Patient Assistant PA97000
DRAFT
Patient Manual
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Caution: Federal law (USA) restricts this device to sale by or on the
order of a physician.
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The following list includes trademarks or registered trademarks of Medtronic in the United
States and possibly in other countries. All other trademarks are the property of their
respective owners.
Medtronic
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Contents
How to contact Medtronic ............................................. 5
Contact us online ........................................................ 5
Contact us by phone ..................................................... 5
Contact us by mail or fax ................................................ 6
Using your Patient Assistant .......................................... 6
Intended use ............................................................. 6
What is the Patient Assistant? ........................................... 7
Patient Assistant button and lights ....................................... 8
Instructions for using the Patient Assistant .............................. 9
Electrical interference and the Patient Assistant ....................... 12
Troubleshooting ....................................................... 12
Handling your Patient Assistant ....................................... 16
Cleaning and maintenance ............................................ 17
Patient Assistant disposal ............................................. 18
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Warnings and precautions .......................................... 18
Contraindications .................................................... 19
Patient Assistant specifications .................................... 20
FCC compliance information ........................................ 21
Conditions for operating, transporting, and storing the Patient
Assistant ............................................................. 22
Operating Conditions .................................................. 22
Transport and Storage Conditions ..................................... 23
Explanation of symbols ............................................. 24
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How to contact Medtronic
Contact us online
Medtronic is dedicated to providing you with the most up-to-date information
available about your Medtronic heart device. Information about your
condition and device is available 24 hours a day on our website.
• Medtronic website: www.medtronic.com
• Patient Services website: www.medtronic.com/patients
If you would like to submit questions, suggestions, or requests to us online,
you can use the online form provided at www.medtronic.com/contact-us.
Contact us by phone
Our experienced Patient Services group is available to answer any questions
or concerns you have about your heart device. To speak directly with a Patient
Services Specialist, call 1-800-551-5544. Our staff is available Monday
through Friday from 7:00 AM to 7:00 PM (Central Time).
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Contact us by mail or fax
Medtronic Inc.
Patient Services Department
Mail Stop MVS 14
8200 Coral Sea Street NE
Mounds View, MN 55112
USA
Fax: +1 (763) 367-5809
Using your Patient Assistant
Intended use
The Patient Assistant model PA97000 initiates the recording of cardiac event
data in the device memory of compatible Medtronic cardiac implantable
electronic devices. The Patient Assistant is intended for unsupervised patient
use away from a hospital or clinic.
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What is the Patient Assistant?
The Patient Assistant is a handheld device that you use to prompt your
cardiac monitor to begin recording symptoms. Your Patient Assistant
connects wirelessly to your cardiac device. Data about your symptoms is
stored in the cardiac device, not in the Patient Assistant. Your doctor uses the
data to check your heart rhythm and to help determine if your symptoms are
heart-related. Examples of heart-related symptoms (sometimes called
“events”) include fainting, a fast heart rate, dizziness, and shortness of
breath.
Carry the Patient Assistant with you at all times. Use it as instructed by your
doctor while, or just after, you have symptoms.
This manual provides instructions on using, handling, and maintaining the
Patient Assistant, and other information about it. If you have questions,
contact your doctor or clinic, or contact Medtronic using the information on
“How to contact Medtronic”.
Warning: The Patient Assistant can’t be used as an alarm system in
situations where you need medical attention. Seek medical attention
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immediately if you are feeling ill and think you might need to go to the hospital.
If there is an emergency, call your local emergency number. If your doctor has
provided other instructions, follow them. Waiting to seek medical attention
could be dangerous to your health.
Pediatric use – The Patient Assistant has not been tested specifically for
pediatric use.
Patient Assistant button and lights
The Patient Assistant’s button, lights, and Connector loop are shown in
Figure 1. The lights do not turn on until you press the button. Use the
Connector loop to attach the Patient Assistant to a key chain, lanyard, or other
personal item.
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Figure 1. Patient Assistant
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1 Record Symptom button
2 Searching light (blue)
3 Success light (green)
4 Connector loop
Instructions for using the Patient Assistant
You or a helper should follow these steps while you are having symptoms or
as soon as possible afterward, as directed by your doctor.
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1. Press and release the button. The Searching light will start flashing blue.
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2. Quickly hold the Patient Assistant flat against your chest, directly over
your cardiac device. (Your cardiac device may be in a different location
than shown in this figure.)
3. When you successfully record an event in your cardiac device, two
success signals will occur: a success tone will sound and the Success
light will illuminate green.
Note: If the success signals do not occur within 15 s, reposition the
Patient Assistant so that it is near your cardiac device but not directly on
top of it. Then repeat Step 1 and Step 2. If you are wearing bulky clothing,
such as a jacket or heavy sweatshirt, remove that item of clothing before
repeating the steps.
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Electrical interference and the Patient Assistant
Everything that uses electricity produces an electromagnetic energy field.
This energy field surrounds an electrical item while it is connected to a source
of electricity, such as an outlet or a battery. The energy field is strongest near
the item and weakens with distance from the item. The relationship between
these energy fields and the Patient Assistant PA97000 is called
electromagnetic compatibility (EMC).
The energy fields from most electrical items are weak and won’t affect your
Patient Assistant. But strong magnets and electrical items such as cell
phones and cordless phones can affect the connection between your Patient
Assistant and your cardiac device. When you are trying to record a symptom,
keep these items at least 15 cm (6 in) away from your Patient Assistant.
Troubleshooting
If you have difficulty using your Patient Assistant, see Table 1 to determine if
one of the described problems occurred, and follow the corrective action
provided. If you still have trouble, your Patient Assistant may not be working
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correctly. Contact Medtronic Patient Services (see “How to contact
Medtronic”), or your doctor or clinic, to troubleshoot further or to replace the
Patient Assistant.
Table 1. Problems, possible causes, and possible solutions Problem: You pressed the button, but the blue Searching light does not
flash.
• Possible cause and solution: You didn’t press the button hard
enough. Retry recording the symptom, this time making sure to press
the button firmly. Wait for a response. If you are unable to successfully
record a symptom after 2 attempts, write down your symptom and the
time it occurred. Then bring the note with you the next time you visit your
doctor or clinic.
• Possible cause and solution: The Patient Assistant might have been
in an environment that was too cold or hot. Write down your symptom
and the time it occurred. Then bring the note with you the next time you
visit your doctor or clinic. Meanwhile, allow the Patient Assistant to
come to room temperature.
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Table 1. Problems, possible causes, and possible solutions (continued)
• Possible cause and solution: The Patient Assistant might not be
working correctly. Contact Medtronic Patient Services (see “How to
contact Medtronic”) to replace the Patient Assistant.
Problem: You pressed the button and the blue Searching light flashes, but
no success tone sounds and no green Success light illuminates.
• Possible cause and solution: The Patient Assistant did not commu-
nicate with the cardiac device. Reposition the Patient Assistant in a new
location near, but not directly on top of, your cardiac device, retry
recording the symptom, and wait for a response. If you are unable to
successfully record a symptom after 2 attempts, write down your symptom and the time it occurred. Then bring the note with you the next time
you visit your doctor or clinic.
• Possible cause and solution: Electromagnetic interference: move
away from the source of interference (an electrical or magnetic item),
retry recording the symptom, and wait for a response. If you are unable
to successfully record a symptom after 2 attempts, write down your
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Table 1. Problems, possible causes, and possible solutions (continued)
symptom and the time it occurred. Then bring the note with you the next
time you visit your doctor or clinic.
Problem: You pressed the button, the blue Searching light flashes, and the
green Success light illuminates, but no success tone sounds.
• Possible cause and solution: Your current environment might be too
loud to hear the success tone. If you saw the green Success light, then
you successfully recorded a symptom, so don’t worry that your symptoms weren’t recorded. When you mark a symptom in a quieter environment, you should be able to hear the success tone.
• Possible cause and solution: The Patient Assistant might not be
working correctly. If you saw the green Success light, then you successfully recorded a symptom, so don’t worry that your symptoms
weren’t recorded. Contact Medtronic Patient Services (see “How to
contact Medtronic”) to replace the Patient Assistant.
Problem: You pressed the button, the blue Searching light flashes, the
success tone sounds, but the green Success light does not illuminate.
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Table 1. Problems, possible causes, and possible solutions (continued)
• Possible cause and solution: Your current environment might be too
bright to allow you to see the green Success light. If you heard the success tone, then you successfully marked the symptom, so don’t worry
that your symptoms weren’t recorded. When you mark a symptom in a
darker environment, you should be able to see the green Success light.
• Possible cause and solution: The Patient Assistant might not be
working correctly. If you heard the success tone, then you successfully
marked the symptom, so don’t worry that your symptoms weren’t recorded. Contact Medtronic Patient Services (see “How to contact
Medtronic”) to replace the Patient Assistant.
Handling your Patient Assistant
The Patient Assistant is designed for daily use. Take the following precautions
in order to avoid damaging it:
• Do not immerse the Patient Assistant in liquid or spill fluid on it.
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• Do not drop or mishandle the Patient Assistant in any way that might
cause damage. Contact your doctor or clinic, or contact Medtronic (see
“How to contact Medtronic”), if the Patient Assistant has been dropped
and does not function.
• Do not open the Patient Assistant. The batteries cannot be replaced.
• To avoid accidental recordings, do not carry the Patient Assistant directly
in front of your cardiac device, such as in the pocket of a shirt or coat that
you are wearing.
• Keep the Patient Assistant away from children and pets.
• Keep the Patient Assistant at room temperature. See “Conditions for
operating, transporting, and storing the Patient Assistant” for more
information about the best conditions for transporting and storing your
Patient Assistant.
Cleaning and maintenance
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 soft, slightly damp cloth, as needed. Do not
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clean the Patient Assistant with solvents (for example, nail polish remover) or
chlorine-based cleansers (for example, bleach).
Regularly inspect the Patient Assistant for damage or defects. If it is damaged
or if you cannot fix the problem, contact your doctor or clinic, or contact
Medtronic (see “How to contact Medtronic”) for assistance.
Patient Assistant disposal
Do not throw your Patient Assistant in the garbage. The Patient Assistant
contains materials, such as batteries, that can harm the environment. Follow
local regulations regarding how to throw it away.
Warnings and precautions
Warning: The Patient Assistant is not intended to be used as an alarm
system for situations where medical attention is needed. Seek medical
attention immediately if you are feeling ill and think you might need to go to the
hospital. If there is an emergency, call your local emergency number. If your
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doctor has provided other instructions, follow them. Waiting to seek medical
attention could be dangerous to your health.
Caution: To prevent the risk of infection, do not place the Patient Assistant in
direct contact with your incision site until the incision site is completely
healed.
Caution: Do not modify the Patient Assistant. Modifications may impair its
effectiveness.
Caution: Use the Patient Assistant only as directed by your doctor. Do not
“play” with your Patient Assistant, including unnecessarily pressing the
button, because doing so can cause inappropriate data to be recorded.
Caution: Do not take the Patient Assistant into an MRI-controlled room
(magnet room). Doing so can damage the Patient Assistant or the MR
scanner.
Contraindications
There are no known contraindications for the use of this device.
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Patient Assistant specifications
• Dimensions: Approximately 10 cm x 4 cm x 1 cm (4 in x 1.5 in x 0.4 in)
• Power source: Non-replaceable lithium coin-cell battery
• Battery longevity (service life): When used within the recommended
operating temperature range (5°C to 40°C [41°F to 104°F]), the button on
your Patient Assistant can be pressed at least 200 times before the
battery is depleted.
• Protection from electric shock (IEC 60601-1): Type BF Applied Part
• Protection from ingress: IP22. This means that the product is protected
from ingress in the following 2 ways:
– Against access to hazardous parts with a finger
– Against vertically falling water drops when the enclosure is tilted up to
15°
The Patient Assistant is moisture resistant but not waterproof.
• Mode of operation: Continuous
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FCC compliance information
This device complies with Part 15 of the FCC rules. Operation is subject to the
following two conditions: (1) this device may not cause harmful interference,
and (2) this device must accept any interference received, including
interference that may cause undesired operation.
The user is cautioned that changes or modifications not expressly approved
by the party responsible for compliance could void the user’s authority to
operate the equipment.
This portable transmitter and its antenna comply with FCC and Industry
Canada radiofrequency (RF) exposure limits for the general population and
for situations of uncontrolled exposure. These RF exposure limits apply when
the general public may be exposed to radiofrequencies from the device. They
also apply when people who are exposed to radiofrequencies from the device
don’t know about, don’t understand, or can’t control their exposure.
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Conditions for operating, transporting, and storing the Patient Assistant
Operating Conditions
The Patient Assistant is designed to operate in the following conditions:
• Temperatures from 5 to 40°C (41 to 104°F)
• Relative humidity of 15% to 90%, non-condensing, but not requiring
water vapor partial pressure greater than 50 hPa
• An atmospheric pressure of 700 to 1060 hPa
Store and use the Patient Assistant within the ranges listed here. If it’s
exposed to conditions outside these ranges, it may not work until it sits at
room temperature for 10 minutes. If you experience a symptom and the
Patient Assistant doesn’t work, write down your symptom and the time it
occurred. Then bring the note with you the next time you visit your doctor or
clinic.
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Transport and Storage Conditions
The Patient Assistant may not work correctly if it is exposed to heat, humidity,
or atmospheric-pressure levels outside the following ranges:
Short-term storage and transport conditions – If the Patient Assistant is
exposed to conditions in the following ranges for more than 24 hours, it may
stop working entirely:
• Temperatures of -25 to 5°C (-13 to 41°F) at a relative humidity up to 90%,
non-condensing
• Temperatures of 35 to 60°C (95 to 140°F)
Long-term storage conditions – The Patient Assistant is designed to be
exposed to conditions in the following ranges for up to 2 years while still
functioning:
• From 15 to 30°C (59 to 86°F) at a relative humidity up to 90%
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Explanation of symbols
Table 2. Explanation of symbols on package labeling
Symbol Explanation
Conformité Européenne (European Conformity) This
symbol means that the device fully complies with applicable European Union acts.
For US audiences only
Caution: Federal law (USA) restricts this device to sale
by or on the order of a physician
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.
Type BF applied part. The Patient Assistant is the
applied part and the patient is the operator.
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Table 2. Explanation of symbols on package labeling (continued)
Symbol Explanation
Medical equipment, with respect to electric shock, fire,
and mechanical hazards, in accordance with AAMI
ES60601- 1:2012, CSA C22.2 No 60601-1:2014, and
IEC 60601-1:2012
This symbol means that the device fully complies with
the Australian Communications and Media Authority
(ACMA) and the New Zealand Ministry of Economic
Development Radio Spectrum Management standards
for radio communications products.
China RoHS
Technical Conformity (Ministry of Internal Affairs and
Communications) mark for Japan
The product complies with international electrical safety
rating IP22 with regard to ingress of dust, other foreign
objects, and water, as required by IEC 60601-1-11. This
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Table 2. Explanation of symbols on package labeling (continued)
Symbol Explanation
means that the product is protected both against access
to hazardous parts with a finger and against vertically
falling water drops when the enclosure is tilted up to 15°.
The Patient Assistant is moisture resistant but not waterproof.
Non-ionizing electromagnetic radiation
Date of manufacture
Serial number
Caution
Consult instructions for use
Manufacturer
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Temperature limitation
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Table 2. Explanation of symbols on package labeling (continued)
EC REP
Symbol Explanation
Humidity limitation
Storage temperature
Transit temperature
Package contents
Product documentation
Reorder number
Use by
Authorized representative in the European community
Patient Assistant
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*M974653A*
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432
USA
www.medtronic.com
+1 763 514 4000
Europe/Middle East/Africa
Medtronic International
Trading Sàrl
Route du Molliau 31
Case Postale 84
CH-1131 Tolochenaz
Switzerland
+41 21 802 7000
© 2018 Medtronic
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