BIOTRONIK SE and KG CM06-1 Patient Device User Manual Manual3

BIOTRONIK SE & Co. KG Patient Device Manual3

Manual3

23
When you are finished, the connection
should look like as follows:
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CardioMessenger.book Page 24 Tuesday, May 2, 2006 5:05 PM
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How Do I Understand the Lights of the
CardioMessenger?
Your CardioMessenger has four lights and
one light on the charging station.
The lights numbered 1 - 3 represent the
general functions of the CardioMessenger,
light 4 is the battery monitor light, and light
5 shows the operational status of the
charging station.
Note: Whether or not the lights flash or are
lit continuously, the operation of your
implant remains unaffected.
Light 1
Off – This is the normal status.
Yellow flashing – When this light flashes
yellow, your physician wants you to call. This
situation may never occur. You will be
informed by your physician if s/he will use
this feature.
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Note: After you have switched the
CardioMessenger off and on, this light
will not flash anymore. However, please
do not forget to call your physician.
Light 2
This light will only be used during a follow-
up visit and can be triggered via the implant
programmer ICS 3000. Your physician will
find further information in the ICS 3000
manual.
Note: Light 2 is not illuminated when your
implant transmits regular messages.
This light may be illuminated or flash yellow,
or flash green.
Off – This is the normal status.
Yellow illumination – When the light is
illuminated yellow, the CardioMessenger is
receiving a message. Please wait until the
data transmission has finished (light
flashing green) before you walk away from
the CardioMessenger.
Green flashing – When the light flashes
green several times, the transmission of the
message has been completed.
Yellow flashing – However, when the light
flashes yellow several times, the
transmission was not successful. Your
physician will decide what to do next.
Light 3
This light informs you about the normal
operation of the CardioMessenger.
Green flashing –
When the light single-flashes green
repeatedly, the CardioMessenger is
operating properly. This is the normal
status.
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Green flashing –
When the light double-flashes green
repeatedly, the CardioMessenger is also
operating properly. Additionally, there are
messages stored that have to be transmitted
to the Service Center.
Yellow flashing –
When the light double-flashes yellow
repeatedly, there is no connection to the
GSM network or modem and additionally the
CardioMessenger has messages stored to
be transmitted to the Service Center. For
further information, see the „How Do I
Resolve Problems?" on page 32.
Yellow illumination – When the light is
illuminated yellow, the CardioMessenger is
performing a self-test.
This test should last no longer than 10
seconds after the CardioMessenger has
been switched on.
Off – The CardioMessenger is switched off.
Light 4
In the following, the four statuses of the
battery monitor light are described as
follows:
Green Illumination – When the light is
illuminated green, the CardioMessenger is
fully charged. You may now use it in mobile
operation for at least 24 hours. But the
CardioMessenger can certainly also be kept
in the charging station.
Off – This is the normal status when the
CardioMessenger is used in mobile
operation.
When this light is off but the CardioMes-
senger is in the charging station, please
refer to „How Do I Resolve Problems?" on
page 32.
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Red flashing – When the light flashes red,
the CardioMessenger batteries are nearly
depleted. Please place the CardioMessenger
in the charging station.
Yellow illumination – When the light is
illuminated yellow, the CardioMessenger is
charging.
Light 5
Green Illumination – This is the normal
status when the charging station is
connected to the power supply.
If this is not the case, there might be an
error. Additional information can be found in
„How Do I Resolve Problems?" on page 32.
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How Do I Turn On the CardioMessenger?
As soon as you place the CardioMessenger
in the charging station, it is automatically
switched on.
You certainly may also switch on the
CardioMessenger when it is not placed in the
charging station; the On/Off button is located
on the right side of the CardioMessenger.
Press the On/Off button of the
CardioMessenger until you can feel slight
resistance. A brief tone will sound, the
CardioMessenger will start its self-test, and
light 3 will be illuminated yellow. You can
now release the button.
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When the self-test of the CardioMessenger
has finished, light 3 flashes yellow. Now, the
CardioMessenger will try to connect to the
BIOTRONIK Service Center.
After a successful connection to the Service
Center, light 3 flashes green. Your
CardioMessenger is now operational.
In case light 3 does not flash green, please
refer to „How Do I Resolve Problems?" on
page 32.
Note: When the CardioMessenger has not
been used for a long time or if it was
stored below operational temperature,
the battery can be completely depleted. In
this case, the CardioMessenger switches
itself on only after the battery has been
charged for about 30 minutes.
How Do I Turn Off the CardioMessenger?
Press and hold the CardioMessenger On/Off
button for at least two seconds. A brief tone
will sound and light 3 will go out after a short
period of time.
The CardioMessenger is switched off; no
data can be received or transmitted.
Note: A switched-off or improperly
functioning CardioMessenger does not
affect the operation of your implant.
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How Do I Charge the CardioMessenger?
The CardioMessenger has to be charged
when the battery monitor light (light 4)
flashes red. If you wish to use the
CardioMessenger in mobile operation, you
should charge it every 24 hours.
It is recommended that you charge the
CardioMessenger before you use it for the
first time.
To do so, place the CardioMessenger in the
charging station; the charging process will
start immediately.
During the charging process, the battery
monitor light (light 4) of the
CardioMessenger will be illuminated yellow.
Once the CardioMessenger is charged, the
battery monitor light is illuminated green.
Charging usually takes no longer than three
and a half hours.
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32
However, if the battery monitor light (light 4)
is off even though the CardioMessenger is in
the charging station, there might be a
problem.
Please refer to „How Do I Resolve
Problems?" on page 32 to find out how to
resolve this problem.
Note: In case the CardioMessenger has
been stored outside the operational
temperature, i.e., below 0° (32° F) and
above 40° Celsius (104° F), the batteries
discharge themselves much more quickly.
You should then first charge the
CardioMessenger before attempting to
use it.
How Do I Resolve Problems?
Problems with your CardioMessenger are
easy to identify, and they are ususally easy to
resolve.
Light 3
Yellow illumination – When this light is
continuously illuminated yellow, the
CardioMessenger was not able to end its
self-test.
Solution – Reset the CardioMessenger and
turn it on again. If light 3 is still illuminated
yellow, inform your physician. You will find
information on a reset in „How Do I Reset the
CardioMessenger?" on page 34.
Yellow flashing – When this light
continuously flashes yellow, the
CardioMessenger cannot connect to the
Service Center.
Solutions – Check if the charging station is
connected to the power supply and if the
cables from the charging station to the
telephone wall outlet are loose.
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Check that the standard telephone line is not
dead, i.e., the CardioMessenger is not
blocked by other devices.
Check if you are able to dial toll-free
numbers with your telephone. If this is
generally not possible, have this service set
up for you by your telephone provider or
inform your physician.
Light 4
Off – When this light is off even though the
CardioMessenger is in the charging station,
proceed as follows:
Solutions – Check if light 5 on the charging
station is illuminated. Is this not the case,
refer to the solutions described for light 5.
If light 5 is illuminated, check whether the
connecting parts on the CardioMessenger or
on the charging station are easily accessible
and not dirty.
If light 4 is still off, inform your physician so
that the device can be checked and the
battery may be exchanged.
Note: If you take the CardioMessenger out
of the charging station, the battery
monitor light will go out to save energy.
Light 5
Off – If this light is off, proceed as follows:
Solutions – Check that the plugs of the
power cables are connected both to the
outlet in the wall and to the power supply.
Check that the green light of the power
supply is illuminated. If this is not the case,
either the power outlet is not being supplied
with electricity or the power supply is
defective. Return a non-functioning power
supply to your physician.
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34
How Do I Reset the CardioMessenger?
You should reset your CardioMessenger by
restarting it when light 3 is lit continuously in
yellow and if this error could not be
eliminated by turning the CardioMessenger
off and on.
The reset button is located on the back of the
CardioMessenger, on the left towards the
lower end of the belt clip.
Press the reset button (located on the back
of the CardioMessenger) with a sharp object
such as a ballpoint pen or the end of a
straightened paper clip.
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35
If the problem still exists, inform your
physician.
Note: Only reset the CardioMessenger if
you have eliminated other sources of
error. When resetting the
CardioMessenger, you abruptly cut off the
current and data might be lost. Also,
please note when you have done a reset;
this could be useful for future
troubleshooting.
How Do I Take Care of the
CardioMessenger?
Handle the CardioMessenger with care, so
that you will be able to use it for a long time
and so that BIOTRONIK can guarantee its
proper operation:
2Keep the CardioMessenger clean and
away from dirty or dusty environments.
2Don't bend the antenna and don't hold the
CardioMessenger by the antenna.
2Use a soft cloth for cleaning. If necessary,
this can be moistened with water or ethyl
alcohol. However, avoid bringing the
device into direct contact with water or
other solvents.
2Protect the CardioMessenger from direct
contact with water. For example, wear it
under your coat when it rains.
2Don't turn on the CardioMessenger if it
has been recently stored in a cold
environment. Let it warm up slowly to
room temperature, since the resulting
condensed water may harm the
electronic circuit.
Return the CardioMessenger to your
physician if it no longer works.
Maintenance at regular intervals is not
necessary for the CardioMessenger.
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Note: Before use, make sure the
CardioMessenger, charging station,
power supply unit and cable are not visibly
damaged. If you find damage, consult
your physician.
If handled properly, the installed batteries
should supply the CardioMessenger with
24 hours of power even after 500 charging
cycles (which is at least two years).
If you feel the CardioMessenger is not
lasting long enough during mobile
operation, ensure that it has been charged in
the charging station for at least three and a
half hours before mobile use. Additional
information can be found in „How Do I
Charge the CardioMessenger?" on page 31.
If you find that the battery is always running
low too soon, contact your physician. The
physician will have a new battery installed.
Note: When authorized personnel change
the battery, they should also check the
button cell.
In particular, rechargeable lithium ion
batteries should be disposed of by the
manufacturer according to legal guidelines.
How Do I Carry the CardioMessenger?
You can wear your CardioMessenger in
various ways:
2With the clip of the CardioMessenger on
your belt
2With the carrying strap
If you don't need the clip or if you wish to
attach the carrying strap, proceed as
follows:
Remove the clip by pressing the
symbol with your thumb (see figure) and
slide the clip downwards - away from the
antenna.
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The carrying strap has a clip attached. Take
the carrying strap and reattach the clip of
the carrying strap.
To do so, slide the clip upwards toward the
antenna until the clip snaps in.
Warning! When you use the clip with the
carrying strap, make sure that the
distance between the implant and
CardioMessenger is greater than 20
centimeters (7 inches).
Warning! Do not carry the
CardioMessenger inside the breast
pocket of your shirt or jacket, and do not
place it directly on your skin.
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Safety Precautions - What Should I Watch Out For?
The CardioMessenger and its components
are medical devices and therefore comply
with strict requirements for their
development, manufacture and testing.
Please observe the following safety
instructions, which are summarized below:
Warning! Turn off the CardioMessenger in
locations where cell phones are
prohibited for safety reasons (such as in
hospitals or airplanes).
Such areas can be identified by the following
or similar signs:
Warning! To avoid interference, maintain a
minimum distance of 20 centimeters
(7 inches) between the CardioMessenger
and implant.
Like a cellular phone, the CardioMessenger
device can temporarily interfere with your
implant if it is too close to it.
Warning! Do not carry the
CardioMessenger inside the breast
pocket of your shirt or jacket, and do not
place it directly on your skin.
Warning! According to government
regulations, the charging station of the
CardioMessenger may not be operated
within a distance of 1.5 m (5 feet) of a
patient in a hospital environment. At
home, this restriction does not apply.
Caution! Protect the CardioMessenger and
charging station from:
- Water and high humidity (e.g., in the
bathroom)
- Temperatures above 40° C (104º F)
- Temperatures below -5° C (23° F)
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(mobile operation for CardioMessenger)
- Barometric pressure below 700 and
above 1060 hPa
- Violent shocks or other strong
mechanical influences
- Intensive light sources (direct sunlight,
strong halogen emitters)
-Solvents, acids, detergents, and lyes
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 and that all
necessary components have been delivered
to you. Additional information can be found
in „Included Equipment" on page 4.
Caution! The CardioMessenger may only
be opened and repaired by authorized
trained personnel, and the rechargeable
batteries may only be exchanged by
professionals.
Note: For proper operation, the
CardioMessenger must be put into the
charging station for at least three and a
half hours each day.
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Guidelines
USA
Your implant is equipped with a radio
frequency (RF) transceiver for wireless
communications to the CardioMessenger.
These messages are transmitted via an RF
assigned by the Federal Communications
Commission's (FCC) Medical Implant
Communications Service (MICS)1).
The transmitter is authorized by rule of 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 transceiver
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 transceiver 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 transceiver will be
free from interference.
The FCC ID number for the
CardioMessenger is QRICM06-1.
The FCC ID number for the cable modem in
the charging station is AU7MD04B2456.
1) Federal Communications Commission for Medical Implant Communications Service
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The CardioMessenger, as well as the
implant itself, must conform to appropriate
government standards and regulations.
The CardioMessenger uses a GSM modem
that connects to the mobile cellular
telephone service at 850/1900 MHz.
BIOTRONIK uses the modem according to
the specifications of the manufacturer in
compliance with FCC approval
requirements.
FCC RF Exposure Requirements
This device has been tested for operation
when worn on the body and meets the FCC
RF exposure guidelines when used with
BIOTRONIK accessories supplied or
designated for this product. Use of other
accessories may not ensure compliance with
FCC RF exposure guidelines.
This EUT (Equipment Under Test) has been
shown to be capable of compliance for
localized specific absorption rate (SAR) for
uncontrolled environment/ general
population exposure limits specified in
ANSI/ IEEE Std. C95.1-1992 and had been
tested in accordance with the measurement
procedures specified in FCC/OET Bulletin 65
Supplement C (2001) and IEEE Std. 1528-
200X (Draft 6.5, January 2002).
Canada
The CardioMessenger is registered at
Industry Canada with the following number:
IC: 4708A-CM06V1.
The cable modem in the charging station is
registered at Industry Canada with the
following number: IC: 125A-0008.
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42
The term "IC:" before the certification/
registration number only signifies that the
Industry Canada technical specifications
were met.
Note: This device may not interfere with
stations operating in the 400.150-406.000
MHz band in the meteorological aids,
meteorological-satellite, and earth
exploration-satellite services and must
accept any interference received,
including interference that may cause
undesired operation.
In addition, the CardioMessenger contains a
GSM modem (Motorola g24) that establishes
the connection to the cellular network at the
frequencies of 900/1800 MHz. BIOTRONIK
uses the modem in accordance with the
manufacturer’s specifications and in
compliance with the approval requirements.
The GSM modem has been evaluated and
approved by an independent authority for its
compliance with the statutory regulations.
As an indication of this, it carries the
following approval mark
(IMEI Number: 35726200-xxxxxx-x):
Electromagnetic Compatibility
Note: The CardioMessenger is protected
from disturbances resulting from
electromagnetic interference,
electrostatic discharges, and other
sources – including interference induced
by cables. Interfering emissions from the
CardioMessenger have been minimized.
The CardioMessenger therefore meets
the requirements of EN 60601-1-2 in
every respect.
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43
Warning! Other equipment, including
portable and mobile RF
radiocommunications equipment may
interfere with the CardioMessenger, even
if this equipment complies with CISPR
emission requirements. However, this
possible interference does not affect the
implant functionality.
Warranty
The CardioMessenger and all original
components by BIOTRONIK are not subject
to warranty when used improperly or stored
and transported incorrectly. Use only the
original packaging when shipping the
device.
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Technical Data
General
2Class of protection: II
2Operating mode: Continuous operation
Permissible Environmental Conditions
During Operation:
2Temperature: - 5° C (23° F) to + 40° C
(104° F) (remote unit)
0° C (32° F) to + 40° C (104° F) (charging
station)
2Relative humidity:
30% to 75% (non-condensing)
2Atmospheric pressure:
700 hPa to 1060 hPa
Shipping and Storage:
2Temperature:
- 20°C (- 4° F) to + 60° C (140° F)
2Relative humidity:
30% to 75% (non-condensing)
2Atmospheric pressure:
700hPa to 1060hPa
CardioMessenger Remote Unit
2Dimensions (WxHxD): 60 x 132 x 45 mm
2Charging voltage: 5,2 V DC / 0.8 A
2Max. charge time: 3.5 hours
2Interfaces:
Serial infrared port and IrDA1.0 standard
2MICS: Modulation FSK
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45
2MICS frequencies:
402 - 405 MHz, 9 channels, 300 kHz band
width
2MICS transmission power: 25 µW EIRP
2GSM: Modulation GMSK
2GSM frequencies:
850 MHz, 900 MHz, 1800 MHz, 1900 MHz,
9,6 kHz band width
2GSM transmission power:
0.8 Watt (850 MHz); 2 Watt (900 MHz);
1 Watt (1800/1900 MHz)
CardioMessenger Charging Station
2Dimensions (WxHxD): 90 x 82 x 105 mm
2Input voltage: 6 V DC / 1 A
2Output voltage: 5.2 V DC / 1 A
Rechargeable Battery (integrated)
2Type: Lithium ions (CGA 103460A)
2Dimensions (WxHxD):
approx. 36.5 x 64.5 x 12 mm
2Operating voltage: 3.6 V (nominal)
2Charging voltage: 4.1 V DC
2Max. charging current: 2 A
2Capacity: 1850 mAh or more
Power Supply
2Type: FW 7555M/06
2Dimensions: 51.5 x 87.5 x 34 mm
2Power cable in m: 2.0
2Connector type to the device:
According to EN 60320/C8
2Input voltage:
100 - 240 V AC at 50 - 60 Hz, 400 mA
2Output voltage: 6 V DC / 2.1 A
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46
Appendix
Electromagnetic emitted interference
according to IEC 601-1-2
The CardioMessenger is suitable for
operation in the indicated electromagnetic
environment. The customer and/or operator
of the CardioMessenger should make sure
that it is used in an electromagnetic
environment as described below.
Measuring the interference Compliance Guidelines for the Electromagnetic Environment
High-frequency interference
according to CISPR 11 Group 1 The CardioMessenger uses RF energy only for its internal
function. Therefore, the HF interference is very low and not likely
to cause any interference in nearby electronic equipment.
High-frequency interference
according to CISPR 11 Class B The CardioMessenger is suitable for use in all areas, including
living space and those areas that are directly connected to a
public power supply system that also supplies buildings
intended for residential purposes.Interference of harmonics according
to IEC 61000-3-2 Class A according to IEC 61000-3-2
Voltage fluctuations/ flicker
emissions according to
IEC 61000-3-3
Complies
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47
Electromagnetic emitted interference
according to IEC 601-1-2
The CardioMessenger is suitable for
operation in the indicated electromagnetic
environment. The customer and/or operator
of the CardioMessenger should make sure
that it is used in an electromagnetic
environment as described below.
Testing
resistance to
interference
Test level
according to IEC
60601-1-2
Conformance
level Guidelines for the electromagnetic environment
Conducted RF
interference
according to
IEC 61000-4-6
3Veff
150 kHz to 80 MHz Same as test level The minimum distance of the CardioMessenger from portable and mobile
radio devices, including the cables, should correspond to the recommended
safe distance that is calculated according to the equation for the suitable
transmission frequency. Recommended safe distance:
D= 1,17
Radiated RF
interference
according to IEC
61000-4-3
3V/m
80 MHz to 2.5 GHz Same as test level D= 1,17 for 80 to 800 MHz
D= 2,34 for 800 MHz to 2.5 GHz with P as the nominal output of the
transmitter in Watts (W) according to the information from the transmitter
manufacturer, and d as the recommended safe distance in meters (m).
The field strength of stationary transmitting devices should be measured on
sitea and must be lower than the compliance level at all frequenciesb.
Interference can be generated when the CardioMessenger is close to devices
that have the following warning sign:
Note: The higher frequency range applies at 80MHz and at 800MHz.
Note: These guidelines may not be applicable in all cases. The spread of electromagnetic waves is influenced by absorption and reflection from
buildings, objects, and humans.
p
p
p
CardioMessenger.book Page 47 Tuesday, May 2, 2006 5:05 PM
48
a. Field strengths from fixed transmitters, such as base stations for radio (cellular(/cordless) telephones and land mobile radios, amateur radio,
AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the CardioMessenger is used exceeds the applicable RF compliance level above, the CardioMessenger
should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-
orienting or relocating the CardioMessenger.
b. Above the frequency range of 150KHz to 80MHz, ensure that field strengths are less than 3V/m.
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49
Electromagnetic emitted interference
according to IEC 601-1-2
The CardioMessenger is suitable for
operation in the indicated electromagnetic
environment. The customer and/or operator
of the CardioMessenger should make sure
that it is used in an electromagnetic
environment as described below.
Checking
immunity to noise Test level according
to IEC 60601-1-2 Conformance
level Guidelines for the electromagnetic environment
Discharge of static
electricity (ESD)
According to IEC 61000-
4-2
± 6 kV contact discharge
±8 kV air discharge
Same as test level Floors should be made of wood or cement, or have ceramic tiles.
When the floor consists of a synthetic material, the relative
humidity must be at least 30%.
Rapid transient
electrical disturbances/
bursts
According to IEC 61000-
4-4
± 2 kV for
power supply lines
± 1 kV for input/output
lines
Same as the test
level The quality of the supply voltage should correspond to that in a
typical business and/or hospital.
Surge
According to IEC 61000-
4-5
±1kV normal mode
voltage
± 2 kV common mode
voltage
Same as the test
level The quality of the supply voltage should correspond to that in a
typical business and/or hospital.
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50
Voltage dips, brief
interruptions and
fluctuations in the
supply voltage
According to IEC 61000-
4-11
‹ 5% UT for
1/2 cycle
(› 95% drop)
40% UT for 5 periods
(60% drop)
70% UT for 25 periods
(30% drop)
‹ 5% UT for 5 s
(› 95% drop)
Same as the test
level The quality of the supply voltage should correspond to that in a
typical business and/or hospital.
The CardioMessenger is powered by a battery. An interruption in
the supply voltage to the power supply unit will not impair the
functioning of the CardioMessenger.
Magnetic field at the
supply frequencies (50/
60 Hz)
According to IEC 61000-
4-8
3A/m Same as the test
level The magnetic field strength should correspond to the typical
value in business and hospital environments.
Comment: UT is the mains alternating voltage before applying the test levels.
Checking
immunity to noise Test level according
to IEC 60601-1-2 Conformance
level Guidelines for the electromagnetic environment
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51
Recommended separation distances
between portable and mobile RF
communications equipment and the
CardioMessenger
Transmission
frequency 150 kHz to 80 MHz 80 kHz to 800 MHz 800 MHz to 2.5 GHz
Equation D= 1,17 : D= 1,17 : D= 2,34 :
Rated power
of transmitter (W) Safe distance (m) Safe distance (m) Safe distance (m)
0.01 0.12 0.12 0.24
0.1 0.37 0.37 0.74
1 1.17 1.17 2.34
10 3.7 3.7 7.4
100 11.7 11.7 23.4
For transmitters whose maximum nominal output is not indicated in the above table, the distance can be calculated using the equation in the
column, where P is the maximum nominal output of the transmitter in Watts (W) according to the transmitter’s manufacturer.
Note: The higher frequency range applies at 80MHz and at 800MHz.
Note: These guidelines may not be applicable in all cases. The propagation of electromagnetic values is affected by absorption and reflection by
structures, objects and people.
p p p
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