BIOTRONIK CardioMessenger Smart User manual

CRM // BIOTRONIK Home Monitoring®
CardioMessenger®Smart
en Technical Manual
es Manual técnico
fr Manuel technique
420160--H_GA_CardioMessenger-Smart_e-MUL_Cover.indd 1 21.03.2016 12:35:35

You can also find the CardioMessenger Smart manual
in the Internet by visiting the BIOTRONIK website:
http://www.biotronikusa.com/manuals/
420160--H_GA_CardioMessenger-Smart_e-MUL_Cover.indd 2 21.03.2016 12:35:35

Español
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420160--H
420160--H_GA_CardioMessenger-Smart_e-MUL.book Page -1 Thursday, March 24, 2016 11:34 AM

Table of Contents 1
English
Table of Contents
Table of Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
First Steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Check the Package Contents . . . . . . . . . . . . . . . . . . . . . . . . . 3
Where Do I Put the CardioMessenger? . . . . . . . . . . . . . . . . . 5
How Do I Connect the CardioMessenger? . . . . . . . . . . . . . . . 6
How Do I Use the CardioMessenger? . . . . . . . . . . . . . . . . . . . 8
How Do I Turn Off the CardioMessenger? . . . . . . . . . . . . . . . 9
The CardioMessenger Icons . . . . . . . . . . . . . . . . . 11
Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Self-Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Call Back Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Error Resolution . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Error type A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Error type B. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Error type C. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Handling. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Charging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Disposal. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Precautionary Measures . . . . . . . . . . . . . . . . . . . . 25
Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Symbols on the Device. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Legend for the Label . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Electromagnetic Emitted Interference according to
IEC 60601-1-2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Electromagnetic Resistance to Interference according to
IEC 60601-1-2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Recommended Safe Distances between Portable
and Mobile RF Communications Equipment and the
CardioMessenger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
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2Introduction
1 Introduction
Introduction1399229-GTechnical ManualCardioMessenger®Smart
Dear Patient:
You have received a device with the additional Home
Monitoring function by BIOTRONIK.
How Home Monitoring works
Your device (1) is equipped with a special transmitter
which sends cardiac information to your Cardio-
Messenger (2). This usually happens at night.
The transmission power from your device is low and does
not impair your health in any way. Its limited transmission
range, however, requires the use of the Cardio-
Messenger.
The CardioMessenger collects the information and
transmits it to the BIOTRONIK Service Center (4) as
encoded messages via a mobile connection (3).
Here, the messages are decoded and can be viewed by
your physician (5) on a protected web site.
Usage of this additional data is specific to the patient and
the implanted device. Your physician will explain to you
how he or she will use the Home Monitoring function.
Note: Home Monitoring is not an emergency system. If
you are not feeling well, contact a physician.
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First Steps 3
English
2 First Steps
First Steps2399229-GTechnical ManualCardioMessenger®Smart
Check the Package Contents
Your CardioMessenger is supplied ready for use, and you
can operate it immediately by inserting the power plug
into the wall outlet.
However, prior to usage, check the CardioMessenger and
its accessories for any visible damage and use only
undamaged components.
Return a damaged CardioMessenger to your physician.
Use only the provided original power supply brick (see the
technical data).
Other equipment may impair proper functioning of the
CardioMessenger and increase the emitted electromag-
netic interference or decrease the CardioMessenger's
resistance to electromagnetic interference.
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4First Steps
The product package includes the CardioMessenger (1)
with power supply brick (2), the quick reference guide (3)
and the technical manual (4).
(1) (2)
(3)
(4)
® Smart
CRM // BIOTRONIK Home Monitoring®
CardioMessenger®Smart
de Gebrauchsanweisung
en Technical Manual
es Manual técnico
fr Manuel technique
it Manuale tecnico di istruzioni
nl Technische handleiding
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First Steps 5
English
Where Do I Put the CardioMessenger?
At night, the CardioMessenger should be placed close
to your bed to ensure the nightly data transfer from the
implanted device.
The bedside table is therefore the best location for your
CardioMessenger, as it usually meets the following
conditions:
The CardioMessenger is placed on a solid base and
cannot fall.
The distance to the implanted device is less than 2 m
(6 feet), so that regular data transmission from the
implanted device to the CardioMessenger at night is
assured.
Positioned on the bedside table, you can clearly see
the symbols on the CardioMessenger's display. This
enables you to verify on a daily basis that it is ready for
service.
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6First Steps
However, if the bedside table is made of metal, you
should not place the CardioMessenger directly on the
table. For example, place a stack of books to establish
a distance of approx. 5 cm between the two so that the
metal does not interfere with the device's data reception.
Please take the following also into consideration:
Do not place the CardioMessenger next to a television
set, microwave oven, or a similar source of electro-
magnetic disturbance.
You may hear noises typical of cellular phones if you
place the CardioMessenger too close to a radio alarm
or a television set, for example.
Do not expose the CardioMessenger to temperatures
exceeding 40°C (104°F). Do not put it in places where it
is subjected to direct sunlight and do not put it directly
under a halogen spotlight.
Do not expose the CardioMessenger to temperatures
below negative 5°C (23°F). The power supply brick
should not be exposed to temperatures lower than O°C
(32°F).
Protect the CardioMessenger against water and high
humidity.
Do not place it in the bathroom.
How Do I Connect the CardioMessenger?
Your CardioMessenger is already configured and is ready
for use. You can operate it immediately by inserting the
power plug (see Appendix, p. 30 for the type) into the wall
outlet.
Note: Also refer to the included quick reference guide.
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First Steps 7
English
However, proceed as follows if the plug has been discon-
nected during removal from the package or during
shipping:
1Connect the small plug (micro USB plug) on the
right to the CardioMessenger.
Make sure that the marking (white arrow) is on
the upper side of the plug.
The connector port is labeled with the following
symbol:
2Insert the power plug into the wall outlet.
UP
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8First Steps
Make sure that the outlet is easily accessible and not
connected to a light switch in order to prevent the Cardio-
Messenger from accidentally being turned off.
The CardioMessenger now turns on automatically and
performs a self-test.
The CardioMessenger is ready for use once the self-test
is completed and the following icons are displayed:
If this is not the case, please refer to: Error Resolution,
p. 15.
How Do I Use the CardioMessenger?
The CardioMessenger automatically receives the infor-
mation from your implanted device and transmits it to the
BIOTRONIK Service Center. Therefore, there are only a
few points that need to be considered.
Check once a day whether your CardioMessenger is
switched on and ready for use.
This is indicated by the following icons:
If you want to use the CardioMessenger in mobile opera-
tion, we recommend that you make a habit of charging it
every night on the bedside table.
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First Steps 9
English
How Do I Turn Off the CardioMessenger?
Since the CardioMessenger contains a mobile ("cellular")
module, you may need to switch off the CardioMessenger
for safety reasons in areas where the use of mobile
phones is prohibited (e.g., in an airplane).
Such areas can be identified by the following or similar
signs:
In some locations, the use of cellular phones is prohibited
to provide quiet zones (e.g., in a theater or cinema). As the
CardioMessenger is silent, it does not need to be turned
off in such locations.
Press and hold the blue key on the right of the Cardio-
Messenger for two seconds until the display turns off.
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10 First Steps
The blue key is labeled with the following symbol:
The CardioMessenger is switched off.
Note: The functions of your implanted device are not
affected by the CardioMessenger at any time.
Your implanted device remains fully functional even if
the CardioMessenger is not ready for use.
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The CardioMessenger Icons 11
English
3 The CardioMessenger Icons
The CardioMessenger Icons3399229-GTechnical ManualCardioMessenger®Smart
The CardioMessenger has the following icons:
1Operation icon
2Call back icon
See Call Back Function, p. 13
3Information icon
See Error Resolution, p. 15
4The battery icon is always displayed
with 1-3 bars according to the charging
status.
5When the CardioMessenger is
connected to the power supply brick
and charging, a battery icon with a
small power plug is displayed.
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12 Functions
4 Functions
Functions4399229-GTechnical ManualCardioMessenger®Smart
Self-Test
The CardioMessenger automatically conducts a self-test
after being connected.
If the connection was not established, the information
icon flashes.
Additional information can be found under: Error Resolu-
tion, p. 15.
1All icons on the CardioMessenger are displayed.
The CardioMessenger then checks the connec-
tion to the cellular phone network.
2The operation icon flashes and the battery icon is
displayed.
The connection test can take up to 15 minutes.
3Once the connection is established, the
operation and battery icons remain permanently
activated.
The CardioMessenger is now ready for use.
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Functions 13
English
Call Back Function
The call back function is an additional function that your
physician can use in different ways. You will be informed
by your physician if and how he or she will use this
function.
For example, your physician can use the call back button
to ask you for a call. Your physician can turn on the icon
via the cellular phone network. It will then flash for a
maximum of three days.
Contact your physician during office hours as soon as you
notice that the call back icon is flashing.
Turning off the call back icon
To turn off the call back icon, briefly turn off the Cardio-
Messenger.
1Press the blue key on the right side of the
CardioMessenger for about two seconds.
2All symbols disappear.
3Wait approximately ten seconds.
4Press the blue key again for approximately two
seconds.
Note: If the CardioMessenger is connected to the power
supply brick, it starts automatically. You neither have to
wait nor switch it on.
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14 Functions
The CardioMessenger performs a self-test.
The operation and battery icon is then displayed, and the
call back icon stops flashing.
However, please do not forget to call your physician.
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Error Resolution 15
English
5 Error Resolution
Error Resolution5399229-GTechnical ManualCardioMessenger®Smart
If your physician contacts you because device messages
are not being received but your CardioMessenger was
ready for use during the period in question, you should
remove possible sources of electromagnetic disturbance
from the immediate vicinity of the CardioMessenger.
Possible sources of electromagnetic disturbance can be
communication devices such as wireless home network
equipment, cellular phones, cordless phones, and their
base stations.
In the IEC 60601-1-2: 2007 standard, a distance of 3.3 m
(3.6 yd) is recommended for these cases. (For more infor-
mation, refer to Appendix, p. 30).
Malfunctions on the CardioMessenger are indicated by
the icons.
Icon Behavior Operational status
Off Error type A: No power
supply
Flashing Error type B: Self-test
failed
Flashing Error type C: No
mobile connection
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16 Error Resolution
Error type A
No power supply
The operation icon is not displayed. The Cardio-
Messenger is not ready for use.
Make sure the micro USB plug is properly inserted into
the CardioMessenger.
Make sure the power plug is properly inserted into the
wall outlet.
Make sure the outlet provides an electrical current, for
example by temporarily connecting the bedside lamp to
the outlet and turning the lamp on.
If you do not find any errors, contact your physician.
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Error Resolution 17
English
Error type B
Self-test failed
All symbols are flashing.
Repeat the self-test as the CardioMessenger did not
finish it.
The CardioMessenger is not ready for use.
The CardioMessenger starts and automatically repeats
the self-test. When the self-test is completed, the
CardioMessenger is ready for use.
If all symbols continue to flash, the CardioMessenger is
defective. Return it to your physician.
1Disconnect the CardioMessenger from the
power supply brick if relevant.
2Press the blue key on the right side of the
CardioMessenger for about two seconds.
3Leave the CardioMessenger turned off for about
thirty seconds.
4Turn on the CardioMessenger by connecting it to
the power supply.
Note: The connection test can take up to 15 minutes.
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