BIOTRONIK CardioMessenger User 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
Sa ety Precautions – What Should I Watch Out For? . . . . . . . . . . . 6
Electronic Article Surveillance (EAS) Systems . 8
How Do I Use the CardioMessenger? . . . . . . . . . . . . . . . . . . . . . . . . 9
What must e done efore 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 atteries are running
low? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
How do I know that the CardioMessenger is
receiving and transmitting implant data? . . . . 13
Trou leshooting . . . . . . . . . . . . . . . . . . . . . . . . 13
Resetting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
When Does My Implant Transmit Data? . . . . . . . . . . . . . . . . . . . . . 16
How Do I Take Care o 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 compati ility . . . . . . . . . . . . . 25
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
General information . . . . . . . . . . . . . . . . . . . . . 26
Permissi le environmental conditions . . . . . .26
CardioMessenger remote unit . . . . . . . . . . . . . 26
CardioMessenger charging station . . . . . . . . .27
Rechargea le attery (integrated) . . . . . . . . . . 27
Power supply . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

3What is Home Monitoring?
What is Home Monitoring?
Dear Patient.
You have received a BIOTRONIK pacemaker or
implanta le cardioverter-defi rillator (ICD) with a
Home Monitoring function. The Home Monitoring fea-
ture provides your attending physician with messages
recorded y your implant at regular intervals, giving
him or her information a out 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 e viewed only y
your physician via fax and on the Internet (when avail-
a le) 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 e updated or if your therapy
plan needs to e changed. If necessary, your physician
will contact you a out making an appointment for a
follow-up examination.
For Home Monitoring to work, your implant must have
the Home Monitoring function, and there must e 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 y the implant cannot e 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.

4A out This Technical Manual
About This Technical Manual
User group
The CardioMessenger is to e used y patients with a
BIOTRONIK pacemaker or an implanta le cardio-
verter-defi rillator (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 o served, minor injury or
equipment damage may occur.
WARNING! If these instructions are not o served, 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 rechargea le atteries
— A charging station with a power supply unit and
ca le
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 mo ile telephone net-
work to the BIOTRONIK Service Center. The uilt-in,
rechargea le atteries provide at least 24 hours of
wireless operation (away from the charging station).
Naturally, the CardioMessenger can also e used
when placed in the charging station.
1) Catalog num er 343 265
2) Catalog num er 343 227
3) Catalog num er 343 228

6Safety Precautions – What Should I Watch Out For?
Sa ety 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 o serve the following safety instructions:
WARNING! Turn off the CardioMessenger in locations where cell
phones are prohibited, such as hospitals or airplanes.
Such areas can e identified y the following or simi-
lar signs:
WARNING! Maintain a minimum distance etween 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) etween the
CardioMessenger and implant.
Never place the CardioMessenger on your chest
directly over the implant.
Do not carry the CardioMessenger inside the reast
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 athroom)
— Temperatures a ove 40°C (104°F)
— Temperatures elow 10°C (50°F) for the charging
station

7Safety Precautions – What Should I Watch Out For?
— Temperatures elow -5°C (23°F) for the Cardio-
Messenger
— Barometric pressure elow 700 and a ove
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 een dam-
aged; return it to your physician.
Before use, make sure that none of the components
are visi ly 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 suscepti ility to interference.
Caution! The CardioMessenger may only e opened and
repaired y authorized trained personnel, and the
rechargea le atteries (type LP 103463) may only e
exchanged y 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, rechargea le lithium ion atteries
should e disposed of y 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 e 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 descri es how to operate and
use the CardioMessenger.
What must be done be ore using the
CardioMessenger?
Find a suita le place to put the CardioMessenger and
charging station.
The distance etween your implant and the Cardio-
Messenger should not e too close in order to prevent
interference with implant operation. On the other
hand, the distance should not e eyond the implant
transmitter’s range.
Note: Home Monitoring can only work when the distance
etween 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 ase so that it cannot
fall.
• Keep the CardioMessenger from eing exposed to
moisture; athrooms, for example, are unsuita le
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 e a good place for the Cardio-
Messenger since the distance etween you and the
CardioMessenger would pro a ly not e more than
2 meters (6 feet). In addition, your attending physician
will pro a ly select nighttime as the regular trans-
mission time.

10 How Do I Use the CardioMessenger?
While resting at night, your implant data can e 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
permissi le operating range of 100-240 Volts at 50-
60 Hz.
If this is the case, insert the power supply ca le plug
into the socket.
The power supply has a long ca le with a small plug at
the end. Connect this plug to the charging station.
The corresponding port is located on the ack of the
charging station.
After connecting the charging station, the light will e
illuminated, and the charging station will then e
operational.
The CardioMessenger "tra ic light"
system
Your CardioMessenger has four lights. Three are
arranged like a traffic light, and one is separate and
monitors the attery. All lights can e 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
e informed y 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
pro lem. For further information, see the ”Trou le-
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 attery moni-
tor light are descri ed as follows:
Red: When the light flashes red, the CardioMessenger
atteries are nearly empty.
Yellow: When the light flashes yellow, there is a pro -
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 e used up to 24 hours away
from the ase.
Turning on the CardioMessenger
Press the on/off utton of the CardioMessenger for
approximately two seconds. A rief 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 esta lish a connection with the mo ile
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 ”Trou le-
shooting” section on page 13.
Turning o the CardioMessenger
Press the CardioMessenger on/off utton for approxi-
mately two seconds. You will hear a rief tone, and the
yellow light will go out.
The CardioMessenger is now switched off; no data can
e received or transmitted.
You can only turn the CardioMessenger ack on after
approximately five to six seconds.
Charging the CardioMessenger
When the attery monitoring light flashes red, the
CardioMessenger needs to e recharged.
Place the CardioMessenger in the charging station.
The charging process will start immediately.
During the charging process, the attery monitor light
of the CardioMessenger will e yellow.
If the attery monitor light flashes yellow, there is a
pro lem. Please refer to the ”Trou leshooting” sec-
tion on page 13 to find out how to resolve this pro lem.
When the attery monitor light of the Cardio-
Messenger is green, charging is complete. Charging
usually takes no longer than six hours.
Note: When the CardioMessenger is eing charged and used
at the same time, the attery monitor light can e
alternately illuminated green and yellow at the end of
the charging process. This does not signify a pro lem;
it simply means that the attery 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 atteries are nearly
empty, the attery monitor light will flash red.
Place the CardioMessenger in the charging station.
Charging will start immediately, which is indicated
when the attery monitor light is illuminated yellow.
When the atteries are completely charged, the at-
tery monitor light will e green.
Note: If you take the CardioMessenger out of the charging
station, the attery 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 y 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
o serve 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 een transmitted to the BIOTRONIK Ser-
vice Center.
Troubleshooting
Pro lems 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 pro lem. 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 pro lem.
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 ack 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 efore a connection is
esta lished to a GSM network.
If the CardioMessenger is close to your ed and gen-
erally cannot esta lish a connection to the GSM net-
work, contact your physician.
Continuous
illumination
Turn the CardioMessenger on and off. If the yellow
light continues to e illuminated, reset the
CardioMessenger y 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 possi le sources
of error, reset it y restarting the CardioMessenger.
Press the reset utton (located on the ack of the
CardioMessenger) with a sharp o ject such as a all-
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 e 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 y 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 e activated y a special magnet
(pacemaker patients only). This is done y 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 implanta le cardioverter-defi rillators
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 suita le magnet.

17 How Do I Take Care of the CardioMessenger?
How Do I Take Care o the Cardio-
Messenger?
Handle the CardioMessenger with care, so that you
will e a le 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 e 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 elt carrying
case.
Give the CardioMessenger ack to your doctor when it
no longer works.
The CardioMessenger does not need to e serviced at
regular intervals y a technician.
Note: Before each use, inspect the CardioMessenger,
charging station, power supply unit and ca le, and
make sure they are not damaged. If you find damage,
consult your physician.
If handled properly, the installed atteries should
supply the CardioMessenger with 24 hours of power
even after 500 charging cycles (which is a out two
years).
If this is not the case, check whether the Cardio-
Messenger was completely charged during the next
charging cycle. Additional information can e found in
the ”Charging the CardioMessenger” section on page
12.
If you find that the attery is always running low too
soon, contact your physician. The physician will have a
new attery installed.
Note: When authorized personnel change the attery, they
should also check the utton cell.

18 Accessories
Accessories
You can wear your CardioMessenger in various ways:
• With a clip on your elt (with or without the elt
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 etween the implant and the
CardioMessenger is not less than 20 centimeters
(7 inches).

19 Frequently Asked Questions
Frequently Asked Questions
What happens i I orget 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 y your implant will not get lost
either; they will remain availa le 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 i the CardioMessenger device ails?
Does this a ect 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 y the implant and
can e transmitted and evaluated during a regular fol-
low-up examination with your doctor.
Try to turn on the CardioMessenger. Additional infor-
mation can e found in the ”Trou leshooting” 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
prohi ited.