Caution: Federal law (USA) restricts this device to
sale by or on the order of a physician.
The following list includes trademarks or registered trademarks
of Medtronic in the United States and possibly in other countries.
All other trademarks are the property of their respective owners.
Medtronic, MyCareLink Heart, MyCareLink Smart
(patient reader) This product complies with international
electrical safety rating IP20 with regard to ingress of dust, other
foreign objects, and water as required by IEC 60601-11.
Keep dry
Security key
Standby button
Bluetooth connection
Tel eme tr y
Low battery
Batteries
Type BF applied part
Caution
Consult instructions for use
Follow instructions for use (blue)
Package contents
patient reader
Product documentation
Non-ionizing electromagnetic radiation
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.
Reorder number
Serial number
Accessories
Storage temperature
Transit temperature
Temperature limitation
Humidity limitation
For US audiences only
Manufacturer
Date of manufacture
Authorized representative in the European community
System meets the applicable Canadian and U.S. electrical
safety standards.
Contents
Introduction9
About your patient reader9
Indications for use10
Contraindications10
Warnings10
Precautions12
Contents of the patient reader package13
Battery installation13
Indicator lights and the standby button15
Downloading the application17
Bluetooth enabling between the patient reader and the
application18
Security key code entry with the patient reader and the
application18
Communicating with your implanted device19
Troubleshooting error messages22
Traveling with your patient reader26
Patient reader care26
Storing the patient reader27
How to contact Medtronic29
Patient reader specifications29
Consumer information and Requirements31
5
678
Introduction
This manual is intended to help you use the Medtronic
MyCareLink Smart™ 25000 Patient Reader (patient reader).
If you have any questions setting up or using the patient reader,
or if you have problems with the patient reader, please contact
Medtronic. See “How to contact Medtronic” on page 29, or use
the information found on the back cover of this manual.
Follow the instructions for use in this manual to properly use the
patient reader. Formal training from your clinician is not required
to use the patient reader properly.
If you have questions about your medical condition, talk to your
doctor. Your doctor knows your medical history.
About your patient reader
The patient reader is an electronic device that provides an easy
way for your doctor to obtain information about your implanted
device. The patient reader gathers this information from your
implanted device and transmits it to the Medtronic CareLink
network to allow your doctor to manage your care.
The patient reader is intended specifically for your use only and
should only be used by you as directed by your doctor. Do not
use the patient reader with other implanted devices.
Unauthorized use by others with implanted devices could delay
your implanted device date from reaching your doctor.
9
Figure 1: Patient reader
Indications for use
The patient reader is a portable electronic device that
communicates with your Medtronic implanted heart device and
transmits implanted heart device data to the CareLink Network
via the Medtronic MyCareLink Heart™ application.
Contraindications
There are no known contraindications for the patient reader.
Warnings
Warni ng : If you are feeling ill, seek immediate medical attention.
Do not use the patient reader unless directed by your doctor. If
there is an emergency, call your local emergency number. If your
10
doctor has provided instructions, follow them. Waiting to seek
medical attention could be dangerous to your health.
Warni ng : To ensure the safe operation of the patient reader and
your implanted heart device, follow these instructions:
• Use the patient reader as described in this manual. Save this
manual.
• Use the patient reader only at the times prescribed by your
doctor.
If you need further assistance, please contact Medtronic. See
“How to contact Medtronic” on page 29, or use the information
found on the back cover of this manual.
Warni ng : Do not use the patient reader if it does not operate as
described in “Communicating with your implanted device” on
page 19. To ensure proper operation of your implanted heart
device, follow the instructions in this manual about positioning
the patient reader over your implanted heart device. If you do not
follow these instructions, the patient reader may not be recording
or sending information from your implanted heart device. If you
need further assistance, please contact Medtronic. See “How to
contact Medtronic” on page 29, or use the information found on
the back cover of this manual.
Warni ng : Do not modify this equipment. Modifications to the
equipment may impact patient reader effectiveness, and
adversely affect your safety.
Warni ng : Important safety instructions. When using the patient
reader, basic safety precautions should always be followed to
11
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