Medtronic PA97000 Users Manual
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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