BIOTRONIK CardioMessenger Smart User manual

CardioMessenger Smart
en Technical Manual
es Manual técnico
fr Manuel technique
404202
GA_CardioMessengerSmart_Cover_1.indd 11 31.07.2019 17:02:57

404202
You can also find the CardioMessenger Smart manual in the
Internet by visiting the BIOTRONIK website:
http://www.biotronikusa.com/manuals/
GA_CardioMessengerSmart_Cover_1.indd 12 31.07.2019 17:02:57

en • English ...................................................... 2
es • Español ..................................................... 46
fr • Français ..................................................... 95
404202--K

Table of Contents
2
Table of Contents
1 Introduction ................................................... 4
2 First Steps ..................................................... 6
Check the Package Contents ................................. 6
Where Do I Put the CardioMessenger? .................. 8
How Do I Connect the CardioMessenger? ............. 10
How Do I Use the CardioMessenger? ..................... 13
How Do I Turn Off the CardioMessenger? ............. 14
3 The CardioMessenger Icons .......................... 16
4 Functions ....................................................... 17
Self-Test .................................................................. 17
Call Back Function .................................................. 19
5 Error Resolution ........................................... 21
Error Type A - No Power Supply ............................. 22
Error Type B - Self-Test Failed .............................. 23
Error Type C - No Mobile Connection .................... 24
6 Handling ........................................................ 25
Charging .................................................................. 26
Cleaning ................................................................... 28
Maintenance ............................................................ 28
Disposal ................................................................... 29
7 Precautionary Measures ............................... 30
8 Guidelines ..................................................... 33
Telemetry Data for Europe ..................................... 33
Telemetry Data for the USA .................................... 35
Telemetry Data for Canada ..................................... 36
en • English

Table of Contents 3
Electromagnetic Compatibility ............................... 37
Warranty .................................................................. 37
9 Appendix ....................................................... 38
Technical Data ......................................................... 38
Symbols on the Device ............................................ 40
Legend for the Label ............................................... 41
Electromagnetic Emitted Interference .................. 43
Resistance to Electromagnetic Interference ......... 44
en • English

Introduction
4
1 Introduction
Dear Patient:
You have received a device with the additional
Home Monitoring function by BIOTRONIK.
How Home Monitoring works
Your implanted device (1) is equipped with a
special transmitter which sends cardiac
information to your CardioMessenger (2). This
usually happens at night.
The transmission power of your implanted device
is low and does not pose a health risk. However,
the transmission range from your implanted
device is limited, and therefore, the use of a
CardioMessenger is required.
The CardioMessenger collects the information
and transmits it to the BIOTRONIK Service
Center (4) as encoded messages via a mobile
connection (3).
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.
en • English

Introduction 5
Attention
Home Monitoring is not an emergency
system. If you are not feeling well, contact a
physician.
en • English

First Steps
6
2 First Steps
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.
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).
Use of other equipment may impair proper
functioning of the CardioMessenger and increase
the emitted electromagnetic interference or
decrease the CardioMessenger's resistance to
electromagnetic interference.
en • English

First Steps 7
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
WARNING
The CardioMessenger package may contain
ingestible small parts, therefore, keep the
package away from children under three
years of age.
en • English

First Steps
8
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 ft).
• Positioned on the bedside table, you can
clearly see the symbols on the
CardioMessenger's display.
Attention
Make sure that the distance to the implanted
device is less than 2m (6 ft), so that regular
data transmission from the device to the
CardioMessenger is ensured.
Verify on a daily basis that it is ready for
service.
en • English

First Steps 9
However, if the bedside table is made of metal,
you should not place the CardioMessenger
directly on the table. For example, place the
CardioMessenger on a stack of books to
establish a distance of approximately 5cm
(2 inches) between the two so that the metal does
not interfere with the device's data reception.
If you want to use the CardioMessenger in mobile
operation, we recommend that you make a habit
of charging it every night on the bedside table.
en • English

First Steps
10
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 into the wall outlet.
For more information, consult the included quick
reference guide.
WARNING
• Lay the power cord so that it is not a trip
hazard or a risk of strangulation.
The outlet must be easily accessible and should
not be connected to a light switch in order to
prevent the CardioMessenger from accidentally
being turned off.
Proceed as follows if the plug has been
disconnected during removal from the package
or during shipping:
en • English

First Steps 11
UP
1. Connect the small plug (micro USB plug) on
the right to the CardioMessenger.
The connector port is labeled with the
following symbol:
2. Make sure that the marking on the plug is
facing upward.
3. Insert the power plug into the wall outlet.
The CardioMessenger now turns on
automatically and performs a self-test.
en • English

First Steps
12
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 [Page21].
en • English

First Steps 13
How Do I Use the CardioMessenger?
The CardioMessenger automatically receives the
information from your implanted device and
transmits it to the BIOTRONIK Service Center.
Attention
Check once a day whether your
CardioMessenger is powered on and ready
for use.
This is indicated by the following icons:
en • English

First Steps
14
How Do I Turn Off the CardioMessenger?
Since the CardioMessenger contains a mobile
("cellular") module, you may need to power off
the CardioMessenger for safety reasons in areas
where the use of cellular phones is prohibited
(e.g., on an airplane).
Such areas can be identified by signs similar to
the following:
Press and hold the blue key on the right side of
the CardioMessenger for two seconds until the
display turns off.
The blue key is labeled with the following symbol:
en • English

First Steps 15
WARNING
If the CardioMessenger is powered off for an
extended period of time, data may be lost.
• After leaving the area where cellular
phones are prohibited, power on the
CardioMessenger again.
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 powered off in such
locations.
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.
en • English

The CardioMessenger Icons
16
3 The CardioMessenger Icons
The CardioMessenger has the following icons:
Operation icon
Call back icon
See Call Back Function
[Page19].
Information icon
See Error Resolution
[Page21].
The battery icon is always
displayed with 1-3 bars
according to the charging
status.
When the CardioMes-
senger is connected to
the power supply brick
and charging, a battery
icon with a small power
plug is displayed.
en • English

Functions 17
4 Functions
Self-Test
The CardioMessenger automatically conducts a
self-test after being connected.
All icons on the CardioMessenger are displayed.
The CardioMessenger then checks the
connection to the cellular phone network.
The operation icon flashes and the battery icon is
displayed.
The connection test can take up to 15minutes.
Once the connection is established, the operation
and battery icons remain permanently activated.
The CardioMessenger is now ready for use.
If the connection was not established, the
information icon flashes.
en • English

Functions
18
Additional information can be found under: Error
Resolution [Page21].
en • English