Medtronic 24951 24951 User Manual
Medtronic, Inc. 24951
User Manual
0123
0123
MyCareLink™ Patient
Monitor
Model 24951
Caution: Federal Law (USA)
restricts this device to sale by
or on the order of a physician.
Patient Manual
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 and MyCareLink
Conformité Européenne (European
Conformity).This symbol means that the
device fully complies with European
Directives.
This symbol means that the device fully
complies with the AIMD Directive
90/385/EEC (as amended by
2007/47/EC)(NB 0123) and R&TTE
1999/5/EC
(Reader) This product complies with
international electrical safety rating IP22 with
regard to ingress of dust, other foreign
objects, and water as required by IEC
60601-11.
(Monitor base) This product complies with
international electrical safety rating IP21 with
regard to ingress of dust, other foreign
objects, and water as required by IEC
60601-11.
Keep dry
Use only with provided power supply
Type BF applied part
Caution
Consult instructions for use
Package contents
Home monitor
Product documentation
Accessories
MyCareLink Patient Monitor
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
Temperature limitation
Humidity limitation
For US audiences only
Manufacturer
Date of manufacture
Authorized representative in the European
community
Medical equipment with respect to electric
shock, fire, and mechanical hazards, only in
AAMI/ES 60601-1(2006) / A2 (2010) and
CSA 22.2 NO 60601-1 CAN/CSA:2008
China RoHS
USB port
Direct current. 5V 0.3A
Refer to instruction manual
7
Contents
Introduction 9
About your monitor 9
Indications for use 10
Contraindications 11
Warnings 11
Precautions 14
Contents of the monitor package 15
About the monitor 16
Choosing a place to set up the monitor 18
Setting up the monitor 19
Sending information using the monitor 20
Start-up screen information 26
Reader LED indicator lights 28
Troubleshooting error messages 29
Traveling with your monitor 37
Monitor care 38
How to contact Medtronic 39
Monitor specifications 40
Consumer information and Requirements 43
9
Introduction
This manual is intended to help you use the
MyCareLink Patient Monitor Model 24951.
If you have any questions setting up or using the
monitor, or if you have problems with the monitor,
please contact Medtronic. See “How to contact
Medtronic” on page 39, or use the information
found on the back cover of this manual.
If you have questions about your medical
condition, talk to your doctor. Your doctor knows
your medical history.
About your monitor
The monitor is an electronic device that provides
an easy way for your doctor to obtain information
about your implanted device. The monitor gathers
this information to allow your doctor to manage
your care.
The monitor is intended specifically for your use
only. It will not work with other implanted devices
and should only be used by you as directed by
your doctor. Unauthorized use by others with
10
implanted devices could interrupt the prescribed
operation of their device.
Indications for use
The monitor is an external electronic device that
interfaces with Medtronic implanted heart devices
and a telecommunications connection to transmit
stored implanted heart device data to the
physician or clinician.
Sending information at the request of your
doctor or clinic
You will sometimes need to send information at
times other than those scheduled by your doctor or
clinic. These times are:
• When completing first-time setup
• At the request of your doctor or clinic
See “Sending information using the monitor” on
page 20 of this manual.
11
Contraindications
There are no known contraindications for the
monitor.
Warnings
Warning: If you are feeling ill, seek immediate
medical attention. Do not use the monitor unless
directed by your doctor. If there is an emergency,
call your local emergency number. If your 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
monitor and your implanted heart device, follow
these instructions:
Use the monitor as described in this manual. Save
this manual.
Use the monitor only at the times prescribed by
your doctor.
If you need further assistance, please contact
Medtronic. See “How to contact Medtronic” on
12
page 39, or use the information found on the back
cover of this manual.
Warning: Do not use the monitor if the monitor
does not operate as described in “Sending
information using the monitor” on page 20. To
ensure proper operation of your implanted heart
device, follow the instructions in this manual
about positioning the reader over your implanted
heart device. If you do not follow these
instructions, the monitor 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 39, or use the information
found on the back cover of this manual.
Warning: Do not modify this equipment.
Modifications may impact monitor effectiveness,
and adversely affect your safety.
Warning: Do not touch open ports or plugs, or
insert your finger or any objects into the open ports
on the monitor. Inserting your finger or objects into
an open port may result in electrical shock.
13
Warning: Important safety instructions. When
using the monitor, basic safety precautions should
always be followed to reduce the risk of fire,
electric shock, and injury to persons, including the
following:
• Do not use the monitor near water, for
example, near a bath tub, wash bowl, kitchen
sink or laundry tub, in a wet basement, or
near a swimming pool.
• If you suspect a gas leak, do not use the
monitor and do not use a telephone in the
vicinity of the leak to report a gas leak.
14
Precautions
• Use only the supplied power cord with this
monitor. Using a different power cord could
damage the monitor and adversely affect
your safety.
• Do not use the monitor within two meters
(six feet) of a television, computer monitor or
screen, or wireless communications
equipment such as wireless home network
devices, mobile phones, cordless telephones
and their base stations, or ‘walkie-talkies.’
Using your monitor near these devices could
interfere with communication between your
implanted heart device and the monitor.
15
Contents of the monitor package
You should receive the following:
• One Medtronic MyCareLink Patient Monitor
Model 24951 base
• One Medtronic MyCareLink Model 24955
removable reader
• One Medtronic MyCareLink Model 24956
power cord
• One Patient Manual
•One Quick Start Guide
• One set of ‘For Your Records’ labels
• One Cellular Modem safety manual
16
About the monitor
Figure 1: Monitor base and removable reader (front
view)
1 Reader 4 Power LED
2 Accept Button 5 Power port
3 Monitor screen
1
2
3
4
5
18
Figure 3: Monitor reader (front and back view,
approximately 1/3 actual size)
Choosing a place to set up the monitor
Consider the following recommendations for
choosing a place to set up the monitor:
• Place the monitor where you can sit comfortably
and see the front of the monitor.
• Place the monitor in a location that receives an
adequate cellular signal.
• Place the monitor within reach of a power
outlet, and position it so that it can be
unplugged from the power outlet if necessary.
19
• Do not place the monitor anywhere it could get
wet.
Setting up the monitor
Before you use the monitor you will need to plug
the monitor into a power outlet.
To plug in your monitor, locate the power cord
port on the left side of the monitor base. Insert the
power cord end into the monitor side port, then
plug the wall plug into a wall outlet.
Caution: Use only the supplied power cord with
this monitor. Using a different power cord could
damage the monitor and adversely affect your
safety.
20
Figure 4: Plugging in the monitor
Sending information using the monitor
Use this procedure at these times:
• When completing first-time set-up.
• At the request of your doctor or clinic.
Before using your monitor:
• Turn off any television, computer monitor, or
screen within two meters (six feet) of the
monitor.
21
• Turn off or remove any cellular phone or other
wireless device that is within two meters (six
feet) of the monitor.
When you send a transmission using this
procedure, your monitor screen will also show step
by step instructions for you to follow. You can use
these on-screen instructions to guide you through
this procedure.
Note: If the monitor screen shows an error
message icon during this procedure, refer to
“Troubleshooting error messages” on page 29 of
this manual.
To send information using your monitor,
perform the following steps:
1. If the monitor screen is dark, press the “Accept”
button on the front of the monitor to wake up
the screen.
2. When monitor wake-up is complete, the
monitor screen will show an image indicating
that the monitor is ready to begin a
transmission.
22
3. Press the “Accept” button. The monitor screen
will show an image instructing you to pick up
the reader.
4. When the monitor screen shows an image of a
reader being placed over a device, hold the
reader over your implanted device. You may
either hold the reader snugly against your
clothing, or against your bare skin.
23
5. When the monitor begins reading data from
your implanted device, the monitor screen will
show a green progress bar, indicating that data
is being sent from the reader to the monitor
base.
120 s
24
– While the monitor is communicating with
your implanted device, remain still and make
sure the monitor reader is placed over your
implanted device. This process typically takes
less than 3 minutes, but may take up to
12 minutes.
6. When the monitor is finished communicating
with your implanted device, the monitor will
make two short tones, and the monitor screen
will instruct you to return the reader to the
monitor base.
7. The monitor will send your implanted device
data to the CareLink Network. The monitor
screen will show a green progress bar
indicating that data is being sent.
25
8. Your transmission is complete when the
monitor makes two short tones and the monitor
screen shows a green check mark image.
120 s
26
Start-up screen information
When your monitor is activated by pressing the
“Accept” button, your monitor screen will show a
system status image with the following
information:
Table 1. Start screen information
Image Description
1 Reader status icon This area shows the status of the
reader. The reader icon may show
the reader is charging, missing, or
has a low battery.
1
2
3
4
27
2 Cellular signal icon This icon shows the status of the
monitor’s connection to a cellular
network
3 Last transmission This icon shows the date of your last
successful transmission to the
CareLink Network. Note: The date
format shown on your monitor will
depend on which country you are
from.
4 Start transmission
icon This icon means the monitor is ready
to begin a transmission. Press the
“Accept” button to begin a
transmission.
Table 1. Start screen information
Image Description
28
Reader LED indicator lights
The monitor’s reader has three LED indicator
lights that indicate the status of a transmission, the
connection between the reader and monitor base,
and the reader’s battery status.
Table 2. reader LED indicator lights
Indicator Light Description
1 Green indicator light The green indicator light shows
transmission of data between the
reader and monitor base. When the
green indicator light is lit, the reader
is transmitting data to the monitor
base.
1
23
29
When you place the reader on the monitor base, all
three indicator lights will flash briefly to indicate
that the reader is properly docked with the
monitor base.
Troubleshooting error messages
Use the information in this section to troubleshoot
the use of your monitor.
2 Blue indicator light The blue indicator light shows the
connection between the reader and
monitor base.
• A flashing blue light means the
reader is establishing a
connection with the monitor base
• A sold blue light means the reader
and monitor base are connected.
3 Amber indicator light The amber indicator light shows the
battery status of the reader. If the
amber indicator light is lit, the
reader battery is low. Place the
reader on the monitor base to
recharge the reader battery.
Table 2. reader LED indicator lights
Indicator Light Description
30
You can find information about the following
errors:
• Error #3230 - “Reader not found by monitor
base” on page 31
• Error #3248 - “Reader battery status” on page 32
• Error #5704 - “No cellular signal” on page 33
• “Reader position” on page 35
• “System errors” on page 36
If you receive an error message while using your
monitor, your monitor screen will show an error
icon with an orange background, and a 4 digit
error number.
Some error messages may include an animated
demonstration to help you correct the problem.
Follow these instructions to resolve the error.
For some errors, you will be instructed to contact
Medtronic. See “How to contact Medtronic” on
page 39, or use the information found on the back
cover of this manual.
31
Reader not found by monitor base
When you activate the monitor, if the monitor base
is unable to communicate with the reader, the
monitor screen will show Error #3230 - No reader
found by monitor base.
Figure 5: No reader found by monitor base
This can occur when:
• The reader is off the monitor base, and has
powered down.
• The reader is off the base station and has no
battery life remaining.
• The reader is out of range of the monitor base.
To restore communication between the reader and
monitor base, return the reader to the monitor base
cradle, and wait for the error message to disappear.
If returning the reader to the monitor base does not
1 2
32
correct the error, contact Medtronic for assistance.
See “How to contact Medtronic” on page 39, or use
the information found on the back cover of this
manual.
Reader battery status
The monitor reader includes a rechargeable
battery. If the reader battery needs to be recharged,
the monitor’s screen will show Error #3248 -
Recharge Reader. In addition, the amber LED
indicator light on the reader head may be lit.
• To recharge the reader, place the reader on the
monitor base. Recharging the reader battery
will take approximately 20 minutes.
33
Figure 6: Reader battery status
Note: The monitor reader should be replaced
when your reader battery no longer recharges, or
only holds a charge for a brief period. If you are
unable to complete a transmission without
receiving the Recharge Reader error message,
please contact Medtronic. See “How to contact
Medtronic” on page 39, or use the information
found on the back cover of this manual.
No cellular signal
Your monitor uses a cellular telephone connection
to transmit implanted device data to your doctor.
20
34
If your monitor does not have adequate cellular
service connection, the monitor’s screen will show
Error # 5704 - No cellular signal. See Figure 7
• Change the orientation of the monitor by
rotating the monitor base.
• Change the location of your monitor so it is near
a window or outside wall.
• If you are unable to find an adequate cellular
signal for your monitor, please contact
Medtronic. See “How to contact Medtronic” on
page 39, or use the information found on the
back cover of this manual.
Figure 7: No cellular signal
1 2
35
Reader position
The monitor reader must be properly positioned
over your implanted device in order to
communicate with it.
If the monitor reader is moved out of position
during a transmission, you will hear 3 short tones
from your monitor, and see the Reader Placement
Problem image on the monitor screen. See Figure 8
Figure 8: Reader placement problem
• Reposition the reader over your implanted
device.
• When the reader is repositioned correctly a
green progress bar will appear on the monitor
screen. When the reader is positioned correctly,
the monitor will resume data collection. Hold
the reader in position until your transmission is
completed.
1 2
36
System errors
If your monitor encounters a system error, your
monitor screen will show a system error icon and
an error message code.
This image indicates that your monitor has
encountered an internal error, and does not mean
that there is a problem with your implanted heart
device.
If this occurs, restart the monitor by disconnecting
then reconnecting the monitor’s power supply.
If restarting your monitor does not correct the
error, please contact Medtronic. See “How to
contact Medtronic” on page 39, or use the
information found on the back cover of this
manual.
Refer to the error code shown on your monitor
screen to help Medtronic identify the problem.
37
Figure 9: System error
Traveling with your monitor
Note: Your monitor will work in most locations.
However, in some locations, cellular service may
not be available. If you are planning on traveling
with your monitor, please contact Medtronic to
confirm availability of coverage.
Replacing your power supply or reader
If your power supply or monitor reader is lost or
damaged, you can contact Medtronic to receive
information on ordering a replacement. See “How
to contact Medtronic” on page 39, or use the
information found on the back cover of this
manual.
38
Monitor care
Do not drop your monitor or reader on hard
surfaces. Dropping the monitor or reader can
damage them and prevent them from functioning
properly. If your monitor or reader has been
damaged, please contact Medtronic. See “How to
contact Medtronic” on page 39, or use the
information found on the back cover of this
manual.
You can clean the exterior of your monitor by using
a clean cloth and light application of water,
hydrogen peroxide, alcohol (methyl, ethyl or
Isopropyl) or a mild detergent.
The monitor does not require any preventative
inspection or maintenance.
Caution: Do not get your monitor wet. If you get
your monitor wet, please contact Medtronic. See
“How to contact Medtronic” on page 39, or use the
information found on the back cover of this
manual.
39
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
monitor. 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 heart monitor, please contact
Medtronic using the information found on the
back cover of this manual.
40
Monitor specifications
Open Source Software
The operating system for this device includes open
source software.
Information on open source software licensing can
be found at www.medtronic.com/mycarelink/
monitor/software
Standards (The monitor complies with the
following:)
EMC: CFR 47 Part 15
Patient Safety: IP22 (monitor base); IP21 (reader);
IEC 60601-1, ETL, Type BF applied part (Reader),
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.
41
Recommended environmental conditions
during storage and transport
Temperature: -40 °C to 70 °C (-40 °F to 158 °F)
Relative Humidity: 5% to 95%
Safe when 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 40 °C (41 °F to 104 °F)
Safe when operated at temperatures from 5 °C to
40 °C (41 °F to 104 °F) in relative humidity from
15% to 93%, non-condensing.
Power supply
To assure compliance to the specified standards,
use only the power supply that came with your
monitor: Medtronic Model Number 24956.
Rated Voltage AC 100 - 240V
Rated Line Frequency 50 - 60Hz
42
Current 0.5A Max. at 90 VAC input
The power supply is to be used for mains
disconnection.
Expected service life
The expected service life of a monitor is 5 years.
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.
Testing
Electromagnetic Compliance (EMC) testing shows
that the monitor provides reasonable protection
against harmful interference in a typical medical
installation. However, there is no guarantee that
interference will not occur in a particular
installation. If the monitor does cause harmful
interference to other devices or is negatively
43
impacted by other devices, the user is encouraged
to try to correct the interference by one or more of
the following measures:
• Reorient or relocate the devices.
• Increase the separation between the devices.
• Consult Medtronic for help.
If you experience performance issues with your
24951 MyCareLink Monitor, try using it at least
two meters (6 feet) away from all wireless
communication devices such as cellular phones,
television monitors, or computer screens.
Safety and technical inspection
An annual safety and technical inspection of the
monitor is not required.
Consumer information and
Requirements
Declaration of conformity
Medtronic declares that this product is in
conformity with the essential requirements of
Directive 1999/5/EC on Radio and
44
Telecommunications Terminal Equipment and
Directive 90/385/EEC on Active Implantable
Medical Devices.
FCC Requirements
The monitor has been tested for compliance to FCC
regulations. Changes or modifications of any kind
not expressly approved by Medtronic could void
the user’s authority to operate the monitor.
FCC ID LF524951
FCC ID LF524955 (contains FCC ID T7V1315)
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 monitor has
been tested for compliance to FCC regulations.
Changes or modifications of any kind not
expressly approved by Medtronic could void the
user’s authority to operate the monitor.
45
Industry Canada Requirements
IC ID 3408D-24951
IC ID 3408D-24955 (contains IC ID 216Q-1315)
Operation is subject to the following two
conditions: (1) this device may not cause
interference, and (2) this device must accept any
interference, including interference that may cause
undesired operation of the device.
*M953325A001*
© Medtronic, Inc. 2012
M953325A001A
2013-01-15
Manufacturer
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432
USA
www.medtronic.com
Tel. +1 763 514 4000
Fax +1 763 514 4879
Medtronic USA, Inc.
Information for patients:
Toll-free +1 800 551 5544
(7 a.m. – 6 p.m., Monday–Friday,
central time)
Fax +1 763 514 1855
Medtronic E.C. Authorized
Representative
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel.+31455668000
Fax +31 45 566 8668
Europe/Africa/Middle East
Headquarters
Medtronic International Trading Sàrl
Route du Molliau 31
Case Postale 84
CH-1131 Tolochenaz
Switzerland
Tel.+41218027000
Fax +41 21 802 7900
Australia
Medtronic Australasia Pty Ltd
97 Waterloo Road
North Ryde, NSW 2113
Australia
Canada
Medtronic of Canada Ltd.
99 Hereford Street
Brampton Ontario L6Y 0R3
Tel. +905 460 3800
Fax +905 826 6620
Toll-free in Canada
+1 800 268 5346
Technical manuals:
www.medtronic.com/manuals