Medtronic 9538 Patient Assistant User Manual
Medtronic, Inc. Patient Assistant Users Manual
Contents
- 1. Users Manual Insert
- 2. Users Manual
Users Manual
REVEAL®
Patient Assistant 9538/9539
Clinician Manual
Caution: Federal Law (USA) restricts this device to sale by or on
the order of a physician.
The following are trademarks of Medtronic:
Medtronic and Reveal
Explanation of symbols:
Conformité Européenne (European Conformity). This symbol means that the device fully complies with
AIMD DIrective 90/385/EEC (NB 0123) and R&TTE 1999/5/EC.
Package contents
Patient Assistant model 9538
Patient Assistant model 9539
Product documentation
For U.S. audiences only
Temperature limitation
Authorized representative in the European Community
Manufacturer
Consult instructions for use
Date of manufacture
Serial number
Reorder number
Medical equipment with respect to electric shock, fire, and mechanical hazards, only in
accordance with UL2601-1, and CAN/CSA C22.2 no. 601.1
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.
Battery polarity as shown
Type BF equipment
EC REP
Battery condition
Position of Cell
RF transmitter
Humidity Limitation
Contents
Explanation of symbols: 2
1 Description and intended use 7
1.1 Reveal Patient Assistant model 9538 8
1.2 Reveal XT Patient Assistant model 9539 8
2 Package contents and inspection 9
2.1 Contents of the Patient Assistant package 9
2.2 Inspection 9
3 Preparing the Patient Assistant for patient use 10
4 Recording cardiac rhythm data 10
4.1 How to record cardiac rhythm data 10
4.2 Response when a recording is requested 12
5 Checking for cardiac rhythm events 13
5.1 How to check for cardiac rhythm data storage 13
5.2 Response when a query is requested 14
6 Troubleshooting 15
7 Battery information 16
7.1 Replacement batteries 16
7.2 When to install batteries 16
7.3 How to install new batteries 16
8 Attaching the optional wrist strap 18
9 Maintenance 18
9.1 Care and handling 18
9.2 Cleaning 19
9.3 Service 19
9.4 Disposal 19
10 Specifications 20
10.1 Device specifications 20
10.2 Safety and compatibility standards 20
9538/9539 Clinician manual
Reveal Patient Assistant 7
1 Description and intended use
The Reveal Patient Assistant model 9538 and the Reveal XT
Patient Assistant model 9539 are handheld, battery-operated,
radio-frequency devices used to communicate with the Reveal
Insertable Cardiac Monitor. See the Reveal Clinician Manual
provided with the Insertable Cardiac Monitor for specific
compatibility information.
The Patient Assistant is intended for unsupervised patient use
away from a hospital or clinic. The Patient Assistant activates one
or more of the data management features in the Reveal Insertable
Cardiac Monitor:
■To verify whether the implanted device has detected a
suspected arrhythmia or device related event.
■To initiate recording of cardiac event data in the implanted
device memory.
The Patient Assistant is not intended to detect or indicate the
presence or absence of medical conditions. Instruct the patient to
seek immediate medical attention if he or she is feeling ill,
regardless of indications from the Patient Assistant.
As directed by the clinician, the patient uses the Patient Assistant
during or immediately after a symptomatic event. By pressing a
button on the Patient Assistant and holding it in front of his or her
implanted device, patients may record the event into the memory
of the implanted device. At follow-up visits the implanted device
recording is used to check the patient’s cardiac rhythm and help
determine if the patient’s symptoms are cardiac related.
The patient should be advised to carry or keep their Patient
Assistant nearby at all times to avoid the possibility of missing an
opportunity to mark a symptomatic episode.
Caution: Do not take the Patient Assistant (handheld activator)
into the MRI controlled room (magnet room). Doing so can
damage the Patient Assistant or the MR scanner.
The physician should instruct the patient when to use the Record
Symptoms button (both models) and Query button (model 9539)
and what to do when a response indicator is received. The Reveal
Patient Manual provides a place to record such instructions. See
“Preparing the Patient Assistant for patient use” on page 10.
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Reveal Patient Assistant
8
1.1 Reveal Patient Assistant model 9538
The Reveal Patient Assistant model 9538, shown in Figure 1, is
identified by its single user-operated button located at the
upper-right corner of the display area.
The Patient Assistant provides the patient with the ability to
activate storage of cardiac data when a symptomatic event occurs
or has occurred by pressing the Record Symptoms button [ ].
See “Recording cardiac rhythm data” on page 10. When the
Record Symptoms button is pressed, the Patient Assistant also
indicates if its battery voltage is low and if telemetry with the
implanted device was successful.
Figure 1. Reveal Patient Assistant model 9538 with all response
indicators displayed for reference.
1.2 Reveal XT Patient Assistant model 9539
The Reveal XT Patient Assistant model 9539, shown in Figure 2,
is identified by its 2 user-operated buttons, located at the upper-left
and upper-right corners of the display area.
In addition to the features of the Reveal Patient Assistant
model 9538, the Reveal XT Patient Assistant model 9539 has a
Query button [ ]. The patient presses the Query button to check
if the implanted device has detected important status information
such as; low battery, if maximum auto-detected episodes have
been reached, or if programmed criteria have been met for cardiac
event data. Refer to the Reveal XT 9529 Clinician Manual for
information on how to select and enable notification criteria.
Record Symptoms
button. Press to
record cardiac event
data.
Te lemetr y Status
light
Wrist strap
connector
Response indicator
display area. One or both
indicators light after the
button is pressed.
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Reveal Patient Assistant 9
Figure 2. Reveal XT Patient Assistant model 9539 with all response
indicators displayed for reference.
2 Package contents and inspection
2.1 Contents of the Patient Assistant package
The Patient Assistant package contains the following items:
■Patient Assistant
■N-size 1.5 V batteries
■Carrying case
■Wrist strap
■Reveal Patient Manual
■Quick reference card with attached ICM ID card
■Electromagnetic Compatibility Declaration
■Warranty card
2.2 Inspection
Inspect the Patient Assistant for damage or defects before giving
the Patient Assistant to a patient. If the case is cracked or you
discover other defects, return the Patient Assistant to Medtronic.
Check the battery date code before installing batteries to ensure
there is six months or more of battery life remaining.
Record Symptoms
button. Press to
record cardiac event
data.
Telemetr y Stat u s
light
Wrist strap
connector
Response indicator
display area. One or more
indicators light after the
button is pressed.
Query button. Press to
check for stored cardiac
event data.
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10
3 Preparing the Patient Assistant for patient use
The following steps should be completed before giving the Patient
Assistant to a patient:
1. Place new batteries in the Patient Assistant. See “How to
install new batteries” on page 16.
2. Record the necessary information in the Reveal Patient
Manual. The Reveal Patient Manual provides a place to
record instructions about using the Patient Assistant in the
section “Instructions from your doctor,” found in the chapter
“Using the Patient Assistant.” The instructions should indicate
when the patient should press the Record Symptoms button
(both models) and the Query button (model 9539), depending
on what notification criteria have been programmed. The
instructions should also include when and how the patient
should contact the clinician.
3. Fill in both sides of the “Reveal ICM Device Identification
Card,” which is attached to the Quick Reference Card.
4. Attach the provided wrist strap to the Patient Assistant or the
loop on the provided carrying case. See “Attaching the
optional wrist strap” on page 18.
Note: Refer to the Reveal DX 9528 Clinician Manual or the
Reveal XT 9529 Clinician Manual for information about the
particular features that apply to the Patient Assistant.
4 Recording cardiac rhythm data
4.1 How to record cardiac rhythm data
The patient should follow this procedure while experiencing
symptoms or as soon as possible after experiencing symptoms:
1. Press the Record Symptoms button [ ]. The Patient
Assistant makes a short beep and the Telemetry Status light
flashes green, which means the Patient Assistant is ready to
initiate recording of cardiac rhythm data in the patient’s
implanted device.
Note: If the Patient Assistant does not respond within
15 seconds of pressing the button, see “Troubleshooting” on
page 15.
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Reveal Patient Assistant 11
2. Immediately after pressing the button, while the Telemetry
Status light is flashing, the Patient Assistant should be held
against the patient’s skin or clothing directly in front of the
implanted device. See Figure 3. The side with the buttons can
be held facing the patient or away from the patient.
Figure 3. Hold the Patient Assistant in front of the implanted device. (The
device may be implanted in a different location than is shown here.)
3. When the Telemetry Status light turns to a solid light and the
Patient Assistant makes a long beep, remove the Patient
Assistant from in front of the implanted device. A solid status
light and long beep mean the implanted device has
successfully responded.
Note: If the Patient Assistant does not respond within
15 seconds, see “Troubleshooting” on page 15.
4. Immediately look at the Patient Assistant response indicator
display area to see which indicator is lit (Figure 4). See
“Response when a recording is requested” on page 12 for
descriptions of the indicators.
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12
Figure 4. Reveal Patient Assistant model 9538 showing all possible
response indicators when the Record Symptoms button is pressed.
4.2 Response when a recording is requested
The Patient Assistant displays the appropriate indicator for
approximately 10 seconds after receiving a response from the
implanted device.
Indicator Description/Action to take (if any)
Successful Recording indicator. After pressing the
Record Symptoms button, this indicator means that
cardiac rhythm data has been successfully recorded into
the implanted device memory.
Low Batteries indicator. This indicator means that the
batteries must be replaced in the Patient Assistant. See
“Battery information” on page 16 for instructions.
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Reveal Patient Assistant 13
5 Checking for cardiac rhythm events
5.1 How to check for cardiac rhythm data storage
Note: This feature is available only with the Reveal XT Patient
Assistant model 9539. Refer to the Reveal XT 9529 Clinician
Manual for information on how to enable notification criteria.
1. Press the Query button [ ]. The Patient Assistant makes a
short beep and the Telemetry Status light flashes green,
which means the Patient Assistant is ready to query the
implanted device.
Note: If the Patient Assistant does not respond within
15 seconds of pressing the button, see “Troubleshooting” on
page 15.
2. Immediately after pressing the button, while the Telemetry
Status light is flashing, the Patient Assistant should be held
against the patient’s skin or clothing, directly in front of the
implanted device. See Figure 5. The side with the buttons can
be held facing the patient or away from the patient.
Figure 5. Hold the Patient Assistant in front of the implanted device. (The
device may be implanted in a different location than is shown here.)
3. When the Telemetry Status light turns to a solid light and the
Patient Assistant makes a long beep, remove the Patient
Assistant from in front of the implanted device. A solid status
light and long beep mean the Patient Assistant has
successfully queried the implanted device.
Note: If the Patient Assistant does not respond within
15 seconds, see “Troubleshooting” on page 15.
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Reveal Patient Assistant
14
4. Immediately look at the Patient Assistant response indicator
display area to see which indicator is lit (Figure 6). See
“Response when a query is requested” on page 14 for
descriptions of the indicators.
Figure 6. Reveal XT Patient Assistant model 9539 showing all possible
response indicators when the Query button is pressed.
5.2 Response when a query is requested
The Patient Assistant displays the appropriate indicators for
approximately 10 seconds after receiving a response from the
implanted device.
Indicator Description/Action to take (if any)
OK indicator. This indicator means the implanted device has no recorded events
that require follow-up; however, if the patient feels ill, instruct the patient to seek
medical attention.
Note: The OK indicator will also be received in the following situations:
■If notifications of the Patient Assistant query function are not enabled.
■If a Reveal Patient Assistant model 9539 is used with a Reveal DX 9528 ICM.
Event indicator. This indicator means the implanted device has recorded events,
and the patient should notify the clinician. These events include:
■Cardiac rhythm episodes matching selected notification criteria
■Implanted device requires attention (battery low or maximum auto-detected
episodes reached)
Low Batteries indicator. This indicator means that the batteries in the Patient
Assistant must be replaced. See “Battery information” on page 16 for instructions.
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Reveal Patient Assistant 15
6 Troubleshooting
Problem Possible causes Possible solutions
Te le m e t r y S tatu s
light does not flash
and no beep
sounds.
The batteries are inserted
incorrectly.
Reinstall the batteries.
The batteries are depleted. Replace the batteries.
The wrong type batteries are
inserted.
Verify that batteries are N-size, 1.5 V.
There is a component failure. Replace the Patient Assistant.
Te le m e t r y S tatu s
light flashes, but no
beep sounds.
The speaker has failed. The response on the display area can be
followed, but the Patient Assistant should
be replaced.
Te le m e t r y S tatu s
light stops flashing
without a response
after the button is
pressed.
Insufficient telemetry: the
Patient Assistant did not
communicate with the implanted
device.
Reposition the Patient Assistant directly
over the implanted device, press the
button again, and wait for a response.
There is electromagnetic
interference.
Move away from the source of
interference.
There is a component failure. Replace the Patient Assistant.
Te le m e t r y S tatu s
light turns a solid
color, beeps, but no
response indicator
appears in the
display area.
The light in display area is
broken.
Contact a Medtronic representative.
There is a component failure. Replace the Patient Assistant.
Repeated failures
occur.
The Patient Assistant is outside
its temperature range: 49 °F
(9 °C) to 110 °F (43 °C).
Move to warmer or cooler surroundings.
There is electromagnetic
interference.
Move away from the source of
interference.
The Patient Assistant needs to
be replaced.
Contact a Medtronic representative.
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16
7 Battery information
7.1 Replacement batteries
The Patient Assistant operates with 2 N-size 1.5 V batteries. The
recommended battery type is alkaline manganese dioxide, type
ANSI/NEDA 910A and IEC LR1, which can be purchased at retail
and camera stores and from online merchants.
7.2 When to install batteries
■Install new batteries before giving the Patient Assistant to a
patient.
■If the Low Batteries indicator appears, both batteries should
be replaced as soon as possible. The Patient Assistant will
operate for several more uses after the initial appearance of
the Low Batteries indicator.
Note: Follow local regulations for proper disposal of used
batteries.
7.3 How to install new batteries
Note: Check the battery date code before installing batteries to
ensure there is six months or more of battery life remaining.
Follow these steps to install batteries in the Patient Assistant:
1. Slide the battery cover tab toward the center of the Patient
Assistant and push upward to open the battery compartment.
See Figure 7.
Figure 7. Opening the battery compartment.
2. Remove the old batteries.
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Reveal Patient Assistant 17
3. Insert 2 new batteries (Figure 8). Follow the polarity diagram
shown on the outside of the battery compartment.
Figure 8. Replacing the batteries.
4. Snap the battery cover closed. See Figure 9.
Figure 9. Closing the battery cover.
5. Make sure to test the Patient Assistant after installing
batteries to determine if the batteries were installed correctly.
Press a Patient Assistant button while the Patient Assistant is
away from the implanted device. The Patient Assistant should
beep and the Telemetry Status light should flash green,
confirming correct battery installation. If you press a button
and the Telemetry Status light does not flash green, make
sure the new batteries have been installed correctly.
9538/9539 Clinician manual
Reveal Patient Assistant
18
8 Attaching the optional wrist strap
The provided wrist strap can be attached to the Patient Assistant
so the patient can hang the Patient Assistant around his or her
wrist. This ensures the Patient Assistant is always accessible and
not dropped. The wrist strap can be attached as shown in
Figure 10. The strap can also be attached to the loop on the
provided carrying case. See “Care and handling” on page 18.
Figure 10. Attaching the optional wrist strap.
9 Maintenance
9.1 Care and handling
The Patient Assistant is designed to be used on a daily basis;
however, it is an electronic device and susceptible to many
environmental stresses. Precautions should be taken to avoid
damage to the unit, including (but not limited to) those listed here.
Precautions:
■Do not immerse the Patient Assistant in liquid or spill fluid on it.
■Do not drop the Patient Assistant or mishandle it in a way that
might cause damage.
■Do not open the Patient Assistant, except to install batteries.
■Do not sterilize the Patient Assistant.
■Do not carry the Patient Assistant in a pocket located directly
over an implanted device. Use the supplied carrying case if the
Patient Assistant is carried in a pocket or handbag.
?
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Reveal Patient Assistant 19
■Do not “play” with the Patient Assistant. Doing so can cause
previously recorded data to be lost.
■Electromagnetic interference (EMI) can impair the reliable
performance of the Patient Assistant. Normal operation can be
restored by moving away from the source of the interference.
■Although the instruction to the patient is to carry the Patient
Assistant at all times, it is not allowed to take the Patient
Assistant into the MRI controlled room (magnet room).
■Keep the Patient Assistant at room temperature. The Patient
Assistant may not operate at full strength outside the range of
49 °F (9 °C) to 110°F (43 °C).
9.2 Cleaning
■Be careful to prevent moisture from entering the Patient
Assistant. The Patient Assistant is moisture resistant but not
waterproof.
■Clean the outside of the Patient Assistant with a slightly damp
cloth. Mild household cleansers will not damage the case or
labels.
■Do not clean the Patient Assistant with solvents (such as nail
polish remover) or chlorine-based cleansers (such as bleach).
9.3 Service
All Medtronic Reveal Patient Assistant devices have been
carefully engineered, manufactured, and quality tested to provide
long, trouble-free service. Should service or replacement be
necessary, contact your local Medtronic representative. Please
refer to the model number and serial number (located on the back
of the Patient Assistant) when calling Medtronic.
9.4 Disposal
Follow local regulations for proper disposal of the Patient Assistant
at the end of its useful service life.
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20
10 Specifications
10.1 Device specifications
Dimensions: Approximately 3.77 in x 2.20 in x 0.86 in
(96 mm x 56 mm x 22 mm)
Power source: 2 N-size, 1.5 volt batteries, alkaline (manganese
dioxide)
Battery dimensions: 0.39 in diameter x 1.18 in (10 mm x 30 mm)
Battery longevity: 180 uses minimum, when used once a day at
room temperature. Operating the Patient Assistant below 60 °F
(15 °C) for extended periods of time shortens battery longevity.
Operating temperature: 49 °F (9 °C) to 110 °F (43 °C)
Transport and storage (batteries not installed):
Ambient temperature: -40 °F (-40 °C) to 150 °F (65.5 °C)
Relative humidity: up to 95%
Audible output level: 65 dBA minimum at 3.77 in (96 mm)
Classification with respect to electric shock: Internally
powered
Protection from electric shock (IEC 60601-1): Ty p e B F
Protection against ingress of liquids: Ordinary equipment
Mode of operation: Non-continuous
10.2 Safety and compatibility standards
The Patient Assistant models 9538 and 9539 comply with the
following standards:
IEC 60601-1, Medical electrical equipment safety
IEC 60601-1-2, Electromagnetic compatibility
EN45502-1, Safety, marking and information of medical devices
FCC Part 15
*M942629A001*
© Medtronic, Inc. 2010
M942629A001A
2010-08-03
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