BIOTRONIK CardioMessenger Preliminary 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
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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 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
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What 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 feature 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 CardioMessenger, 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 available) in the form of a comprehensive report called a
Cardio report.
Your doct or can use these data to deci de wh ether 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 cellular 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 transmitted, they are saved so that your physici an can evaluate
them during your regularly scheduled follow-up
examina tion. If you have an y quest ions, please cont act
your physician.
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About This Technical Manual
About This Technical Manual
User group
The CardioMessenger is to be used by patients with a
BIOTRONIK pacemaker or an implantable cardioverter-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.
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The 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 clip
1)
—Carrying strap
2)
— Belt carrying case
3)
The CardioMessenger works like a cell phone and
transmits the information received from the implant
as a short message (SMS) via a mobile telephone network 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
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Safety Precautions – What Should I Watch Out For?
Safety Precautions – What Should
I Watch Out For?
The CardioMessenger and its components are medical 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 similar 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
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Safety 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 damaged; 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 household 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.
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Safety 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.
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How Do I Use the CardioMessenger?
How Do I Use the CardioMessenger?
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 CardioMessenger 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 CardioMessenger 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 transmission time.
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