BIOTRONIK CardioMessenger II-LLT User manual

CardioMessenger II-LLT
Transmitter for
BIOTRONIK Home Monitoring®
sbiotronik
Technical Manual
BIOTRONIK SE & Co. KG
Woermannkehre 1
12359 Berlin · Germany
Tel [phone]
Fax [phone]
BIOTRONIK, Inc.
6024 SW Jean rd. Bldg. B
Lake Oswego, OR 97035
Phone [phone] (24-hr)
Fax [phone]
[e-mail]
www.biotronik.com
© BIOTRONIK SE & Co. KG
All rights reserved. Specifications subject to
modification, revision and improvement.
® CardioMessenger is a registered trademark of
BIOTRONIK SE & Co. KG.
13-D-xx
Revision: J (2013-03-04)
sbiotronik
356845--J_GA_CardioMessenger-II_en-US_Cover.indd 2-3 04.03.2013 13:07:46

Overview
Belt clip (1)
On/off button (2)
Telephone jack (3)
Restart (4)
Power supply port (5)
Overview
Physician callback signal (1)
Follow-up data transmission (2)
Ready (CardioMessenger II) (3)
Battery monitor light (4)
Ready (charging station) (5)
Data interface (6)
A view of the rear side of the device can be
found on the back cover. 1
2
3
6
4
5
1
2
3
4
5
356845--J_GA_CardioMessenger-II_en-US_Cover.indd 4-5 04.03.2013 13:07:47

Overview
Belt clip (1)
On/off button (2)
Telephone jack (3)
Restart (4)
Power supply port (5)
Overview
Physician callback signal (1)
Follow-up data transmission (2)
Ready (CardioMessenger II) (3)
Battery monitor light (4)
Ready (charging station) (5)
Data interface (6)
A view of the rear side of the device can be
found on the back cover. 1
2
3
6
4
5
1
2
3
4
5
356845--J_GA_CardioMessenger-II_en-US_Cover.indd 4-5 04.03.2013 13:07:47

1
Contents
Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
What is Home Monitoring? . . . . . . . . . . . . 3
Included Equipment . . . . . . . . . . . . . . . . . . 4
How Do I Use the CardioMessenger? . . . . 6
Where Should I Put the CardioMessenger? . 6
How Do I Install the CardioMessenger? . . 8
Telephone connection . . . . . . . . . . . . . 11
Version A . . . . . . . . . . . . . . . . . . . . . . . . 13
Version B . . . . . . . . . . . . . . . . . . . . . . . . 19
How Do I Understand the Lights of the
CardioMessenger? . . . . . . . . . . . . . . . . . . 24
Light 1 . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Light 2 . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Light 3 . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Light 4 . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Light 5 . . . . . . . . . . . . . . . . . . . . . . . . . . 27
How Do I Turn On the CardioMessenger? . 28
How Do I Turn Off the CardioMessenger? . 29
How Do I Charge the CardioMessenger? . 30
How Do I Turn Off the Charging Station? . 31
How Do I Resolve Problems? . . . . . . . . . . . 32
Light 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Light 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Light 5 . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
How Do I Reset the CardioMessenger? . . . 34
How Do I Take Care of the 
CardioMessenger? . . . . . . . . . . . . . . . . . . . 35
How Do I Carry the CardioMessenger? . . . 36
Safety Precautions – What Should I Watch
out For? . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
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Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . 40
USA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
FCC RF exposure requirements . . . . . . 41
UL classification . . . . . . . . . . . . . . . . . . 41
Canada . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Electromagnetic Compatibility . . . . . . . . . 43
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Technical Data . . . . . . . . . . . . . . . . . . . . . . 44
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Permissible Environmental Conditions . . 44
During operation . . . . . . . . . . . . . . . . . . 44
Shipping and storage . . . . . . . . . . . . . . 44
CardioMessenger Remote Unit . . . . . . . . . 44
CardioMessenger Charging Station . . . . . 45
Rechargeable Battery (Integrated) . . . . . . 46
Power Supply . . . . . . . . . . . . . . . . . . . . . . . 46
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Electromagnetic emitted interference
according to IEC 60601-1-2 . . . . . . . . . 47
Electromagnetic emitted interference
according to IEC 60601-1-2 . . . . . . . . . 48
Electromagnetic emitted interference
according to IEC 60601-1-2 . . . . . . . . . 50
Recommended separation distances
between portable 
and mobile RF communications
equipment and the CardioMessenger . 52
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What is Home Monitoring?
Dear Patient:
You have received a BIOTRONIK pacemaker
or implantable cardioverter-defibrillator
(ICD) with Home Monitoring function.
Home Monitoring pacemakers and ICDs are
additionally equipped with a special trans-
mitter. This transmitter automatically
transmits medical and technical information
to a mobile device, the CardioMessenger.
The CardioMessenger works like a cell
phone and automatically transmits the
information received from your device as
encoded messages to the BIOTRONIK
Service Center.
The transmission power from your device is
low so as to not impair your health in any
way. Since the transmission range is short,
the CardioMessenger is needed to send 
the information to the BIOTRONIK Service
Center.
At the Service Center, the data are processed
and can be viewed only by your physician 
on a secured Internet site in the form 
of a comprehensive report called a 
Cardio Report.
Your doctor can use this Cardio Report to
decide whether your device settings need 
to be updated or if your therapy plan needs
to be changed. Thus, Home Monitoring
serves as a practical diagnostic aid.
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Included Equipment
The set comes equipped with the following
components:
1. Mobile unit
2. Charging station
3. Wall mounted power supply 
4. Telephone cable
5. Belt clip (already affixed)
6. Carrying strap
7. Patient manual
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Before use, make sure that none of the
components are visibly damaged and that all
necessary components have been delivered
to you.
Caution! Never use the CardioMessenger
if it has been damaged; return it to your
physician. 
Only use the following original
BIOTRONIK devices, as other accessories
can increase the interference emitted and
the device's susceptibility to interference:
– The CardioMessenger 
– The charging station with the wall
mounted power supply (type: FW 7555 M/06) 
– The telephone cord 
(type: BIOTRONIK VK-117)
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How Do I Use the CardioMessenger?
The following section describes:
2How to optimize CardioMessenger
placement
2How to operate it
2How it functions
Where Should I Put the CardioMessenger?
On your bedside table or close to your bed 
is a suitable place for your CardioMessenger
since it generally fulfills the following 
conditions:
2The distance to the device is less than
2 meters (6 feet), so that regular data
transmission at night is guaranteed.
2The distance to the device is more than
20 centimeters (7 inches), so that the
CardioMessenger does not interfere 
with the device.
2The CardioMessenger is placed on 
a solid base and cannot fall.
Please also consider the following:
2Do not expose the device to moisture or
heat; exposure to direct sunlight and
taking the device into the bathroom are
not recommended.
2The CardioMessenger should not be
connected to a power outlet controlled 
by a light switch.
2Do not place the device next to a television
set, microwave oven, or similar source of
electromagnetic interference.
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Warning! The distance between the device
and CardioMessenger must not be less
than 20 centimeters (7 inches).
Note: If the CardioMessenger is too close
to a loudspeaker (or a radio alarm or TV),
you may hear interference noises typical
for mobile phones.
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8
How Do I Install the CardioMessenger?
Insert the plug into a socket in your wall.
Make sure you do not connect the Cardio-
Messenger to a power outlet controlled by 
a light switch.
Make sure that the socket to which the
charging station is connected is easily
accessible. This ensures that you can
disconnect the power supply from the mains
at any time.
Arrange power cable carefully to reduce the
risk of entanglement or strangulation.
Now the green light on the upper side of 
the power supply should be illuminated; 
if not, please refer to “How Do I Resolve
Problems?” on page 32.
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Now, insert the small plug of the power
supply cable into the charging station.
Arrange power cable carefully to reduce 
the risk of entanglement or strangulation.
The port for the small plug is situated on 
the rear side of the charging station and 
is marked with the following symbol:
Follow the instructions for use!
Use only the original power supply that
came with the CardioMessenger, see
“Included Equipment” on page 4.
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Light 5 is situated on the front side of the
charging station. The charging station is
operational when this light is illuminated.
If this light is not illuminated, please refer to
“How Do I Resolve Problems?” on page 32.
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11
Telephone connection
You need a telephone connection so that
your CardioMessenger can send the 
Home Monitoring data to your physician.
You may operate your CardioMessenger with
your existing telephone sharing one single
telephone socket (version A) or connect it
directly to a free telephone socket 
(version B).
Either way, your normal phone use remains
unaffected.
Version A
Version B
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Note: The CardioMessenger is designed to
operate with standard analog phone lines
providing Plain Old Telephone Service
(POTS). Compatibility with other phone
lines or services (e.g., Voice over IP (VoIP)
via analog or digital lines, cable TV phone
lines or ISDN) is not guaranteed. In these
cases compatibility testing at the patient’s
home is recommended. Proper set up of
the system at the patient’s home may
require installation of adapters and/or
analog phone lines. Please contact your
telephone service provider for informa-
tion on the type of phone line that you
have.
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Version A
Unplug your telephone cable from your
telephone socket in your wall.
Remove the safety plug on port 1 
on the rear side of the charging station.
Keep the sealing plug of the telephone inlet
out of the reach of children.
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Now insert the free end 
of your telephone cable into port 1 
of the charging station.
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Take the telephone cable that came with 
the CardioMessenger, remove 
the second safety plug from port 2 
of the charging station.
Keep the sealing plug of the telephone inlet
out of the reach of children.
Plug one end of the 
telephone cable into port 2.
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Insert the other end of your telephone cable
into the telephone socket in your wall.
Arrange the telephone cable carefully
toreduce the risk of entanglement or stran-
gulation.
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Now, place the CardioMessenger into the
charging station. The CardioMessenger
should switch itself on immediately, unless
the batteries are completely depleted. 
A brief tone will sound when the Cardio-
Messenger is switched on.
If the batteries are completely depleted, then
the CardioMessenger first charges itself and
then switches itself on later (approximately
after 30 minutes).
Additional information can be found in 
“How Do I Charge the CardioMessenger?” on
page 30.
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