Medtronic 25000 Patient Reader 25000 User Manual
Medtronic, Inc. Patient Reader 25000
User Manual
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MyCareLink Smart™ Patient Reader
25000
Caution: Federal law (USA) restricts this device to
sale by or on the order of a physician.
Patient Manual
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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, 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
Teleme t r y
Low battery
Batteries
Type BF applied part
Caution
Consult instructions for use
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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
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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.
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Contents
Introduction 9
About your patient reader 9
Indications for use 10
Contraindications 10
Warnings 10
Precautions 12
Contents of the patient reader package 13
Battery installation 13
Indicator lights and the standby button 15
Downloading the application 17
Bluetooth enabling between the patient reader and the
application 18
Security key code entry with the patient reader and the
application 18
Communicating with your implanted device 19
Troubleshooting error messages 22
Traveling with your patient reader 26
Patient reader care 26
Storing the patient reader 27
How to contact Medtronic 29
Patient reader specifications 29
Consumer information and Requirements 31
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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.
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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
Warning: 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
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doctor has provided instructions, follow them. Waiting to seek
medical attention could be dangerous to your health.
Warning: 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.
Warning: 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.
Warning: Do not modify this equipment. Modifications to the
equipment may impact patient reader effectiveness, and
adversely affect your safety.
Warning: Important safety instructions. When using the patient
reader, basic safety precautions should always be followed to
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reduce the risk of electric shock, and injury to persons, including
the following:
• Do not use the patient reader near water, for example, near
a bath tub, wash bowl, kitchen sink or laundry tub, in a wet
basement, or near a swimming pool.
Precautions
Caution: Only install the recommended batteries in the patient
reader. Batteries with different physical dimensions, non-alkaline
(e.g., lithium or rechargeable), or batteries with contamination on
the battery terminals, may result in erratic operation of the
patient reader or damage to the patient reader, specifically to the
battery compartment.
Caution: Replace the batteries for the patient reader when the
amber indicator light is lit. The patient reader does not function
with dead batteries.
Caution: Only install new, fresh batteries that have not passed
their expiration date when replacing the batteries. The patient
reader may not operate properly if batteries that have passed
their expiration date are installed.
Caution: Inspect battery terminals for contamination. Using
batteries with contaminated terminals can result in the patient
reader turning off, decreased battery life, or corrosion to the
battery compartment.
Caution: Verify that the battery compartment door is fully closed
when installing or replacing batteries. If the battery compartment
door is not fully closed, the batteries may become dislodged or
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fall out of the patient reader. If the batteries become dislodged or
fall out of the patient reader, the patient reader will not operate.
Caution: Verify that the batteries are installed with correct
polarity by verifying that the batteries align with the polarity
markings on the inside of the battery compartment.
The patient reader requires proper battery polarity for operation.
After installing the batteries, ensure that the amber indicator light
is not lit. The patient reader will not operate if the batteries are
not installed with correct polarity.
Contents of the patient reader package
The patient reader package includes the following items:
• One Medtronic MyCareLink Smart™ Patient Patient reader
25000
•Batteries
• Literature
• One set of ‘For Your Records’ labels
Battery installation
Your patient reader is internally powered by three LR6-sized
(AA) alkaline batteries. Install the batteries in the battery
compartment located on the bottom of the patient reader.
The patient reader requires proper battery polarity for operation.
Ensure that the batteries align with the polarity markings on the
inside of the battery drawer. The patient reader will not turn on
or operate if the batteries are installed with incorrect polarity.
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Install the batteries before each use and remove them when the
patient reader is not in use. Replace the batteries when the amber
indicator on the patient reader is lit.
Warning: Do not inhale or swallow the batteries. Inhaling or
swallowing the batteries can cause serious physical harm.
To install the batteries, perform the following steps:
1. Open the battery packaging.
2. Open the patient reader battery compartment door.
3. Install three new LR6 (AA-sized) alkaline batteries. Verify that
the batteries align with the polarity markings on the inside of
the battery compartment (see Figure 2).
Figure 2: Install the batteries with proper polarity
Caution: Ensure that the batteries are installed with the correct
battery polarity by verifying that the batteries align with the
polarity markings on the inside of the battery compartment. The
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patient reader requires proper battery polarity for operation. The
patient reader will not turn on or operate if the batteries are
installed with incorrect battery polarity.
4. Close the battery compartment door firmly.
Note: Always operate the patient reader with the battery
compartment door firmly closed. If the battery compartment door
is not firmly closed, the door could open and the batteries could
fall out or become dislodged. The patient reader will not turn on
or operate if the batteries are dislodged or have fallen out of the
patient reader.
5. Discard the old batteries according to local regulations if you
are replacing old batteries with new batteries.
Indicator lights and the standby button
The patient reader has three indicator lights and a standby
button. See Table 1 for a description of each indicator light and
the standby button.
123
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.Table 1. Patient reader indicator lights and standby button
Indicator light or
button
Icon Description
1. Blue The blue indicator light indicates
if the patient reader is turned on
and shows the connection
between the patient reader and
the smart phone or tablet.
• A flashing blue light indicates
that the patient reader is
turning on and establishing a
connection with the smart
phone or tablet.
• A solid blue light indicates
that the patient reader is
turned on and connected to
the smart phone or tablet.
2. Green The green indicator light
indicates communication
between the patient reader and
the implanted device. When the
green indicator light is lit, the
patient reader is communicating
with the implanted device.
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Downloading the application
To download the application, perform the following steps:
1. Verify that your smart phone or tablet is connected to the
Internet.
2. Use the browser on our smart phone or tablet to navigate to
the following Medtronic website:
www.mycarelinkheart.com
3. Click on the appropriate button to install the application on
your smart phone or tablet.
3. Amber The amber indicator light shows
the battery status of the patient
reader. If the amber indicator
light is lit, the patient reader
batteries are low. Replace the
batteries when the amber
indicator is lit.
4. Standby
button
The standby button turns on the
patient reader.
Note: The standby button only
turns on the patient reader; it
does not turn off the patient
reader. The patient reader
automatically turns off after
approximately two minutes of
inactivity.
Table 1. Patient reader indicator lights and standby button
Indicator light or
button
Icon Description
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4. Install the application.
5. Open the application.
Bluetooth enabling between the patient reader and
the application
Your patient reader is paired with the application using a
Bluetooth connection.
To enable the patient reader and the application with Bluetooth,
perform the following steps:
1. Verify that Bluetooth is enabled on your smart phone or tablet.
2. Start the application.
3. Press the Start button in the application.
4. Turn on the patient reader by pressing the standby button.
5. Start the application.
6. Follow the steps in the application to enable the patient reader
with the application.
Security key code entry with the patient reader and
the application
The device label on the bottom of the patient reader contains
product symbols and the security key code. The key code will be
entered into the application to pair your patient reader with the
application.
To pair the patient reader with the application, perform the
following steps:
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1. Locate the security key code on the device label on the bottom
of the patient reader on the left side of the security key
symbol.
2. Open the application.
3. Follow the prompts in the application and enter the security
key code.
Once these steps are completed, your patient reader is ready to
use with the application.
Communicating with your implanted device
Consider the following recommendations when using the patient
reader to communicate with your implanted device:
• Find a location where you can sit comfortably when the
patient reader is communicating with your implanted device.
1. Security key code
Figure 3: patient reader device label including the security key code
1
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The patient reader is not intended to be operated while you are
walking, mobile, or traveling in a vehicle.
• Choose a location that receives an adequate cellular or wireless
network signal.
• Hold the smart phone or tablet in a location where you can see
its screen and can sit comfortably.
• Do not place the patient reader anywhere it could get wet.
To use the patient reader to communicate with your implanted
device, perform the following steps:
1. Open the application from your smart phone or tablet.
2. Press the Start button in the application and follow the
prompts in the application.
3. Press the standby button to turn on the patient reader.
4. Hold the patient reader over your implanted device. You may
either hold the patient reader snugly against your clothing, or
against your bare skin.
Note: The patient reader can become warm to the touch if it is
used repeatedly for twenty minutes or more. If the patient
reader has been used repeatedly for twenty minutes or more,
allow it to cool for ten minutes before you use it again.
Allowing the patient reader to cool for ten minutes after
twenty minutes of repeated use ensures that patient reader
warmth does not cause discomfort.
5. Verify that the green indicator light is lit on the patient reader.
When the green indicator light is lit, the patient reader is in
acceptable proximity to the implanted device.
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Figure 4: Patient reader held over an implanted device
6. Watch the application to follow the status of the implanted
device interrogation.
7. Remove the patient reader from over your implanted device
when the application indicates that the interrogation is
complete.
8. View the application to follow the status of the transmission
of your implanted device data from the application to the
Medtronic CareLink network.
9. Remove the batteries from the patient reader and store it
according to the instructions in “Storing the patient reader”
on page 27.
Caution: Do not modify the patient reader or perform any service
or maintenance on the patient reader while it is in use. Modifying
or performing service or maintenance on the patient reader while
it is in use can impact patient reader effectiveness. Contact
Medtronic at the telephone number on the back cover of this
manual if your patient reader is not functioning properly.
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Notes:
• While the patient reader is communicating with your
implanted device, remain still and make sure the patient
reader is placed over your implanted device. This process
typically takes less than 3 minutes.
• Your interrogation session or transmission will be interrupted
if you answer an incoming phone call or open a received text
message. If you interrupt the interrogation by answering the
phone call or opening the text message, you will need to
perform the interrogation again.
• The patient reader automatically shuts off after 2 minutes of
inactivity. You can not turn off the patient reader manually by
pressing the standby button.
Troubleshooting error messages
Use the information in this section to troubleshoot the use of your
patient reader.
You can find information about the following errors:
• “Patient reader battery status” on page 23
• “Patient reader position” on page 23
• “Bluetooth connection lost” on page 24
If an error occurs while using your patient reader, your patient
mobile application screen will show an error icon with an orange
background, and an error number.
Some error messages may include an animated demonstration to
help you correct the problem. Follow these instructions to resolve
the error.
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For some errors, you will be instructed to contact Medtronic. See
“How to contact Medtronic” on page 29, or use the information
found on the back cover of this manual.
Patient reader battery status
The patient reader requires batteries with power to operate
properly. If the batteries need to be replaced, the following errors
may occur:
Patient reader position
The patient reader must be properly positioned over your
implanted device in order to communicate with it. If the patient
reader is not properly positioned over your implanted device, the
following errors may occur:
Error Action
The amber light on the patient
reader head is lit.
Replace the batteries and verify
that the amber is not lit.
The application screen
displays an error message and
emits a tone.
Replace the batteries and view
the application to verify that
the error message is not
displayed.
Error Action
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When the patient reader is repositioned correctly, a green
progress bar will appear on the application screen. When the
patient reader is positioned correctly, the patient reader will
resume data collection. Hold the patient reader in position until
your transmission is completed.
Bluetooth connection lost
The patient reader must establish a connection with the
application to transmit data. If the patient reader loses the
Bluetooth connection with the application, the following errors
may occur:
The green indicator light is not
lit.
Reposition the patient reader
over your implanted device
and verify that the green
indicator light on the patient
reader is fully lit. When the
green indicator light is lit, the
patient reader is
communicating with the
implanted device.
The application screen displays
a message to place the patient
reader over your implanted
device.
Reposition the patient reader
over your implanted device
and view the application to
verify that the patient reader is
communicating with the
implanted device.
Error Action
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The blue indicator light flashes Verify that the blue indicator
light on the patient reader is
fully lit. When the blue
indicator light is lit, the
Bluetooth connection has been
established between the
patient reader and the
application.
The application screen displays
an error message and the
application emits a tone.
Move your smart phone or
tablet closer to the patient
reader and view the
application to verify that the
Bluetooth connection has been
reestablished.
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Patient reader does not function
Traveling with your patient reader
Remove the batteries from the patient reader before traveling or
flying in an airplane. Store the batteries and the patient reader
either in the box the patient reader was shipped in or in a safe
location before traveling or flying.
Replacing your patient reader
If your patient reader is lost or damaged, you can contact
Medtronic to receive information on ordering a replacement. See
“How to contact Medtronic” on page 29, or use the information
found on the back cover of this manual.
Patient reader care
Do not drop your patient reader on hard surfaces. Dropping the
patient reader can damage them and prevent them from
functioning properly. If your patient reader has been damaged,
Error Action
The amber, green, and blue
indicator lights flash
simultaneously.
If all of the indicator lights
flash simultaneously when the
standby button is pressed, the
patient reader is no longer
functioning properly and must
be replaced. Contact
Medtronic at the telephone
number on the back cover of
this manual
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please contact Medtronic. See “How to contact Medtronic” on
page 29, or use the information found on the back cover of this
manual.
You can clean the exterior of your patient reader by using a clean
cloth and light application of water, hydrogen peroxide, alcohol
(methyl, ethyl or isopropyl) or a mild detergent.
To clean the exterior of the patient reader, perform the following
steps:
1. Dampen the cloth with a light application of one of the
recommended cleaning fluids.
2. Gently wipe the exterior of the patient reader. Do not get the
patient reader wet.
3. Clean the patient reader before and after each use.
The patient reader does not require any preventative inspection
or maintenance.
Caution: Do not get your submerse your patient reader in fluid or
damage may occur. If you get your patient reader wet and it no
longer functions properly, please contact Medtronic. See “How to
contact Medtronic” on page 29, or use the information found on
the back cover of this manual.
Storing the patient reader
Store patient reader in the box it was shipped in when it is not
being used for an interrogation.
When the patient reader in not in use, store it out of reach of pets,
pests, and children.
Store the patient reader and the box in a cool, dry location.
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Battery removal and disposal
Remove the three LR6-sized (AA) alkaline batteries from the
patient reader when it is not in use. Store the batteries in the box
the patient reader was shipped in when it is not being used.
Caution: Remove the batteries from the patient reader when the
patient reader is not in use, after an interrogation, or when you
are traveling with the patient reader. The batteries could leak
inside the patient reader if the are not removed when the patient
reader is not in use. Leakage from the batteries could damage the
patient reader and cause it to not operate correctly.
If the batteries need to be replaced, discard the old batteries
properly according to local regulations.
Warning: Do not inhale or swallow the batteries. Inhaling or
swallowing the batteries can cause serious physical harm.
Patient reader Disposal
Follow local regulations for proper disposal of this product. Do
not dispose of this product in the unsorted municipal waste
stream. This product contains materials that can harm the
environment. See http://recycling.medtronic.com for instructions
on proper disposal of this product.
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How to contact Medtronic
Patients in the United States
To speak directly with a Patient Services Specialist, call 1-800-929-
4043. Our staff is available Monday through Friday from 8:00 AM
to 5:00 PM (Central Standard Time).
Medtronic is dedicated to providing you with the most up-to-
date information available about your patient reader. Website
information is available 24 hours a day.
• Medtronic website: www.medtronic.com
• Medtronic CareLink Network information:
www.medtronic.com/patients/carelink
Patients outside the United States
If you have questions that are not covered in this manual or you
want more in-depth information about your patient reader,
please contact Medtronic using the information found on the
back cover of this manual.
Patient reader specifications
Standards (The patient reader complies with the following:)
EMC: CFR 47 Part 15
Patient Safety: IP20; IEC 60601-1, Type BF applied part, ordinary,
continuous operation, Class II, not suitable for use in the presence
of a flammable anaesthetic mixture with air or with oxygen or
nitrous oxide.
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Recommended environmental conditions during distribution,
storage, and transport
The temperature range for the patient reader applies to all of the
following conditions:
• Distribution in the packaging
• Transport in the packaging
• Storage in the packaging
• Storage and transport after the patient reader has been
removed from the packaging
Temperature: -40 °C to 70 °C (-40 °F to 158 °F)
Relative Humidity: 15% to 93%
Safe when distributed, stored, or transported in temperatures
from -40 °C without relative humidity control to 70 °C at a
relative humidity of 5% to 95%, including condensation.
Recommended operating conditions
Temperature: 5 °C to 35 °C (41 °F to 95 °F)
Safe when operated at temperatures from 5 °C to 35 °C (41 °F to
95 °F) in relative humidity from 15% to 93%, non-condensing.
Atmospheric pressure range
Safe when stored or operated in an atmospheric pressure range of
700 hPa to 1060 hPa.
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Maximum altitude usage
Do not use the patient reader above an altitude of 3000 meters
(9,842 feet).
Expected service life
The expected service life of a patient reader is 5 years.
Electromagnetic interference
Keep your smart phone or tablet in your hand and follow the
instructions in the app while interrogating your implanted
device.
If you experience performance issues with your patient reader,
try using it at least two meters (6 feet) away from a television,
computer monitor or screen, or wireless communications
equipment such as wireless home network devices, cordless
telephones and their base stations, or ‘walkie-talkies.’ Using your
patient reader near these devices could interfere with
communication between your implanted heart device and the
patient reader.
Safety and technical inspection
An annual safety and technical inspection of the patient reader is
not required.
Consumer information and Requirements
FCC Requirements
FCC ID LF525000 (contains FCC ID T7V1316)
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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 patient reader has been tested for
compliance to FCC regulations. Changes or modifications of any
kind could void the user’s authority to operate the patient reader.
RF Exposure Guidance: This equipment complies with FCC
radiation exposure limits set forth for an uncontrolled
environment. This transmitter must not be co-located or
operating in conjunction with any other antenna or transmitter,
except in accordance with FCC multi-transmitter product
procedures.
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*M957944A001*
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© Medtronic, Inc. 2014
M957944A001A
2014-04-11
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432
USA
www.medtronic.com
+1 763 514 4000
Medtronic USA, Inc.
Toll-free in the USA (24-hour technical
consultation for physicians and medical
professionals)
Bradycardia: +1 800 505 4636
Tachycardia: +1 800 723 4636
Europe/Middle East/Africa
Medtronic International Trading Sàrl
Route du Molliau 31
Case Postale 84
CH-1131 Tolochenaz
Switzerland
+41 21 802 7000
Technical manuals
www.medtronic.com/manuals
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