Medtronic 53401 Technical Manual

Single Chamber Temporary External Pacemaker

53401

Technical Manual

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

The following list includes trademarks or registered trademarks of Medtronic in the United States and possibly in other countries. All other trademarks are the property
of their respective owners.

Medtronic

Contents

1 Overview ................................................................................................ 4

1.1 About this manual ................................................................................... 4

1.2 Symbols ........................................................................................... 4

1.3 General description ................................................................................. 5

1.4 Intended use ....................................................................................... 6

1.5 Contraindications ................................................................................... 6

1.6 Package contents ................................................................................... 7

1.7 Compatible accessory components .................................................................... 7

1.8 Special notice for the temporary pacemaker ............................................................ 7

2 Warnings, precautions, and adverse events ............................................................... 7

2.1 Warnings .......................................................................................... 7

2.2 Precautions ........................................................................................ 8

2.3 Environmental precautions .......................................................................... 10

2.4 Adverse effects .................................................................................... 10

3 Controls, indicators, and other features .................................................................. 11

3.1 Temporary pacemaker controls and indicators .......................................................... 11

3.2 Controls .......................................................................................... 12

3.3 Indicators ......................................................................................... 14

3.4 Physical features ................................................................................... 17

4 Preparation for use ..................................................................................... 21

4.1 Training ........................................................................................... 21

4.2 Checks prior to use ................................................................................. 22

4.3 Batteries .......................................................................................... 22

4.4 Battery installation and replacement .................................................................. 23

4.5 Connector Setup ................................................................................... 24

4.6 Placement during use ............................................................................... 27

5 Instructions for use ..................................................................................... 27

5.1 Basic operation .................................................................................... 27

5.2 Thresholds ........................................................................................ 30

5.3 Rapid Atrial Pacing (RAP) ........................................................................... 33

6 Cleaning, disinfecting, and maintenance ................................................................. 35

6.1 Cautions and notes for cleaning and disinfection ........................................................ 35

6.2 Cleaning and disinfecting the temporary pacemaker .................................................... 36

6.3 Safety and technical checks ......................................................................... 40

6.4 Service ........................................................................................... 43

6.5 Troubleshooting .................................................................................... 43

6.6 Product life ........................................................................................ 48

7 Specifications .......................................................................................... 48

7.1 Device specifications ............................................................................... 48

7.2 Pacing information tables ............................................................................ 49

3

1 Overview

1.1 About this manual

This manual describes the features and functions of the Medtronic Model 53401 Single Chamber Temporary External Pacemaker
(referred to as the “temporary pacemaker”).

1.2 Symbols

The following table describes symbols that may or may not be present on your product or package labels. The presence of a symbol
in this table is not a statement of compliance.

Explanation of symbols

System meets the applicable Canadian and U.S. electrical safety standards.

Consult instructions for use

Follow instructions for use

Caution

Conformité Européenne (European Conformity)
This symbol means that the device fully complies with applicable European Union Acts.

Temporary external pacemaker

Defibrillation-proof type CF applied part

Do not dispose of this product in the unsorted municipal waste stream. Dispose of this
product according to local regulations. See http://recycling.Medtronic.com for instruc­tions on proper disposal of this product.

For US audiences only

Package contents

Single chamber temporary pacemaker

Product documentation

Accessories

4

Explanation of symbols

Storage temperature limitation

Humidity limitation

Battery

Reorder number

Authorized representative in the European Community

Manufacturer/Date of manufacture

Date of manufacture

Serial number

Non-ionizing electromagnetic radiation

Notice of proper disposal

This product conforms to IP21. There are no openings that allow the user to insert a finger
or similarly sized objects. The product is resistant to dripping water or vertically falling
drops.

MR Unsafe. An item that is known to pose hazards in all MR environments.

1.3 General description

The temporary pacemaker is a battery-powered, single chamber, external pulse generator designed primarily for temporary
antibradycardia pacing therapy in asynchronous or demand (synchronous) modes. High-rate, burst pacing therapy up to 800 ppm for
atrial tachyarrhythmias is available in the asynchronous mode.

The temporary pacemaker is typically connected to temporary transvenous, epicardial, or myocardial pacing leads in a bipolar
configuration, using either Medtronic patient cables, Medtronic surgical cables, or compatible patient cables (see Section 1.7).

The temporary pacemaker operates using 2 LR6-sized (AA-sized) alkaline batteries (see Section 7.1). The batteries are installed in
the battery drawer at the bottom of the temporary pacemaker. The temporary pacemaker is classified as Internally Powered ME
Equipment.

1

1.3.1 Safety features

The temporary pacemaker includes the following safety features:

1

For atrial use only.

5

• Protective cover to prevent accidental manipulation of controls

• Self-test function

• Low battery indicator

• Lock feature to prevent accidental change of parameters

• Power button requires push-and-hold to turn off the temporary pacemaker to avoid unintended shutdown

• Runaway rate protection

• Protection from defibrillation shock

• Continuous operation during battery replacement

• Electrostatic protection

• Minimized susceptibility to electromagnetic and magnetic interference

• Protective cover over Rapid Atrial Pacing (RAP) controls to avoid unintentional use

• Cautionary label at the RAP controls

1.3.2 Operating features

The temporary pacemaker includes the following operating features:

• Three-dial operation – provides adjustable rate, output, and sensitivity settings

• Ability to pace in single chamber pacing modes – AAI, AOO, VVI, and VOO

• Easy-to-view rate, output, and sensitivity settings

• Pacing and sensing status indicators – shows temporary pacemaker interaction with the heart

• Low battery indicator – indicates when to replace the batteries

• Lock/Unlock button – safeguards against unintentional parameter changes

• Constant current device – the current output is maintained at a constant value when the temporary pacemaker emits a pulse. This
value is set by the output control and does not vary.

1.4 Intended use

The Medtronic Model 53401 Single Chamber EPG pacemaker is intended to be used in conjunction with a cardiac pacing lead system
for temporary atrial or ventricular pacing in a clinical environment. The 53401 Single Chamber EPG can be used where short-term
demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylactic, or diagnostic purposes.

Specific indications for temporary cardiac pacing include, but are not limited to, the following indications:

• Complete heart block;

• Sinus bradycardia;

• Sick Sinus Syndrome;

• Bradycardia with congestive heart failure;

• Atrial and/or ventricular arrhythmias;

• Cardiac arrest;

• Temporary support, management, and evaluation of a patient prior to permanent pacemaker implantation;

• Support during permanent pacemaker replacement;

• Cardiac complications during invasive or surgical procedures;

• Temporary support of a patient following cardiac surgery;

• Acute myocardial infarction complicated by heart block; and

• High-rate burst pacing for the treatment of supraventricular tachyarrhythmias

The 53401 Single Chamber EPG can be used to determine sensing potentials of temporary and permanently implanted lead systems.
When implanting a permanent pacemaker, however, Medtronic recommends the use of a Medtronic Pacing System Analyzer.

This device has not been specifically tested for pediatric use.

1.5 Contraindications

There are no known contraindications for the use of temporary pacing as a means to control heart rate. However, the patient’s age and
medical condition may dictate the type of temporary pacemaker and lead system that the physician uses.

1.5.1 Atrial pacing

Atrial pacing is ineffective in the presence of atrial fibrillation or flutter.

Single chamber atrial pacing is contraindicated in the presence of AV conduction disorders.

6

1.5.2 Asynchronous pacing

Asynchronous pacing is contraindicated in the presence of intrinsic cardiac rhythms.

1.5.3 Atrial high-rate burst pacing therapy

Atrial high-rate burst pacing therapy is intended for use in the atrium only. High-rate burst pacing is contraindicated in the ventricle; it
may result in life-threatening arrhythmias.

1.5.4 Concomitant pacing

Temporary pacing is contraindicated in the presence of another pacing system.

Do not use the temporary pacemaker to pace a patient while another pacing system is also actively pacing the patient. Concomitant
pacing can occur where both pacing systems compete to pace the patient.

If concomitant pacing occurs, the temporary pacemaker may not be able to pace the patient, or may pace the patient asynchronously.
Concomitant pacing could cause the temporary pacemaker to potentially pace into a T-Wave or result in a pacemaker-mediated
tachycardia.

1.6 Package contents

The temporary pacemaker is supplied with the following items:

• Two LR6-sized (AA-sized) alkaline batteries (see Section 7.1)

• Literature

• Carrying case

1.7 Compatible accessory components

The following compatible accessory components are available for the temporary pacemaker:

• Medtronic Model 5409 Disposable Pouch

The following reusable compatible cables are available for the temporary pacemaker:

• Medtronic Patient Cables (Model 5433 family)

• Medtronic Surgical Cables (Model 5832 family)

The following disposable compatible cables are available for the temporary pacemaker:

• Medtronic Surgical Cable (Model 5833 family)

• Medtronic Patient Cables (Model 5846 family)

• Medtronic Patient Cables (Model 5487 family)

• Compatible temporary transvenous, epicardial, or myocardial pacing leads

Contact your local Medtronic representative to order compatible accessory components and cables.

1.8 Special notice for the temporary pacemaker

Use of prior Medtronic temporary pacemakers has met with some success in the treatment of certain heart disorders, including heart
block and heart arrhythmias. However Medtronic makes no warranty that the Model 53401 Single Chamber Temporary External
Pacemaker will efficiently restore adequate cardiac function for all patients. For information regarding common causes of pacing
difficulty, consult other portions of the manual.

2 Warnings, precautions, and adverse events

2.1 Warnings

Patient monitoring – Monitor the patient continuously while the temporary pacemaker is in use to ensure it is operating properly and

delivering appropriate therapy to the patient.

Equipment modification – Do not modify the temporary pacemaker. Modifications could impact the temporary pacemaker
effectiveness and adversely affect patient safety.

Temporary pacemaker compatibility – Only connect items that have been specified as part of the temporary pacemaker or that
have been specified as being compatible with the temporary pacemaker.

Temporary pacemaker use – The temporary pacemaker is not suitable for use in the presence of a flammable anesthetic mixture
with air or with oxygen or nitrous oxide.

Defibrillation/cardioversion – The temporary pacemaker is protected from damage caused by internal defibrillation discharges up
to 50 J (watt-seconds) and external defibrillation discharges up to 360 J. However, it is recommended that paddles be placed as far
away from the temporary pacemaker or the lead system as is practical.

7

Whenever possible, for the safety of the patient, disconnect the temporary pacemaker from the implanted lead system before
defibrillating or cardioverting. Excessive defibrillation energy can damage the temporary pacemaker. This can result in a large current
flowing through the implanted lead system and temporary pacemaker, which could reduce intended defibrillation energy delivered to
the patient or cause myocardial damage.

If damage to the temporary pacemaker is suspected due to defibrillation, disconnect it from the patient and return it to Medtronic for
service.

Line-powered equipment – An implanted lead or a lead with an extension cable constitutes a direct, low-resistance current pathway
to the myocardium. Due to the danger of tachyarrhythmias resulting from alternating current leakage, extreme caution must be taken
to properly ground all line-powered equipment used on or in the vicinity of the patient.

Electrosurgical units (cautery) – Electrosurgical units can cause loss of pacing from oversensing or tachyarrhythmias by inducing
current on the leads, and thus should never be used within 15 cm (6 in) of the pacemaker/lead system.

Ablation (RF ablation or microwave ablation) – Ablation is a surgical technique in which radio frequency (RF) or microwave energy
is used to destroy cells by creating heat. Ablation used in cardiac device patients may result in, but is not limited to, induced ventricular
tachyarrhythmias, oversensing, unintended tissue damage, device damage, or device malfunction.

Pulse-modulated ablation systems may pose higher risk for induced ventricular tachyarrhythmias. Medtronic cardiac devices are
designed to withstand exposure to ablation energy. To mitigate risks, observe the following precautions:

• Ensure that temporary pacing and defibrillation equipment is available.

• Avoid direct contact between the ablation catheter and the temporary leads.

• Position the return electrode patch so that the electrical current pathway does not pass through or near the device and leads.

• Continuously monitor the patient during ablation with at least two separate methods, such as arterial pressure display, ECG,
manual monitoring of the patient’s rhythm (taking pulse) or monitor by some other means such as ear or finger pulse oximetry, or
Doppler pulse detection.

To avoid or mitigate the effects of oversensing, if appropriate for the patient, initiate asynchronous pacing.

Electromagnetic interference (EMI) – Pacemakers operating in the demand mode respond to intracardiac potentials with
magnitudes of a few mV. This level of sensitivity makes the temporary pacemaker inherently sensitive to some external fields. In the
presence of excessive levels of interference, the temporary pacemaker may inhibit completely or revert to asynchronous operation,
pacing at the rate set by the RATE dial.

It is recommended that the temporary pacemaker be set to an asynchronous pacing mode at a rate higher than the patient’s intrinsic
rate when operated in the presence of strong electromagnetic interference (EMI).

The following list includes sources of excessively strong EMI that may temporarily affect the operation of the temporary pacemaker:

• Electrosurgical equipment

• Diathermy equipment

• Some medical telemetry equipment (when operated within 1 m [about 3 feet] of the pacemaker)

• Communication transmitters such as cellular phones, “walkie talkies”, and transmitters in emergency transport vehicles

• Magnetic resonance imaging (MRI) equipment

Atrial High-Rate Burst Pacing Therapy (Rapid Atrial Pacing) – Use of high rates in the atrium could result in high-rate conduction
to the ventricle. Defibrillation equipment should be on standby, immediately available during atrial high-rate burst pacing therapy.

There is no ventricular back-up pacing during delivery of atrial high-rate burst pacing therapy.

Connecting the lead system – The patient cables should be connected to the temporary pacemaker before the lead is connected
to the patient cable.

Handling implanted leads – When handling implanted leads (temporary or permanent), the terminal pins or exposed metal must not
be touched nor be allowed to contact electrically conductive or wet surfaces.

MR unsafe – The temporary pacemaker is MR unsafe. Do not bring the temporary pacemaker into Zone 4 (magnet room), as defined
by the American College of Radiology.

2.2 Precautions

Random failures – The physician should be aware that operational failure of the temporary pacemaker can occur as the result of

battery depletion, mishandling, or random component failure.
The following list includes possible operational failures of the temporary pacemaker:

• No output or erratic output

• No sensing or erratic sensing

• False indicator light signals

• Inappropriate variance of rate, output pulse width, or output amplitude

8

• Reversion to asynchronous pacing

• Loss of control of rate, output, sensitivity, or power

If loss of control of rate, output, sensitivity, or power occurs, and it is not due to a low battery, disconnect the temporary pacemaker from
the patient and return it to Medtronic for service.

Temporary pacemaker repair – Do not attempt to repair the temporary pacemaker. Only a qualified Medtronic Technical Services
representative can repair the temporary pacemaker. Contact Medtronic at the telephone number on the back cover of this manual if
the temporary pacemaker requires service.

Service condition – Before each use, evaluate the temporary pacemaker for damage and observable defects. Do not use the
temporary pacemaker if the case is cracked, the controls are not functioning, the display is not working, or if the controls, display, or
connectors are broken. If the temporary pacemaker has any observable defects, contact Medtronic at the telephone number on the
back cover of this manual for service.

Cleaning and disinfection – Clean and disinfect the temporary pacemaker as needed according to your organization’s policies. Use
only the recommended methods to clean and disinfect the temporary pacemaker.

Batteries – Only install the recommended batteries in the temporary pacemaker. Batteries with different physical dimensions,
non-alkaline (e.g., lithium or rechargeable) or batteries with contamination on the battery terminals, may result in erratic operation of
the temporary pacemaker, no pacing output, or damage to the temporary pacemaker, specifically to the battery compartment.

Replace the batteries when the low battery indicator flashes during temporary pacemaker operation.
Only use new batteries that have not passed their expiration date.
Inspect battery terminals for contamination. Using batteries with contaminated terminals can result in the temporary pacemaker

turning off, decreased battery life, or corrosion to the battery compartment.
Check the battery status prior to use and routinely while in use. Replace the batteries when the low battery indicator flashes. Verify that

the battery drawer is fully closed and latched in place.
Failure to ensure that the battery drawer is fully latched may result in loss of power. Continued temporary pacemaker operation is not

an indication that the battery drawer is properly latched.

New battery installation – Ensure that the new batteries are installed with the correct battery polarity by verifying that the batteries
align with the polarity markings on the inside of the battery drawer. The temporary pacemaker requires proper battery polarity for
operation. After installing the batteries, ensure that the battery status indicator displays full battery power and that the low battery
indicator is not flashing. The temporary pacemaker may temporarily continue to pace and sense with weak, dead, or incorrectly
installed batteries.

Pacing leads and cables – Improper connection, displacement, or fracture of leads or cables may result in pacemaker system
failure. Inspect leads and cables for damage before each use.

Pacing system adjustments – Monitor the patient’s ECG and blood pressure. Keep defibrillation equipment on standby,
immediately available for emergency use during evaluation of stimulation and sensing thresholds, pacemaker and pacing lead
connections and adjustments, and atrial high-rate burst pacing therapy.

Default synchronous (demand) pacing mode – The default power-up settings for the synchronous (demand) pacing mode are not
always appropriate for every patient or situation. Set the temporary pacemaker to the appropriate pacing mode to meet the pacing
needs of the patient.

Patient monitoring after defibrillation – Monitor the patient after a defibrillation has occurred to verify that the temporary
pacemaker and the cable/lead systems are still delivering the appropriate therapy.

Bipolar lead systems – Bipolar lead systems are recommended because they are less susceptible to electromagnetic interference.
Separation between the positive (+) electrode and negative (–) electrode of the same lead system should not exceed 15 mm (0.6 in).
Failure to follow this spacing recommendation could result in oversensing. Clinical risks for not following this spacing recommendation
include, but are not limited to, loss of pacing output.

Unipolar lead systems – Unipolar lead systems are not recommended because they are more susceptible to electromagnetic
interference, which may result in inappropriate pacing.

Atrial sensing – When use of the temporary pacemaker requires atrial sensing, the sensing threshold should be evaluated for
sufficient safety margin.

Place the temporary pacing lead on the right atrial free wall, oriented along the direction of the myocardial fibers, approximately 1 cm
(0.4 in) apart. It is important to achieve a sensing threshold of at least 1.0 mV. Set atrial sensitivity to a minimum of one-half the
measured threshold. The setting ensures a minimum safety margin of two times the sensing threshold. Failure to follow this procedure
can lead to delivery of asynchronous pulses.

Sensing thresholds – Do not use the temporary pacemaker to determine sensing thresholds for permanently implanted lead
systems. When implanting a permanent pacemaker, Medtronic recommends the use of a pacing system analyzer (PSA).

Sensitivity settings – Since the sensitivity setting determines the smallest signal that can be sensed by the pacemaker, set the
sensitivity dial to one-half the mV value of the patient’s sensitivity threshold. This setting will provide a 2x safety margin to ensure
proper sensing.

9

A more sensitive setting may be chosen to provide a greater safety margin. However, be aware that setting the sensitivity value too low
(too sensitive) could result in inappropriate sensing of far field signals (for example, sensing of R-waves or T-waves on the atrial
channel or P-waves on the ventricular channel), leading to inappropriate inhibition of pacing pulses.

Sensitivity threshold testing – Complete the sensitivity threshold testing to determine the appropriate settings for sensitivity.
Clinical risks for failure to perform this step include, but are not limited to, asynchronous ventricular pacing.

Output threshold testing – Complete the output threshold testing to determine the appropriate settings for output. Clinical risks for
failure to perform this step include, but are not limited to, loss of capture, induced tachycardia, and loss of hemodynamic support.

Electrostatic discharge (ESD) – The pacing lead(s) provides a low-impedance pathway to the heart. Therefore, it is recommended
that attending health care professionals discharge any static electricity by touching a large metal or conductive, grounded surface
before touching the patient, the cable, the leads, or the temporary pacemaker. Also, neutralize any static electricity from the patient
by touching the patient away from (i.e., distal to) the leads.

Termination of pacing – Abrupt termination of pacing stimuli may result in intervals of asystole before an intrinsic rhythm is
re-established. Before terminating pacing, set the temporary pacemaker to a demand mode (AAI/VVI); then gradually reduce the
pacing rate below the patient’s intrinsic rate.

2.3 Environmental precautions

The temporary pacemaker has been carefully designed and tested to ensure reliability during normal use. However, electronic
devices are susceptible to many environmental stresses. To avoid damage to the temporary pacemaker, observe the following
precautions:

• Do not drop the temporary pacemaker or handle it in a way that might physically damage it. The temporary pacemaker may appear
to work appropriately immediately after being dropped or mishandled, but operational damage may have occurred. Perform safety
and technical checks if the temporary pacemaker has been dropped.

• Secure the temporary pacemaker during use to prevent the temporary pacemaker from falling or being dropped. A fall or drop may
cause dislodgement of the cables and/or leads from the temporary pacemaker or may cause damage to the temporary
pacemaker.

• Do not place the temporary pacemaker in any area where a patient may interact with it. Tampering with programmed parameters
may have direct and serious patient health effects. The temporary pacemaker should be placed in an area that minimizes
tampering with the device by unauthorized personnel (for example, patients or visitors).

• Avoid spilling fluid on the temporary pacemaker. The temporary pacemaker was carefully designed to minimize leakage, but fluid
incursion may still occur. Medtronic recommends the use of a protective cover, such as the Model 5409 Disposable Pouch, to
minimize fluid incursion and exposure to contamination.

• Avoid contaminating the patient cable receptacles with blood or other body fluids.

• Always use safe electrostatic discharge (ESD) procedures; the temporary pacemaker could be adversely affected by ESD.

• Do not open the temporary pacemaker. The seam joining the unit is designed to minimize fluid incursion and may not be effective
if improperly opened and resealed. Furthermore, removing the label on the back of the temporary pacemaker may compromise
the ESD barrier. Opening the temporary pacemaker voids the warranty.

• Do not sterilize the temporary pacemaker by ethylene oxide, gamma irradiation, or steam (autoclave).The temporary pacemaker
is not intended to be sterilized.

• Do not store the temporary pacemaker for long periods of time with the batteries in the battery drawer. Remove the batteries for
long-term storage to prevent damage to the temporary pacemaker in the event of battery leakage.

• Rapid temperature changes may affect proper operation. Always allow the temperature of the temporary pacemaker to stabilize
in the environment in which it will be used before attachment and operation.

• Prolonged storage or operation of the temporary pacemaker in high humidity may affect proper operation. Allow the temporary
pacemaker to dry after exposure to humidity.

• Use only the recommended cleaners and disinfectants on the temporary pacemaker. Use of other cleaners and disinfectants may
cause damage to the temporary pacemaker.

Other environmental factors may impact proper performance of the temporary pacemaker in the hospital setting. Use of appropriate
environmental health and safety practices will help prevent environmental damage to the temporary pacemaker.

2.4 Adverse effects

Atrial high-rate burst pacing – Atrial high-rate burst pacing may result in the onset of tachycardia, acceleration of an existing

tachycardia, or fibrillation. Application of temporary atrial high-rate burst pacing should be performed in a carefully monitored and
controlled patient environment. Monitor the patient’s ECG and blood pressure. Keep defibrillation equipment on standby and
immediately available for emergency use.

Lead systems – Potential adverse effects related to the use of pacing lead systems used in conjunction with the temporary
pacemaker include, but are not limited to, the following events:

10

• Inappropriate lead connections

• Inadvertent disconnection of the lead system

• Lead fracture or displacement causing intermittent or complete loss of capture and/or sensing

• Perforation and tamponade

Other potential adverse effects related to the use of any implanted lead system include, but are not limited to, the following events:

• Myocardial irritability resulting in fibrillation

• Infarction

• Pericarditis

• Body rejection phenomena (local tissue reaction)

• Muscle and nerve stimulation

• Infection

Nerve or muscle stimulation – Nerve or muscle stimulation can be caused by pacing lead contact with the nerve or muscle tissue
and/or by high-output settings. The stimulation may be controlled by repositioning or replacing the electrode, or by reducing the output
pulse amplitude.

Safety margins – Determine an adequate safety margin for sensing and pacing in both the ventricle and atrium. Failure to do so may
result in inappropriate pacing.

Temporary pacemakers – Potential adverse effects related to the use of the temporary pacemaker include, but are not limited to, the
following events:

• Asystole following abrupt cessation of pacing

• Inhibition or reversion in the presence of strong electromagnetic interference

• Initiation of a tachyarrhythmia or acceleration of an existing tachyarrhythmia

3 Controls, indicators, and other features

3.1 Temporary pacemaker controls and indicators

The screen indicators display the RATE, OUTPUT, and SENSITIVITY values, pacing and sensing status, Rapid Atrial Pacing (RAP)
use, the battery status, and the lock status. See Figure 1.

The controls next to the screen are used to do the following actions:

• Adjust the RATE, OUTPUT, and SENSITIVITY values using the RATE, OUTPUT, and SENSITIVITY dials

• Turn on or turn off the temporary pacemaker by pressing the On/Off button

• Lock or unlock the temporary pacemaker by pressing the Lock button

11

Figure 1. Controls and indicators

min

-1

mA

mV

0.4 mV

PACE SENSE

RATE

OUTPUT

SENSE

Async

HOLD TO
DELIVER

ENABLE

DISABLE

ATRIAL USE ONLY

RAPID ATRIAL PACING

1 Screen
2 Pacing and sensing status indicator LEDs
3 RAP indicator LED
4 ASYNC indicator LED
5 Battery status indicator
6 On/Off button

Note: Screen values contained in this manual are presented for reference only. Actual values may vary, depending parameter value
selections.

7 Lock indicator
8 RATE dial

9 OUTPUT dial
10 SENSITIVITY dial
11 Lock/Unlock button

3.2 Controls

The dials and buttons used to control the functions and parameter settings of the temporary pacemaker are described in this section.

Notes:

• All adjustments to the RATE, OUTPUT, and SENSITIVITY dials take effect within the next two pacing cycles.

• The RATE, OUTPUT, and SENSITIVITY values are displayed numerically. The numerical value for each setting appears to the
left of the dial.

3.2.1 On/Off button

Use the On/Off button to turn on or turn off the temporary pacemaker (see Figure 2).

12

Figure 2. On/Off button

ppm

PACE SENSE

RATE

mA

OUTPUT

3.2.2 Rate dial

Use the RATE dial to set the base rate, in ppm, at which pacing pulses are delivered (see Section 5.1.4).

The RATE ranges from 30 to 200 ppm. Turn the RATE dial clockwise to increase RATE and counterclockwise to decrease RATE.

When the temporary pacemaker is turned on, the RATE is set to 80 ppm (nominal). See Section 7.1 for more information about the

RATE range and increments.

Figure 3. RATE value and dial

3.2.3 OUTPUT dial

The OUTPUT dial is used to set the current amplitude, in mA, of the pacing pulse (see Section 5.1.4).

The output ranges from 0.1 to 25 mA. Turn the OUTPUT dial clockwise to increase OUTPUT, or counterclockwise to decrease or turn
off OUTPUT.

When the temporary pacemaker is turned on, OUTPUT is set to10 mA (nominal). See Section 7.1 for more information about the

OUTPUT range and increments.

Figure 4. OUTPUT value and dial

3.2.4 SENSITIVITY dial

The SENSITIVITY dial is used to enable and adjust the sensitivity, in mV, of the sensing circuitry (see Section 5.1.4).

The sensitivity ranges from 0.1 to 20 mV. When the sensitivity is set above 20 mV by turning the dial fully clockwise to the ASYNC
position, the temporary pacemaker switches to asynchronous mode. To decrease SENSITIVITY, turn the dial clockwise (the mV value
increases). To increase SENSITIVITY, turn the dial counterclockwise (the mV value decreases).

When the temporary pacemaker is turned on, SENSITIVITY is set to 2 mV (nominal). See Section 7.1 for more information about the
SENSITIVITY range and increments.

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Figure 5. SENSITIVITY value and dial

mV

SENSE

0.4 mV

Async

3.2.5 Lock/Unlock button

The Lock/Unlock button locks the temporary pacemaker to prevent inadvertent adjustment of the pacing parameters, or unlocks the
temporary pacemaker when it is locked. See Figure 6.

Figure 6. Lock/Unlock button

3.2.6 Rapid atrial pacing controls

The rapid atrial pacing controls activate and deliver rapid atrial pacing (RAP) therapy. The controls are located under the RAP cover.
The ENABLE/DISABLE button activates or deactivates RAP, and the HOLD TO DELIVER button delivers RAP therapy. See Figure 7.

Figure 7. RAP controls

3.3 Indicators

The screen displays indicators for pacing and sensing status, Rapid Atrial Pacing (RAP) status, battery power, and lock status. See
Figure 8.

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Figure 8. Indicators

ppm

mA

mV

0.4 mV

R

A

P

I

D

A

T

R

I

A

L

P

A

C

I

N

G

RATE

OUTPUT

SENSE

Async

SENSEPACE

HOLD TO
DELIVER

ENABLE
DISABLE

ATRIAL USE ONLY

1 Pacing and sensing status indicator LEDs
2 RAP indicator LED

4 Battery status indicator
5 Lock indicator

3 ASYNC indicator LED

3.3.1 Pacing and sensing indicators

The PACE and SENSE LEDs indicate delivery of a pacing pulse or a sensed event. The following LED actions occur in response to
pacing or sensing events:

• The green PACE LED in the upper left corner of the screen flashes each time the temporary pacemaker delivers a pacing pulse.
Note: The green PACE LED flashes indicate delivery of a pacing pulse, but they are not confirmation that the pacing pulse has

delivered cardiac stimulation.

• The blue SENSE LED in the upper right corner of the screen flashes when events are sensed.
Note: The blue SENSE LEDs indicate a sensed event by the temporary pacemaker, but they are not confirmation of a cardiac

contraction.

15

Figure 9. Pacing and sensing indicators

ppm

R

A

P

I

D

A

T

R

I

A

L

P

A

C

I

N

G

SENSE

PACE

RATE

RATE

SENSEPACE

HOLD TO
DELIVER

ENABLE

DISABLE

ATRIAL USE ONLY

ppm

R

A

P

I

D

A

T

R

I

A

L

P

A

C

I

N

G

RATE

SENSEPACE

HOLD TO
DELIVER

ENABLE

DISABLE

ATRIAL USE ONLY

1 PACE indicator LED
2 SENSE indicator LED

3.3.2 Rapid Atrial Pacing (RAP) indicator

The Rapid Atrial Pacing (RAP) LED indicates delivery of rapid atrial pacing. The LED flashes when the temporary pacemaker is
delivering RAP therapy.

Figure 10. RAP indicator

1 RAP indicator LED

3.3.3 Status indicators

The status indicators, at the bottom of the screen, display the battery status and lock indicators (see Figure 11).

16

Figure 11. Status indicators

mV

0.4 mV Async

SENSE

mV

0.4 mV Async

1 Battery status indicator
2 Lock indicator

Battery status indicator – The battery status indicator displays the amount of available battery power remaining. When all of the
indicator bars are visible, the batteries have full power or have been replaced with a new set of batteries.

The low battery indicator, a red light, flashes behind the battery status indicator when only one bar is visible. When the low battery
indicator begins flashing, the temporary pacemaker has 24 hours of battery life remaining.

If the batteries are removed, no bars are visible in the battery status indicator and the battery indicator light flashes. The temporary
pacemaker continues to pace and sense and the battery indicator light continues to flash until insufficient power is available (see
Section 4.3). When new batteries are properly installed, bars will appear in the battery status indicator and the battery indicator light
will no longer flash.

After the batteries are depleted, the temporary pacemaker shuts down.

Note: When the low battery indicator first appears, the temporary pacemaker maintains pacing for a minimum of 24 hours if the
settings are at nominal values (see Section 7.1). The user should replace the batteries as soon as it is possible to do so safely.

Lock indicator – The Lock indicator appears when the temporary pacemaker is locked.
If any of the dials are turned or buttons are pressed while the temporary pacemaker is locked, the Lock indicator flashes in the lower

right corner of the screen. When the temporary pacemaker is locked, the RATE, OUTPUT, and SENSITIVITY settings or pacing
parameters cannot be adjusted until the temporary pacemaker is unlocked. See Section 5.1.2.

3.4 Physical features

3.4.1 Batteries

Battery drawer – The battery drawer, on the bottom of the temporary pacemaker, accepts two LR6-sized (AA-sized) alkaline

batteries.

Battery life – The battery life is 7 days minimum with continuous operation for new alkaline batteries when the RATE is set at 80 ppm
and all other parameters are at nominal values (see Section 7.1).

Note: The low battery status indicator flashes when the battery status displays 1 bar. When the low battery indicator begins flashing,
the temporary pacemaker has 24 hours of battery life remaining when operated at nominal values (see Section 7.1).

Battery drawer latch release buttons – The battery drawer has two latch release buttons on either side of the temporary
pacemaker. Both buttons must be simultaneously pressed to open the battery drawer.

Continued operation after the batteries are removed – If the batteries are removed, the temporary pacemaker continues to
operate for a minimum of 30 s (see Section 7.1) under the following conditions: RATE of 80 ppm or less and OUTPUT of 10 mA or less
with the backlight off. If the batteries are removed, they should be replaced with new batteries within 30 s to ensure continued device
operation.

Note: The temporary pacemaker may shut down immediately, depending upon the battery level, if the batteries are removed while it
is turned on.

17

3.4.2 Connector block

The connector block, at the top end of the temporary pacemaker, has a single socket that accepts patient and/or surgical cables (see
Figure 12).

Figure 12. Temporary pacemaker connector block

3.4.3 IV pole hanger

The Medtronic Model 53407 IV pole hanger is attached to the back of the temporary pacemaker and is used to hang the temporary
pacemaker on an IV pole (see Figure 13). Fold the IV pole hanger flat against the back of the temporary pacemaker when it is not in
use.

Figure 13. IV pole hanger

1 IV pole hanger

Note: If the Medtronic Model 53407 IV pole hanger requires replacement, contact your Medtronic sales or service representative.

3.4.4 Protective covers

Protective cover – The temporary pacemaker controls and screen are covered by the Medtronic Model 53408 clear protective cover

(see Figure 14). The protective cover is removable and replaceable.

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Figure 14. Protective cover

1 Temporary pacemaker with protective cover on and closed
2 Opening protective cover

To remove the protective cover, open the cover and place the thumb and forefinger at the hinge (see Figure 15). Push the hinge up and
away from the temporary pacemaker.

19

Figure 15. Removing protective cover

To replace the protective cover, align the hinges of the cover with the temporary pacemaker with the cover in the closed position. Press
down on both hinges simultaneously as illustrated in Figure 16.

20

Figure 16. Replacing protective cover

RAP cover – The RAP controls are located underneath a flip-up RAP cover located at the top of the temporary pacemaker underneath

the protective cover (see Figure 17). The RAP cover is removable and replaceable. To remove the RAP cover, open the cover and use
the thumb to squeeze one hinge toward the other hinge. While squeezing, move the cover out and away from the temporary
pacemaker. To replace the RAP cover, reverse this motion by engaging the hinge at one corner while squeezing the cover and aligning
the other hinge before releasing.

Figure 17. RAP cover

1 Temporary pacemaker with RAP cover on and closed
2 Opening RAP cover

Note: If the Medtronic Model 53408 protective cover or RAP cover require replacement, contact your Medtronic sales or service
representative.

3 Removing RAP cover

4 Preparation for use

4.1 Training

4.1.1 Training prior to use

Train clinical personnel on the functionality and use of the temporary pacemaker prior to initial use of the device, as needed, and per
clinic procedures. Contact your Medtronic representative to schedule training.

21

4.2 Checks prior to use

4.2.1 Cleaning and disinfection

During normal use, the temporary pacemaker and cables can be contaminated. Verify that the temporary pacemaker is cleaned
according to your organization’s policies. See Section 6.2 for instructions on cleaning and disinfecting the temporary pacemaker.

Verify that the reusable cables are cleaned and sterilized according to your organization’s policy.

Note: For information about cleaning and sterilizing the reusable cables, refer to the applicable technical manual.

Caution: Clean and disinfect the temporary pacemaker as needed according to your organization’s policies. Clean and sterilize the

reusable cables as needed according to your organization’s policies.

4.2.2 Service condition

Check the temporary pacemaker and reusable cables before each use for a new patient to verify that there are no observable defects.
Do not use the temporary pacemaker or the reusable cables if there are any observable defects. Verify that the temporary pacemaker
controls function and that the battery drawer closes.

Visually inspect the reusable cables and connectors. Do not use the reusable cables if they are damaged. Damage includes, but is
not limited to, deterioration of the cable insulation, brittleness, cracking, thinning, or bare spots. Do not use the reusable cables if the
conductive wires are exposed.

Caution: Before each use, evaluate the temporary pacemaker for damage and observable defects. Do not use the temporary
pacemaker if the case is cracked, the controls are not functioning, the displays are not working, or if the controls, displays, or
connectors are broken. If the temporary pacemaker has any observable defects, contact Medtronic at the telephone number on the
back cover of this manual for service.

4.2.3 Battery status

Check battery status prior to use. The battery status indicator displays the amount of available battery power remaining (see
Section 3.3.3). Continue to check the battery status while in use according to your organization’s policy. More frequent checks are
recommended as less remaining power is displayed by the battery status indicator. Replace the batteries when the low battery
indicator flashes.

Note: The specified battery life of 7 days minimum with continuous operation at nominal settings only applies when using new alkaline
batteries. Continued use of partially depleted batteries that do not provide a full battery indication will result in early low battery
indication. When the low battery indicator begins flashing, the temporary pacemaker maintains pacing for a minimum of 24 hours if
the settings were at nominal values (see Section 7.1).

4.3 Batteries

The temporary pacemaker uses two LR6–sized (AA–sized) alkaline batteries for operation (for example, Duracell MN1500 or
Eveready E91 batteries).

Warning: Properly ground all line-powered equipment used on the patient or in the vicinity of the patient (see Section 2.1).

Battery removal for long term storage – Remove the batteries when the temporary pacemaker is stored for long periods of time.

Cautions:

• Only install the recommended batteries in the temporary pacemaker. Batteries with different physical dimensions, non-alkaline
(e.g., lithium or rechargeable) or batteries with contamination on the battery terminals, may result in erratic operation of the
temporary pacemaker, no pacing output, or damage to the temporary pacemaker, specifically to the battery compartment.

• Inspect battery terminals for contamination. Using batteries with contaminated terminals can result in the temporary pacemaker
turning off, decreased battery life, or corrosion to the battery compartment.

• Check the battery status regularly while the temporary pacemaker is in use. When new batteries are installed, the low battery
indicator should turn off. If it persists, ensure that the battery door was fully closed and the inserted batteries were new.

4.3.1 Battery installation and replacement recommendations

Check the battery status prior to use. Replace the batteries when the low battery indicator flashes during temporary pacemaker
operation (see Section 3.3.3).

Comply with the following instructions when installing batteries in the temporary pacemaker:

• Install only the recommended batteries. Using non-recommended batteries may result in less than 24 hours of battery life after the
low battery indicator illuminates, degraded pacemaker performance, and/or overall reduced battery life.

• Install two new LR6-sized (AA-sized) alkaline batteries.

• Install the batteries with proper polarity. The temporary pacemaker does not turn on or provide pacing therapy with incorrect
battery polarity.

22

Caution: Medtronic does not recommend replacing the batteries while the temporary pacemaker is turned on or actively pacing the
patient. However, if during an emergency situation the batteries must be replaced while the temporary pacemaker is in use, ensure
that the temporary pacemaker is locked before replacing the batteries with new batteries. When the battery drawer is opened, the
temporary pacemaker will temporarily disable all knobs and buttons and the user will be unable to change the device’s current
settings. Pacing is maintained at the current settings for a minimum of 30 s if the settings are at nominal values (see Section 7.1).

4.3.2 Battery polarity

The temporary pacemaker requires proper battery polarity for operation. Ensure that the batteries align with the polarity markings on
the inside of the battery drawer.

The temporary pacemaker does not turn on when batteries are installed with incorrect polarity. If the batteries are replaced while the
temporary pacemaker is turned on and the battery polarity is incorrect, the temporary pacemaker continues to pace and sense until
insufficient power is available. The low battery indicator continues to flash, and pacing is maintained at the current settings for a
minimum of 30 s with the settings at nominal values. When internal reserve power is depleted, the temporary pacemaker shuts down.

The following events occur when the new batteries are installed with proper polarity in the temporary pacemaker:

• The low battery indicator stops flashing.

• The battery status indicator displays full battery power.

The following events occur when the batteries are installed with incorrect polarity:

• If the temporary pacemaker is turned off, it does not turn on.

• If the temporary pacemaker is turned on, the low battery indicator continues to flash. The temporary pacemaker continues to pace
and sense until internal reserve power is depleted. When internal reserve power is depleted, the temporary pacemaker shuts
down.

4.4 Battery installation and replacement

Perform the following actions to install (or replace) the batteries:

1. Press the battery drawer latch release buttons until the battery drawer opens (see Figure 18).
Caution: Avoid contaminating areas that are difficult to clean on the temporary pacemaker. Keep hands and gloves free of blood

and body fluids when opening and closing the battery drawer and installing or replacing the batteries. Figure 18. Battery drawer latch release buttons

2. Remove the old batteries.

3. Install two new LR6-sized (AA-sized) alkaline batteries. Verify that the batteries align with the polarity markings on the inside of
the battery drawer (see Figure 19).

23

Figure 19. Installing the batteries with proper polarity

Caution: Ensure that the new batteries are installed with the correct battery polarity by verifying that the batteries align with the

polarity markings on the inside of the battery drawer. The temporary pacemaker requires proper battery polarity for operation.
After installing the batteries, ensure that the battery status indicator displays full battery power and that the low battery indicator
is not flashing. The temporary pacemaker may temporarily continue to pace and sense with weak, dead, or incorrectly installed
batteries.

4. Close the battery drawer firmly until the battery drawer is fully latched.
Note: Failure to close the battery drawer completely can result in the battery drawer opening and the temporary pacemaker

shutting down.

5. Discard the old batteries properly according to local regulations.

4.5 Connector Setup

4.5.1 Using cables with the temporary pacemaker

The temporary pacemaker is compatible with both reusable and disposable cables, which deliver the pacing therapy. Refer to
Section 1.7 for a list of compatible cables. Comply with the following instructions before connecting the cable to the temporary
pacemaker:

• Reusable cables are supplied non-sterile. Clean and sterilize reusable cables as needed according to your organization’s
policies. Refer to the applicable technical manual for cleaning, disinfecting, and sterilizing instructions.

• Carefully inspect the reusable cable for visible signs of wear or damage before connecting it to the temporary pacemaker. Do not
use the reusable cable if it appears damaged. Damage includes, but is not limited to, deterioration of the cable insulation,
brittleness, cracking, thinning, or bare spots. Do not use the reusable cable if the conductive wires are exposed.

• Do not connect the temporary pacemaker to the lead system if it is turned on and is operating at an output amplitude that could
cause capture.

Warnings:

• Before connecting the cable to the temporary pacemaker, verify that it is turned off.

• Connect the cable to the temporary pacemaker before connecting the lead to the cable.

• To prevent pacing into the vulnerable period of the T-wave, turn on the temporary pacemaker and turn down OUTPUT to the
minimum amplitude before connecting the temporary pacemaker to the patient’s lead system. Determine sensing thresholds
before turning up OUTPUT to threshold levels.

Cautions:

• When mechanical support is necessary, hang the temporary pacemaker by the IV pole hanger from an IV pole. Do not hang the
temporary pacemaker to an IV pole by the cable.

• Avoid contaminating areas that are difficult to clean on the temporary pacemaker. Keep hands and gloves free of blood and body
fluids when connecting or disconnecting the patient cable, surgical cable, and/or pacing lead to the temporary pacemaker.

• Monitor the patient’s ECG and blood pressure and keep defibrillation equipment on standby, immediately available for emergency
use during pacing lead insertion and pacemaker connection.

4.5.2 Connecting the cable to the temporary pacemaker

Perform the following actions to connect the cable to the temporary pacemaker:

24

1. Verify that the temporary pacemaker is turned off.

2. Plug the patient cable or surgical cable into the socket on the connector block on top of the temporary pacemaker. Connect the
leads to the cable. Match positive (+) and negative (–) leads to positive (+) and negative (–) sockets or clips for the atrium and
ventricle (not shown).

3. Verify that the cable clicks when it is inserted into the temporary pacemaker connector receptacle (see Figure 20).

Note: The audible click verifies that the plug is completely inserted into the receptacle. Figure 20. Connecting the cable to the temporary pacemaker

4. To ensure a good connection, pull gently on the cable after insertion.

Refer to the applicable patient cable or surgical cable technical manual for more information.

4.5.3 Connecting the pacing lead system to the patient cable

Caution: Unipolar lead systems are not recommended because they are more susceptible to electromagnetic interference, which

may result in inappropriate pacing.

Perform the following actions to connect the pacing lead system to the patient cable:

1. Loosen the patient cable connector knob by twisting the knob counterclockwise until resistance is felt.

2. Insert the lead connector pins into the patient cable receptacle as shown (see Figure 21).

3. Rotate the patient cable connector knob clockwise until finger tight.

4. Gently pull on the lead conductor to verify secure connection.

25

Figure 21. Connecting the pacing lead system to the patient cable receptacle

Refer to the applicable patient cable technical manual for more information.

Bipolar systems – For bipolar systems, insert each connector pin into the appropriate receptacle (marked + and –). Bipolar lead
systems may exhibit different threshold values depending on the polarity of the lead connections.

Refer to the applicable patient cable technical manual for more information.

Unipolar systems (1-lead systems) – Perform the following actions to connect single chamber unipolar lead systems to the
temporary pacemaker:

1. Insert the cardiac lead connector pin into the negative (–) receptacle of the cable.

2. Insert the connector pin of the “indifferent” electrode (or “ground”) into the positive (+) receptacle of the cable.

Refer to the applicable patient cable technical manual for more information.

4.5.4 Disconnecting the cable from the temporary pacemaker

Perform the following actions to disconnect the cable from the temporary pacemaker:

1. Set the controls of the temporary pacemaker to allow the patient’s intrinsic rhythm to take over pacing. See Section 5.1.3.

2. Press the connector release button on the cable plug (see Figure 22).

3. Gently pull the plug from the receptacle.

26

Figure 22. Disconnecting the cable from the temporary pacemaker

Refer to the applicable patient cable or surgical cable technical manual for more information.

4.6 Placement during use

When the temporary pacemaker is in use, place it in an area that reduces potential unauthorized access from patient interaction or
tampering by non-medical personnel.

Do one or more of the following actions to reduce potential unauthorized access to the temporary pacemaker when it is in use:

• Verify that the temporary pacemaker is directly observable by medical staff.

• Hang the temporary pacemaker by either the IV pole hanger or the attachment panel of the disposable pouch to an IV pole.

Caution: Tampering with programmed parameters may have direct and serious patient health effects.

5 Instructions for use

5.1 Basic operation

5.1.1 Turning on or turning off the temporary pacemaker

Turning on the temporary pacemaker – To turn on the temporary pacemaker, press and hold the On/Off button (Figure 23)

momentarily.

Figure 23. On/off button

The following actions occur when the temporary pacemaker is turned on:

• The screen and the backlight illuminate.
Note: If the batteries are nearing depletion, a red backlight begins flashing behind the battery status indicator, indicating that the

batteries have approximately 24 hours of battery life. If the batteries are depleted, the LEDs may flash momentarily when the
On/Off button is pressed, but the temporary pacemaker does not operate.

• A self-test is initiated (see Section 6.5.1).

• When the self-test completes successfully, the temporary pacemaker first searches for cardiac activity (during the first pacing
cycle), and then begins sensing and pacing (AAI/VVI pacing mode).

27

Notes:

• If the temporary pacemaker fails the self-test, it remains on but does not pace, and the LEDs will remain illuminated until the

user re-starts the device.

• See Section 7.1 for nominal values when the temporary pacemaker is turned on.

Warning: To prevent pacing into the vulnerable period of the T-wave, turn on the temporary pacemaker and turn down OUTPUT to the
minimum amplitude. Determine sensing thresholds before turning up OUTPUT to threshold levels.

Turning off the temporary pacemaker – Perform the following actions to turn off the temporary pacemaker:

1. Unlock the temporary pacemaker if it is locked (see Section 5.1.2).

2. Press and hold the On/Off button for two seconds.
Note: If the On/Off button is not held for two seconds, the temporary pacemaker remains on and continues to pace at the currently

selected values.

5.1.2 Lock/Unlock

The Lock/Unlock button locks the temporary pacemaker to prevent inadvertent adjustment of the parameters, or unlocks the
temporary pacemaker when it is locked (see Section 3.2.5).

The temporary pacemaker locks when one of the following events occurs:

• 60 s elapses after the last parameter adjustment is made
Note: When RAP is enabled, the temporary pacemaker will lock after 300 s have elapsed

• The Lock/Unlock button is pressed

When the temporary pacemaker locks, the following changes occur:

• The RATE, OUTPUT, and SENSITIVITY parameter values lock and cannot be adjusted.

• Pacing therapy continues to be delivered at the currently selected values.

• The Lock indicator appears in the lower right corner of the screen.

• The On/Off button and RAP buttons lock and will not function

Notes:

• If any parameter dials are adjusted or any buttons are pressed while the temporary pacemaker is locked, the Lock indicator
flashes.

Press the Lock/Unlock button to unlock the temporary pacemaker if it is locked.

When the temporary pacemaker unlocks, the following changes occur:

• The Lock indicator disappears.

• Pacing therapy continues to be delivered at the currently selected values.

• The RATE, OUTPUT, and SENSITIVITY pacing parameters unlock and can be adjusted.

• The On/Off button and RAP buttons unlock and will function

5.1.3 Viewing the patient’s intrinsic rhythm

To view the patient’s intrinsic rhythm, Reduce the RATE gradually, while watching the ECG, until the patient’s intrinsic rhythm takes
over and the temporary pacemaker is no longer pacing.

5.1.4 RATE, OUTPUT, and SENSITIVITY adjustments

Use the dials next to the screen to adjust the pacing rate, output, and sensitivity. The screen displays a numerical value that reflects
the current setting for each dial. See Figure 24.

Caution: Avoid contaminating areas that are difficult to clean on the temporary pacemaker. Keep hands and gloves free of blood and
body fluids when touching and/or turning the RATE, OUTPUT, and SENSITIVITY dials.

28

Figure 24. RATE, OUTPUT, and SENSITIVITY

ppm

mA

mV

RATE

OUTPUT

SENSE

0.4 mV

Async

ppm

mA

mV

PACE SENSE

RATE

OUTPUT

ASYNC

0.4 mV

Async

To adjust RATE, OUTPUT, and SENSITIVITY, turn the RATE, OUTPUT, and SENSITIVITY dials clockwise to increase their values;
turn the dials counterclockwise to decrease their values.

See Section 7.1 for RATE, OUTPUT, and SENSITIVITY ranges.

5.1.5 Determining the pacing mode

The pacing mode is determined by the chamber in which the lead is placed and by the SENSITIVITY setting. The temporary
pacemaker can be set to several single chamber pacing modes (AOO, VOO, AAI, VVI).

The sensitivity setting determines whether the pacemaker is in a synchronous (demand) or asynchronous mode. The pacing mode
can be set by adjusting the SENSITIVITY. To increase SENSITIVITY, turn the dial counterclockwise (the mV value decreases). To
decrease SENSITIVITY, turn the dial clockwise (the mV value increases). Changes to SENSITIVITY take effect within the next two
pacing cycles.

To turn off SENSITIVITY and allow the temporary pacemaker to pace asynchronously, turn the SENSITIVITY dial clockwise until the
screen displays the term ASYNC (see Figure 25).

Figure 25. Adjusting SENSITIVITY to ASYNC mode

The pacing information tables (see Section 7.2) provide a quick reference for selecting a pacing mode.

5.1.6 Synchronous (demand) pacing

During synchronous (demand) pacing, output is inhibited when the pacemaker senses intrinsic activity to minimize competition
between the paced rhythm and the intrinsic activity of the heart.

Note: Determine sensitivity and stimulation thresholds (see Section 5.2); otherwise asynchronous pacing and/or loss of heart capture
may occur.

29

Synchronous pacing occurs as the default pacing mode when the device is powered on and provides pacing in either the AAI or the

200 ms

VVI pacing mode.

The AAI pacing mode provides synchronous pacing in the atrium. Pacing and sensing occur only in the atrium during the AAI pacing
mode. No pacing or sensing occurs in the ventricle.

The VVI pacing mode provides synchronous pacing in the ventricle. Pacing and sensing occur only in the ventricle during the VVI
pacing mode. No pacing or sensing occurs in the atrium.

To pace using a synchronous mode, adjust the SENSITIVITY dial to a setting (between 0.4 and 20 mV ) that is one-half the mV value
of the patient’s sensitivity threshold (see Section 5.2.2).

5.1.7 Asynchronous pacing

Patients best suited for asynchronous (non-sensing) modes have one of the following issues:

• An intrinsic rate consistently below the pacing rate.

• No intrinsic activity.

Caution: Because it may compete with the intrinsic activity of the heart, asynchronous pacing may result in tachyarrhythmia. Use
caution when setting the device to asynchronous modes.

Asynchronous pacing occurs when SENSITIVITY is decreased (the mV value is increased) to the point where the temporary
pacemaker is no longer sensing and provides pacing in either the AOO or VOO pacing mode. During asynchronous pacing modes,
adjust OUTPUT to provide an adequate safety margin (see Section 5.2.1).

The AOO pacing mode provides asynchronous pacing in the atrium. Pacing occurs only in the atrium and no sensing occurs during
the AOO pacing mode. No pacing occurs in the ventricle.

The VOO pacing mode provides asynchronous pacing in the ventricle. Pacing occurs only in the ventricle and no sensing occurs
during the VOO pacing mode. No pacing occurs in the atrium.

To pace using an asynchronous mode, turn the SENSITIVITY dial fully clockwise to the ASYNC position and adjust OUTPUT to
provide an adequate safety margin (see Section 5.2.1).

Note: Determine the patient’s stimulation threshold; otherwise loss of heart capture may occur (see Section 6.5.4).

Terminating asynchronous pacing – To terminate asynchronous pacing and to return to synchronous (demand) pacing, adjust
SENSITIVITY by turning the dial counterclockwise and selecting an appropriate SENSITIVITY value. The ASYNC LED will no longer

be illuminated when the device has exited asynchronous pacing mode.

5.2 Thresholds

Threshold values are needed to determine the appropriate settings for output and sensitivity. Procedures for finding atrial and
ventricular sensing and stimulation thresholds are described in this section.

Note: To reduce the risk of competitive pacing, determine the sensing thresholds first, if the patient’s intrinsic rhythm is adequate.

5.2.1 Sensing definitions

The ECG in Figure 26 shows the intrinsic beats mixed with paced beats. The temporary pacemaker detects the heart’s own beat and
does not deliver a pacing stimulus. When undersensing occurs, the temporary pacemaker does not detect intrinsic activity and thus
paces on or between beats.

Figure 26. Sensing

Sensing threshold – The sensing threshold is the least sensitive mV setting at which the temporary pacemaker can detect a

heartbeat. Monitor the patient’s ECG and blood pressure as you follow the procedure below to determine the sensing thresholds.

Sensing threshold safety margin – Lead maturation and drug therapy can affect the sensing threshold. To ensure sensing and
accommodate a changing threshold, it is important to provide at least a 2:1 safety margin. Set SENSITIVITY to values that are at least
one-half to one-third of the sensing threshold values. For example, an appropriate setting for a patient with a 5.0 mV sensing threshold
is 2.5 mV or less.

30

Caution: Avoid selecting a pacing mode that requires sensing if adequate sensing margins cannot be established. A 2:1 safety

ppm

mA

mV

0.4 mV

OUTPUT

SENSE

RATE

PACE SENSE

Async

margin cannot always be achieved due to a low sensing amplitude and/or a high pacing amplitude. If a 2:1 safety margin cannot be
achieved, increase monitoring of the patient to verify that the expected therapy is being delivered.

5.2.2 Determining atrial or ventricular sensing thresholds

Caution: Pacing-dependent patients have limited or no intrinsic rate or rhythm. Only use this procedure on patients with adequate

intrinsic rhythm.

To determine atrial or ventricular sensing threshold, perform the following steps:

1. Turn on the temporary pacemaker without connecting it to the patient lead system.
Caution: Do not connect the temporary pacemaker to the patient lead system until step 4.

2. Set RATE to at least 10 ppm under the patient’s intrinsic rate (see Figure 27).

3. Adjust the output to prevent the risk of competitive pacing (see Figure 27), by setting OUTPUT to 0.1 mA.

4. Connect the temporary pacemaker to the patient lead system. If necessary, reduce RATE until the temporary pacemaker is not
pacing the patient.

5. Decrease SENSITIVITY: Slowly turn the dial clockwise (increase mV value) until the SENSE indicator stops flashing (see
Figure 27).

Figure 27. Decrease RATE , OUTPUT, and SENSITIVITY

The PACE indicator flashes continuously, but capture is not likely because the OUTPUT value is set to minimum.

6. Increase SENSITIVITY: Slowly turn the dial counterclockwise (decrease mV value) until the SENSE indicator starts flashing (see
Figure 28). The following events occur:

• The PACE indicator stops flashing.

• This value is the sensing threshold.

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Figure 28. Increase sensitivity

mV

SENSE

0.4 mV

Async

200 ms

7. Set SENSITIVITY to half (or less) the threshold value. This setting provides at least a 2:1 safety margin.

8. Restore RATE and OUTPUT to previous values.

Note: Determine the atrial or ventricular stimulation thresholds after determining sensing thresholds.

5.2.3 Capture definitions

When a pacing pulse captures the heart, it causes the heart to beat — that is, contract and pump blood. The ECG shows a P-wave
or QRS complex after the pulse. The example in Figure 29 shows a QRS complex after the pulse. When capture is lost, the ECG shows
no heart response after the pulse.

Figure 29. Capture

Stimulation threshold – The stimulation threshold is the minimum output (mA) needed to consistently capture the heart. Monitor the

patient’s ECG and blood pressure as you follow the procedure to find the atrial or ventricular stimulation thresholds.

Stimulation threshold safety margin – Lead maturation and drug therapy can affect the stimulation threshold. To achieve
consistent capture and accommodate a changing threshold, it is important to provide at least a 2:1 safety margin. Set OUTPUT to a
value at least 2 to 3 times greater than the stimulation threshold value. For example, the appropriate output setting for a patient with
a 1.0 mA threshold is 2.0 mA or greater.

Caution: A 2:1 safety margin cannot always be achieved due to a very high pacing amplitude. If a 2:1 safety margin cannot be
achieved, increase monitoring of the patient to verify that the expected therapy is being delivered.

5.2.4 Determining atrial or ventricular stimulation thresholds

To determine atrial or ventricular stimulation thresholds, perform these steps:

1. Verify that the patient is connected to the temporary pacemaker and is being monitored on the ECG.

2. Set RATE at least 10 ppm above the patient’s intrinsic rate (see Figure 30).
If necessary, continue to increase the RATE until the temporary pacemaker is pacing the patient. The PACE indicator flashes.

3. Decrease OUTPUT: Slowly turn the OUTPUT dial counterclockwise until the ECG shows loss of capture (see Figure 30).
The PACE and SENSE indicators flash intermittently.

32

Figure 30. Increase RATE, decrease OUTPUT

ppm

mA

PACE SENSE

RATE

OUTPUT

ppm

mA

SENSEPACE

RATE

OUTPUT

4. Increase OUTPUT: Slowly turn the output dial clockwise until ECG shows consistent capture (see Figure 31). The following
events occur:

• The PACE indicator flashes continuously; the SENSE indicator stops flashing.

• This value is the stimulation threshold.

Figure 31. Increase OUTPUT

5. Set OUTPUT to a value at least 2 to 3 times greater than the stimulation threshold value. This setting provides at least a 2:1 safety
margin.

6. Restore RATE to the previous value.

5.3 Rapid Atrial Pacing (RAP)

RAP can be used to interrupt some types of atrial tachycardias or to induce an atrial tachycardia.

Caution: RAP is for atrial use only. Before enabling RAP, be sure that the atrial leads are connected to the atrium, not the ventricle.

5.3.1 Rapid Atrial Pacing (RAP) overview

To access the RAP controls, flip open the small plastic RAP cover at the top of the temporary pacemaker and expose the controls. See
Figure 32.

Figure 32. Rapid Atrial Pacing controls

33

Press the ENABLE/DISABLE button to enter and exit RAP Standby mode. Once the device is in RAP Standby, the user can change

ppm

HOLD TO

DELIVER

PACE

SENSE

ENABLE
DISABLE

250

RAP RATE

ppm

mA

mV

0.4 mV

HOLD TO

DELIVER

PACE

SENSE

ENABLE
DISABLE

080

OUTPUT

ASYNC

Async

BASE RATE

the RAP pacing values by turning the RATE dial. The value of the RAP rate will appear in small text above the RATE value. See
Figure 33.

Figure 33. RAP rate display

When the HOLD TO DELIVER button is pressed and held, the temporary pacemaker waits a maximum of two pacing cycles, and then
begins pacing asynchronously in the atrium (AOO pacing mode) at the selected RAP rate. See Figure 34.

Figure 34. Delivering rapid atrial pacing

Note: The temporary pacemaker does not deliver RAP until the HOLD TO DELIVER button is pressed and held. RATE and OUTPUT
remain at their selected values for the current pacing mode until the HOLD TO DELIVER button is pressed and held.

5.3.2 Using RAP

Caution: RAP may result in tachycardia, acceleration of existing tachycardia, or fibrillation. Apply high rates under careful patient

monitoring and control. Monitor the patient’s ECG and blood pressure, and ensure that defibrillation equipment is immediately
available.

Delivering RAP – Perform the following steps to deliver RAP:

1. Open the RAP cover to expose the RAP controls.

2. Press the ENABLE/DISABLE button once to enable RAP and enter RAP Standby. The RAP LED illuminates next to the RAP
rate. The RAP rate (initially the rate of 320 ppm) displays in small text above the current pacing rate. Pacing continues at the
currently displayed settings.

3. Adjust the RAP rate as needed. Turn the RATE dial clockwise to increase the RAP rate, or counterclockwise to decrease the RAP
rate. The range for RAP is 80 ppm to 800 ppm.

4. Press and hold the HOLD TO DELIVER button to deliver RAP burst. During RAP delivery, the following events occur:

• The previously set pacing rate and the RAP rate will switch places between the small and large text fields during RAP delivery.

• AOO pacing begins at displayed RAP rate and current atrial OUTPUT. The PACE LED flashes during delivery of RAP pulses.

• RAP delivery stops when either the HOLD TO DELIVER button is released, or after 2 min have passed.

Value settings during RAP – During the delivery of RAP, the following value settings occur:

34

• OUTPUT does not lock and may be adjusted during RAP delivery.

• The SENSITIVITY is automatically adjusted to ASYNC during RAP delivery and the ASYNC LED illuminates.

Adjusting rate or atrial output during RAP delivery – The RAP rate and OUTPUT can be adjusted during RAP delivery. Follow
these steps to adjust the RAP rate and OUTPUT:

1. Continue to press and hold the HOLD TO DELIVER button.

2. Turn the RATE dial clockwise or counterclockwise to adjust RAP rate.

3. Turn the OUTPUT dial clockwise or counterclockwise to adjust atrial output.

Resuming pacing at previous settings – Perform the following steps to resume pacing at previous settings:

1. Release the HOLD TO DELIVER button to resume pacing at the previous settings. The temporary pacemaker stops delivering
RAP and resumes operation at the non-RAP settings within 3 s. The RAP rate and pacing rate will switch places between the
small and large text fields.

Note: If the OUTPUT is adjusted during RAP, the new setting is retained when RAP is terminated.

2. Press the ENABLE/DISABLE button once to exit RAP Standby and disable RAP controls. The RAP LED will no longer be
illuminated when the device has exited RAP Standby mode, and the RAP rate will no longer be displayed above the pacing rate.

Note: When resuming operation in a synchronous mode, the temporary pacemaker first searches for cardiac activity (during the first
pacing cycle), and then begins sensing and pacing (AAI/VVI pacing mode).

Caution: If the temporary pacemaker continues to deliver RAP after the HOLD TO DELIVER button is released, press and hold the
On/Off button to stop RAP. If RAP continues to be delivered, remove the batteries from the temporary pacemaker and return the
temporary pacemaker for service.

6 Cleaning, disinfecting, and maintenance

6.1 Cautions and notes for cleaning and disinfection

Cautions:

• Clean and disinfect the temporary pacemaker as needed according to your organization’s procedures. Depending on the level of
contamination, such as exposure to blood or body fluid, it is recommended to clean and disinfect the temporary pacemaker
promptly after use to minimize drying and cross contamination.

• Do not immerse the temporary pacemaker in water or cleaning agents. Severe damage to the temporary pacemaker may occur.
Do not use automated machine washers. Do not sterilize the temporary pacemaker by ethylene oxide, gamma radiation or
steam-sterilization (autoclave). Damage to the temporary pacemaker may occur using these methods.

• Use only the recommended methods to clean and disinfect the temporary pacemaker. If the temporary pacemaker cannot be
sufficiently cleaned using these methods, return the temporary pacemaker to Medtronic for service.

• Use only recommended cleaners and disinfectants on the temporary pacemaker. Using other cleaners and disinfectants may
cause damage to the temporary pacemaker plastic, circuitry, or metal components.

• If cleaning the battery drawer, ensure the batteries are removed prior to cleaning.

• Excess amounts of cleaners or disinfectants in the battery drawer may damage the temporary pacemaker. If the temporary
pacemaker cannot be easily or completely cleaned using the recommended procedure below, return the temporary pacemaker
to Medtronic for service.

Notes:

• The temporary pacemaker should be cleaned and disinfected at normal operating temperature and normal environmental
pressure and humidity.

• The provided disinfection method has been tested and shown to achieve a 4.8 log or greater reduction.

• The temporary pacemaker is designed to withstand normal cleaning and disinfection over its normal product life.

• During use, the temporary pacemaker can become too contaminated for effective cleaning by the clinic. If the temporary
pacemaker has blood or soil ingress in its battery compartment, cable ports, or under the knobs, return it to Medtronic for service.
When blood or soil enters into these areas, the clinic cannot effectively clean the temporary pacemaker.

• Do not expose the temporary pacemaker to ethers, acetone, chlorinated solvents, or disinfectants that are not included in the
instructions below. These solvents may damage the case, labels, or metal components.

• For more information on cleaning and disinfecting medical devices, visit the CDC and HICPAC website
(http://www.cdc.gov/hicpac/Disinfection_Sterilization/14_00ReuseMedicalDevices.html).

35

6.2 Cleaning and disinfecting the temporary pacemaker

6.2.1 Disassembly

Figure 35. Disassembly, Step 1. Remove the clear plastic cover.

Figure 36. Disassembly, Step 2. Remove the Rapid Atrial Pacing (RAP) cover.

36

6.2.2 Cleaning

Figure 37. Cleaning, Step 3. Clean all surfaces of the temporary pacemaker thoroughly using a 70% isopropyl alcohol prep pad.

Figure 38. Cleaning, Step 4. Clean all surfaces of the clear plastic cover using a 70% isopropyl alcohol prep pad.

Figure 39. Cleaning, Step 5. Clean all surfaces of the Rapid Atrial Pacing (RAP) cover using a 70% isopropyl alcohol prep pad.

Cleaning, Step 6. Allow the temporary pacemaker, clear plastic cover, and RAP cover to air dry approximately 5 min or until dry.

6.2.3 Disinfecting

15 min of wet/damp exposure to 70% isopropyl alcohol is needed for disinfection. To achieve 15 min of moistened exposure, wrap the
temporary pacemaker and covers in cloths dampened with 70% isopropyl alcohol and place them in a sealed bag or container.

37

Figure 40. Disinfection, Step 7. After cleaning, wrap the temporary pacemaker in damp cloth.

Figure 41. Disinfection, Step 8. Wrap the clear plastic cover in damp cloth.

Figure 42. Disinfection, Step 9. Wrap Rapid Atrial Pacing (RAP) cover in damp cloth.

38

Figure 43. Disinfection, Step 10. Place the wrapped temporary pacemaker, clear plastic cover, and RAP cover in a sealed bag for 15 min.

Figure 44. Disinfection, Step 11. Remove the items from the bag. Unwrap them and allow them to air dry for 5 min or until dry.

6.2.4 Reassembly

Figure 45. Reassembly, Step 12. After cleaning or disinfection, reattach the Rapid Atrial Pacing (RAP) cover.

39

Figure 46. Reassembly, Step 13. Reattach the clear plastic cover.

6.2.5 Additional resources

For additional information about cleaning and disinfecting the temporary external pacemaker, contact Medtronic Instruments
Technical Services:

• Phone: [phone]

• Email: [e-mail]

For more information and resources on cleaning and disinfecting medical devices, visit the CDC and HICPAC websites.

6.3 Safety and technical checks

Perform safety and technical checks on the temporary pacemaker periodically and after any malfunction or accident (such as
dropping the temporary pacemaker or a defibrillation event). Medtronic recommends that qualified engineers and technicians trained
in the service of Medtronic products perform the checks. Contact your Medtronic sales or service representative for additional service
or training. If a checkout or test of a pacemaker indicates improper operation, the unit should be returned to Medtronic for evaluation
and repair. Understanding the warnings listed in this manual is necessary to perform safety and technical checks successfully.

Note: There is no method to adjust an out-of-tolerance parameter at an off-site location. The temporary pacemaker must be returned
for recalibration.

Note: Do not open the external case of the temporary pacemaker. Opening the external case of the temporary pacemaker voids the
warranty.

6.3.1 Visual inspection

Perform the following visual inspections each time the temporary pacemaker is used:

• Check that there is no mechanical or physical damage to the temporary pacemaker.

• Inspect the battery compartment and battery connection for corrosion and other contamination.

6.3.2 Functional inspection

Perform the following functional inspections each time the temporary pacemaker is used:

• Verify that the temporary pacemaker passes the self-test at power-up.

• Verify that the front panel dials, buttons, and displays function and work properly.

• Inspect all connections and cables. Verify that the patient cables are properly connected and are not damaged.

6.3.3 Conducting a system test

Test Equipment – When conducting tests on temporary pacemaker, Medtronic recommends the use of a Transvenous External

Temporary Pacemaker Analyzer (Transvenous Analyzer) such as Sigma Pace 1000, Netech EXPMT, or Bio-Tek PMA testers.

Note: The temporary pacemaker should be tested through the ventricular channel of the transvenous analyzer. Atrial testing is not
required. Use of a test analyzer designed for defibrillators is not recommended test equipment for the temporary pacemaker. If you
use the defibrillator test analyzer, the device MUST have the following capabilities:

40

• The defibrillator test analyzer MUST have the capability to test a transvenous temporary pacemaker.

V

500Ω

1%

Transvenous

analyzer

Temporary

pacemaker

Ventricular Connector

• The defibrillator test analyzer MUST have the capability to inject a simulated R-wave for sensitivity testing.

• The defibrillator test analyzer MUST have the capability of applying an impedance load of 500 Ω

Notes:

• When using the Sigma Pace 1000, make sure you have selected “invasive” test and 500 Ω load.

• When using the Netech EXPMT, make sure the selection switch is in the A-V position.

• When using the Bio-Tek PMA, you must use the ventricular channel of the tester to measure Ventricular Sensitivity.

Figure 47. Setup for Testing Rate, Pulse Width, Pulse Amplitude

6.3.4 Practical measurements

The following paragraphs define each of the test parameters covered by the checkout procedures in this manual:

Rate – Rate is the number of output pulses per minute (ppm). It is the inverse of the time interval measured between successive output
pulses. A control knob sets the base rate.

Rapid Atrial Pacing Rate – The rapid rate delivered only to the atrium is measured in the same manner as the base rate.

Pulse Width – Pulse width is the time duration of any given output pulse. Pulse width is fixed at 1.5 ms in the temporary pacemaker.

Output – Output current is determined by measuring the voltage amplitude of a pulse delivered to a known resistive load. The output

current is then calculated by dividing the measured voltage by the value of the resistive load in Ω.

Sensitivity – Sensitivity is tested by determining the amplitude of a test wave (simulated R wave) that will inhibit pacing. This test first
injects a sub-threshold signal, resulting in the temporary pacemaker pacing. The test increases amplitude until it is above the
threshold, resulting in the temporary pacemaker sensing.

6.3.5 Test conditions

For an accurate measurement of temporary pacemaker parameters the test instrument inaccuracy should not exceed 10% of the
tolerance for that particular parameter.

Note: A defibrillator analyzer with pacemaker test function is for transcutaneous pacemakers and is not recommended for testing the
temporary pacemaker. Medtronic recommends that a transvenous analyzer be used for testing the temporary pacemaker.

Measurements are to be made under the following conditions and at the specified parameter settings:

• All unspecified tolerances ± 5%

• Temperature 21.11 ± 11°C (70 ± 20°F)

• Relative humidity 80% or less

• Analyzer test load 500 Ω ± 1%

• New batteries

• Analyzer simulated R wave 40 ms (25 Hz) sine2 pulses at 400 ms intervals

• Temporary pacemaker settings shall be the nominal settings in the AAI/VVI mode (see Section 7.1), unless otherwise specified.

6.3.6 Rate test procedure

• Use a transvenous analyzer as in Figure 47.

41

Note: If available on the transvenous analyzer, select the ventricular test.

• Set the output to 10 mA and the sensitivity to 2.0 mV. Set the rate to the values listed below and verify that the pulse to pulse
intervals are within specified tolerances.

Table 1. Rate test procedure tolerances Setting Acceptable range

30 ppm 27-33 ppm
80 ppm 72-88 ppm
200 ppm 180-220 ppm

6.3.7 Rapid atrial pacing (RAP) test

• Use a transvenous analyzer as in Figure 47.

Note: The RAP test can be completed using the ventricular channel of the transvenous analyzer.

• Press the ENABLE/DISABLE button. RAP RATE will illuminate on the display above RATE display. The base rate will remain at
80 ppm. Above the base rate the default RAP of 320 ppm will be displayed. Once the ENABLE/DISABLE button is pressed, the
output will continue at the programmed level and the displayed rate will be replaced by the RAP rate.

• To increase the RAP rate, rotate the RATE dial. An amber LED to the left and beneath RAP indicates that the RAP function is active.

• Press the HOLD TO DELIVER button and measure the output rate. It should be 320 ppm ±10% (304-336 ppm). RAP is available
over the range of 80-800 ppm ±10%, using the rate control knob to adjust the rate. Increase the RAP rate to 800 ppm ±10%
(760-840 ppm) and measure the output rate.

6.3.8 Pulse width test

• Use a transvenous analyzer as in Figure 47.

• Set the temporary pacemaker rate to 80 ppm, output to 10 mA, and sensitivity to 2 mV.

• Verify that the pulse width is 1.5 ms ± 10% (1.35-1.65 ms).

6.3.9 Output test

• Use a transvenous analyzer as in Figure 47.

• Set the temporary pacemaker rate to 80 ppm and sensitivity to 2 mV.

• Set the temporary pacemaker’s output to the values listed in the table below. Verify the measured outputs are within specified
tolerances.

Table 2. Output test tolerances Output Setting Acceptable range

1 mA .9-1.1 mA
10 mA 9-11 mA
20 mA 18-22 mA

6.3.10 Sensitivity test

• Use a transvenous analyzer as in Figure 47.

Note: If available on the analyzer, use the invasive test and the 500 Ω setting.

• Select the Ventricular channel to test sensitivity. The SENSITIVITY range is 0.4-20 mV ± 55%.

• Use a simulated R-wave input and 40 ms SSQ (Sine Square Wave).

Note: If the analyzer has a selection for adjusting the amplitude, start at the lowest mV or output level available on the analyzer. An
example would be starting sensitivity testing with the analyzer output set to .05 mV with the temporary pacemaker SENSITIVITY set
to 2 mV.

• Turn on the temporary pacemaker and set the rate to 80 ppm and the output to 10 mA.

• Set SENSITIVITY to the values in the table below. For each setting of the temporary pacemaker, the test analyzer output will
automatically increase (simulated R-wave) from below threshold, resulting in pacing by the temporary pacemaker. Output will
increase to above threshold (the device senses at least five consecutive input signals). The test result must fall within the range
specified for each setting.

Table 3. Sensitivity test tolerances SENSITIVITY setting Specified tolerance

2 mV 1-3 mV
10 mV 5-15 mV

42

6.3.11 Battery removal test

200 ms

200 ms

Note: The temporary pacemaker settings shall be the nominal settings in the AAI/VVI mode (see Section 7.1), unless otherwise
specified.

• Using a new set of batteries, turn on the temporary pacemaker and let it operate for a minimum of 3 min.

• After the temporary pacemaker has been operating for 3 min, open the battery drawer.

• With the battery door open, the temporary pacemaker will continue to operate and the battery indicator will flash red.

• The temporary pacemaker should operate with the battery door open for a minimum of 30 s.

6.4 Service

Medtronic employs highly trained representatives and engineers located throughout the world to serve you and, upon request, to
provide training to qualified hospital personnel in the use of Medtronic products. Medtronic also maintains a professional staff to
provide technical consultation to product users. For medical consultation, Medtronic can often refer product users to outside medical
consultants with appropriate expertise. For more information, contact your local Medtronic representative.

Should service or repair be necessary, contact your local Medtronic sales or service representative.

A serial number identifying each individual temporary pacemaker is printed on the back surface of the device. Reference this serial
number in any correspondence regarding this device.

6.5 Troubleshooting

6.5.1 Self-test

The self-test includes a check of all buttons and critical internal circuits. The PACE, SENSE, ASYNC, and RAP LEDs illuminate during
the self-test. These LEDs remain illuminated until the self-test successfully completes.

Note: Pressing any button while the self-test is in process can cause the temporary pacemaker to fail the self-test. The temporary
pacemaker interprets the pressed button as being “stuck” and, therefore, malfunctioning. If a button is pressed during the self-test,
causing a self-test failure, the screen displays an error message until the button is released.

The screen initializes when the temporary pacemaker turns on. All indicators display, including the low battery indicator, for 2 s. The
low battery indicator displaying during the screen initialization does not indicate that the batteries are low. If the batteries are low, the
low battery indicator remains visible during temporary pacemaker operation.

After successful completion of the self-test, the temporary pacemaker first searches for cardiac activity (during the first pacing cycle),
and then begins sensing and pacing (AAI/VVI pacing mode).

If the temporary pacemaker fails the self-test, the PACE, SENSE, ASYNC, and RAP LEDs remain on, indicating the failed test, and
no output pulses are issued. Failure codes may be displayed on the screen. Follow the instructions that appear on the screen to restart
the temporary pacemaker, or to return the temporary pacemaker for service (contact your Medtronic representative). When returning
the temporary pacemaker, remove the batteries, and return both the temporary pacemaker and the batteries.

6.5.2 Loss of sensing

Figure 48. Loss of atrial sensing (AAI/VVI pacing mode)

Figure 49. Loss of ventricular sensing (AAI/VVI pacing mode)

Keys to identifying loss of sensing – If a P-wave or R-wave is present, the temporary pacemaker does not detect intrinsic activity

and delivers a pacing pulse. The following events occur during loss of sensing:

• Pacing artifacts are seen asynchronously on the ECG.

• The sense indicator does not flash, though the ECG shows depolarization.

43

Potential causes for loss of sensing – Loss of sensing may occur due to several causes:

200 ms

200 ms

Heart/patient related

• inadequate cardiac signal

Patient cable/lead related

• Loose connection at the connector block

• Inappropriate lead placement

• Insulation break or wire fracture

Temporary pacemaker related

• Inappropriate sensitivity setting

• Inappropriate pacing mode selection

• Small sensing window

• Electrical noise

Potential solutions for loss of sensing – Perform one or more of the following actions to troubleshoot the cause of loss of sensing:

• Check the cable connections for loose wires.

• Verify that the apparent loss of sensing is not due to blanking periods.

• Perform a sensing threshold test for the affected chamber. Provide at least a 2:1 safety margin.
Note: If the patient does not have adequate intrinsic rhythm, consult a physician before the test.

• Increase SENSITIVITY for the appropriate chamber. Slowly turn the SENSITIVITY dial counterclockwise (decrease mV until the
ECG shows intrinsic activity).

Note: Use caution when adjusting SENSITIVITY for patients with a history of sustained ventricular tachycardia.

6.5.3 Oversensing

Figure 50. Atrial oversensing

Figure 51. Ventricular oversensing

Keys to identify oversensing – During oversensing, the following events may occur:

• The ECG shows erratic prolonging or shortening of the pacing interval.

• Persistent oversensing may result in asynchronous pacing or no pacing output.

Potential causes of oversensing – Oversensing may occur due to one (or more) of several causes:
Heart of patient related

• T-wave sensing

• Far-field sensing (sensing, P- waves, or R-waves)

• Muscle sensing

• EMI

Patient cable or lead related

• Insulation break

• Conductor wire fracture

Temporary pacemaker related

• Inappropriate sensitivity setting(s)

44

Potential solutions for oversensing – Perform one or more of the following actions to troubleshoot the cause of oversensing:

200 ms

200 ms

• Check the cable connections for loose wires.

• Replace the cable if there is an insulation break or wire fracture.

• Perform the sensing threshold test for the affected chamber. Provide at least a 2:1 safety margin.
Note: If the patient does not have adequate intrinsic rhythm, consult a physician before the test.

• If the source is muscle activity, EMI, T-wave, or far-field sensing, decrease SENSITIVITY for the affected chamber. Slowly turn the

SENSITIVITY dial clockwise (increase the mV value).
Note: When adjusting SENSITIVITY or OUTPUT, verify the appropriate safety margin.

6.5.4 Loss of capture

Figure 52. Loss of atrial capture

Figure 53. Loss of ventricular capture

Keys to identifying loss of capture – If the ECG shows no depolarization after delivery of a pacing stimulus, loss of capture has

occurred.

Note: If the intrinsic event occurs just before pacing, see Section 6.5.2.

Potential causes of loss of capture – Loss of capture may occur due to one of the following causes:

Heart or patient related

• Increased stimulation threshold

• Exit block

• Tissue changes

• General metabolic imbalances

• Drug effects

Patient cable or lead related

• Loose connection at the connector block

• Heartwire dislodgement

• Inappropriate lead placement

• Insulation break or wire fracture

Temporary pacemaker related

• Inadequate output setting – mA

Possible misdiagnosis of loss of capture – Loss of capture may be misdiagnosed due to one or more of the following causes:

• The bipolar artifacts are too small to be seen.

• The digital ECG monitor or recorder is not sensitive to pacing spikes.

Possible solutions for loss of capture – Perform one or more of the following actions to troubleshoot the cause of loss of capture:

• Check the cable connections for loose wires.

• Replace the cable if there is an insulation break or wire fracture.

• Verify that the correct chamber is being paced.

• Verify the pacing mode.

45

• Perform the stimulation threshold test for the affected chamber. Provide at least a 2:1 safety margin.

• If necessary, increase the output for the appropriate chamber. Slowly turn the OUTPUT dial clockwise until the ECG shows
capture.

Note: Use caution when adjusting OUTPUT for patients with a history of sustained ventricular tachycardia.

6.5.5 Stimulation of chest wall or diaphragm

Potential causes of stimulation of the chest wall or diaphragm – Stimulation of the chest wall or diaphragm may occur due to one

of the following causes:
Patient cable or lead related

• Improper lead placement

• Loose connection at the connector block

• Conductor wire fracture

Temporary pacemaker related

• Excessive output settings – mA

Possible solutions for stimulation of chest wall or diaphragm – Perform one or more of the following actions to troubleshoot the
cause of chest wall or diaphragm stimulation:

• Determine if the lead is the cause of the problem by reducing OUTPUT to the lead.

• Perform the stimulation threshold test. Set the output to a value more than 2 times the threshold value, but below the point of
stimulating the chest or diaphragm.

• If the outcome does not improve, correct the placement of the lead.

6.5.6 No output pulse

Key to identifying output pulse – The ECG does not show the pacing spikes when there is no output.

Possible misdiagnosis of no output pulse – No output pulse may be misdiagnosed due to one or more of the following causes:

• Pacing is inhibited because of sensed noise or intrinsic activity.

• The digital ECG monitor or recorder is not sensitive to pacing spikes.

Possible solutions for no output pulse – Perform one or more of the following actions to troubleshoot the cause of no output pulse:

• Observe the pace indicators.

• Re-insert the patient cable.

• Replace the batteries.

• Change the ECG monitor or recorder.

• Set OUTPUT to the appropriate safety margin.

6.5.7 Hemodynamic changes

Keys to identifying hemodynamic changes – Check the following items when identifying possible causes of hemodynamic

changes:

• Decreased blood pressure

• Altered brachial pulse rate

Possible solutions to hemodynamic changes – Perform one or more of the following actions to troubleshoot the cause of
hemodynamic changes:

• Consult a physician.

• Check the pacing mode. If necessary, change to the AAI/VVI pacing mode.

• Verify that sensing or capture has not been lost. Correct if necessary.

• Adjust the pacing rate (increase it in most cases).

6.5.8 Recoverable error message

If the temporary pacemaker displays the recoverable error message (see Figure 54), press and hold the ON/OFF button until the
temporary pacemaker powers off. Then, press the ON/OFF button to restart the temporary pacemaker. Upon restarting, the
temporary pacemaker will perform the self-test.

46

Figure 54. Recoverable error message

Cycle

Power

E : 160

Contact
Service

E : 800

6.5.9 Non-recoverable error message

If the temporary pacemaker displays the non-recoverable error message (see Figure 55), contact Medtronic for service.

Figure 55. Non-recoverable error message

6.5.10 Button press detected error message

If the temporary pacemaker displays the Button Press Detected error message, a button has been pressed while the temporary
pacemaker is turning on. Release any pressed button and the temporary pacemaker continues to power on normally.

47

Figure 56. Error – Button Press Detected

Release

Keys

E : 715

6.6 Product life

Long-term reliability of the temporary pacemaker is subject to the actual use conditions of the device. The routine testing and
preventative maintenance recommended in this manual will help provide reliable operation of the temporary pacemaker.

The service life of the temporary pacemaker is seven years. Medtronic will not service or repair the temporary pacemaker after seven
years. Contact your Medtronic representative to replace your temporary pacemaker after it has been in service for seven years.

7 Specifications

7.1 Device specifications

Table 4. Temporary pacemaker specifications Pacing modes AAI, AOO, VVI, VOO RATE Range (in ppm) Increments (in ppm) Tolerance

30 – 50
50 – 100
100 – 170
170 – 200

RAP rate Range (in ppm) Increments (in ppm) Tolerance

80 – 250
250 – 320
320 – 430
430 – 800

Output amplitude Range (in mA) Increments (in mA) Tolerance

0.1 – 0.4

0.4 – 1.0

1.0 – 5.0

5.0 – 25

Pulse width (fixed) 1.5 ms ±10%
Input impedance 40,000 Ω
Sensitivity

a

Range (in mV) Increments (in mV) Tolerance

0.4 – 1.0

1.0 – 3.0

3.0 – 10
10 – 20

Blanking

200 ms +5/-30 ms – after pace
120 ms +2/-30 ms – after sense

b

5
2
5
6

20
5
10
20

0.1

0.2

0.5

1.0

0.2

0.5

1.0

2.0

30 – 200 ±2%

80 – 360 ±2%
370 – 800 ±4%

0.1 – 20
Greater of ±0.1 mA or ±10%
(200-1000 Ω)

20 – 25
±10%
(200–500 Ω)

±55%

48

Table 4. Temporary pacemaker specifications (continued)
RATE limit (non-RAP) 230 ppm If a non-RAP rate exceeds 230 ppm, pacing is terminated, a recov-

erable error message will be displayed.

Nominal values

Pacing mode AAI/VVI
RATE 80 ppm

Output amplitude 10 mA
Pulse width (fixed) 1.5 ms
Sensitivity 2.0 mV

RAP rate 320 ppm

Dimensions

Height 20.27 cm (7.98 in) ±10%
Width 6.68 cm (2.63 in) ±3%
Depth 4.14 cm (1.63 in) ±4%
Weight (with battery) 499 g (17.6 ounces) maximum

Temperature

Operating 10°C to 40°C (50°F to 104°F)
Storage (without bat-

-25°C to 70°C (-13°F to 158°F)

tery)

Humidity (storage) > 80% and ≤ 95% at 40°C (104°F), use after 48 hours dry time

≥ 10% and ≤ 80% at 40°C (104°F), for immediate use

Battery type Two IEC type LR6-sized (AA-sized) 1.5 V alkaline batteries (Duracell MN1500, Eveready E91 or equiv-

alent)

Battery life 7 days minimum, when the RATE is 80 ppm, and all other parameters are at the nominal values. Higher

amplitudes and rates decrease battery life.

Operation after battery
removal

30 s (typical) under the following conditions: RATE of 80 ppm or less and OUTPUT of 10 mA or less,
backlight off.

Standards The temporary pacemaker complies with requirements from IEC 60601-1.

a

When sensing 40 ms-wide Haversine waveform.

b

When tested with a 1 ms square pulse with sufficient amplitude.

7.2 Pacing information tables

Table 5. Temporary pacemaker single chamber pacing setup table Pacing mode AOO/VOO AAI/VVI

PACE and SENSE Indicators PACE PACE + SENSE

Instructions

1. Set OUTPUT On On

2. Set SENSITIVITY ASYNC On

Table 6. Rate and interval conversion chart for RATE and RAP Rate RAP

Rate Interval Rate Interval
30 ppm 2000 ms 80 ppm 750 ms
35 ppm 1714 ms 100 ppm 600 ms
40 ppm 1500 ms 120 ppm 500 ms
45 ppm 1333 ms 140 ppm 429 ms
50 ppm 1200 ms 160 ppm 375 ms
52 ppm 1154 ms 180 ppm 333 ms
54 ppm 1111 ms 185 ppm 324 ms
56 ppm 1071 ms 190 ppm 316 ms
58 ppm 1034 ms 195 ppm 308 ms
60 ppm 1000 ms 200 ppm 300 ms
62 ppm 968 ms 205 ppm 293 ms
64 ppm 938 ms 210 ppm 286 ms

49

Table 6. Rate and interval conversion chart for RATE and RAP (continued)
Rate RAP

66 ppm 909 ms 215 ppm 279 ms
68 ppm 882 ms 220 ppm 273 ms
70 ppm 857 ms 225 ppm 267 ms
72 ppm 833 ms 230 ppm 261 ms
74 ppm 811 ms 235 ppm 255 ms
76 ppm 789 ms 240 ppm 250 ms
78 ppm 769 ms 245 ppm 245 ms
80 ppm 750 ms 250 ppm 240 ms
82 ppm 732 ms 260 ppm 231 ms
84 ppm 714 ms 270 ppm 222 ms
86 ppm 698 ms 280 ppm 214 ms
88 ppm 682 ms 290 ppm 207 ms
90 ppm 667 ms 300 ppm 200 ms
92 ppm 652 ms 310 ppm 194 ms
94 ppm 638 ms 320 ppm 188 ms
96 ppm 625 ms 330 ppm 182 ms
98 ppm 612 ms 340 ppm 176 ms
100 ppm 600 ms 350 ppm 171 ms
105 ppm 571 ms 360 ppm 167 ms
110 ppm 545 ms 380 ppm 158 ms
115 ppm 522 ms 400 ppm 150 ms
120 ppm 500 ms 420 ppm 143 ms
125 ppm 480 ms 440 ppm 136 ms
130 ppm 462 ms 460 ppm 130 ms
135 ppm 444 ms 480 ppm 125 ms
140 ppm 429 ms 500 ppm 120 ms
145 ppm 414 ms 520 ppm 115 ms
150 ppm 400 ms 540 ppm 111 ms
155 ppm 387 ms 560 ppm 107 ms
160 ppm 375 ms 580 ppm 103 ms
165 ppm 364 ms 600 ppm 100 ms
170 ppm 353 ms 620 ppm 97 ms
176 ppm 341 ms 640 ppm 94 ms
182 ppm 330 ms 660 ppm 91 ms
188 ppm 319 ms 680 ppm 88 ms
194 ppm 309 ms 700 ppm 86 ms
200 ppm 300 ms 720 ppm 83 ms

740 ppm 81 ms
760 ppm 79 ms
780 ppm 77 ms
800 ppm 75 ms

50

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M962462A001 E
2016-09-26