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EXTERNA.L PACEMAKER ANALYZER

Model PMA-1

OPERATOR'S MANUAL I

BIO- TEK INSTRUMENTS, INC.

Highland Park, SQX 998 Winooski¡ Vermont 05404-0998 Phone: 802-655-4040

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EXTERNAL PACEMAKER ANALYZER - OPERA TOR'S MANUAL Model PMA-l U

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BIO- TEK INSTRUMENTS me.

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Model PMA-l Operator's Manual

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Revision 00

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1 July 1998

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Infonnation eontained within this manual is subject to copyright 1

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BIO- TEK INSTRUMENTS, INe. HIGHLAND PARK, BOX 998 WINOOSKI, VERMONT 0~0404-0998 USA 802-655-4040 800-451-5172

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800-24-BIOTK (SERVICE) TELEX: 94-0136 BIO TEK SHVT FAX: 802-655-7941

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EXTERNAL PACEMAKER ANALYZER - OPERA TOR'S MANUAL Section 1 - Key to Manual Section 1.1 DOCUMENT REVISION RECORD

~ Revision, Date, Section, ROM Version

1 1

Changes

A

1 JuIy 1990

1.0

Original version

B

1 December 1990-

1.0

Minor Changes

c

26 March 19911.2

D

01 July 1991

1.2

Section 4.4 Pulsed Ref. Period and Sensed Ref. PeriodoMinor changetoinstructions

E

31 January 1993

2.0

As required by introduction of V2.0 Finnware and V1.l Wavefonns See Section 1.1.1 for details of Finnware Changes.

F

01Apri119952.6

V2 PCB with 9pin RS232 Minor changes to Instructions

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.....

1 1

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As required by introduction of V2.6 Finnware. See section 1.1.2 for details of Fimiware Changes. AIso minor changes to specification in sections 3.2.1, 3.2.2, 3.3.5

1 1

N.E. Revision E & F apply only to PMA-ls with Serial Number greater than 1059.

l F

21 June 1995 2.7

G

26 Feb 1996

2.712.8

Insert section 1.1.3 with details of changes on CE marked version (European).

H

30 Mar 1996

2.8

Changes to Section 3.3.7

00

1 July 1997

Minor Changes not affecting operation or specification

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Accuracy

statements

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Document renumbered as UMO129

UMO129/00 Last updated 1 luly 1997 UIM Part 1374 UK, 1373 INT

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EXTERNAL PACEMAKER ANAL YZER

- OPERATOR'S Section

MANUAL 1 - Key to Manual

Section 1.1.1

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Details of Manual Revision E

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Changes in Version 2.0 compared to Version 1.2

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The Operator's Manual Revision D was written to correspond to Version 1.2 Firmware in the PMA-l, together with Version 1.0 simulated waveforms (ROM label not numbered). Version 2.0 programs together with Version 1.1 of Waveforms is the latest release of PMA-l Programs and includes a number of changes as set out below.

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The main changes are a new computer control facility for the PMA-l, an extra simulated waveform, and a number of changes to the default settings and ranges of pulse parameters.

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A PMA-l with a serial number greater features by replacing the two ROMS.

than 1059 can be upgraded to use the new

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Manual Section Affected

Details

Change

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Restriction

3.3.4

on PRP and SRP periodo

On PRP and SRP tests the shortest period selectable is now lOms greater than the width of the simulated R-wave. The mínimum period is now 30ms.

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Restriction of simulated in PRP and SRP tests.

3.3.5

R-wave pulse length

This now has a maximum pulse length of 50ms

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3.

New PRP and SRP default The default now 100ms

(starting)

4.4

period

period in the PRP and SRP tests

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4.

New pulse lengths for simulated

R-waves

2.2 3.3.5

Simulated R-waves can now also be set to 17ms and 40ms pulse length, except for the new ISO waveform (below) which is fixed at 15ms.

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EXTERNAL PACEMAlillRANALYZER- OPERATOR'S MANUAL

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Section 1 - Key to Manual

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5.

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New ISO wavefonn for simulated R-wave

3.3.5 5.3.5

ISO 5841 which relates to implantable pacemakers pro poses a waveform for a simulated R-wave which has a rise time of 2ms and a fall time of 13ms. This (positive) waveform has been added to R-wave sensitivity, PRP and SRP tests.

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This waveform can be inspected in the engineer's diagnostic test initiated by switching the PMA-l on while pressing key 46, and then repeatedly pressing key 170. In this test aI1 waveforms now have 15ms pulse length (previously 20ms) to match the ISO waveform.

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Smaller step changes to interf erence signal.

3.3.3 4.4

On the interference tests the amplitude of the sinusoidal (50/60Hz) can now be changed in O.2mV steps up to 3mV, and lmV steps above this level. .

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EXTERNAL PACEMAKER ANALYZER

- OPERATOR'S Section

7.

Smaller amplitude

8.

Changed amplitude defaults S-wave Sensitivity Tests. Default amplitudes of 2m V.

9.

4.4

steps in PRP and SRP tests.

The simulated R-wave amplitude (default 10mV) can be adjusted 2mV).

MANUAL 1 - Key to Manual

in the PRP and SRP tests in lmV steps (previously

4.3

on R-wave and

on the above now start at 1mV instead

2.6

Change in Serial Port Baud Rate All computer communications in both directions are now conducted at 9600 BAUD (previously 2400), but with the same protocol (N,8,l)

10.

Controlling

All tests New Section 4.6

the PMA-1 from a computer.

The PMA-1 will support bidirectional transfer. There are two test modes:

data

Otis Mode, in which all the tests can be operated from a computer, with the print-strip details being copied to the computer.

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Interactive Mode, in which all information appearing on the LCD panel is returned to the computer so that full control, including some automatic testing is possible from a computer.

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EXTERNAL PACEMAKER ANAL YZER - OPERATOR'S MANUAL Section 1 - Key to Manual

Section 1.1.2 -

Details of Manual Revision F

Changes in Version 2.7 compared to Version2.0

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The Operator's Manual Revision E was written to correspond to Version 2.0 Firmware in the PMA-1, together with Version 1.1 simulated waveforms. Version 2.7 Firmware is the next release and inc1udes a number of changes as set out below.

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routine

The main changes are the addition of a 30 ms pulse width and a peak capture for transthoracic amplitude.

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Details

Change

Manual Section Aff ected

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3.3.5

Addition of 30 ms pulse width On simulated R, S and T wave tests a 30 ms pulse width has been added, giving the choice of 5, 10, 15, 17, 20, 30,40, 50, 100 & 200 ms widths.

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on Transthoracic

amplitude

3.3.1

The method of measuring pulse amplitude of transthoracic pacers has been changed. Previously the amplitude was detected 2ms into the pulse. Now a peak value is found, after 2ms.

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Peak value detect

3.

A-V interval

uncertainty

reJJloved

None

V2.0 has been reported as occasionally producing spurious values for the A-V interval. The cause for this has been removed.

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EXTERNAL PACEMAKER ANAL YZER

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MANUAL to Manual

Section 1.1.3 Details

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of Manual Revision G (7)

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Changes relating to release of CE marked

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Version

(European)

To comply with requirements of the European Directives for electrical equipment, it has been necessary to provide the PMA-l as an internal1y powered unit for sale in the European Union. Accordingly the CE marked units do not have the external power socket, nor can they be used connected to an external power supply.

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Therefore references to use on external power supply, particularly and 3.2.4, do not apply to the CE marked units.

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in Sections 2.1.3, 2.5,

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EXTERNAL PACEMAKER ANALYZER - OPERATOR'S MANUAL Section 1 - Kev to Manual

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1.2

TABLE OF CONTENTS

Page

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Section

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KEY TO MANUAL Document Revision Records 1.1 1.1.1 List of ehanges introdueed in V2.0 Firmware

1.2 I I

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1.1.2 List of ehanges introdueed in V2.7 Firmware 1.1.3 CE Marked (European Version) Table of Contents

1.3

2.

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9 9 10

2.4 2.5 2.6 2.7

Power Supply and Batteries Conneeting to a Printer Conneeting to a Computer

10 11 11

DESCRlPTION

AND SPECIFICA TIONS

3.1.1 3.1.2 3.1.3

Front Panel Rear Program MENU

12 13 14

3.2.1

Input Details Ventricular Pacíng Input Atrial Pacíng Input Transthoracíe Pacíng Input Output Details

15

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15

Parallel Printer Port Serial Computer Port

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Warnings General Information Applieations of the PMA-l Not Used

2.1 2.2

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5b 5e 6

GENERAL INFORMATION

2.3

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Introduetion to the Model PMA-1 Operator's Manual

2 3

3.2.3

3.2.4 i, f

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3.2.5

Display

15

Power Requirements Batteries

15

External 6-9 Volt Supply Size/Weight

15

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3.3.2 3.3.3

3.3.4 3.3.5

Measurement of Pacíng Pulse A-V Pulse Time Interval 50/60Hz Interference Signal

Refraetory Period Measurements Simulated R,S & T waves Width Setting Waveforrn Selection

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3.3.1

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Rate Setting Amplitude Setting 6

16 16 17

17 19

EXTERNAL PACEMAKER ANAL YZER

u 3.3.6 3.3.7

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- OPERATOR'S

MANUAL

Section 1 - Kev to Manual

4.

OPERA TING INSTRUCTIONS 4.1 4.2 4.3

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21 21

Long Term (Extended) Tests Overall Accuracy Statements

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4.3.1 4.3.2 4.3.3 4.3.4

Overview of Proposed Test Procedures Connection to the Pacemaker Short Test Procedure Ventricular Pulse Test Atrial Pulse Test and A-V time Interval R-Wave Sensitivity Test Sample Results

22 22 24 24 24 25 27

4.4.1 4.4.2 4.4.3 4.4.4 4.4.5 4.4.6

Supplementary Tests Response to AC Interference T-Wave Sensitivity S-Wave Sensitivity Pulsed Refractory Period Sensed Refractory Period Long Term Test (EXT.)

28 28 30 30 30 31 33

Sample Results Operating with a Computer

34 35

L., 4.4

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4.5 4.6 5.

TROUBLESHOOTING, 5.1 5.2 5.3 5.4 5.5 5.6

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MAINTENANCE, SERVICE, AND CALIBRATION 37 37 . 37 39 39 39

Operating Precautions Cleaning Service, Checking, Calibration Troubleshooting Returning the Unit for Service Warranty

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b APPENDIX

1

External

Pcemakers

- description

and applications

40

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EXTERNAL PACEMAKER ANALYZER - OPERATOR'S MANUAL Section 1 - Key to Manual

1

1.3

INTRODUCTION TO THE PMA-l OPERA TOR 'S MANUAL Rev. F

..

This document is the operator's manual for the External Pacemaker Analyzer Model PMA-1 using V2.0 Firmware or laterl. This Manual contains general information about the Model PMA-1, a description of its main components, and instructions for its use. It only contains basic instructions required to service the unit. If a problem develops, the user should contact the supplier. The user should not attempt to service the unit before consulting with the supplier.

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The objectives

of this manual are to provide:

1.

General

Information

2.

Warnings, shipping and storage

3.

Description

4.

Detailed operating instructions and descriptions of specific tests (Section 4)

5.

User Maintenance,

..

about the Model PMA-l, instructions

of the unit and specifications

inc1uding applications

(Section 2) (Section 3)

Service and Calibration

procedures

(Section 5)

.. Appendix

1. Theory of Operation

of External

Pacemakers

The information contained in this manual is the subject of copyright. Copying of a11or parts of the manual are permitted only for use by the purchaser in connection with use of the PMA-l.

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1 V2.0 can

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upgraded

Firmware as

far

can

only

as Version

be fitted

to

1.4 which

PMA-ls

with

is covered

serial

number

in Operator's

greater Manual

than

Revision

1059.

Earlier

PMA-ls

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EXTERNAL PACEMAKER ANAL YZER - OPERA TOR'S MANUAL Section 2 - General Infonnation

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GENERAL INFORMATION 2.1

Warnings Under no circumstances should the unit be used on a Pacemaker CONNECTED TO A PATIENT. Remove Batteries time.

is to be stored

for a long period of

When using with a mains adaptor, make sure the delivered supply is 69volts. Incorrect voltages or Dolarity (see back overlay) may cause Dermanent damage to the unit. 2.2

General Infonnation

The PMA-l is designed as a universal analyzer/tester suitable for most types of external pacemaker. The current version of the software (ROM program) enables the tests listed below to be performed on invasive and non-invasive types of external pacemaker.

..

The test procedures

*

..

-

*

TAKEOVER and INHIBIT rate can be measured on demand pacemakers. On some pacemaker-s these may be the same value, but on others aRATE HYSTERESIS is introduced to prevent frequent changes of mode.

*

Response to SO/60Hz a.c. interference. The PMA-l provides a 50Hz or 60Hz sinusoidal signal with amplitudes from 0-25mV, to establish the level of interference causing malfunction. At the same time a simulated Rwave can be introduced for pacemakers operating in demand mode.

*

Pulsed Refractory Period (ms) measures the time after a paced pulse during which the pacemaker will not respond to a received stimulus.

...

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types)

Demand mode - R,S and T wave sensitivity tests using pulse widths of 5,10,15,17,20,40,50,100 & 200ms and amplitudes of 0-25mV. (30ms width also avaliable with firmware version 2.5) All these settingsare available with Sine Squared (SSQ) (Haversine), Triangular (TRI) and Square wave (SQU) pulses. An alternative 'ISO' wavefonn is also available but only as a positive wave with a width of ISms.

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Pulse Width (ms) Pulse Amplitude (V) and (mA) (mA only for transthoracic Pulse Interval (bpm)

*

-

..

are as follows (see Section 4 for fuller details):

A-V time interval (ms) provides arneasurement of the time between atrial and ventricular pulses from dual chamber pacemakers.

-

-

available

*

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if the instrument

which is

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EXTERNAL PACEMAKER ANAL YZER - OPERA TOR 'S MANUAL Section 2 - General Information

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Sensed Refractory Period (ms) measures the time after a sensed stimulus during which the pacemaker will not respond to a further stimulus. Extended Test. This is a long term test which averages the pulse amplitudes and pulse intervals of the first ten pulses received, and reports if any subsequent pulses (amplitudes or intervals) are not within 10% of the average values. All results may be printed using the parallel port or sent to a computer via the serial port. The PMA-l can also be controlled from a computer.

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2.3 ~

Applications

of PMA-l

The PMA-l has been designed for use in the following applications.

1.

Routine checking of pacernakers in the cardiology department using three or four of the basic tests above in only one or two combinations of pacemaker/analyzer settings. Such tests might be performed before a new patient is connected to the pacemaker.

2.

Checking in the Biomedical Engineering Department after service or repair. For routine maintenance a basic set of tests may be performed to demonstrate the continued satisfactory function of pacemakers. Alternatively, for acceptance testing, evaluations and after repair a fuller set of tests can be performed and the results recorded (printed) as a QA baseline.

3.

As an aid to troubleshooting and repair. Faults on pacemakers can be identified using the PMA-l. Intermittent faults can be located using the Extended test, which will identify even occasional variations from the set pacing parameters.

4.

F-!Jruse in teaching well as measuring powerful simulator, dernonstrating the SENSITIVITY, and

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2.5

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and dernonstrating the functioning of pacernakers. As the pulse parameters of pacemakers the PMA-l is a which can be used to generate signals required when INHIBIT and TAKEOVER rates, the R,S and T wave the REFRACTOR Y PERIOD measurements.

Power Supply and Batteries The unit may be powered from batteries (4 x 1.5 volt AA cells) or frorn a 6-9 volt external supply. When used on an external supply the cells are automatically disconnected. The celIs are not charged. frorn the external supply. We recornmend the use of leak-proof Alkaline cells which have a long shelf and service life. A battery-Iow warning appears on the display when the voltage has fallen sufficiently to need replacing. Rechargeable cells (1.2v) and Mercury cells (1.35V) should be avoided because of the lower output voltage. We recornrnend the use of an external supply whenever possible and particularly when performing the extended test, to conserve battery power.

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EXTERNAL PACEMAKER ANALYZER - OPERATOR'S Scction 2

2.6

Connecting

- General

MANUAL Infonnation

to a Printer

The printer port is the 25-"Yay D-type connector on the top of the instrumento This provides a standard Parallel printer signal with the same pin configuration as used on IBM compatible computers. The standard printer lead used with these computers should work with the PMA-l. Information is sent to the printer when the [PRINT] button is pressed. Usually this prints the contents of the LCD Display. In the EXTended test, the printer is particularly useful as any pulses from the pacemaker which are not within the set limit (+/-10%) of the average are sent to the printer. Only standard ASCII codes are used and thus the interface almost a11 basic printers.

2.7

Using the Computer

should work with

Interface

A serial computer communication port is provided via 9-pin Female D-type connector on the top face of the instrumento This is in tended to send test results direct to a computer for paperless storage of test results, and for use under computer control. The protocol {bi-directional} is 9600 N 8 1. See Section 4.6 for further details

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II»>] to return to the menu.

.

Press [A-V] to measure the A-V time interval: .1

24

e

the