Biotronik RUCM200 Users Manual
Brochure for patients using the
Home Monitoring
Patient Device
ContentsContents
Contents
ContentsContents
Page
What is Home Monitoring? 2
How does the patient device work? 4
Safety precautions –what to look out for 5
How to handle the patient device 8
How do I turn my mobile patient device on? 10
How do I turn my mobile patient device off? 11
When does my implant transmit messages? 14
How do I take care of the device? 15
Frequently asked questions by patients 16
Technical terms and abbreviations 18
Electronic Article Surveillance (EAS) Systems 18
Regulatory Aspects 19
Technical data 21
Throughout this manual many references are made to
“your doctor” for simplicity purposes. If you have a number
of doctors, these references are for the specific doctor that
follows your implanted device, pacemaker or defibrillator.
1
What is Home Monitoring?What is Home Monitoring?
What is Home Monitoring?
What is Home Monitoring?What is Home Monitoring?
Dear Patient,
You are the recipient of an implanted pacemaker (PM) or
Implantable Cardioverter Defibr illator (ICD). Your implant
is a complex electronic device, which benefits your health
and improves your quality of life.
BIOTRONIK has developed a new feature for your implant
called,
the Home Monitoring function.the Home Monitoring function.
the Home Monitoring function.
the Home Monitoring function.the Home Monitoring function.
The Home Monitoring function permits implant-related
monitoring by your doctor. Therefore, an optimal adaption
of the implant to your personal and physical needs is
possible. Your implanted device has a small wireless
transmitter that sends out signals, which have been
recorded by the device.
A patient device, provided to you for home use, receives
these signals from the implant and transmits them to a
BIOTRONIK Service Center. The implant data are compiled at the Service Center in a comprehensive report
known as the Cardio Report.
Service CenterService Center
Service Center
Service CenterService Center
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The Cardio Report is sent to your doctor via FAX at certain
predetermined periods decided upon by your doctor. Your
doctor can then decide whether your implant settings
should be optimized or if the therapy schedule should be
changed. If necessary, he or she will contact you about an
appointment for a follow-up examination to optimize your
pacemaker or ICD.
Because of the restricted transmission range of your
implant’s wireless transmitter, the patient device is required for receiving and forwarding the implant data.
If your patient device is not operational or too farIf your patient device is not operational or too far
If your patient device is not operational or too far
If your patient device is not operational or too farIf your patient device is not operational or too far
away from your implant, it does not affect the opera-away from your implant, it does not affect the opera-
away from your implant, it does not affect the opera-
away from your implant, it does not affect the opera-away from your implant, it does not affect the operation of your implanted device. tion of your implanted device.
tion of your implanted device. In this case, your implant
tion of your implanted device. tion of your implanted device.
still “works” as usual. Only the Home Monitoring function
is inactive. This means that messages can not be transmitted to the patient device and forwarded to the Service
Center. The messages recorded by the implant can still
be transmitted and evaluated during a regular follow-up
examination. Your doctor will answer any further questions.
On the following pages you will learn interesting facts
about the patient device and how to handle it.
3
How does the patient device work?How does the patient device work?
How does the patient device work?
How does the patient device work?How does the patient device work?
BIOTRONIK has developed a mobile patient device which
can always be taken with you to ensure that your personal
freedom and mobility are restricted as little as possible.
The patient unit consists of the following components:
• Mobile Patient device with internal batteries
• Charging stand with power supply set
The mobile patient device works similarly to a cellular
telephone and transmits the messages received from the
implant using the Short Message System (SMS). These
digital messages are sent from the patient device to a
BIOTRONIK Service Center. Once fully charged, the builtin batteries ensure approximately 15 hours of operating
time. The mobile patient device remains operational while
placed on the charging stand.
LED mobile patient deviceLED mobile patient device
LED mobile patient device
LED mobile patient deviceLED mobile patient device
On/Off buttonOn/Off button
On/Off button
On/Off buttonOn/Off button
LED charging standLED charging stand
LED charging stand
LED charging standLED charging stand
4
Safety precautions – What to look out forSafety precautions – What to look out for
Safety precautions – What to look out for
Safety precautions – What to look out forSafety precautions – What to look out for
The patient device and its components were developed,
produced and tested according to the latest guidelines and
standards. It meets the strict regulations for medical
devices. So that your patient device functions without
problems, the following safety measures must be carried
out:
Do not use the patient device in areas where a cellularDo not use the patient device in areas where a cellular
Do not use the patient device in areas where a cellular
Do not use the patient device in areas where a cellularDo not use the patient device in areas where a cellular
!!
!
!!
phone is forbidden – hospitals, aircraftphone is forbidden – hospitals, aircraft
phone is forbidden – hospitals, aircraft
phone is forbidden – hospitals, aircraftphone is forbidden – hospitals, aircraft
Switch your patient device off before you enter areas
where cellular phones are forbidden.
,,
etc etc
,
etc
,,
etc etc
..
.
..
Keep a minimum distance between the mobile patientKeep a minimum distance between the mobile patient
Keep a minimum distance between the mobile patient
Keep a minimum distance between the mobile patientKeep a minimum distance between the mobile patient
!!
!
!!
device and your implant.device and your implant.
device and your implant.
device and your implant.device and your implant.
Your mobile patient device, similar to cellular telephones,
can effect your implant if the distance between the mobile
patient device and the implant is less than 15 cm (about
6 inches). To prevent disturbances, please keep the
patient device at least this minimum distance from your
implant. You can keep the mobile patient device in the
supplied soft case, and transport it attached to your belt.
Do not place the patient device directly over your implant.
Do not carry the patient device inside the breast pocket of
your shirt.
5
Protect the patient device from external influencesProtect the patient device from external influences
Protect the patient device from external influences
Protect the patient device from external influencesProtect the patient device from external influences
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!
!!
such as:such as:
such as:
such as:such as:
– Water immersion
– High humidity (e.g., in the bathroom)
– High temperatures >40°C (104ºF)
– Low Temperatures <5°C (41ºF)
– Extreme pressures
– Violent shocks or other strong mechanical influences
– Bending the charging contacts on the charging stand
– Placing conductive items in the charging stand (such as
coins)
– Intensive light sources (direct sunlight, strong halogen
bulbs)
– Detergents, solvents, acids and bases
Do not use a damaged patient device.Do not use a damaged patient device.
Do not use a damaged patient device.
Do not use a damaged patient device.Do not use a damaged patient device.
!!
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Verify that none of the components are damaged before
usage. Only use the following original parts from
BIOTRONIK: The mobile patient device RUCM 200, the
charging stand RUCL 1000 and the corresponding power
supply (12Vdc @600mA, UL 2601-1 certified).
The patient device may only be opened and repairedThe patient device may only be opened and repaired
The patient device may only be opened and repaired
The patient device may only be opened and repairedThe patient device may only be opened and repaired
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!!
by authorized qualified personnel.by authorized qualified personnel.
by authorized qualified personnel.
by authorized qualified personnel.by authorized qualified personnel.
If the device is damaged, please return it to your doctor.
The batteries (type LG ICR 18650) installed by qualified
personnel must also be replaced by these specialists.
6
Handle the antenna with care.Handle the antenna with care.
Handle the antenna with care.
Handle the antenna with care.Handle the antenna with care.
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!!
Modifying or sticking other materials on the antenna
interfere with the transmission qualities of the patient
device.
In the following cases, return the patient device toIn the following cases, return the patient device to
In the following cases, return the patient device to
In the following cases, return the patient device toIn the following cases, return the patient device to
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your doctor or to the clinic that issued the device:your doctor or to the clinic that issued the device:
your doctor or to the clinic that issued the device:
your doctor or to the clinic that issued the device:your doctor or to the clinic that issued the device:
–Your patient device does not function anymore.
–You do not need it anymore.
Do not dispose of the device in household garbage.Do not dispose of the device in household garbage.
Do not dispose of the device in household garbage.
Do not dispose of the device in household garbage.Do not dispose of the device in household garbage.
!!
!
!!
Because of the rechargeable batteries (Lithium-ion
batteries), the device must be disposed of separately.
7
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