BIOTRONIK SE and KG CM02-1 Patient Device User Manual CardioMessenger
BIOTRONIK SE & Co. KG Patient Device CardioMessenger
users manual
Preliminary
Manual
for
CardioMessenger
FCC ID: QRICM02-1
BIOTRONIK GmbH & Co.
1
Contents
What is Home Monitoring? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
About This Technical Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
User group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Conventions used in this technical manual . . . 4
The CardioMessenger Set and Its Components . . . . . . . . . . . . . . . 5
Safety Precautions – What Should I Watch Out For? . . . . . . . . . . . 6
Electronic Article Surveillance (EAS) Systems . 8
How Do I Use the CardioMessenger? . . . . . . . . . . . . . . . . . . . . . . . . 9
What must be done before using the Cardio-
Messenger? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Where should I put the CardioMessenger? . . .9
How do I plug in the CardioMessenger? . . . . . 10
The CardioMessenger "traffic light" system .10
Turning on the CardioMessenger . . . . . . . . . . 11
Turning off the CardioMessenger . . . . . . . . . . 12
Charging the CardioMessenger . . . . . . . . . . . . 12
How do I know when the batteries are running
low? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
How do I know that the CardioMessenger is
receiving and transmitting implant data? . . . . 13
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . 13
Resetting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
When Does My Implant Transmit Data? . . . . . . . . . . . . . . . . . . . . . 16
How Do I Take Care of the CardioMessenger? . . . . . . . . . . . . . . . 17
343 851/A
2
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Frequently Asked Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Technical Terms and Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . 21
Cardio Report . . . . . . . . . . . . . . . . . . . . . . . . . . 21
GSM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Home Monitoring . . . . . . . . . . . . . . . . . . . . . . . 21
BIOTRONIK Service Center . . . . . . . . . . . . . . . 21
SMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
US Regulatory Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
FCC RF Exposure Requirements . . . . . . . . . . .23
Legal Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Electromagnetic compatibility . . . . . . . . . . . . .25
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
General information . . . . . . . . . . . . . . . . . . . . .26
Permissible environmental conditions . . . . . .26
CardioMessenger remote unit . . . . . . . . . . . . . 26
CardioMessenger charging station . . . . . . . . .27
Rechargeable battery (integrated) . . . . . . . . . . 27
Power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
3What is Home Monitoring?
What is Home Monitoring?
Dear Patient.
You have received a BIOTRONIK pacemaker or
implantable cardioverter-defibrillator (ICD) with a
Home Monitoring function. The Home Monitoring fea-
ture provides your attending physician with messages
recorded by your implant at regular intervals, giving
him or her information about your heart’s status.
Your implant has a small wireless transmitter. Your
patient device, which we will call the Cardio-
Messenger, receives the implant messages and
transmits them to the BIOTRONIK Service Center. The
data are processed there and can be viewed only by
your physician via fax and on the Internet (when avail-
able) in the form of a comprehensive report called a
Cardio report.
Your doctor can use these data to decide whether your
implant settings need to be updated or if your therapy
plan needs to be changed. If necessary, your physician
will contact you about making an appointment for a
follow-up examination.
For Home Monitoring to work, your implant must have
the Home Monitoring function, and there must be cel-
lular service in your area (GSM network).
The power of the transmission in your implant is low
so as not to impair your health in any way. Since the
transmission range is so short (less than 2 meters, or
6 feet), you need to use the CardioMessenger to send
the information to the BIOTRONIK Service Center.
Note: If the CardioMessenger is not operational or is located
too far from the implant to receive information (more
than 6 feet), your implant still functions normally. Only
the Home Monitoring function is inactive. Although
the data recorded by the implant cannot be transmit-
ted, they are saved so that your physician can evaluate
them during your regularly scheduled follow-up
examination. If you have any questions, please contact
your physician.
4About This Technical Manual
About This Technical Manual
User group
The CardioMessenger is to be used by patients with a
BIOTRONIK pacemaker or an implantable cardio-
verter-defibrillator (ICD) with the Home Monitoring
function.
Conventions used in this technical manual
Note: Provides additional information on the features of the
CardioMessenger and how to operate it.
Caution! If these instructions are not observed, minor injury or
equipment damage may occur.
WARNING! If these instructions are not observed, death, serious
physical injury, or major equipment damage may
result.
5The CardioMessenger Set and Its Components
The CardioMessenger Set and Its
Components
The BIOTRONIK CardioMessenger will not restrict
your routine activities. The set comes equipped with
the following components:
— The CardioMessenger with rechargeable batteries
— A charging station with a power supply unit and
cable
Accessories:
— Belt clip1)
—Carrying strap
2)
— Belt carrying case3)
The CardioMessenger works like a cell phone and
transmits the information received from the implant
as a short message (SMS) via a mobile telephone net-
work to the BIOTRONIK Service Center. The built-in,
rechargeable batteries provide at least 24 hours of
wireless operation (away from the charging station).
Naturally, the CardioMessenger can also be used
when placed in the charging station.
1) Catalog number 343 265
2) Catalog number 343 227
3) Catalog number 343 228
6Safety Precautions – What Should I Watch Out For?
Safety Precautions – What Should
I Watch Out For?
The CardioMessenger and its components are medi-
cal devices and therefore comply with strict standards
for their development, manufacture, and testing.
Please observe the following safety instructions:
WARNING! Turn off the CardioMessenger in locations where cell
phones are prohibited, such as hospitals or airplanes.
Such areas can be identified by the following or simi-
lar signs:
WARNING! Maintain a minimum distance between the patient
device and your implant.
Like a cellular phone, the CardioMessenger device
can temporarily interfere with your implant if it is too
close to it. To avoid interference, maintain a minimum
distance of 20 centimeters (7 inches) between the
CardioMessenger and implant.
Never place the CardioMessenger on your chest
directly over the implant.
Do not carry the CardioMessenger inside the breast
pocket of your shirt or jacket, and not directly on your
skin.
Caution! Protect the CardioMessenger and charging station
from:
— Water and high humidity (e.g., in the bathroom)
— Temperatures above 40°C (104°F)
— Temperatures below 10°C (50°F) for the charging
station
7Safety Precautions – What Should I Watch Out For?
— Temperatures below -5°C (23°F) for the Cardio-
Messenger
— Barometric pressure below 700 and above
1060 hPa
— Violent shocks or other strong mechanical influ-
ences
— Strong sources of light (direct sunlight, strong
halogen lamps)
— Solvents, acids, detergents, and lyes
— Handle the antenna with care.
Caution! Never use the CardioMessenger if it has been dam-
aged; return it to your physician.
Before use, make sure that none of the components
are visibly damaged.
Only use the following original BIOTRONIK devices:
— The CardioMessenger
— The charging station with the appropriate power
supply unit, type FW 7555 M/06
Other accessories can increase the interference emit-
ted and the device’s susceptibility to interference.
Caution! The CardioMessenger may only be opened and
repaired by authorized trained personnel, and the
rechargeable batteries (type LP 103463) may only be
exchanged by professionals.
Note: Do not throw away the CardioMessenger with house-
hold trash. Dispose of it according to legal guidelines,
like you would for other electronic components, such
as computers.
In particular, rechargeable lithium ion batteries
should be disposed of by the manufacturer according
to legal guidelines.
Caution! The covered data ports are not intended for the user.
Do not remove the cover.
8Safety Precautions – What Should I Watch Out For?
Electronic Article Surveillance (EAS)
Systems
Equipment such as retail theft prevention systems
may interact with the implanted device. Patients
should be advised to walk directly through and not to
remain near an EAS system longer than necessary.
9How Do I Use the CardioMessenger?
How Do I Use the Cardio-
Messenger?
The following section describes how to operate and
use the CardioMessenger.
What must be done before using the
CardioMessenger?
Find a suitable place to put the CardioMessenger and
charging station.
The distance between your implant and the Cardio-
Messenger should not be too close in order to prevent
interference with implant operation. On the other
hand, the distance should not be beyond the implant
transmitter’s range.
Note: Home Monitoring can only work when the distance
between the implant and CardioMessenger is not less
than 20 centimeters (7 inches) and not more than
2 meters (6 feet).
• Place the device on a solid base so that it cannot
fall.
• Keep the CardioMessenger from being exposed to
moisture; bathrooms, for example, are unsuitable
locations for the CardioMessenger.
• Do not expose the device to heat; direct sunlight is
also not recommended.
• Do not place the device next to a television, micro-
wave oven, or a similar source of interference.
Where should I put the CardioMessenger?
A nightstand would be a good place for the Cardio-
Messenger since the distance between you and the
CardioMessenger would probably not be more than
2 meters (6 feet). In addition, your attending physician
will probably select nighttime as the regular trans-
mission time.
10 How Do I Use the CardioMessenger?
While resting at night, your implant data can be sent to
the CardioMessenger and then transmitted to the
BIOTRONIK Service Center.
How do I plug in the CardioMessenger?
Make sure that the local supply voltage lies within the
permissible operating range of 100-240 Volts at 50-
60 Hz.
If this is the case, insert the power supply cable plug
into the socket.
The power supply has a long cable with a small plug at
the end. Connect this plug to the charging station.
The corresponding port is located on the back of the
charging station.
After connecting the charging station, the light will be
illuminated, and the charging station will then be
operational.
The CardioMessenger "traffic light"
system
Your CardioMessenger has four lights. Three are
arranged like a traffic light, and one is separate and
monitors the battery. All lights can be lit continuously,
flash quickly or slowly, or out.
Whether or not the lights flash or are lit continuously,
the operation of your implant remains unaffected.
Lights
The following section discusses the three modes of
the “traffic light” system.
Red: When the red light flashes, your attending physi-
cian wants you to call. This will rarely occur. You will
be informed by your physician if it is necessary to use
this feature.
11 How Do I Use the CardioMessenger?
Yellow: An illuminated or flashing yellow light indi-
cates a temporary stage. This occurs, for example,
when the CardioMessenger is looking for a connection
to the GSM network.
When the yellow light is continuously lit, there is a
problem. For further information, see the ”Trouble-
shooting” section on page 13.
Green: When the green light flashes, it means that the
CardioMessenger is operating properly.
Battery monitor light
In the following, the three states of the battery moni-
tor light are described as follows:
Red: When the light flashes red, the CardioMessenger
batteries are nearly empty.
Yellow: When the light flashes yellow, there is a prob-
lem with charging the CardioMessenger. If the light is
continuously yellow, the CardioMessenger is charg-
ing.
Green: When the light is green, the CardioMessenger
is fully charged and can be used up to 24 hours away
from the base.
Turning on the CardioMessenger
Press the on/off button of the CardioMessenger for
approximately two seconds. A brief tone will sound,
and the yellow light goes on.
After approximately ten seconds when the
CardioMessenger self-test is over, the yellow and
green lights will start to flash. The CardioMessenger
is then trying to establish a connection with the mobile
telephone network.
After five minutes at most, the yellow light will stop
flashing, and the green light will start to flash slowly.
This means your CardioMessenger is now ready to
work.
12 How Do I Use the CardioMessenger?
If this does not happen, please refer to the ”Trouble-
shooting” section on page 13.
Turning off the CardioMessenger
Press the CardioMessenger on/off button for approxi-
mately two seconds. You will hear a brief tone, and the
yellow light will go out.
The CardioMessenger is now switched off; no data can
be received or transmitted.
You can only turn the CardioMessenger back on after
approximately five to six seconds.
Charging the CardioMessenger
When the battery monitoring light flashes red, the
CardioMessenger needs to be recharged.
Place the CardioMessenger in the charging station.
The charging process will start immediately.
During the charging process, the battery monitor light
of the CardioMessenger will be yellow.
If the battery monitor light flashes yellow, there is a
problem. Please refer to the ”Troubleshooting” sec-
tion on page 13 to find out how to resolve this problem.
When the battery monitor light of the Cardio-
Messenger is green, charging is complete. Charging
usually takes no longer than six hours.
Note: When the CardioMessenger is being charged and used
at the same time, the battery monitor light can be
alternately illuminated green and yellow at the end of
the charging process. This does not signify a problem;
it simply means that the battery is almost completely
charged.
13 How Do I Use the CardioMessenger?
How do I know when the batteries are run-
ning low?
When the CardioMessenger batteries are nearly
empty, the battery monitor light will flash red.
Place the CardioMessenger in the charging station.
Charging will start immediately, which is indicated
when the battery monitor light is illuminated yellow.
When the batteries are completely charged, the bat-
tery monitor light will be green.
Note: If you take the CardioMessenger out of the charging
station, the battery monitor light will go out to save
energy.
How do I know that the CardioMessenger is
receiving and transmitting implant data?
The data are received and transmitted automatically
at specific intervals determined by your doctor so that
you do not have to monitor data transmission.
When the CardioMessenger is receiving data from
your implant, the green light will flash faster than nor-
mal for two to three seconds.
Since this usually occurs at night, you will rarely
observe the rapidly flashing green light of the
CardioMessenger.
After the CardioMessenger receives the implant data,
they are sent to the BIOTRONIK Service Center.
The green light will flash again slowly until the infor-
mation has been transmitted to the BIOTRONIK Ser-
vice Center.
Troubleshooting
Problems with your CardioMessenger are easy to
identify, and they are usually easy to deal with.
14 How Do I Use the CardioMessenger?
Note: When the red light in the “traffic light” flashes, it does
not indicate a problem. It means you must call your
physician. Your physician will inform you if this fea-
ture is used.
However, when the yellow light in the “traffic light”
flashes or is continuously lit, there is a problem.
Continuous
flashing
First turn the CardioMessenger on and off. If you see
the green and yellow light flashing for five minutes
after turning the CardioMessenger back on, there is
no connection to the GSM network.
If you place the CardioMessenger in a location with
good reception, you will not necessarily need to turn it
on or off.
Note: It can take up to 15 minutes before a connection is
established to a GSM network.
If the CardioMessenger is close to your bed and gen-
erally cannot establish a connection to the GSM net-
work, contact your physician.
Continuous
illumination
Turn the CardioMessenger on and off. If the yellow
light continues to be illuminated, reset the
CardioMessenger by restarting it.
Note: Other transmitters can interfere with the receiver that
the CardioMessenger uses for implant information. If
this should occur, the physician will contact you.
Note: A properly functioning CardioMessenger has no influ-
ence on the operation of your implant.
Resetting
If the yellow CardioMessenger light is flashing or con-
tinuously illuminated, you have already turned it on
and off, and you have eliminated all possible sources
of error, reset it by restarting the CardioMessenger.
Press the reset button (located on the back of the
CardioMessenger) with a sharp object such as a ball-
point pen or the end of a straightened paper clip.
15 How Do I Use the CardioMessenger?
Then turn the CardioMessenger on as usual. If only
the yellow light is illuminated after five minutes, the
CardioMessenger may be defective. Talk with your
physician.
16 When Does My Implant Transmit Data?
When Does My Implant Transmit
Data?
There are three times when your implant sends infor-
mation.
• Your implant is configured by your physician to
periodically send messages at a specific time,
usually while you are sleeping.
• Your physician can also set your implant to auto-
matically send a message when certain events
occur.
• Transmission can be activated by a special magnet
(pacemaker patients only). This is done by placing
the magnet directly over the implant. Your doctor
will explain this to you if, how, and when it is nec-
essary.
WARNING! Patients with implantable cardioverter-defibrillators
should not place a magnet over their chest, as this
interferes with the proper functioning of their ICD.
WARNING! Pacemakers sometimes use a special magnet to trig-
ger a message. If you have a pacemaker, only apply
the magnet if your physician explicitly requests it and
gives you a suitable magnet.
17 How Do I Take Care of the CardioMessenger?
How Do I Take Care of the Cardio-
Messenger?
Handle the CardioMessenger with care, so that you
will be able to use it for a long time and so that
BIOTRONIK can guarantee its proper operation:
• Keep the device clean and away from dirty or dusty
environments.
• Use a soft cloth for cleaning. If necessary, the
cloth can be moistened with water. Do not
immerse the device in water.
• Protect the device from direct contact with water.
For example, wear the device under your coat
when it rains, and use the provided belt carrying
case.
Give the CardioMessenger back to your doctor when it
no longer works.
The CardioMessenger does not need to be serviced at
regular intervals by a technician.
Note: Before each use, inspect the CardioMessenger,
charging station, power supply unit and cable, and
make sure they are not damaged. If you find damage,
consult your physician.
If handled properly, the installed batteries should
supply the CardioMessenger with 24 hours of power
even after 500 charging cycles (which is about two
years).
If this is not the case, check whether the Cardio-
Messenger was completely charged during the next
charging cycle. Additional information can be found in
the ”Charging the CardioMessenger” section on page
12.
If you find that the battery is always running low too
soon, contact your physician. The physician will have a
new battery installed.
Note: When authorized personnel change the battery, they
should also check the button cell.
18 Accessories
Accessories
You can wear your CardioMessenger in various ways:
• With a clip on your belt (with or without the belt
carrying case)
• With the clip and the carrying strap.
If you wear the CardioMessenger infrequently or do
not need the clip to wear it, you can remove the clip.
Press the holder and slide it downwards (away from
the antenna) and remove the clip.
To reattach the clip, slide the holder upwards toward
the antenna.
Note: When you use the clip with the carrying strap, make
sure that the distance between the implant and the
CardioMessenger is not less than 20 centimeters
(7 inches).
19 Frequently Asked Questions
Frequently Asked Questions
What happens if I forget to recharge my
CardioMessenger?
If the CardioMessenger is not charged, it cannot
receive any data from your implant and transmit them
to the BIOTRONIK Service Center.
There is no danger to your health, since the implant
operates independently from your CardioMessenger.
The data recorded by your implant will not get lost
either; they will remain available to your physician
during your next follow-up appointment.
Just recharge the CardioMessenger in the charging
station. If this does not work, inform your doctor and
follow his instructions.
What happens if the CardioMessenger device fails?
Does this affect my implant?
No, your implant will continue to function as usual.
If the CardioMessenger stops working, it cannot
receive any information from your implant and send it
to the BIOTRONIK Service Center.
The messages are still recorded by the implant and
can be transmitted and evaluated during a regular fol-
low-up examination with your doctor.
Try to turn on the CardioMessenger. Additional infor-
mation can be found in the ”Troubleshooting” section
on page 13. If this does not work, inform your physi-
cian.
Can I take my CardioMessenger with me everywhere
– while I go shopping, walk, or participate in sports?
Yes. You can always take your CardioMessenger with
you during work or leisure activities, as long as you
are not in areas where the use of cellular phones is
prohibited.
20 Frequently Asked Questions
The CardioMessenger can be comfortably attached to
your belt and transported with and without the pro-
vided belt carrying case. You can also use a carrying
strap. Additional information can be found in the
”Accessories” section on page 18.
You can also carry it in a normal bag or a backpack.
Please always remember that the distance between
the implant and CardioMessenger should not be less
than 20 centimeters (7 inches).
What should I do when I want to travel?
Consult your physician beforehand and inform him or
her of your travel plans. You can take the Cardio-
Messenger everywhere and plug it in wherever there
is suitable supply voltage of 100 - 240 Volts at
50 - 60 Hz. You might need a country-specific adapter.
A suitable cellular network is required for the Home
Monitoring function. Ask your travel agent about the
cellular networks in the country where you’ll be going.
While en route to your destination, you must follow the
instructions of the carrier, i.e., you will need to turn off
the CardioMessenger when on an airplane.
21 Technical Terms and Abbreviations
Technical Terms and Abbrevia-
tions
Cardio Report
A report informing a physician of his or her patient's
current therapy status; the report is based on the data
sent by the implant.
GSM
Global System for Mobile Communications – digital
telephone network.
Home Monitoring
Pacemakers and ICDs with the Home Monitoring
function are equipped with a transmitter that sends
messages over a specific frequency to a mobile
patient device.
These messages are then transmitted via a cellular
network to the BIOTRONIK Service Center and can
only be viewed by your physician via fax and the Inter-
net (when available) in the form of a Cardio Report.
BIOTRONIK Service Center
This is where the implant data from the patient device
are received, processed into graphs and tables, and
sent to your physician.
SMS
Short Message Service – The transmission of text
messages on the cellular network.
22 US Regulatory Requirements
US Regulatory Requirements
Your implant is equipped with a radio frequency (RF)
transmitter for wireless communications to the
patient device. These messages are transmitted via an
RF assigned by the Federal Communications Com-
mission's (FCC) Medical Implant Communications
Service (MICS).
The transmitter is authorized by rule under the Medi-
cal Implant Communications service (47 CFR Part 95)
and 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 Meteorologi-
cal Satellite, or the Earth Exploration Satellite Ser-
vices and must accept interference that may be
caused by such aids, including interference that may
cause undesired operation. This transmitter shall be
used only in accordance with the FCC rules governing
the Medical Implant Communications Service.
Analog and digital voice communications are prohib-
ited. 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 receiver will be
free from interference.
The FCC ID number for this device is QRICM02-1.
The patient device, as well as the implant itself, must
conform with appropriate government standards and
regulations.
The patient device uses a GSM-Modem that connects
to the mobile cellular telephone service at (1900 MHz).
BIOTRONIK uses the modem according to the specifi-
cations of the manufacturer in compliance with FCC
approval requirements.
23 US Regulatory Requirements
FCC RF Exposure Requirements
For body-worn operation, this phone has been tested
and meets the FCC RF exposure guidelines when used
with BIOTRONIK accessories supplied or designated
for this product. Use of other accessories may not
ensure compliance with FCC RF exposure guidelines.
This EUT (Equipment Under Test) has been shown to
be capable of compliance for localized specific
absorption rate (SAR) for uncontrolled environment/
general population exposure limits specified in ANSI/
IEEE Std. C95.1-1992 and had been tested in accor-
dance with the measurement procedures specified in
FCC/OET Bulletin 65 Supplement C (2001) and IEEE
Std. 1528-200X (Draft 6.5, January 2002).
24 Legal Considerations
Legal Considerations
Your implant transmits diagnostic data to the Cardio-
Messenger via an RF assigned by the European Con-
ference of Postal and Telecommunications Adminis-
tration 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
implant 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 interference with other services as well as with
the data transmission of the implant is unlikely.
Furthermore, BIOTRONIK is obligated to inform you
that the regulatory agency can withdraw the fre-
quency allocation and prohibit the radio service
between the implant and CardioMessenger. Since this
service is currently being established throughout
Europe and North America, withdrawal of the fre-
quency allocation is not expected in the foreseeable
future.
The CardioMessenger, like the implant itself, has
been evaluated by an independent testing authority for
its compliance with statutory regulations. Therefore,
the device carries the following approval mark:
25 Legal Considerations
In addition, the CardioMessenger contains a GSM
modem (Motorola g18e) that establishes the connec-
tion to the cellular network at the frequencies of 900/
1800 MHz and 1900 MHz. BIOTRONIK uses the modem
in accordance with the manufacturer’s specifications
and in compliance with regulatory requirements.
The GSM modem has been evaluated and approved by
an independent authority for its compliance with the
statutory regulations. As an indication of this, it car-
ries the following approval mark
(IMEI Number: 350030-95-xxxxxx-x):
Electromagnetic compatibility
Note: The CardioMessenger is protected from disturbances
resulting from electromagnetic interference, electro-
static discharges, and other sources – including inter-
ference induced by cables. Interfering emissions from
the CardioMessenger have been minimized. The
CardioMessenger therefore meets the requirements
of EN 60601-1-2 60601 in every respect.
Warranty
The CardioMessenger and all original components by
BIOTRONIK are not subject to warranty when used
improperly, or stored and transported incorrectly. Use
only the original packaging when shipping the device.
26 Technical Data
Technical Data
General information
Class of protection II
Degree of
protection
IP 30
Operating mode Continuous operation
Permissible environmental conditions
During operation:
Temperature: + 10°C to + 40°C (50°F to 104°F) while charging
- 5°C to + 40°C (23°F to 104°F) while discharging
Rel. humidity: 30% to 70% (non-condensing)
Atmospheric
pressure:
700 hPa to 1060 hPa
Shipping and storage:
Storage temp.: - 20°C to + 25°C (- 4°F to 77°F) for 2 years with battery
- 20°C to + 70°C (- 4°F to 158°F) without battery
Shipping temp.: - 20°C to + 50°C (- 4°F to 122°F) for 2 weeks with bat-
tery
Rel. humidity: 30% to 70% (non-condensing)
Atmospheric
pressure:
700 hPa to 1060 hPa
CardioMessenger remote unit
Dimensions
(WxHxD)
60 x 132 x 38 mm
Weight Approx. 200 g (with battery)
Charging voltage 5.2 V DC / 0.8 A
Max. charge time 6hours
Serial ports Infrared and 15-pin connector
Receiving frequency 403.65 MHz
27 Technical Data
Bandwidth 300 kHz
Transmission
frequencies
900/1800 MHz (not for US), 1900 MHz
Transmission
power
Max. 1 Watt (1900 MHz); Max. 2 Watt (900/1800 MHz)
CardioMessenger charging station
Dimensions
(WxHxD)
90 x 82 x 105 mm
Weight Approx. 110 g
Input voltage 6 V DC / 1 A
Output voltage 5.2 V DC / 1 A
Rechargeable battery (integrated)
Model Lithium ion (LP 103463 AR)
Dimensions
(WxHxD)
Approx. 34 x 63 x 10.2 mm
Weight Approx. 45 g
Operating voltage 3.7 V (nominal)
Charge voltage 4,2 V DC
Max. charging
current
1.5 C (2700 mA)
Capacity 1800 mAh (typical)
Power supply
Model FW 7555M/06
Dimensions 51.5 x 87.5 x 34 mm
Power cable length 2 meters
Connector type
to the device
According to EN 60320/C7
Connector type
to the power outlet
According to EN 50075 p.1
Input voltage 100 - 240 V AC at 50 - 60 Hz, 400 mA
Output voltage 6 V DC / 2.1 A
28 Appendix
Appendix
Electromagnetic emitted interference according to
IEC 601-1-2
The CardioMessenger is suitable for operation in the indicated electromagnetic environ-
ment. The customer and/or operator of the CardioMessenger should make sure that it is
used in an electromagnetic environment as described below.
Measuring the emitted
interference Conformance Guidelines for the electromagnetic
environment
Radiofrequency emitted
interference according
to CISPR 11
Group 1 The CardioMessenger must trans-
mit electromagnetic energy to ful-
fill the function for which it was in-
tended. Nearby electronic devices
can be affected.
Radiofrequency emitted
interference according
to CISPR 11
Class B The CardioMessenger is suitable
for use in all areas, including living
space and those areas that are di-
rectly connected to a public power
supply system that also supplies
buildings intended for residential
purposes.
Emitted interference of
harmonics according to
IEC 61000-3-2
Class D according to IEC
61000-3-2
Emitted interference of
voltage fluctuations/
flicker according to IEC
61000-3-3
Conformance
29 Appendix
Susceptibility to electromagnetic interference
according to IEC601-1-2
Note: These guidelines may not be applicable in all
instances. The spread of electromagnetic waves is
influenced by absorption and reflection from build-
ings, objects, and humans.
Note: Interference can be generated when the CardioMes-
senger is close to devices that have the following
warning sign:
The CardioMessenger is suitable for operation in the indicated electromagnetic environ-
ment. The customer and/or operator of the CardioMessenger should make sure that it is
used in an electromagnetic environment as described below.
Testing susceptibility to
interference Test level ac-
cording to IEC
60601-1-2
Conformance
level Guidelines for the electro-
magnetic environment
Conducted RF interfer-
ence according to
IEC 61000-4-6
3 Veff
150 kHz to
80 MHz
Same as the
test level The minimum distance of
the CardioMessenger from
portable and mobile radio
devices, including the ca-
bles, should correspond to
the recommended safe dis-
tance that is calculated ac-
cording to the equation for
the suitable transmission
frequency. Recommended
safe distance:
Radiated RF interfer-
ence according to
IEC 61000-4-3
3 V/m
80 MHz to
2.5 GHz
Same as the
test level for 80 to 800
MHz
for 800 MHz to
2.5 GHz with P as the nomi-
nal output of the transmitter
in Watts (W) according to the
information from the trans-
mitter manufacturer, and d
as the recommended safe
distance in meters (m).
D12P,=
D12P,=
D23P,=
30 Appendix
Susceptibility to electromagnetic interference
according to IEC 601-1-2
Note: The user can experience environmental conditions in
a home different from those cited in the guidelines
concerning the electromagnetic environment without
endangering himself or herself.
The CardioMessenger is suitable for operation in the indicated electromagnetic environ-
ment. The customer and/or operator of the CardioMessenger should make sure that it is
used in an electromagnetic environment as described below.
Checking
susceptibility to
interference
T es t l ev el ac co r di ng
to IEC 60601-1-2 Conform-
ance level Guidelines for the electro-
magnetic environment
Discharge of static
electricity (ESD)
according to IEC 61000-
4-2
± 6 kV contact
discharge
± 8 kV air discharge
Same as
test level Floors should be made of
wood or cement, or have ce-
ramic tiles. When the floor
consists of a synthetic ma-
terial, the relative humidity
must be at least 30%.
Rapid transient electri-
cal disturbances/bursts
according to IEC 61000-
4-4
± 2 kV for
power cables Same as
the test
level
The quality of the supply
voltage should correspond
to that in a typical business
and/or hospital.
Power surges
according to IEC 61000-
4-5
± 1 kV normal mode
voltage
± 2 kV common
mode voltage
Same as
the test
level
The quality of the supply
voltage should correspond
to that in a typical business
and/or hospital.
Voltage dips, brief inter-
ruptions and fluctua-
tions in the supply volt-
age
according to IEC 61000-
4-11
‹ 5% UT for
1/2 period
(› 95% drop)
40% UT for 5 periods
(60% drop)
70% UT for
25 periods
(30% drop)
‹ 5% UT for 5 s
(› 95% drop)
Same as
the test
level
The quality of the supply
voltage should correspond
to that in a typical business
and/or hospital. The Cardio-
Messenger is powered by a
battery. An interruption in
the supply voltage to the
power supply unit will not
impair the functioning of the
CardioMessenger.
Magnetic field at the
supply frequencies
(50/60 Hz)
according to IEC 61000-
4-8
3 A/m Same as
the test
level
The magnetic field strength
should correspond to the
typical value in business
and hospital environments.
NOTE: UT is the AC supply voltage before applying the test level
31 Appendix
Susceptibility to electromagnetic interference for
devices that are not life-sustaining.
These guidelines may not be applicable in all
instances. The spread of electromagnetic waves is
influenced by absorption and reflection from struc-
tures, objects, and humans.
Transmission
frequency 150 kHz to 80 MHz 150 kHz to 800 MHz 800 MHz to 2.5 GHz
Equation
Nominal output of the
transmitter (W) Safe distance (m) Safe distance (m) Safe distance (m)
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters whose maximum nominal output is not indicated in the above table, the dis-
tance can be calculated using the equation in the column, where P is the maximum nominal out-
put of the transmitter in Watts (W) according to the transmitter’s manufacturer.
NOTE: These guidelines may not be applicable in all instances. The spread of electromagnetic
waves is influenced by absorption and reflection from structures, objects, and humans.
D12P,= D12P,= D23P,=