Fluke SigmaPace 1000 Operator's Manual
  1. Manuals
  2. Brands
  3. Fluke Manuals
  4. Measuring Instruments
  5. SigmaPace 1000
  6. Operator's manual

Fluke SigmaPace 1000 Operator's Manual

External pacemaker analyzer
Hide thumbs Also See for SigmaPace 1000:
Table of Contents

Advertisement

Quick Links

Download this manual
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.

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the SigmaPace 1000 and is the answer not in the manual?

Questions and answers

Related Manuals for Fluke SigmaPace 1000

Summary of Contents for Fluke SigmaPace 1000

  • Page 1 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.
  • Page 2 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.
  • Page 3 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.
  • Page 4 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.
  • Page 5 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.

  • Page 7: Table Of Contents

    Table of Contents Chapter Title Page Introduction and Specifications..........1-1 Introduction ..................1-3 Compatible Pacemaker Types............1-3 Incompatible Pacemaker Types ............1-3 General Safety Considerations.............. 1-4 Symbols .................... 1-4 Warnings and Cautions ..............1-4 Power Supply..................1-5 Defibrillators and Transcutaneous Pacemakers......... 1-5 Applications..................
  • Page 8 SigmaPace 1000 Operators Manual Service and Calibration ................ 2-9 Packing Instructions ................. 2-10 Shipping ................... 2-10 Transcutaneous Pacemaker Testing........3-1 Test Options ..................3-3 Output....................3-4 Demand Mode .................. 3-5 Asynchronous Mode................. 3-5 Amplitude Sensitivity............... 3-5 Line Frequency / Noise Immunity............ 3-6 Refractory Period ................
  • Page 9 (continued) Contents Non-Capture ................. 4-7 Non-Function ................4-7 DC Leakage ..................4-7 Static Tests (Pacemaker Power OFF): .......... 4-8 Dynamic Tests (Pacemaker Power ON):........4-9 Current Drain Test ................4-9 Long Term Test ................4-11 Setup and Testing ................. 4-11 Output ....................
  • Page 10 SigmaPace 1000 Operators Manual...
  • Page 11 List of Tables Table Title Page 1-1. Symbols ....................1-4 1-3. Standard Accessories ................1-28 1-4. Pacemaker Disposable Electrode Adapters........... 1-28 1-5. Serial Cables ..................1-29 1-6. Compatible Power Supply ..............1-29 1-7. Disposable Transcutaneous Pacemaker Adapters ......... 1-29 1-8. High-Level Output Cables ..............1-30 5-1.
  • Page 12 SigmaPace 1000 Operators Manual...
  • Page 13 List of Figures Figure Title Page 1-1. Analyzer Features and Controls............1-8 3-1. Scheme for Testing Transcutaneous Pacemakers ......... 3-4 3-2. Paced Refractory Period ............... 3-7 3-3. Sensed Refractory Period..............3-8 4-1. Scheme for Testing Transvenous Pacemakers ........4-3 4-2. DC Leakage Testing ................4-8 4-3.
  • Page 14 SigmaPace 1000 Operators Manual viii...

  • Page 15: Introduction And Specifications

    Chapter 1 Introduction and Specifications Contents Page Introduction .................. 1-3 Compatible Pacemaker Types........... 1-3 Incompatible Pacemaker Types ..........1-3 General Safety Considerations ............. 1-4 Symbols ..................1-4 Warnings and Cautions............. 1-4 Power Supply................1-5 Defibrillators and Transcutaneous Pacemakers ......1-5 Applications .................
  • Page 16 SigmaPace 1000 Operators Manual...

  • Page 17: Introduction

    Introduction and Specifications 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.

  • Page 18: General Safety Considerations

    Description Important information; refer to manual. Hazardous voltage Do not dispose of this product as unsorted municipal waste. Go to Fluke’s website for recycling information. Conforms to relevant Australian EMC requirements Œ Conforms to relevant Canadian and US standards Conforms to European Union directives IEC Measurement Category I –...

  • Page 19: Power Supply

    Introduction and Specifications General Safety Considerations XW 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.

  • Page 20: Applications

    SigmaPace 1000 Operators Manual W 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.

  • Page 21: 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.”...

  • Page 22: Instrument Familiarization

    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...
  • Page 23 Introduction and Specifications Instrument Familiarization Table 1-2. Analyzer Features and Controls Number Description Top Panel LCD Readout (8 Lines X 21 Characters) F4 / UP and DOWN Arrow Keys F3 / UP and DOWN Arrow Keys F2 Key F1 Key ENTER and POWER ON Key ESCAPE and POWER OFF Key Atrial Channel Sense Indicator (Yellow LED)

  • Page 24: Abbreviations

    SigmaPace 1000 Operators Manual Abbreviations The following list includes abbreviations used in this document. ampere ANSI American National Standards Institute Association for the Advancement of Medical AAMI Instrumentation blue (color) beats per minute decibel °C degrees Celsius (centigrade) Contact Quality Monitor...
  • Page 25 Introduction and Specifications Abbreviations kΩ kilohm pound light-emitting diode liquid crystal display meg(a) (10 megahertz MΩ megohm meter milli (10 milliampere millimeter millivolt peak-to-peak Return Electrode Monitor second yellow (color) micro (10 µ µA microampere µV microvolt Ω 1-11...

  • Page 26: General Specifications

    SigmaPace 1000 Operators Manual General Specifications Listed product specifications are subject to change. Temperature Operating.............18 - 40 °C Storage ..............0 - 50 °C Relative Humidity, Operating .......90 % max (non-condensing) Altitude ..............2000 m Serial Port Connector Type...........DB-9 (Male) Baud Rates............2400, 9600, and 19200 Service Manual ............2243314...

  • Page 27: Transcutaneous Pacemaker Tests

    Introduction and Specifications Instrument Specifications Transcutaneous Pacemaker Tests Output Pulse Measurement Test Type ............... Quantitative Measurement Ranges Output ..............4.0 mA to 9.99 mA 10.0 mA to 99.9 mA 100 mA to 250 mA Accuracy ............±2 % of reading or ±50 µA (whichever is greater) Rate ..............
  • Page 28 SigmaPace 1000 Operators Manual Auxiliary Rate Range Underdrive (minimum).........10 BPM Overdrive (maximum)..........300 BPM 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........30 to 200 PPM Intended Type .............External Transcutaneous VVI...
  • Page 29 Introduction and Specifications Instrument Specifications Amplitude Sensitivity Test Physiological Simulation Selection ............. +R-Wave, -S-Wave, and + T-Wave Rate (Interval) ............. Default: 120 BPM (500 mS) Available Test Load Selection(s)............(30) 50 Ω to 1550 Ω in 50 Ω steps Waveform Selections.......... Square (SQU) Triangle (TRI) Haversine (HSN) Amplitude...
  • Page 30 SigmaPace 1000 Operators Manual Active Outputs Selected Ventricular Channel Test load Five lead ECG Testload Amplitude Output Ventricular Channel Range..............0.00 (OFF) to 10.0 mV peak-to-peak Accuracy............±5 % of setting Resolution (Step Size)........0.50 mV steps peak-to-peak Pacer Load Range ..........(30) 50 Ω to 1550 Ω 1 % Five Lead ECG Output Range ..............0.00 (OFF) to 10.0 mV...

  • Page 31: Transvenous Pacemaker Tests

    Introduction and Specifications Instrument Specifications Pulse Width............40 mS Rate ..............Double pulse: interactive with applied pacemaker pulse activity in the demand mode of operation. Amplitude .............. 1.0 m V Lead I peak Active Outputs ............Five Lead ECG and selected ventricular channel test load.
  • Page 32 SigmaPace 1000 Operators Manual Voltage ..............0.050 V to .999 V peak peak 1.00 V to 9.99 V peak peak 10.0 V to 30.0 V peak peak Accuracy............2 % of reading or 0.05 V peak (whichever is greater) Polarity Indicator..........+ or - Energy ..............1 nJ to 999 nJ...
  • Page 33 Introduction and Specifications Instrument Specifications Simulation Waveform ............SSQ Atrial Channel ............. Simulated P-wave Width............... 30 mS Amplitude............2.0 mV peak Ventricular Channel ..........Simulated R-wave Width............... 40 mS Amplitude............2.5 mV peak PR Interval ............90 mS Interactive Simulated Rates Default Settings Underdrive ............
  • Page 34 SigmaPace 1000 Operators Manual Amplitude Sensitivity Test Test Type..............Qualitative Channels Single Channel Operation Only (Atrial or Ventricular) Atrial Channel Test Type..............Quantitative Physiological Simulation Selection..............+P-Wave Rate ..............30 to 120 BPM, Waveform delayed by 80 % of the pulse-to-pulse interval or 400 mS (whichever is shorter).
  • Page 35 Introduction and Specifications Instrument Specifications Pacer Load Selection.......... 1000 Ω Range ............. 0.05 mV (50 V ) to 100 mV peak peak peak-to- peak Accuracy ............±5 % of setting Resolution (Step Size)........0.05 mV steps from 0.05 mV peak peak 0.95 mV peak...
  • Page 36 SigmaPace 1000 Operators Manual Available Selection(s)........(3) 200, 500 and 1000 Ω ±1 % Default Setting..........500 Ω Amplitude Pacer Load Selection ..........500 Ω Range..............0.05 mV (50 V ) to 50.0 mV peak peak peak Accuracy............±5 % of setting Resolution ............0.05 mV steps from 0.05 mV...
  • Page 37 Introduction and Specifications Instrument Specifications Noise Immunity Test Test Type ............... Qualitative Channels Single..............Atrial or Ventricular Only Waveform .............. Sine Wave Frequency.............. 50 and 60 Hz Accuracy..............0.5 Hz Active Output(s)............ Selected atrial and / or ventricular channel test load Output Selections Atrial Channel Only Ventricular Channel Only...
  • Page 38 SigmaPace 1000 Operators Manual Physiological Simulation Selection (Default)..........Single Channel Simulation (A) Square Wave Atrial Channel ............Simulated P-wave Width ..............1.0 mS Amplitude ............20.0 mV peak Active Outputs .............Atrial Channel (4 mm Banana Jacks) Only Additional Waveform Selections Square (SQU) Triangle (TRI)
  • Page 39 Introduction and Specifications Instrument Specifications Resolution ............. ±1 LSD Display Format............3 digits Physiological Simulation Selection (Default) ..........Single Channel Simulation (V) Square Wave Ventricular Channel ..........Simulated R-wave Width..............1.0 mS Amplitude............20 mV peak Active Outputs ............ Ventricular Channel (4 mm Banana Jacks) Only Available Test Load(s) ........
  • Page 40 SigmaPace 1000 Operators Manual DC Leakage Current Test Type..............Quantitative Measurement Range ..........00.1 µA to 99.9 µA Input Polarity............Positive and Negative Resolution ..............1 LSD Display Format............3 digits plus decimal point Test Selections Static ..............Continuous measurement Pacemaker Power ..........OFF Input Configurations ..........Atrial+ and Atrial-...
  • Page 41 Introduction and Specifications Instrument Specifications Battery Test Fixture ..........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..........Atrial Channel or Ventricular Channel Pulse Count Range..........

  • Page 42: Accessories

    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 Description Part Number Transvenous Test Lead Red (2 each)
  • Page 43 Introduction and Specifications Accessories Table 1-5. Serial Cables Description Part Number 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 Part Number Universal Power Supply 15V (90 to 264 VAC) IEC320 2184298 C6 3-wire USA / CAN Power Cord IEC320 C5 3-wire...
  • Page 44 SigmaPace 1000 Operators Manual Table 1-8. High-Level Output Cables Description Part Number Subminiature Phone Plug to BNC Cable 2199932 (Oscilloscope Application) Subminiature Phone Plug to 3-Conductor 2200116 ¼” Phone Plug Cable (AA-900) 1-30...

  • Page 45: Setup, Operation, And Maintenance

    Chapter 2 Setup, Operation, and Maintenance Contents Page Setting Up the Analyzer............... 2-3 Connecting External Transcutaneous Pacemakers ....2-3 Connecting External Transvenous Pacemakers......2-4 Load Test Cable Connector ............2-4 RS-232 Serial Port Connector ..........2-5 High Level ECG Output Jack........... 2-5 Ventilation................
  • Page 46 SigmaPace 1000 Operators Manual...

  • Page 47: Setting Up The Analyzer

    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.

  • Page 48: Connecting External Transvenous Pacemakers

    Use these test leads to connect the output of the transvenous single-channel (atrial or ventricular) or dual-channel (atrial and ventricular) external pacemaker to the SigmaPace 1000. W X Warning To avoid injury to a patient, do not connect the Analyzer to a patient or equipment connected to a patient.

  • Page 49: Rs-232 Serial Port Connector

    Setup, Operation, and Maintenance 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.
  • Page 50 SigmaPace 1000 Operators Manual eyr008.eps The LCD then advances to the Select external pacemaker type screen: eyr001.eps...

  • Page 51: Transcutaneous Pacemaker Testing

    Setup, Operation, and Maintenance Transcutaneous Pacemaker Testing 2. From this screen, you can select one of the following options: • F1 NONINV to begin Non-Invasive (transcutaneous) external pacemaker testing. • F2 INV to begin Invasive (transvenous) external pacemaker testing. • F4 UTIL to access the Utility menu.

  • Page 52: Maintenance

    SigmaPace 1000 Operators Manual 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.

  • Page 53: Cleaning

    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.”...

  • Page 54: Packing Instructions

    Fluke Biomedical Service. 5. Enclose your return address and Return Authorization Number. 6. Insure the unit for full retail value and ship to the nearest Fluke Biomedical service center. 2-10...

  • Page 55: Transcutaneous Pacemaker Testing

    Chapter 3 Transcutaneous Pacemaker Testing Contents Page Test Options ................. 3-3 Output..................3-4 Demand Mode ................3-5 Asynchronous Mode..............3-5 Amplitude Sensitivity............... 3-5 Line Frequency / Noise Immunity..........3-6 Refractory Period ..............3-6 Paced Refractory Period (PRP)..........3-6 Sensed Refractory Period (SRP) ........... 3-7 Long Term Test ................
  • Page 56 SigmaPace 1000 Operators Manual...

  • Page 57: Test Options

    Transcutaneous Pacemaker Testing Test Options Test Options The scheme for 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 Ω to 1550 Ω in 50 Ω steps) with each measurement algorithm.

  • Page 58: Output

    SigmaPace 1000 Operators Manual Monitor V1/C1 LL/F Sensing LA/L & Pacer RA/R RL/N High Level Output Transcutaneous SIGMAPACE 1000 Pacemaker External Pacemaker Analyzer eyr002.eps Figure 3-1. Scheme for Testing Transcutaneous Pacemakers Output The Analyzer measures the output of the transcutaneous pacemaker and displays the following parameters: •...

  • Page 59: Demand Mode

    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.

  • Page 60: Line Frequency / Noise Immunity

    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.

  • Page 61: Sensed Refractory Period (Srp)

    Transcutaneous Pacemaker Testing Test Options P a c i n g R a t e I n t e r v a l @ 8 0 B P M = 7 5 0 m S P R P C a r d i a c Te s t P u l s e P a c i n g R a t e I n t e r v a l R e s e t >...

  • Page 62: Long Term Test

    SigmaPace 1000 Operators Manual P ac ing R ate Interval R es et > 750 mS P R P "S ens ed" C ardiac T es t P uls e #1 S R P P ac ing R ate Interval...

  • Page 63: Interactive Pacemaker / Ecg Simulation

    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 limits. Interactive Pacemaker / ECG Simulation The pacemaker responds to a wide range of simulated ECG signals using the Analyzer test feature.

  • Page 64: Non-Function

    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 following describes how to set up and test a transcutaneous pacemaker.
  • Page 65 Transcutaneous Pacemaker Testing Setup and Testing 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 Ω...

  • Page 66: Output

    SigmaPace 1000 Operators Manual eyr012.eps eyr013.eps 7. Press ESC to return to previous menu(s). Output The following test measures the output of the transcutaneous pacemaker. eyr014.eps 1. From the SELECT TEST menu, press F1 PULSE OUTPUT. 3-12...
  • Page 67 Transcutaneous Pacemaker Testing Setup and Testing eyr015.eps 2. Press the F4 LOAD UP or DOWN arrow key to select the desired load. 3. Press F1 HOLD to advance the screen: eyr016.eps 4. Press F4 XMIT DATA to transmit data through the serial port. 5.

  • Page 68: Demand Mode Pacemaker's Interaction With Ecg Signal

    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. eyr014.eps 1. From the SELECT TEST menu, press F2 DMAND MODE. eyr058.eps 2. Press the F4 UP or DOWN arrow key to select the desired load.

  • Page 69: Continuous Mode Pacemaker's Interaction With Ecg Signal

    Transcutaneous Pacemaker Testing Setup and Testing eyr017.eps 4. Press F2 SELECT DRIVE< 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.
  • Page 70 SigmaPace 1000 Operators Manual 1. From the SELECT TEST menu, press F3 ASYNC MODE. eyr059.eps 2. Press the F4 LOAD UP or DOWN arrow key to select the load. 3. Press F1 START to advance the screen and start the test.

  • Page 71: Demand Mode Pacemaker's Ability To Sense Ecg Activity

    Transcutaneous Pacemaker Testing Setup and Testing eyr018.eps 4. Press F2 SELECT DRIVE< 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.
  • Page 72 SigmaPace 1000 Operators Manual eyr012.eps 1. From the SELECT TEST menu, press F1 REFRCT DEMAND. eyr060.eps 2. Press F4 LOAD UP or DOWN arrow key to select the load. 3. Press F1 START to advance screen and start the test.
  • Page 73 Transcutaneous Pacemaker Testing Setup and Testing eyr020.eps After the calculations are complete, the following screen appears. eyr021.eps 3-19...

  • Page 74: Amplitude Of Ecg Signal For Demand Mode Pacemaker

    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 amplitude of the simulated ECG signal required by the demand mode pacemaker.
  • Page 75 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. eyr062.eps 4. Press F3 UP or DOWN arrow key to select waveform type. 5.
  • Page 76 SigmaPace 1000 Operators Manual 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...

  • Page 77: Pacemaker's Ability To Filter Line Noise

    Transcutaneous Pacemaker Testing Setup and Testing eyr022.eps 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 The following test measures a pacemaker’s ability to filter line noise at either 50 or 60 Hz.
  • Page 78 SigmaPace 1000 Operators Manual eyr064.eps 2. Press F3 UP or DOWN arrow key select the line frequency. 3. Press F4 LOAD UP or DOWN arrow key to select the load. 4. Press F1 NEXT to advance the screen. 3-24...
  • Page 79 Transcutaneous Pacemaker Testing Setup and Testing eyr065.eps 5. Press F3 ECG UP or DOWN arrow key to toggle the ECG function ON or OFF. 6. Press F4 AMP UP or DOWN arrow key to adjust the amplitude of the line frequency. 7.

  • Page 80: Purpose Of The Ecg Simulation Test

    SigmaPace 1000 Operators Manual eyr066.eps 8. Press F4 XMIT DATA to transmit data. 9. Press F1 RELEASE to release the hold and return to the HOLD screen. 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.

  • Page 81: Long Term Tests

    Transcutaneous Pacemaker Testing Setup and Testing eyr025.eps 2. Press F1 OUTPUT to toggle among four simulated operational modes: • Demand • Continuous • Non-capture • Non-function. 3. Press F3 THRESH UP or DOWN arrow key to adjust the threshold amplitude. 4.
  • Page 82 SigmaPace 1000 Operators Manual 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.
  • Page 83 Transcutaneous Pacemaker Testing Setup and Testing 3. For each, pulse rate and amplitude, press F3 LIMIT UP or DOWN arrow key to select the limit value. 4. Press F4 LOAD UP or DOWN arrow key to select the load. 5. Press F1 NEXT to advance the screen. eyr027.eps 6.
  • Page 84 SigmaPace 1000 Operators Manual eyr028.eps 9. Press F1 END to end the test. eyr029.eps 3-30...
  • Page 85 Transcutaneous Pacemaker Testing Setup and Testing 10. 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.
  • Page 86 SigmaPace 1000 Operators Manual 3-32...

  • Page 87: Transvenous Pacemaker Testing

    Chapter 4 Transvenous Pacemaker Testing Contents Page Test Options ................. 4-3 Output..................4-4 Demand Mode ................4-4 Asynchronous Mode..............4-4 Amplitude Sensitivity............... 4-5 Line Frequency / Noise Immunity..........4-5 Refractory Period ..............4-5 Paced Refractory Period (PRP)..........4-5 Sensed Refractory Period (SRP) ........... 4-5 Interactive Pacemaker/ ECG Simulation ........
  • Page 88 SigmaPace 1000 Operators Manual...

  • Page 89: Test Options

    The test load resistance values track for both the atrial and ventricular channels. Atrial Channel V1/C1 LL/F Sensing LA/L & Pacer RA/R RL/N High Level Output Ventricular Channel SIGMAPACE 1000 Transvenous External Pacemaker Analyzer Pacemaker eyr005.eps Figure 4-1. Scheme for Testing Transvenous Pacemakers...

  • Page 90: Output

    SigmaPace 1000 Operators Manual Output The Analyzer measures the output of the transvenous pacemaker, and displays the following parameters: • Pulse Amplitude = milliamperes • Pulse Rate = pulses per minute • Pulse Width = milliseconds • AV Delay = milliseconds •...

  • Page 91: Amplitude Sensitivity

    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.

  • Page 92: Interactive Pacemaker/ Ecg Simulation

    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.

  • Page 93: Non-Capture

    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.

  • Page 94: Static Tests (Pacemaker Power Off)

    SigmaPace 1000 Operators Manual Transvenous SIGMAPACE 1000 Pacemaker External Pacemaker Analyzer Atrial Channel Static & Dynamic Sensing & Pacer Control Leakage Ventricular Channel Power ON/OFF eyr006.eps Figure 4-2. DC Leakage Testing Potentially harmful dc levels can be detected using the various test...

  • Page 95: Dynamic Tests (Pacemaker Power On)

    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: • Atrial Channel: dc leakage across the atrial channel 500 Ω test load. •...
  • Page 96 SigmaPace 1000 Operators Manual Transvenous SIGMAPACE 1000 Pacemaker External Pacemaker Analyzer Current Internal Battery Compartment Power ON/OFF 9 VDC Battery eyr007.eps Figure 4-3. Current Drain Test Readings are made in three pacemaker operating modes: • Pacemaker Power OFF • Pacemaker Power ON and Display Backlight OFF •...

  • Page 97: Long Term Test

    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.
  • Page 98 SigmaPace 1000 Operators Manual eyr031.eps 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.

  • Page 99: Output

    Transvenous Pacemaker Testing Setup and Testing eyr033.eps eyr034.eps eyr035.eps Output The following test measures the output of the transvenous pacemaker. eyr032.eps 1. From the SELECT TEST menu, press F1 PULSE OUTPUT. 4-13...
  • Page 100 SigmaPace 1000 Operators Manual eyr037.eps 2. Select the desired configuration: • Press F2 ATR ONLY to display only atrial channel data. • 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.
  • Page 101 Transvenous Pacemaker Testing Setup and Testing eyr038.eps 6. Press F2 RATE to toggle between NORM and <20. Note The RATE <20 is used to measure pacer activity under the rate of 20 PPM. The sampling time is extended to accommodate this lower rate. 7.

  • Page 102: Demand Mode And Dual-Channel (Av) Ecg Signal

    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. eyr032.eps 1. From the SELECT TEST menu, press F2 DMAND MODE.
  • Page 103 Transvenous Pacemaker Testing Setup and Testing eyr039.eps 4. Press F2 SELECT DRIVE< to toggle between the Over and Under BPM rates. 5. Once a rate is selected, press F4 DRIVE RATE BPM UP or DOWN arrow key to adjust the rate. 6.

  • Page 104: Continuous Mode And Dual-Channel (Av) Ecg Signal

    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. eyr032.eps 1. From the SELECT TEST menu, press F3 ASYNC MODE.
  • Page 105 Transvenous Pacemaker Testing Setup and Testing eyr040.eps 4. Press F2 SELECT DRIVE< to toggle between the Over and Under BPM rates. 5. Once a rate is selected use F4 DRIVE RATE BPM UP or DOWN arrow key to adjust that rate. 6.

  • Page 106: Demand Mode Pacemaker's Ability To Sense Ecg Activity

    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).
  • Page 107 Transvenous Pacemaker Testing Setup and Testing The screen advances for wave and width selection (the example is the atrial channel). eyr070.eps 4. Press F3 WAVE UP or DOWN arrow key to select a waveform. 5. Press F4 WIDTH UP or DOWN arrow key to adjust the width of the waveform.
  • Page 108 SigmaPace 1000 Operators Manual eyr071.eps 7. Press F3 POLARITY UP or DOWN arrow key to toggle the polarity. 8. Press F4 AMPLITUDE to adjust amplitude. 9. Press F1 START to advance the screen and start the test. 4-22...

  • Page 109: Amplitude Of Ecg Signal For A Demand Mode Pacemaker

    Transvenous Pacemaker Testing Setup and Testing eyr042.eps 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 This test determines the required amplitude of the simulated ECG signal to be detected by the demand mode pacemaker.
  • Page 110 SigmaPace 1000 Operators Manual eyr072.eps 2. Select either of the two options: • F1 ATR for the atrial channel. • F2 VENT for the ventricular channel. After pressing the desired key, the appropriate screen appears: 4-24...
  • Page 111 Transvenous Pacemaker Testing Setup and Testing eyr073.eps 3. Press F4 LOAD UP or DOWN arrow key to select the load. 4. Press F1 NEXT to advance to the next screen. 4-25...
  • Page 112 SigmaPace 1000 Operators Manual eyr075.eps 5. Press F3 WAVE UP or DOWN arrow key to select a waveform. 6. Press F4 WIDTH UP or DOWN arrow key to adjust the width of the waveform. 7. Press F1 NEXT to advance to the next screen.
  • Page 113 Transvenous Pacemaker Testing Setup and Testing eyr076.eps 8. Press F3 POL UP or DOWN arrow key to select polarity. 9. Press F4 AMP UP or DOWN arrow key to adjust amplitude. 10. Press F1 START to start the test and advance to the next screen. After calculations, the following screen appears.

  • Page 114: Pacemaker's Ability To Filter Line Noise

    SigmaPace 1000 Operators Manual 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 eyr033.eps...
  • Page 115 Transvenous Pacemaker Testing Setup and Testing eyr078.eps 2. Press F2 CHAN to toggle between the two options: • A - atrial channel • V - ventricular channel. 3. Press F3 LINE to toggle between two line frequencies (50 or 60 Hz). 4.
  • Page 116 SigmaPace 1000 Operators Manual 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: eyr016.eps...

  • Page 117: Dc Leak Test

    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 eyr034.eps 1. From the SELECT TEST menu, press F1 DC LEAK. eyr080.eps 4-31...
  • Page 118 SigmaPace 1000 Operators Manual 2. Select a test type: • F1 OFF - Static test (Turn pacemaker power OFF) • F2 ON - Dynamic test (Turn pacemaker power ON) The screen advances: eyr081.eps 3. Press one of the three options: •...
  • Page 119 Transvenous Pacemaker Testing Setup and Testing eyr046.eps 9. Press F1 HOLD to advance the screen: eyr016.eps Press F4 XMIT DATA to transmit data through the serial port. Press F1 RELEASE to release the hold and return to the HOLD screen. Press ESC to return to previous menu(s).

  • Page 120: Dc Load Test

    Plug the supplied 9 V dc Load Test Cable into the matching connector on the left side of the Analyzer. b. A 9 V dc Load Test Cable (Fluke Biomedical Part# 2201074) is supplied as a standard accessory with the Analyzer. It is designed specifically for the testing of Medtronic models 5388 Dual Channel and 5348 Single Channel transvenous pacemakers.
  • Page 121 Transvenous Pacemaker Testing Setup and Testing 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. 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.

  • Page 122: Ecg Simulation Test

    SigmaPace 1000 Operators Manual Press F4 XMIT DATA to transmit data through the serial port. Press F1 RELEASE to release the hold and return to the HOLD screen. Press ESC to return to previous menu(s). ECG Simulation Test eyr034.eps 1. From the SELECT TEST menu, press F3 ECG SIM.
  • Page 123 Transvenous Pacemaker Testing Setup and Testing • Non-Capture • Non-Function 3. Press F1 NEXT to advance to the following screen: eyr048.eps 4. Press F1 PR to adjust the PR Interval. 5. Press F2 THCH to toggle between atrial and ventricular of the threshold amplitude.

  • Page 124: Long Term Tests

    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 parameters into the Analyzer.
  • Page 125 Transvenous Pacemaker Testing Setup and Testing eyr049.eps 2. Select one of the following two options: • Press F1 ATRIAL for the atrial channel. • Press F2 VENT for the ventricular channel. The screen advances (the example is the ventricular channel): 4-39...
  • Page 126 SigmaPace 1000 Operators Manual eyr050.eps 3. Press F2 RATE to toggle between pulse rate and amplitude. This parameter works with the LIMIT parameter to assign limits to both. 4. For each, pulse rate and amplitude, press F3 LIMIT UP or DOWN arrow key to select the limit value.
  • Page 127 Transvenous Pacemaker Testing Setup and Testing eyr051.eps 7. Press F3 AMP to adjust the amplitude. 8. Press F4 RATE to adjust the rate. 9. Press F1 START to advance screen and start the test. Note Target values for amplitude and rate must be entered for test to perform correctly.
  • Page 128 SigmaPace 1000 Operators Manual eyr052.eps 10. Press F1 END to end the test. eyr053.eps 4-42...
  • Page 129 Transvenous Pacemaker Testing Setup and Testing 11. 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.
  • Page 130 SigmaPace 1000 Operators Manual 4-44...

  • Page 131: Remote Operation

    Chapter 5 Remote Operation Contents Page Introduction ................. 5-3 Entering Remote Mode ............5-3 Working in Remote Mode............5-3 Exiting Remote Mode .............. 5-3 Command Syntax ..............5-4 Responses to Commands............5-4 Remote Mode Analyzer Setup Commands ......5-4 Error Codes ................5-5 Transcutaneous Pacemaker Remote Setup and Testing....
  • Page 132 SigmaPace 1000 Operators Manual...

  • Page 133: Introduction

    Remote Operation 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.

  • Page 134: Command Syntax

    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.

  • Page 135: Error Codes

    Remote Operation 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;...

  • Page 136: Transcutaneous Pacemaker Remote Setup And Testing

    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.
  • Page 137 Remote Operation 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.
  • Page 138 SigmaPace 1000 Operators Manual (Example: SETLOAD=0050 is the command for a 50 Ω test load) Selections for “nnnn” range from 0050 to 1550, in 50 Ω increments. RDLOAD Reads the current test load setting. When this command is sent to the Analyzer it returns: LOAD=nnnn;...
  • Page 139 Remote Operation 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”...
  • Page 140 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.
  • Page 141 Remote Operation 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.
  • Page 142 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.

  • Page 143: Transvenous Pacemaker Remote Setup And Testing

    Remote Operation Transvenous Pacemaker Remote Setup and Testing zz= % test limit for rate. nnn= Set point for rate (1PPM 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.
  • Page 144 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.
  • Page 145 Remote Operation Transvenous Pacemaker Remote Setup and Testing 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...
  • Page 146 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.
  • Page 147 Remote Operation 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...
  • Page 148 SigmaPace 1000 Operators Manual 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.)
  • Page 149 Remote Operation 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.
  • Page 150 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;...
  • Page 151 Remote Operation 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.
  • Page 152 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.
  • Page 153 Remote Operation 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= XXX mA to the host controller.
  • Page 154 SigmaPace 1000 Operators Manual 5-24...

Table of Contents