BIOTRONIK SE and KG CMII User Man

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
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
356845--PreJ
1
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
2

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 trans­mitter. 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.
3

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
4
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)
5

How Do I Use the CardioMessenger?

The following section describes:
2 How to optimize CardioMessenger
placement
2 How to operate it
2 How 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:
2 The distance to the device is less than
2 meters (6 feet), so that regular data transmission at night is guaranteed.
2 The distance to the device is more than
20 centimeters (7 inches), so that the CardioMessenger does not interfere with the device.
2 The CardioMessenger is placed on
a solid base and cannot fall.
Please also consider the following:
2 Do not expose the device to moisture or
heat; exposure to direct sunlight and taking the device into the bathroom are not recommended.
2 The CardioMessenger should not be
connected to a power outlet controlled by a light switch.
2 Do not place the device next to a television
set, microwave oven, or similar source of electromagnetic interference.
6
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.
7
How Do I Install the CardioMessenger?
Insert the plug into a socket in your wall.
Make sure you do not connect the Cardio­Messenger 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.
8
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.
9
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.
10
Telephone connection
Version A
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 B
11
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 informa­tion on the type of phone line that you have.
12
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.
13
Now insert the free end of your telephone cable into port 1 of the charging station.
14
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.
15
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 stran­gulation.
16
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