Biotronik RUCM200 Patient Device User Manual MN004
Biotronik, Inc. Patient Device MN004
users manual
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| Document ID | 291248 |
| Application ID | GkCVz9cB3eOsRWQiIXLVdw== |
| Document Description | users manual |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | No |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 15.38kB (192227 bits) |
| Date Submitted | 2002-12-20 00:00:00 |
| Date Available | 2002-12-18 00:00:00 |
| Creation Date | 2002-11-27 08:59:25 |
| Producing Software | Acrobat Distiller 4.0 for Windows |
| Document Lastmod | 2002-11-27 08:59:31 |
| Document Title | MN004 |
| Document Creator | Adobe PageMaker 6.52 |
| Document Author: | Collier |
Brochure for patients using the
Home Monitoring
Patient Device
Contents
Page
What is Home Monitoring?
How does the patient device work?
Safety precautions –what to look out for
How to handle the patient device
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.
What is Home Monitoring?
Dear Patient,
You are the recipient of an implanted pacemaker (PM) or
Implantable Cardioverter Defibrillator (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 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 Center
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 far
away from your implant, it does not affect the operation of your implanted device. In this case, your implant
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.
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 device
On/Off button
LED charging stand
Safety 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 cellular
phone is forbidden – hospitals, aircraft
aircraft,, etc
etc..
Switch your patient device off before you enter areas
where cellular phones are forbidden.
Keep a minimum distance between the mobile patient
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.
!
Protect the patient device from external influences
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.
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 repaired
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.
!
Handle the antenna with care.
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 to
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.
Because of the rechargeable batteries (Lithium-ion
batteries), the device must be disposed of separately.
How do I handle the patient device?
Below describes how to begin operating and how to use
your patient device.
What must be done before starting to use the patient
device?
Find a safe place for the device. That means:
• The device cannot be knocked to the floor or dropped.
• It is not too warm or too humid (not in a bathroom).
• The device is not in direct sun light.
Normally, a bedside table is a suitable place. When you
sleep, the distance between your implant and the patient
device should not be more than approximately two meters
(about 6 feet). In this way, during the night your implant
data can be successfully transmitted to the patient device.
How do you connect the device?
Check that the operating voltage of your power cord
matches the outlet in your home (normally 120 Vac,
60Hz).
If both voltages correspond, insert the plug of the power
cord into the wall-socket. The power supply cord has a
small plug at the opposite end of the cable. Connect this
plug to the socket that is located in the back of the charging stand.
Insert the plug of the power supply
unit into the wall socket
Connect the small end of the
power cord to the socket in the
patient device’s charging stand.
How do I turn the mobile patient device on?
Push the button on the side of the
mobile patient device until a short beep
is heard.
The light on the top of the patient device
will begin to flash orange for approximately 0.5 to 2 minutes.
When the light begins flashing green,
your patient device is ready for use.
If the light alternately flashes two times green and two
times orange, your patient device is not able to log onto
the local cellular phone system. In this instance, please
place your device in another location which may receive a
stronger signal from the cellular network. Once operational, the light will begin to flash green.
Note: When changing locations, turn the patient device off
and then on again (i.e. switch off, find new location, switch
on again).
10
How do I turn the mobile patient device off?
Push and hold the power button on the
side of the patient device until a short
“beep” is heard and the light goes out.
The unit is off, and no further data can
be received or transmitted.
How do I recharge the batteries of the
mobile patient device?
Place the mobile device onto the charging stand. Charging begins immediately.
Charging will occur whether the mobile
patient device is on or off.
During charging, the light on the charging stand is orange.
When the batteries are recharged, the
light turns green again.
Note: The system is operational while charging if the
mobile patient device has been left on. This is the preferable method. Usually, the charging operation takes no
longer than 5 hours. It is acceptable to permanently keep
the patient device in the charger stand.
11
How do I know if the batteries are low or discharged?
If the battery charge falls below 10% of the maximum
charge, the light on the top of the mobile patient device
flashes red. At the same time, 3 short beeps will be heard.
When this occurs, recharge the mobile patient device in
the charging stand.
How can I see if the patient device is transmitting
messages?
When a message is being transmitted, the light on top of
the patient device will flash orange for as long as two
minutes. Transmission of data is conducted automatically
at certain intervals as determined by your doctor. The
message transmission by the implant is repeated several
times in an interval of 8 to 9 minutes.
Transmission of messa
ge
messag
During the entire message transmission,
the light on the mobile patient device
flashes orange.
After the transmission is finished, the
light flashes green again.
12
What do I do if the mobile patient device does not
function any more?
If the patient device does not function (i.e., the light is out
and there is no beep), place the device in the charging
stand to recharge it.
If the device does not function after recharging, first push
the Reset button on the back of the mobile patient device
with a pointed object. Then switch the device on, using
the power on button on the side – as described on page 9.
If the light does not flash green after 5 minutes, please
inform your doctor.
Reset
Push the Reset button on the back of
the patient device with a pointed object.
Push and hold the power on button on
the side of the patient device until a
short beep is heard.
13
When does my implant transmit
messages?
Your doctor can adjust your implanted device so that it can
transmit messages under certain circumstances. There
are two possible ways to activate a message transmission:
Periodically after a predefined time interval. This
yy
our doctor
inter
val is set b
interv
by
your
doctor..
The doctor has adjusted your implant so that it transmits
periodic messages at a certain time and at periodic
intervals (for example: every night at 2:00 am).
Transmission activ
ated b
y a special ma
gnet
activated
by
magnet
(pacemaker patients only)
In certain cases, the transmission of data can be activated
by placing a special magnet directly over the implant.
Your doctor will explain to you if, how and when you
should do this.
Please use this function only if your doctor requests it and
gives you a suitable magnet. Your doctor must program
this function for your implant.
Note: Patients with implantable cardioverter defibrillators
should not place a magnet over your chest, as this interferes with the proper functioning of your ICD.
14
How do I take care of the device?
In order to use the patient device over a long period of
time, it is necessary to treat the device with care. The
faultless operation of the device can only be ensured
when the following conditions are observed:
Keep the device clean and away from dirty or dusty
environments.
To clean, use a soft cloth. Moisten the cloth with water
when necessary. Avoid direct contact of the device with
water.
If the patient device does not work, return it to your doctor.
15
Frequently asked questions by patients
What happens if I forget to recharge my mobile patient
device?
The batteries generally supply power for about 15 hours.
If the light on the mobile patient device turns red, place the
device on the charging stand until the light turns green
again (usually up to 5 hours). During the recharging
process, the light on the charging stand is orange. If the
mobile patient device is not recharged, the functions of the
patient device are affected and no message can be
received and transmitted to the Service Center.
There is no health risk if the patient device is not recharged because the regular functions of your implant are
independent of the patient device.
What happens if the patient device fails? Does that
affect my implant?
No. Your implant “works ”as usual. During a failure of the
mobile patient device, only the Home Monitoring function
is no longer available. This means that messages can not
be transmitted via the patient device to your physician.
The messages are still recorded by the implant and can be
transmitted and evaluated during a regular follow-up
examination with your doctor.
Try to turn it on again and to recharge the mobile patient
device. If this does not work, inform your doctor and
follow his instructions.
16
?
Can I take my patient device with me everywhere–
shopping, walking, sports?
Yes. You can always take your mobile patient device with
you during your private and working activities, as long as
your doctor recommends it and you are not within areas
where cellular phones are not permitted. The mobile
patient device can be comfortably transported attached to
your belt in the supplied soft case. It is also possible to
carry it in a normal bag or backpack. The distance between implant and patient device should not be more than
approximately two meters (about 6 feet), but must be at
least 15 cm (6 inches). The patient device is supplied with
a big carrying case for convenient and secure transportation and travelling.
What do I have to do when I go on vacation/travelling?
Consult your doctor beforehand and inform him/her of your
travel plans. You can take the patient device with you
everywhere and connect it where there is a suitable power
outlet (120 Vac, 60Hz). A country-specific adapter may be
necessary when travelling outside of the U.S. Your doctor
will give you detailed information. When transporting the
device on airlines, the regulations for cellular telephones
must be followed (e.g., do not use the patient device
during a flight).
17
Tec
hnical terms and abbre
viations
echnical
abbreviations
SMS
Short Message Service – This is a digital communication
system for mobile phones.
Cardio Report
Short report containing the current therapy status of the
patient on the basis of data transmitted from the implant.
Home Monitoring
Technical feature of pacemakers and ICDs used to
transmit messages over a certain frequency and make
them available to your doctor.
Service Center
Location where implant data is received, analyzed and
forwarded to your doctor.
Electr
onic Ar
tic
le Sur
veillance (EAS)
Electronic
Artic
ticle
Surveillance
Systems
Equipment such as retail theft prevention systems may
interact with pulse generators. Patients should be advised
to walk directly through and not to remain near an EAS
system longer than necessary.
18
Regulator
y aspects
Regulatory
Your implant is equipped with an RF transmitter for wireless communications to the patient device. These messages are transmitted via a radio frequency assigned by
the Federal Communications Commission for Medical
Implant Communications Service (MICS).
The transmitter is authorized by rule under the Medical
Implant Communications service (47 CFR Part 95) and
must not cause harmful interference to stations operating
in the 400.150 - 406.000 MHz band in the Meteorological
Aids (i.e., transmitters and receivers used to communicate
weather data), the Meteorological Satellite, or the Earth
Exploration Satellite Services and must accept interference that may be caused by such aids, including interference that may cause undesired operation. This transmitter shall be used only in accordance with the FCC rules
governing the Medical Implant Communications Service.
Analog and digital voice communications are prohibited.
Although this transmitter has been approved by the
Federal Communications Commission, there is no guarantee that it will not receive interference or that any particular
transmission from this receiver will be free from interference.
The FCC ID number for this device is PG6BA0T
The patient device, as well as the implant itself, are tested
by an independent regulatory authorities such as the FCC,
to comply with the appropriate standards and regulations.
The patient device uses a GSM-Modem that connects to
the mobile cellular telephone service at (1900 MHz).
BIOTRONIK uses the modem according to the specifications of the manufacturer and in compliance with FCC
approval requirements.
19
For body worn operation, this device has been tested and
meets the FCC RF exposure guidelines when used with a
Biotronik, Inc. accessory designated for this product, or
when used with an accessory that contains no metal and
that positions the device a minimum of 0.5 cm from the
body.
20
Tec
hnical Data
echnical
power
supply
charging
stand
mobile
patient device
Model /type
120Vac, 600mA*
RUCL 1000
RUCM 200
Volta
ge/
oltag
power input
120 Vac±10%,
60 Hz
12 V dc,
600 mA
9 V DC,
500 mA
Volta
ge/
oltag
power output
12 Vdc DC/
600 mA
9 V dc,
500 mA
–
* UL 2601-1 certified
Stoc
k and Transpor
tation Conditions
Stock
ransportation
temperature
+5° C to +55° C
humidity
93% relative humidity
air pressure
50 mbar to 1250 mbar
21
Addresses
BIOTRONIK, Inc.
6024 SW Jean rd. Bldg. B
Lake Oswego, OR 97035
Phone (800) 547-0394 (24-hr)
FAX (503) 635-9936
BIOTRONIK, Inc.
6024 SW Jean rd. Bldg. B
Lake Oswego, OR 97035
Phone (800) 547-0394 (24-hr)
FAX (503) 635-9936
M4039-C 5/02
MN004r1 5/02
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