BIOTRONIK CardioMessenger Smart User manual

CardioMessenger® Smart
Patient device for the
BIOTRONIK Home Monitoring
system
Technical Manual
404202
Revision: J (2019-01-29)

BIOTRONIK SE & Co. KG
Woermannkehre 1
12359 Berlin / Germany
Tel [phone]
Fax[phone]
[email protected]
www.biotronik.com
© BIOTRONIK SE & Co. KG
All rights reserved.
Specifications subject to modification, revision and
improvement.
® All product names in use may be trademarks or
registered trademarks held by BIOTRONIK or the
respective owner.
0123 2015

Introduction
3
1 Introduction
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
CardioMessenger (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 CardioMessenger.
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.
Attention
Home Monitoring is not an emergency system. If you are not feeling well, contact a physician.

First Steps
Check the Package Contents
4
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.
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
electromagnetic interference or decrease the CardioMessenger's resistance to electromagnetic
interference.
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.

First Steps
Where Do I Put the CardioMessenger?
5
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).
• Positioned on the bedside table, you can clearly see the symbols on the CardioMessenger's display.
Attention
Make sure that the distance to the device is less than 2m (6feet), so that regular data
transmission from the implanted device to the CardioMessenger at night is assured.
Verify on a daily basis that it is ready for use.
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.
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.

First Steps
How Do I Connect the CardioMessenger?
6
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. Also consult the included quick reference guide.
WARNING
• Lay the power cord so that there is no risk of strangulation and nobody may stumble.
The outlet must be easily accessible and 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:
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 is on the upper side of the plug.
3. Insert the power plug into the wall outlet.
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 [Page12].

First Steps
How Do I Use the CardioMessenger?
7
How Do I Use the CardioMessenger?
The CardioMessenger automatically receives the information from your device and transmits it to the
BIOTRONIK Service Center.
Attention
Check once a day whether your CardioMessenger is switched on and ready for use.
This is indicated by the following icons:

First Steps
How Do I Turn Off the CardioMessenger?
8
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:
Press and hold the blue key on the right of the CardioMessenger for two seconds until the display turns
off.
The blue key is labeled with the following symbol:
WARNING
If the CardioMessenger is turned off for a longer period of time, data may get lost.
• Turn on the CardioMessenger once you are leaving the area where the use of mobile phones
is prohibited.
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
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.

The CardioMessenger Icons
9
3 The CardioMessenger Icons
The CardioMessenger has the following icons:
Operation icon
Call back icon
See Call Back Function [Page11]
Information icon
See Error Resolution [Page12]
The battery icon is always displayed with 1-3 bars
according to the charging status.
When the CardioMessenger is connected to the
power supply brick and charging, a battery icon
with a small power plug is displayed.

Functions
Self-Test
10
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.
Additional information can be found under: Error Resolution [Page12].

Functions
Call Back Function
11
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 icon 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.
Attention
Check once a day whether your CardioMessenger is switched on and ready for use.
Turning off the call back icon
To turn off the call back icon, briefly turn off the CardioMessenger.
1. Press the blue key on the right side of the CardioMessenger for about two seconds.
2. All symbols disappear.
3. Wait approximately thirty seconds.
4. Press the blue key again for approximately two seconds.
5. The CardioMessenger performs a self-test.
6. The operation and battery icon is then displayed, and the call back icon stops flashing.
However, please do not forget to call your physician.
If the CardioMessenger is connected to the power supply brick, it starts automatically. You neither have
to wait nor switch it on.

Error Resolution
Error Type A - No Power Supply
12
5 Error Resolution
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.
According to the standard IEC60601-1-2: 2014 a distance of 0.3m is recommended (for further details
see: Appendix [Page25]).
Malfunctions on the CardioMessenger are indicated by the icons.
Symbol Behavior Operational status
Off Error type A: No power supply
Flashing Error type B: Self-test failed
Flashing Error type C: No mobile connection
Error Type A - No Power Supply
The operation icon is not displayed, that is, the CardioMessenger is not ready for use.
Make sure that
• the micro USB plug is properly inserted into the CardioMessenger,
• the power plug is properly inserted into the wall outlet,
• 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.

Error Resolution
Error Type B - Self-Test Failed
13
Error Type B - Self-Test Failed
All symbols are flashing, thast is the CardioMessenger is not ready for use.
Repeat the self-test as the CardioMessenger did not finish it.
1. Disconnect the CardioMessenger from the power supply brick if relevant.
2. Press the blue key on the right side of the CardioMessenger for about two seconds.
3. Leave the CardioMessenger turned off for about thirty seconds.
4. Turn on the CardioMessenger by connecting it to the power supply.
The CardioMessenger starts and automatically repeats the self-test. When the self-test is completed,
the CardioMessenger is ready for use.
The connection test can take up to 15minutes.
If all symbols continue to flash, the CardioMessenger is defective. Return it to your physician.

Error Resolution
Error Type C - No Mobile Connection
14
Error Type C - No Mobile Connection
The information icon flashes and the battery icon is displayed.
Check the mobile connection since the CardioMessenger cannot connect to the BIOTRONIK Service
Center.
1. Press the blue key on the right side of the CardioMessenger for about two seconds.
2. Put the CardioMessenger in a place with better mobile reception. Make sure that the distance to
the device is still less than 2m (6 feet).
3. Press the blue key again for approximately two seconds.
The CardioMessenger restarts and performs the self-test. It checks the connection to the cellular
phone network.
The connection test can take up to 15minutes.
The operation and battery icon is displayed once the connection test is completed successfully. The
CardioMessenger is now ready for use.
If the CardioMessenger is generally unable to connect to the cellular phone network from near your
bed, contact your physician.
Missing cellular phone network connection can occur in rooms with thick walls or when travelling.

Handling
Charging
15
6 Handling
The CardioMessenger is intended primarily for continuous operation at home because it receives
information from your implanted device once daily, usually at night, and forwards it to the BIOTRONIK
Service Center.
If handled properly, the installed battery should supply the CardioMessenger with 16 hours of power
even after 500 complete charging cycles (which is at least two years).
The CardioMessenger contains a mobile ("cellular") module. In order to prevent any interference with
your implanted device, the prescribed minimum distance between the device and a cellular phone must
also be maintained with the CardioMessenger.
Attention
The distance between the CardioMessenger and the implanted device must be at least 15cm (6
inches) so that the CardioMessenger does not interfere with the device.
To disconnect the CardioMessenger from the alternating current supply, pull the power supply brick
plug out of the socket.
Charging
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.
You should charge the CardioMessenger once before the first mobile commissioning. To do this,
connect the CardioMessenger to the mains supply. The charging process usually takes three hours.
WARNING
Do not charge the CardioMessenger with the power supply brick in the outdoors.
WARNING
At the very latest, the CardioMessenger must be charged when the battery icon flashes.
During charging, the individual segments of the battery icon flash alternatingly and a small power plug
is displayed.
The three bars on the battery icon flash successively until the CardioMessenger is fully charged. Once it
is fully charged, all three bars are completely filled.
Note
The CardioMessenger can be used with the power supply brick if the battery is defective.
Even if the battery is completely discharged, the CardioMessenger can still operate using the
power supply brick.

Handling
Cleaning
16
Cleaning
Keep the CardioMessenger clean and away from dirty or dusty environments.
Use a soft, lint-free cloth for cleaning.
Use a cloth slightly moistened with water for cleaning. However, avoid bringing the CardioMessenger
into direct contact with water or solvents.
Protect the CardioMessenger from direct contact with water.
Unplug the CardioMessenger from the power supply brick before cleaning it with a damp cloth.

Handling
Maintenance
17
Maintenance
The CardioMessenger is intended for continuous, automatic operation. Once correctly installed,
ongoing maintenance typically is not required.

Handling
Disposal
18
Disposal
Do not dispose of the CardioMessenger with your household trash.
CardioMessenger and the associated power supply brick contain materials that must be correctly
disposed of in accordance with environmental protection regulations.
You may dispose of the CardioMessenger and its associated power supply brick as electronic waste in
accordance with the applicable regulations if you no longer use it.
The CardioMessenger and all the parts from the package can be returned to your physician. Your
physician will return all parts to BIOTRONIK.
BIOTRONIK ensures disposal in accordance with the national versions of the European guideline
2012/19/EC on waste electrical and electronic equipment (WEEE 2).

Precautionary Measures
19
7 Precautionary Measures
The CardioMessenger is a medical product and therefore complies with the strict requirements for the
development, manufacturing, and testing of medical devices.
Statutory regulations for electrical devices in hospitals require that the CardioMessenger and its
accessories not be used in areas defined as patient environment (e.g., in the operating room).
Please observe the following safety-relevant notes:
• Do not place the CardioMessenger next to a television set, microwave oven, or a similar source of
electromagnetic 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.
• Protect the CardioMessenger from direct contact with water. For example, wear it under your coat
or keep it in a bag when it rains.
• Do not carry the CardioMessenger inside the breast pocket of your shirt or jacket as the distance
from here to the implanted device could be less than 15 cm.
• Do not bring the CardioMessenger into the vicinity of fire.
• Do not turn on the CardioMessenger if it has recently been in a cold environment. Let it warm up
slowly to room temperature, since the resulting condensed water may harm the electronic
circuitry.
• Do not operate the CardioMessenger in areas where cellular phones are prohibited for safety
reasons (for example, in certain areas of the hospital or in airplanes).
• Make sure that the distance to the device is less than 2 m (6 feet), so that regular data
transmission from the implanted device to the CardioMessenger at night is assured.
Protect the CardioMessenger and the power supply brick from:
• Water and high humidity
• Temperatures above 40°C (104°F) (e.g., direct sunlight, strong halogen spotlights, fire)
• Temperatures below negative 5°C (23°F; CardioMessenger) and below 0°C (32°F; power supply
brick)
• Solvents, acids, detergents, and lyes
• Pressure below 700hPa (corresponding to altitudes above 3000m, approx. 10,000 feet)
• Pressure above 1060hPa (corresponding to altitudes below sea level)
• Violent shocks or other strong mechanical influences
• Intense light sources (direct sunlight, strong halogen spotlights)

Guidelines
Telemetry Data for Europe
20
8 Guidelines
Telemetry Data for Europe
Your device transmits diagnostic data to the CardioMessenger via a radio frequency (RF) assigned by
the European Conference of Postal and Telecommunications Administration for the operation of Ultra
Low Power Active Medical Implants (CEPT/ERC REC 70-03).
BIOTRONIK is legally obligated to inform you that the radio service does not have exclusive use of the
assigned frequencies and that the transmission of device data is not permitted to interfere with other
radio services. The frequency and technical parameters of the built-in transmitter have been carefully
selected to ensure that electromagnetic interference between other services and the data transmission
of the device is unlikely.
Furthermore, BIOTRONIK is obligated to inform you that the regulatory agency can withdraw the
frequency allocation and prohibit the radio service between the device and CardioMessenger. Since this
service is currently established throughout Europe and North America, withdrawal of the frequency
allocation is not expected in the foreseeable future.
The CardioMessenger, like the implantable device itself, has been evaluated by an independent testing
authority for its compliance with statutory regulations. The CardioMessenger carries the following
approval mark:
0123
In addition, the CardioMessenger contains a radio modem that connects to the cellular network at the
frequencies of 850/900/1800/1900/1900MHz. BIOTRONIK uses the radio modem in accordance with the
manufacturer’s specifications and in compliance with the approval requirements.
The radio modem has been evaluated by an independent authority for its compliance with the statutory
regulations. As an indication of this, it carries the following approval mark: