Fluke 1000 User Manual
SigmaPace 1000
External Pacemaker Analyzer
Operators Manual
PN 2243306
July 2007
© 2007 Fluke Corporation, All rights reserved. Printed in USA
All product names are trademarks of their respective companies.
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
All Rights Reserved
© 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.
Copyright Release
Fluke Biomedical agrees to a limited copyright release that allows you to reproduce manuals and
other printed materials for use in service training programs and other technical publications. If
you would like other reproductions or distributions, submit a written request to Fluke Biomedical.
Unpacking and Inspection
Follow standard receiving practices upon receipt of the instrument. Check the shipping carton for
damage. If damage is found, stop unpacking the instrument. Notify the carrier and ask for an
agent to be present while the instrument is unpacked. There are no special unpacking instructions,
but be careful not to damage the instrument when unpacking it. Inspect the instrument for 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.
Table of Contents
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
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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
ii
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
iv
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
v
SigmaPace 1000
Operators Manual
vi
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
1
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
ΠConforms 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.
1
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.
1
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.
16
6
7
Biomedical
SIGMA PACE 1000
EXTERNALPACEMAKER ANALYZER
17
2
1
3
4
8
10
5
11
9
12
15
18
13
14
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)
1
F4 / UP and DOWN Arrow Keys
2
F3 / UP and DOWN Arrow Keys
3
F2 Key
4
F1 Key
5
ENTER and POWER ON Key
6
ESCAPE and POWER OFF Key
7
Atrial Channel Sense Indicator (Yellow LED)
8
Atrial Channel Pacemaker Input Jacks (4 mm)
9
Red: Positive Black: Negative
Ventricular Channel Pacemaker Input Jacks (4 mm)
10
Red: Positive Black: Negative (Transvenous and
Transcutaneous)
1
Right Side Panel
11
12
13
14
15
16
17
18
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
3
)
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
)
1
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
1
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
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
interval / rate
can be independently adjusted in 1
BPM increments.
1-14
Introduction and Specifications
Instrument Specifications
1
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
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)
0.50 mV steps from 1.0
peak
to 5.0 mV
peak
) to 5.0 mV
peak
peak
peak
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
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
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