external pacemaker analyzer

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EXTERNA.L PACEMAKER ANALYZER

Model PMA-1

OPERATOR S MANUAL

BIO- TEK

INSTRUMENTS INC.

Highland Park, SQX 998

Winooski¡ Vermont

54 4 998

USA

Phone:

8 2 655 4 4

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EXTERNAL PACEMAKER ANALYZER -OPERATOR S MANUAL

Model PMA l

BIO-TEK INSTRUMENTS me.

EXTERNALPACEMAKERANALYZER

Model PMA-l Operator sManual

Revision 00

1 July 1998

Infonnation eontainedwithin this

manual is subject to copyright

BIO-TEK INSTRUMENTS, INe.

HIGHLAND PARK, BOX 998

WINOOSKI, VERMONT 0~0404-0998 USA

802-655-4040

800-451-5172

800-24-BIOTK (SERVICE)

TELEX: 94-0136 BIO TEK SHVT

FAX: 802-655-7941

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EXTERNAL PACEMAKER ANALYZER -OPERATOR'S MANUAL

Section 1

-

Key to Manual

Section 1.1

DOCUMENT REVISION RECORD

Revision, Date, Section,ROM Version

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A

1 JuIy 1990

B

1 December 1990-

c

26 March 19911.2

D

01 July 1991

E

31 January 1993

F

01Apri119952.6

F

21 June 1995 2.7

G

26 Feb 1996

H

30 Mar 1996

00

1 July 1997

UMO129/00

Last updated 1luly 1997

UIM Part 1374UK, 1373 INT

Changes

1.0

Originalversion

1.0

Minor Changes

V2PCB with 9pinRS232

Minor changes to Instructions

1.2 Section 4.4 Pulsed Ref. Period

and SensedRef. PeriodoMinor

changetoinstructions

2.0

As requiredby introduction of

V2.0 Finnware and V1.l Wavefonns

See Section 1.1.1 for details of

Finnware Changes.

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

N.E. Revision E F apply only

to PMA-ls with Serial Number

greater than 1059.

Minor Changes not affecting operation or

specification

2 7 2 8

Insert section 1.1.3with details of changes

on CEmarked version (European).

2.8

Changes to Accuracy statements In

Section 3.3.7

Document renumbered as UMO129

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EXTERNAL PACEMAKER ANALYZER - OPERATOR S MANUAL

Section 1 - Key to Manual

Section 1.1.1

Details of Manual Revision

Changes in Version 2 compared to Version

1 2

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.

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.

A PMA-l with a serial number greater than 1059 can be upgraded to use the new

features by replacing the two ROMS.

Change

Manual Section

Affected

Details

1.

Restriction on PRP and SRP periodo

3.3.4

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.

2.

3.3.5

estriction of simulated R-wave pulse length

in PRP and SRP tests.

This now has a maximum pulse length of 50ms

3.

New PRP and SRP default period

4.4

The default (starting) period in the PRP and SRP tests is

now 100ms

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.

3

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EXTERNAL

PACEMAlillRANALYZER

- OPERATOR S MANUAL


5.

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.

C1 1]:

J 5 < J mU

: 2 ms

h_ r n_n r

00 u u r u_u.

, , . ., ,..

, . . . l. .,

: : : :: 1:::::

. . , ., ,.

. , ., . I . ,

. . I l 1 .,

: - - - - - - - ¡- - - - -- - - ~- - - -oo- ~ --- - - - - ~- -- - --- - -- -r -- ~ - - -- - - - ¡-- - - - - -- ~- - -- - - -~ - -- u - - ~

. , . 1 .,.

. , ..

, . , . 1,..

: : : :: 1 ::::

, , , ., I , , . ,

f ~_u_oo--~ 1u--u --{ ----,-- -------~u_-----~ j-- -----~

: : : :: I : : : :

, , ,

I , . , ,

: : : :: ,::::

. , , ., I , , ,

:n + ---_u-~---

~

-------.:..----- -u - f-- -----u:- ~_noo-~- --:

, , . ,..,

. ., , I , . , .: : : :: I : : : :

, , . I . . , ,

, . I

. . , ., I , , , .

: +++-t+++- -7 -t-~ : ++++- I \

I I I I ¡+--+- - -\

. I , ,. I , . . .

, . . I ,

. , . ,.

: : : :: 1:::::

. , . ., l

~ ~ ; ~ ~

uu -

f_n ~ -; nu f _uu {

: : : :: :: ::

. . . ,..

. ,

. . , ,

, , , ,

. . .,. r=~=--=-1 -=u-=J-=>u. ,.

: : : :: .:::::

: : : :: 1:::::

. , . .. 1 , I , .

: : : :: 1:::::

:----_u¡--------~ u ~-------~u----- ----f--:----_u¡--u- u_~ :-------~

, , . ., l I I . ,

: : : :: 1:::::

: : : :: 1:;:::

. , , l

Lu - u L--c----~ --- -- -- ----ru, ----

_u

u- L_u l__-

I .

6.

CHJ: 5 mU :5ms

Additional ISO Wavefonn in Wavefonn ROM V1.1

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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6.

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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7.

8.

9.

10.

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Smaller amplitude steps in PRP and SRP tests.

The simulated R-wave amplitude in the PRP and SRP tests

default 10mV) can be adjusted in lmV steps previously

2mV).

Changed amplitude defaults on R-wave and

S-wave Sensitivity Tests.

Default amplitudes on the above now start at 1mV instead

of 2m V.

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)

Controlling the PMA-1 from a computer.

The PMA-1 will support bidirectional data

transfer. There are two test modes:

Otis Mode, in which all the tests can be operated

from a computer, with the print-strip details being

copied to the computer.

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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4.4

4.3

2.6

All tests

New Section 4.6

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EXTERNAL PACEMAKER ANAL YZER - OPERATOR'S MANUAL


Section 1.1.2

Details of Manual Revision

Changes in Version 2 7 compared to Version2

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.

The main changes are the addition of a 30 ms pulse width and a peak capture

routine for transthoracic amplitude.

Change

Details Manual Section

Aff ected

1.

Addition of 30 ms pulse width

3.3.5

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.

2.

Peak value detect 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.

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 - OPERA TOR S MANUAL

Section 1

-

Key to Manual

Section 1.1.3

Details of Manual Revision G 7) .

Changes relating to release of CE marked

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.

Therefore references to use on external power supply, particularly in Sections 2.1.3, 2.5,

and 3.2.4, do not apply to the CE marked units.

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EXTERNAL PACEMAKER ANALYZER - OPERATOR'S MANUAL

Section 1 - Kev to Manual

I

1.2

TABLE OF CONTENTS

Page

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Section

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1.

KEY TO MANUAL

1.1

Document Revision Records

2

1.1.1

List of ehanges introdueed in V2.0 Firmware

3

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1.1.2 List of ehanges introdueed in V2.7Firmware 5b

1.1.3

CE Marked (EuropeanVersion)

5e

1.2

Table of Contents

6

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1.3

Introduetion to the Model PMA-1 Operator's Manual

8

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2. GENERAL INFORMATION

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2.1

Warnings

9

2.2

General Information

9

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2.3

Applieations of the PMA-l

10

2.4

Not Used

2.5 Power Supply and Batteries 10

2.6

Conneeting to a Printer

11

2.7

Conneeting to a Computer

11

3.

DESCRlPTION AND SPECIFICA TIONS

3.1.1

Front Panel

12

3.1.2

Rear

13

3.1.3

Program MENU

14

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3.2.1

Input Details

15

Ventricular Pacíng Input

Atrial Pacíng Input

Transthoracíe Pacíng Input

3.2.2

Output Details

15

Parallel Printer Port

Serial Computer Port

.

3.2.3

Display

15

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3.2.4

Power Requirements

15

Batteries

,

External 6-9 Volt Supply

r

3.2.5

Size/Weight

15

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3.3.1

Measurement of Pacíng Pulse

16

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3.3.2

A-V Pulse Time Interval

16

3.3.3

50/60Hz Interference Signal

17

3.3.4

Refraetory Period Measurements

17

3.3.5

Simulated R,S T waves

19

WidthSetting

,

Waveforrn Selection

Rate Setting

Amplitude Setting

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EXTERNAL PACEMAKER ANAL YZER - OPERATOR S MANUAL

Section 1 - Kev to Manual

3.3.6

3.3.7

Long Term Extended) Tests

Overall Accuracy Statements

21

21

4.

OPERA TING INSTRUCTIONS

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4.1

Overview of Proposed Test Procedures

22

4.2 Connection to the Pacemaker 22

4.3 Short Test Procedure 24

4.3.1

Ventricular Pulse Test 24

4.3.2

Atrial Pulse Test and A-V time Interval

24

4.3.3

R-Wave Sensitivity Test

25

4.3.4

Sample Results

27

4.4

Supplementary Tests

28

4.4.1

Response to AC Interference

28

4.4.2

T-Wave Sensitivity

30

4.4.3 S-Wave Sensitivity 30

4.4.4

Pulsed Refractory Period

30

4.4.5

Sensed Refractory Period

31

4.4.6

Long Term Test EXT.)

33

4.5

Sample Results

34

4.6

Operating with a Computer

35

5.

TROUBLESHOOTING, MAINTENANCE, SERVICE, AND CALIBRATION

5.1

Operating Precautions

37

5.2 Cleaning 37

5.3

Service, Checking, Calibration

. 37

5.4

Troubleshooting

39

5.5

Returning the Unit for Service

39

5.6

Warranty

39

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APPENDIX 1

External Pcemakers - description and applications

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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.

The objectives of this manual are to provide:

1.

General Information about the Model PMA-l, inc1uding applications

2.

Warnings, shipping and storage instructions (Section 2)

3.

Description of the unit and specifications (Section 3)

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

4)

5.

User Maintenance, 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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V2.0 Firmware can only be fitted to PMA-ls with serial number greater than 1059. Earlier PMA ls

can be upgraded as far as Version 1.4 which is covered in Operator s Manual Revision

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EXTERNAL PACEMAKER ANALYZER - OPERA TOR'S MANUAL

Section 2 - General Infonnation

GENERAL INFORMATION

2.1

2.2

Warnings

Under no circumstances should the unit be used on a Pacemaker which is

CONNECTED TO A PATIENT.

Remove Batteries if the instrument is to be stored for a long period of

time.

When using with a mains adaptor, make sure the delivered supply is 6-

9volts. Incorrect voltages or Dolarity (see back overlay) may cause

Dermanent damage to the unit.

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

*

Pulse Width (ms)

Pulse Amplitude (V) and (mA)

(mA only for transthoracic types)

Pulse Interval (bpm)

*

A-V time interval (ms) provides arneasurement of the time between atrial

and ventricular pulses from dual chamber pacemakers.

*

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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*

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 R-

wave 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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2.3

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2.5

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EXTERNAL PACEMAKER ANAL YZER - OPERA TOR 'S MANUAL

Section 2 - General Information

*

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.

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 and dernonstrating the functioning of pacernakers. As

well as measuring the pulse parameters of pacemakers the PMA-l is a

powerful simulator, which can be used to generate signals required when

dernonstrating the INHIBIT and TAKEOVER rates, the R,S and T wave

SENSITIVITY, and 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.

10



EXTERNAL PACEMAKER ANALYZER -

OPERATOR'S MANUAL

Scction 2 - General Infonnation

2.6

Connecting 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 should work with

almost a11basic printers.

2.7

Using the Computer 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

IUB3

M II»<C

<C :MI

n»A1r J[JE ILIE

25-pin

TX

7-

RTS 1:'

I OSR:

2

RX

CTS

av

RS232 connections Pin 2=RX receive, Pin 3=TXTransmit, Pin4=DTR, Pin5=GND.

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g-pin

O

RX

D

TX

3

DTR

4

---/'

IP>:MIA

av

5




Section 3 - DescriDtion 3nd SDecification

3.

DESCRIPTION AND SPECIFICATIONS

3.1.1 Front View

[d~

.

:::::l:YJ'::::::::S:'~:OV'1.O .OmA

. ::..:::61 B.PM,':2 ..O5mS.

{die

ampliiude

sensrtivity

R R

+

n rac period

.

PRP

SRP

,

[JJ[lIj]l Jo

externalpacen akeranafyzer

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EXTERNAL PACEMAKER ANALYZER -

OPERATOR S MANUAL

Section 3 - DescriPtion and Sp~cification

3.1.2

Rear View

6

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OPEN

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LCD eontrast Parallel Printer

@

6-9 V de

8:J

@

RS232 On-Off

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11 yentricular input

11

Atrial input

11 Atrioventricular. interval

I I I I I

PMA-l

11

Transthoracicinput

Inputs

111 AC interference

V

I I I I

500Ohm

11

Paced refractoryperiod

0A

500 Ohm

11 Sensed refractory period

Tr

I I I I

50Ohm

11

Long tenn test

Made in the UK



EXTERNAL PACEMAKER ANAL YZER OPER1\TOR S MANUAL

Sectlon 3 - DescriDtion 3nd SDecification

3.1.3 Program Menu

SelecL

Function

v

V/mA/BPM/mS

(view)

A

V/mA/BPM/mS

(view)

A-V

mS

(view)

Tr.

mA/BPM/mS

(view)

Rf ~

)

WidLh/Type

(sel)

s-

Sens

WidLh/Type

(se L)

INT

50/60Hz

(sel)

J.

N.B. press

~ ]

Togelher lo

prinL header

on prinler

PRP

V/Tr.

(seL)

-

SRP

V/Tr.

(sel)

-

-i

EXT

V¿

A/Tr.el)

BPM/ Amp

l NlI

(seL/

TAK R T

view) (prinl only)

SPMIAmp

I

(se l/

view)

Wave

Pulse lnl

Yes

J

Type

Amplilude AmpliLude

R-WAVE

r

(sel) (sel)

(sel/view)

(y/n)

I

lNT

mV

No

I

sel/view

Widlh/

PRP(m,)

Type

(seL/

(sel) (sel) view)

Widlh/

G_rRP(ms)

Type

(sel/

(set)

sel) view)

Sampling

1

Avg. Amp/BPM

(10 beals)

Curr Amp/BPM

(view)



EXTERNAL PACEMAKER ANAL YZER

- OPERATOR S MANUAL

Section 3 - Descrivtion and SDecification

3.2.1

Input Details

Ventricular Pacing Signal/ Atrial Pacing Signal

Connectors: Sub-miniature Bayonet SMB) male

Leads -

50cm coaxial with female 5MB - to 4 2mm pins

O.3-12.5V/25mA, 500 ohm load, 30-1200 BPM)

Transthoracic Pacing Signal

Connector: Sub-miniature Bayonet SMB) male

00-250mA, 50 ohm load, 30-1200 BPM)

3.2.2 Output Details

Parallel Printer Port

25-way D type female connector

Serial Computer Port

9-Pin Female D-type connector

9

Baud, 8 bits, no parity, 1 stop

Bi-directional

3.2.3 Display

2 line by 16 character LCD

3.2.4 Power Requirements

Batteries: 4x 1.5 volt AA cells rechargeable types not suitable)

.

-

current drawn 30mA approx.

- Battery Low message appears when voltage falls below 5.5.

Readings become inaccurate when this message shows.

External Supply 6-9V

- connecting external supply automatically disconnects the battery.

3.2.5 Size/Weight

Case 135 x 191 x

46mm

plus protruding connectors

Weight 600g approx)




Section 3 - Description and Specification

3.3.1 Measurement of Pacing Pulse

Pulse Width

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Amplitude

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Interval between pulses

Rate bpm

= 60/lnterval(sec)

-Amplitude

-(0.3-12. 5V/25mA) invasive

Measurement taken O.lms after start of pulse

-(10 - 250mA) non-invasive

Measurement taken 2ms after start of pulse

(Ver. 2.6 firmware uses a peak detect routine

.

which is activated 2ms after start of pulse.)

-Rate 30-1200 bpm

-Pulse length 0.5 (2.2 for transthoracic) - 50mS in O.OlmS steps

3.3.2 A-V Pulse Time Interval

-(0-1000ms) .

Atrial

/

n

n

n

Ventricular

l. .1

\

A-V Interval

n

16



EXTERNAL PACEMAKER ANALYZER

-

OPERATOR S MANUAL

Seetion 3 - Deseription and Spccifieation

3.3.3 50/60Hz Interferenee Signal

Delivered via the V signal port.

1.

o - 50mV ae peak to peak at 50hz or 60Hz:

- in l.OmV steps above 3mV

- in O.2mV steps below 3mV

2.

o - 50mV ae peak to peak at 50Hz or 60Hz, together with simulated R-

wave of 20ms width at l20BPM, 0-25mV, with choice of SSQ Sine

Squared), TRI triangular) or SQU square) waves.

3.3.4 Refraetory Period Mcasurements

Pulsed Refraetory Period

This is the time after delivery of a pacing pulse during which the

pacemaker will not detect cardiac activity R-wave)

30 - 500ms)

/

Pulsed Refractory Period

. of Pacemaker

.e

1

pulse from

pacemaker

\.

Simulated R-Wave

from PMA-1

Next Pacemaker

pulse delayed

Note: The time of the simulated R-wave is assumed to be the midpoint of the

wave.

17

~



EXTERNAL PACEMAKER ANAL YZER - OPERATOR S MANUAL

Section 3 - Descriotion and Soecification

Sensed Refractory Period

This is the period after the pacemaker senses cardiac activity slmulated

R-wave) during which it will not detect a further R-wave.

30 - 500ms)

Sensed Refractory Period SRP)

Simulated R-Waves

from PMA-1

Pulse from pacemaker

~

~

pacin

p~~ interval

~

SRP

~.

t

ext Pulse

delayed

Simulated R-Wave

detected outside SRP

How the PMA-1 does this

Adjustable time period

~ ..

500mS

SRP

Simulated R-Wave

~

18




Section 3

-

Descrivtion and Svecification

3.3.5 Simulated R,S T waves

Examples of R,S andT waves.

R Wave

/\

T Wave

.

..

1 2 ms

Width Settings

5,1O,15,17,20,40,50,100,200ms

30ms

with ver. 2.6)

30-125 bpm

+/-0 to 25mV:

in 0.1mV steps for R,S,T Sensitivity

Ín

1 rnV

steps for PRP, SRP, and INT

Square SQU)

Triangular TRI)

Sine Squared SSQ) Haversine)

ISO Waveform

Rate Settings

Amplitude Settings

Waveform Selection:

S Wave

20m s

1

V




Section 3 - Description and Svecification

Waveforrn Options

Sine Squared Waveform (Haversine)

Triangular Waveform

Pulse Amplitude 25mV Max

. .

L

Puls e Wid th 5,10,15, 17,20,40,,50,100,200ms

( 30ms with Ver.2.6)

Square Waveform

ISO

+ve

o

......--.

13ms

2ms

(Fixed Wldth)



EXTERNAL PACEMAKER ANAL YZER - OPERA TOR S MANUAL

Section 3 - Description and Specification

3.3.6 Long Term Tests

A reference value fOI: the pulse rate and amplitude is established from

the first 10 pulses. Thereafter any deviation over 10 is flagged and sent

to the printer.

3.3.7 Overall Accuracy Statements

All timings

Clock: 1 +/

-

1 digit

Note: Pulse length timing measurement requires

detection of start and end times, which in turn

depends upon pulse amplitudes and rise/fall times.

All amplitudes

5 +/- 1 digit

Note: Amplitude measurements are an average value

taken over approximately 80 microseconds.

Very short pulses with rapid rise/fall times may be

sub ject to apparent error due to this averaging time.

.



EXTERNAL PACEMAKER ANAL YZER OPERATOR S MANUAL

Section 4 ODcratin~ Instructions

4.

OPERA TING INSfRUCTIONS

4.1

Overview of Test Procedures

The test procedures set out below are to meet two different

requirements:

1. A short test covering the more basic functions of the

pacemaker at fixed control settings.

The full tests which might need carrying out during a full

analysis of pacemaker function. The full test would include

the supplementary tests in Section 4.4 below and the

operations set in it lies in the Short Test in 4.3

2.

4.2

Connection to the Pacemaker: Invasive types

PMA

Ventricular

Pacemaker

.

~

22

I

I

PMA

Dual Chamber

Pacemaker

:J

V

:J

:J A



EXTERNAL PACEMAKER ANALYZER OPERATOR S MANUAL

Section 4 Operating Instructions

Connection to the Pacemaker: Transthoracic types

emand est

PMA -1

Transthoracic

Pacemaker

.

Non-demand test

~

23

I

I

PMA -1

Transthoracic

Pacemaker

. ] ECG

INPUT

:J

. ]

PACER

UT UT

.




Section 4 - Operating Instructions

4.3

Short Test Procedure

This is a proposed procedure for the quick testing of pacemakers before reuse or

as a basic QA test.

The comments set in italics suggest expansion of the test to inc ude other

pacemaker settings for

a

fuller test

*

Connect the pacemaker appropriately as shown in Section 4.2.

*

Connect a printer/computer ir required.

*

Use the mains supply adaptor if many tests, and/or long term tests are to

be conducted.

*

Press [»] followed by [PRINT] to produce a test header on the printer.

*

Set Pacemaker to 60bpm, 5v(1amA), 2ms pulse length.

4.3.1 Ventricular Pulse Test

* Ir testing Ventricular Pacemaker press [V]

Ir testing Transthoracic Pacemaker press [Tr]

This will measure the pacing pulse for amplitude, pulse width, aod pulse

rate e.g.:

~ .~ ~~ ~ .~~~ ~ ~

. . .~ . ..~ ~ ~ ~ ~ . ~ ~ ~~ ~

~ ~ ~ ~ ~ ~ ~ . ~ ~ ~ . .. ~ . ~ ~ .. .

. . . . ..

. ... .. ... . ... ..

. ... .. .. . ...

[V]: :..;>;Oy:.l0f°Ín1( :

. ...61 BPM::Z;g;fu~::::..

Press [PRINTl if printed/computer output is required.

Press [»] after completion of the test.

e

4.3.2 Atrial Pulse Test

* Ir testing a dual chamber Pacemaker press [A]. This will measure the

Atrial pacing pulse.

. .. .. .. .

.. . .

.. . ... . ... . ... . .. ... . .

. . . .. . . . . . ... . ... . .. . . . . . . . . . . . .

. . .

. .. ..........

[~g~~ ~~~¡ i¡ i~¡~~~ ~~m~¡~

Press [PRINT] ir print is required. .

external pacemaker analyzer

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