Fluke 1000 User Manual

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SigmaPace 1000

External Pacemaker Analyzer

Operators Manual

PN 2243306

July 2007

Warranty and Product Support

Fluke Biomedical warrants this instrument against defects in materials and workmanship for one year from the date of original purchase. During the warranty period, we will repair or at our option replace, at no charge, a product that proves to be defective, provided you return the product, shipping prepaid, to Fluke Biomedical. This warranty covers the original purchaser only and is not transferable. The warranty does not apply if the product has been damaged by accident or misuse or has been serviced or modified by anyone other than an authorized Fluke Biomedical service facility. NO OTHER WARRANTIES, SUCH AS FITNESS FOR A PARTICULAR PURPOSE, ARE EXPRESSED OR IMPLIED. FLUKE SHALL NOT BE LIABLE FOR ANY SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES OR LOSSES, INCLUDING LOSS OF DATA, ARISING FROM ANY CAUSE OR THEORY.

This warranty covers only serialized products and their accessory items that bear a distinct serial number tag. Recalibration of instruments is not covered under the warranty

This warranty gives you specific legal rights and you may also have other rights that vary in different jurisdictions. Since some jurisdictions do not allow the exclusion or limitation of an implied warranty or of incidental or consequential damages, this limitation of liability may not apply to you. If any provision of this warranty is held invalid or unenforceable by a court or other decision-maker of competent jurisdiction, such holding will not affect the validity or enforceability of any other provision.

07/07

Notices

© Copyright 2007, Fluke Biomedical. No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or translated into any language without the written permission of Fluke Biomedical.

Fluke Biomedical agrees to a limited copyright release that allows you to reproduce manuals and other printed materials for use in service training programs and other technical publications. If you would like other reproductions or distributions, submit a written request to Fluke Biomedical.

Unpacking and Inspection

Follow standard receiving practices upon receipt of the instrument. Check the shipping carton for damage. If damage is found, stop unpacking the instrument. Notify the carrier and ask for an agent to be present while the instrument is unpacked. There are no special unpacking instructions, but be careful not to damage the instrument when unpacking it. Inspect the instrument for physical damage such as bent or broken parts, dents, or scratches.

Technical Support

For application support or answers to technical questions, 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 resalable condition. Products not returned within 90 days of purchase, or products which are not in “as new” and resalable condition, are not eligible for credit return and will be returned to the customer. The Return Procedure (see below) must be followed to assure prompt refund/credit.

Restocking Charges

Products returned within 30 days of original purchase are subject to a minimum restocking fee of 15 %. Products returned in excess of 30 days after purchase, but prior to 90 days, are subject to a minimum restocking fee of 20 %. Additional charges for damage and/or missing parts and accessories will be applied to all returns.

Return Procedure

All items being returned (including all warranty-claim shipments) must be sent freight-prepaid to our factory location. When you return an instrument to Fluke Biomedical, we recommend using United Parcel Service, Federal Express, or Air Parcel Post. We also recommend that you insure your shipment for its actual replacement cost. Fluke Biomedical will not be responsible for lost shipments or instruments that are received in damaged condition due to improper packaging or handling.

Use the original carton and packaging material for shipment. If they are not available, we recommend the following guide for repackaging:

 Use a double-walled carton of sufficient strength for the weight being shipped.  Use heavy paper or cardboard to protect all instrument surfaces. Use nonabrasive

material around all projecting parts.

 Use at least four inches of tightly packed, industry-approved, shock-absorbent

Returns for partial refund/credit:

Every product returned for refund/credit must be accompanied by a Return Material Authorization (RMA) number, obtained from our Order Entry Group at 1-800-648-7952 or 1-425-446-

6945.

Repair and calibration:

To find the nearest service center, go to www.flukebiomedical.com/service

In the U.S.A.: Cleveland Calibration Lab Tel: 1-800-850-4606 Email: globalcal@flukebiomedical.com

Everett Calibration Lab Tel: 1-888-99-FLUKE (1-888-993-5853) Email: service.status@fluke.com

In Europe, Middle East, and Africa: Eindhoven Calibration Lab Tel: +31-402-675300 Email: ServiceDesk@fluke.com

In Asia: Everett Calibration Lab Tel: +425-446-6945 Email: service.international@fluke.com

material around the instrument.

, or

Certification

This instrument was thoroughly tested and inspected. It was found to meet Fluke Biomedical’s manufacturing specifications when it was shipped from the factory. Calibration measurements are traceable to the National Institute of Standards and Technology (NIST). Devices for which there are no NIST calibration standards are measured against in-house performance standards using accepted test procedures.

WARNING

Unauthorized user modifications or application beyond the published specifications may result in electrical shock hazards or improper operation. Fluke Biomedical will not be responsible for any injuries sustained due to unauthorized equipment modifications.

Restrictions and Liabilities

Information in this document is subject to change and does not represent a commitment by Fluke Biomedical. Changes made to the information in this document will be incorporated in new editions of the publication. No responsibility is assumed by Fluke Biomedical for the use or reliability of software or equipment that is not supplied by Fluke Biomedical, or by its affiliated dealers.

Manufacturing Location

The SigmaPace 1000 External Pacemaker Analyzer is manufactured in Everett, Washington by Fluke Biomedical, 6920 Seaway Blvd., Everett, WA, U.S.A.

Chapter Title Page

1 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.......................................................................................... 1-6

Features................................................................................................. 1-6

Unpacking and Inspection..................................................................... 1-7

Instrument Familiarization.................................................................... 1-8

Abbreviations........................................................................................ 1-10

General Specifications .......................................................................... 1-12

Instrument Specifications...................................................................... 1-12

Transcutaneous Pacemaker Tests...................................................... 1-13

Transvenous Pacemaker Tests .......................................................... 1-17

Accessories ........................................................................................... 1-28

2 Setup, Operation, and Maintenance ....................................... 2-1

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 ........................................................................................ 2-5

Power Up Sequence.............................................................................. 2-5

Transcutaneous Pacemaker Testing...................................................... 2-7

Transvenous Pacemaker Testing........................................................... 2-7

Utility Functions ................................................................................... 2-7

Maintenance.......................................................................................... 2-8

Avoiding Damage............................................................................. 2-8

Cleaning............................................................................................ 2-9

SigmaPace 1000

Operators Manual

Service and Calibration ........................................................................ 2-9

Packing Instructions ......................................................................... 2-10

Shipping ........................................................................................... 2-10

3 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 ............................................................................. 3-6

Paced Refractory Period (PRP) .................................................... 3-6

Sensed Refractory Period (SRP)................................................... 3-7

Long Term Test................................................................................ 3-8

Interactive Pacemaker / ECG Simulation......................................... 3-9

Simulated ECG Rate..................................................................... 3-9

Adjustable Threshold Level.......................................................... 3-9

Operational Modes ........................................................................... 3-9

Continuous ................................................................................... 3-9

Non-Capture ................................................................................. 3-9

Non-Function ............................................................................... 3-10

Setup and Testing................................................................................. 3-10

Output............................................................................................... 3-12

Demand Mode Pacemaker’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......................................... 3-23

Purpose of the ECG Simulation Test................................................ 3-26

Long Term Tests .............................................................................. 3-27

4 Transvenous Pacemaker Testing........................................... 4-1

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.......................................... 4-6

Simulated ECG Rate ........................................................................ 4-6

PR Interval ....................................................................................... 4-6

Adjustable Threshold Level.............................................................. 4-6

Operational Modes ........................................................................... 4-6

Continuous ................................................................................... 4-6

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 ............................................................................................... 4-13

Demand Mode and Dual-channel (AV) ECG Signal ........................ 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.............. 4-23

Pacemaker’s Ability to Filter Line Noise.......................................... 4-28

DC Leak Test................................................................................ 4-31

DC Load Test................................................................................ 4-34

ECG Simulation Test.................................................................... 4-36

Long Term Tests............................................................................... 4-38

5 Remote Operation .................................................................... 5-1

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........................ 5-6

Transvenous Pacemaker Remote Setup and Testing............................. 5-13

(continued)

iii

SigmaPace 1000

Operators Manual

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. SETMAKE Protocols by Manufacturer ................................................ 5-7

SigmaPace 1000

Operators Manual

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. Current Drain Test ................................................................................ 4-10

vii

SigmaPace 1000

Operators Manual

viii

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 ................................................................................. 1-6

Features ........................................................................................ 1-6

Unpacking and Inspection ............................................................ 1-7

Instrument Familiarization ........................................................... 1-8

Abbreviations ............................................................................... 1-10

General Specifications.................................................................. 1-12

Instrument Specifications............................................................. 1-12

Transcutaneous Pacemaker Tests ............................................. 1-13

Transvenous Pacemaker Tests.................................................. 1-17

Accessories................................................................................... 1-28

1-1

SigmaPace 1000

Operators Manual

1-2

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.

Compatible Pacemaker Types

The Analyzer is designed to test temporary EXTERNAL pacemakers (pacers) only. These devices are commonly referred to by the following nomenclature:

• External transcutaneous pacemaker

• External transthoracic pacemaker

• External transvenous pacemaker

• External temporary pacemaker

• External AV sequential pacemaker

• Dual-Chamber temporary pacemaker

• 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:

• Internal pacemaker

• Implantable pacemaker

• 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

Symbol Description

W Important information; refer to manual.

X 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

P Conforms to European Union directives

IEC Measurement Category I – CAT I equipment designed to

CAT I

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 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.

• 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 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 highvoltage shocks to a patient in order to correct a life-threatening heart condition.

1-5

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.

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.

The 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

• Tests both external transcutaneous and transvenous pacemakers.

• Large 21-character x 8-line alphanumeric LCD readout shows more

information than other external pacemaker Analyzers.

• Full range of selectable measurement algorithms and test loads for

external pacemakers.

1-6

Introduction and Specifications 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 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.

Biomedical

SIGMA PACE 1000

EXTERNALPACEMAKER ANALYZER

1-8

Figure 1-1. Analyzer Features and Controls

eyr056.eps

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)

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)

Right Side Panel

Ventricular Channel Sense Indicator (Yellow LED)

Low Level ECG Output (Disposable Snap Compatible)

High Level ECG Output (Subminiature Phone Jack)

Charger / dc Power Supply Input Jack

Ventilation Slots

Left Side Panel

Load Current (Phantom Battery) Input Connector

RS-232 Serial Port

Bottom Panel

RESET Button

1-9

SigmaPace 1000

Operators Manual

Abbreviations

The following list includes abbreviations used in this document.

A ampere

ANSI American National Standards Institute

AAMI

BLU blue (color)

BPM beats per minute

dB decibel

°C degrees Celsius (centigrade)

CQM Contact Quality Monitor

DMM digital multimeter

DUT device under test

EEPROM electrically erasable PROM

ECG electrocardiograph or electrocardiogram

ESU Electrosurgery Unit

EUT equipment under test

°F degrees Fahrenheit

GRA gray (color)

GRN green (color)

Hz hertz

Association for the Advancement of Medical Instrumentation

in inch

J Joules

k kilo (10

kg kilogram

kHz kilohertz

)

1-10

Introduction and Specifications Abbreviations

kΩ kilohm

lb pound

LED light-emitting diode

LCD liquid crystal display

M meg(a) (106)

MHz megahertz MΩ megohm

m meter

m milli (10

mA milliampere

mm millimeter

mV millivolt

p-p peak-to-peak

REM Return Electrode Monitor

-3

)

s second

YEL yellow (color)

µ micro (10-6)

µA microampere

µV microvolt Ω ohm

1-11

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

Power Requirement

External Battery Charger / Power Supply

Input ................................................................90-264 V, 50/60 Hz

Output..............................................................15 V +/-5 %, 1500mA 100 to 240 V ac

Auto power off / sleep mode

Sleep Modes

Reset ...................................................................Analyzer reset button accessed via

Physical

Size .....................................................................8” X 4” X 2” (approx.) (203 mm X 101

Weight .................................................................2 lb (0.90 kg) approximate

50 / 60 Hz operation

bottom panel. Sleep mode conditions.

mm X 50 mm)

Instrument Specifications

Modes of Operation

Manual

Remote (via standard RS-232 serial port)

User Interface

Display

LCD Readout...................................................21 characters X 8 lines

Pushbuttons

Eight keys........................................................F-1, F-2, F-3 (UP Arrow), F-4 (UP

1-12

Brightness / viewing angle adjustment

Arrow), 2 Down Arrows, ESCAPE, and ENTER

Introduction and Specifications Instrument Specifications

Transcutaneous Pacemaker Tests

Output Pulse Measurement

Test Type ............................................................... Quantitative

Measurement Ranges

Output ................................................................. 4.0 mA to 9.99 mA

Accuracy......................................................... ±2 % of reading or ±50 µA (whichever

Rate .................................................................... 5.0 PPM to 99.9 PPM

Accuracy......................................................... ±0.5 % of reading or 0.3 PPM

Width................................................................... 1.00 mS to 9.99 mS

Accuracy......................................................... ±0.5 % of reading or 14 µS (whichever

Energy ................................................................ 1µJ to 999 µJ

Accuracy......................................................... ±5 % of reading / computation

10.0 mA to 99.9 mA 100 mA to 250 mA

is greater)

100 PPM to 300 PPM

(whichever is greater)

10.0 mS to 99.9 mS

is greater)

1 mJ to 999 mJ

1.00 J to 1.99 J

Demand Mode Test

Test Type ............................................................... Qualitative

Physiological Simulation

Selection ............................................................. Normal Sinus Rhythm (NSR)

Amplitude............................................................ (V

Mode of Operation

Underdrive .......................................................... NSR @ 85 % of measured pulse

Overdrive ............................................................ NSR @ 115 % of measured pulse

Auxiliary Control................................................... The under / overdrive NSR simulations

1-13

generates the complete P-QRS-T complex.

): 1.0 mV Lead I.

peak

interval / rate

can also be independently adjusted in 1 BPM increments.

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

(Ventricular Only Pace and Sense)

Asynchronous Mode Test

Test Type................................................................Qualitative

Physiological Simulation Selection

Selection..............................................................Normal Sinus Rhythm (NSR)

Amplitude (V

Rate (Interval)

Underdrive...........................................................NSR @ 85 % of measured pulse

Overdrive.............................................................NSR @ 115 % of measured pulse

Auxiliary Control ..................................................The under / overdrive NSR simulations

Auxiliary Rate Range

Underdrive (minimum).........................................10 BPM

Overdrive (maximum)..........................................300 BPM

Active Outputs

Five lead ECG

Selected Ventricular Channel Test Load

This waveform is present on both outputs.

Pacemaker Compatibility

Compatible Pulse Rates......................................30 to 200 PPM

Intended Type

External Transcutaneous

VOO (Asynchronous Ventricular Only Pace)

)..................................................1.0 mV Lead I

peak

generates the complete P-QRS-T complex.

interval / rate

can be independently adjusted in 1 BPM increments.

1-14

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)

Amplitude

Range ................................................................. 0.05 mV

Accuracy ............................................................. ±5 % of setting

Resolution (Step Size)........................................ 0.05 mV steps from 0.05 mV

Width

Range ................................................................. 0.15 mS to 300 mS

Accuracy ............................................................. ±5 % of setting

Selection Count .................................................. 50

Resolution (Step Size)........................................ 0.05 mS steps from 0.15 mS to 0.95

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 (Minimum)

Intended Pacemaker Type.................................. VVI (Ventricular Pace and Sense

Triangle (TRI) Haversine (HSN) SSQ

(50 V

peak

95 mV mV

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

Only)

0.50 mV steps from 1.0

peak

to 5.0 mV

peak

) to 5.0 mV

peak

to 0.

Noise Immunity Test

Waveform .............................................................. Sine Wave

Frequency.............................................................. 50 and 60 Hz

Accuracy................................................................ 0.5 Hz

1-15

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

Accuracy..........................................................±5 % of setting

Resolution (Step Size).....................................0.50 mV

Pacer Load Range ..........................................(30) 50 Ω to 1550 Ω 1 %

Five Lead ECG Output

Range..................................................................0.00 (OFF) to 10.0 mV

Accuracy..............................................................±5 % of setting

Resolution (Step Size).........................................0.50 mV steps

Calibration Reference..........................................Lead I (RA to LA)

peak-to-peak

steps

peak-to-peak

Paced Refractory Period Test (PRP)

Range......................................................................20 mS to 500 mS

Accuracy..............................................................5 % of reading or 1 mS whichever is

Physiological Simulation

Selection..............................................................Triangle (TRI) Wave

Pulse Width .........................................................40 mS

Rate.....................................................................Single pulse: Interactive with applied

Amplitude...............................................................1.0 mV

Active Outputs .....................................................Five Lead ECG and selected

Pacemaker Compatibility

Compatible Pulse Rates......................................30 to 200 BPM

Intended Pacemaker Type ..................................VVI (Ventricular Pace and Sense

greater

pacemaker pulse activity in the demand mode of operation.

Lead I

peak

ventricular channel test load This waveform is present on both outputs.

Only)

Sensed Refractory Period Test (SRP)

Range......................................................................15 mS to 500 mS

Accuracy..............................................................±5 % of reading or ±1 mS, whichever

Physiological Simulation

Selection..............................................................Triangle (TRI) Wave

1-16

is greater

Introduction and Specifications Instrument Specifications

Pulse Width......................................................... 40 mS

Rate .................................................................... Double pulse: interactive with applied

Amplitude .............................................................. 1.0 m V

Active Outputs ...................................................... Five Lead ECG and selected

Pacemaker Compatibility

Compatible Pulse Rates ..................................... 30 to 200 BPM

Intended Pacemaker Type.................................. VVI (Ventricular Pace and Sense

pacemaker pulse activity in the demand mode of operation.

Lead I

peak

ventricular channel test load. This waveform is present on both outputs.

Only)

Transvenous Pacemaker Tests

Output Pulse Measurement

Test Type ............................................................... Quantitative

Display Formats

Single.................................................................. Atrial or Ventricular only

Dual .................................................................... Atrial and ventricular Channels

Measurement Ranges

Current................................................................ 0.05 mA to .999 mA* (Single Channel

Accuracy......................................................... 2 % of reading or ±50 µA (whichever is

Polarity Indicator ................................................. + or -

Rate .................................................................... 10 PPM to 99.9 PPM

Accuracy......................................................... 0.5 % or 0.3 PPM (whichever is

Width................................................................... 0.02 mS to .999 mS

Accuracy......................................................... 0.5 % or ±14 µS (whichever is greater)

Resolution........................................................... ±1 LSD or ±4 µS (whichever is

Only)

1.00 mA to 9.99 mA

10.0 mA to 30.0 mA

greater)

100 PPM to 999 PPM

greater)

1.00 mS to 9.99 mS

10.0 mS to 99.99 mS

greater)

1-17

SigmaPace 1000

Operators Manual

Voltage ................................................................ 0.050 V

1.00 V

10.0 V

peak

to 9.99 V

peak

to 30.0 V

peak

to .999 V

peak

Accuracy..........................................................2 % of reading or 0.05 V

(whichever is greater)

Polarity Indicator..................................................+ or -

Energy .................................................................1 nJ to 999 nJ

1 µJ to 999 µJ – add “J” range

Accuracy..........................................................5 % of reading / computation

Displayed Data

Single: Amplitude - Current

Amplitude ........................................................Volts

Rate

Width

Energy

Dual: Atrial and Ventricular

Amplitude ........................................................Current

Rate

Width

AV Interval

AV Interval (Delay Time)

Test Type................................................................Quantitative

Measurement Ranges

10.0 mS to 99.9 mS

100 mS to 999 mS

Start / Stop Points

Start.................................................................Leading edge of atrial pacemaker

Stop .................................................................Leading edge of ventricular

Accuracy..............................................................1 % of reading / computation

pulse

pacemaker pulse

peak

Demand Mode Test

Test Type................................................................Qualitative

Channels

Single ..................................................................Atrial or Ventricular Only

Dual .....................................................................A+V

1-18

Introduction and Specifications Instrument Specifications

Simulation

Waveform ........................................................... SSQ

Atrial Channel ..................................................... Simulated P-wave

Width............................................................... 30 mS

Amplitude........................................................ 2.0 mV

Ventricular Channel ............................................ Simulated R-wave

Width............................................................... 40 mS

Amplitude........................................................ 2.5 mV

PR Interval .......................................................... 90 mS

Interactive Simulated Rates

Default Settings

Underdrive ...................................................... NSR @ 85 % of measured pulse

interval / rate

Overdrive ........................................................ NSR @ 115 % of measured pulse

interval / rate

Manual Control ............................................... The under / overdrive NSR simulations

can also be independently adjusted in 1 BPM increments.

Manual Rate Limits

Underdrive (minimum) .................................... 10 BPM

Overdrive (maximum) ..................................... 300 BPM

Active Outputs (Synchronous)

Selected Ventricular Channel Test Load

Selected Atrial Channel Test Load

Pacemaker Compatibility

Pulse Rate Range............................................... 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)

peak

Asynchronous Mode Test

Test Type ............................................................... Qualitative

Channels

Single.................................................................. Atrial or Ventricular Only

Dual .................................................................... A+V

1-19

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

Active Outputs

Atrial Channel (4mm Banana Jacks) Only Test Load(s)

Available Selection(s)..........................................(3) 200 Ω, 500 Ω, and 1000 Ω ±1 %

Default Setting.....................................................500 Ω

Waveform Selections ..........................................Square (SQU)

Default Setting .......................................................SSQ

Amplitude

Pacer Load Selection ..........................................500 Ω (default)

Range..............................................................0.05 mV

Accuracy..........................................................±5 % of setting

Resolution (Step Size).....................................0.05 mV

Pacer Load Selection ..........................................200 Ω

Range..............................................................0.05 mV

Accuracy..........................................................±5 % of setting

Resolution (Step Size).....................................0.05 mV

80 % of the pulse-to-pulse interval or 400 mS (whichever is shorter).

Triangle (TRI) Haversine (HSN) Sine Square (SSQ) Asymmetrical Triangle (ISO) (Fixed Width 2 mS rise time / 13 mS fall time)

0.95 mV

0.50 mV

50.0 mV

0.95 mV

0.50 mV

20.0 mV

(50 V

peak

steps from 0.05 mV

peak

steps from 1.0 mV

peak

(50 V

peak

steps from 0.05 mV

peak

steps from 1.0 mV

peak

) to 50.0 mV

peak

) to 20.0 mV

peak

1-20

Introduction and Specifications Instrument Specifications

Pacer Load Selection.......................................... 1000 Ω

Range ............................................................. 0.05 mV

peak

Accuracy......................................................... ±5 % of setting

Resolution (Step Size).................................... 0.05 mV

0.95 mV

0.50 mV

49.5 mV

05.0 mV 100 mV

Default Setting

Amplitude............................................................ 2.0 mV

Width

Range ................................................................. 0.15 mS to 95.0 mS

Accuracy ............................................................. ±5 % of setting

Selection Count .................................................. 50

Resolution (Step Size)........................................ 0.05 mS steps from 0.15 mS to 0.95

1.0 mS steps from 1.0 mS to 19.0 mS

5.0 mS steps from 20 mS to 95.0 mS

Intended Pacemaker Types

AAI (Atrial Pace and Sense Only)

Compatible Pulse Rates ..................................... 30 to 200 PPM

(50 V

peak

steps from 0.05 mV

peak

steps from 1.0 mV

peak

steps from 50 mV

peak

) to 100 mV

peak

peak-to-

peak

Ventricular Channel

Physiological Simulation

Selection ............................................................. +R-Wave, -S-Wave, and + T-Wave

Rate .................................................................... 30 to 120 BPM, Delayed from the

Active Outputs ...................................................... Selected ventricular test load (4 mm

Waveform Selections

Square (SQU)

Triangle (TRI)

Haversine (HSN)

Sine Square (SSQ)

Asymmetrical Triangle (ISO)

(Fixed Width........................................................ 2 mS rise time / 13 mS fall time)

Default Setting .................................................... Sine Square (SSQ)

Test Load(s)

1-21

ventricular demand pacemaker pulse by 80 % of the pulse-to-pulse interval or 400 mS (whichever is shorter).

Banana Jacks) only.

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

Accuracy..........................................................±5 % of setting

Resolution .......................................................0.05 mV

0.95 mV

0.50 mV

50.0 mV

Pacer Load Selection ..........................................200 Ω

Range..............................................................0.05 mV

Accuracy..........................................................±5 % of setting

Resolution .......................................................0.05 mV

0.95 mV

0.50 mV

20.0 mV

Pacer Load Selection ..........................................1000 Ω

Range..............................................................0.05 mV

peak

Accuracy..........................................................±5 % of setting

Resolution .......................................................0.05 mV

0. 95 mV

0.50 mV

49.5 mV

05.0 mV 100 mV

Default Setting .......................................................2.5 mV

Width

Range..................................................................0.15 mS to 300 mS

Accuracy..............................................................±5 % of setting

Selection Count ...................................................58

Resolution (Step Size).........................................0.05 mS steps from 0.15 mS to 0.95

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......................................30 to 200 PPM

(50 V

peak

steps from 0.05 mV

peak

steps from 1.0 mV

peak

(50 V

peak

steps from 0.05 mV

peak

steps from 1.0 mV

peak

(50 V

peak

steps from 0.05 mV

peak

steps from 1.0 mV

peak

steps from 50 mV

peak

) to 50.0 mV

peak

) to 20.0 mV

peak

) to 100 mV

peak

peak-to-

peak

1-22

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

Output Selections

Atrial Channel Only

Ventricular Channel Only

ECG Signal ............................................................ ECG Signal can be added to the

Amplitude

Pacer Load Selection.......................................... 500 Ω

Range ............................................................. 0.00 (OFF) to 100 mV

Accuracy......................................................... ±5 % of setting

Resolution....................................................... 5 mV

Pacer Load Selection.......................................... 200 Ω

Range ............................................................. 0.00 (OFF) to 40 mV

Accuracy......................................................... ±5 % of setting

Resolution....................................................... 5 mV

Pacer Load Selection.......................................... 1000 Ω

Range ............................................................. 0.00 (OFF) to 200 mV

Accuracy......................................................... ±5 % of setting

Resolution....................................................... 5 mV

channel test load

selected Channel

steps

peak-to-peak

steps

peak-to-peak

steps

peak-to-peak

Refractory Period Test (Atrial Channel)

Test Selections

Paced Refractory Period (PRP)

Sensed Refractory Period (SRP)

Period..................................................................... 20 to 500 mS

Accuracy................................................................ ±5 % of reading or ±1 mS whichever is

Resolution ............................................................. ±1 LSD

Display Format...................................................... 3 digits

1-23

greater

SigmaPace 1000

Operators Manual

Physiological Simulation

Selection (Default)...............................................Single Channel Simulation (A)

Atrial Channel......................................................Simulated P-wave

Width ...................................................................1.0 mS

Amplitude ............................................................20.0 mV

Active Outputs .....................................................Atrial Channel (4 mm Banana Jacks)

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

Range...................................................................05 mV

Accuracy..............................................................±5 % of setting

Resolution (Step Size).........................................0.05 mV

Width

Range..................................................................0.15 mS to 95.0 mS

Accuracy..............................................................±5 % of setting

Selection Count ...................................................50

Resolution (Step Size).........................................0.05 mS steps: 0.15 mS to 0.95 mS

Active Output.......................................................Atrial Channel (4 mm Banana Jacks)

Intended Pacemaker Types ................................AAI (Atrial Pace and Sense Only)

Compatible Pacemaker Rates.............................30 to 200 PPM

Available Test Load.............................................500 Ω ±1 %

Square Wave

peak

Only

peak

0.50 mV mV

peak

(50 V

peak

) to 50.0 mV

peak

steps: 0.05 mV

steps: 1.0 mV

peak

to 49.5

1.0 mS steps: 1.0 mS to 19.0 mS

5.0 mS steps: 20 mS to 95.0 mS

Only

peak

to 0.95

Refractory Period Test (Ventricular Channel)

Test Selections

Paced Refractory Period (PRP)

Sensed Refractory Period (SRP)

Period .....................................................................20 to 500 mS

Accuracy ................................................................±5 % of reading or 1 mS whichever is

1-24

greater

Introduction and Specifications Instrument Specifications

Resolution ............................................................. ±1 LSD

Display Format...................................................... 3 digits

Physiological Simulation

Selection (Default) .............................................. Single Channel Simulation (V)

Ventricular Channel ............................................ Simulated R-wave

Width................................................................... 1.0 mS

Amplitude............................................................ 20 mV

Active Outputs .................................................... Ventricular Channel

Available Test Load(s)........................................ 500 Ω 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 Ω

Range ............................................................. 0.05 mV

Accuracy......................................................... ±5 % of setting

Resolution (Step Size).................................... 0.05 mV

Default Setting ................................................ 20.0 mV

Width

Range ................................................................. 0.15 mS to 300 mS

Accuracy ............................................................. 5 % of setting

Selection Count .................................................. 58

Resolution (Step Size)........................................ 0.05 mS steps from 0.15 mS to

Default Setting (mS) ........................................... 30 mS

Intended Pacemaker Types................................ VVI (Ventricular Pace and Sense

Compatible Pacemaker Rates ............................ 20 to 200 PPM

Square Wave

peak

(4 mm Banana Jacks) Only

50.0 mV

0.95 mV

0.50 mV

50.0 mV

(50 V

peak

steps from 0.05 mV

peak

steps from 1.0 mV

peak

) 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

Only)

peak

1-25

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-

Dynamic ..............................................................Gated measurement preceding the

Pacemaker Power ...............................................ON

Input Configurations ............................................Atrial+ and Atrial-

Ventricular+ and VentricularAtrial+ and Ventricular- (third internal 500 Ω test load)

delivered pacemaker pulse.

Ventricular+ and VentricularAtrial+ and Ventricular+ (third internal 500 Ω test load)

Current Drain Test

Test Type................................................................Quantitative

Measurement Ranges

DC Current ..........................................................0.100 mA to .999 mA

Polarity ................................................................Positive or Negative

Polarity Indicator..................................................+ or - symbol preceding the numeric

Resolution ...........................................................±1 LSD

Display Format ....................................................3 digits plus decimal point

Accuracy..............................................................±5 % of Reading 10 µA

Input DC Voltage

Nominal ...............................................................±9 Volts

Range..................................................................5.0 Volts to 10.5 Volts

Input Protection ...................................................Short-circuit protection

Protection Type ...................................................Internal in-line fast-acting fuse rated at

Selectable Testloads ...........................................200 Ω, 500 Ω, and 1000 Ω

1.00 mA to 9.99 mA

10.0 mA to 99.9 mA

value

½ Ampere.

1-26

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............................................... 999,999 (maximum)

Rate ........................................................................ 2 % to 20 % (10 % default)

Amplitude .............................................................. 2 % to 20 % (10 % default)

Test Time (max) .................................................... 999:59:59 (hhh:mm:ss)

Maximum error Count .......................................... 200

Test Termination................................................... Manual or when maximum error count

Testloads Selectable ............................................ 200 , 500 , or 1000 

is sensed.

Interactive Pacer ECG Simulation

Simulates demand, continuous, non-capture, and non-function patient ECG activity.

Additional user-selectable parameters

PR Interval .......................................................... 0.05 to 0.300 Seconds

Independent Capture / threshold ........................ 1 mA to 25 mA (1 mA steps) for each

pacemaker channel.

Available Testloads (500 Ω Default)

Atrial Channel

Selections ........................................................... 200 Ω, 500 Ω, or 1000 Ω

Accuracy ............................................................. ±1.0 % of selection

Power Rating ...................................................... 2 Watts

Ventricular Channel

Selections ........................................................... 200 Ω, 500 Ω, or 1000 Ω

Accuracy ............................................................. ±1.0 % of selection

Power Rating ...................................................... 2 Watts

Tracking .............................................................. Atrial and ventricular channel settings

1-27

are identical.

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) 2201166

Transvenous Test Lead Black (2 each) 2201153

9 V dc Load Test Cable 2392272

Operators Manual 2243306

PC Interface Cable Female DB-9 to Female DB-9 2392260

Nylon Carry Case 2392906

Universal-Input Battery Eliminator 2184298

Table 1-4. Pacemaker Disposable Electrode Adapters

Description

All Pacemaker Disposable Electrode Adapters

Physio-Control QUIK COMBO 2201095

Physio-Control QUIK PACE 2201088

Hewlett Packard CodeMaster 2201109

Marquette Medical Responder 2201111

MDE / MRL R2 / DAROX 2201127

Zoll NTP Series 2201130

Zoll PD and M-Series 2201148

Part Number

1-28

Introduction and Specifications Accessories

Table 1-5. Serial Cables

Description Part Number

PC Interface Cable Female DB-9 to Female DB-9

medTester Serial Interface 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 C6 3-wire

USA / CAN Power Cord IEC320 C5 3-wire 2198724 United Kingdom (UK) Power Cord IEC320 C5 3-wire 2201428

European Power Cord IEC320 C5 3-wire (SCHUKO) 2201437 Australia Power Cord IEC320 C5 3-wire 2201443

Table 1-7. Disposable Transcutaneous Pacemaker Adapters

Device Manufacturer Model/Designation Part Number

Medtronic/Physio Control QUIK COMBO

Medtronic/Physio Control QUIK PACE

HP/Agilent Technologies Codemaster/HeartStream XL Series

GE Medical/Marquette Responder Series

MDE Medical Data Electronics MRL Medical Research Laboratories R2/DAROX

Zoll Medical NTP Series•

Zoll Medical PD and M Series (Multi- Function)

2200962

2200102

2184298

2201095

2201088

2201109

2201111

2201127

2201130

2201148

1-29

SigmaPace 1000

Operators Manual

Table 1-8. High-Level Output Cables

Description Part Number

Subminiature Phone Plug to BNC Cable (Oscilloscope Application)

Subminiature Phone Plug to 3-Conductor ¼” Phone Plug Cable (AA-900)

2199932

2200116

1-30

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................................................................................ 2-5

Power Up Sequence ..................................................................... 2-5

Transcutaneous Pacemaker Testing ............................................. 2-7

Transvenous Pacemaker Testing.................................................. 2-7

Utility Functions .......................................................................... 2-7

Maintenance................................................................................. 2-8

Avoiding Damage..................................................................... 2-8

Cleaning ................................................................................... 2-9

Service and Calibration................................................................ 2-9

Packing Instructions ................................................................. 2-10

Shipping ................................................................................... 2-10

2-1

SigmaPace 1000

Operators Manual

2-2

Setup, Operation, and Maintenance 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 to 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.”

W X 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 (atrial or ventricular) or dual-channel (atrial and ventricular) external pacemaker to the SigmaPace 1000.

W X Warning

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 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.”

Ventilation

Heat generated during use is dissipated through ventilation slots on both the left and right side panels.

W 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

F1 F2 F3 F4

The LCD then advances to the Select external pacemaker type screen:

F1 F2 F3 F4

2-6

eyr008.eps

eyr001.eps

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.

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 Testing” 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

F1 F2 F3 F4

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 Service and Calibration

W 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 detergent solution. Take care to keep liquids out of the interior of the unit.

W 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.”

W 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 service center.

1. Before returning the Analyzer for factory service, contact the Fluke

Biomedical Service Center for a required Return Authorization Number.

2. Provide the following information:

• The Analyzer serial number

• The specific steps that reproduce your problem

• A daytime phone number

• Your name/company

• A fax number (if available)

3. Pack the instrument carefully, using the original packing 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.

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

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........................................................................ 3-8

Interactive Pacemaker / ECG Simulation................................. 3-9

Simulated ECG Rate............................................................. 3-9

Adjustable Threshold Level.................................................. 3-9

Operational Modes ................................................................... 3-9

Continuous............................................................................ 3-9

Non-Capture ......................................................................... 3-9

Non-Function........................................................................ 3-10

Setup and Testing......................................................................... 3-10

Output....................................................................................... 3-12

Demand Mode Pacemaker’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................................. 3-23

Purpose of the ECG Simulation Test........................................ 3-26

Long Term Tests ...................................................................... 3-27

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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.

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 Ω)

• HP / Agilent Codemaster (400 Ω)

• GE / Marquette Responder Series (300 Ω)

• Medical Data Electronics (600 Ω)

• Medical Research Laboratories (500 Ω)

• Zoll Medical PD-Series (1000 Ω)

• Zoll Medical M-Series (100 Ω)

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

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ECG

Monitor

ECG Sensing & Pacer

ECG

V1/C1

LL/F

LA/L

RA/R

RL/N

L O A

High Level

Output

D S

Transcutaneous Pacemaker

SIGMAPACE 1000 External Pacemaker Analyzer

Figure 3-1. Scheme for Testing Transcutaneous Pacemakers

Output

The Analyzer measures the output of the transcutaneous pacemaker and displays the following parameters:

• Pulse Amplitude (milliamperes)

• Pulse Rate (pulses per minute

• Pulse Width (milliseconds)

• Pulse Energy (joules)

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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 nondemand) mode, output should 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.

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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.

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Transcutaneous Pacemaker Testing Test Options

Pacing Rate

Interv al

@ 8 0 BPM=750 mS

PRP

Cardiac Test Pu lse

Pacing Rate

Interv al

Reset>750 mS

PRP

"Sensed" Cardiac Test Pu ls e

Figure 3-2. Paced Refractory Period

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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.

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Pacing Rate

Interv al

Reset > 750 mS

PRP

"S ens ed" Cardiac Test Puls e # 1

SRP

Pacing Rate

Interval

Reset (2 X)

PRP

"S ens ed" Cardiac Test Puls e # 1

"S ens ed" Cardiac Test Puls e # 2

SRP

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.

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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. 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.

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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.

1. Start from the Select external pacemaker type screen.

F1 F2 F3 F4

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2. Press F1 NONINV to begin Non-Invasive (transcutaneous) pacemaker

testing.

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F1 F2 F3 F4

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 to 1550 Ω in 50 Ω increments.

5. Press F1 NEXT to advance the display to the SELECT TEST menu.

There are eight Non-Invasive tests.

F1 F2 F3 F4

6. Press the F4 >>> UP arrow key to advance to the next screen and to see

more available tests.

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F1 F2 F3 F4

7. Press ESC to return to previous menu(s).

Output

The following test measures the output of the transcutaneous pacemaker.

F1 F2 F3 F4

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1. From the SELECT TEST menu, press F1 PULSE OUTPUT.

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F1 F2 F3 F4

2. Press the F4 LOAD UP or DOWN arrow key to select the desired load.

3. Press F1 HOLD to advance the screen:

F1 F2 F3 F4

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.

6. Press ESC to return to previous menu(s).

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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.

F1 F2 F3 F4

1. From the SELECT TEST menu, press F2 DMAND MODE.

F1 F2 F3 F4

2. Press the F4 UP or DOWN arrow key to select the desired load.

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3. Press F1 START to advance the screen and start the test.

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Transcutaneous Pacemaker Testing Setup and Testing

F1 F2 F3 F4

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. Press ESC to return to previous menu(s).

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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.

F1 F2 F3 F4

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1. From the SELECT TEST menu, press F3 ASYNC MODE.

F1 F2 F3 F4

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.

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Transcutaneous Pacemaker Testing Setup and Testing

F1 F2 F3 F4

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. Press ESC to return to previous menu(s).

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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).

Note

A transcutaneous pacemaker must be set to Demand operation for these tests.

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F1 F2 F3 F4

1. From the SELECT TEST menu, press F1 REFRCT DEMAND.

F1 F2 F3 F4

2. Press F4 LOAD UP or DOWN arrow key to select the load.

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3. Press F1 START to advance screen and start the test.

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F1 F2 F3 F4

After the calculations are complete, the following screen appears.

F1 F2 F3 F4

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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.

F1 F2 F3 F4

1. From the SELECT TEST menu, press F2 SENSE AMP.

F1 F2 F3 F4

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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.

F1 F2 F3 F4

4. Press F3 UP or DOWN arrow key to select waveform type.

5. Press F4 UP or DOWN arrow key to select waveform width.

6. Press F1 NEXT for amplitude and polarity selection.

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F1 F2 F3 F4

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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.

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Transcutaneous Pacemaker Testing Setup and Testing

F1 F2 F3 F4

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).

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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.

F1 F2 F3 F4

1. From the SELECT TEST menu, press F3 NOISE LINE.

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F1 F2 F3 F4

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.

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F1 F2 F3 F4

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. Press F1 HOLD to advance the screen.

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F1 F2 F3 F4

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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. Additionally, it is an excellent training tool for clinical staff in the setup and use of external pacemakers.

F1 F2 F3 F4

1. From the SELECT TEST menu, press F1 ECG SIM.

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Transcutaneous Pacemaker Testing Setup and Testing

F1 F2 F3 F4

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. 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.

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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

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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.

F1 F2 F3 F4

1. From the SELECT TEST menu, press F2 LONG TERM.

F1 F2 F3 F4

2. Press F2 RATE to toggle between pulse rate and amplitude. This parameter works with the LIMIT parameter to assign limits to both.

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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.

F1 F2 F3 F4

6. Press F3 AMP UP or DOWN arrow key to adjust the amplitude.

7. Press F4 RATE UP or DOWN arrow key to adjust the rate.

Note

Target values for amplitude and rate must be entered for the test to perform correctly.

8. Press F1 START to advance the screen and start the test.

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F1 F2 F3 F4

9. Press F1 END to end the test.

F1 F2 F3 F4

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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. The pulse width at the “out of limit” pacemaker pulse is also reported.

11. Press F4 XMIT to transmit data.

12. Press F1 RESTART to restart the test.

13. Press ESC to return to previous menu(s).

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3-32 4-1

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.................................. 4-6

Simulated ECG Rate ................................................................ 4-6

PR Interval................................................................................ 4-6

Adjustable Threshold Level ..................................................... 4-6

Operational Modes ................................................................... 4-6

Continuous............................................................................ 4-6

Non-Capture ......................................................................... 4-7

Non-Function........................................................................ 4-7

DC Leakage.............................................................................. 4-7

Static Tests (Pacemaker Power OFF): .................................. 4-8

Dynamic Tests (Pacemaker Power ON): .............................. 4-9

Current Drain Test.................................................................... 4-9

Long Term Test........................................................................ 4-11

Setup and Testing......................................................................... 4-11

Output....................................................................................... 4-13

Demand Mode and Dual-channel (AV) ECG Signal................ 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 ..... 4-23

Pacemaker’s Ability to Filter Line Noise................................. 4-28

DC Leak Test........................................................................ 4-31

DC Load Test........................................................................ 4-34

ECG Simulation Test............................................................ 4-36

Long Term Tests ...................................................................... 4-38

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Transvenous Pacemaker Testing Test Options

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 Ω, which is the Analyzer default setting. For most transvenous pacemaker tests, two additional loads of 200 Ω and 1000 Ω are also available. The test load resistance values track for both the atrial and ventricular channels.

Atrial Channel

A+

L O A D

A-

ECG Sensing & Pacer

V+

ECG

L O

Ventricular Channel

Transvenous Pacemaker

A D

V-

SIGMAPACE 1000 External Pacemaker Analyzer

Figure 4-1. Scheme for Testing Transvenous Pacemakers

V1/C1

LL/F

LA/L

RA/R

RL/N

High Level

Output

eyr005.eps

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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

• Voltage = volts

• 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’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

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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 amplitude 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

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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 Analyzer outputs either asystole or a normal sinus rhythm (NSR) at rates covering the bradycardia, normal, and tachycardia range.

PR Interval

The PR interval of the 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.

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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.

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Transvenous Pacemaker

Atrial Channel

ECG Sensing & Pacer

Control

Ventricular Channel

Power ON/OFF

SIGMAPACE 1000 External Pacemaker Analyzer

A+

O A D

A-

A+

O A

V+

O A D

V-

Figure 4-2. DC Leakage Testing

Static & Dynamic

Leakage

eyr006.eps

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:

• Atrial Channel: dc leakage across the atrial channel 500 Ω test load.

• Ventricular Channel: dc leakage across the ventricular channel 500 Ω

test load.

• AV Channel: dc leakage across an auxiliary 500 Ω test load

connected to the +atrial and +ventricular outputs.

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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.

• Ventricular Channel: dc leakage across the ventricular channel 500 Ω

test load.

• AV Channel: dc leakage across an auxiliary 500 Ω 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 from 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.

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Transvenous Pacemaker

Internal Battery Compartment

Power ON/OFF

SIGMAPACE 1000 External Pacemaker Analyzer

L O A D

Current

O A D

9 VDC

Battery

Figure 4-3. Current Drain Test

Readings are made in three pacemaker operating modes:

• Pacemaker Power OFF

• Pacemaker Power ON and Display Backlight OFF

• Pacemaker Power ON and Display Backlight ON

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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 test a transvenous pacemaker.

F1 F2 F3 F4

1. From the Select external pacemaker type screen, press F2 INV to

begin Invasive (transvenous) pacemaker testing.

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F1 F2 F3 F4

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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.

F1 F2 F3 F4

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4. Use the F4 >>> UP arrow key to navigate through the available test

selections.

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F1 F2 F3 F4

Output

The following test measures the output of the transvenous pacemaker.

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F1 F2 F3 F4

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1. From the SELECT TEST menu, press F1 PULSE OUTPUT.

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F1 F2 F3 F4

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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.

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

Fluke 1000 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

Notices

Table of Contents

List of Tables

List of Figures

Introduction and Specifications

Introduction

Compatible Pacemaker Types

Incompatible Pacemaker Types

General Safety Considerations

Symbols

Warnings and Cautions

Power Supply

Defibrillators and Transcutaneous Pacemakers

Applications

Features

Unpacking and Inspection

Instrument Familiarization

Abbreviations

General Specifications

Instrument Specifications

Transcutaneous Pacemaker Tests

Transvenous Pacemaker Tests

Accessories

Setup, Operation, and Maintenance

Setting Up the Analyzer

Connecting External Transcutaneous Pacemakers

Connecting External Transvenous Pacemakers

Load Test Cable Connector

RS-232 Serial Port Connector

High Level ECG Output Jack

Ventilation

Power Up Sequence

Transcutaneous Pacemaker Testing

Transvenous Pacemaker Testing

Utility Functions

Maintenance

Avoiding Damage

Cleaning

Service and Calibration

Packing Instructions

Shipping

Transcutaneous Pacemaker Testing

Test Options

Output

Demand Mode

Asynchronous Mode

Amplitude Sensitivity

Line Frequency / Noise Immunity

Refractory Period

Paced Refractory Period (PRP)

Sensed Refractory Period (SRP)

Long Term Test

Interactive Pacemaker / ECG Simulation

Simulated ECG Rate

Adjustable Threshold Level

Operational Modes

Continuous

Non-Capture

Non-Function

Setup and Testing

Output

Amplitude of ECG Signal for Demand Mode Pacemaker

Purpose of the ECG Simulation Test

Long Term Tests

Transvenous Pacemaker Testing

Test Options

Output

Demand Mode

Asynchronous Mode

Amplitude Sensitivity

Line Frequency / Noise Immunity

Refractory Period

Paced Refractory Period (PRP)

Sensed Refractory Period (SRP)

Interactive Pacemaker/ ECG Simulation

Simulated ECG Rate