5388 Tech Manual
5388 Tech Manual
5388 Tech Manual
QXD
01/29/2001
1:23 PM
Page 1
5388
Dual Chamber Temporary Pacemaker (DDD)
Technical Manual
Caution: Federal law (USA) restricts this device to sale by or on
the order of a physician.
5388FC-198618-001.QXD
01/29/2001
1:23 PM
Page 2
Medtronic
Confidential
Model 5388
Dual Chamber
Temporary Pacemaker
Technical Manual
Medtronic
Confidential
Symbols
Explanation of Symbols
Type CF Equipment
MEDTRONIC CONFIDENTIAL
Table of Contents
Symbols
ii
Overview
General Description 1-2
Intended Use 1-5
Contraindications 1-6
Warnings, Precautions, and Adverse Effects
Warnings 2-2
Precautions 2-5
Environmental Precautions 2-9
Adverse Effects 2-11
Controls, Indicators, and Other Features
Controls 3-2
Light-Emitting Diodes 3-11
Upper Screen 3-12
Lower Screen 3-18
Physical Features 3-31
Functional Features 3-34
Timing Violations 3-41
Preparation for Use
Battery Installation 4-2
Disposable Pouch 4-3
Cables 4-4
Connector Setup 4-6
User Guide
Overview 5-2
Indicators 5-4
Basic Operation 5-6
Connector Setup 5-17
Pacing Parameter Adjustments 5-19
iii
MEDTRONIC CONFIDENTIAL
Thresholds 5-27
Pacing Setup 5-35
RAP (Rapid Atrial Pacing) 5-39
Battery Replacement 5-41
Tables 5-43
Device Maintenance
Cleaning and Sterilization 6-2
Safety and Technical Checks 6-4
Service 6-4
Special Notices 6-5
Specifications
Device Specifications 7-2
Pacemaker Diagnostic Diagrams
About the Chapter A-2
Definitions A-3
Single Chamber Modes A-7
Dual Chamber Modes A-14
Index
iv
MEDTRONIC CONFIDENTIAL
List of Figures
Figure 1-1.
The Medtronic Model 5388 Dual Chamber Temporary Pacemaker and the
Model 5433A or 5433V Patient Cable. 1-2
Figure 3-1.
Figure 3-2.
Figure 3-3.
Ring and Bails on the Back Side of the Model 5388. 3-33
Figure 4-1.
Figure 4-2.
Figure 4-3.
The Model 5433A Atrial Use symbol and the Model 5433V Ventricular Use
symbol. 4-5
Figure 4-4.
Connecting the Model 5433A or 5433V Patient Cable to the Model 5388
Temporary Pacemaker. 4-7
Figure 4-5.
Disconnecting the Model 5433A or Model 5433V Patient Cable from the
Model 5388 Temporary Pacemaker. 4-7
Figure 4-6.
Connecting the pacing lead system to the Model 5433A or 5433V Patient Cable
receptacles. 4-9
Figure 4-7.
Figure 4-8.
Figure 5-1.
Indicators. 5-4
Figure 5-2.
On/Off. 5-6
Figure 5-3.
Figure 5-4.
Emergency. 5-8
Figure 5-5.
Lock/Unlock. 5-9
Figure 5-6.
Pause. 5-10
Figure 5-7.
Figure 5-8.
Cables. 5-17
Figure 5-9.
Figure 5-10.
MEDTRONIC CONFIDENTIAL
Figure 5-11.
Figure 5-12.
Sensitivity. 5-21
Figure 5-13.
Figure 5-14.
PVARP. 5-24
Figure 5-15.
Figure 5-16.
Figure 5-17.
Sensing. 5-27
Figure 5-18.
Figure 5-19.
Figure 5-20.
Figure 5-21.
Figure 5-22.
Capture. 5-31
Figure 5-23.
Figure 5-24.
Figure 5-25.
Figure 5-26.
Figure 5-27.
Dial-A-Mode. 5-37
Figure 5-28.
Figure 5-29.
Figure A-1.
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Overview
General Description
Intended Use
1-2
1-5
Contraindications
1-6
1-1
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Overview
General Description
General Description
The Medtronic Model 5388 is a battery-powered, temporary,
dual chamber pacemaker designed primarily for temporary
antibradycardia pacing therapy. The device provides eight
selectable modes of pacing therapy: DDD, DVI, DDI, DOO, VOO,
VVI, AOO, and AAI. High-rate, burst pacing therapy up to
800 ppm (pulses per minute), for atrial tachyarrhythmias, is
1
available in the asynchronous mode.
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Overview
General Description
Safety Features
The Medtronic Model 5388 is designed to be reliable, easy to
operate, and comfortable to hold. Safety features of the
Model 5388 include:
Self-test function;
Electrostatic protection;
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Overview
General Description
Package Contents
See the enclosed card for a detailed list of package contents. Check
the package prior to use. Damaged packages should be returned
to Medtronic (see back cover for address).
Registration Card
Please complete the registration card and return it to Medtronic,
using the address labels provided.
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Overview
Intended Use
Intended Use
The Medtronic Model 5388 temporary pacemaker is intended to
be used in conjunction with a cardiac pacing lead system for
temporary single or dual chamber pacing in a clinical
environment. The Model 5388 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:
Sinus bradycardia;
Cardiac arrest;
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Overview
Contraindications
Contraindications
There are no known contraindications to the use of temporary
pacing as a means to control the heart rate. The patients age and
medical condition, however, may dictate the type of temporary
pacemaker and lead system used by the physician.
Atrial Sensing
Pacing modes which allow sensing in the atrium to trigger a
ventricular response are contraindicated in the presence of rapid
atrial arrhythmias such as atrial fibrillation or atrial flutter.
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.
Asynchronous Pacing
Asynchronous pacing is contraindicated in the presence of
intrinsic cardiac rhythms.
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Warnings,
Precautions, and
Adverse Effects
Warnings
2-2
Precautions
2-5
Environmental
Precautions 2-9
Adverse Effects 2-11
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Warnings
Defibrillation/Cardioversion
Defibrillation discharges up to 360 watt-seconds have not affected
the Model 5388 in laboratory tests. However, for maximum safety,
it is recommended that paddles be placed at least 15 cm (6 inches)
away from the Model 5388 or the lead system.
Whenever possible, for the safety of the patient, disconnect the
pacemaker from the lead system before defibrillating or
cardioverting. A relatively low resistance pathway exists between
the positive (+) and negative () electrodes of the implanted lead
system. During defibrillation a large current could flow across this
pathway, causing myocardial damage.
Line-powered Equipment
An implanted lead or lead with 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.
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Electrosurgical equipment;
Diathermy equipment;
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Precautions
Random Failures
The physician should be aware that operational failure of the
Model 5388 temporary pacemaker can occur as the result of
battery depletion, mishandling, or random component failure.
Possible operational failures of the Model 5388 can include:
Batteries
Use of batteries with different physical dimensions from that of
the recommended batteries may result in erratic, or no,
pacing output.
Replace the battery for each new patient, and when the low
battery indicator appears during device operation (see page 3-13).
Check the battery status at least twice daily. Replace alkaline
batteries at least once every week when the temporary pacemaker
is in continuous use.
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Atrial Sensing
The atrial sensing threshold should be evaluated to ensure
maximum electrogram amplitude and that an adequate atrial
sensing threshold is obtained prior to programming to a mode
that requires atrial sensing (DDD, DDI, or AAI).
Place the wires on the right atrial free wall, oriented along the
direction of the myocardial fibers, approximately 1 cm apart. It is
important to achieve a sensing threshold of at least 1.0 mV. The
atrial sensitivity should be set to a minimum of one-half the
measured threshold. This ensures a minimum safety margin of 2x
the sensing threshold. Failure to follow this procedure can lead to
delivery of asynchronous pulses.
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 patients sensitivity threshold (see Sensing
Threshold on page 5-28). This setting will provide a 2x safety
margin to ensure proper sensing.
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 (e.g., sensing of R- or T-waves on the atrial channel or
P-waves on the ventricular channel), leading to inappropriate
inhibition of pacing pulses.
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Retrograde Conduction
If retrograde P-waves are being sensed outside the ratedependent, automatic Post-Ventricular-Atrial-Refractory Period
(PVARP) setting, manually increase the PVARP until the
retrograde waves fall inside the PVARP. Failure to follow this
procedure may lead to a pacemaker mediated tachycardia (PMT).
Termination of Pacing
Abrupt termination of pacing stimuli may result in intervals of
asystole before an intrinsic rhythm is reestablished. Prior to
terminating pacing, set the pacemaker to a demand mode, then
gradually reduce the pacing rate below the patients intrinsic rate.
PAUSE Key
Use the PAUSE key with care, since the patient is without pacing
support (for a maximum of 10 seconds at a time) when PAUSE is
pressed and held.
A-V Interval
Programming long A-V intervals may result in pacing the
ventricle during the vulnerable period of ventricular
repolarization, thus precipitating ventricular arrhythmias in
unstable patients.
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Environmental Precautions
The Model 5388 has been carefully designed and tested to ensure
reliability during normal use. However, electronic devices are
susceptible to many environmental stresses. Precautions should
be taken to avoid damage to the unit, including (but not limited
to) the precautions listed in this chapter.
Do not place the Model 5388 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 (patients, visitors, etc.).
Do not open the device. 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 unit may compromise the ESD barrier.
Opening this unit will void the warranty (see the warranty
information packaged with the device).
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Adverse Effects
Temporary Pacemakers
Potential adverse effects related to the use of temporary external
pacemakers such as the Model 5388 include, but are not limited to:
Safety Margins
Determine an adequate safety margin for sensing and pacing in
both the ventricle and atrium (see Chapter 5). Failure to do so may
result in inappropriate pacing.
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Lead Systems
Potential adverse effects related to the use of pacing lead systems
used in conjunction with the Model 5388 temporary pacemaker
include, but are not limited to:
Infarction;
Pericarditis;
Infection.
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Controls, Indicators,
and Other Features
Controls
3-2
3-11
Light-Emitting Diodes
Upper Screen
3-12
3-31
Functional Features
Timing Violations
3-34
3-41
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Controls
The dials and keys used to control the functions and parameter
settings of the Model 5388 are described below.
Note: All adjustments to the RATE, A (Atrial) OUTPUT, and
V (Ventricular) OUTPUT dials take effect within the next two
pacing cycles.
Lock/Unlock Key
This key allows the user to lock and unlock the upper screen
parameter values, RATE, A OUTPUT, and V OUTPUT (see Lock
Feature on page 3-34).
When the upper screen is unlocked, press this key to lock the upper
screen parameters at their current settings. The backlight will turn
off and the lock indicator appears in the upper right-hand corner
of the upper screen. Pressing this key while a lower menu is active
causes the device to exit the menu.
Note: If this key is not pressed, the device automatically locks the
parameters on the upper screen 60 seconds after the last device
adjustment, with the exception of Menu 3. When in Menu 3 (Rapid
Atrial Pacing), the device waits five minutes before locking.
When the upper screen is locked, press this key to unlock the upper
screen, allowing the upper screen parameters to be adjusted again.
The backlight turns on, unless the low battery indicator is flashing
(see Low Battery Indicator on page 3-13).
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2
1.
Pace/Sense LEDs
2.
Lock/Unlock Key
21
3
+
20
3.
Lock Indicators
4.
Rate Dial
5.
6.
7.
8.
9.
A +V A +V
DDI
19
80
30
18
RATE
16
A OUTPUT
15
V OUTPUT
120
200
ppm
3
5
17
OFF
OFF
0.1
0.1
10
10
20
mA
20
25
mA
14
10
ASYNC.
13
12
Dual Chamber
Temporary Pacemaker
11
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ON Key
f
ON
Press the ON key once to power the device up. The device first
senses, then begins sensing and pacing in both chambers
(DDD mode).
The upper screen and the backlight illuminate and a self-test is
initiated (see Self-test on page 3-35). After the self-test is
successfully completed the following occurs:
If the battery has sufficient power, the device begins sensing
and pacing in both the atrium and ventricle at the following
nominal parameter values:
80 ppm
10 mA
1.0 ms*
1.5 ms*
V SENSITIVITY
0.5 mV
2.0 mV
A TRACKING
ON
UPPER RATE
110 ppm
300 ms
170 ms
A SENSITIVITY
PVARP
A-V INTERVAL (paced)
* Pulse width is not adjustable.
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If the battery is depleted, the LEDs may come on (see LightEmitting Diodes on page 3-11) while ON is pressed, but the
device will not operate.
When the upper screen is locked, press the ON key once to unlock the
upper screen (see Lock/Unlock Key on page 3-2). The backlight
comes on and the upper screen parameters may be adjusted. The
device continues to pace at the currently selected values.
When the device is pacing asynchronously, to return the device to
demand (synchronous) pacing:
current setting
current settings
A SENSITIVITY
V SENSITIVITY
0.5 mV (nominal)*
2.0 mV (nominal)*
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OFF Key
To turn the device off, press the OFF key twice within 5 seconds.
(After the first press, a message appears in the lower screen telling
the user to press OFF a second time to turn the device off.)
OFF
The backlight turns off, the screens blank, and three LEDs
illuminate, then turn off, when OFF is pressed the second time.
To SHUT DOWN,
Press OFF again.
Note: If the OFF key is pressed once when the upper screen
parameters are locked:
The lower screen displays the message telling the user to press
OFF a second time (Ignoring this message allows the device to
continue pacing at the currently selected values).
ASYNC.
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ASYNC.
current setting, or
80 ppm if device was off
A OUTPUT
20 mA
25 mA
V OUTPUT
A SENSITIVITY
V SENSITIVITY
A TRACKING,
UPPER RATE, PVARP
not applicable
A-V INTERVAL
automatic rate-dependent, or
current manual setting
ASYNCHRONOUS
PACING
To Resume
Synchronous Pacing
Press ON
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PAUSE Key
This key interrupts pacing and sensing to allow the user to view
the patients intrinsic rhythm.
PAUSE
PACEMAKER
PAUSE
Caution: Pacing
and Sensing
are suspended.
Caution: Use the PAUSE key with care, since the patient is without
pacing support (for a maximum of 10 seconds at a time) when
PAUSE is pressed and held.
When the PAUSE key is pressed and held, the device stops pacing and
sensing for a maximum of 10 seconds. The message to the left
appears in the lower screen, reminding the user that pacemaker
operation is suspended.
To suspend device operation for up to another 10 seconds, release,
then press and hold the PAUSE key again. Repeat this as many
times as required.
When the PAUSE key is released, the device first senses, then resumes
pacing at the programmed parameters. The device also senses
before pacing if PAUSE times out at 10 seconds.
If the PAUSE key is pressed when the upper screen is locked, pacing and
sensing are suspended, as described above, and the upper screen
parameters unlock.
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MENU Key
The MENU key is used to activate and page through the Menus on
the lower screen, from Menu 1 to Menu M.
MENU
If pressed when the upper screen is locked, the Menu screen becomes
active, and the upper screen parameters unlock.
SELECT Key
The SELECT key is only active when the Menu screens are active.
SELECT
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Rate Dial
The top dial is used to set the base rate at which pacing pulses are
delivered, in pulses-per-minute (ppm) (see RATE on page 3-15).
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Light-Emitting Diodes
All light-emitting diodes (LEDs) are illuminated during the
Power-on Self-test.
PACE LEDs
There are two green LEDs at the top of the device, marked PACE.
The green LED next to the A flashes each time the device
delivers a pacing pulse on the atrial channel.
The green LED next to the V flashes each time the device
delivers a pacing pulse on the ventricular channel.
SENSE LEDs
There are two orange LEDs at the top of the device, marked SENSE.
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Upper Screen
The upper screen displays:
Indicators:
A +V A +V
DDI
80
30
120
RATE
OFF
0.1
10
Lock Indicators
DDI Indicator
200
ppm
20
A OUTPUT
mA
HIGH OUTPUT
OFF
0.1
10
V OUTPUT
20
25
mA
RATE
(Atrial) OUTPUT
(Ventricular) OUTPUT
When the device is off, the upper screen is blank, except for the
number lines, which are painted on the glass.
When the device is on, the numerical and graphical values for the
parameters appear, and the screen is illuminated by a backlight.
The backlight remains on while parameters are adjusted but is
turned off 60 seconds after the last adjustment even while Menu 3
(RAP) is active [see Menu 3 (Rapid Atrial Pacing) on page 3-28].
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Indicators
Low Battery Indicator
This indicator comes on and flashes when the battery reaches
replacement time.
When the Low Battery indicator begins to flash during device operation,
the device will operate satisfactorily for a minimum of 24 hours at
or below a RATE of 70 ppm, nominal OUTPUTs, and with the lower
screen inactive (Nominal Values on page 7-4). The backlight
will not illuminate once the low battery indicator appears.
To extinguish the Low Battery indicator, replace the low battery (see
Battery Installation on page 4-2) with a recommended new
9-Volt battery.
The PACE and SENSE labels painted on the light gray bar above the
upper screen, and the A and V indicators that appear on the screen
below the labels communicate to the user which chambers
(A for atrium, V for ventricle) the device is currently set to pace
and/or sense. These indicators can be used to determine the
current pacing mode (see Model 5388 Pacing Setup Table. on
page 5-43).
SENSE
A +V A +V
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Lock Indicators
To UNLOCK RATE,
A OUTPUT, and
V OUTPUT,
The lower screen message and the two icons in the center of the
upper screen disappear after approximately 15 seconds if nothing
is done to unlock the upper screen parameters. All three indicators
disappear when the parameters are unlocked (see Lock Feature
on page 3-34).
Press
DDI Indicator
A +V A +V
DDI
Parameters
The RATE, A OUTPUT, and V OUTPUT settings are displayed both
numerically and graphically. The line next to each dial shows the
range available for that parameter. Line segments appear,
showing where, within the range, the parameter is set. The
settings numerical value appears just below the segmented
line graph.
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RATE
The base pacing rate ranges from 30 to 200 ppm and is
incremented as in Table 3-4.
Table 3-4. Rate Increments.
Range
Increment
30 to 50 ppm
5 ppm
50 to 100 ppm
2 ppm
5 ppm
Turn the top dial clockwise to increase RATE, and counterclockwise to decrease RATE.
The (nominal) RATE setting at which the device powers up is
80 ppm.
A +V A +V
30
RATE
80
120
200
For rates above 120 ppm, the line segments become taller and
wider to warn the user that RATE is set above the typical range.
ppm
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A (Atrial) OUTPUT
The atrial output ranges from 0.1 to 20 mA, and is incremented as
in Table 3-5.
Table 3-5. Atrial Output Increments.
Range
Increment
0.1 to 0.4 mA
0.1 mA
0.4 to 1.0 mA
0.2 mA
1.0 to 5 mA
0.5 mA
5 to 20 mA
1.0 mA
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V (Ventricular) OUTPUT
The ventricular output ranges from 0.1 to 25 mA, and is
incremented as in Table 3-6.
Table 3-6. Ventricular Output Increments
Range
Increment
0.1 to 0.4 mA
0.1 mA
0.4 to 1.0 mA
0.2 mA
1.0 to 5 mA
0.5 mA
5 to 25 mA
1.0 mA
HIGH OUTPUT
OFF
0.1
10
V OUTPUT
20
25
mA
When V OUTPUT is set to OFF, both the ventricular output and the
ventricular sensitivity are turned off (i.e., there is no ventricular
pacing or sensing). If V OUTPUT is turned back on within
approximately 7 seconds, ventricular sensitivity is set to the
previously selected value. If V OUTPUT is OFF for longer than
approximately 7 seconds, ventricular sensitivity is set to the
nominal value of 2.0 millivolts (mV) when V OUTPUT is turned
back on.
Notes:
can be adjusted using Menu 1 on the lower
screen [see V (Ventricular) SENSITIVITY on page 3-21].
V SENSITIVITY
V OUTPUT
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Lower Screen
Functions
The Lower Screen has two functions:
DDD
0.5 mV
A Sensitivity
10
0.4
V Sensitivity
2.0 mV
A-V Interval
170 mS
A Tracking
ON
MENU 1:
MENU 2:
MENU 3:
Controls
The controls for the Menus and their parameters are:
MENU PARAMETER
SELECT
MENU
dial.
key, and
key.
While the Menus in the lower screen are in use, the upper screen
remains unlocked, and the upper screen parameters may be
adjusted at any time using the corresponding dial.
Press [
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Status Line
The NASPE and British Pacing and Electrophysiology Group
(NBG) code is displayed at the top of every Menu and is updated
when parameter adjustments cause a mode change (see page 5-44
and Pacemaker Diagnostic Diagrams on page A-1 for
information on NBG codes).
The phrase *MANUAL appears at the top of every Menu screen
if one or more of the three rate-dependent parameters are
manually adjusted (see SETTING on page 3-27).
Note: Once activated, if Menu 1, 2, M, and the upper screen
parameters remain unchanged for over 60 seconds, the menu goes
blank. Menu 3 goes blank five minutes after the last adjustment or
RAP delivery.
Menu 1
This Menu provides access to the:
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A (Atrial) SENSITIVITY
Unless manually adjusted, the atrial sensitivity (A SENSITIVITY) is set
to the nominal value of 0.5 mV.
When selected, the A SENSITIVITY may be adjusted between 0.4 and
10 mV by turning the MENU PARAMETER dial.
Turn the dial clockwise to increase A SENSITIVITY (the mV value
decreases), and counterclockwise to decrease A SENSITIVITY (the
mV value increases). The change will take effect within the next
two pacing cycles.
DVI
ASYNC
A Sensitivity
10
0.4
V Sensitivity
2.0 mV
A-V Interval
170 mS
The Setup Indicators at the top of the upper screen reflect the
change by the absense of the A under SENSE, and the A SENSE
LED will no longer flash.
The NBG code at the top of the lower screen also reflects the
change in mode (i.e., chamber(s) paced and sensed).
A Tracking
EMERGENCY
RAP is delivered, or
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V (Ventricular) SENSITIVITY
Unless manually adjusted, ventricular sensitivity (V SENSITIVITY) is
set to the nominal value of 2.0 mV.
When selected, the sensitivity may be adjusted between 0.8 and
20 mV by turning the MENU PARAMETER dial.
Turn the dial clockwise to increase V SENSITIVITY (the mV value
decreases), and counterclockwise to decrease V SENSITIVITY (the
mV value increases). The change will take effect within the next
two pacing cycles.
can be turned off, allowing the pacemaker to pace
asynchronously in the ventricle, by turning the MENU PARAMETER
dial counterclockwise until the term, ASYNC, appears.
V SENSITIVITY
DOO
ASYNC
A Sensitivity
ASYNC
V Sensitivity
20
A-V Interval
10
0.8
The Setup Indicators at the top of the upper screen reflect the
change by the absence of the V under SENSE, and the V SENSE
LED will no longer flash.
The NBG code at the top of the lower screen also reflects the
change in pacing mode (i.e., chamber(s) paced and sensed).
170 mS
A Tracking
EMERGENCY
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A-V Interval
A-V INTERVAL may be adjusted from 20 to 300 ms in increments of
10 ms (see A-V Interval on page 3-26).
A (Atrial) TRACKING
This feature is only accessible or applicable when the device is set
to sense and pace in both chambers. When ON, A (Atrial)
TRACKING causes the device to pace the ventricle in synchrony
with intrinsic atrial depolarizations.
When A TRACKING is ON (DDD mode), each sensed event on the
atrial lead not only inhibits the scheduled atrial pacing pulse, but
also triggers an A-V INTERVAL.
DDI
A Sensitivity
0.5 mV
V Sensitivity
2.0 mV
A-V Interval
170 mS
A Tracking
OFF
OFF ON
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Menu 2
This Menu allows manual adjustment of these dual chamber, ratedependent parameters:
UPPER RATE,
PVARP
A-V INTERVAL
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Press the MENU key to activate Menu 2 and adjust the ratedependent parameter.
After 10 seconds the message will disappear, and the device will
continue operating at the currently selected parameter values.
Upper Rate
This parameter is designed to set the maximum ventricular pacing
rate allowed while tracking the atrium. At sensed atrial rates
above the UPPER RATE, a Wenckebach-type response results (see
page 3-39). This parameter is adjustable only in dual chamber
modes with atrial tracking.
Unless manually adjusted, this parameter is limited to the range of
110 to 230 ppm and is determined by the RATE setting using the
following formula:
UPPER RATE
= RATE + 30 ppm
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Rate
Increment
80 to 130 ppm
2 ppm
5 ppm
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PVARP
100 ppm
300 ms
250 ms
225 ms
>180 ppm
200 ms
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A-V Interval
Displayed on both Menu 1 and Menu 2, the A-V Interval after an
atrial pace (i.e., PAV, or A-V INTERVAL) is the amount of time, in
ms (milliseconds), that the pacemaker waits between the delivery
of an atrial pacing pulse and delivery of the corresponding
ventricular pacing pulse.
Note: The A-V Interval after an atrial sensed event (i.e., SAV) is not
programmable. The SAV is automatically set to a value 30 ms less
than the A-V INTERVAL.
Unless manually adjusted, A-V INTERVAL is set to a value determined
by the RATE setting. It can never be shorter than 50 ms or longer
than 250 ms, as determined by the following formula:
A-V INTERVAL ms
The final value is rounded off to the nearest higher multiple of 10,
within the automatic range (i.e., 50, 60, 70, . . . 230, 240, 250). For
example, at a RATE of 70 ppm, the A-V INTERVAL would be rounded
to 190 ms.
When selected on Menu 1 or 2, however, the A-V INTERVAL can be
manually set to values from 20 to 300 ms (in 10 ms increments)
that do not cause a timing violation (see Timing Violations on
page 3-41).
Note: If A-V INTERVAL is set shorter than 50 ms, ventricular events
may not be sensed during that interval, due to ventricular
blanking after an atrial event.
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SETTING
This feature sets the A-V INTERVAL, UPPER RATE, and PVARP to
automatic, rate-dependent settings (see Auto on page 7-3).
*MANUAL
DDD
Upper Rate
110 ppm
PVARP
300 mS
A-V Interval
SETTING
*200 mS
MANUAL
MANUALAUTO
SETTING
becomes accessible.
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320 ppm
RAP
80
Press
440
800
This Menu enables the Rapid Atrial Pacing (RAP) feature, but the
device continues to operate at the RATE, A OUTPUT, V OUTPUT, and
mode on the upper screen until the SELECT key is pressed.
SELECT
to DELIVER
RAPID ATRIAL
PACING
3
the nominal RAP rate of 320 ppm if RAP has not been used
since the device has been powered ON.
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Notes:
To exit Menu 3 (RAP) before five minutes have passed, press the
[
] key or the MENU key.
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Menu M (Dial-A-Mode)
This Menu allows the user to select:
AAI
DDD
DIAL-A-MODE
DDDDVIDOOVVI
Press
SELECT
to ACTIVATE
When the mode is underlined, the message to the left appears and
an arrow points to the SELECT key.
new Mode
M
The new mode is activated within the next two cycles. The PACE
and SENSE LEDs, the Setup Indicators at the top of the upper
screen, and the NBG code at the top of the Menu screens reflect
this change.
The new mode will retain the current setting of all applicable
parameters of the previous mode, if no timing violations occur. If
timing violations occur, the rate-dependent parameters will be set
to automatic values (see Timing Violations on page 3-41).
Parameters that did not apply in the previous mode will be set to
nominal values in the new mode (see Pacing Mode Transitions
on page 3-40).
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Physical Features
Battery
Battery Drawer The battery drawer, located on the lower right
side of the device, accepts a standard 9-volt alkaline or lithium
battery (see Battery Type on page 7-5).
Battery Life Battery life is typically 9 days, minimally 7 days,
continuous operation for an alkaline battery or approximately
16 days continuous operation for a lithium battery, when RATE is
set at 70 ppm and all other parameters are at nominal values (see
Nominal Values on page 7-4).
Battery Drawer Release Button Press the button at the lower
end of the device to open the battery drawer.
Reversible Battery Polarity The polarity is marked inside the
battery drawer; however, the device will also function properly if
the battery is installed with the polarity reversed.
Continued Operation After Battery Removal If the battery is
removed, the device will continue to operate for 15 seconds,
typical (seeOperation After Battery Removal on page 7-5),
under the following conditions: RATE of 70 ppm or less, A OUTPUT
and V OUTPUT of 10 mA or less, backlight off, and lower
screen blank.
Note: If the battery is removed while the backlight is on or the
lower screen is active, the device may shut down immediately
depending upon the battery level.
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Connector Block
Located at the top end of the device, the connector block has
sockets which accept patient and surgical cables (Medtronic
Patient Cable Models 5433A and 5433V and Medtronic Surgical
Cable Models 5832 and 5832S). Chamber designations are marked
A for atrium and V for Ventricle. The sockets are also color-coded
blue for atrium and white for ventricle.
The connector block also has openings for the direct connection of
heartwires or leads from 0.38 mm to 2.28 mm (0.015 inch to
0.09 inch) in diameter and from 12.67 mm to 22.8 mm (0.5 inch to
0.9 inch) in length. These connector pin receptacles are covered
with removable rubber seals to minimize contamination.
Chamber designations are marked A for atrium and V for
ventricle. The receptacles are also color-coded blue for atrium and
white for ventricle.
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1.
Ring
2.
Bails
2
Figure 3-3. Ring and Bails on the Back Side of the Model 5388.
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Functional Features
Lock Feature
This safety feature is intended to prevent inadvertent adjustment
of the upper screen parameters RATE, A OUTPUT, and V OUTPUT.
When the upper screen is locked, turning the upper screen dials
does not change the upper screen parameter values.
The upper screen parameters will lock:
When the [
] key is pressed.
When the upper screen is locked, the backlight turns off and a
padlock [ ] appears in the upper right corner of the upper screen.
To UNLOCK RATE,
A OUTPUT, and
V OUTPUT,
If the upper dials are turned while the parameters are locked, the [ ]
remains on, the backlight illuminates, and a [ ] and a
flashing [
] appear in the center of the upper screen. The lower
screen displays the message to the left.
To unlock the upper parameters, press the [
] key.
Press
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Notes:
Self-test
When the Model 5388 is turned on, the device takes approximately
four seconds to complete the power-on self-test and initialize the
screens. The self-test includes a check of the SELECT, OFF, PAUSE,
MENU, and LOCK keys, and critical internal circuits. The PACE and
SENSE LEDS light one at a time during the Power-on Self-test.
During the self-test, information in the display buffer from the
previous use of the device will appear on the upper display. This
information is cleared during screen initialization and nominal
values are restored.
Note: Pressing a key while the self-test is in process can cause the
Model 5388 to fail the self-test, and display error code, 0004. The
device may interpret the pressed key as being stuck and,
therefore, malfunctioning. If a key is pressed during the self-test,
remove and re-insert the battery to clear the error code. If the
self-test fails again, remove the battery and return the device to
Medtronic for service (see the addresses on the back cover of
the manual).
During screen initialization the low battery indicator may appear.
This does not indicate that the battery is low, unless the backlight
does not turn on and the indicator remains visible during
device operation.
Sensing begins after successful completion of the self-test. Pacing
begins approximately one second after sensing, if not inhibited by
a sensed event.
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Should the device fail the self-test, one of the PACE or SENSE LEDS
remains on and no output pulses are issued. Failure codes may be
displayed on the lower screen. Remove the battery and return the
device for service (see the addresses on the back cover of
the manual).
Note: Each time the MENU key is pressed the device checks the
SELECT key. If the SELECT key is found to be stuck, the menus will
not advance. Shut the device down by pressing OFF twice and
return the device for service.
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Refractory Periods
The refractory period is the interval during which a sensed event
does not affect pacing timing. However, an event sensed inside
refractory but outside blanking (i.e., a refractory sense) restarts
blanking and refractory periods (see the Pacemaker Diagnostic
Diagrams).
During refractory, a sensed event in the atrium causes the A SENSE
LED to flash. However, a refractory sensed event in the ventricle
does not cause the V SENSE LED to flash.
Atrial Refractory The two types of atrial refractory periods in
the Model 5388 are:
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Reversion Operation
This safety feature is designed to prevent inappropriate pacing
therapy during continuous interference, such as noise or
arrhythmias. When sensed events are continuously detected by
the pacemaker, the device reverts to predetermined modes until
the interference stops.
This response occurs when refractory sensed events are
continuously detected.
In single-chamber pacing, continuous refractory sensing will
cause AAI to revert to AOO, and VVI to revert to VOO.
In dual-chamber pacing, continuous refractory sensing in the
atrium causes the device to inhibit atrial pacing pulses.
Continuous refractory sensing in the ventricle causes the device to
pace asynchronously in the ventricle.
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Wenckebach Response
In DDD mode, when the intrinsic atrial rate increases beyond the
UPPER RATE, the device continues to lengthen the SAV interval
until a P-wave falls within the PVARP, and thus is not sensed.
Because the P-wave is not sensed, the SAV interval is not started,
and a ventricular pace is not issued.
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3-40
Parameters that did not apply in the previous mode will be set
to nominal (or rate-dependent) values in the new mode.
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Timing Violations
If the relationship between two or more parameters reaches a
point where improper pacing could occur, further change in the
conflicting direction is prevented.
A summary of the timing violations not allowed by the
5388 follows.
Mode Changes
During a mode change, if one or more of the rate-dependent
parameters was manually set in the previous mode to a value
that will cause improper pacing to occur in the new mode, then
the device changes the parameter to its automatic,
rate-dependent setting.
Parameter Adjustments
During adjustments of the rate-dependent parameters, if the user
tries to set the parameters to values that violate timing rules, a
warning message will overwrite the Menu and stay on for 10
seconds (see the following paragraphs for the specific messages).
During those 10 seconds, either:
Press the MENU key to activate Menu 2 and adjust the ratedependent parameter or set the device to automatic settings,
using SETTING (see SETTING on page 3-27).
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Adjust RATE or
parameters
on Menu 2.
+ 70 ms RATE Interval
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WARNING
Pacemaker block
point reached.
A-V INTERVAL
Adjust RATE or
parameters
on Menu 2.
Turn the RATE down, or access Menu 2 and adjust the manually set
parameter, or set the device to automatic using SETTING (see
SETTING on page 3-27).
WARNING
RATE cannot
exceed UPPER
RATE.
If the user tries to set the RATE above the UPPER RATE or vice versa,
then the message to the left appears in the lower screen:
Adjust RATE or
UPPER RATE
on Menu 2.
Turn the RATE down, or access Menu 2 and increase UPPER RATE or
set UPPER RATE to automatic, using SETTING (see SETTING on
page 3-27).
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4-3
4-4
Connector Setup
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Battery Installation
To install (or replace) the battery, press the battery drawer release
button until the battery drawer opens (see Figure 4-1). Remove
the old battery and replace it with a new 9-Volt type 6LR61 or
type 6F22E, or NEDA 1604A (Eveready 522 or equivalent)
alkaline battery or a NEDA 1604LC (Ultralife U9VL or equivalent)
lithium battery. Make sure the drawer clicks shut.
Note: Use of other than the recommended batteries may result in
one of the following conditions: (1) less than 24 hours of operation
after the low-battery indicator comes on, (2) degraded pacemaker
performance, and/or (3) overall reduced battery life.
NT
ZX.
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Disposable Pouch
Description
The Model 5409 Disposable Pouch is designed to protect and hold
the Model 5388 Temporary Pacemaker. The pouch consists of a
see-through plastic pocket mounted on an attachment panel. The
pouch should be disposed of after one patient use. The pouch
can be hung from an IV stand, secured to the patient or the
patients bed (Figure 4-2.1), or secured to an ambulatory patient
with the addition of velcro straps (Figure 4-2.2), which may be
ordered from Medtronic (see the Medtronic Instrument
Accessories catalog).
PACE
A SENSE
PACE
PACE
V SENSE
SENSE
SELECT
MENU
EMERGENCY
PAUSE
A S Y NC
OFF
ON
MEDTRONIC 5388
Dual Chamber
Temporary Pacemaker
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Cables
Medtronic Models 5433A and 5433V
Patient Cables
The Patient Cable Models 5433A and 5433V are designed to
connect atrial and ventricular pacing lead systems to the
Medtronic Model 5388 Temporary Pacemaker for temporary,
external pacing.
The Patient Cable Models 5433A and 5433V have recessed, nonexposed pins. They are reusable, supplied non-sterile, and should
be sterilized prior to use, using either steam (reliable up to
25 autoclave cycles) or ethylene oxide (see Sterilization on
page 6-3).
The lead connector assembly at one end of each cable accepts
endocardial or myocardial pacing lead connector pins 0.38 mm to
2.41 mm (0.015 inch to 0.095 inch) in diameter. The terminal
connector at the other end of each cable is designed to mate with
the output terminal on the Model 5388 pacemaker.
Do not expose the cables to storage temperatures above
66C (150F) or below -40C (-40F).
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The two cables are identical except for color coding and markings:
The Model 5433A, for atrial use, has a blue connector block
and blue band around the terminal pin block. One side of the
connector block carries a symbol denoting Atrial Use (see
Figure 4-3.1).
1.
Atrial Use
2.
Ventricular Use
Figure 4-3. The Model 5433A Atrial Use symbol and the Model 5433V
Ventricular Use symbol.
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Connector Setup
Connecting or disconnecting the
Model 5433A or 5433V Patient Cable to
or from the Model 5388
w
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Figure 4-4. Connecting the Model 5433A or 5433V Patient Cable to the
Model 5388 Temporary Pacemaker.
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Figure 4-6. Connecting the pacing lead system to the Model 5433A or
5433V Patient Cable receptacles.
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2. Push the connector pins into the holes on the connector block
as shown (see Figure 4-8).
Caution: DO NOT insert the pins into the receptacle for the
patient cable.
For bipolar systems Insert each pin into the proper
receptacle (marked + and ) of the appropriate chamber
(marked A or V). Bipolar lead systems may exhibit
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User Guide
Overview
Indicators
5-2
5-4
Basic Operation
5-6
Connector Setup
5-17
Pacing Parameter
Adjustments 5-19
Thresholds 5-27
Pacing Setup 5-35
RAP (Rapid Atrial
Pacing) 5-39
Battery Replacement
5-41
Tables 5-43
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User Guide
Overview
Overview
Features
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User Guide
Overview
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User Guide
Indicators
Indicators
Pace/Sense LEDs
Low Battery
Indicator
A +V
A +V
DDI
30
RATE
DDI Indicator
80
120
Setup
ppm
Indicators
Padlock Icon
200
Pace/Sense LEDs
One set of pace/sense LEDs is for the atrium; the other for the
ventricle. The green pace LED flashes each time the device
delivers a pacing stimulus. The orange sense LED flashes each
time the device senses the patients heartbeat.
Setup Indicators
The setup indicators identify in which chamber(s) the device is
setup to pace and in which chamber(s) the device is setup to sense
,
A
V , or A +V .
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User Guide
Indicators
DDI Indicator
This indicator appears while the device is pacing in the DDI mode.
When the device is in DDD mode (dual chamber pacing and
sensing), manually turning off A (Atrial) TRACKING changes the
mode to DDI.
Lock Indicator
The padlock icon appears when the three upper dials are locked,
indicating that RATE and OUTPUT cannot be adjusted. If you turn
the RATE, A OUTPUT, or V OUTPUT dial, the upper screen displays
another padlock symbol along with a flashing key symbol. The
lower screen displays a message that tells you how to unlock the
upper dials for RATE and OUTPUT.
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User Guide
Basic Operation
Basic Operation
On/Off
ASYNC.
Dual Chamber
Temporary Pacemaker
If the device fails the self-test, the device remains on but does
not pace.
If the device passes the self-test, the upper and lower screens
initialize, the backlights turn on, and dual chamber pacing
and sensing begin at these nominal values:
Table 5-1. Nominal Values at Power-On.
RATE
80 ppm
A-V INTERVAL
170 ms
A OUTPUT
10 mA
A SENSITIVITY
0.5 mV
V OUTPUT
10 mA
V SENSITIVITY
2.0 mV
UPPER RATE
110 ppm
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User Guide
Basic Operation
To Turn Device On
Press the ON key.
Note: Pressing the EMERGENCY key also turns the device on.
To SHUT DOWN,
Press OFF again.
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User Guide
Basic Operation
Emergency Pacing
Pressing the EMERGENCY key initiates high output dual chamber
asynchronous pacing at these parameter values:
Table 5-2. Emergency Pacing Values.
Current setting
(or 80 ppm) if
device is off
when
RATE
A-V INTERVAL
Current setting
(or 170 ms if
device is off
when
EMERGENCY
EMERGENCY
key is pressed)
key is pressed)
A OUTPUT
20 mA
A SENSITIVITY
ASYNC.
V OUTPUT
25 mA
V SENSITIVITY
ASYNC.
Dual Chamber
Temporary Pacemaker
A SENSITIVITY
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User Guide
Basic Operation
Lock/Unlock
The LOCK/UNLOCK key locks and unlocks the three upper dials.
When the upper dials are locked, the padlock icon appears and the
rate, atrial output, and ventricular output cannot be adjusted.
Also, the screen backlight is turned off.
A +V A +V
30
80
120
RATE
200
ppm
The lock icon and flashing key icon appear in the middle
of the screen if dials are turned while the upper screen
is locked.
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User Guide
Basic Operation
To Pause
ASYNC.
Dual Chamber
Temporary Pacemaker
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User Guide
Basic Operation
30
120
RATE
OFF
0.1
10
20
A OUTPUT
OFF
0.1
200
ppm
10
V OUTPUT
mA
20
25
mA
The upper dials are used to adjust the pacing rate (ppm), atrial
output (mA), and ventricular output (mA). The upper screen
displays a numerical value and segmented line graph that reflects
the current setting for each dial.
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User Guide
Basic Operation
To Adjust Rate
Turn the RATE dial clockwise to increase the rate;
counterclockwise to decrease the rate.
Rate range: 30 ppm to 200 ppm
Note: When the rate is set higher than 120 ppm, the bar size
on the segmented line graph gets taller and thicker.
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User Guide
Basic Operation
Demand Pacing
During demand (synchronous) pacing, output is inhibited when
the pacemaker senses intrinsic activity. This minimizes
competition between the paced rhythm and the intrinsic activity
of the heart.
Note: Be sure to determine sensitivity thresholds (see page 5-28),
or asychronous pacing may occur.
When the device is off, pressing the ON key immediately initiates
dual chamber demand pacing. To quickly change from dual
chamber to single chamber demand pacing, set either A OUTPUT or
V OUTPUT to OFF.
A SENSITIVITY is
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Basic Operation
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User Guide
Basic Operation
Asynchronous Pacing
Patients best suited for asynchronous (non-sensing) modes have:
No intrinsic activity.
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User Guide
Basic Operation
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User Guide
Connector Setup
Connector Setup
Model 5832
Model 5433A/
5433V
Figure 5-8. Cables.
Notes:
Do not connect the Model 5388 to the lead system if the Model
5388 is turned on and is operating at an output amplitude that
could cause capture.
1. Plug the Model 5433A and Model 5433V patient cables into
appropriate sockets at the top end of device (see Figure 5-9).
or
Plug a pair of Model 5832 or Model 5832S surgical cables into
appropriate sockets at the top end of device (see Figure 5-9).
One socket is marked A (atrium); the other V (ventricle).
Note: To disconnect cable from the device, press connector release
button on cable and pull gently from socket.
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User Guide
Connector Setup
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User Guide
Pacing Parameter Adjustments
The MENU key activates the lower screen and allows you to
page through the four menus listed here (see Figure 5-11):
Menu 1
Menu 2
Menu 3
Menu M
Dial-a-Mode
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User Guide
Pacing Parameter Adjustments
DDD
DDD
A Sensitivity
0.5 mV
80
V Sensitivity
10
20
2.0 mV
155
170 mS
A Tracking
ON
300 mS
A-V Interval
170 mS
SETTING
Menu 1:
Pacing Parameters
DDD
Menu 2:
Rate-Based
Pacing Parameters
AAI
320 ppm
RAP
440
Press
230
PVARP
0.8
A-V Interval
80
110 ppm
Upper Rate
800
SELECT
to DELIVER
DOO
DIAL-A-MODE
DDDDVIDOOVVI
Press
SELECT
to ACTIVATE
RAPID ATRIAL
PACING
3
new Mode
M
Menu 3:
Rapid Atrial Pacing
Menu M:
Dial-A-Mode
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User Guide
Pacing Parameter Adjustments
Sensitivity
DDD
A Sensitivity
0.5 mV
V Sensitivity
2.0 mV
20
10
0.8
A-V Interval
170 mS
A Tracking
ON
SELECT
MENU
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Pacing Parameter Adjustments
Notes:
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User Guide
Pacing Parameter Adjustments
Rate-Dependent Parameters
UPPER RATE, PVARP,
DDD
*106 ppm
Upper Rate
80
155
230
PVARP
300 mS
A-V Interval
170 mS
SETTING
MANUAL
2
Figure 5-13. Upper Rate.
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User Guide
Pacing Parameter Adjustments
To Adjust PVARP
1. Press the MENU key until Menu 2 is displayed.
2. Press the SELECT key until PVARP is highlighted.
3. Turn the MENU PARAMETER dial clockwise to lengthen the
PVARP; counterclockwise to shorten the PVARP.
DDD
*MANUAL
*106 ppm
Upper Rate
*310 mS
PVARP
150
325
A-V Interval
SETTING
500
170 mS
MANUAL
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User Guide
Pacing Parameter Adjustments
DDD
Upper Rate
*106 ppm
PVARP
*310 mS
*200 mS
A-V Interval
20
160
SETTING
300
MANUAL
2
Figure 5-15. A-V Interval.
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Pacing Parameter Adjustments
110 ppm
PVARP
300 mS
A-V Interval
170 mS
SETTING
AUTO
MANUALAUTO
2
Figure 5-16. Resetting to Automatic Values.
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User Guide
Thresholds
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 presented
in this section.
Note: To reduce the risk of competitive pacing, find the sensing
thresholds first (if the patients intrinsic rhythm is adequate).
Sensing Definitions
The ECG below shows intrinsic beats mixed with paced beats. The
pacemaker detects the hearts own beat and does not deliver a
pacing stimulus.
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User Guide
Thresholds
Sensing Threshold
The sensing threshold is the least sensitive setting at which the
pacemaker can detect a heartbeat. Monitor the patients ECG and
blood pressure as you follow the procedure to find the atrial and
ventricular sensing thresholds.
Safety Margin
Lead maturation and drug therapy can affect the threshold. To
ensure sensing and accommodate a changing threshold, it is
important to provide at least a 2:1 safety margin. Set
A SENSITIVITY/V SENSITIVITY to a value that is at least one-half to
one-third the sensing threshold value. For example, an
appropriate setting for a patient with a 5.0 mV sensing threshold
is 2.5 mV or less.
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User Guide
Thresholds
80
30
120
RATE
OFF
0.1
10
20
A OUTPUT
OFF
0.1
200
ppm
10
mA
20
V OUTPUT
25
mA
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Thresholds
0.5 mV
V Sensitivity
2.0 mV
20
10
0.8
0.5 mV
V Sensitivity
2.0 mV
20
10
0.8
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Thresholds
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, as in the example shown here:
When capture is lost, the ECG shows no heart response after the
pulse, as in the example shown here:
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User Guide
Thresholds
Stimulation Threshold
The stimulation threshold is the minimum output (mA) needed to
consistently capture the heart. Monitor the patients ECG and
blood pressure as you follow the procedure to find the atrial and
ventricular stimulation thresholds.
Safety Margin
Lead maturation and drug therapy can affect the threshold. To
achieve consistent capture and accommodate a changing
threshold, it is important to provide at least a 2:1 safety margin. Set
A OUTPUT/V 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.
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User Guide
Thresholds
30
120
RATE
OFF
0.1
200
ppm
10
20
A OUTPUT
mA
Atrial or
Ventricular
OFF
0.1
10
V OUTPUT
20
25
mA
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Thresholds
80
30
120
RATE
OFF
0.1
200
ppm
10
20
A OUTPUT
mA
Atrial or
Ventricular
OFF
0.1
10
V OUTPUT
20
25
mA
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User Guide
Pacing Setup
Pacing Setup
The Medtronic Model 5388 Temporary Pacemaker can be set to a
single chamber mode (AOO, VOO, AAI, VVI) or a dual chamber
mode (DDD, DDI, DVI, DOO).
To quickly set the device to the desired pacing mode, adjust
OUTPUT (upper dials), SENSITIVITY (Menu 1), and/or A (Atrial)
TRACKING (Menu 1).
The Pacing Setup Table (see page 5-43) provides a quick reference
for selecting a pacing mode. Refer to Basic Operation (see
page 5-6) and Pacing Parameter Adjustments (see page 5-19) for
step-by-step instructions on how to adjust output and sensitivity.
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User Guide
Pacing Setup
Atrial Tracking
To change from DDD to DDI mode, set A TRACKING to OFF (from
Menu 1). Conversely, to change from DDI to DDD mode, set
A TRACKING to ON (from Menu 1).
DDI
A Sensitivity
0.5 mV
V Sensitivity
2.0 mV
A-V Interval
170 mS
A Tracking
OFF
SELECT
OFF ON
MENU
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User Guide
Pacing Setup
Dial-A-Mode
Menu M allows you to select DDD, DOO, DVI, or VVI pacing
modes.
AAI
DOO
DIAL-A-MODE
DDDDVIDOOVVI
Press
SELECT
to ACTIVATE
SELECT
new Mode
M
MENU
To Dial-a-Mode
1. Press the MENU key until Menu M is displayed.
2. Turn the MENU PARAMETER dial to underline desired
pacing mode.
3. Press the SELECT key to activate the selected pacing mode.
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Pacing Setup
Example: If you change from DVI to DDD mode, the setting for
A-V INTERVAL is retained or carried forward. UPPER RATE and
PVARP are set to their automatic, rate-dependent values.
Nominal or previously programmed settings for OUTPUT
and SENSITIVITY.
Example: If you change from AAI to DDD mode, the value for
is retained; V OUTPUT is set to the nominal value.
A OUTPUT
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User Guide
RAP (Rapid Atrial Pacing)
Caution: RAP is for atrial use only. Be sure the leads are
connected to the atrium, not the ventricle, before enabling RAP.
DDD
320 ppm
RAP
80
Press
440
800
SELECT
to DELIVER
RAPID ATRIAL
PACING
3
SELECT
MENU
To Deliver Rap
1. Verify that the leads are in contact with the atrium and are
connected to the atrial channel of the device through a
patient or surgical cable.
2. Press the MENU key until Menu 3 is displayed.
Screen displays RAP rate (initial rate of 320 ppm or rate last set).
Pacing continues at currently displayed settings.
3. Adjust RAP rate as needed: Turn the MENU PARAMETER dial
clockwise to increase rate; counterclockwise to decrease rate.
Range: 80 ppm - 800 ppm
4. Press and hold SELECT to deliver RAP burst.
AOO pacing begins at displayed RAP rate and current A OUTPUT.
The A PACE LED flashes during delivery of RAP pulses.
Note: There is no ventricular support during RAP.
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User Guide
RAP (Rapid Atrial Pacing)
Note: If A OUTPUT is set to OFF when you press the SELECT key,
RAP is delivered at 10 mA. A OUTPUT returns to the OFF setting as
soon as you release the SELECT key even if you adjust A OUTPUT
during RAP delivery.
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User Guide
Battery Replacement
Battery Replacement
Replace the battery for each new patient, and when the low
battery indicator appears during device operation (see page 3-13).
Use a fresh 9V alkaline or lithium battery (Ultralife U9VL,
Eveready 522, or equivalent).
Check the battery status at least twice daily. Replace alkaline
batteries at least once every week when the temporary pacemaker
is in continuous use.
NT
ZX.
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User Guide
Battery Replacement
To Replace Battery
Note: Medtronic does not recommend replacing the battery while
the pacemaker is turned on. However, if during an emergency
situation the battery must be replaced while the device is in use,
ensure that the device is locked (see Lock/Unlock Key on
page 3-2), then replace the battery. Pacing is maintained for 15
seconds, typical, at 70 ppm and nominal outputs (see Operation
After Battery Removal on page 7-5).
1. Turn device off.
2. Press button on the bottom of the device to open
battery drawer.
3. Remove old battery and discard.
4. Insert fresh battery as shown on the diagram inside the
battery drawer.
Note: The device works with the battery polarity reversed.
5. Close battery drawer. Make sure it clicks.
6. Press the ON key to start power-on self-test.
The pace/sense and battery indicators flash briefly. If the device
passes the power-on self-test, dual chamber demand pacing and
sensing begin.
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123
1
NA
NA
ASYNC
Off
On
PACE SENSE
VOO
A
NA
On
NA
On
Off
PACE SENSE
AAI
NA
NA
On
Off
On
PACE SENSE
VVI
NA
ASYNC
ASYNC
On
On
A+V
PACE SENSE
DOO
NA
ASYNC
On
On
On
A+V
PACE SENSE
DVI
On
On
On
On
On
A+V A+V
PACE SENSE
DDD
DDI
Off
On
On
On
On
A+V A+V
DDI
PACE SENSE
* Caution: DAD and OOO are accessible modes, but are not recommended. Refer to Controls, Indicators, and Other Features in the
technical manual.
NA
3. Set A Tracking
On
Off
ASYNC
NA
PACE SENSE
AOO
A Sensitivity
V Sensitivity
2. Set Sensitivity
A Output
V Output
1. Set Output
Instructions
Setup Indicators
Tables
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User Guide
Tables
124
5-43
5-44
X
Chamber Sensed
V Ventricle
A Atrium
D Dual (A+V)
O None
X
Chamber Paced
V Ventricle
A Atrium
D Dual (A+V)
O None
O None
D Dual
I Inhibits pacing
T Triggers pacing
Sensed Response
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User Guide
Tables
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User Guide
Tables
Int
(ms)
Rate
(bpm)
Int
(ms)
Rate
(bpm)
Int
(ms)
30
2000
100
600
390
154
35
1714
110
545
400
150
40
1500
120
500
410
146
45
1333
130
462
420
143
50
1200
140
429
430
140
52
1154
150
400
440
136
54
1111
160
375
450
133
56
1071
170
353
460
130
58
1034
180
333
470
128
60
1000
190
316
480
125
62
968
200
300
490
122
64
938
210
286
500
120
66
909
220
273
510
118
68
882
230
261
520
115
70
857
240
250
530
113
72
833
250
240
540
111
74
811
260
231
550
109
76
789
270
222
560
107
78
769
280
214
570
105
80
750
290
207
580
103
82
732
300
200
590
102
84
714
310
194
600
100
86
698
320
188
610
98
88
682
330
182
620
97
90
667
340
176
630
95
92
652
350
171
640
94
94
638
360
167
650
92
96
625
370
162
98
612
380
158
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User Guide
Tables
5-46
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Device Maintenance
Cleaning and
Sterilization 6-2
Safety and Technical
Checks 6-4
Service
6-4
6-1
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Device Maintenance
Cleaning and Sterilization
Sterilization
The Model 5388 can be exposed to ethylene oxide gas for
disinfection. Due to the variability among sterilizers, precise
sterilization instructions must come from the sterilizer
manufacturer. However, the process should not exceed
temperatures of 52C (125F) nor pressures of 103 kPa (15 PSIG).
Use an acceptable method such as biological indicators for
determining sterilizer effectiveness.
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Device Maintenance
Cleaning and Sterilization
Cleaning
Prior to sterilization, the Model 5433A or 5433V Patient Cable
should be cleaned thoroughly with a mild detergent or
70% isopropyl alcohol to remove all visible blood and body fluids.
The cables may be immersed for cleaning. The cables must be
thoroughly dried after cleaning.
Inspection and testing by a qualified technician should be done
after cleaning to verify proper cable function.
Sterilization
Note: While either of the following sterilization methods is
acceptable, repeated steam sterilization typically causes more
rapid degradation.
Steam Sterilization Remove the cable from the original package
and place the cable in a suitable autoclavable packaging material.
The packaged cable should be autoclaved at:
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Device Maintenance
Safety and Technical Checks
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, or call
or write Medtronic at the appropriate address or telephone
number listed on the back cover.
The Medtronic Model 5388 Temporary Pacemaker has been
carefully engineered, manufactured and quality tested to provide
long, trouble-free service. Should service or repair be necessary,
contact your local Medtronic representative at the appropriate
address or telephone number listed on the back cover.
A serial number identifying each individual pacemaker is printed
on the back surface of the device. This serial number should be
referenced in any correspondence regarding this device.
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Device Maintenance
Special Notices
Special Notices
Special Notice for the Medtronic Model
5388 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 5388 Temporary Pacemaker will
efficiently restore adequate cardiac function for all patients. For
information regarding common causes of pacing difficulty,
consult other portions of the manual.
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Device Maintenance
Special Notices
6-6
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Specifications
Device Specifications
7-2
7-1
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Specifications
Device Specifications
Device Specifications
The following specifications apply at 20C (68F) 2C (4F) and
with a 500 ohm ( 1%) load.
Modes
Base Rate
30 200 ppm 5%
80 800 ppm 5%
Output Amplitude
Atrial
(200-1000 Ohms)
Ventricular
7-2
1.0 ms 10%
1.5 ms 10%
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Specifications
Device Specifications
Sensitivity**
Atrial
Ventricular
A-V Interval
Auto
ASYNC,
0.4 10 mV 0.3 mV or 25%
ASYNC,
0.8 20 mV 0.3 mV or 25%
50 250 ms
5 ms or 5% (PAV)
15 ms or 15% (SAV)
Manual
in 10 ms increments
Refractory Period
Atrial
At atrial event
250 ms 10%
At ventricular event
(PVARP)
Auto
(all values are 10%)
Rate range
100 ppm
105 150 ppm
155 180 ppm
>180 ppm
Manual
PVARP
300 ms
250 ms
225 ms
200 ms
250 ms 10%
Ventricular
Upper Rate
Auto
Manual
Occurs 110 ms after atrial pace, if A-V interval is set to more than
110 ms, or at programmed A-V interval if A-V interval is set to less than
110 ms
Safety Pace
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Specifications
Device Specifications
Blanking
Atrial
At atrial pace
DDD, DDI
AAI
At atrial sense
At atrial refractory
sense
At ventricular pace
At ventricular sense
Ventricular
At atrial pace
At ventricular pace
At ventricular sense
Rate Limit
Nominal Values
Mode
Rate
Output Amplitude
Atrial
Ventricular
Pulse Width (fixed)
Atrial
Ventricular
Sensitivity
Atrial
Ventricular
AV Interval
Sensed
Paced
PVARP
Upper Rate
Rapid Atrial Pacing Rate
7-4
A-V Interval
125 ms + 50 ms/-0 ms
AAI
A-V Interval
75 ms + 50 ms/-0 ms
75 ms + 50 ms/-0 ms
DDD, DDI
125 ms + 50 ms/-0 ms
75 ms + 50 ms/-0 ms
20 ms + 5 ms/-10 ms
125 ms + 50 ms/-0 ms
75 ms + 50 ms/-0 ms
A crystal is used to set the pacing rate. If the crystal rate deviates from
the appropriate value, the rate runaway protection circuit resets the
device once. If the crystal rate remains incorrect, the rate runaway
protection circuit turns the device off.
DDD
80 ppm
10 mA
10 mA
20 mA for Emergency
25 mA for Emergency
1.0 ms
1.5 ms
0.5 mV
2.0 mV
140 ms
170 ms
300 ms
110 ppm
320 ppm
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Specifications
Device Specifications
Dimensions
Height
Width
Depth (without dials)
Weight (with battery)
Temperature
Operating
Storage (without battery)
Battery Type
Safety Standards
International
Canadian
Japanese
EMC Standards
International
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Specifications
Device Specifications
7-6
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Pacemaker Diagnostic
Diagrams
A-2
A-3
A-7
A-1
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Definitions
A-3
AOO
A-8
VOO
A-9
AAI
A-10
VVI
A-12
A-2
A-2
DOO Mode
DVI Mode
DDD Mode
DDI Mode
A-7
A-14
A-14
A-16
A-24
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Definitions
Throughout this manual certain terms and symbols are used that
are defined here for clarity.
The software program operating in the Model 5388 provides the
pacemaker with the capabilities to respond to sensed signals in
unique ways and to produce appropriate output signals. Some of
the most frequently used terms to describe the software program
activity of the Model 5388 are:
Ventricular Safety Pace. A stimulus to the ventricle to prevent
inappropriate inhibition (see Ventricular Safety Pacing on
page 3-39).
VSP
PVC
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A-4
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A-PACE
*
A
ARS
PAAB
V
PAVB
PVVB
PVVR
V-PACE
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Refractory Periods
PVARP The Post Ventricular Atrial Refractory Period prevents
atrial sensing of crosstalk (far-field R-wave, retrograde conducted
R-wave), which may trigger PMT (pacemaker-mediated
tachycardia). PVARP also provides a reversion window.
PVVR Period The Post Ventricular Ventricular Refractory period
provides a reversion window.
PAAR Period The Post Atrial Atrial Refractory period is started
only when an atrial event is sensed inside PVARP.
The two A-V intervals are:
PAV Interval Pace A-V interval (A-V INTERVAL) is the A-V interval
after an atrial pace. It is programmable.
SAV Interval Sense A-V interval is the A-V interval after an atrial
sense. This parameter is not programmable and is set to PAV
minus 30 ms.
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A-7
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AOO
Intrinsic Atrial
Activity
Programmed
Base Rate
A
A00
V
When the base RATE interval times out, the pacemaker will:
A-8
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VOO
PVC
Programmed
Base Rate
A
V00
V
When the base RATE interval times out, the pacemaker will:
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AAI
Programmed
Base Rate
Programmed
Base Rate
Restarted
A
AAI
V
Blanking After Sense = 125 ms
Blanking After Pace = 175 ms
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AAI
Programmed
Base Rate
Noise
Programmed
Base Rate
Restarted
A
AAI
V
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VVI
Programmed
Base Rate
Programmed
Base Rate
Restarted
A
VVI
V
A-12
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VVI
Programmed
Base Rate
Noise
Programmed
Base Rate
Restarted
A
VVI
V
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DOO Mode
When pacing in the A-V sequential asynchronous mode (DOO),
the pacemaker will pace the atrium and the ventricle
asynchronously at the programmed base RATE and with the
programmed A-V INTERVAL. Both channels are
continuously blanked.
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DOO
PVC
PAC
A
DOO
V
Programmed
Base Rate
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DVI Mode
In the ventricular demand A-V sequential (DVI) mode there is no
atrial sensing function. If a ventricular event is sensed outside of
a refractory period during the V-A interval, the pacemaker
restarts the V-A interval. If a ventricular event is sensed during
the programmed A-V INTERVAL, the pacemaker inhibits the
ventricular stimulus and starts the V-A interval. The exception to
this is safety pacing, which is described later.
This mode is normally used when A-V synchrony is desired but
the atrium is prone to arrhythmias.
Notes:
A-16
PVARP
When pacing in the DVI mode, the pacemaker will pace the
atrium and the ventricle at the programmed base RATE and
with the programmed A-V INTERVAL in the absence of detected
ventricular electrical activity. The atrial sense amplifier is
continuously blanked.
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DVI
A
DVI
V
Start
VSP
Timer
AV Interval = 170 ms
VA Interval = 580 ms
Base Rate Interval = 750 ms
* End
VSP
Timer
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DVI
PVC
A
DVI
V
*
VA Interval
Restarted
AV Interval = 170 ms
VA Interval = 580 ms
Base Rate Interval = 750 ms
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DVI
PVC
A
DVI
V
*
AV Interval = 170 ms
VA Interval = 580 ms
Base Rate Interval = 750 ms
*
Ventricular Refractory = 250 ms
Blanking After Pace = 175 ms
Blanking After Sense = 125 ms
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DVI
A
DVI
V
Start
VSP
Timer
Stop
VSP
Timer
(110 ms)
AV Interval = 170 ms
VA Interval = 580 ms
Base Rate Interval = 750 ms
A-20
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DVI
A
DVI
V
Sense Due
To Crosstalk
Start
VSP
Timer
AV Interval = 170 ms
VA Interval = 580 ms
Base Rate Interval = 750 ms
*
Safety
Pace
110 ms
If the A-V INTERVAL is programmed to more than 110 ms, then when
a ventricular sensed event occurs inside the ventricular safety
pace window, the pacemaker will:
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DVI
A
DVI
V
*
AV
Interval
Start
VSP
Timer
Sense Due
To Crosstalk
80
ms
AV
Interval
*
80
ms
Stop
VSP
Timer (110 ms)
VA Interval
670 ms
AV Interval = 80 ms
VA Interval = 670 ms
Base Rate Interval = 750 ms
VA Interval
670 ms
Ventricular Refractory = 250 ms
Blanking After Pace = 175 ms
Blanking After Sense = 125 ms
If the A-V INTERVAL is programmed to less than 110 ms, then when
a ventricular sensed event occurs inside the ventricular safety
pace window, the pacemaker will:
Start the PVVR and PVVB (after sense) periods.
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DVI
Noise
A
DVI
V
Safety Pace
AV Interval = 170 ms
VA Interval = 580 ms
Base Rate Interval = 750 ms
A-V INTERVAL
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DDD Mode
This mode provides a P-wave synchronous rate response with AV sequential pacing. Intrinsic activity in the atrium and ventricle
inhibits output stimuli and restarts certain timers.
Without atrial events within certain periods, the pacemaker
delivers a pacing stimulus to the atrium at the end of the
V-A interval which is equal to the programmed base RATE minus
the programmed A-V INTERVAL.
Without ventricular activity during certain periods, the
pacemaker delivers a pacing stimulus to the ventricle at the end of
the programmed A-V INTERVAL. An exception to this is safety
pacing, which is illustrated in the diagrams.
The pacing rate can be limited by the programmed UPPER RATE so
that the pacemaker does not pace the ventricle too fast in the
presence of atrial arrhythmias.
When pacing in the DDD mode, the pacemaker will pace the
atrium and the ventricle at the programmed base RATE and with
the programmed A-V INTERVAL in the absence of detected atrial or
ventricular intrinsic events.
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DDD
PVARP
A
DDD
V
Programmed
Upper
Rate
Start
VSP
Timer
AV Interval = 170 ms
VA Interval = 580 ms
Base Rate Interval = 750 ms
Upper Rate Interval = 545 ms
Stop
VSP
Timer
PVARP = 300 ms
Ventricular Refractory = 250 ms
Blanking After Pace = 175 ms
Blanking After Sense = 125 ms
Start the PAAB period, which is set to the same value as the
A-V INTERVAL,
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DDD
PVARP
A
DDD
V
Programmed
Upper
Rate
Start
VSP
Timer
Stop
VSP
Timer
AV Interval = 170 ms
VA Interval = 580 ms
Base Rate Interval = 750 ms
Upper Rate Interval = 545 ms
PVARP = 300 ms
Ventricular Refractory = 250 ms
Blanking After Pace = 175 ms
Blanking After Sense = 125 ms
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DDD
A
DDD
V
Start
VSP
Timer
Stop
VSP
Timer
*
PVARP = 300 ms
Ventricular Refractory = 250 ms
Blanking After Pace = 175 ms
Blanking After Sense = 125 ms
Start the PAAB period, which is set to the same value as the
SAV interval, and
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DDD
Retrograde
Conduction
A
DDD
V
*
PVARP = 300 ms
Ventricular Refractory = 250 ms
Blanking After Pace = 175 ms
Blanking After Sense = 125 ms
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DDD
PAC
A
DDD
V
Programmed
Upper Rate
Programmed
Upper Rate
PVARP = 300 ms
Ventricular Refractory = 250 ms
Blanking After Pace = 175 ms
Blanking After Sense = 125 ms
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DDD
*
A
DDD
V
Programmed
Upper Rate
Programmed
Upper Rate
(Restarted)
PVARP = 300 ms
Ventricular Refractory = 250 ms
Blanking After Pace = 175 ms
Blanking After Sense = 125 ms
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DDD
A
DDD
V
Programmed
Upper Rate
Programmed
Upper Rate
(Restarted)
SAV Interval = 170 ms 30 ms = 140 ms
VA Interval = 580 ms
Base Rate Interval = 750 ms
Upper Rate Interval = 545 ms
PVARP = 300 ms
Ventricular Refractory = 250 ms
Blanking After Pace = 175 ms
Blanking After Sense = 125 ms
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DDD
A
DDD
V
Start
VSP
Timer
Stop
VSP
Timer
AV Interval = 170 ms
VA Interval = 580 ms
Base Rate Interval = 750 ms
Upper Rate Interval = 545 ms
PVARP = 300 ms
Ventricular Refractory = 250 ms
Blanking After Pace = 175 ms
Blanking After Sense = 125 ms
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DDD
A
DDD
V
Sense Due
To Crosstalk
Start
VSP
Timer
Programmed
Upper Rate
Safety
Pace
AV Interval = 170 ms
VA Interval = 580 ms
Base Rate Interval = 750 ms
Upper Rate Interval = 545 ms
PVARP = 300 ms
Ventricular Refractory = 250 ms
Blanking After Pace = 175 ms
Blanking After Sense = 125 ms
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Then when the ventricular safety pace period times out 110 ms
later, the pacemaker will:
A-34
171
Medtronic
Confidential
DDD
A
DDD
V
Sense Due
To Crosstalk
AV
Interval
*
80
ms
AV Interval = 80 ms
VA Interval = 670 ms
Base Rate Interval = 750 ms
Upper Rate Interval = 545 ms
PVARP = 300 ms
Ventricular Refractory = 250 ms
Blanking After Pace = 175 ms
Blanking After Sense = 125 ms
A-35
Medtronic
Confidential
Then when the A-V INTERVAL does time out, the pacemaker will:
A-36
173
Medtronic
Confidential
DDD
PVC
Start
PVARP
(Programmed value)
Restart
VA Interval
Restart
PVARP
(400 ms)
A
DDD
V
Upper
Rate
Upper
Rate
(Restarted)
AV Interval = 170 ms
VA Interval = 580 ms
Base Rate Interval = 750 ms
Upper Rate Interval = 545 ms
PVARP = 300 ms
Ventricular Refractory = 250 ms
Blanking After Pace = 175 ms
Blanking After Sense = 125 ms
Note: PVARP is extended only during the cycle in which the PVC
is recognized. Otherwise it goes back to the programmed value.
A-37
Medtronic
Confidential
DDD
Noise
Cancelled A-Pace
A
DDD
V
Restart
Upper Rate
Interval
AV Interval = 170 ms
VA Interval = 580 ms
Base Rate Interval = 750 ms
Upper Rate Interval = 545 ms
PVARP = 300 ms
Ventricular Refractory = 250 ms
Blanking After Pace = 175 ms
Blanking After Sense = 125 ms
Notes:
atrial pace.
PVARP,
A-38
175
Medtronic
Confidential
DDD
PVC
Restart
PVARP
(400 ms)
Start
PVARP
ogrammed value)
Start PVARP
(back at
programmed value)
A
DDD
V
Start
Upper
Rate
This
sensed
event is
treated as
a PVC
PVARP = 300 ms
Ventricular Refractory = 250 ms
Blanking After Pace = 175 ms
Blanking After Sense = 125 ms
Note: PVARP is extended only during the cycle in which the PVC
is recognized. Otherwise it goes back to the programmed value.
A-39
Medtronic
Confidential
DDD
Cancelled A-pace
*
A
DDD
V
Start
Upper Rate
Interval
AV Interval = 170 ms
VA Interval = 580 ms
Base Rate Interval = 750 ms
Upper Rate Interval = 545 ms
Stop
Upper Rate
Interval
PVARP = 300 ms
Ventricular Refractory = 250 ms
Blanking After Pace = 175 ms
Blanking After Sense = 125 ms
Note: Since the atrial pacing stimulus is inhibited, the atrial pace
indicator will not be lit. The atrial sense indicator will light each
time there is an atrial event sensed inside or outside the
refractory period.
The pacemaker is essentially in VVI mode.
Note: A cancelled atrial pace will not start a ventricular safety
pace window.
A-40
177
Medtronic
Confidential
DDI Mode
The device behaves in DDI mode as in DDD mode in all aspects
except the following: the pacing in the ventricle does not track
atrial sensed events. This mode is used when physiological pacing
is desired, but the patient is prone to atrial arrhythmia.
Note: In DDI mode, UPPER RATE is not applicable.
A-41
Medtronic
Confidential
DDI
Cancelled A-Pace
*
A
DDI
V
*
Start
VSP
Timer
Stop
VSP
Timer
AV Interval = 170 ms
VA Interval = 580 ms
Base Rate Interval = 750 ms
Start the PAAB (after sense) period, which starts with the
atrial sensed event and continues until the delivery of the
ventricular pace, and
A-42
179
MEDTRONIC CONFIDENTIAL
Index
AAI mode
definition A-7
diagnostic diagrams A-10 to A-11
pacing setup table 5-43
Symbols
!? 3-20, 3-21
Numerics
2:1 safety margin
sensing threshold 5-28
stimulation threshold 5-32
3-letter code (NBG)
definition 5-44
A
A
A (atrial) SENSITIVITY
3-20
nominal value 7-4
range, increments 7-3
vs. A OUTPUT 3-20
A TRACKING
I-1
MEDTRONIC CONFIDENTIAL
Index
Atrial
arrhythmias 1-6
mapping 2-7
Atrial pacing
asynchronous 5-16
blanking specifications 7-4
contraindicated 1-6
demand (synchronous) 5-14
mode transition 3-40
output dial 3-10
refractory (ARF) 3-37
reversion response 3-38
Battery
drawer 3-31
drawer release button 3-31
indicator 3-13
life 3-31, 7-5
precaution 2-5
type 4-2, 7-5
A-V INTERVAL
A-V Intervals
paced A-V interval see A-V INTERVAL (PAV)
sensed A-V interval see SAV (sensed A-V
interval)
B
Backlight
during lock 3-2, 3-34
during low battery 3-2
C
Cable to device connections 5-17
Cable to lead system connections 4-8
Cables
description, patient 4-4
precautions 2-6
sockets for 3-32
surgical 1-2
Capture, definition 5-31
Cardioversion 2-2
Cautery 2-2
I-2
181
MEDTRONIC CONFIDENTIAL
Index
Chart
mode vs parameter settings 5-43
Contraindications 1-6
Dials 3-10
Dimensions 7-5
Disposable pouch 2-9, 4-3
DOO mode
definition A-14
diagnostic diagram A-15
menu M (Dial-a-mode) 3-30, 5-37
pacing setup table 5-43
Dual chamber modes
definitions A-14, A-16, A-24, A-41
diagnostic diagrams A-14 to A-42
I-3
MEDTRONIC CONFIDENTIAL
Index
DVI mode
definition A-16
diagnostic diagrams A-17 to A-23
menu M (Dial-a-mode) 3-30, 5-37
Features
functional 3-34 to 3-43
physical 3-31 to 3-33
safety 1-3
Failures
random 2-5
self-test 3-36
E
Electromagnetic interference (EMI) 2-3
Heartwires
connection to cables 4-8
connections directly to device 4-10
device receptacles 3-32
EMERGENCY/ASYNC. key
HIGH OUTPUT
I
Indications 1-5
I-4
183
MEDTRONIC CONFIDENTIAL
Index
L
Lead systems
adverse effects 2-12
bipolar 1-2, 2-6, 4-8
connecting directly to device 4-10
fig. 4-11
connecting to patient cables 4-8
fig. 4-9
inappropriate connections 2-12
precautions 2-6
reposition 2-12
unipolar 2-6, 4-8
warnings 2-4
Intrinsic rhythm
effect on pacing therapy 5-3
view using PAUSE 3-8, 5-9
Lock
indicators 3-14, 5-5
I-5
MEDTRONIC CONFIDENTIAL
Index
M
Magnetic resonance imaging (MRI) 2-3
MANUAL/AUTO 3-27
Mapping, atrial 2-7
Medical telemetry equipment 2-3
Menu 1 3-19 to 3-22
A (atrial) SENSITIVITY 3-20
A TRACKING 3-22, 5-36
A-V INTERVAL 3-22
V (ventricular) SENSITIVITY 3-21
Menu 2 3-23 to 3-27
A-V INTERVAL 3-26, 5-25
PVARP 3-25, 5-24
SETTING 3-27, 5-26
UPPER RATE 3-24, 5-23
Menu 3 (RAP) 3-28 to 3-29, 5-39 to 5-40
see also Rapid atrial pacing
key 3-9
timing violations 3-41
MENU
I-6
Messages
2:1 block point 3-42
asynchronous pacing 3-7
OFF 5-7
PAUSE 3-8
UPPER RATE violation 3-43
upper screen is locked 3-34
Mode selection 5-35 to 5-38
DDI 5-36
menu M (DDD, DVI, DOO, VVI) 3-30, 5-37
timing violations 3-41
transition rules 3-30, 3-40
Modes 7-2
definition, diagrams
AAI A-7, A-10 to A-11
AOO A-7, A-8
DDD A-24, A-25 to A-40
DDI A-41, A-42
DOO A-14, A-15
DVI A-16, A-17 to A-23
VOO A-7, A-9
VVI A-7, A-12 to A-13
nominal 7-4
N
NBG code
!? 3-20, 3-21
lower screen 3-19
parameter settings, chart 5-43
tables 5-44
Noise, reversion operation 3-38
Nominal values 7-4
emergency pacing 5-8
power-on 5-6
RAP rate 3-28
185
MEDTRONIC CONFIDENTIAL
Index
O
OFF key
key 3-4
function 3-4, 5-7
if upper screen is locked 3-35, 3-5
to pace synchronously (demand) 3-5
OUTPUT
Pacing
asynchronous, contraindication 1-6
atrial 1-6
atrial, contraindication 1-6
dual chamber, asynchronous 5-15
dual chamber, demand 5-13
high-output, asynchronous 3-7
high-rate therapy 1-6, 2-4
setup table 5-43
single chamber, asynchronous 5-16
single chamber, demand 5-14
termination of 2-8
Pacing mode 7-2
nominal 7-4
selection 5-35 to 5-38
menu M 5-37
transitions 3-40
Pacing system analyzer (PSA) 1-5
Package contents 1-4
Parameters
PACE
3-22
A-V INTERVAL 3-26
OUTPUT 5-12
PVARP 3-25
RATE 5-12
SENSITIVITY 3-20, 3-21, 5-21
SETTING 3-27
timing violations 3-41
UPPER RATE 3-24, 5-23
A TRACKING
PACE
I-7
MEDTRONIC CONFIDENTIAL
Index
PAUSE key
3-8
how to 5-9
if upper screen is locked 3-35
precaution 2-8, 3-8
time limit 5-10
PVAB period
definition A-5
3-25, A-6
manual adjustments 5-24
nominal value 7-4
range, increments 7-3
timing violations
vs. RATE, A-V INTERVAL 3-43
vs. SAV, UPPER RATE 3-42
wenckebach response 3-39
PVARP
R
Random failures 2-5
I-8
3-15
dial 3-10
during RA 3-29
high-rate indicators 3-15, 5-12
inappropriate variance 2-5
limit 7-4
loss of control 2-5
nominal value 3-15, 7-4
range, increments 5-12, 7-2
timing violations 3-41, 3-42
versus A-V INTERVAL, PVARP 3-43
versus UPPER RATE 3-43
RATE
187
MEDTRONIC CONFIDENTIAL
Index
Sensing 5-27
atrial, contraindication 1-6
5-21
loss of control 2-5
nominal values 7-4
precaution 2-7
ranges, increments 7-3
vs. corresponding output 5-22
SENSITIVITY
Reversion
operation 3-38
random failure 2-5
window A-4
Ring, bails 3-33, 4-6
Service 6-4
Safety
checks 6-4
features 1-3
margin, sensing threshold 5-28
margin, stimulation threshold 5-32
pacing 3-39, 7-3
standards 7-5
SETTING,
SELECT
Self-test 3-35
LEDs 3-11
during self-test 3-35
SENSE
SENSE
menu 2 3-27
resetting manual adjustments 5-26
Status line
lower screen 3-19
upper screen 3-13 to 3-14
I-9
MEDTRONIC CONFIDENTIAL
Index
Sterilization
environmental precaution 2-9
patient cables 6-3
temporary pacemaker 6-2
Stimulation threshold
capture definition 5-31
precaution 2-6
procedure 5-33
safety margin 5-32
UPPER RATE
T
Table
pacing setup 5-43
Tables
NBG code definition 5-44
rate and interval conversion 5-45
Tachyarrhythmia 2-11
Technical checks 6-4
Technical service 6-4
Temperature
operating 7-5
stabilization 2-10
storage 7-5
I-10
189
MEDTRONIC CONFIDENTIAL
Index
V
V (ventricular) OUTPUT
5-12
dial 3-10
during RAP 3-29
high output indicator 3-17, 5-12
nominal value 3-17, 7-4
range, increments 3-17
V (ventricular) SENSITIVITY
3-21
I-11
MEDTRONIC CONFIDENTIAL
Index
I-12
191
MEDTRONIC CONFIDENTIAL
Index
I-13
MEDTRONIC CONFIDENTIAL
Index
I-14
180
MEDTRONIC CONFIDENTIAL
REF_R00
198618001
Rev
MEDTRONIC CONFIDENTIAL
REF_R00
Europe
Americas
Canada
Medtronic of Canada Ltd.
6733 Kitimat Road
Mississauga, Ontario L5N 1W3
Canada
Tel. 905-826-6020
Fax 905-826-6620
Toll-free in Canada: 1-800-268-5346
United States
World Headquarters
Medtronic, Inc.
710 Medtronic Parkway NE
Minneapolis, MN 55432-5604
USA
Internet: www.medtronic.com
Tel. 763-514-4000
Fax 763-514-4879
Asia-Pacific
Japan
Medtronic Japan
Solid Square West Tower 6F
580 Horikawa-cho, Saiwai-ku
Kawasaki, Kanagawa 210-0913
Japan
Tel. 81-44-540-6112
Fax 81-44-540-6200
Australia
Medtronic Australasia Pty. Ltd.
Unit 4/446 Victoria Road
Gladesville NSW 2111
Australia
Tel. 61-2-9879-5999
Fax 61-2-9879-5100
Asia
Medtronic International Ltd.
Suite 1602 16/F, Manulife Plaza
The Lee Gardens, 33 Hysan Avenue
Causeway Bay
Hong Kong
Tel. 852-2891-4068
Fax 852-2591-0313
*198618001*
198618001
Rev