MINIATURE TEMPORARY CARDIAC PACEMAKER

Instruction Manual

MODELS EV4542 AND EV4543

CAUTION: Federal Law (USA) restricts

this device to use by or on the order
of a physician.

PACE Medical, Inc.

391 Totten Pond Road
Waltham, MA 02451 USA

and

APC Medical Ltd.

Welwyn Garden City,AL7 1BD
United Kingdom

P/N 03-001-000 rev 5 © 1998 Pace Medical, Inc.

Collet terminal (RED) Collet terminal (BLACK)
For connecting the For connecting the active
indifferent electrode electrode lead (negative)
lead (positive)

Function Indicators Output

Indicate pacing, Adjusts the voltage of the
sensing and battery pacing pulse

Sensitivity Rate
Adjusts the ‘R’ –wave Adjusts the frequency of
sensing level in the pacing pulses
demand mode

On/Off switch with Demand/Asynchronous

x1/x3 rate position Select mode of operation

Hinged Plastic Cover

Key to MINIATURE Pacemaker Controls and Features

Figure 1

1
 CONTENTS

1. System familiarization 4
1.1 Introduction 4
1.2 Parts supplied 5
1.3 Specifications 6
1.4 Indications and contraindications 7
2. Features and controls 8
2.1 Function indicators 8
2.1.1 Pacing
2.1.2 Sensing
2.1.3 Battery replacement
2.1.4 Interference
2.2 Controls 9
2.2.1 Sensitivity
2.2.2 Output
2.2.3 Rate
2.2.4 Demand/asynchronous switch
2.2.5 On (X1)/off and X3 switch
2.3 Collet terminals 9
3. Operating instructions 10
3.1 Lead placement 10
3.2 Connecting the lead to the pacemaker 10
3.3 Determination of pacing threshold 11
3.4 Determination of sensing threshold 12
4. Precautions 13
5. Equipment care 15
6. Troubleshooting 16
6.1 Interference 16
6.2 High rate protection 18
6.3 Battery replacement 18
6.4 Miscellaneous clinical problems 19
7. Accessories 20
8. Miscellaneous 21
8.1 Additional information 21
8.2 Limited warranty 22
9. Storage 23
10. Use and care of the extension cable 24
11. Classifications / certifications 25

2
 Illustrations

Key to MINIATURE pacemaker controls 1

Pace, sense and battery level indicator LEDs 8

Connecting the lead to the pacemaker 10

Relationship of selected rate and interference rate 16

Changing the battery 18

Connecting the extension cable 23

3
1. System Familiarization

1.1 Introduction
The Pace Medical MINIATURE Temporary Pacemaker, an external
cardiac pacemaker with internal power source, offers short-term
pacing support for a patient with myocardial infarction or temporary
heart block.

The MINIATURE pacemaker operates in either the R-wave

inhibited (demand) or the asynchronous mode with rate
continuously variable within the range of 30 - 150 ppm when the
switch is moved from off to on. The EV4543 has two ranges of
operation, selected by an X1 and an X3 rate multiplier switch. In
X1, the unit operates in the same manner as the EV4542, but in X3
the unit operates in the asynchronous mode only for high rate
pacing up to 450ppm. Selection of the X3 rate position will
automatically change the unit to asynchronous mode and will
override the demand mode of the demand/async switch.

WARNING: THE X3 POSITION IS FOR SPECIAL SHORT-

TERM HIGH RATE ATRIAL PACING ONLY.

To prevent accidental selection of high rate atrial pacing, the switch

knob must be lifted before it can be turned to the X3 position. The
hinged, transparent cover will not fully close during high rate atrial
pacing.

The output and sensitivity control scales are expanded at the lower
settings to facilitate approximate threshold measurement.
In the presence of an excessive level of electrical interference
(EMI), the pacemaker will automatically switch from the demand
mode to a temporary asynchronous pacing mode approximately
25% higher than the selected rate. Normal function is resumed
when the level of interference is reduced below the level of
detection or stops completely.

Should an electronic component failure occur in the unit, the

maximum high asynchronous rate is limited to 200ppm in model
EV4542 or in the model EV4543 in the X1 mode. Model EV4543
operated in the X3 mode is limited to 500ppm.

4
1.2 Parts supplied

MINIATURE Temporary Cardiac Pacemaker

One 9 volt alkaline battery (IEC Type 6LR61)

Two straps

Instruction manual

Extension cable

Carrying case

5
1.3 Specifications (@ 20°C ± 2°C and 500 Ohms ± 1%)

Mode of Operation R-wave inhibited or asynchronous

Voltage output (continuously variable) 0.2 - 12 V

Accuracy ± 0.05V or ± 20%

Pulse rate (continuously variable) 30 - 150 ppm

Accuracy ± 5%

Pulse duration (fixed) 1.5ms

Accuracy ± 0.15 ms

Interference rate (6 Hz and above) Selected rate +25%

Inhibit sensitivity (cont. var.) Calibrated for +1.0 - +12mV

Accuracy ± 30%

Refractory period (after a stimulus) 330 ms

Accuracy ± 30 ms

Refractory period (after a sensed event) 150 ms

Accuracy ± 15 ms

Dimensions 76mm x 145mm x 33mm

Weight 280 g or 9.8 oz.

Recommended conditions for:

Operation: +10°C (+50°F) to +40°C (+104°F); RH 30% to 70%
Transport/Storage: -20°C (-4°F) to +60°C (+140°F); RH less than 85%
Exceeding the transport and storage temperature range may result in
damage to a Model EV4543 or EV4542.

6
1.4 Indications and Contraindications

The MINIATURE Temporary Pacemaker may be used in any

clinical situation in which the use of a temporary pacemaker on a
patient provides therapeutic or diagnostic value, or serves a
prophylactic purpose. Specifically, indications for temporary
pacemakers include, but are not limited to, the following:
intermittent or complete heart block associated with asystole or
bradycardia, symptomatic sinus bradycardia, surgically-induced
heart block and heart block accompanying an acute myocardial
infarction.

There are no known contraindications to the use of temporary

cardiac pacing as a therapeutic or prophylactic modality. Never-
theless, certain relative contraindications may exist in any given
patient. Among others, the application of asynchronous pacing in
competition with an intrinsic rhythm may provoke arrhythmias in
electrically unstable individuals.

CAUTION: When clinically indicated, supplemental monitoring of a

patient should be considered during temporary cardiac pacing.

WARNINGS
A MINIATURE pacemaker which has been subjected to conditions
of transport or storage at temperatures below 10°C (50°F) or above
40°C (104°F), should be allowed to sit at room temperature (about
20°C or 68°F) for an hour before being placed in use on a patient.
Before handling an external pulse generator, patient cable(s), or
indwelling lead(s), steps should be taken to equalize the
electrostatic potential between the user and the patient; e.g. by
touching the patient at a site remote to the pacing lead.
Continuous ECG monitoring is necessary prior to pacing, during
any pacing procedure, and in the immediate post-operative phase.
Equipment for defibrillation, I.V. infusion, endotrachael intubation
and oxygen administration must be immediately available.

7
2. Features and controls

2.1 Function indicators

Light Emitting Diodes (LEDs) are used to indicate
pacing, sensing, when the battery should be replaced,
and the presence of detected interference.
2.1.1 Pacing
This light flashes once for every
pulse delivered by the pacemaker
in either the demand or asyn-
chronous mode.
2.1.2 Sensing
This light flashes once for every
sensed spontaneous R-wave in
the demand mode only.
2.1.3 Battery replacement
This light flashes simultaneously
with the flashing of the Sense or
Pace light to indicate good battery
condition. As the battery nears
depletion, the Battery light will
become less visible. IN THIS
CONDITION, THE UNIT WILL CON-
TINUE TO PACE NORMALLY, BUT
THE BATTERY SHOULD BE RE-
PLACED AS SOON AS POSSIBLE.
2.1.4 Interference
If the unit is in the presence of
detected interference; i.e. a signal
repeating more frequently than
6Hz, both the Sense and Pace
lights will flash. The Sense light is
flashing in response to the inter-
ference signal. The Pace light is
flashing to indicate continued
pacing in an asynchronous mode
at a 25% increase from the rate
indicated by the rate setting.
Figure 2
8
2.2 Controls
All controls are located on the face of the pacemaker and are
protected by a hinged transparent cover.
2.2.1 Sensitivity
This control adjusts the R-wave sensing level. It is contin-
uously variable from +1.0 to +12 mV and is ineffective when
the demand/async switch is set to async or when the rate
multiplier switch on the EV4543 is set to X3.
2.2.2 Output
This control adjusts the amplitude of the pacing pulse over the
calibrated range of 0.5 to 20 milliamperes or 0.2 to 12 volts.
2.2.3 Rate
This control adjusts the frequency at which pacing pulses are
generated over the continuously variable range of 30 to 150 ppm.
Model EV4543 has two switched ranges: X1 provides a pacing
range of 30 - 150ppm and X3 provides a pacing range of 90-
450ppm. All rates are continuously variable. The X1/OFF/X3 rate
switch in the model EV4543 must be lifted before turning to the X3
rate position. Selection of the X3 position overrides the
demand mode of the demand/async switch.
WARNING: For special short-term high rate atrial pacing only.
2.2.4 Demand/Asynchronous switch
Selects the mode of operation.
2.2.5 On/off switch
Switches the pacemaker on and off. In devices having the rate
tripler feature, this switch is also used to switch from normal rate
(X1) to triple the set rate (X3).
2.3 Collet terminals
Accepts unipolar or bipolar leads with connector pins from 0.25 -
2mm in diameter.

9
3. Operating instructions

3.1 Lead placement

When positioning the lead in the heart, it is recommended that

the intracardiac ECG be monitored so that S-T segment
elevation, indicating contact with the myocardium and
impaction, can be noted.

3.2 Connecting the lead to the pacemaker

Switch the pacemaker off. With bipolar, transvenous electrodes or

leads where only one electrode is in contact with the myocardium,
connect the proximal or skin electrode to the indifferent (+) red
terminal and the distal or contacting electrode to the active (–)
black terminal (with heartwires in a bipolar configuration, connect
one lead to the indifferent (+) red terminal and one lead to the
active (–) black terminal) by the following method.

Connecting the Lead to the Pacemaker

Figure 3

Twist the terminal caps approximately three full turns counter-

clockwise, as illustrated. Push the lead connector pins into the end
of the collet terminals and tighten by twisting the caps clockwise
until they are just finger-tight. Do not over-tighten.

WARNING: When handling indwelling leads, the connector pins or

exposed metal should not be touched or allowed to come into
contact with electrically conductive or wet surfaces.

10
3.3 Determination of pacing threshold

a) Set the pacemaker on/off switch to off (taking any special

requirements of the patient into account).

b) Set the output control to 4V.

c) Set the pulse rate control to a value higher than the patient's
spontaneous rate.

d) Select the desired pacing mode, demand or async and set

the on/off switch to on (X1). The function indicator will show
that pacing pulses are being generated at the preset rate.

e) Turn the output control counterclockwise until cardiac

stimulation ceases and then slowly turn the control clockwise
until pacing resumes. Note the stimulation threshold.

f) For reliable capture, increase the output control to a value

three times the stimulation threshold. If necessary, readjust
the pulse rate control to the minimum pacing rate required for
the patient.

11
3.4 Determination of sensing threshold

To ensure reliable pacemaker detection of the patient's R-wave,

the sensitivity level should be preset as follows:

a) Ensure the pacemaker is switched off (taking any special

requirements of the patient into account).

b) Set the demand/async switch to demand.

c) Set the rate control to a value below the patient's spontaneous

rate.

d) Set the output control fully counterclockwise to 0.2V.

e) Set the sensitivity control fully clockwise to 1.0 mV.

f) Set the on/off switch to on (X1).

g) Turn the sensitivity control counterclockwise until the sense

light stops flashing. When this occurs, note the sensitivity
setting.

h) For reliable R-wave detection, increase the sensitivity three-

fold; ie. if noted setting is 3 mV, the recommended setting is 1
mV.

i) Increase the pacing rate control to the desired level and the
output control to three times the pacing threshold.

12
4. Precautions

The controls on the Pace Medical MINIATURE Temporary Cardiac

Pacemaker should be operated only by qualified medical
personnel.

The MINIATURE temporary cardiac pacemaker is protected from

damage caused by defibrillatory discharges, but care should be
exercised in the placing of defibrillator paddles well away from the
pacing leads.

Great care should be exercised when using diathermy in asso-

ciation with any cardiac pacing system. Adequate monitoring must
be used.

Line-powered monitoring equipment should be avoided when

pacing, since even minute leakage currents flowing through the
heart may cause ventricular fibrillation. If line-powered equip-ment
is used, the manufacturer of the equipment, or person(s)
responsible for safety within your organization should be consulted
on the safest method of connection.

The MINIATURE pacemaker described in this information manual

is not waterproof and it must not be immersed in cold sterilizing
solutions. Additionally, it must not be sterilized using steam
autoclaving or gamma irradiation techniques.

The MINIATURE pacemaker is a life-support device. Section 6 of

this manual describes the routine for battery maintenance. This
is the only recommended user-serviceable item. In general, it is
recommended that repair operations be performed by the
specially-trained technicians of Pace Medical, Inc.

When in routine use, it is recommended that calibration be

checked at yearly intervals.

13
CAUTION: The control knobs are individually calibrated.
The pacemaker will need to be recalibrated if a knob is
removed for any reason (see Section 8 for Warranty
limitations).

14
5. Equipment care

Isopropanol or a dilute solution of a mild, non-abrasive detergent

and water applied with a soft cloth may be used to clean the
MINIATURE Temporary Cardiac Pacemaker. A MINIATURE must
NOT be immersed in a cleaning solution.

Ethylene oxide may be used to sterilize the MINIATURE. The

temperature is typically 50°C (122°F) and the relative humidity
should be 50 - 55%.

The battery should be removed before sterilization and a new

battery installed afterwards.

The MINIATURE pacemaker must not be sterilized by steam

autoclaving or irradiation.

NOTE: The MINIATURE pacemaker and its extension cable should

be routinely inspected for signs of physical damage or
contamination, particularly damage or contamination that may have
a detrimental effect on the electrical isolation properties of these
devices. If such damage or contamination is identified, the
pacemaker should be returned to the Company for repair. The
extension cable should be promptly replaced. See sections 7 and
8 of this instruction manual.

15
6. Troubleshooting

6.1 Interference

The MINIATURE pacemaker is designed to reject interference

frequencies outside of the R-wave bandpass. Detected signals
which repeat with a frequency of 6Hz or greater will cause
reversion to the interference mode.

When operating in the demand mode, an excessive level of

electrical interference, for example, from diathermy or microwave
ovens, will cause the pacemaker to switch automatically to
asynchronous pacing at nominally 25% higher than that set on the
rate control and both the sense and pace lights will flash. Normal
function is resumed when the level of interference is sufficiently
reduced.

The typical relationship between the selected pacing rate and the
pacing rate when excessive electrical interference is present, is
illustrated below in Figure 4.

16
Figure 4

17
6.2 High rate protection

Should an electronic component failure occur in the unit, the

maximum high asynchronous rate is limited to 200 ppm, unless the
unit is an X3 being operated in its rapid atrial pacing mode.

6.3 Battery depletion and replacement

All MINIATURE pacemakers are designed to operate on 9V

alkaline batteries (IEC type 6LR61). Spare batteries should be
kept available at all times. It is recommended that a new battery
be used with each patient. A single, fresh 9V battery will typically
last approximately thirty (30) days. Battery depletion is shown by
a reduced visibility of the battery light during sensing or pacing.
When this occurs, the battery should be replaced without
delay even though the MINIATURE pacemaker will continue to
operate for at least 24 additional hours.
Although the pacemaker will continue to function for 10
seconds after battery removal, it is recommended that
batteries not be changed while the pacemaker is in use on a
patient. By temporarily substituting another unit, a battery
change can be carried out without risk that a patient may
accidently be left without pacing support; e.g. if a battery is
dropped.
To change the battery, push the cover up over the battery
compartment, as illustrated below, remove the battery and
disengage the connector. Ensure that the contact terminals are
clean. Fit the connector to the new battery, observing the correct
polarity and replace the battery and cover. As an additional safety
precaution, the battery and contact terminals should be checked
for corrosion at regular intervals.

Figure 5

18
6.4 Miscellaneous clinical problems

Additional minor device operating problems: A failure to tighten the

connector collets securely may lead to intermittent pacing and/or
sensing. Improperly set output and/or sensitivity controls may lead
to the appearance of intermittent or complete failure to pace or
sense. Inappropriate asynchronous operation may be due entirely
to the device being switched to asynchronous mode, or as noted
earlier, interference from EMI.

These normal and minor pacing complications should be

considered prior to concluding that a more serious device
malfunction is occurring. Repair, if needed, should be referred to a
qualified biomedical technician or equivalent, or to Pace Medical,
Inc.

19
7. Accessories / Parts

Parts supplied with a MINIATURE pacemaker are available from

Pace Medical individually. No catalog number is required. A
simple description of the accessory needed is usually adequate.

Similarly, certain parts of a MINIATURE itself, ex. battery

compartment cover or clear control panel cover, may be ordered
by mail or by calling the company at (617) 890-5656.

For the convenience of those who must utilize part numbers when
ordering replacement items, the following is a list of the more
commonly ordered replacement items and the Pace Medical part
number.

Part Number Description

83-004-000 Battery compartment cover

83-003-000 Transparent face cover
01-003-003 Extension cable
03-001-000 Instruction manual
99-020-000 Arm strap
99-022-000 Carrying case

20
8. Miscellaneous

8.1 Information

Further information about the MINIATURE Temporary Cardiac

Pacemaker and other Pace Medical, Inc. products may be
obtained from:

PACE MEDICAL, INC. APC MEDICAL LTD.

391 Totten Pond Road
Waltham, MA 02451
U. S. A.
Tel.: (781) 890-5656
Fax: (781) 890-4894
68-70 Tewin Road
Welwyn Garden City
Herts. AL7 1BD
England
Tel.: (01707) 327641
Fax: (01707) 333117

Within the intent of Council Directive 93/42/EEC, paragraph 13.3

APC Medical Ltd. is the Authorized European Representative of
Pace Medical, Inc.

21
8.2 Limited warranty for Pace Medical, Inc./APC Medical Ltd. (the
Company) MINIATURE Temporary Cardiac Pacemakers

The Company, warrants the MINIATURE Temporary Cardiac

Pacemaker to be free from defects in materials and workmanship
for one year from the date of delivery when operated in accordance
with the written Operating instructions which accompany the
equipment.

This Warranty extends to the original purchaser of the equipment

only and not to any subsequent purchaser.

The Company's obligation under this Warranty shall be limited to

repair or replacement of part or parts found to be defective during
the Warranty period. All expendable items, such as Arm Straps,
Extension Cables, and Batteries are not covered by this Warranty.

The equipment as sold may embody design or performance

modifications not reflected in applicable literature. However, the
Company warrants that such modifications will not reduce the
design performance of the equipment.

Any repair or calibration to the circuitry during the period of the

Warranty will invalidate the terms of the Warranty unless performed
by Company personnel.

22
9. Storage

A MINIATURE pacemaker should be stored in its carrying case to

protect it from accidental damage. The storage area should be
clean and dry. The temperature of the storage area should be
within the range –20°C and +60°C (–4°F - +149°F).

Always remove the battery from a MINIATURE pacemaker which is

to be stored for any significant length of time. Life of the alkaline
batteries to be used with the MINIATURE pacemaker will be
extended if they are maintained in normal refrigeration and rotated
at least once annually.

NOTE: It is recommended that a MINIATURE pacemaker be

allowed to come to ambient temperature prior to use following
prolonged storage at temperatures outside of the specified range
of operating temperature.

23
10. Care and Use of the Extension Cable

The extension cable provided with this product has “booted” male
connector pins. The molded silicone rubber boots slip over the
caps of the collet terminals during connector pin insertion, then
freely rotate the boots to tightenand/or loosen the terminal caps.

The extension cable has a T-type dual collet connector at one end
and a two pin plug connector at the other. In addition to color
coding, this cable is marked (+) or (–). This is commonly provided
with single chamber pacemakers.

WARNING: When an extension cable is to be used, it should be

connected to the pacemaker prior to connecting the pacing lead to
the extension cable.

To use, first turn the unit off. Then simply plug the pin ends into
opened pacemaker terminals and tighten firmly. Connect the
terminals of the opposite end to the implanted lead(s), being sure
to observe proper polarity. See Figure 6, below.

As supplied, the cable is NON-STERILE. It may be sterilized, if

desired, by autoclaving at a standard USP cycle; ex. 121°C for 15
minutes. .

Figure 6

24
11. Classifications / Certifications

The Models EV4542 and EV4543 have been tested to ensure

compliance with the intent of Directive 89/336/EEC for
Electromagnetic Compatibility.

Compliance was demonstrated to the following specifications as

listed in the Official Journal of the European Communities:

EMC Directive 89/336/EEC:

EN 55011 Class B Radiated Emissions

EN 61000-4-3 RF Electromagnetic Field Immunity

EN 61000-4-2 Electrostatic Discharge Immunity

The Models EV4542 and EV4543 are classified as Type CF

defibrillation-proof applied parts and bear the international symbol
identifying them as such shown below:

Additionally, the Models EV4542 and EV4543 bear the CE Mark to

indicate compliance with the requirements of Annex I of Council
Directive 93/42/EEC, known as the "Medical Device Directive".

0086
25