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

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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.