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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
Section 1 - Key to 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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EXTERNAL PACEMAKER ANALYZER - OPERATOR S MANUAL
Section 1 - Key to Manual
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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5
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 - Key to 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.
Sb
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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
I
Section
I
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
I
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
¡
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
t
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
..
APPENDIX 1
External Pcemakers - description and applications
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EXTERNAL PACEMAKER ANALYZER - OPERATOR'S MANUAL
Section 1 - Key to Manual
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
Dl
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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.
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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.
11
~
g-pin
O
RX
D
TX
3
DTR
4
---/'
IP>:MIA
av
5
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EXTERNAL PACEMAKER ANALYZER - OPERATOR'S MANUAL
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
I
OPEN
I
LCD eontrast Parallel Printer
@
6-9 V de
8:J
@
RS232 On-Off
J
13
..
I I I
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
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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)
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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)
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EXTERNAL PACEMAKER ANALYZER - OPERATOR S MANUAL
Section 3 - Description and Specification
3.3.1 Measurement of Pacing Pulse
Pulse Width
~
.
nl
Amplitude
n
~
.
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
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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
~
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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
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EXTERNAL PACEMAKER ANALYZER - OPERATOR S MANUAL
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
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EXTERNAL PACEMAKER ANALYZER - OPERATOR S MANUAL
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)
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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.
.
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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
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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
.
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EXTERNAL PACEMAKER ANALYZER - OPERATOR S MANUAL
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. .