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SigmaPace 1000 External Pacemaker Analyzer

1. L O A D he S Static amp Dynamic ECG fe Sensing amp Pacer gt A gt Control D V gt DC Leakage L V O A D y S Ventricular Channel Power ON OFF eyr006 eps Figure 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 leakage as follows e Atrial Channel de leakage across the atrial channel 500 Q test load e Ventricular Channel dc leakage across the ventricular channel 500 Q test load e AV Channel dc leakage across an auxiliary 500 Q test load connected to the atrial and ventricular outputs 4 8 Transvenous Pacemaker Testing Test Options Dynamic Tests Pacemaker Power ON These tests are triggered measurements of dc leakage measured prior to the specific output pulse as follows e Atrial Channel de leakage across the atrial channel 500 Q test load e Ventricular Channel dc leakage across the ventricular channel 500 Q test load e AV Channel dc leakage across an auxiliary 500 Q test load connected to the atrial and ventricular outputs Note Refer to the check out procedure for your specific pacemaker regarding testing protocols and limits for these dc leakage tests Current Drain Test This test measures the load current drawn by the pacemaker f
2. a OLITPLUT oe aff AMP 3 99 3 33 mA Rate 30 2 Bo 2 PPP Width 1 01 1251 A5 Aint 120 mS ATE WENT S00 HOLE OLY OHLY LOAD F1 F2 F3 F4 C eyr037 eps 2 Select the desired configuration e Press F2 ATR ONLY to display only atrial channel data e Press F3 VENT ONLY to display only ventricular channel data 3 Press F4 LOAD UP or DOWN arrow key to simultaneously select the desired test 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 single channel atrial single channel ventricular and dual channel atrial and ventricular pacemaker activity The unused channel goes blank if no pacemaker activity is sensed 4 Press F2 ATR ONLY or F3 VENT ONLY to display the following types of information the example is atrial channel 4 14 Transvenous Pacemaker Testing Setup and Testing Co C y OUTPUT A CH AMP 59 mA if i Holts kate 35 2 PFH Width 1 01 mS Energy 5r mJ io 4 RATE 5002 HOLD 20 LOAD F1 F2 F3 F4 OO S eyr038 eps 6 Press F2 RATE to toggle between NORM and lt 20 Note The RATE lt 20 is used to measure pacer activity 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
3. GE Medical Marquette 2201111 Responder Series MDE Medical Data Electronics 2201127 MRL Medical Research Laboratories R2 DAROX Zoll Medical NTP Seriese carne Zoll Medical PD and M Series Multi Function noone 1 29 SigmaPace 1000 Operators Manual Table 1 8 High Level Output Cables Subminiature Phone Plug to BNC Cable 2199932 Oscilloscope Application Subminiature Phone Plug to 3 Conductor 2200116 14 Phone Plug Cable AA 900 1 30 Chapter 2 Setup Operation and Maintenance Contents Page Setting Up the Analyzer cccecccccecssessceesceesceseceseensecsseeseeeaeenaes 2 3 Connecting External Transcutaneous Pacemakers 04 2 3 Connecting External Transvenous Pacemakers 000 2 4 Load Test Cable Connectoren sienien ia ieies 2 4 RS 232 Serial Port Connector esesessesseeessseseessesersrsersreseeseesee 2 5 High Level ECG Output Jack ceccecceseesseeseeeeeeeseeereeeeeeeeees 2 5 Ventilation eheann deca teaa prae aAa aaa ana 2 5 Power Up Seguente niana thine e e E e a E 2 5 Transcutaneous Pacemaker Testing c cccsceessesseeeseeeeeeeeeeeens 2 7 Transvenous Pacemaker Testing ccccccssecsseeseeeseeeeeeeseeereeeens 2 7 Utility Functions ener en diievecedtessnceiceee 2 7 Maintenance 24 nane a E N Metin E A 2 8 Avoiding Damage ccccesccssesssecsseeseeeseeeseeeseseeeseeneenseenseenaes 2 8 Cle amini 2 3 bon E acct fos tocecs ewaetesids acnehs Soetia feds
4. eyr073 eps 4 25 SigmaPace 1000 Operators Manual 5 Press F3 WAVE UP or DOWN arrow key to select a waveform ra N 7 SEMSE AMNF A CH Select waveform and width then press HEST S50 30 0m5 HEST WAVE WIDTH F1 F2 F3 F4 O000 UU eyr075 eps 6 Press F4 WIDTH UP or DOWN arrow key to adjust the width of the waveform 7 Press F1 NEXT to advance to the next screen 4 26 Transvenous Pacemaker Testing Setup and Testing SEMSE AMP A CH Select waveform amFlitude and polarity then Press START 2 00 mli START POL AMF F4 0000 OG 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 screen XS eyr076 eps After calculations the following screen appears 4 27 SigmaPace 1000 Operators Manual ir SEMSE ANF A CH Complete Rate 80 PRM Wave S50 Width 30 00 mS Ame 36 0 mi HIT RESTART CATA F2 F3 F4 SOAS a eyr077 eps 11 Press F4 XMIT DATA to transmit 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 either 50 or 60 Hz REFRACT SEHSE HOISE CEMAHD AMF LIHE SPEL From the SELECT TEST menu press
5. 8 Press F1 HOLD to advance the screen MIT RELEASE HUG SPEL 9 Press F4 XMIT DATA to transmit data through the serial port eyr016 eps 10 Press F1 RELEASE to release the hold and return to the HOLD screen 4 15 SigmaPace 1000 Operators Manual 11 Press ESC to return to previous menu s Demand Mode and Dual channel AV ECG Signal The following test measures the demand mode pacemaker s ability to interact with a simulated dual channel AV ECG signal PULSE DMAHD ASYHC OUTPUT MOCE MODE Dae PEE 1 From the SELECT TEST menu press F2 DMAND MODE eyr032 eps a D DEMAHD Seb Pacer bo demand mode AAT WUT or DOC then press START S000 START LOAD F1 F2 F3 F4 1019 QO 2 Press F4 LOAD UP or DOWN arrow key to select the load 3 Press F1 START to advance the screen and start the test X eyr067 eps 4 16 Transvenous Pacemaker Testing Setup and Testing OO DEMAMD Fate 80 BPH Dyer 32 BFH Under 68 PFH DRIVE SEEEHH FATE HOLG DRIVES BPM F1 F2 F3 F4 OO _ Ue 4 Press F2 SELECT DRIVE lt to toggle between the Over and Under BPM rates eyr039 eps 5 Once arate is selected press F4 DRIVE RATE BPM UP or DOWN arrow key to adjust the rate 6 Press F1 HOLD to advance the screen SMIT FELEASE DATA F1 F2 F3 F4 1091 7 Press F4 XMIT DATA to transmit data through the serial port
6. 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 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 by its affiliated dealers Manufacturing Location The SigmaPace 1000 External Pacemaker Analyzer is manufactured in Everett Washing ton by Fluke Biomedical 6920 Seaway Blvd Everett WA U S A Table of Contents Chapter Title Page 1 Introduction and Specifications scccseeeesseeeeenseeeeeees 1 1 IntroducttOn t i Setede ada tls te Aa shin Ae alee And 1 3 Compatible Pacemaker Types c ccsccssesssessceeceeeneeeseeeeceaeeeeeeeeaees 1 3 Incompatible Pacemaker Types 1 3 General Safety Considerations ccccceeccessceseeseeeeceeceseeseeeeceseenseeneens 1 4 SYMONS 3 23 r a Nien teal Ea A aa EE aoso 1 4 Warnings and Cautions 1 4 Power SUPPLY periminen AE A E AAEE A 1 5 Defibrillators and Transcutaneous PacemaketS csccssesseeeeeeees 1 5 Applications 1 6 Features 1 6 Unpacking and Inspection cececcceseeseeesceseeneeeeceecesecaecaeeeeeeseeeaeeneees 1 7 Instrument Familiarization 2 ceccceescesececeeseeeeceecesecseeseeeeeeseenaeeneees 1 8 ADDTe Vat ONS vs sci cates isesi sicer tiririka
7. eyr016 eps 8 Press F1 RELEASE to release the hold and return to the HOLD screen 9 Press ESC to return to previous menu s 4 17 SigmaPace 1000 Operators Manual Continuous Mode and Dual channel AV ECG Signal The following test measures the continuous or non demand pacemaker s ability to interact with a simulated dual channel AV ECG signal PULSE DMAHD ASYHC OUTPUT MOCE MODE oe SPE 1 From the SELECT TEST menu press F3 ASYNC MODE eyr032 eps a r ASYM Set Pacer bo ASYM mode ADO WOO or DO then press START S000 START LORD F1 F2 F3 F4 1919 _ 90 2 Press F4 LOAD UP or DOWN arrow key to select the load 3 Press F1 START to advance the screen and start the test eyr068 eps 4 18 Transvenous Pacemaker Testing Setup and Testing CSS o y ASYHC Fate 80 BPH Dyer 32 BFH Under 68 PFH DRIVE SEEEHH FATE HOLG DRIVES BPM F1 F2 F3 F4 OO _ Ue 4 Press F2 SELECT DRIVE lt to toggle between the Over and Under BPM rates eyr040 eps 5 Once arate is selected use F4 DRIVE RATE BPM UP or DOWN arrow key to adjust that rate 6 Press F1 HOLD to advance the screen SMIT FELEASE DATA F1 F2 F3 F4 1091 7 Press F4 XMIT DATA to transmit data through the serial port eyr016 eps 8 Press F1 RELEASE to release the hold and return to the HOLD screen 9 Press ESC to return to previous menu
8. Transcutaneous Pacemaker Testing Test Options Pacing Rate Interval 80 BPM 750 mS PRP Cardiac Test Pulse Pacing Rate _ Interval Reset gt 750 mS PRP Sensed Cardiac Test Pulse eyr003 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 the PRP See Figure 3 3 This coupling interval is slowly extended until the simulated ECG signal falls outside the PRP The signal is then sensed by the pacemaker causing the escape interval to reset The result is a longer pacing pulse interval 3 7 SigmaPace 1000 Operators Manual Pacing Rate Interval Reset gt 750 mS Sensed Cardiac Test Pulse 1 SRP Pacing Rate Interval Reset 2 X Sensed Cardiac Sensed Cardiac Test Pulse 1 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 continuously over an extended time period Each measured pulse is compared to factory preset limits of 10 for both monitored variables Test limits are adjustable by the user 3 8 Transcutaneous Pacemaker Testing Test Options Upon completion of the desired long term test duration the user can review pacemaker output pulses falling outside these test limit
9. Both the frequency and the amplitude of this sine wave are encrypted in the following serial command structure The serial command structure is NOISE XX nn n where the XX represents the power line frequency in Hz 50 or 60 and nn n represents the amplitude in millivolts Example NOISE 60 05 5 generates a sine wave at a frequency of 60 Hz at an amplitude of 5 5 mV ECG ON ECO OFF SETTEST TREND The Analyzer runs the prescribed trend test using 02 to 20 as the deviation point from the computed average pulse amplitude rate and width TREND uu nnnn zz nnn uu test limit for amplitude nnnn Set point for amplitude 0 1 mA resolution 5 12 Remote Operation 5 Transvenous Pacemaker Remote Setup and Testing zz test limit for rate nnn Set point for rate IPPM resolution The data is returned in the following format AMP XXX mA RATE XXX PPM WIDTH XXX mS when a reading is out of the prescribed test limit range For each parameter the Analyzer returns a three digit numeric value XXX with a floating decimal point to cover the multiple ranges The unit of measure remains the same for all transmitted readings mA PPM and mS The Analyzer marks the out of limit readings 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 Pacemaker Remote Setup and Testi
10. whichever is greater 0 02 mS to 999 mS 1 00 mS to 9 99 mS 10 0 mS to 99 99 mS 0 5 or 14 uS whichever is greater 1 LSD or 4 uS whichever is greater SigmaPace 1000 Operators Manual VONAGE riseiras aviati 0 050 Vpeak to 999 V peak 1 00 Vpeak to 9 99 Vpeak 10 0 Vpeax to 30 0 Vpeax ACCURACY airar ina aaiae a scenes 2 of reading or 0 05 Vpeak whichever is greater Polarity Indicato fisians or ENGL GY AEE A A 1 nJ to 999 nJ 1 uJ to 999 uJ add J range PCCULAGCY erine i naaa 5 of reading computation Displayed Data Single Amplitude Current Amplitude 0 cccececeeeeeeeeeeeneeeeeeeeeteeeeetee Volts Rate Width Energy Dual Atrial and Ventricular AMPIU E iscsi Current Rate Width AV Interval AV Interval Delay Time TESE TYPE nats cca e aaa RE NEER Quantitative Measurement Ranges 10 0 mS to 99 9 mS 100 mS to 999 mS Start Stop Points Sta ear I E Ta Leading edge of atrial pacemaker pulse SLOP ATA A E Leading edge of ventricular pacemaker pulse ACCURACY isseccsscrssicesectstecsctvessecsiscasieanavetevaninacterss 1 of reading computation Demand Mode Test TSH TY Pe ercepeae eaaa EEE Qualitative Channels 5110 0 Wane Nees eet ne ee ear ene Ape en re Atrial or Ventricular Only Dualliz ceaciainiein cated AN A V Introduction and Specifications 1 Instrument Specifications Simulation SSQ Simulated P wave WV OU scat cane ated aa teen tocaeguene eden 30 m
11. 4 7 DCCA Age titeiniiigicestanesale tated 4 7 Static Tests Pacemaker Power OFF 4 8 Dynamic Tests Pacemaker Power ON wee 4 9 Current Drain Test wee 49 Long Term Test we 4 11 Setup and Testing wee 4 11 Output essa hairs ee i Tss tered vee 4 13 Demand Mode and Dual channel AV ECG Signal we 4 16 Continuous Mode and Dual channel AV ECG Signal 4 18 Demand Mode Pacemaker s Ability to Sense ECG Activity 4 20 Amplitude of ECG Signal for a Demand Mode Pacemaker wee 4 23 Pacemaker s Ability to Filter Line NOiSe eceeseesseesceteeneeeeeeees 4 28 DC Leak Test ussccnvawenadendienaaiin dane AENA 4 31 DC Load Test 4 34 ECG Simulation Test wee 4 36 Long Term Tests E wee 4 38 Remote Operation ssssssunsennsnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn we 5 1 Introduction 0 0 0 cece o7 wee 5 3 Entering Remote Mode cccccceessssscesecsecseeseceseceaecaeeeeeeeceaeeeeeeeeaees 5 3 Working in Remote Mode ceceeccescesceesceeeceeceaecseeeeeeeeceaeeeeeeenaees 5 3 Exiting Remote Mode 5 3 Command Syntax 5 4 Responses to Commands e cesceeeeeeeeees 5 4 Remote Mode Analyzer Setup Commands 5 4 ETOL COGS A Maren Mahe tt aloha Aol ip Ae 5 5 Transcutaneous Pacemaker Remote Setup and Testing we 5 6 Transvenous Pacemaker Remote Setup and Testing ceeeeseeseeee 5 13 iii SigmaPace 1000 Operators Man
12. F3 NOISE LINE eyr033 eps 1 4 28 Transvenous Pacemaker Testing Setup and Testing _ a C y HOT SE AMP elect 30 or 60 Hz g T sired channel en Press HEAT He an her ee i A 60 Hz SO0Q CHAN LIHE LOAD MEST F2 oleae Press F2 CHAN to toggle between the two options eyr078 eps e A atrial channel e V ventricular channel Press F3 LINE to toggle between two line frequencies 50 or 60 Hz Press F4 LOAD UP or DOWN arrow key to select the load Press F1 NEXT to advance to the next screen 4 29 SigmaPace 1000 Operators Manual N HOTSE AMF A CH Ame 33 3 mil Sinewave 60 Hz ECG HOLE OH AMF F1 F2 F3 F4 eyr044 eps 6 Press F3 ECG to toggle the ECG function ON or OFF 7 Press F4 AMP UP or DOWN arrow key to adjust the amplitude of the noise line frequency selection 8 Press F1 HOLD to advance the screen MIT RELEASE DATH G0aa 9 Press F4 XMIT DATA to transmit data through the serial port eyr016 eps 10 Press F1 RELEASE to release the hold and return to the HOLD screen 11 Press ESC to return to previous menu s 4 30 Transvenous Pacemaker Testing Setup and Testing Integrity of the Pacemaker s Final Stage The integrity of the pacemaker s final stage is evaluated using the following tests DC Leak Test BC DE ECG LEAK LOAL SIH Dno oleleie 1 From the SELECT TEST menu
13. amplitude of the simulated ECG signal required by the demand mode pacemaker 1 From the SELECT TEST menu press F2 SENSE AMP 3 20 REFRCT SENSE HOISE DEMAND AMP LINE r F1 F2 F3 SLAA 7 lt a SEHSE AMP 2ZOLL M Select waveform and width TEI 40 Ome HEST WAJE WIDTH F1 F2 F3 F4 1019 9O eyr012 eps eyr062 eps Transcutaneous Pacemaker Testing Setup and Testing 2 Press the F4 LOAD UP or DOWN arrow key to select the load 3 Press F1 NEXT to advance the screen for waveform selection nn SEMSE AMNP Z LL Select waveform and width then press HEAT TRI 40 0ms HET WALE WIDTH F1 F2 F3 F4 OO88 _ 9o 4 Press F3 UP or DOWN arrow key to select waveform type eyr062 eps 5 Press F4 UP or DOWN arrow key to select waveform width 6 Press F1 NEXT for amplitude and polarity selection 3 21 SigmaPace 1000 Operators Manual ra W 7 SEMSE AMNF 2O0LL M Select waveform amplitude and polarity then press START 1 00ml START POL AMP F1 F2 F3 F4 O000 UU 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 test 3 22 le XS Transcutaneous Pacemaker Testing Setup and Testing SEMSE ANF Z0LL M Complete Rate 80 PPH Wave SSA Width
14. input terminals during this power off continuous test e During the atrial and the ventricular channel DYNAMIC tests An error message PULSE is returned if pulse output is present on the Analyzer input terminals during these power on triggered tests 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 error message NO PULSE is returned if no pacer pulse output is present on the Analyzer input terminals during these two power on triggered tests This error message is not active during the DCLEAK DYNAMICAYV test since no discernable pulse should be present across the two A and V pacemaker channel outputs during the DDD mode of operation SETTEST DCLOADI The Analyzer measures the dc current present at its associated input terminals This dc current can be input in either a positive or negative polarity RDDCLOADI This command queries the Analyzer for the current dc load current test reading and the Analyzer returns the data in the following format DCLOADI XX X mA 5 22 Remote Operation 5 Transvenous Pacemaker Remote Setup and Testing The polarity of the dc current is indicated with either positive or negative sign Readings are available in milliamperes as specified if the input dc current exceeds the maximum response of DCLOADI X
15. numeric value XXX with a floating point decimal to cover the multiple ranges The unit of measure remains the same for all transmitted readings mA PPM and mS 5 15 SigmaPace 1000 Operators Manual RDMETERAVI This command is compatible with dual chamber AV sequential pacemakers only The Analyzer transmits the following information string for the AV interval or delay from the atrial and the ventricular data frozen from the above HOLD serial command The data is returned in the following format AV Interval XXX mS The Analyzer returns a three digit numeric value XXX with a floating point decimal to cover the multiple ranges The unit of measure remains the same for all transmitted readings mS 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 above HOLD serial command The data is returned in the following format A Channel AMP XXXmA V Channel AMP XXXmA For each parameter the Analyzer returns a three digit numeric value XXX with a floating point decimal to cover the multiple ranges The unit of measure remains the same for all transmitted readings mA RDRATEA RDRATEV The Analyzer transmits the following information string for rate from the data frozen with the above HOLD serial command The data is returned in the following format A Ch
16. press F1 DC LEAK eyr034 eps fr gt DE LEAKAGE Select test ture OFF Static Test OH Dynamic Test OFF OH F1 F2 F3 F4 C J eyr080 eps 4 31 SigmaPace 1000 Operators Manual 2 Select a test type e F1 OFF Static test Turn pacemaker power OFF e F2 ON Dynamic test Turn pacemaker power ON The screen advances a N rc DC LEAKAGE Static Test Turn Facer Power OFF Select racer channel ATRIAL WENT A F1 F2 F3 F4 OOOO J eyr081 eps 3 Press one of the three options e F1 ATRIAL for atrial channel only e F2 VENT for ventricular channel only e F3 A V for both atrial and ventricular channels The screen advances 4 32 Transvenous Pacemaker Testing Setup and Testing OO OC LEAKAGE A STATIC OC Leask 3 9 pA OC HOLD F1 F2 F3 F4 OO VO 9 Press F1 HOLD to advance the screen XS eyr046 eps MIT RELEASE DATA SPE 12 Press F4 XMIT DATA to transmit data through the serial port 13 Press F1 RELEASE to release the hold and return to the HOLD screen eyr016 eps 14 Press ESC to return to previous menu s 4 33 SigmaPace 1000 Operators Manual DC Load Test DE DE ECG LEAF LOAL F1 F2 SLAA 1 From the SELECT TEST menu press F2 DC LOAD eyr034 eps C N DC LOAD 100 mA MAs Connect ext battery and test fixture to racer SUD power inl
17. relevant Australian EMC requirements Conforms to relevant Canadian and US standards Conforms to European Union directives IEC Measurement Category CAT equipment designed to CAT protect against transients in equipment on circuits not directly connected to MAINS Under no circumstances should the terminals of the Analyzer be connected to any MAINS voltage Warnings and Cautions 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 permanent loss of data 1 4 Introduction and Specifications 1 General Safety Considerations AA Warning To avoid possible electrical shock or personal injury follow these guidelines Use this Analyzer only in the manner specified by the manufacturer or the protection provided may be impaired Read the Operators Manual before operating the Analyzer Do not use the Analyzer if it operates abnormally Do not use the Analyzer in wet locations around explosive gases or dust Use extreme caution when working with voltages above 30 volts Use the proper terminals functions and ranges for the test being performed Do not connect the Analyzer to a patient or 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
18. teases coigeesides 2 9 Service anid Calibrations coneis 2 9 Packing Instructions ccscceseeeseseeceseeeeeceecseeeseeeseeneeeerenseens 2 10 SHIPPING eee eee n a heen eae ee ee 2 10 2 1 SigmaPace 1000 Operators Manual 2 2 Setup Operation and Maintenance a Setting Up the Analyzer Setting Up the Analyzer The Analyzer utilizes an external plug in universal power supply It automatically operates with applied main voltages rated from 83 to 264 V ac or from the internal battery No transformer taps jumpers or programming tabs are required for Analyzer operation The Analyzer is shipped from the factory with the power supply configured for the desired or specified country or region If your Analyzer is equipped with an incompatible power supply configuration contact the Fluke Biomedical Service Center regarding replacement order adjustment Compatible power supplies and associated part numbers are listed in the chapter Introduction and Specifications Set up the Analyzer for initial operation by plugging 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 the transcutaneous pacemaker to the Analyzer optional disposable electrode adapters are available from Fluke Biomedical and are compatible with most device manufacturers These adapters connect the external pacemaker t
19. 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 dc leakage measurement Unpacking and Inspection When unpacking the Analyzer check for damage during shipment If the Analyzer has been damaged call your Fluke Biomedical Service Center immediately If you must return the Analyzer to Fluke for service follow the procedure given under Service and Calibration 1 7 SigmaPace 1000 Operators Manual Instrument Familiarization The Analyzer s features and controls are shown in Figure 1 1 and described in Table 1 2 eyr056 eps Figure 1 1 Analyzer Features and Controls Introduction and Specifications 1 Instrument Familiarization Table 1 2 Analyzer Features and Controls Number Description Top Panel Atrial Channel Pacemaker Input Jacks 4 mm Red Positive Black Negative Ventricular Channel Pacemaker Input Jacks 4 mm Red Positive Black Negative Transvenous and Transcutaneous e Right Side Panel 11 Ventricular Channel Sense Indicator Yellow LED 12 Low Level ECG Output Disposable Snap Compatible High Level ECG Output Subminiature Phone Jack 14 Charger dc Power Supply Input Jack 15 Ventilation Slots Left Side Panel Load Current Phantom Battery Input Connector RS 232 Serial Port Bottom Panel RESET Button 1 9 SigmaPace 1000 Operators Ma
20. transcutaneous pacemaker testing is shown in Figure 3 1 The specified or default test load is pre selected with each algorithm If desired you can easily select any test load 50 Q to 1550 Q in 50 Q steps with each measurement algorithm Ensure that you select a test load within the device manufacturer s specified operational range Device specific measurement algorithms are selectable for the following list of manufacturers Physio Control Lifepak Series 50 Q HP Agilent Codemaster 400 Q GE Marquette Responder Series 300 Q Medical Data Electronics 600 Q Medical Research Laboratories 500 Q Zoll Medical PD Series 1000 Q Zoll Medical M Series 100 Q Tests requiring ECG simulation have three available active outputs Low Level 2 5 Lead RL N RA R LA L LL F and V1 C1 Transthoracic Across the selected ventricular test load High Level 1 Output Amplitude tracks low level Lead I 1000 1 5 0V peak maximum amplitude Connector Type Subminiature Phone Jack 3 3 SigmaPace 1000 Operators Manual ECG Monitor ECG Sensing amp Pacer High Level Co Pe 0 F Transcutaneous SIGMAPACE 1000 Pacemaker External Pacemaker Analyzer H eyr002 eps Figure 3 1 Scheme for Testing Transcutaneous Pacemakers Output The Analyzer measures the output of the transcutaneous pacemaker and displa
21. 40 mS Ame 0 15 mil MIT FESTART CATA F1 F2 F3 F4 OO YUU 10 Press F4 XMIT DATA to 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 eyr022 eps The following test measures a pacemaker s ability to filter line noise at either 50 or 60 Hz 1 From the SELECT TEST menu press F3 NOISE LINE fae SENSE NOISE E ae DEMAMG AMF LIHE F1 F2 F3 SLAA eyr012 eps 3 23 SigmaPace 1000 Operators Manual 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 r N HOTSE AMF ZOLL Select 50 or 60 Hz then press HEST 60Hz 1000 NEXT LINE LOAD F1 F2 F3 F4 oog O YUU 4 Press F1 NEXT to advance the screen 3 24 eyr064 eps Transcutaneous Pacemaker Testing Setup and Testing i _ o gt y HOTSE AMP Z LL Ame 1 0 ll Sinewave 60 Hz ECG HOLE OH AMP F1 F2 F3 F4 eyr065 eps Press F3 ECG UP or DOWN arrow key to toggle the ECG function ON or OFF Press F4 AMP UP or DOWN arrow key to adjust the amplitude of the line frequency Press F1 HOLD to advance the screen 3 25 SigmaPace 1000 Operators Manual N HOTSE AMF ZOLL Ame 1 0 mii FINEAJE 60 Hz SMIT RELEASE DATA F1 F2 F3 F4 O080
22. AKE ZM07 Table 5 1 SETMAKE Protocols by Manufacturer Manufacturer Make Selection Default Physio Control Cardiotronics PCO1 Hewlett Packard Codemaster HP02 Marquette Medical MQ03 RDMAKE This command returns the NAME and Reference for the specified make Example ZM 07 Zoll Medical M Series pacemaker SETLOAD SETLOAD nnnn This command is used to select the desired test load The above nnnn represents the actual test load resistance value in ohms and is based upon the available factory preset selections 5 7 SigmaPace 1000 Operators Manual Example SETLOAD 0050 is the command for a 50 Q test load Selections for nnnn range from 0050 to 1550 in 50 Q increments RDLOAD Reads the current test load setting When this command is sent to the Analyzer it returns LOAD nnnn where nnnn equals the resistance in ohms from 50 to 1550 Q SETTEST SETTEST PULSE The Analyzer monitors the applied pulse rate amplitude width and energy data HOLD Freezes the pacer measurement 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 data is returned in the following vertical format AMP XXX mA RATE XXX PPM WIDTH XXX mS For each parameter the Analyzer returns a three digit numeric value XXX with a floating decimal point to cover the multiple
23. FLUKE EE Biomedical 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 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 war ranty 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 exclusion or limitat
24. Period ccceccceeseesscescceeceseeeeeceeeseeeeeeeeeeneeeerenrens 3 6 Paced Refractory Period PRP cc cssceeseeseeeeseeeteeeees 3 6 Sensed Refractory Period SRP c ccscssseeseeeeeseeeeeseeees 3 7 Tong Term Testaan aeaa N ae ea 3 8 Interactive Pacemaker ECG Simulation ccsceeeseeees 3 9 Simulated ECG Rate seescsesseseseseecesesesenecsersnenevenenees 3 9 Adjustable Threshold Level ccccesccesecsceeseeeseeeseesseeseeees 3 9 Operational Modes ccccesceseessceseceseceeecaeeeseeeaeeeseeneeeereneeens 3 9 Continiuous 4 00 setae iia ae ee eae 3 9 Non aptures joc recSiviea actepenkeaviehasdersnectoateetiheaebees S 3 9 NOD FUnCHOD eigne iiiar E Ea E ak 3 10 Setup and Testing ccecccesccssecsecsecseecseeeeeeseeseeeeeeseeeseeeeeeeeaees 3 10 OUPA iea Sted ed REEE REE ieee ames E ENE 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 Amplitude of ECG Signal for Demand Mode Pacemaker 3 20 Pacemaker s Ability to Filter Line Noise cc eeeeeeeeeeneeeees 3 23 Purpose of the ECG Simulation Test ccccccsseeseereeeeeeeees 3 26 Long Term Tests i i250 ce Gisk cote Ses cao cs kaa eek cv a a cokes cbse 3 27 3 1 SigmaPace 1000 Operators Manual Transcutaneous Pacemaker Testing Test Options Test Options The scheme for
25. RP Sensed Refractory Period SRP POTN OD oc sicitaicta dani cesienvsanegnsdusateasieeweeteianatanaeedeues 20 to 500 mS PC CURACY oot esac side dises sac inariana aanita 5 of reading or 1 mS whichever is greater 1 24 Introduction and Specifications 1 Instrument Specifications Resolutioniin sc siieisccdeceesditeeasececieeneaicdtedersvcsvenevsavensis 1 LSD Display Format 3 digits Physiological Simulation Selection Default cceeeeeeeeeteeeeeseeeeeeneeeees Single Channel Simulation V Square Wave Ventricular Channel ceeeeeeeeeeneeeeees Simulated R wave Widths a nce N E rte 1 0 mS AMplitude inia siendi inian s 20 MVpeak Active Outputs inienn a ai Ventricular Channel 4 mm Banana Jacks Only Available Test Load S cccceseceeeeeteeeeeeees 500 Q Only Additional Waveform Selections Square SQU Triangle TRI Haversine HSN Sine Square SSQ Asymmetrical Triangle ISO Fixed Width2 mS rise time 13 mS fall time Amplitude Pacer Load Selection 500 Q Range iii ataa ea lea ee 0 05 MVpeak 50 Vpeax to 50 0 MVpeak ACCURACY nade der eedsschisvcadssetvedicstaneessidesntuncueds 5 of setting Resolution Step Size ceccceeeeeeeeeeeeees 0 05 MVpeax Steps from 0 05 MVpeax to 0 95 MVpeak 0 50 MVpeax Steps from 1 0 MVpeax to 50 0 MVpeak Default Setting vii ccicsscccsecsesseecincencessevenrtesteces 20 0 MVpeak Width Range sui banea sd corel GNR ot tate 0 15 mS to 300 m
26. S ACCUTACY mor hiera aiats anaana itai 5 of setting Selection Count ccccccciesedeseecceaieeseateiegvisesenes 58 Resolution Step Size ccceceeeseseeeeeeeeeeeeeee 0 05 mS steps 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 25 mS steps from 100 mS to 300 mS Default Setting MS ceeeeeeeeeeeeeeeteeeeeee 30 mS Intended Pacemaker Types VVI Ventricular Pace and Sense Only Compatible Pacemaker Rates c ceeee 20 to 200 PPM 1 25 SigmaPace 1000 Operators Manual DC Leakage Current Test Type Measurement Range Input Polarity Resolution Display Format Test Selections Dynamic Pacemaker Power Input Configurations Current Drain Test Test Type Measurement Ranges DC CUNO esc cceseadecvesncs cacsiseveteaseccesterssteeyereaasceetie Polarity Polarity Indicator FRESOIULIOM visiirisi aiiai Display Format cesars oisinn ACOA CY aranana R E a T Input DC Voltage Nominal RANJE serenti retkineen Input Protection Protection Type Selectable Testloads 1 26 Atrial and Atrial Ventricular and Ventricular Atrial and Ventricular third internal 500 Q test load Gated measurement preceding the delivered pacemaker pulse ON Atrial and Atrial Ventricular and Ventricular Atrial and Ventricular third internal 500 Q test load Quantitative 0 100 mA to 999 mA 1 00 mA to 9 99 mA 10 0 mA to 99 9 mA Po
27. S AMPlITUGG caninin 2 0 MV peak Ventricular Channel cccccceeeeeeeeeeeeeeeeeeeees Simulated R wave Width wcsedcecascssiedenevaciaviseand ba edinrectsenneeaceneet 40 mS AMpPlitUG Geis aisevecesses ccaczecaseysicansceeossznatevasdonses 2 5 MVpeak PR Inte nal pms naaa tend 90 mS Interactive Simulated Rates Default Settings UnNdErdrVe aniisi etniniai aiaiai NSR 85 of measured pulse interval rate Overdri yE oasis cccccvsscsdstcs cocedceesieceesncsssesavertacetssoes NSR 115 of measured pulse interval rate Manual Control c ccccccceeesceeeeeneeeteeeeeeees The under overdrive NSR simulations can also be independently adjusted in 1 BPM increments Manual Rate Limits Underdrive minimum ccceeeeeeeeeeees 10 BPM Overdrive MAXiMUM cceeeeeeeesteeteeeees 300 BPM Active Outputs Synchronous Selected Ventricular Channel Test Load Selected Atrial Channel Test Load Pacemaker Compatibility Pulse Rate Range ccccsceeeeeeeeeteeeeeeeeeeeee 30 to 200 PPM Intended Pacemaker Types VVI Ventricular Channel Only Pace and Sense AAI Atrial Channel Only Pace and Sense DDD Both Channels Pace and Sense Asynchronous Mode Test Qualitative Atrial or Ventricular Only ATV SigmaPace 1000 Operators Manual Amplitude Sensitivity Test TeSt Ty P erci a eaaa Qualitative Channels Single Channel Operation Only Atrial or Ventricular Atrial Channel TeSt TYPE erii
28. START to restart the test Press ESC to return to previous menu s 4 43 SigmaPace 1000 Operators Manual 4 44 Chapter 5 Remote Operation Contents Page Introductions eon E Aaa ee eae Rais 5 3 Entering Remote Mode 0 cececeeccssesceseceeeeeceeeeeceeeeeeeaeeaeeaeens 5 3 Working in Remote Mode ccccccsesseeesceseceeeeeseesseeeseenseeneeenes 5 3 Exiting Remote Mode ou ceescsssesscseeeececeeeceseeeeeseeeeeseeeeerenee 5 3 Command Syntax secesie iinr ci iinis rise 5 4 Responses to Commands ccccccesseeesceseceseceeeeseeeseeseeeeeenes 5 4 Remote Mode Analyzer Setup Commands ceeeeeeeeeeee 5 4 Error Codes i 44 i deena dentin Ven ae e aan hae 5 5 Transcutaneous Pacemaker Remote Setup and Testing 5 6 Transvenous Pacemaker Remote Setup and Testing 4 5 13 5 1 SigmaPace 1000 Operators Manual Remote Operation 5 Introduction Introduction Remote commands can be used to control the Analyzer Remote operations can be accessed through the RS232 serial port using a controller such as the medTester 5000C or a personal computer The remote mode of operation provides Analyzer command control and data capture transfer functions Primary commands are valid when the instrument is in the MAIN MENU or in the REMOTE MAIN mode At power up global variables are set to the default The global variable setup commands are valid in the MAIN MENU and also in the modes where they ar
29. Types The Analyzer is designed to test temporary EXTERNAL pacemakers pacers only These devices are commonly referred to by the following nomenclature e External transcutaneous pacemaker e External transthoracic pacemaker e External transvenous pacemaker e External temporary pacemaker e External AV sequential pacemaker e Dual Chamber temporary pacemaker e Non Invasive pacemaker Incompatible Pacemaker Types The Analyzer is not designed to test internal pacemakers Additionally it is not used to test any programmable implantable pacemakers or any related implanted cardiovascular catheters or lead wires These devices are commonly referred to using the following nomenclature e Internal pacemaker e Implantable pacemaker e Permanent pacemaker Note The Analyzer does not perform any clinical diagnostic therapeutic or monitoring functions and is not for use directly with patients 1 3 SigmaPace 1000 Operators Manual General Safety Considerations This instrument and related documentation must be reviewed for familiarization with safety markings and instructions before you operate the instrument Symbols Table 1 1 describes the symbols used on the instrument and or in this document Table 1 1 Symbols oo Important information refer to manual Hazardous Hazardous voltage Do not dispose of this product as unsorted municipal waste Go to Fluke s website for recycling information a Conforms to
30. XX mA to the host controller EXITTEST Exits the selected test measurement EXITMODE Halts all tests and returns the Analyzer to main menu serial control 5 23 SigmaPace 1000 Operators Manual 5 24
31. actory period is first computed and then reported in the following format PRP XXX mS The sensed refractory period SRP is computed and reported in the following format SRP XXX ms Note This reported data has three digits and no displayed decimal point SETTEST SENSE The demand sensitivity test can run with one of three different waveforms square triangle and sine squared Set the test to SENSE then select the desired waveform for the test SENSE SQU nnn nn SENSE TRI nnn nn SENSE SSQ nnn nn SENSE HSN nnn nn The nnn represents the width selection mS of the sensitivity test waveform 5 11 SigmaPace 1000 Operators Manual The Analyzer begins the demand sensitivity test by measuring the pacemaker pulse rate then it places the selected waveform at 50 of the pacemaker pulse to pulse rate interval and initiates the protocol as stated in the main product specification document The Analyzer response displays SENSE XXX ZZZ ZZm SYYYmv XXX is the waveform type as indicated above ZZZ ZZ is the pulse width YYY are the three digit amplitude numeric reading either with or without the floating decimal point Example SENSE SSQ 100mS 12 5mV for the sine square selection 12 5 mV amplitude and width of 100 mS SETTEST 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
32. advance to the next screen 4 40 Transvenous Pacemaker Testing Setup and Testing OO LOWG TERM W CH Select target START amFlitude and rate then press START Ame 10 0 mA Fate 80 PPH AMF RATE F1 F2 F3 F4 OO XS S Press F3 AMP to adjust the amplitude Press F4 RATE to adjust the rate Press F1 START to advance screen and start the test Note eyr051 eps Target values for amplitude and rate must be entered for test to perform correctly 4 41 SigmaPace 1000 Operators Manual r LOH TERM WU CH eTime OOO 02 24 Ame 10 3 mA 10 Rate 70 FFH 10 Width 1 77 mS Count 00234 001 EMD F1 F2 F3 F4 10 Press F1 END to end the test 4 42 a rc LOHWG TERM U CH etime O0O0 15 46 Ame 10 3 mA 10 Rate 54 2 FRM 10 Width 1 77 mS Count O0z44 001 Total Errors 013 RESTART REWTEM MIT F1 F2 F3 F4 ooog eyr052 eps eyr053 eps 11 12 13 14 Transvenous Pacemaker Testing Setup and Testing Press F3 REVIEW UP or DOWN arrow key to view deviations falling outside the selected deviation 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 pacemaker pulse is also reported Press F4 XMIT to transmit data Press F1 RE
33. al or ventricular or dual channel atrial and ventricular external pacemaker to the SigmaPace 1000 A A Warning To avoid injury to a patient do not connect the Analyzer to a patient or 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 contact with a patient Load Test Cable Connector The load test cable plugs directly into the Analyzer left side panel connector marked CURRENT DRAIN TEST This standard accessory cable contains a nine volt battery to power the external pacemaker Note A 0 5 Amp FAST BLO fuse protects the load test metering circuitry from an accidental short circuit or overload 2 4 Setup Operation and Maintenance a Power Up Sequence RS 232 Serial Port Connector The RS 232 serial port is used to connect the Analyzer to a controller for remote operation Refer to Instrument Familiarity for the location of this connector and to the Remote Operation chapter for instructions on how to operate the Analyzer remotely High Level ECG Output Jack From the right side panel you can connect the high level ECG output to a compatible oscilloscope 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 Specifications Ventila
34. ameters 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 from 2 to 20 in 1 increments 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 reviewed LOHS TERM R GOOG 1 From the SELECT TEST menu press F3 LONG TERM eyr035 eps 4 38 Transvenous Pacemaker Testing Setup and Testing CoN LOH TERM SELECT CHAHHEL ATRIAL WEHT F1 F2 F3 F4 p XS eyr049 eps 2 Select one of the following two options e Press F1 ATRIAL for the atrial channel e Press F2 VENT for the ventricular channel The screen advances the example is the ventricular channel 4 39 SigmaPace 1000 Operators Manual r N 7 LOHG TERM W CH Select pulse rate and amplitude limits then press HEST AMP lt itt SCC HEST FATE LIMIT LOAD F1 F2 F3 F4 O000 YUU 3 Press F2 RATE to toggle between pulse rate and amplitude This parameter works with the LIMIT parameter to assign limits to both eyr050 eps 4 For each pulse rate and amplitude press F3 LIMIT UP or DOWN arrow key to select the limit value 5 Press F4 LOAD UP or DOWN arrow key to select the load 6 Press F1 NEXT to
35. annel RATE XXXPPM V Channel RATE XXXPPM 5 16 Remote Operation 5 Transvenous Pacemaker Remote Setup and Testing RDWIDTHA RDWIDTHV The Analyzer transmits the following information string for width from the data frozen with the above HOLD serial command The data is returned in the following format A Channel WIDTH XXXmS V Channel WIDTH XXXmS RDENERGYA RDENERGYV A pacemaker pulse energy reading is not displayed when the above RDMETER serial command is evoked It is computed and the Analyzer transmits the following information from the data frozen from the above HOLD serial command in one of these formats depending upon the energy level of the transvenous pacemaker pulse A Channel ENERGY XXXnJ ENERGY XXXupJ V Channel ENERGY XXXnJ ENERGY XXXupJ RESUME Releases the HOLD serial command and proceeds to making measurements SETTEST DEMAND The Analyzer enters the qualitative demand test All serial commands that do not return data or a predetermined response send OK to indicate that the serial command was received understood and executed The applied pacemaker pulse rate is measured if it is ZERO the Analyzer shall transmit RATE 000 and not start the test until a pulse rate is detected If the rate is between 30 and 200 PPM it waits for either of the following commands OVERDRIVE nn 5 17 SigmaPace 1000 Operators Manual The Analyzer computes a dual AV channel overdrive higher ECG signal
36. cceceseeeeeeeeeeeee 500 Q RANG AAEE E 0 05 MVpeak 50 Vpeak to 50 0 MVpeak Accuracy t5 of setting Resolution ji ia ada aed 0 05 MVpeax Steps from 0 05 MVpeax to 0 95 MVpeak 0 50 MVpeax Steps from 1 0 MVpeax to 50 0 MVpeak Pacer Load Selection cec eects 200 Q 0 05 MVpeak 50 Vpeak to 20 0 MV peak ACCUIACY inniinn hahau 5 of setting RESOlUtO M aee oiaro eai e a 0 05 MVpeak steps from 0 05 MVpeak to 0 95 MVpeak 0 50 MVpeak Steps from 1 0 MVpeak to 20 0 MVpeak Pacer Load Selection 1000 Q Range ntteiadl indian gianni nae eae 0 05 MV peak 50 Vpeak to 100 MVpeak to peak AACCUIACY stints auc aeaaea ee EN TE aANT 5 of setting RESOIUTION saisisit isenana aaiae 0 05 MVpeax Steps from 0 05 MVpeak to 0 95 MVpeak 0 50 MVpeax Steps from 1 0 MVpeax to 49 5 MV peak 05 0 MVpeak Steps from 50 MV peak to 100 MV peak Default Setting 0 0 0 0 c eee reeeteeenees 2 5 MVpeak Width See e E E A 0 15 mS to 300 mS ACCULACY adana a a a ead 5 of setting Selection CouNt snssararirosieniiiirii 58 Resolution Step SiZe ccccceeeeeeeeeeeteeeeeeees 0 05 mS steps 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 25 mS steps from 100 mS to 300 mS Intended Pacemaker Type s VVI Atrial Pace and Sense Only Compatible Pulse Rates cccceeceeeeeeeeeeeee 30 to 200 PPM 1 22 Introduction and Specifications 1 Instrument Specifications Noise Immu
37. cemaker pulse rate is measured if it is ZERO the Analyzer transmits RATE 000 and will not 5 9 SigmaPace 1000 Operators Manual start the test until a pulse rate is detected If the rate is between 30 and 200 PPM it waits for either of the following commands OVERDRIVE nn The Analyzer computes an overdrive higher ECG signal rate based upon the earlier measured pacemaker pulse rate A two digit number nn represents the percentage that ECG signal is higher than the measured pacemaker pulse rate Example With a measured pacemaker pulse rate of 60 PPM and the following overdrive command OVERDRIVE 20 a computed ECG signal rate of 72 BPM is generated The pacemaker will either PASS or FAIL this qualitative test based upon the criteria stated in the main product specification document UNDERDRIVE nn The Analyzer computes an underdrive lower ECG signal rate based upon the earlier measured pacemaker pulse rate A two digit 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 UNDERDRIVE 20 a computed ECG signal rate of 48 BPM is generated The pacemaker will either PASS or FAIL this qualitative test based upon the criteria stated in the main product specification document SETTEST ASYNC The Analyzer begins the async test by measuring the pacemaker pulse rate if it is ZERO the Analy
38. e listed If power is interrupted and restores the Analyzer powers up in the manual mode Entering Remote Mode When a valid REMOTE 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 unavailable during remote operation When entering a transcutaneous or transvenous pacemaker mode the variables for that mode are set to the default The default setting is the one listed first unless otherwise stated Other measurement commands are valid only in the specific mode they are listed in Working in Remote Mode See Transcutaneous Pacemaker Remote Setup and Testing and Transvenous Pacemaker Remote Setup and Testing below for pacemaker specific commands associated with remote operation To exit any remote mode test sent the EXITTEST command returning to the REMOTE MAIN MODE Exiting Remote Mode To exit the remote mode send the LOCAL command returning the instrument to the MAIN MENU and local control 5 3 SigmaPace 1000 Operators Manual Command Syntax Commands can be sent in upper or lower case All command strings must be terminated with a carriage return CR and or a line feed LF in the format command CR LF Spaces are ignored A command shown with an equals sign is a setup command that requires at least one parameter to be included with the command Mult
39. e Frequency Noise Immunity Refractory Period Paced Refractory Period PRP cccssseescesecsseeseeeeceeenseeseeeeeeaes Sensed Refractory Long Term Test Interactive Pacemaker ECG Simulation Simulated ECG Rate ccceeseeseesteeee Adjustable Threshold Level Operational Modes Continuous Non Capture Non Function Continuous Mode Pacemaker s Interaction with ECG Signal Demand Mode Pacemaker s Ability to Sense ECG Activity Amplitude of ECG S Pacemaker s Ability Purpose of the ECG Simulation Test Long Term Tests Period SRP ignal for Demand Mode Pacemakert to Filter Line Noise 4 Transvenous Pacemaker Testing scsesssseeessseeenseeeeeseeees Asynchronous Mode Amplitude Sensitivity Line Frequency Noise Immunity Refractory Period Paced Refractory Period PRP cccesscessesseeseeeeceeenseeseeeeeeaes Sensed Refractory Period SRP Interactive Pacemaker ECG Simulation 0 cccccccceescccesseeeeseees Simulated ECG Rate PR Interval Adjustable Threshold Level Operational Modes Continuous ii U br city fete fll ea A acto A Contents continued NOn Captite i cscteccsstssacbevstsessevscondbciasdersstbecoshiesddssseesuatesgs doses 4 7 Non PUunCtlOteig sci vest natin Lilet nda sia
40. e is fixed Refractory Period Tests are performed independently for the atrial and ventricular channels These two 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 Analyzer first measures the pacemaker s applied pulse rate then generates a simulated ECG signal within the expected PRP interval This coupling interval is slowly extended until the simulated ECG signal falls outside the PRP at which time it is sensed by the pacemaker resetting the escape interval resulting in a longer pacing pulse interval Sensed Refractory Period SRP The Analyzer now generates a second simulated ECG signal immediately trailing the first simulated ECG signal used to determine the PRP This 4 5 SigmaPace 1000 Operators Manual coupling interval is slowly extended until the simulated ECG signal falls just outside the SRP at which time it is sensed by the pacemaker resetting the escape interval resulting in a longer pacing pulse interval Interactive Pacemaker ECG Simulation Tests are performed simultaneously for both atrial and ventricular channels The response of the pacemaker to a wide range of simulated ECG signals is demonstrated using this Analyzer test feature Several variables are user selectable to best simulate actual real life conditions Simulated ECG Rate The Ana
41. eeeeeeeeeeeeeeneees Single Channel Simulation A Square Wave Atrial Channel Simulated P wave Widths a REE 1 0 mS Amplitude 0 0 2 cece eeceeeceeneeeeeeeeeeeeneeeeeeaeeeteneeeeteaaes 20 0 MVpeak Active Outputs Atrial Channel 4 mm Banana Jacks Only Additional Waveform Selections Square SQU Triangle TRI Haversine HSN Sine Square SSQ Asymmetrical Triangle ISO Fixed Width 2 mS rise time 13 mS fall time Amplitude FRAN QC renia iaa a a eet 05 MVpeak 50 Vpeak to 50 0 MVpeak ACCURACY inier rrie Eiaa darii E eaae Eria 5 of setting Resolution Step SiZe ccceeeeeeseeeeeeeeeeeeeee 0 05 MVpeak Steps 0 05 MVpeak to 0 95 MV peak 0 50 MVpeax Steps 1 0 MVpeak to 49 5 MV peak Width RANG i ar EENE E NEE 0 15 mS to 95 0 mS ACCURACY sccccescisvecesstvevecsssevesteduncrestnecseabecaedt ecasesee 5 of setting Selection COUN cscesecsecrsensecessensnerersnesees 50 Resolution Step SiZe cccceeeeeeeeeeeesteeee 0 05 mS steps 0 15 mS to 0 95 mS 1 0 mS steps 1 0 mS to 19 0 mS 5 0 mS steps 20 mS to 95 0 mS Active Output speien eanes Atrial Channel 4 mm Banana Jacks Only Intended Pacemaker Types cceeeeeeeeeee AAI Atrial Pace and Sense Only Compatible Pacemaker Rates c ceeeee 30 to 200 PPM Available Test Load cece eeeeeeeeeereneeeeeeees 500 Q 1 Refractory Period Test Ventricular Channel Test Selections Paced Refractory Period P
42. eeees 1 3 General Safety Considerations ccccesesceesseeseeeeeeeeeeeseeeenseees 1 4 SVIMDOIS ores E estes bates E AT 1 4 Warnings and Cautions ccsccesececeesseeseeeseeeeeeeeeeeeeneeenseeeens 1 4 Power ESITT a D1 NAAR E EE 1 5 Defibrillators and Transcutaneous Pacemakers 0 06 1 5 Applications snesen nenni ii bet nee cedegesven gen E E E 1 6 Pe E S a a Aaa See E 1 6 Unpacking and Inspection ccccecsecseecceeseeeseeeeeeeeceeenseenaeenaes 1 7 Instrument Familiarization ccccesesseeseesceeseeeeeeeeeeseeseeeerenrens 1 8 Abbreviations innn erni iee E E i 1 10 General Specifications ssssesessseseeeeseesreseesesseeressreressesersesseese 1 12 Instrument Specifications s sssssseeseeseesseserseeseeeessterrsseserseeseese 1 12 Transcutaneous Pacemaker Tests c scssccssecseeseeeeeeeeeereees 1 13 Transvenous Pacemaker Tests cesccsseeseeeseeeeeeeeeeereeseeeeeees 1 17 INCCESSOTIES 3 os cosh c8ts cities E A A E E EOR 1 28 1 1 SigmaPace 1000 Operators Manual Introduction and Specifications 1 Introduction Introduction The SigmaPace 1000 External Pacemaker Analyzer hereafter referred to as the Analyzer is the latest in external pacemaker analyzer technology This efficient handheld Analyzer satisfies a wide range of external pacemaker testing with a comprehensive range of test suites measurement algorithms and test loads Compatible Pacemaker
43. eensecnseenseenseenaes 4 4 Amplitude Sensitivity ccccccecscsseeseseeereeesceeeeeseceseenseeneeeeees 4 5 Line Frequency Noise Immunity ccccesseesseereeeeeeeeeeeees 4 5 Refractory Period ccccccesseessceseceseceseeeeeceeeseeeaeeeeeeneeeeresrens 4 5 Paced Refractory Period PRP cc cesssssseseereesseeseeeees 4 5 Sensed Refractory Period SRP c cccccesseeseeeseeseeeeeeeeeees 4 5 Interactive Pacemaker ECG Simulation ceccesceseeeees 4 6 Simulated ECG Rate ee ecesesecssesseeeeceeeeeeeceeeeceeeeeeeaeeeteneeas 4 6 PR Tnterval ccs oct a stten Manel ethene tt 4 6 Adjustable Threshold Level c cccceescessceseceteeeseeseeeteenseenaes 4 6 Operational Modes ecccescceseescceseceseceseceeceeeeseeeaeeneeenneeenees 4 6 Continuous e i iii scotia a ee eae 4 6 NOn apture ccpseicecieripancvpiedeasvenaadecbpecsoaveedagteas bees enreaiesereess 4 7 NOD FUNCHON neccennais E En 4 7 DC Leakage E EA EI E T E 4 7 Static Tests Pacemaker Power OFF sseeeeeeeeeeeeeeee 4 8 Dynamic Tests Pacemaker Power ON sesser 4 9 Current Drain Rese cacses ash eedesicucct vate a a E e 4 9 L ng Term Test ics ccenice netata naren nn e ieii 4 11 Setup and Testings o o erea eea AEEA EKS 4 11 Outputs ich coin eee ae E E E aden Rah aks 4 13 Demand Mode and Dual channel AV ECG Signal 4 16 Continuous Mode and Dual channel AV ECG Signal 4 18 Demand Mode Pacema
44. ent to the Analyzer it returns nnnn where nnnn equals resistance in ohms from 0200 to 1000 Q SETTEST SETTEST PULSE The Analyzer monitors the applied pulse rate amplitude width and energy data for both the atrial and the ventricular pacemaker channels HOLD Freezes the pacer measurement and maintains last reading in memory for both the atrial and the ventricular pacemaker channels 5 14 Remote Operation 5 Transvenous Pacemaker Remote Setup and Testing RDA RDV The Analyzer transmits the following information for rate amplitude and width from the atrial or the ventricular data frozen from the above HOLD serial command The data is returned in the following format AMP XXX mA RATE XXX PPM WIDTH XXX mS For each parameter the Analyzer returns a three digit numeric value XXX with a floating point decimal to cover the multiple ranges The unit of measure remains 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 for rate amplitude and width from the atrial or the ventricular data frozen from the above HOLD serial command The data is returned in the following format A Channel AMP XXX mA RATE XXX PPM WIDTH XXX mS V Channel AMP XXX mA RATE XXX PPM WIDTH XXX mS AV Interval XXX mS For each parameter the Analyzer returns a three digit
45. eps for each pacemaker channel Available Testloads 500 2 Default Atrial Channel SES CONS ei ois hcccsccidesieccdtasviegacansusbensdonaeorsoes G 200 Q 500 Q or 1000 Q PCCUPACY uiure eoio nea aa EEk 1 0 of selection Power Rating oiii soiuri esirdin ede 2 Watts Ventricular Channel SEISCUONS isene aara E ea 200 Q 500 Q or 1000 Q ACCA CVa cicna a evan Cenioevsavepnichsnenes 1 0 of selection Power Rating s cic0nsesitiailani ennloniad 2 Watts WMACKIING iirinn a Atrial and ventricular channel settings are identical 1 27 SigmaPace 1000 Operators Manual Accessories Standard accessories and associated part numbers are listed in Table 1 3 optional accessories and associated part numbers are listed in Tables 1 4 through 1 8 Table 1 3 Standard Accessories Table 1 4 Pacemaker Disposable Electrode Adapters Description Part Number All Pacemaker Disposable Electrode Adapters Physio Control QUIK COMBO 2201095 Physio Control QUIK PACE 2201088 Hewlett Packard CodeMaster 2201109 1 28 Introduction and Specifications 1 Accessories Table 1 5 Serial Cables PC Interface Cable 2200962 Female DB 9 to Female DB 9 medTester Serial Interface 2200102 Female DB 9 to Female DB 25 Table 1 6 Compatible Power Supply Region of Operation Universal Power Supply 15V 90 to 264 VAC IEC320 2184298 C6 3 wire United Kingdom UK Power Cord IEC320 C5 3 wire Table 1 7 Disposable Transcutaneous Pacemaker Adapters
46. et then press HEAT HEST F1 F2 F3 F4 OOR 2 Make necessary connections as follows eyr083 eps a Plug the supplied 9 V dc Load Test Cable into the matching connector on the left side of the Analyzer b A9 V dc Load Test Cable Fluke Biomedical Part 2201074 is supplied as a standard accessory with the Analyzer It is designed specifically for the testing of Medtronic models 5388 Dual Channel and 5348 Single Channel transvenous pacemakers 4 34 Transvenous Pacemaker Testing Setup and Testing c Remove the battery from the pacemaker and slide the black block with the two banana plugs into the empty battery compartment d Apply light pressure to the 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 between the test fixture banana plugs and the exposed battery contacts 3 Press F1 NEXT to advance the screen and start the test DC LOAD 100 mA MAM Current 99 9 mA DE HOLE F1 F2 SOA YUU 4 Press F1 HOLD to advance the screen Ne eyr047 eps MIT RELEASE DATA F1 F2 SPAS eyr016 eps 4 35 SigmaPace 1000 Operators Manual 5 Press F4 XMIT DATA to transmit data through the serial port 6 Press F1 RELEASE to release the hold and return to the HOLD screen 7 Press ESC
47. ew and resalable condition are not eligible for credit return and will be returned to the cus tomer 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 acces sories 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 rec ommend the following guide for repackaging z Use a double walled carton of sufficient strength for the weight being shipped z Use heavy paper or cardboard to protect all instrument surfaces Use nonabrasive material around all projecting parts 7 Use at least four inches of tightly packed industry approved shock absorbent mate
48. from 100 mS to 300 mS This waveform is present on these three outputs Pacemaker Compatibility Compatible Pulse Rates Intended Pacemaker Type Noise Immunity Test Waveform Frequency Accuracy 30 to 200 PPM Minimum VVI Ventricular Pace and Sense Only Sine Wave 50 and 60 Hz SigmaPace 1000 Operators Manual Active Outputs Selected Ventricular Channel Test load Five lead ECG Testload Amplitude Output Ventricular Channel Ragase pev dnai aninda taa aiaia 0 00 OFF to 10 0 MV peak to peak PACCUIACY nernet erea aa TE REEN 5 of setting Resolution Step Size 0 50 MV peak to peak StEpS Pacer Load Range sescssssesrresnseriaansunsaessvaseas 30 50 Q to 1550 Q 1 Five Lead ECG Output RANQ A E AT 0 00 OFF to 10 0 MV peak to peak ACCUrACY aaen ES 5 of setting Resolution Step SiZe cccceeeeeeceeesteeeeee 0 50 mV steps Calibration Reference Lead I RA to LA Paced Refractory Period Test PRP FRAN GC iosas a aaia aAa eai 20 mS to 500 mS ACCUACV coe san cat en cestsenntsdennernsanceshcaverocanceneptasstidetones 5 of reading or 1 mS whichever is greater Physiological Simulation SeOlOCHION ceeceeeceeeeeeeeeeeeeeeeeeteeaeeeeeeeeeeeaeeeeees Triangle TRI Wave Pulse Widths ccc ave fic asian aanraai 40 mS Pate 2 coe see A N A A T Single pulse Interactive with applied pacemaker pulse activity in the demand mode of operation AMplhtuUd sisinarieun 1 0 MVpeax Lead Active Outpu
49. gent solution Take care to keep liquids out of the interior of the unit A Caution To avoid damage to the Analyzer or adverse affects on its performance clean it only by gently wiping down with 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 cable connections for integrity of the cable clamp and strain relief Service and Calibration If your new Analyzer fails to operate successfully please contact the Fluke Biomedical Service Center immediately as indicated under Warranty and Product Support A Caution To avoid damage to the Analyzer or adverse affects on its performance allow only qualified technical personnel to service the Analyzer Calibration of the Analyzer by an authorized Fluke Biomedical Service Center is recommended Fluke Biomedical Service Centers have the appropriate tools and procedures for performing calibrations as well as factory authorized updates 2 9 SigmaPace 1000 Operators Manual International customers should contact their Fluke Biomedical dealers for service product support To obtain the name of your local dealer or service center contact Fluke Biomedical as indicated under Return Procedures Repair and calibration Packing Instructions If calibration or repairs are required return the Analyzer to the factory or the nearest ser
50. he Analyzer is also a valuable clinical training and demonstration 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 output with your bedside monitor strip chart recorder or oscilloscope The Analyzer realistically mimics a patient s cardiac response to the attached pacemaker including threshold capture basic asynchronous operation and the four states of dual channel transvenous pacemaker operation Testing is made easier with the Analyzer because you no longer need to switch test leads to conduct your desired atrial or ventricular channel test All test functions with the required ECG waveforms are instantly available to the user via internal relay routing Features e Tests both external transcutaneous and transvenous pacemakers e Large 21 character x 8 line alphanumeric LCD readout shows more information than other external pacemaker Analyzers e Full range of selectable measurement algorithms and test loads for external pacemakers 1 6 Introduction and Specifications 1 Unpacking and Inspection Dual channel signal acquisition for capturing synchronous transvenous AV Sequential pacemaker pulse output data Interactive pacemaker and ECG simulation with 5 Lead output A Sleep mode conserves the charge of the internal lithium ion battery when not in use Sleep mode is disabled when
51. i 1 10 General Specifications 1 12 Instrument Specifications 6 1 12 Transcutaneous Pacemaker Tests ccccssessseescesecseeeeceeeceseeneeeeeeeees 1 13 Transvenous Pacemaker Tests 1 17 ACCESSOLLES fis us Bice os cancGe es PE EEEE EE ETETEA EEE Ai i 1 28 2 Setup Operation and Maintenance ccsseecsseeeeeeees 2 1 Setting Up the An lyz l sion e E E 2 3 Connecting External Transcutaneous Pacemake s ccseseeees 2 3 Connecting External Transvenous Pacemakers seeeseeeeeereeee 2 4 Load Test Cable Connectot ccceccceesceseesseesceseceseceeeseeeceaeeneeeeeesees 2 4 RS 232 Serial Port Connector ecceecesesseeeceesceecseeeeeeeeceaeeneeeeeesees 2 5 High Level ECG Output Jack ceeccccecsceeecesecneeneeeeeeeeceseeneeeeeesees 2 5 Ventilati n enipe decker aime a S a E EES 2 5 PoOWer Up Segquente senenin naaa e area a iaaa 2 5 Transcutaneous Pacemaker Testing cccseeseesseesceseceseeeeeeeeeeeneeneees 2 7 Transvenous Pacemaker Testing cccccescceseeseeeeceeeceseeseeeeceeeeseeneees Utility Funct ONS esni aana REE TOO EE EEE A iTr Maintenances senoressa en a a a a e bettie Avoiding Damage 3 CSOT Th i osc ctv hens apes gaged ch TET AN ANEA SigmaPace 1000 Operators Manual Service and Calibration Packing Instructions Shipping 0 3 Transcutaneous Pacemaker TeSting ssssessseeesseenenseees Asynchronous Mode Amplitude Sensitivity Lin
52. ion of an implied warranty or of incidental or conse quential damages this limitation of liability may not apply to you If any pro vision of this warranty is held invalid or unenforceable by a court or other de cision maker of competent jurisdiction such holding will not affect the validity or enforceability of any other provision 07 07 Notices All Rights Reserved Copyright 2007 Fluke Biomedical No part of this publication may be reproduced transmit ted 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 physi cal damage such as bent or broken parts dents or scratches Technical Support For application support or answers to technical questio
53. iple parameters are separated by commas All possible parameter choices are shown Unless otherwise stated the default parameters are listed first Responses to 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 characters until it has responded to the one at hand Remote Mode Analyzer Setup Commands The following are common commands associated with setting up remote operation of the Analyzer VER XX The firmware version level is returned in a three digit format with a fixed decimal point Example VER 1 03 Beta version firmware is identified with an additional pair of alphanumeric characters Example VER 1 03B1 IDENT The firmware returns the identity of the Analyzer name and firmware revision Example IDENT ANALYZER 1 03 5 4 Remote Operation 5 Introduction REMOTE The Analyzer enters the remote mode of operation All serial commands that do not return data or a predetermined response send OK to indicate that the serial command was received understood and executed LOCAL The Analyzer enters the local manual mode of operation QBAUD 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 Codes The f
54. ker PULSE DHANDE ASV OUTPUT MOCE MODE PEE F1 F2 F3 F4 eyr014 eps 1 From the SELECT TEST menu press F1 PULSE OUTPUT 3 12 Transcutaneous Pacemaker Testing Setup and Testing OO OUTPUT ZOLL Ame 31 0 mA Rate 142 FFH Width 40 0 mS Energy 159 mJ RATE 100a HOLD lt 20 LOAD F1 F2 F3 F4 oogg OQ 2 Press the F4 LOAD UP or DOWN arrow key to select the desired load 3 Press F1 HOLD to advance the screen XS eyr015 eps MIT RELEASE DATA SPE 4 Press F4 XMIT DATA to transmit data through the serial port 5 Press F1 RELEASE to release the hold and return to the HOLD screen eyr016 eps 6 Press ESC to return to previous menu s 3 13 SigmaPace 1000 Operators Manual Demand Mode Pacemaker s Interaction with ECG Signal The following test verifies the demand mode pacemaker s ability to interact with a simulated ECG signal 1 From the SELECT TEST menu press F2 DMAND MODE 2 Press the F4 UP or DOWN arrow key to select the desired load 3 Press F1 START to advance the screen and start the test 3 14 Ne PULSE BMAD ASYHC OUTPUT MOCE MODE Pee F1 F2 F3 F4 O0OOG DEMAND 20LL M Seb pacer to demand then press START 000 START LOAL F1 F2 F3 F4 1019 UU eyr014 eps eyr058 eps Transcutaneous Pacemaker Testing Setup and Testing DEMAWD ZOLL Rate 80 BPM Dye
55. ker 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 cc eceeeeeeeeeeeeees 4 28 DG L ak Pest scchsessesceehieetoeseessescidh Niacin bende sec eek 4 31 DG Toad Testis ccs er tie e n a aiia aaa aiaia 4 34 ECG Simulation Test reseo a a 4 36 Long Term Testsin carere annn hi en teik 4 38 4 1 SigmaPace 1000 Operators Manual 4 2 Test Options Transvenous Pacemaker Testing Test Options The scheme for transcutaneous pacemaker testing is shown in Figure 4 1 The measurement algorithms protocols and default waveform selections are based on the requirements published by Medtronic for their Model 5388 dual chamber temporary external pacemaker Waveform selections for other brands and models of pacemakers are available in the Analyzer menus Typically transvenous pacemaker measurements are specified at a test load setting of 500 Q which is the Analyzer default setting For most transvenous pacemaker tests two additional loads of 200 Q and 1000 Q are also available The test load resistance values track for both the atrial and ventricular channels Atrial Channel ECG Sensing amp Pacer Ventricular Channel High Level Output Transvenous Pacemaker Figure 4 1 SIGMAPACE 1000 External Pacemaker Analyzer eyr005 eps Scheme fo
56. ld be active ON when either the underdrive ECG signal or overdrive ECG signal is selected The rates of these underdrive and overdrive ECG signals can be adjusted across a wide physiological range by the user Amplitude Sensitivity This quantitative test determines the amplitude of the simulated ECG signal required by the demand mode pacemaker The amplitude of the simulated ECG signal is increased in very small steps until the pacemaker senses it and inhibits the output pulse 3 5 SigmaPace 1000 Operators Manual Line Frequency Noise Immunity This qualitative test verifies the pacemaker s ability to filter line frequency noise at either 50 or 60 Hz and sense a simultaneously applied simulated ECG signal The user can change the amplitude of the line frequency noise while the simulated ECG signal amplitude is fixed Refractory Period These two 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 Analyzer first measures the pacemaker s applied pulse rate and then generates a simulated ECG signal within the expected PRP interval See Figure 3 2 This coupling interval is slowly extended until the simulated ECG signal falls outside the PRP The signal is then sensed by the pacemaker causing the escape interval to reset The result is a longer pacing pulse interval 3 6
57. le the polarity 8 Press F4 AMPLITUDE to adjust amplitude 9 Press F1 START to advance the screen and start the test 4 22 Transvenous Pacemaker Testing Setup and Testing OC REFRACTORY A CH Calculating Sense 20 0 mli Ame 0 55 mld Rate 30 PPH PEP 125 mS SEP 234 mS MIT RESTART CATA F1 F2 F3 F4 J XS 10 Press F4 XMIT DATA to transmit data 11 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 eyr042 eps This test determines the required amplitude of the simulated ECG signal to be detected by the demand mode pacemaker REFRACT SENSE HOISE DEMAND AMP LINE F1 F2 F3 F4 oogg 1 From the SELECT TEST menu press F2 SENSE AMP eyr033 eps 4 23 SigmaPace 1000 Operators Manual 2 After pressing the desired key the appropriate screen appears 4 24 ra N 7 SEMSITIWITY AIR LEHT F1 F2 F3 F4 oogogG UU Select either of the two options F1 ATR for the atrial channel F2 VENT for the ventricular channel eyr072 eps Transvenous Pacemaker Testing Setup and Testing C O SEMSE AMP A CH Seb pacer to demand mode then press HEAT SOO HET LIAC F1 F2 F3 F4 OO _ Ye 3 Press F4 LOAD UP or DOWN arrow key to select the load 4 Press F1 NEXT to advance to the next screen
58. llowing describes how to set up and test a transcutaneous pacemaker 1 Start from the Select external pacemaker type screen ir 7 SITGEMAPACELIOOO Hon Tnvasive or Ine NONINU THU UTIL F1 F2 F3 F4 O080 x eyr009 eps 2 Press F1 NONINV to begin Non Invasive transcutaneous pacemaker testing 3 10 Transcutaneous Pacemaker Testing Setup and Testing a a y C lt a SIGMAPACEL O00 Select ERAND and LOAD Then press HEAT FHYS Eme aoi HET BRAHD LOAL F1 F2 F3 F4 oogg YUU eyr010 eps 3 Press the F3 PHYS CTL BRAND UP or DOWN arrow key to select instrument Brand Model The test load specified 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 Q to 1550 Q in 50 Q increments 5 Press F1 NEXT to advance the display to the SELECT TEST menu There are eight Non Invasive tests PULSE DMAND ASYNC OUTPUT MODE MODE 33 F1 F2 F3 F4 1091 eyr011 eps 6 Press the F4 gt gt gt UP arrow key to advance to the next screen and to see more available tests SigmaPace 1000 Operators Manual REFRCT SEHSE HOISE DEMAHG AMF LIHE Pee F1 F2 F3 F4 eyr012 eps ECG LOOMIS SIM TERM oad 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 pacema
59. lyzer 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 above ECG waveform complex is also user selectable Adjustable Threshold Level When the measured pacemaker output current exceeds the threshold amplitude setting in milliamperes the Analyzer outputs a simulated ventricular paced beat The pacemaker output current level required to effect ventricular capture is selectable by the user Operational Modes Three simulated operational modes are available in the Analyzer Continuous The user selects a rate and the Analyzer generates a simulated ECG signal The threshold interaction with the pacemaker is observed 4 6 Transvenous Pacemaker Testing Test Options Non Capture The Analyzer operates in the above continuous mode However every 8th expected ventricular capture event is skipped 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 leakage tests See Figure 4 2 Over time the pacemaker s active and passive electronic components can deteriorate and possibly couple dc voltage potentials to its final output stage 4 7 SigmaPace 1000 Operators Manual Transvenous SIGMAPACE 1000 Pacemaker External Pacemaker Analyzer Atrial Channel
60. maker s Ability to Sense ECG Activity The two following related tests PRP and SRP determine the demand mode pacemaker s ability to sense ECG activity immediately following either a paced event PRP or a sensed ECG event SRP Note A transcutaneous pacemaker must be set to Demand operation for these tests 3 17 SigmaPace 1000 Operators Manual REFRCT SEHSE HOISE DEMAHG AMF LIHE Pee oleleie 1 From the SELECT TEST menu press F1 REFRCT DEMAND eyr012 eps REFRACTORY z LL M Seb pacer to demand mode then press START 100Q START LOAD F2 F3 F4 SOA i oy 2 Press F4 LOAD UP or DOWN arrow key to select the load 3 Press F1 START to advance screen and start the test eyr060 eps Transcutaneous Pacemaker Testing Setup and Testing OO REFRACTORY 20LL MH Calculating Rate 30 FFH PREF 1235 mS HOLE F1 F2 F3 Olea XS YUU After the calculations are complete the following screen appears N REFRACTORY ZOLL M Calculating Sense 2 0 mld Fate 30 PFH PRP 123 mS SRP BSS m3 WMIT RESTART ana F1 F2 F3 F Q Q eyr020 eps eyr021 eps 3 19 SigmaPace 1000 Operators Manual 4 Press F1 RESTART to restart the test 5 Press F4 XMIT DATA to transmit data 6 Press ESC to return to previous menu s Amplitude of ECG Signal for Demand Mode Pacemaker The following test determines the
61. n aae eetirieastiesavevancs Quantitative Physiological Simulation SCO CUOM Aaina nena na ornatae A Ai S P Wave R lea nmana ekaa N ieina 30 to 120 BPM Waveform delayed by 80 of the pulse to pulse interval or 400 mS whichever is shorter Active Outputs Atrial Channel 4mm Banana Jacks Only Test Load s Available Selection S c ccccececeeeeseeeeesees 3 200 Q 500 Q and 1000 Q 1 Default Setting 0 cccccceceeseeeeeeeeeeeseeeeeeeeeeeeees 500 Q Waveform Selections ccccceeceeeeeeteeeteeeee Square SQU Triangle TRI Haversine HSN Sine Square SSQ Asymmetrical Triangle ISO Fixed Width 2 mS rise time 13 mS fall time Default Setting 0 ccc cece eceeeeeeeeeteeeteeeees SSQ Amplitude Pacer Load Selection s es 500 Q default RANGE e naaa aia aaa 0 05 MVpeak 50 Vpeak to 50 0 MVpeak Accuracy t5 of setting Resolution Step Size cceeeceeeeeeeeteeees 0 05 MVpeax Steps from 0 05 MVpeax to 0 95 MVpeak 0 50 MVpeak Steps from 1 0 MVpeak to 50 0 MVpeak Pacer Load Selection ce eeeeeeeeeeeeneeeees 200 Q 0 05 MVpeak 50 Vpeak to 20 0 MVpeak ACCULACY arseron anatina dannii Ea 5 of setting Resolution Step Size cceeceeeeeeeeeeeeees 0 05 MVpeak Steps from 0 05 MVpeax to 0 95 MVpeak 0 50 MVpeax Steps from 1 0 MVpeax to 20 0 MV peak 1 20 Introduction and Specifications AACGUNACY ise sce eeebcche eee asna aa seeks Resolu
62. ng The following commands are associated with setting up and testing a transvenous pacemaker in remote mode The synchronized measurement of the pacemaker s atrial and ventricular output amplitude rate width energy activity can be easily accomplished using the Analyzer in a dual channel mode The remaining pacemaker tests demand async sensitivity trend or the setting of specific adjustments test load must be conducted for only one channel at a time SETMODE SETMODE TVPACEA atrial channel only 5 13 SigmaPace 1000 Operators Manual SETMODE TVPACEV ventricular channel only SETMODE TVPACEAV Both atrial and ventricular channels Selects the Analyzer s transvenous pacer test mode of operation Note All subsequent serial port communications must relate to transvenous pacer features and follow the prescribed measurement protocols listed below SETLOAD SETLOAD nnnn Both atrial and ventricular channels This command is used to select the desired test load The above nnnn represents the actual test load resistance value in ohms and is based upon the available factory preset selections The default test load value is 500 Q for both channels Example SETLOAD 0500 is the command for the selection of a 500 ohm test load for both the atrial and ventricular channels Valid selections for nnnn are as follows 0200 0500 and 1000 Q RDLOAD Reads the current test load setting When this command is s
63. ng chapter for test options and specific directions Utility Functions To access the utility functions do the following 1 From the Select external pacemaker type screen press F4 UTIL The UTILITY screen displays 2 7 SigmaPace 1000 Operators Manual N a Lat Tp a Select WIE COM DIAG AHGLE FORT BATT TEST F1 F2 F3 F4 O080 YO S eyr057 eps 1 Press F1 VIEW ANGLE to adjust the viewing angle 2 Press F2 COM PORT to select baud rate 3 Press F3 BATT to view battery voltage and charging status 4 Press F4 DIAG 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 such The following describes how to maintain the Analyzer and the method of company support Avoiding Damage Do not drop the instrument or subject it to any mechanical abuse that could cause a shift in the calibrated settings 2 8 Setup Operation and Maintenance a Service and Calibration A Caution To avoid damage to the Analyzer or adverse affects on its performance do not expose the system to temperature extremes Ambient temperatures should remain between 18 and 40 C System performance may be adversely affected if temperatures fluctuate above or below this range Cleaning Clean the exterior of the Analyzer occasionally with a cloth dampened with a mild deter
64. nity Test TeSt TYPO iinne eniran aaa vacates Qualitative Channels SNIE nayan Atrial or Ventricular Only Waveform osiinsa nii Sine Wave FREQUENCY sinnsir ania aes 50 and 60 Hz ACCUIACY see eeeeccecceceeneeeeeneeeteeeeeeeenaeeeseeeeteneeeeeaee 0 5 Hz Active Output S cccccecseeeeeeeeeeeseeeeeeeeeeneee Selected atrial and or ventricular channel test load Output Selections Atrial Channel Only Ventricular Channel Only ECG Signal oo ci 02 scecuecea elie lieseiin ECG Signal can be added to the selected Channel Amplitude Pacer Load Selection 500 Q Rage iccis cies tsasscperciceeatlacinavece vit aR Siah 0 00 OFF to 100 MV peak to peak ACCULACY Aripin iiia dovancnsatvertedasceastnesscavebeeds 5 of setting RROSOIUIOMN seus cessecnscavtas seine necdeswisaneaeconeetcencestonedy 5 MVpeak to peak StEPS 200 Q 0 00 OFF to 40 MVpeak to peak 5 of setting 5 MV peak to peak StEPS 1000 Q 0 00 OFF to 200 MV peak to peak AC CULACY anireo icaro eaei pE E nak 5 of setting R SolUtON siiras 5 MV peak to peak StEpS Refractory Period Test Atrial Channel Test Selections Paced Refractory Period PRP Sensed Refractory Period SRP 20 to 500 mS ACCUIACY i inore aAa 5 of reading or 1 mS whichever is greater Resolution apeina 1 LSD Display Fomati saaa 3 digits 1 23 SigmaPace 1000 Operators Manual Physiological Simulation Selection Default eee eeeeee
65. ns either email techser vices 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 re salable condition Products not returned within 90 days of purchase or products which are not in as n
66. nual Abbreviations The following list includes abbreviations used in this document ANSI AAMI BLU BPM dB C CQM DMM DUT EEPROM ECG ESU EUT F GRA GRN Hz ampere American National Standards Institute Association for the Advancement of Medical Instrumentation blue color beats per minute decibel degrees Celsius centigrade Contact Quality Monitor digital multimeter device under test electrically erasable PROM electrocardiograph or electrocardiogram Electrosurgery Unit equipment under test degrees Fahrenheit gray color green color hertz inch Joules kilo 10 kilogram kilohertz kQ LED LCD MHz MQ mA mm mV Introduction and Specifications 1 Abbreviations kilohm pound light emitting diode liquid crystal display meg a 10 megahertz megohm meter milli 10 milliampere millimeter millivolt peak to peak Return Electrode Monitor second yellow color micro 10 microampere microvolt ohm SigmaPace 1000 Operators Manual General Specifications Listed product specifications are subject to change Temperature Operating Asnetiacinnicic tia anadetescs 18 40 C SlOPAQS PEE AATA 0 50 C Relative Humidity Operating 0 00 90 max non condensing Altitude sss SA eek aa 2000 m Serial Port Connector Typ s 4c secccseseneaatincsepeesecieeediies DB 9 Male Batid Rates cess ities aetaie uct 2400 9600 and 19200 Ser
67. o the 4 mm safety banana receptacle jacks located on the Analyzer top panel and are listed with their Fluke part numbers in the chapter Introduction and Specifications A A Warning To avoid injury to a patient do not connect the Analyzer to a patient or 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 contact with a patient Refer to the latest Fluke Biomedical price list for availability of optional electrode adapters 2 3 SigmaPace 1000 Operators Manual Note If desired you may fabricate your own adapter cables by using comparable general purpose test leads with 4 mm safety male banana plugs terminated with the requisite brand designated electrode connector Connecting External Transvenous Pacemakers Two identical pairs of transvenous pacemaker test leads are supplied as standard accessories with the Analyzer These test leads are color coded RED Part Number 2201166 and BLACK Part Number 2201153 for connection to the 4 mm safety banana receptacle jacks located on the Analyzer top panel To securely connect the external transvenous pacemaker to the Analyzer these test leads incorporate 0 08 diameter pin probes compatible with external transvenous pacemaker output jacks terminals Use these test leads to connect the output of the transvenous single channel atri
68. ollowing error codes are returned in response to commands that cannot be executed ERR 00 No commands allowed at this time ERR 01 Unknown command Returns the question mark character to the host controller via the serial port ERR 02 Illegal command The command was recognized but not allowed at this time 5 5 SigmaPace 1000 Operators Manual ERR 03 Illegal parameter A parameter sent as part of the command was not the correct type or was out of range or it contained an incorrect number of parameters Transcutaneous 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 s transcutaneous pacer test mode of operation Note All subsequent serial port communications must relate to transcutaneous pacer features and follow the prescribed measurement protocols listed below 5 6 Remote Operation 5 Transcutaneous Pacemaker Remote Setup and Testing SETMAKE SETMAKE nnnn The specific protocol required for each manufacturer or make is selected using this command Each protocol contains a set of measurement algorithms for rate width amplitude and refractory SETMAKE followed by the four digit alphanumeric entry assigned to each manufacturer completes this serial command The following table shows the SETMAKE protocol for the indicated manufacturers Example SETM
69. oth outputs Pacemaker Compatibility Compatible Pulse Rates Intended Type External Transcutaneous VOO Asynchronous Ventricular Only Pace 1 14 10 BPM 300 BPM 30 to 200 PPM External Transcutaneous VVI Ventricular Only Pace and Sense Qualitative Normal Sinus Rhythm NSR generates the complete P QRS T complex 1 0 mV Lead NSR 85 of measured pulse interval rate NSR 115 of measured pulse interval rate The under overdrive NSR simulations can be independently adjusted in 1 BPM increments 30 to 200 PPM Introduction and Specifications Amplitude Sensitivity Test Physiological Simulation Selection Rate Interval Available Test Load Selection s Waveform Selections Amplitude ACCULACY anae aeaea araa EEEk Resolution Step Size Width A COULACY siisi aa e a Selection Count Resolution Step Size Active Outputs Five lead ECG Selected Ventricular Channel Test Load High Level ECG Jack Instrument Specifications R Wave S Wave and T Wave Default 120 BPM 500 mS 30 50 Q to 1550 Q in 50 Q steps Square SQU Triangle TRI Haversine HSN SSQ 0 05 MVpeak 50 Vpeak to 5 0 MV peak 5 of setting 0 05 mV steps from 0 05 MVpeak to 0 95 MVpeak 0 50 mV steps from 1 0 MV peak tO 5 0 MV peak 0 15 mS to 300 mS 5 of setting 50 0 05 mS steps 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 25 mS steps
70. pi 8 Press F4 XMIT DATA to transmit data 9 Press F1 RELEASE to release the hold and return to the HOLD screen eyr066 eps 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 Additionally it is an excellent training tool for clinical staff in the setup and use of external pacemakers ECG LONG SIM TERM ee F2 F3 oleae 1 From the SELECT TEST menu press F1 ECG SIM eyr013 eps 3 26 Transcutaneous Pacemaker Testing Setup and Testing OO SIMULATION TRAHS t Quteut DEMAHD Thresh 100 mA Fate 30 BPH HSR OUTPUT THRESH RATE F1 F2 F3 F4 oogo OQ 2 Press F1 OUTPUT to toggle among four simulated operational modes XS eyr025 eps e Demand e Continuous e Non capture e Non function 3 Press F3 THRESH UP or DOWN arrow 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 The overall stability of the pacemaker s pulse rate and amplitude are monitored continuously over an extended period of time The user enters the desired target values for these two parameters into the Analyzer This program 3 27 SigmaPace 1000 Operators Manual flexibility allo
71. r 88 BR Under 72 PPM DRIWE SELECT RATE HOLD DRIVES EFH F1 F2 F3 F4 J XS eyr017 eps 4 Press F2 SELECT DRIVE lt to toggle between the Overdrive and Underdrive 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 Signal The following test verifies the continuous or non demand pacemaker s ability to interact with a simulated ECG signal PULSE BMAD ASYHC OUTPUT MODE MODE Pee F1 F2 F3 SLAA eyr014 eps 3 15 SigmaPace 1000 Operators Manual 1 From the SELECT TEST menu press F3 ASYNC MODE a N ASYHE 20LL M Set Pacer bo ASYM mode then press START 1000 START LOAD F1 F2 F3 F4 OOOO _ 90 2 Press the F4 LOAD UP or DOWN arrow key to select the load 3 Press F1 START to advance the screen and start the test eyr059 eps Transcutaneous Pacemaker Testing Setup and Testing C 5 ASYHE ZOLL kate 80 FRM Over 88 BPH Under 72 BPM DRIWE SELECT RATE HOLG DRIVES EFH F1 F2 F3 F4 oogg OO 4 Press F2 SELECT DRIVEK lt to toggle between the Overdrive and Underdrive BPM rates XS eyr018 eps 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 Demand Mode Pace
72. r Testing Transvenous Pacemakers 4 3 SigmaPace 1000 Operators Manual Output The Analyzer measures the output of the transvenous pacemaker and displays the following parameters e Pulse Amplitude milliamperes e Pulse Rate pulses per minute e Pulse Width milliseconds e AV Delay milliseconds e Voltage volts e Energy joules To view these parameters three choices are available from the menu A V Channels A Channel Only and V Channel Only Demand Mode Tests are performed simultaneously for both atrial and ventricular channels This qualitative test checks the demand mode pacemaker s ability to interact with a simulated dual channel AV ECG signal The Analyzer first measures the pacemaker s applied pulse rate then computes underdrive and overdrive rates for the simulated dual channel AV ECG signal Initially the underdrive rate is 90 of 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 ECG signal and then inhibited OFF when the overdrive ECG signal is selected The rates of these underdrive and overdrive ECG signals can be adjusted across a wide physiological range Asynchronous Mode Tests are performed simultaneously for both atrial and ventricular channels This qualitative test checks the continuous or non demand mode pacemaker
73. ranges The unit of measure remains the same for all transmitted readings mA PPM and mS Additionally single parameter information can be acquired RDMETERH The data is returned in the following horizontal format AMP XXX mA RATE XXX PPM 5 8 Remote Operation 5 Transcutaneous Pacemaker Remote Setup and Testing RDAMP The Analyzer transmits the following information string for amplitude from the data frozen with the above HOLD serial command The data is returned in the following format AMP XXXmA RDRATE The Analyzer transmits the following information string for rate from the data frozen with the above HOLD serial command The data is returned in the following format RATE XXXPPM RDWIDTH The Analyzer transmits the following information string for width 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 RDMETER serial command is utilized it is computed The Analyzer transmits information from the data frozen with the HOLD serial command One of the following formats is used depending on the energy level of the transcutaneous pacemaker pulse ENERGY XXX J ENERGY XxXXmJ ENERGY X XXJ RESUME Releases the HOLD serial command and proceeds with making measurements SETTEST DEMAND The Analyzer enters the qualitative demand test The applied pa
74. rate based upon the earlier measured pacemaker pulse rate A two digit number nn represents the percentage that ECG signal is higher than the measured pacemaker pulse rate Example With a measured pacemaker pulse rate of 60 PPM and the following overdrive command of OVERDRIVE 20 a computed ECG signal rate of 72 BPM is generated All serial commands that do not return data or a predetermined response send OK to indicate that the serial command was received understood and executed The pacemaker will either PASS or FAIL this qualitative test based upon the criteria stated in the main product specification document UNDERDRIVE nn The Analyzer computes a dual AV channel underdrive lower ECG signal rate based upon the earlier measured pacemaker pulse rate A two digit 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 UNDERDRIVE 20 a computed ECG signal rate of 48 BPM is generated All serial commands that do not return data or a predetermined response shall send OK to indicate that the serial command was received understood and executed The pacemaker will either PASS or FAIL this qualitative test based upon the criteria stated in the main product specification document SETTEST ASYNC The Analyzer begins this async test by measuring the pacemaker pulse rate if it is ZERO the Analyzer
75. rial around the instrument Returns for partial refund credit Every product returned for refund credit must be accompanied by a Return Material 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 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 3 1 402 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 us ing 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 re sponsible for any injuries sustained due to unauthorized equipment modifications
76. rom a 9 volt source See Figure 4 3 A load test cable Part 2201074 is provided with the Analyzer as a standard accessory to facilitate connections to the recessed battery terminals of the Medtronic 5388 and 5348 4 9 SigmaPace 1000 Operators Manual Transvenous SIGMAPACE 1000 Pacemaker External Pacemaker Analyzer DC Current NUSFOT nNAUSFOT Internal Battery Compartment Power ON OFF We 9 VDC Battery eyr007 eps Figure 4 3 Current Drain Test Readings are made in three pacemaker operating modes e Pacemaker Power OFF e Pacemaker Power ON and Display Backlight OFF e Pacemaker Power ON and Display Backlight ON 4 10 Transvenous Pacemaker Testing Setup and Testing Standard test leads or short jumpers can be used to make connections on other brands and models of pacemakers Long Term Test Tests are performed for only one channel at a time The overall stability of the pacemaker s pulse rate and amplitude are monitored continuously 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 test duration the user can review pacemaker output pulses falling outside these test limits Setup and Testing The following describes how to set up and te
77. s 4 19 SigmaPace 1000 Operators Manual Demand Mode Pacemaker s Ability to Sense ECG Activity The two following related tests PRP and SRP determine the demand mode pacemaker s ability to sense ECG activity immediately following either a paced event PRP or a sensed ECG event SRP REFRACT SEHSE HOISE DEMAHG AMP LIME Pee PEE 1 From the SELECT TEST menu press F1 REFRACT DEMAND eyr033 eps REFRACTORY Seb pacer to demand mode AAT or LLI Select AM Channel AIR WEHT F2 F3 SLAA eo XS eyr069 eps 2 Select either of the two options e F1 ATR for the atrial channel e F2 VENT for the ventricular channel 4 20 Transvenous Pacemaker Testing Setup and Testing The screen advances for wave and width selection the example is the atrial channel y REFRACTORY A CH Select waveform tyre and width then press HEST SOF 1 O05 HET WALE WIDTH F2 F3 F4 SLAA OO Press F3 WAVE UP or DOWN arrow key to select a waveform Press F4 WIDTH UP or DOWN arrow key to adjust the width of the waveform eyr070 eps Press F1 to advance to the next screen 4 21 SigmaPace 1000 Operators Manual ra W REFRACTORY A CH Select waveform amplitude and Polarity then press START 20 0 mi NEXT pees F1 F2 Ee a O000 J eyr071 eps 7 Press F3 POLARITY UP or DOWN arrow key to togg
78. s Interactive Pacemaker ECG Simulation The pacemaker responds to a wide range of simulated ECG signals using the Analyzer test feature Several variables are user selectable to best simulate actual real life conditions Simulated ECG Rate The Analyzer outputs either asystole or a normal sinus rhythm NSR at rates covering the bradycardia normal and tachycardia range Adjustable 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 level required to effect ventricular capture is selectable by the user Operational Modes Three simulated operational modes are available in the Analyzer Continuous The user selects a rate and the Analyzer generates a simulated ECG signal The threshold interaction with the pacemaker is observed No normal sinus rhythm NSR output is available in this operational mode Non Capture The Analyzer operates in continuous mode However every 8th expected ventricular capture event is skipped No normal sinus rhythm NSR output is available in this operational mode 3 9 SigmaPace 1000 Operators Manual Non Function The Analyzer operates in continuous mode without ventricular capture events occurring No normal sinus rhythm NSR output is available in this operational mode Setup and Testing The fo
79. s ability to interact with a simulated dual channel AV ECG signal The Analyzer first measures the pacemaker s applied pulse rate and then computes underdrive and overdrive rates for the simulated ECG signal Initially the underdrive rate is 90 of the applied pacemaker rate and the overdrive rate is 110 of the applied pacemaker rate When testing the attached pacemaker operating in the continuous or non demand mode output should be active 4 4 Transvenous Pacemaker Testing Test Options ON when either the underdrive ECG signal or overdrive ECG signal is selected The rates of these underdrive and overdrive ECG signals can be adjusted across a wide physiological range by the user Amplitude Sensitivity Tests are performed independently for the atrial and ventricular channels This quantitative test determines the required amplitude of the simulated ECG signal to be detected by the demand mode pacemaker The amplitude of the simulated ECG signal is increased in very small steps until the pacemaker senses it and inhibits the output pulse Line Frequency Noise Immunity Tests are performed in two formats atrial channel only and ventricular channel only This qualitative test checks the pacemaker s ability to filter line frequency noise 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 amplitud
80. s the three digit amplitude numeric reading either with or without the floating decimal point Example SENSE SSQ100mS12 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 frequency of either 50 or 60 Hz at a prescribed amplitude Range 0 to 100 mV in 5 mV steps upon the receipt of this command This sine wave can be applied to a single channel either atrial or ventricular Both the frequency and the amplitude of this sine wave are encrypted in the following serial command structure The serial command structure is NOISE XX nnn where the XX represents the power line frequency in Hz 50 or 60 and nn n represents the amplitude in millivolts Example NOISE 60 055 generates a sine wave at a frequency of 60 Hz at an amplitude of 55 mV SETTEST TREND The Analyzer runs the prescribed trend test using 02 to 20 as the deviation point percentage from the selected pulse amplitude and rate TREND uu nnnn zz www 5 20 Remote Operation 5 Transvenous Pacemaker Remote Setup and Testing uu test limit for amplitude nnnn Set point for amplitude 0 1 mA resolution zz test limit for rate nnn Set point for rate 1 PPM resolution The data is returned in the following format when a reading is out of the prescribed test limit range For each parameter the Analyzer ret
81. se rate if it is ZERO the Analyzer transmits RATE 000 and will not start the test until a pulse rate is detected The paced refractory period is computed then reported in the following format PRP XXX mS The sensed refractory period SRP is computed and reported in the following format SRP XXX mS Note Note This reported data has three digits and no displayed decimal point It returns A PRP 248mSRP 253mS SETTEST SENSEA SETTEST SENSEV The single channel demand sensitivity test can run either on the atrial or the ventricular channels with one of three different waveforms square triangle and sine squared at one of six pulse widths Set the test to SENSE then select the desired waveform for the test and finally set the pulse width SENSE SQU nnn nn SENSE TRI nnn nn SENSE SSQ nnn nn 5 19 SigmaPace 1000 Operators Manual SENSE HSN nnn nn The nnn represents the width selection mS of the sensitivity test waveform Valid width entries are 010 025 030 040 100 and 200 mS only The Analyzer begins the demand sensitivity test by measuring the pacemaker pulse rate then it places the selected waveform at 50 of the pacemaker pulse to pulse rate interval and initiates the protocol as stated in the main product specification document The Analyzer displays the following A Channel SENSE XXXZZZmSY YYmV V Channel SENSE XXXZZZmSY YYmV The XXX is the waveform type as indicated above ZZZ is the pulse width YYY i
82. serencescaeesserverends ots OVGNGIIN E iriran ar EA ET Auxiliary Control Quantitative 4 0 mA to 9 99 mA 10 0 mA to 99 9 mA 100 mA to 250 mA 2 of reading or 50 pA whichever is greater 5 0 PPM to 99 9 PPM 100 PPM to 300 PPM 0 5 of reading or 0 3 PPM whichever is greater 1 00 mS to 9 99 mS 10 0 mS to 99 9 mS 0 5 of reading or 14 uS whichever is greater 1pJ to 999 uJ 1 mJ to 999 mJ 1 00 J to 1 99 J 5 of reading computation Qualitative Normal Sinus Rhythm NSR generates the complete P QRS T complex Vpeak 1 0 mV Lead I NSR 85 of measured pulse interval rate NSR 115 of measured pulse interval rate The under overdrive NSR simulations can also be independently adjusted in 1 BPM increments SigmaPace 1000 Operators Manual Auxiliary Rate Range Underdrive minimum Overdrive maximum Active Outputs Five lead ECG Selected Ventricular Channel Test Load High Level ECG Jack This waveform is present on these three outputs Pacemaker Compatibility Compatible Pulse Rates Intended Type Asynchronous Mode Test Test Type Physiological Simulation Selection Selection Amplitude Vpeak scscctctssssccssesessessessernastenseronse Rate Interval Underdrive Overdrive Auxiliary Control Auxiliary Rate Range Underdrive minimum Overdrive maximum Active Outputs Five lead ECG Selected Ventricular Channel Test Load This waveform is present on b
83. sitive or Negative or symbol preceding the numeric value 1 LSD 3 digits plus decimal point 5 of Reading 10 pA 9 Volts 5 0 Volts to 10 5 Volts Short circuit protection Internal in line fast acting fuse rated at Y Ampere 200 500 Q and 1000 Q Introduction and Specifications 1 Instrument Specifications Battery Test Fixture 00 cccceeseeeesseeeeeeeeeeeeee Includes the 9 volt battery supply and facilitates connection of Analyzer to the recessed battery terminals within the Medtronic 5388 and 5348 Temporary Pacemakers Long Term Test Test Configuration ccccccceeeeeeeeeeeeeeeeeee Atrial Channel or Ventricular Channel Pulse Count Range 999 999 maximum Rates ccicisiecctites ie scat EEEE ieee 2 to 20 10 default Amplitude sridi radat 2 to 20 10 default Test Time max ccccccceeeeeeeeeetecteeeeeneeeeeeee 999 59 59 hhh mm ss Maximum error Count 200 Test Termination 00ccccecccceeeteeteeeeteeeeeeee Manual or when maximum error count is sensed Testloads Selectable ccccceceeeeeeeeeeeee 200 500 or 1000 Interactive Pacer ECG Simulation Simulates demand continuous non capture and non function patient ECG activity Additional user selectable parameters PRIN Wal siaccccitsnichicsesnesiibetaaennenigaues 0 05 to 0 300 Seconds Independent Capture threshold 60 1 mA to 25 mA 1 mA st
84. st a transvenous pacemaker OO STGEMAPACE1IOOO Select external Facemaker tyre Hon Invasive or Iny HORT THU UTIL F2 F3 Olea eo 1 From the Select external pacemaker type screen press F2 INV to begin Invasive transvenous pacemaker testing Ne eyr001 eps SigmaPace 1000 Operators Manual S EXT IHMWASIUE PACER Select LOAD then Fress WEST aoin HET LOC F1 F2 F3 F4 O000 VO 2 Press the F4 LOAD UP or DOWN arrow key to select the desired load Test 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 are ten available Invasive tests N eyr031 eps PULSE DMAMD ASYHC OUTPUT MOCE MODE Pee oleleie 4 Use the F4 gt gt gt UP arrow key to navigate through the available test selections eyr032 eps 4 12 Output Transvenous Pacemaker Testing Setup and Testing REFRACT SEHSE HOISE DEMAHG AMP LIME F1 F2 F3 F4 eyr033 eps DE DE ECG LEAK LOAL eyr034 eps LONG TERM ied F1 F2 F3 F4 eyr035 eps The following test measures the output of the transvenous pacemaker PULSE DMAHD ASYHC OUTPUT MOCE MODE Pee F1 F2 F3 SLAA eyr032 eps 1 From the SELECT TEST menu press F1 PULSE OUTPUT 4 13 SigmaPace 1000 Operators Manual
85. test to perform correctly Press F1 START to advance the screen and start the test 3 29 SigmaPace 1000 Operators Manual 9 3 30 ir Lowe TERM FHY S CTL eime 000 03 24 AMP 100 mA 10 Rate 69 PPH 10 Width 17 4 mS Count 000234 001 EHD F1 F2 F3 F4 C Press F1 END to end the test a rc AMP Rabe Width Count FESTART LOHG TERM PHYS CTL eime O00 1 46 100 mA 10 63 PPM 10 1 4 mS OOOE44 001 Total Errors 013 REVIEW MIT F1 F2 F3 F4 ooog eyr028 eps eyr029 eps 10 11 12 13 Transcutaneous Pacemaker Testing Setup and Testing Press F3 REVIEW UP or DOWN arrow key to view deviations falling outside the selected deviation 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 limit pacemaker pulse is also reported Press F4 XMIT to transmit data Press F1 RESTART to restart the test Press ESC to return to previous menu s 3 31 SigmaPace 1000 Operators Manual 3 32 Chapter 4 Transvenous Pacemaker Testing Contents Page Test Options i242 ndne nants Gasiws KORG eR ween 4 3 OUt eisini i E EE EERE KEER A E 4 4 Demand Mode ereraa eeror lete raea A eoa Aa SERAS edine Traa ta 4 4 Asynchronous Mode cescceseesseeseeeseeeseeceeeeecee
86. the Analyzer would come in contact with a patient Power Supply Make sure the external battery charger power supply is rated and configured for your voltage source and compatible with the voltage and current ratings of the Analyzer Use only the specified power supply included with this instrument See Table 1 6 Defibrillators and Transcutaneous Pacemakers This instrument tests both external transcutaneous and transvenous pacemakers In most cases transcutaneous pacemakers are built into cardiac resuscitation equipment along with defibrillators Defibrillators deliver high voltage shocks to a patient in order to correct a life threatening heart condition 1 5 SigmaPace 1000 Operators Manual A Caution To avoid possible damage to the Analyzer do not discharge defibrillator pulses into the instrument The dual channel pacemaker input jacks are electrically protected to prevent damage if a defibrillator charge is applied The instrument s internal buzzer activates to warn the user whenever a defibrillator pulse is sensed For transcutaneous pacemakers both brand and model specific algorithms and testload ranges can be selected for particular device manufacturers Applications The Analyzer can be used to test external pacemakers in the Coronary Care Unit CCU or Emergency Department ED to verify external pacemaker performance following factory repair upgrade or troubleshooting pacemaker operational problems T
87. tion Heat generated during use is dissipated through ventilation slots on both the left and right side panels A Caution To avoid heat buildup damage to the Analyzer do not block the ventilation slots during use or while the instrument is charging Power Up Sequence Take the following steps to power up the Analyzer 1 Press and release the ENT POWER ON key located on the Analyzer top panel The LCD momentarily displays the following screen 2 5 SigmaPace 1000 Operators Manual 2 6 ra 7 FLUEE BIOMEDICAL SIGMAPACE 1000 EXTERMAL PACEMAKER SERIAL 0101 WERSIOM 1 00 The LCD then advances to the Select external pacemaker type screen r SIGMAPACEIOOO Hon Tnvasive or Inu HONHITHU IHU UTIL F1 F2 F3 F4 ooog eyr008 eps eyr001 eps Setup Operation and Maintenance a Transcutaneous Pacemaker Testing 2 From this screen you can select one of the following options e F1 NONINV to begin Non Invasive transcutaneous external pacemaker testing e F2 INV to begin Invasive transvenous external pacemaker testing e F4 UTIL to access the 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 specific directions Transvenous Pacemaker Testing See the Transvenous Pacemaker Testi
88. tion Step Size Default Setting Amplitude Width ACCURACY isi cis src neeecearevedenasciareecsaeneedenanseneyeaccades Selection Count Resolution Step Size Intended Pacemaker Types AAI Atrial Pace and Sense Only Compatible Pulse Rates Ventricular Channel Physiological Simulation Selection Active Outputs Waveform Selections Square SQU Triangle TRI Haversine HSN Sine Square SSQ Asymmetrical Triangle ISO Fixed Width Default Setting Test Load s Instrument Specifications 0 05 MVpeak 50 Vpeak to 100 MVpeak to peak 5 of setting 0 05 MVpeax Steps from 0 05 MVpeax to 0 95 MVpeak 0 50 MVpeax Steps from 1 0 MVpeax to 49 5 MV peak 05 0 MVpeax Steps from 50 MV peak to 100 MV peak 2 0 MV peak 0 15 mS to 95 0 mS 5 of setting 50 0 05 mS steps 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 30 to 200 PPM R Wave S Wave and T Wave 30 to 120 BPM Delayed from the ventricular demand pacemaker pulse by 80 of the pulse to pulse interval or 400 mS whichever is shorter Selected ventricular test load 4 mm Banana Jacks only 2 mS rise time 13 mS fall time Sine Square SSQ 1 21 SigmaPace 1000 Operators Manual Available Selection S c ceeeeeeeeeeeeeees 3 200 500 and 1000 Q 1 Default Setting eccceceseeeeseeeeeeteeteeteeees 500 Q Amplitude Pacer Load Selection ccc
89. to return to previous menu s ECG Simulation Test DE DE ECG LEAK LOAD PEE 1 From the SELECT TEST menu press F3 ECG SIM eyr034 eps a N SIMULATION TRAHS J Quteut DEMAHCE HEST OUTPUT F1 F2 F3 F4 6660 eyr085 eps 2 Press F4 OUTPUT to toggle among four simulated operational modes e Demand e Continuous 4 36 3 Transvenous Pacemaker Testing Setup and Testing e Non Capture e Non Function Press F1 NEXT to advance to the following screen fj SIMULATIOM TRAMS l Quteuk DEMAMD FE Int AU 150 ms Thresh A 3 U mA Fate 30 BPH HSR PR THCH THRESH FATE F2 F3 F4 SLAA OO Press F1 PR to adjust the PR Interval Ne eyr048 eps Press F2 THCH to toggle between atrial and ventricular of the threshold amplitude Press F3 THRESH UP or DOWN arrow key to adjust the selected atrial or ventricular threshold amplitude Press F4 NSR RATE UP or DOWN arrow key to adjust the NSR rate of the simulation ECG signal Conduct pacemaker testing using the Analyzer to provide the ECG signal Press ESC to return to previous menu s 4 37 SigmaPace 1000 Operators Manual Long Term Tests Tests are preformed for only one channel at a time The overall stability of the pacemaker s pulse rate and amplitude are monitored continuously over an extended period of time The user enters the desired target values for these two par
90. transmits RATE 000 and will not start the test until a pulse rate is detected OVERDRIVE nn The Analyzer computes a dual AV channel overdrive higher ECG signal rate based upon the earlier measured pacemaker pulse rate A two digit number nn represents the percentage that ECG signal is higher than the measured pacemaker pulse rate Example With a measured pacemaker pulse rate of 60 PPM and the following overdrive command of OVERDRIVE 20 a computed ECG signal rate of 72 BPM is generated The pacemaker will either PASS or FAIL this qualitative test based upon the criteria stated in the main product specification document UNDERDRIVE nn 5 18 Remote Operation 5 Transvenous Pacemaker Remote Setup and Testing The Analyzer computes a dual AV channel underdrive lower ECG signal rate based upon the earlier measured pacemaker pulse rate A two digit 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 UNDERDRIVE 20 a computed ECG signal rate of 48 BPM is generated The pacemaker will either PASS or FAIL this qualitative test based upon the criteria stated in the main product specification document SETTEST RFRACTA SETTEST RFRACTV REFRACT zzz nnn nn nnn zzz SQU TRLSSQ HSN nnn nn Width in mS nnn Amplitude in mV The Analyzer begins the refractory test by measuring the pacemaker pul
91. ts 0 ccceceeeceeeeeeeeneeeeeeeeeeeeeeeeeeeaee Five Lead ECG and selected ventricular channel test load This waveform is present on both outputs Pacemaker Compatibility Compatible Pulse Rates 30 to 200 BPM Intended Pacemaker Type VVI Ventricular Pace and Sense Only Sensed Refractory Period Test SRP FRAN QC coos se eso E Aine eee 15 mS to 500 mS ACCUIACY iirinn Eae aAa 5 of reading or 1 mS whichever is greater Physiological Simulation SCIECUOMN iaeoa aia naai aa aE nae Triangle TRI Wave 1 16 Introduction and Specifications Amplitude Active Outputs Pacemaker Compatibility Compatible Pulse Rates Intended Pacemaker Type Transvenous Pacemaker Tests Output Pulse Measurement Test Type Display Formats Measurement Ranges Current RESOMMtIOM ss cenaisdasetsccuecaasecuseichecersueteiaincaieeeccucsiacs Instrument Specifications Double pulse interactive with applied pacemaker pulse activity in the demand mode of operation 1 0 m Vpeak Lead Five Lead ECG and selected ventricular channel test load This waveform is present on both outputs 30 to 200 BPM VVI Ventricular Pace and Sense Only Quantitative Atrial or Ventricular only Atrial and ventricular Channels 0 05 mA to 999 mA Single Channel Only 1 00 mA to 9 99 mA 10 0 mA to 30 0 mA 2 of reading or 50 uA whichever is greater or 10 PPM to 99 9 PPM 100 PPM to 999 PPM 0 5 or 0 3 PPM
92. ual List of Tables Table Title Page Jeler Symbolsiniact cage Aaa ea 1 4 1 3 Standard Accessories ccseceeseeseeeeeeeees 1 28 1 4 Pacemaker Disposable Electrode Adapters 1 28 IPSs SEIE EEI oI A EE E ntact teeta airs E ARER AEAT 1 29 1 6 Compatible Power Supply e eesseseseseseseseseeseseseserenenssseseseseseseserenesseses 1 29 1 7 Disposable Transcutaneous Pacemaker Adapters we 1 29 1 8 High Level Output Cables eee eee eeeeteeeenees 1 30 5 1 SETMAKE Protocols by Manufacturer ccecccseesseesceeeeeseeeeeeeeseenee 5 7 SigmaPace 1000 Operators Manual vi List of Figures Figure Title Page 1 1 Analyzer Features and Controls ccccceeccesccsseeseeeeceseceseceeeeeceeenneeneees 1 8 3 1 Scheme for Testing Transcutaneous Pacemakers 3 4 3 2 Paced Refractory Period cceesesccsteeseereeeeeeees wee 3 7 3 3 Sensed Refractory Period cceecceeceseesseseessceeceseeseeeecesecnseeseeeeeeaeenee 3 8 4 1 Scheme for Testing Transvenous Pacemakers c ceseeeceeesereeeeeees 4 3 4 2 DC Leakage Testing se 4 3 Current Drain T ste esisi trey esne T NTE E r lan vii SigmaPace 1000 Operators Manual viii Chapter 1 Introduction and Specifications Contents Page TnitroductlOiec cscs ek nhc he GARR ARR ee 1 3 Compatible Pacemaker Types c ccssccsseeseereeeseeereeeeeeteeneees 1 3 Incompatible Pacemaker Types csccessessesseeseeeeeeeeeesee
93. urns a three digit numeric value XXX with a floating decimal point to cover the multiple ranges The unit of measure remains the same for all transmitted readings mA PPM and mS The Analyzer marks out of limit readings 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 activated when this serial command is received by the Analyzer The following complementary serial commands are then used to select the specific measurement type and the input configuration of the Analyzer s dc micro amp meter function DCLEAK STATICA Continuous measurement on the atrial inputs DCLEAK STATICV Continuous measurement on the vent inputs DCLEAK STATICAV Continuous measurement on the AV inputs DCLEAK DYNAMICA Gated measurement on the atrial inputs DCLEAK DYNAMICV Gated measurement on the vent inputs DCLEAK DYNAMICAV Gated measurement on the AV inputs 5 21 SigmaPace 1000 Operators Manual RDDCLEAK This command queries the Analyzer for the currently active dc leakage test reading and the Analyzer returns the data in the following format DCLEAK XX X A Error Messages Error messages are returned instead of data if the required test conditions are not fulfilled e During STATIC tests an error message PULSE is returned if a pacer pulse output is present on the Analyzer
94. vice Manual 0 0 cece eee eceeeeeneeeeeeeee 2243314 Power Requirement External Battery Charger Power Supply INPUT remeron rer ere a tienen ra 90 264 V 50 60 Hz QUID UE arinira peviesieessdsedveatenersaess 15 V 5 1500mA 100 to 240 V ac 50 60 Hz operation Auto power off sleep mode Sleep Modes EE T A E acrid Analyzer reset button accessed via bottom panel Sleep mode conditions Physical SIZG a lve iena etaed araid 8 X 4 X 2 approx 203 mm X 101 mm X 50 mm WeIGM endian aupara araea aaia Aa 2 Ib 0 90 kg approximate Instrument Specifications Modes of Operation Manual Remote via standard RS 232 serial port User Interface Display LCD Readout sciri 21 characters X 8 lines Brightness viewing angle adjustment Pushbuttons Eight KEYS neiiunanas F 1 F 2 F 3 UP Arrow F 4 UP Arrow 2 Down Arrows ESCAPE and ENTER Introduction and Specifications 1 Instrument Specifications Transcutaneous Pacemaker Tests Output Pulse Measurement Test Type ensnare advan dace Measurement Ranges ACCULACY 0 eecceeeeeeceeeeeeeneeeeeeeeeeeeeaeeeseneeeeeeeeeess ACCURACY occasion dela aed ENEO fies ies asta aaae i rN E EEGA ACCUIACY ninatan aa a aE Demand Mode Test Test Ty p iarunn AN Physiological Simulation SCLECUON asa ietncsice scene dete a a tvanceesee Amplitude 0 2 eee eceeeeeeeeeeeeeeneeeeeeeeeseeaeeeseseeeteanees Mode of Operation UnderdfiVve oie iiccisasecacsnedaesvodseap
95. vice center 1 Before returning the Analyzer for factory service contact the Fluke Biomedical Service Center for a required Return Authorization Number Provide the following information e The Analyzer serial number e The specific steps that reproduce your problem e A daytime phone number e Your name company e A fax number if available Pack the instrument carefully using the original packing materials If the original packing materials are not available refer to Return Procedures for a list of preferred materials or contact Fluke Biomedical for replacement packing Failure to pack the instrument properly could void your warranty Shipping 4 Place the Return Authorization Number in a prominent place on the outside of the packing box and refer to the number in any correspondence with Fluke Biomedical Service Enclose your return address and Return Authorization Number Insure the unit for full retail value and ship to the nearest Fluke Biomedical service center 2 10 Chapter 3 Transcutaneous Pacemaker Testing Contents Page Test Options 24n2 ndne nani basins ARORA wena 3 3 OUD bs esini i E EE EERE EERE A ERR 3 4 Demand Mode raroa eetere leaena osescead eaoin Aaen dasa cchediasteesederetanss 3 5 Asynchronous Modessa a iono 3 5 Amplitude Sensitivity ssssssesseeeesseseeseeserssseeressrsresseserseseeses 3 5 Line Frequency Noise Immunity sssseesseesesseeeessesesresereeesee 3 6 Refractory
96. ws the user to enter either the actual test pacemaker values or the selected rate and amplitude settings Deviation values are independently selectable from 2 to 20 in 1 increments 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 reviewed ECG LOM SIM TERM fac OOOO 1 From the SELECT TEST menu press F2 LONG TERM eyr013 eps LOHG TERM PHYS CTL Select pulse rate and amelitude limits then press HEXT AMF lt 10 soir HET FATE LIMIT LOAD F1 F2 F3 F4 oogg VO 2 Press F2 RATE to toggle between pulse rate and amplitude This parameter works with the LIMIT parameter to assign limits to both K eyr026 eps 3 28 Transcutaneous Pacemaker Testing Setup and Testing For each pulse rate and amplitude press F3 LIMIT UP or DOWN arrow key to select the limit value Press F4 LOAD UP or DOWN arrow key to select the load Press F1 NEXT to advance the screen E L HG TERM FHYS CTL Select target amPlitude and rate then press START AMF 100 mA Rate 50 FFH START AMF RATE F1 F2 F3 F4 oogg QOQ Press F3 AMP UP or DOWN arrow key to adjust the amplitude Press F4 RATE UP or DOWN arrow key to adjust the rate MS eyr027 eps Note Target values for amplitude and rate must be entered for the
97. ys the following parameters e Pulse Amplitude milliamperes e Pulse Rate pulses per minute e Pulse Width milliseconds e Pulse Energy joules 3 4 Transcutaneous Pacemaker Testing Test Options Demand Mode This qualitative test verifies the demand mode pacemaker s ability to interact with a simulated ECG signal The Analyzer first measures the pacemaker s applied pulse rate then computes underdrive and overdrive rates for the simulated ECG signal Initially the underdrive rate is 90 of the applied pacemaker rate and the overdrive rate is 110 of the applied pacemaker rate When testing the pacemaker operating in the demand mode output should be active ON with the underdrive ECG signal and then inhibited OFF when the overdrive ECG signal is selected The rates of these underdrive and overdrive ECG signals can be adjusted across a wide physiological range using the Analyzer top panel controls Asynchronous 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 computes underdrive and overdrive rates for the simulated ECG signal Initially the underdrive rate is 90 of the applied pacemaker rate and the overdrive rate is 110 of the applied pacemaker rate When testing the attached pacemaker operating in the continuous or non demand mode output shou
98. zer transmits RATE 000 and will not start the test until a pulse rate is detected OVERDRIVE nn The Analyzer computes an overdrive higher ECG signal rate based upon the earlier measured pacemaker pulse rate A two digit number nn represents the percentage that ECG signal is higher than the measured pacemaker pulse rate Example With a measured pacemaker pulse rate of 60 PPM and the following overdrive command of OVERDRIVE 20 a computed ECG signal rate of 72 BPM is generated The pacemaker will either PASS or FAIL this 5 10 Remote Operation 5 Transcutaneous Pacemaker Remote Setup and Testing qualitative test based upon the criteria stated in the main product specification document UNDERDRIVE nn The Analyzer computes an underdrive lower ECG signal rate based upon the earlier measured pacemaker pulse rate A two digit 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 UNDERDRIVE 20 a computed ECG signal rate of 48 BPM is generated The pacemaker will either PASS or FAIL this qualitative test based upon the criteria 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 not start the test until a pulse rate is detected The paced refr

SigmaPace 1000 External Pacemaker Analyzer

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