04202

CardioMessenger Smart
en Technical Manual
es Manual técnico
fr Manuel technique

GA_CardioMessengerSmart_Cover_1.indd 11 31.07.2019 [Link]

 40420

You can also find the CardioMessenger Smart manual in the

Internet by visiting the BIOTRONIK website:
[Link]

GA_CardioMessengerSmart_Cover_1.indd 12 31.07.2019 [Link]

en • English ...................................................... 2

es • Español ..................................................... 46

fr • Français ..................................................... 95

404202--K
2 Table of Contents

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
4 Introduction

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
6 First Steps

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)

®
Smart

(3)

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

(4)

WARNING
The CardioMessenger package may contain
ingestible small parts, therefore, keep the
package away from children under three
years of age.

en • English
8 First Steps

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
10 First Steps

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
12 First Steps

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
14 First Steps

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
16 The CardioMessenger Icons

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
18 Functions

Additional information can be found under: Error

Resolution [Page 21].

en • English
 Functions 19

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 plans to use this function.
For example, your physician can use the call
back icon to ask you to contact them. 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 powered on and ready
for use.
Turning off the call back icon
To turn off the call back icon, briefly power 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.

en • English
20 Functions

4. Press the blue key again for approximately

two seconds.
5. The CardioMessenger performs a self-test.
6. The operation and battery icon are 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 will start automatically; you
neither have to wait nor power it on.

en • English
 Error Resolution 21

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 interference from the
immediate vicinity of the CardioMessenger.
Possible sources of electromagnetic interference
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 (12 inches) from the
CardioMessenger is recommended (for further
details see: Appendix [Page 38]).
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

en • English
22 Error Resolution

Error Type A - No Power Supply

The operation icon is not displayed, indicating
that 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.

en • English
 Error Resolution 23

Error Type B - Self-Test Failed

All symbols are flashing, indicating that the
CardioMessenger is not ready for use.
Repeat the self-test as the CardioMessenger was
not able to complete it.
1. If the CardioMessenger is connected to the
power supply brick, disconnect it.
2. Press the blue key on the right side of the
CardioMessenger for about two seconds.
3. Leave the CardioMessenger powered off for
about thirty seconds.
4. Power on the CardioMessenger by connecting
it to the power supply brick.
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.

en • English
24 Error Resolution

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. Find a place with better cellular reception for
your CardioMessenger. Make sure that the
distance to the implanted device is still less
than 2 m (6 ft).
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.
Once the test is completed successfully, the
operation and battery icon are displayed. 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.
Inadequate cellular phone network connection
can occur in rooms with thick walls or when
traveling.

en • English
 Handling 25

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.

en • English
26 Handling

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
The CardioMessenger must be charged at
the latest when the battery icon flashes.

During charging, the individual segments of the

battery icon flash alternatingly and a small power
plug is displayed.

en • English
 Handling 27

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
If the battery is defective, the
CardioMessenger can still be used with the
power supply brick.
Even if the battery is completely discharged,
the CardioMessenger can still operate using
the power supply brick.

en • English
28 Handling

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.

Maintenance
The CardioMessenger is intended for continuous,
automatic operation. When correctly in-use,
ongoing maintenance typically is not required.

en • English
 Handling 29

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.
If you no longer use the CardioMessenger, you
may dispose of it and its associated power supply
brick as electronic waste in accordance with the
applicable regulations.
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/EU on waste electrical and electronic
equipment (WEEE 2).

en • English
30 Precautionary Measures

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 interference.
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 (6 inches).
• Do not bring the CardioMessenger into the
vicinity of fire.

en • English
 Precautionary Measures 31

• Do not turn on the CardioMessenger if it has

recently been in a cold environment. Let it
warm up to room temperature for 30 minutes,
since the resulting condensed water may
harm the electronic circuitry.
• Do not turn on the CardioMessenger if it has
recently been in a hot environment. Let it cool
down to room temperature for 30 minutes.
• Do not operate the CardioMessenger in areas
where cellular phones are prohibited for
safety reasons (for example, in certain areas
of the hospital or on airplanes).
• 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.
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 ft)

en • English
32 Precautionary Measures

• 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)

en • English
 Guidelines 33

8 Guidelines

Telemetry Data for Europe

Your implanted 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.

en • English
34 Guidelines

The CardioMessenger, like the implanted 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 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:

en • English
 Guidelines 35

Telemetry Data for the USA

This transmitter is authorized by rule under the
Medical Device Radiocommunication Service (in
Part 95 of the FCC Rules) and must not cause
harmful interference to stations operating in the
400.150 to 406.000 MHz band in the
Meteorological Aids (i.e., transmitters and
receivers used to communicate weather data),
the Meteorological Satellite, or the Earth
Exploration Satellite Services and must accept
interference that may be caused by such
stations, including interference that may cause
undesired operation.
This transmitter may only be used in accordance
with the FCC Rules governing the Medical Device
Radiocommunication Service. Analog and digital
voice communications are prohibited. Although
this transmitter has been approved by the
Federal Communications Commission, there is
no guarantee that it will not receive interference
or that any particular transmission from this
transmitter will be free from interference.
This device is registered with the Federal
Communications Commission under the
following number:
FCC ID: QRICMSMART
(CardioMessenger Smart 3G) and
FCC ID: QRI-CMSMART4GNA
(CardioMessenger Smart 4G).

en • English
36 Guidelines

Telemetry Data for Canada

This device must not cause harmful interference
to stations operating in the 400.150-406.000 MHz
band in the Meteorological Aids (i.e., transmitters
and receivers used to communicate weather
data), the Meteorological Satellite, or the Earth
Exploration Satellite Services and must accept
interference that may be caused by such
stations, including interference that may cause
undesired operation.
This device meets the RSS standards of Industry
Canada.
The operation is subject to the following two
conditions: (1) The device must not cause
interference and (2) the device must handle any
interference received, including interference that
may cause undesired operation.
The CardioMessenger is registered at Industry
Canada under the following identification:
IC 4708A-CMSMART
(CardioMessenger Smart 3G)

en • English
 Guidelines 37

Electromagnetic Compatibility
The CardioMessenger is protected from
disturbances resulting from electromagnetic
interference, electrostatic discharges, and other
sources of interference – including interference
induced by wiring. At the same time, interfering
electromagnetic emissions from the
CardioMessenger have been minimized. The
CardioMessenger therefore meets the
requirements of EN 60601-1-2 in every respect.
Other equipment, for example portable and
mobile RF radiocommunications equipment, may
also interfere with the CardioMessenger, even if
this equipment complies with CISPR emission
requirements. However, this possible
electromagnetic interference does not affect the
functionality of the implanted device.

Warranty
WARNING
The CardioMessenger and all original
components by BIOTRONIK are not subject to
warranty when modified, used other than
intended, stored improperly, or transported
incorrectly.
• Do not modify the CardioMessenger and
the power supply brick under any
circumstances and only use the original
packaging for shipment.

en • English
38 Appendix

9 Appendix

Technical Data
General information on the CardioMessenger
Smart and power supply bricks (configured as
medical electrical system)
• Operating mode: continuous operation
• Longevity: 6 years
• IP 22
• Operating temperature: -5°C to +40°C
• Battery charging temperature: 0°C to +40°C
• Storage and transport temperature:
-20°C to +60°C
• Store in a dry place:
Relative humidity: 30% to 75%
(non-condensing)
• Atmospheric pressure: from sea level to
approx. 3000 m
CardioMessenger Smart
• Dimensions (L x W x H): approx.
130 x 65 x 17 mm
• Weight: approx. 127 g
• MICS frequencies: 402–405 MHz, FSK
modulation
• MICS transmission power: 25 µW EIRP

en • English
 Appendix 39

CardioMessenger Smart 2G
• GSM frequencies: 850 MHz, 900 MHz,
1800 MHz, 1900 MHz
GSM transmission power: 2 watts
(850/900 MHz); 1 watt (1800/1900 MHz)
CardioMessenger Smart 3G
• GSM frequencies: 850 MHz, 900 MHz,
1800 MHz, 1900 MHz
GSM transmission power: 2 watts
(850/900 MHz); 1 watt (1800/1900 MHz)
UMTS frequencies: WCDMA band 850 MHz,
900 MHz, 1700 MHz, 1900 MHz, 2100 MHz
UMTS transmission power: 0.25 W
CardioMessenger Smart 4G
• LTE frequencies: 700 MHz, 1700 MHz,
1900 MHz
LTE transmission power: 0.25 W
Power supply bricks
FRIWO FW7520/05
• Input voltage: 100–240 V AC at 50–60 Hz
• Output voltage: 5 V DC; 3 A
• Power cord type: micro USB-B
FRIWO FW8000/05
• Input voltage: 100–240 V AC at 50–60 Hz
• Output voltage: 5 V DC; 2 A
• Power cord type: micro USB-B

en • English
40 Appendix

GlobTek GTM96180-1107-2.0
• Input voltage: 100–240 V AC at 50–60 Hz
• Output voltage: 5 V DC; 2.2 A
• Power cord type: micro USB-B
Battery (integrated)
• Type: lithium-ions

Symbols on the Device

The label icons on the CardioMessenger
symbolize the following:
Observe the technical manual
(see Check the Package Contents [Page 6])

IP 22 Solid particle protection effective against

fingers or similar objects > 12.5 mm
Liquid ingress protection effective against
dripping water when tilted at 15°

Store in a dry place

On and off key (standby)

Port for micro USB connector

en • English
 Appendix 41

Legend for the Label

BIOTRONIK order number

Serial number

Manufacturing date

Follow the instructions for use!

Storage temperature

Air pressure limit

Humidity limit

TP2 Compabiltiy with telemetry protocol

version 2 of BIOTRONIK Home Monitoring

Transceiver frequency

This device contains material that requires

special waste disposal according to the
environmental protection guidelines.
The European Directive 2012/19/EU on
waste electrical and electronic equipment
(WEEE 2) must be observed.
Return devices that are no longer used to
BIOTRONIK.

CE mark

en • English
42 Appendix

Device

Contents

CardioMessenger Smart

Power supply brick

Caution: US laws restrict this device to

sale by or on the order of a medical practi-
tioner.

en • English
 Appendix 43

Electromagnetic Emitted Interference

Electromagnetic Emitted Interference according to
IEC 60601-1-2
7.1 EN 55011 Group 1
(CISPR 11) Class B
Conducted
interference
emissions

Radiated emis-
sion

7.2.1 IEC 61000-3-2 Not applicable

Harmonic See
distortion EN 61000-3-2
(harmonic Section 7, power
currents in the consumption
mains supply) < 75 W

7.2.2 IEC 61000-3-3 Not applicable

Voltage fluctua- See
tions and flicker EN 61000-3-3
in the mains Section 6.1
supply

en • English
44 Appendix

Resistance to Electromagnetic Interference

Resistance to Electromagnetic Interference
according to IEC 60601-1-2
8.9 IEC 61000-4-2 ± (2, 4, 8) 15 kV
Electrostatic air discharge
discharge (ESD)

8.9/8.10 IEC 61000-4-3 10 V/m 80 MHz

Electromagnetic – 2.7 GHz 80%
fields AM 1 kHz
Other measure-
ments see
Table 9 (IEC
60601-1-2 8.10)

8.9 IEC 61000-4-4 ± 2 kV/100 KHz

Transient repetition
conducted frequency
surge voltages
(EFT, bursts)

8.9 IEC 61000-4-5 ± 0.5 kV

Surge voltage ± 1 kV
waves on supply ± 2 kV
lines

en • English
 Appendix 45

Resistance to Electromagnetic Interference

according to IEC 60601-1-2
8.9 IEC 61000-4-6 3 V/0.15 MHz –
Conducted 80 MHz
radiofrequency 6 V in ISM bands
interference between
0.15 MHz and
80 MHz
(according to
Table 5)
For modulation,
see column 2,
80% AM 1 KHz

8.9 IEC 61000-4-8 30 A/m

AC frequency 50/60 Hz
magnetic fields

8.9 IEC 61000-4-11 100 to 240 V

Voltage fluctua- 50/60 Hz
tions and inter-
ruptions in
supply voltage

en • English
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en:
© 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.

es:
© BIOTRONIK SE & Co. KG
Reservados todos los derechos.
Reservado el derecho a efectuar modificaciones técnicas.
® Todos los nombres de productos utilizados pueden ser marcas
o marcas registradas de BIOTRONIK o bien de los titulares
respectivos.

fr:
© BIOTRONIK SE & Co. KG
Tous droits réservés.
Sous réserve de modifications techniques.
® Tous les noms de produit utilisés peuvent être des marques
commerciales ou des marques déposées de BIOTRONIK ou de
leur propriétaire respectif.

USA Distributor: Manufacturer:

0123 BIOTRONIK, Inc.

6024 Jean Road
Lake Oswego,
BIOTRONIK SE & Co. KG
Woermannkehre 1
12359 Berlin / Germany
OR 97 035-5369 Tel +49 (0) 30 68905-0
Tel (800) 547 –0394 (24-hour) Fax +49 (0) 30 6852804
Revision: K (2019-08-08)
Fax (503) 635 –9936 sales@[Link]
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