Medtronic 24950B 24950B User Manual
Medtronic, Inc. 24950B
User Manual
MyCareLink™ Patient
Monitor
Model 24950
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
Explanation of Symbols
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)
(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
Conforms To AAMI Std ES60601-1, IEC Stds
60601-1-6 & 60601-1-11 Certified To CSA
Std C22.2 #60601-1
China RoHS
USB port
Direct current. 5V 3.0A
Refer to instruction manual
7
Contents
Introduction 9
About your monitor 9
Indications for use 11
Contraindications 12
Warnings 12
Precautions 15
Contents of the monitor package 16
About the monitor 17
Choosing a place to set up the monitor 19
Setting up the monitor 20
Sending information using the monitor 21
Start-up screen information 28
Reader LED indicator lights 30
Troubleshooting error messages 31
Traveling with your monitor 38
Monitor care 39
How to contact Medtronic 40
Monitor specifications 41
9
Introduction
This manual is intended to help you use the
MyCareLink Patient Monitor Model 24950.
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 40, 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 heart device. The monitor gathers this
information to allow your doctor to manage your
care.
How your monitor gathers information from your
heart device is determined by the kind of heart
device you have.
10
Some heart devices communicate wirelessly with
your monitor. Once you have set up your monitor
and completed an initial manual transmission, the
monitor is designed to automatically gather
information from your implanted heart device.
This automatic wireless communication between
your heart device and the monitor takes place at
times scheduled by your doctor or clinic. Sending
heart device information to your clinic using
wireless technology does not require you to
interact with your monitor. The process is silent
and invisible.
Clinics typically schedule the automatic process to
occur while you sleep. For this reason, the monitor
must remain plugged in to a power outlet. The
heart device information is sent to your clinic using
the cellular phone network.
Other heart devices require you to use your
monitor’s reader to gather information from your
heart device so your monitor can send the
information to your clinic.
To find out which kind of device you have, see
your heart device patient manual, or talk to your
doctor.
11
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
implanted devices could interrupt the prescribed
operation of their device.
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, to allow
automatic wireless communication between
your monitor and your heart device
• At the request of your doctor or clinic
See “Sending information using the monitor” on
page 21 of this manual.
Indications for use
The monitor is an external electronic device that
interfaces with Medtronic implanted heart devices
and a telecommunications connection to transmit
12
stored implanted heart device data to the
physician or clinician.
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.
13
If you need further assistance, please contact
Medtronic. See “How to contact Medtronic” on
page 40, 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 21. 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 40, 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.
14
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.
15
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.
16
Contents of the monitor package
You should receive the following:
• One Medtronic MyCareLink Patient Monitor
Model 24950 base
• One Medtronic MyCareLink Model 24955
removable reader
•One power cord
• One Patient Manual
•One Quick Start Guide
• One set of ‘For Your Records’ labels
• One Cellular Modem safety manual
17
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
19
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 near where you sleep,
preferably on a nightstand or a table. Your
monitor is capable of receiving signals from
your heart device up to 3 meters (10 feet) away,
but you should consult your heart device
manual for recommended distances specific to
your device.
20
• 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.
• 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.
21
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.
22
• 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 31 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.
23
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
24
either hold the reader snugly against your
clothing, or against your bare skin.
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.
25
– 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.
120 s
26
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.
120 s
27
8. Your transmission is complete when the
monitor makes two short tones and the monitor
screen shows a green check mark image.
28
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
29
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 in.
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
30
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
31
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 solid 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
32
You can find information about the following
errors:
• Error #3230 - “Reader not found by monitor
base” on page 33
• Error #3248 - “Reader battery status” on page 34
• Error #5704 - “No cellular signal” on page 35
• “Reader position” on page 36
• “System errors” on page 37
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 40, or use the information found on the back
cover of this manual.
33
Reader not found by monitor base
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
correct the error, please contact Medtronic. See
“How to contact Medtronic” on page 40, or use the
1 2
34
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.
Figure 6: Reader battery status
20
35
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 40, 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.
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. Remember, your
monitor should be placed within 3 meters
(10 feet) of where you sleep.
• If you are unable to find an adequate cellular
signal for your monitor, please contact
36
Medtronic. See “How to contact Medtronic” on
page 40, or use the information found on the
back cover of this manual.
Figure 7: No cellular signal
Reader position
The reader must be properly positioned over your
implanted device in order to communicate with it.
If the 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.
1 2
37
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.
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.
1 2
38
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 40, 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.
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.
39
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 40, or use the
information found on the back cover of this
manual.
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 40, 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.
40
Caution: Do not get your monitor wet. If you get
your monitor wet, please contact Medtronic. See
“How to contact Medtronic” on page 40, or use the
information found on the back cover of this
manual.
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
41
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 on the back cover
of this manual.
Monitor specifications
Open Source Software
This product contains certain third party software
that is subject to specific license terms.
You may go to
www.Medtronic.com/monitorsource to obtain the
terms and warranty limitations applicable to the
software and, in some cases, a free copy of the
software (subject to nominal distribution charges).
Standards (The monitor complies with the
following:)
EMC: CFR 47 Part 15
42
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.
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.
43
Power supply
To assure compliance to the specified standards,
use only the power supply that came with your
monitor: MENB1020A0502-XXX.
Rated Voltage AC 100 - 240V
Rated Line Frequency 50 - 60Hz
Current 0.5A Max. at 100 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.
44
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
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
Model 24950 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.
45
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
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 LF524950B
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.
46
Changes or modifications of any kind not
expressly approved by Medtronic could void the
user’s authority to operate the monitor
This transmitter is authorized by rule under the
Medical Device Radiocommunication Service (in
part 95 of the FCC Rules) and may not interfere
with stations operating in the 400.15-406 MHz
band in the meteorological aids, meteorological
satellite, and earth exploration satellite services
(i.e. transmitter and receivers used to
communicate weather data) and must accept any
interference received, including interference that
may cause undesired operation. This transmitter
shall be used only in accordance with FCC Rules
governing the Medical Device
Radiocommunication Service. Analog and digital
voice communications are prohibited. Although
this transmitter has been approved by the Federal
Communication Commission there is no
guarantee that it will not receive interference or
that any particular transmission from this
transmitter will be free from interference.
47
Industry Canada Requirements
IC: 3408D-24950B
IC: 3408D-24955 (contains IC: 216Q-1315)
This device complies with Industry Canada's
licence-exempt RSSs.
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.
“This device may not interfere with stations
operating in the 400.150-406.000 MHz band in the
meteorological aids, meteorological-satellite, and
earth exploration-satellite services and must accept
any interference received, including interference
that may cause undesired operation.”
*M953321A001*
© Medtronic, Inc. 2013
M953321A001C
2013-07-15
Manufacturer
Medtronic, Inc.
710 Medtronic Parkway
Minneapolis, MN 55432
USA
www.medtronic.com
+1 763 514 4000
Authorized Representative in the
European Community
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
+31 45 566 8000
Europe/Middle East/Africa
Medtronic International Trading Sàrl
Route du Molliau 31
Case Postale 84
CH-1131 Tolochenaz
Switzerland
+41218027000
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
Canada
+1 905 460 3800
Technical manuals
www.medtronic.com/manuals