace 1000 Operators Manual iv...

Page 11: ...ndard Accessories 1 28 1 4 Pacemaker Disposable Electrode Adapters 1 28 1 5 Serial Cables 1 29 1 6 Compatible Power Supply 1 29 1 7 Disposable Transcutaneous Pacemaker Adapters 1 29 1 8 High Level Out...

Page 12: ...SigmaPace 1000 Operators Manual vi...

Page 13: ...Features and Controls 1 8 3 1 Scheme for Testing Transcutaneous Pacemakers 3 4 3 2 Paced Refractory Period 3 7 3 3 Sensed Refractory Period 3 8 4 1 Scheme for Testing Transvenous Pacemakers 4 3 4 2 D...

Page 14: ...SigmaPace 1000 Operators Manual viii...

Page 15: ...ions 1 4 Symbols 1 4 Warnings and Cautions 1 4 Power Supply 1 5 Defibrillators and Transcutaneous Pacemakers 1 5 Applications 1 6 Features 1 6 Unpacking and Inspection 1 7 Instrument Familiarization 1...

Page 16: ...SigmaPace 1000 Operators Manual 1 2...

Page 17: ...g nomenclature External transcutaneous pacemaker External transthoracic pacemaker External transvenous pacemaker External temporary pacemaker External AV sequential pacemaker Dual Chamber temporary pa...

Page 18: ...o Fluke s website for recycling information Conforms to relevant Australian EMC requirements Conforms to relevant Canadian and US standards P Conforms to European Union directives CAT I IEC Measuremen...

Page 19: ...equipment connected to 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 cont...

Page 20: ...tration tool In addition to measuring the pacemaker s basic output amplitude sensitivity and refractory capabilities you can also present the interactive pacemaker operation using the standard ECG out...

Page 21: ...hen not in use Sleep mode is disabled when the external power supply is plugged into a suitable voltage source A HOLD function to freeze readings on the LCD Test features for battery load current and...

Page 22: ...liarization The Analyzer s features and controls are shown in Figure 1 1 and described in Table 1 2 SIGMA PACE 1000 Biomedical EXTERNALPACEMAKER ANALYZER 16 15 18 12 1 8 17 4 3 2 6 9 10 11 13 14 7 5 e...

Page 23: ...Yellow LED 9 Atrial Channel Pacemaker Input Jacks 4 mm Red Positive Black Negative 10 Ventricular Channel Pacemaker Input Jacks 4 mm Red Positive Black Negative Transvenous and Transcutaneous Right Si...

Page 24: ...cal Instrumentation BLU blue color BPM beats per minute dB decibel C degrees Celsius centigrade CQM Contact Quality Monitor DMM digital multimeter DUT device under test EEPROM electrically erasable PR...

Page 25: ...und LED light emitting diode LCD liquid crystal display M meg a 10 6 MHz megahertz M megohm m meter m milli 10 3 mA milliampere mm millimeter mV millivolt p p peak to peak REM Return Electrode Monitor...

Page 26: ...Supply Input 90 264 V 50 60 Hz Output 15 V 5 1500mA 100 to 240 V ac 50 60 Hz operation Auto power off sleep mode Sleep Modes Reset Analyzer reset button accessed via bottom panel Sleep mode condition...

Page 27: ...idth 1 00 mS to 9 99 mS 10 0 mS to 99 9 mS Accuracy 0 5 of reading or 14 S whichever is greater Energy 1 J to 999 J 1 mJ to 999 mJ 1 00 J to 1 99 J Accuracy 5 of reading computation Demand Mode Test T...

Page 28: ...Selection Selection Normal Sinus Rhythm NSR generates the complete P QRS T complex Amplitude Vpeak 1 0 mV Lead I Rate Interval Underdrive NSR 85 of measured pulse interval rate Overdrive NSR 115 of me...

Page 29: ...o 0 95 mVpeak 0 50 mV steps from 1 0 mVpeak to 5 0 mVpeak Width Range 0 15 mS to 300 mS Accuracy 5 of setting Selection Count 50 Resolution Step Size 0 05 mS steps from 0 15 mS to 0 95 mS 1 0 mS steps...

Page 30: ...t PRP Range 20 mS to 500 mS Accuracy 5 of reading or 1 mS whichever is greater Physiological Simulation Selection Triangle TRI Wave Pulse Width 40 mS Rate Single pulse Interactive with applied pacemak...

Page 31: ...VI Ventricular Pace and Sense Only Transvenous Pacemaker Tests Output Pulse Measurement Test Type Quantitative Display Formats Single Atrial or Ventricular only Dual Atrial and ventricular Channels Me...

Page 32: ...Displayed Data Single Amplitude Current Amplitude Volts Rate Width Energy Dual Atrial and Ventricular Amplitude Current Rate Width AV Interval AV Interval Delay Time Test Type Quantitative Measurement...

Page 33: ...val rate Manual Control The under overdrive NSR simulations can also be independently adjusted in 1 BPM increments Manual Rate Limits Underdrive minimum 10 BPM Overdrive maximum 300 BPM Active Outputs...

Page 34: ...nd 1000 1 Default Setting 500 Waveform Selections Square SQU Triangle TRI Haversine HSN Sine Square SSQ Asymmetrical Triangle ISO Fixed Width 2 mS rise time 13 mS fall time Default Setting SSQ Amplitu...

Page 35: ...teps from 0 15 mS to 0 95 mS 1 0 mS steps from 1 0 mS to 19 0 mS 5 0 mS steps from 20 mS to 95 0 mS Intended Pacemaker Types AAI Atrial Pace and Sense Only Compatible Pulse Rates 30 to 200 PPM Ventric...

Page 36: ...0 50 mVpeak steps from 1 0 mVpeak to 20 0 mVpeak Pacer Load Selection 1000 Range 0 05 mVpeak 50 Vpeak to 100 mVpeak to peak Accuracy 5 of setting Resolution 0 05 mVpeak steps from 0 05 mVpeak to 0 95...

Page 37: ...annel Amplitude Pacer Load Selection 500 Range 0 00 OFF to 100 mVpeak to peak Accuracy 5 of setting Resolution 5 mVpeak to peak steps Pacer Load Selection 200 Range 0 00 OFF to 40 mVpeak to peak Accur...

Page 38: ...ing Resolution Step Size 0 05 mVpeak steps 0 05 mVpeak to 0 95 mVpeak 0 50 mVpeak steps 1 0 mVpeak to 49 5 mVpeak Width Range 0 15 mS to 95 0 mS Accuracy 5 of setting Selection Count 50 Resolution Ste...

Page 39: ...ISO Fixed Width2 mS rise time 13 mS fall time Amplitude Pacer Load Selection 500 Range 0 05 mVpeak 50 Vpeak to 50 0 mVpeak Accuracy 5 of setting Resolution Step Size 0 05 mVpeak steps from 0 05 mVpeak...

Page 40: ...pulse Pacemaker Power ON Input Configurations Atrial and Atrial Ventricular and Ventricular Atrial and Ventricular third internal 500 test load Current Drain Test Test Type Quantitative Measurement Ra...

Page 41: ...or Count 200 Test Termination Manual or when maximum error count is sensed Testloads Selectable 200 500 or 1000 Interactive Pacer ECG Simulation Simulates demand continuous non capture and non functio...

Page 42: ...ck 2 each 2201153 9 V dc Load Test Cable 2392272 Operators Manual 2243306 PC Interface Cable Female DB 9 to Female DB 9 2392260 Nylon Carry Case 2392906 Universal Input Battery Eliminator 2184298 Tabl...

Page 43: ...m UK Power Cord IEC320 C5 3 wire 2201428 European Power Cord IEC320 C5 3 wire SCHUKO 2201437 Australia Power Cord IEC320 C5 3 wire 2201443 Table 1 7 Disposable Transcutaneous Pacemaker Adapters Device...

Page 44: ...rators Manual 1 30 Table 1 8 High Level Output Cables Description Part Number Subminiature Phone Plug to BNC Cable Oscilloscope Application 2199932 Subminiature Phone Plug to 3 Conductor Phone Plug Ca...

Page 45: ...venous Pacemakers 2 4 Load Test Cable Connector 2 4 RS 232 Serial Port Connector 2 5 High Level ECG Output Jack 2 5 Ventilation 2 5 Power Up Sequence 2 5 Transcutaneous Pacemaker Testing 2 7 Transveno...

Page 46: ...SigmaPace 1000 Operators Manual 2 2...

Page 47: ...gging in the power supply plug into the CHARGER INPUT located on the right side panel of the Analyzer Connecting External Transcutaneous Pacemakers To facilitate the safe and convenient connection of...

Page 48: ...obes compatible with external transvenous pacemaker output jacks terminals Use these test leads to connect the output of the transvenous single channel atrial or ventricular or dual channel atrial and...

Page 49: ...illoscope slave monitor or to the Armstrong Medical Industries VIDEO ADAPTER RhythmSim 900 TV Interface Model AA 900 Use the high level output cables listed in the chapter Introduction and Specificati...

Page 50: ...SigmaPace 1000 Operators Manual 2 6 F1 F2 F3 F4 eyr008 eps The LCD then advances to the Select external pacemaker type screen F1 F2 F3 F4 eyr001 eps...

Page 51: ...Utility menu Note Use the ESC or POWER OFF key during operation to return to previous screens Transcutaneous Pacemaker Testing See the Transcutaneous Pacemaker Testing chapter for test options and sp...

Page 52: ...G TEST to select calibration and display test functions Maintenance The Analyzer requires little maintenance or special care however it is a calibrated measuring instrument and should be treated as su...

Page 53: ...th a clean lint free cloth dampened with a mild detergent solution Do not immerse the unit Carefully wipe down the cables and inspect them for damage and deterioration of the insulation Check the cabl...

Page 54: ...The Analyzer serial number The specific steps that reproduce your problem A daytime phone number Your name company A fax number if available 3 Pack the instrument carefully using the original packing...

Page 55: ...CG Simulation 3 9 Simulated ECG Rate 3 9 Adjustable Threshold Level 3 9 Operational Modes 3 9 Continuous 3 9 Non Capture 3 9 Non Function 3 10 Setup and Testing 3 10 Output 3 12 Demand Mode Pacemaker...

Page 56: ...SigmaPace 1000 Operators Manual 3 2...

Page 57: ...Device specific measurement algorithms are selectable for the following list of manufacturers Physio Control Lifepak Series 50 HP Agilent Codemaster 400 GE Marquette Responder Series 300 Medical Data...

Page 58: ...ker SIGMAPACE 1000 External Pacemaker Analyzer L O A D S eyr002 eps Figure 3 1 Scheme for Testing Transcutaneous Pacemakers Output The Analyzer measures the output of the transcutaneous pacemaker and...

Page 59: ...s Mode This qualitative test verifies the continuous or non demand mode pacemaker s ability to interact with a simulated ECG signal The Analyzer first measures the pacemaker s applied pulse rate then...

Page 60: ...o related qualitative tests determine the demand mode pacemaker s ability to sense ECG activity immediately following either a paced event PRP or sensed ECG event SRP Paced Refractory Period PRP The A...

Page 61: ...003 eps Figure 3 2 Paced Refractory Period Sensed Refractory Period SRP The Analyzer then generates a second simulated ECG signal immediately trailing the first simulated ECG signal used to determine...

Page 62: ...C ardiac Test Pulse 1 S ensed C ardiac Test Pulse 2 eyr004 eps Figure 3 3 Sensed Refractory Period Long Term Test The overall stability of the pacemaker s pulse rate and amplitude are monitored contin...

Page 63: ...table Threshold Level When the pacemaker output current exceeds the threshold amplitude setting in milliamperes the Analyzer generates a simulated ventricular paced beat The pacemaker output current l...

Page 64: ...occurring No normal sinus rhythm NSR output is available in this operational mode Setup and Testing The following describes how to set up and test a transcutaneous pacemaker 1 Start from the Select e...

Page 65: ...ied for each Brand Model selection is automatically selected 4 Press the F4 UP or DOWN arrow key to select the load Test loads are available from 50 to 1550 in 50 increments 5 Press F1 NEXT to advance...

Page 66: ...F1 F2 F3 F4 eyr012 eps F1 F2 F3 F4 eyr013 eps 7 Press ESC to return to previous menu s Output The following test measures the output of the transcutaneous pacemaker F1 F2 F3 F4 eyr014 eps 1 From the S...

Page 67: ...e F4 LOAD UP or DOWN arrow key to select the desired load 3 Press F1 HOLD to advance the screen F1 F2 F3 F4 eyr016 eps 4 Press F4 XMIT DATA to transmit data through the serial port 5 Press F1 RELEASE...

Page 68: ...est verifies the demand mode pacemaker s ability to interact with a simulated ECG signal F1 F2 F3 F4 eyr014 eps 1 From the SELECT TEST menu press F2 DMAND MODE F1 F2 F3 F4 eyr058 eps 2 Press the F4 UP...

Page 69: ...rdrive BPM rates 5 Once a rate is selected press F4 DRIVE RATE BPM UP or DOWN arrow key to adjust that rate 6 Press ESC to return to previous menu s Continuous Mode Pacemaker s Interaction with ECG Si...

Page 70: ...0 Operators Manual 3 16 1 From the SELECT TEST menu press F3 ASYNC MODE F1 F2 F3 F4 eyr059 eps 2 Press the F4 LOAD UP or DOWN arrow key to select the load 3 Press F1 START to advance the screen and st...

Page 71: ...E BPM UP or DOWN arrow key to adjust that rate 6 Press ESC to return to previous menu s Demand Mode Pacemaker s Ability to Sense ECG Activity The two following related tests PRP and SRP determine the...

Page 72: ...rs Manual 3 18 F1 F2 F3 F4 eyr012 eps 1 From the SELECT TEST menu press F1 REFRCT DEMAND F1 F2 F3 F4 eyr060 eps 2 Press F4 LOAD UP or DOWN arrow key to select the load 3 Press F1 START to advance scre...

Page 73: ...Transcutaneous Pacemaker Testing Setup and Testing 3 3 19 F1 F2 F3 F4 eyr020 eps After the calculations are complete the following screen appears F1 F2 F3 F4 eyr021 eps...

Page 74: ...smit data 6 Press ESC to return to previous menu s Amplitude of ECG Signal for Demand Mode Pacemaker The following test determines the amplitude of the simulated ECG signal required by the demand mode...

Page 75: ...DOWN arrow key to select the load 3 Press F1 NEXT to advance the screen for waveform selection F1 F2 F3 F4 eyr062 eps 4 Press F3 UP or DOWN arrow key to select waveform type 5 Press F4 UP or DOWN arro...

Page 76: ...igmaPace 1000 Operators Manual 3 22 F1 F2 F3 F4 eyr063 eps 7 Press F3 POLARITY UP or DOWN arrow key to toggle the polarity 8 Press F4 AMPLITUDE to adjust amplitude 9 Press F1 START to initiate the tes...

Page 77: ...transmit data 11 Press F1 RESTART to begin the test again 12 Press ESC to return to previous menu s Pacemaker s Ability to Filter Line Noise The following test measures a pacemaker s ability to filte...

Page 78: ...ace 1000 Operators Manual 3 24 F1 F2 F3 F4 eyr064 eps 2 Press F3 UP or DOWN arrow key select the line frequency 3 Press F4 LOAD UP or DOWN arrow key to select the load 4 Press F1 NEXT to advance the s...

Page 79: ...p and Testing 3 3 25 F1 F2 F3 F4 eyr065 eps 5 Press F3 ECG UP or DOWN arrow key to toggle the ECG function ON or OFF 6 Press F4 AMP UP or DOWN arrow key to adjust the amplitude of the line frequency 7...

Page 80: ...10 Press ESC to return to previous menu s Purpose of the ECG Simulation Test This test lets the technician check external pacemakers for basic operation performance and intermittent problems Additiona...

Page 81: ...row key to adjust the threshold amplitude 4 Press F4 NSR RATE UP or DOWN arrow key to adjust the NSR rate Note The NSR rate function is active only during the demand mode of operation Long Term Tests...

Page 82: ...ements The Analyzer compares these incoming pacer pulses to the target values When the long term test is complete output pulses from the pacemaker that were not within the selected limits may be revie...

Page 83: ...AD UP or DOWN arrow key to select the load 5 Press F1 NEXT to advance the screen F1 F2 F3 F4 eyr027 eps 6 Press F3 AMP UP or DOWN arrow key to adjust the amplitude 7 Press F4 RATE UP or DOWN arrow key...

Page 84: ...SigmaPace 1000 Operators Manual 3 30 F1 F2 F3 F4 eyr028 eps 9 Press F1 END to end the test F1 F2 F3 F4 eyr029 eps...

Page 85: ...tion values for rate and amplitude Up to 200 deviations will be stored in the Analyzer memory Any long term test exceeding 200 deviations is automatically terminated The pulse width at the out of limi...

Page 86: ...SigmaPace 1000 Operators Manual 3 32...

Page 87: ...Operational Modes 4 6 Continuous 4 6 Non Capture 4 7 Non Function 4 7 DC Leakage 4 7 Static Tests Pacemaker Power OFF 4 8 Dynamic Tests Pacemaker Power ON 4 9 Current Drain Test 4 9 Long Term Test 4...

Page 88: ...SigmaPace 1000 Operators Manual 4 2...

Page 89: ...ble in the Analyzer menus Typically transvenous pacemaker measurements are specified at a test load setting of 500 which is the Analyzer default setting For most transvenous pacemaker tests two additi...

Page 90: ...f the applied pacemaker rate and the overdrive rate is 110 of the applied pacemaker rate When testing the attached pacemaker operating in the demand mode output should be active ON with the underdrive...

Page 91: ...at either 50 or 60 Hz and sense a simultaneously applied simulated ECG signal The user can change the amplitude of both the line frequency noise The simulated ECG signal amplitude is fixed Refractory...

Page 92: ...e conditions Simulated ECG Rate The Analyzer outputs either asystole or a normal sinus rhythm NSR at rates covering the bradycardia normal and tachycardia range PR Interval The PR interval of the abov...

Page 93: ...Non Function The Analyzer operates in the above continuous mode However no ventricular capture events occur DC Leakage The integrity of the pacemaker s final output stage is evaluated during these lea...

Page 94: ...e 4 2 DC Leakage Testing Potentially harmful dc levels can be detected using the various test configurations described below Static Tests Pacemaker Power OFF These tests continuously measure dc leakag...

Page 95: ...ad AV Channel dc leakage across an auxiliary 500 test load connected to the atrial and ventricular outputs Note Refer to the check out procedure for your specific pacemaker regarding testing protocols...

Page 96: ...ker Power ON OFF 9 VDC Battery DC Current mA Internal Battery Compartment L O A D S L O A D S M eyr007 eps Figure 4 3 Current Drain Test Readings are made in three pacemaker operating modes Pacemaker...

Page 97: ...ntinuously over an extended time period The user can independently input desired test limits for amplitude and rate 2 20 or use the factory default 10 limits Upon completion of the desired long term t...

Page 98: ...t loads are available at 200 500 and 1000 Ohms Both atrial and ventricular test loads are set simultaneously to the selected value 3 Press F1 NEXT to advance the display to the SELECT TEST menu There...

Page 99: ...and Testing 4 4 13 F1 F2 F3 F4 eyr033 eps F1 F2 F3 F4 eyr034 eps F1 F2 F3 F4 eyr035 eps Output The following test measures the output of the transvenous pacemaker F1 F2 F3 F4 eyr032 eps 1 From the SEL...

Page 100: ...est load for the atrial and ventricular channels The atrial and ventricular channels independently autorange to best measure the incoming pacemaker activity This OUTPUT display can be used to display...

Page 101: ...ity under the rate of 20 PPM The sampling time is extended to accommodate this lower rate 7 Press F4 LOAD UP or DOWN arrow key to select the desired load for the selected channel 8 Press F1 HOLD to ad...

Page 102: ...following test measures the demand mode pacemaker s ability to interact with a simulated dual channel AV ECG signal F1 F2 F3 F4 eyr032 eps 1 From the SELECT TEST menu press F2 DMAND MODE F1 F2 F3 F4...

Page 103: ...er BPM rates 5 Once a rate is selected press F4 DRIVE RATE BPM UP or DOWN arrow key to adjust the rate 6 Press F1 HOLD to advance the screen F1 F2 F3 F4 eyr016 eps 7 Press F4 XMIT DATA to transmit dat...

Page 104: ...the continuous or non demand pacemaker s ability to interact with a simulated dual channel AV ECG signal F1 F2 F3 F4 eyr032 eps 1 From the SELECT TEST menu press F3 ASYNC MODE F1 F2 F3 F4 eyr068 eps 2...

Page 105: ...der BPM rates 5 Once a rate is selected use F4 DRIVE RATE BPM UP or DOWN arrow key to adjust that rate 6 Press F1 HOLD to advance the screen F1 F2 F3 F4 eyr016 eps 7 Press F4 XMIT DATA to transmit dat...

Page 106: ...termine the demand mode pacemaker s ability to sense ECG activity immediately following either a paced event PRP or a sensed ECG event SRP F1 F2 F3 F4 eyr033 eps 1 From the SELECT TEST menu press F1 R...

Page 107: ...dvances for wave and width selection the example is the atrial channel F1 F2 F3 F4 eyr070 eps 4 Press F3 WAVE UP or DOWN arrow key to select a waveform 5 Press F4 WIDTH UP or DOWN arrow key to adjust...

Page 108: ...000 Operators Manual 4 22 F1 F2 F3 F4 eyr071 eps 7 Press F3 POLARITY UP or DOWN arrow key to toggle the polarity 8 Press F4 AMPLITUDE to adjust amplitude 9 Press F1 START to advance the screen and sta...

Page 109: ...1 Press F1 RESTART to restart the test 12 Press ESC to return to previous menu s Amplitude of ECG Signal for a Demand Mode Pacemaker This test determines the required amplitude of the simulated ECG si...

Page 110: ...000 Operators Manual 4 24 F1 F2 F3 F4 eyr072 eps 2 Select either of the two options F1 ATR for the atrial channel F2 VENT for the ventricular channel After pressing the desired key the appropriate scr...

Page 111: ...Transvenous Pacemaker Testing Setup and Testing 4 4 25 F1 F2 F3 F4 eyr073 eps 3 Press F4 LOAD UP or DOWN arrow key to select the load 4 Press F1 NEXT to advance to the next screen...

Page 112: ...ators Manual 4 26 F1 F2 F3 F4 eyr075 eps 5 Press F3 WAVE UP or DOWN arrow key to select a waveform 6 Press F4 WIDTH UP or DOWN arrow key to adjust the width of the waveform 7 Press F1 NEXT to advance...

Page 113: ...27 F1 F2 F3 F4 eyr076 eps 8 Press F3 POL UP or DOWN arrow key to select polarity 9 Press F4 AMP UP or DOWN arrow key to adjust amplitude 10 Press F1 START to start the test and advance to the next scr...

Page 114: ...smit data 12 Press F1 RESTART to restart the test 13 Press ESC to return to previous menu s Pacemaker s Ability to Filter Line Noise This test measures the pacemaker s ability to filter line noise at...

Page 115: ...yr078 eps 2 Press F2 CHAN to toggle between the two options A atrial channel V ventricular channel 3 Press F3 LINE to toggle between two line frequencies 50 or 60 Hz 4 Press F4 LOAD UP or DOWN arrow k...

Page 116: ...AMP UP or DOWN arrow key to adjust the amplitude of the noise line frequency selection 8 Press F1 HOLD to advance the screen F1 F2 F3 F4 eyr016 eps 9 Press F4 XMIT DATA to transmit data through the s...

Page 117: ...sting 4 4 31 Integrity of the Pacemaker s Final Stage The integrity of the pacemaker s final stage is evaluated using the following tests DC Leak Test F1 F2 F3 F4 eyr034 eps 1 From the SELECT TEST men...

Page 118: ...n pacemaker power OFF F2 ON Dynamic test Turn pacemaker power ON The screen advances F1 F2 F3 F4 eyr081 eps 3 Press one of the three options F1 ATRIAL for atrial channel only F2 VENT for ventricular c...

Page 119: ...F2 F3 F4 eyr046 eps 9 Press F1 HOLD to advance the screen F1 F2 F3 F4 eyr016 eps 12 Press F4 XMIT DATA to transmit data through the serial port 13 Press F1 RELEASE to release the hold and return to t...

Page 120: ...ections as follows a Plug the supplied 9 V dc Load Test Cable into the matching connector on the left side of the Analyzer b A 9 V dc Load Test Cable Fluke Biomedical Part 2201074 is supplied as a sta...

Page 121: ...he pacemaker s battery compartment door to seat the test fixture to the recessed battery terminals e To test other brands and or models of transvenous pacemakers just attach test leads not supplied be...

Page 122: ...ress F1 RELEASE to release the hold and return to the HOLD screen 7 Press ESC to return to previous menu s ECG Simulation Test F1 F2 F3 F4 eyr034 eps 1 From the SELECT TEST menu press F3 ECG SIM F1 F2...

Page 123: ...5 Press F2 THCH to toggle between atrial and ventricular of the threshold amplitude 6 Press F3 THRESH UP or DOWN arrow key to adjust the selected atrial or ventricular threshold amplitude 7 Press F4 N...

Page 124: ...into the Analyzer This program flexibility allows the user to enter either the actual test pacemaker values or the selected rate and amplitude settings Deviation values are independently selectable f...

Page 125: ...Setup and Testing 4 4 39 F1 F2 F3 F4 eyr049 eps 2 Select one of the following two options Press F1 ATRIAL for the atrial channel Press F2 VENT for the ventricular channel The screen advances the examp...

Page 126: ...ulse rate and amplitude This parameter works with the LIMIT parameter to assign limits to both 4 For each pulse rate and amplitude press F3 LIMIT UP or DOWN arrow key to select the limit value 5 Press...

Page 127: ...4 4 41 F1 F2 F3 F4 eyr051 eps 7 Press F3 AMP to adjust the amplitude 8 Press F4 RATE to adjust the rate 9 Press F1 START to advance screen and start the test Note Target values for amplitude and rate...

Page 128: ...SigmaPace 1000 Operators Manual 4 42 F1 F2 F3 F4 eyr052 eps 10 Press F1 END to end the test F1 F2 F3 F4 eyr053 eps...

Page 129: ...ation values for rate and amplitude Up to 200 deviations are stored in the Analyzer memory Any long term test exceeding 200 deviations is automatically terminated The pulse width at the out of limit p...

Page 130: ...SigmaPace 1000 Operators Manual 4 44...

Page 131: ...emote Mode 5 3 Working in Remote Mode 5 3 Exiting Remote Mode 5 3 Command Syntax 5 4 Responses to Commands 5 4 Remote Mode Analyzer Setup Commands 5 4 Error Codes 5 5 Transcutaneous Pacemaker Remote S...

Page 132: ...SigmaPace 1000 Operators Manual 5 2...

Page 133: ...command is received from the MAIN MENU the instrument enters the REMOTE MAIN mode This remote mode cannot be entered directly from the sleep mode The local manual user interface is inactive and unavai...

Page 134: ...o Commands The instrument responds to all commands Commands that do not return any other message or data return the confirmation OK After receiving a command the instrument ignores all other incoming...

Page 135: ...D Diagnostic the baud rate setting of the Analyzer is transmitted to the host controller in response to this serial command BAUD nnnn Only baud rate settings of 2400 9600 or 19200 are valid Error Code...

Page 136: ...anscutaneous Pacemaker Remote Setup and Testing The following commands are associated with setting up and testing a transcutaneous pacemaker in remote mode SETMODE SETMODE TQPACE Selects the Analyzer...

Page 137: ...ated manufacturers Example SETMAKE ZM07 Table 5 1 SETMAKE Protocols by Manufacturer Manufacturer Make Selection Default Physio Control Cardiotronics PC01 Hewlett Packard Codemaster HP02 Marquette Medi...

Page 138: ...ment and maintains the last reading in memory RDMETER The Analyzer transmits the following information string for rate amplitude and width from the data frozen from the above HOLD serial command The d...

Page 139: ...from the data frozen with the above HOLD serial command The data is returned in the following format WIDTH XXXmS RDENERGY Even though the pacemaker pulse energy reading is not displayed when the RDMET...

Page 140: ...it number nn represents the percentage that ECG signal is lower than the measured pacemaker pulse rate Example With a measured pacemaker pulse rate of 60 PPM and the following underdrive command of UN...

Page 141: ...stated in the main product specification document SETTEST RFRACT The Analyzer begins the refractory test by measuring the pacemaker pulse rate if it is ZERO the Analyzer transmits RATE 000 and will n...

Page 142: ...TTEST NOISE The Analyzer generates a sine wave at the power line frequency of either 50 or 60 Hz at a prescribed amplitude Range 0 to 10 0 mV in 0 50 mV steps upon the receipt of this command Both the...

Page 143: ...dings with the pound sign TRENDEND Halts the trend test EXITTEST Leaves the selected test measurement EXITMODE Halts all tests and returns the Analyzer to the main serial control menu Transvenous Pace...

Page 144: ...is based upon the available factory preset selections The default test load value is 500 for both channels Example SETLOAD 0500 is the command for the selection of a 500 ohm test load for both the atr...

Page 145: ...s the same for all transmitted readings mA PPM and mS RDAH Returns atrial amplitude and rate RDVH Returns ventricular amplitude and rate RDAV The Analyzer transmits the following information string fo...

Page 146: ...Additionally single parameter information can be acquired for either of the channels RDAMPA RDAMPV The Analyzer transmits the following information string for amplitude from the data frozen with the a...

Page 147: ...HOLD serial command in one of these formats depending upon the energy level of the transvenous pacemaker pulse A Channel ENERGY XXXnJ ENERGY XXX J V Channel ENERGY XXXnJ ENERGY XXX J RESUME Releases t...

Page 148: ...measured pacemaker pulse rate of 60 PPM and the following underdrive command of UNDERDRIVE 20 a computed ECG signal rate of 48 BPM is generated All serial commands that do not return data or a predete...

Page 149: ...Width in mS nnn Amplitude in mV The Analyzer begins the refractory test by measuring the pacemaker pulse rate if it is ZERO the Analyzer transmits RATE 000 and will not start the test until a pulse r...

Page 150: ...5mV for the sine square selection 12 5 mV amplitude and width of 100 mS SETTEST NOISEA Atrial channel only SETTEST NOISEV Ventricular channel only The Analyzer generates a sine wave at the power line...

Page 151: ...gs with the pound sign A Channel AMP XXX mA RATE XXX PPM WIDTH XXX mS TRENDEND Halts the trend test EXITTEST Leaves the selected test SETTEST DCLEAK The basic dc leakage measurement function is activa...

Page 152: ...This error message is not active during the DCLEAK DYNAMICAV test since no discernable pulse should be present across the two A and V pacemaker channel outputs during the DDD mode of operation An erro...

Page 153: ...ted with either positive or negative sign Readings are available in milliamperes as specified if the input dc current exceeds the maximum response of DCLOADI XXX mA to the host controller EXITTEST Exi...

Page 154: ...SigmaPace 1000 Operators Manual 5 24...

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