BIOTRONIK SE and KG CM08V-1 Patient Device User Manual 362454 D GA CM II S US indd

BIOTRONIK SE & Co. KG Patient Device 362454 D GA CM II S US indd

Contents

Manual2

CardioMessenger®II-S
Transmitter for BIOTRONIK Home Monitoring®
Technical Manual
362454_D_GA_CM_II-S_US.indd 1 17.04.08 16:28:16
BIOTRONIK mbH & o K
Woermannkehre 1
12359 Berln  ermany
Tel +49 (0) 30 68905-0
Fax +49 (0) 30 6852804
BIOTRONIK, Inc
6024 SW Jean rd Bldg B
Lake Oswego, OR 97035
Phone (800) 547-0394 (24-hr)
Fax (503) 635-9936
salesbotronkcom
wwwbotronkcom
©
®
by BIOTRONIK GmbH & Co. KG
All rights reserved. Specifications subject to
modification, revision and improvement.
2008-D-05
CardioMessenger is a registered trademark of
BIOTRONIK GmbH & Co. KG
362454_D_GA_CM_II-S_US.indd 2 17.04.08 16:28:16
Call back light (yellow, page 14)
Operating light (yellow/green, page 13)
Use only original power supply units (page 9)
Slot for the brief instructions guide (page 12)
Connection for the power supply (page 9)
362449_D_GA_CM_II-S_innen_EN01.i1 1 29.04.08 16:08:35
CardioMessenger II-S 1
Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . 3
How Home Monitoring works . . . . . . . . . 3
Check the completeness of the delivery . . 5
Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Connection . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Self-test . . . . . . . . . . . . . . . . . . . . . . . . . 10
Insert brief instructions guide . . . . . . . 12
Operate . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Check lights . . . . . . . . . . . . . . . . . . . . . . 13
Call back function . . . . . . . . . . . . . . . . . 14
Switch off the system . . . . . . . . . . . . . . 15
Debugging . . . . . . . . . . . . . . . . . . . . . . . . . 16
Cleaning, maintenance, and disposal . . . 19
Precautionary measures . . . . . . . . . . . . . 21
Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . 23
Technical data . . . . . . . . . . . . . . . . . . . . . . 27
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
CardioM essenger_II-S_en.book Page 1 Tuesday, May 6, 2008 1:11 PM
2
CardioM essenger_II-S_en.book Page 2 Tuesday, May 6, 2008 1:11 PM
CardioMessenger II-S Introduction 3
Introduction
Dear patient:
You have received a pacemaker or implantable
cardioverter-defibrillator (ICD) with the
additional Home Monitoring function by
BIOTRONIK. With Home Monitoring, the state
of your heart's health and your implant are
surveyed on a daily basis while you are at
home. Your physician can catch up at regular
intervals on how your heart is doing.
How Home Monitoring works
Your implant is equipped with a special
transmitter (1). Usually at night, the
transmitter sends daily information on your
heart to the patient device, your
CardioMessenger (2).
The transmission power from your implant is
low and does not impair your health in any way.
Its limited transmission range, however,
requires the use of the CardioMessenger.
The CardioMessenger collects the information
received from the implant and automatically
CardioM essenger_II-S_en.book Page 3 Tuesday, May 6, 2008 1:11 PM
Introduction
4
transmits it to the BIOTRONIK Service Center
(4) as encoded messages via a mobile
connection (3).
Here, the messages are decoded and made
available for viewing by your physician (5) on a
protected web site.
Based on the information received, your
physician can decide if your implant is best
configured, or if the therapy needs
adjustments. In this way, Home Monitoring
serves as a practical diagnostic aid to your
physician.
CardioM essenger_II-S_en.book Page 4 Tuesday, May 6, 2008 1:11 PM
CardioMessenger II-S Check the completeness of the delivery 5
Check the completeness of the delivery
Check all components for visible damage
before using them. Use only components
which are undamaged.
The delivery includes the following:
CardioMessenger II-S
Power supply unit with electricity cable and DC
plug
Technical manual with brief instructions guide
Warning!
Use the CardioMessenger only if it is
undamaged. Return a damaged
CardioMessenger to your physician.
Warning!
Use only the original parts included (for
details, see "Technical data", page 27).
Other equipment may impair proper
functioning of the CardioMessenger and
increase the emitted interference and the
CardioM essenger_II-S_en.book Page 5 Tuesday, May 6, 2008 1:11 PM
Check the completeness of the delivery
6
device's susceptibility to interference.
The label on the back side of the
CardioMessenger indicates the approved
power supply units:
CardioM essenger_II-S_en.book Page 6 Tuesday, May 6, 2008 1:11 PM
CardioMessenger II-S Setup 7
Setup
Place the CardioMessenger on your bedside
table. The bedside table is suitable because it
usually meets the following conditions:
2
The CardioMessenger is placed on a solid
base and cannot fall.
2
The distance to the implant is less than 2
meters so that regular data transmission at
night is assured.
At the same time is the distance to the
implant more than 20 centimeters and the
CardioMessenger has no influence on your
implant.
Warning!
The distance between CardioMessenger and
implant has to be at least 20 centimeters.
The CardioMessenger contains a mobile
module ("Mobile"). In order to prevent any
interferences of the implant, you have to
keep the prescribed minimum distance
between implant and cellular phone also to
the CardioMessenger.
CardioM essenger_II-S_en.book Page 7 Tuesday, May 6, 2008 1:11 PM
Setup
8
Please take the following also into
consideration:
2
Place the CardioMessenger in such a way
that the lights can easily be viewed during
the day. If the lights disturb you in your
sleep, turn the CardioMessenger away from
you. Do not place the CardioMessenger on
the floor, next to, or under your bed.
2
Do not place the CardioMessenger next to a
television set, microwave oven, or a similar
source of electromagnetic interference.
Note
If the CardioMessenger is too close to a
loudspeaker (or a radio alarm or TV), you
may hear interference noises typical for
cellular phones.
2
Do not expose the CardioMessenger to
temperatures exceeding 40 °C. Do not put it
on a place with direct sun light and do not
place it directly under a halogen spotlight.
2
Do not expose the CardioMessenger to
temperatures lower than 10 °C.
2
Protect the CardioMessenger against water
and high humidity. Do not place it in the
bathroom.
CardioM essenger_II-S_en.book Page 8 Tuesday, May 6, 2008 1:11 PM
CardioMessenger II-S Connection 9
Connection
Connect the CardioMessenger to the power
supply. The outlet to be used has to be easily
accessible. Use the supplied power supply unit
with electricity cable and DC plug.
Warning!
Use only the original parts included (for
details, see "Technical data", page 27).
Other equipment may impair proper
functioning of the CardioMessenger and
increase the emitted interference and the
device's susceptibility to interference.
The label on the back side of the
CardioMessenger indicates the approved
power supply units:
1. Connect the DC plug at the end of the
electricity cable to the port on the left side
of the CardioMessenger.
The connector port is
labeled with the following
symbol:
CardioM essenger_II-S_en.book Page 9 Tuesday, May 6, 2008 1:11 PM
Connection
10
2. Connect the power supply unit to the outlet.
See that the outlet is not controlled by a
light switch. This will prevent you from
turning off the CardioMessenger
accidentally.
Self-test
The CardioMessenger automatically conducts
a self-test after being connected.
At first, both
lamps on the
front side of the
CardioMessenger
light up yellow for
a short while.
After about 10 seconds, the call back light will
turn off.
Then the
CardioMessenger checks
the connection to the
BIOTRONIK Service
Center. Only the
operating light
illuminates yellow.
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CardioMessenger II-S Connection 11
The connection check can take up to
15 minutes.
As soon as the
connection has been
checked successfully,
the operating light
illuminates green.
The CardioMessenger is now ready for use.
The CardioMessenger is intended for
continuous operation. It should be connected
at all times, especially at night.
Note
It is a sign of malfunction if the operating
light remains illuminated
yellow
for more
than 15 minutes or if it does not light up at
all. Details on "Debugging" can be found on
page 16.
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Connection
12
Insert brief instructions guide
Attached to the back cover of this technical
manual is a removable instructions guide.
This guide helps to inform you quickly about
the function and colors of the lights.
Additionally, you can list your physician's
phone number at the back cover of this guide.
1. Remove the guide from this technical
manual.
2. Write your physician's or the clinic's name
and phone number on the back cover of this
guide.
3. Insert the brief instructions guide into the
slot on the left side into the housing of the
CardioMessenger.
Now the brief instructions guide with your
physician's phone number are ready at hand.
Use it if the call back function of the
CardioMessenger was activated by your
physician. Details on "Call back function" can
be found on page 14.
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CardioMessenger II-S Operate 13
Operate
The CardioMessenger
does not have an on/off
switch. After connecting it,
it is ready for use as soon
as the operating light
illuminates green.
It is intended for continuous operation and
should remain connected at all times,
especially at night.
The CardioMessenger automatically receives
the information from your implant and
transmits it to the BIOTRONIK Service Center.
Note
It indicates a malfunction if the operating
light illuminates
yellow
or does not light up
at all. Details on "Debugging" can be found
on page 16.
Check lights
Check once a day whether either of the two
lights is illuminated.
Usually the operating
light illuminates green.
The call back light is
not illuminated.
Note
The functions of your implant are not
affected at any time by the
CardioMessenger, irrespective of the
illumination or blinking of the lights.
See the next page for details on the subject
"Call back function".
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Operate
14
Call back function
With the aid of the call back light, your
physician can ask you to call him. Via mobile
network, he can turn the light on. The light will
then blink yellow for a maximum time of 3
days.
The call back light blinks
if your physician expects
your call.
Your physician will let you know whether he or
she intends to use this function in general.
Perform call back
Call your physician as soon as you realize that
the call back light is blinking.
Note
The brief instructions guide with your
physician's phone number is located in the
housing of the CardioMessenger (see
"Insert brief instructions guide", page 12).
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CardioMessenger II-S Operate 15
Turn off the call back light
To turn off the call back light, disconnect the
CardioMessenger briefly from the main supply.
1. Pull the DC plug at the end of the electricity
cable out of the port on the left side of the
CardioMessenger.
Both lights will turn off.
2. Connect the DC plug to the port again.
The CardioMessenger performs the self-test.
Afterwards, the operating light will illuminate
green and the call back light will no longer be
blinking.
Note
Details on "Connection" can be found on
page 9.
Switch off the system
The CardioMessenger does not have an on/off
switch. To turn off the CardioMessenger,
disconnect it from the main supply.
1. Remove the power plug from the wall
outlet.
The operating control lamp will turn out. The
CardioMessenger is switched off.
CardioM essenger_II-S_en.book Page 15 Tuesday, May 6, 2008 1:11 PM
Debugging
16
Debugging
You can identify issues with your CardioMessenger by use of the lights on the front side.
Light Behavior Operating status
Call back
light Off Normal operation;
no malfunction
Yellow blinking Your attending physician is asking for a call (Details on
"Call back function" can be found on page 14.);
no malfunction
Yellow blinking Error type B (both lights blink yellow): Repeat the self-
test, see next page for further details
Operating
light Off Error type A: Check the power supply, see next page
Green illumination The CardioMessenger is now ready for use;
no malfunction
Yellow blinking Error type B (both lights blink yellow): Repeat the self-
test, see next page for further details
Yellow illumination Error type C (only this light illuminates): Check the
mobile connection, see next page
CardioM essenger_II-S_en.book Page 16 Tuesday, May 6, 2008 1:11 PM
CardioMessenger II-S Debugging 17
Error type A
Check the power supply
The operating light is off. CardioMessenger is
not ready for use.
Check the power supply:
2
Make sure that the DC plug of the electrical
cord is plugged in tightly into the port on the
left side of the CardioMessenger.
2
Make sure that the power supply unit is
inserted properly into the wall outlet.
2
Make sure that the outlet has current, for
example by temporarily connecting the
bedside lamp to the outlet and by turning
the lamp on.
If you do not find any errors, contact your
physician.
Error type B
Repeat the self-test
Both lights blink yellow. The CardioMessenger
has not concluded the self-test. It is not yet
ready for use.
1. Remove the power supply unit from the wall
outlet.
2. Reconnect it.
The CardioMessenger restarts and performs
the self-test. Both lights will illuminate yellow.
The call back light will turn off once the self-
test is complete. The operating light will
remain illuminated yellow. Next, the
CardioMessenger checks the connection to the
BIOTRONIK Service Center. The operating
light switches to green once the connection
test is sucessful. The CardioMessenger is now
ready for use.
CardioM essenger_II-S_en.book Page 17 Tuesday, May 6, 2008 1:11 PM
Debugging
18
If both lights stay permanently illuminated
yellow, the CardioMessenger is defective.
Return it to your physician.
Note
The connection check can take up to
15 minutes.
Error type C
Check the mobile connection
The operating light illuminates yellow
continuously (longer than 15 minutes). The call
back light is off. CardioMessenger cannot
connect to the BIOTRONIK Service Center.
1. Remove the power supply unit from the wall
outlet.
2. Put the CardioMessenger on a place with
better mobile reception.
Make sure that the distance to the implant
is still less than two meters.
3. Reconnect the CardioMessenger.
The CardioMessenger restarts and performs
the self-test. It checks the connection to the
BIOTRONIK Service Center. The operating
light switches to green once the connection
test is sucessful. The CardioMessenger is now
ready for use.
Note
The connection check can take up to
15 minutes.
If near your bed is a place where the
CardioMessenger cannot get a connection to
the BIOTRONIK Service Center in general, talk
to your physician.
CardioM essenger_II-S_en.book Page 18 Tuesday, May 6, 2008 1:11 PM
CardioMessenger II-S Cleaning, maintenance, and disposal 19
Cleaning, maintenance, and disposal
Cleaning
2
Keep the CardioMessenger clean and away
from dirty or dusty environments.
2
Use a soft, lint-free cloth for cleaning.
Caution!
Disconnect the CardioMessenger from the
main power supply before attempting to
clean it with a moist cloth.
2
Use a cloth wetted with water for cleaning.
However, avoid bringing the
CardioMessenger into direct contact with
water or solvents.
Maintenance
The CardioMessenger is intended for
continuous, automatic operation. Once
correctly installed, ongoing actions by you are
typically not required (e.g. no maintenance is
required).
In continuous operation, the longevity of the
contained button cell corresponds to the
longevity of the CardioMessenger.
CardioM essenger_II-S_en.book Page 19 Tuesday, May 6, 2008 1:11 PM
Cleaning, maintenance, and disposal
20
Disposal
Do not dispose the CardioMessenger in the
usual household trash.
CardioMessenger and the power supply unit
contain materials that must be correctly
disposed of in accordance with environmental
protection regulations.
If no longer required or if defective, please
return the CardioMessenger and all other
supplied parts to the physician. Your physician
will return all parts to BIOTRONIK.
BIOTRONIK ensures the disposal in
accordance with the national design of the
European guideline 2002/96/EC on electric and
electronic used devices (WEE).
CardioM essenger_II-S_en.book Page 20 Tuesday, May 6, 2008 1:11 PM
CardioMessenger II-S Precautionary measures 21
Precautionary measures
The CardioMessenger is a medical device and
therefore complies with strict requirements for
their development, manufacture and testing.
Please take the following precautions:
Warning!
Do not operate the CardioMessenger in
sections where cellular phones
are not
permitted for safety reasons
(for example
in certain hospital sections).
Warning!
The distance between CardioMessenger and
implant has to be at least 20 centimeters.
This regulatory recommendation applies for
cellular phones as well as for the
CardioMessenger. The minimum distance
assures that the CardioMessenger does not
influence your implant.
Warning!
The device must be located outside the
patient's vicinity if the intended user is to be
introduced to the device in the hospital.
These legal requirements apply for electrical
devices in hospitals and do not apply when the
CardioMessenger is used at home.
Warning!
Use the CardioMessenger only if it is
undamaged. Return a damaged
CardioMessenger to your physician.
Warning!
Use only the original parts included (for
details, see "Technical data", page 27).
Other equipment may impair proper
functioning of the CardioMessenger and
increase the emitted interference and the
device's susceptibility to interference.
CardioM essenger_II-S_en.book Page 21 Tuesday, May 6, 2008 1:11 PM
Precautionary measures
22
The label on the back side of the
CardioMessenger indicates the approved
power supply units:
Caution!
Protect the CardioMessenger from:
– Water and high humidity
– Temperatures above 40 °C (for example
from direct sunlight and strong halogen
spotlights)
–Temperatures below 10°C
– Solvents, acids, detergents, and lyes
Caution!
The CardioMessenger may only be opened
and repaired by authorized trained
personnel.
CardioM essenger_II-S_en.book Page 22 Tuesday, May 6, 2008 1:11 PM
CardioMessenger II-S Guidelines 23
Guidelines
USA
FCC RF exposure requirements
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).
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.
This device complies with Part 15 of the FCC
Rules. Operation is subject to the following two
conditions: (1) this device may not cause harm-
ful interference, and (2) this device must
accept any interference received, including
interference that may cause undesired opera-
tion.
This transceiver shall be used only in accor-
dance with the FCC rules governing the Medi-
cal 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.
1) Federal Communications Commission for Medical Implant Communications Service
CardioM essenger_II-S_en.book Page 23 Tuesday, May 6, 2008 1:11 PM
Guidelines
24
The FCC ID number for the CardioMessenger
is QRICM08V-1.
The FCC ID number for the GSM modem is
IHDT56HQ1 for the CardioMessenger II-S/3
and IHDT56FV1 for the CardioMessenger II-S/
4.
The integrated GSM module comply with the
Grantees instructions for antenna configura-
tion without having obtained a separate FCC
equipment authorization for the module. New
antenna configuration for that device will be
considered unauthorized equipment.
Statement according to FCC part 2.1091:
The internal/external antennas used for this
mobile transmitter must provide a separation
distance of at least 20 cm from all persons and
must not be co-located or operating in con-
junction with any other antenna or transmitter.
Statement according to FCC part 15.105:
NOTE: This equipment has been tested and
found to comply with the limits for a Class B
digital device, pursuant to Part 15 of the FCC
Rules. These limits are designed to provide
reasonable protection against harmful inter-
ference in a residential installation. This equip-
ment generates, uses and can radiate radio
frequency energy and, if not installed and used
in accordance with the instructions, may cause
harmful interference to radio communications.
However, there is no guarantee that interfer-
ence will not occur in a particular installation.
If this equipment does cause harmful interfer-
ence to radio or television reception, which can
be determined by turning the equipment off
and on, the user is encouraged to try to correct
the interference by one or more of the follow-
ing measures:
— Reorient or relocate the receiving antenna.
— Increase the separation between the equip-
ment and receiver.
CardioM essenger_II-S_en.book Page 24 Tuesday, May 6, 2008 1:11 PM
CardioMessenger II-S Guidelines 25
— Connect the equipment into an outlet on a
circuit different from that to which the
receiver is connected.
— Consult the dealer or an experienced radio/
TV technician for help.
Changes or modifications not expressly
approved by this company could void the user's
authority to operate the equipment.
Adress of responsible party:
BIOTRONIK, Inc.
6024 SW Jean rd. Bldg. B
Lake Oswego, OR 97035
Phone (800) 547-0394
Canada
The CardioMessenger is registered at Industry
Canada with the following number: IC: 4708A-
CM08V1.
The GSM modem is registered at Industry Can-
ada with the following number: IC: 1090-FV1 or
1090-HQ1.
The term "IC:" before the certification/regis-
tration number only signifies that the Industry
Canada technical specifications were met.
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.
CardioM essenger_II-S_en.book Page 25 Tuesday, May 6, 2008 1:11 PM
Guidelines
26
Electromagnetic compatibility
Note
The CardioMessenger is protected from dis-
turbances resulting from electromagnetic
interference, electrostatic discharges, and
other sources – including interference
induced by cables. Interfering emissions
from the CardioMessenger have been mini-
mized. The CardioMessenger therefore
meets the requirements of EN 60601-1-2 in
every respect.
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 pos-
sible interference does not affect the
implant functionality.
Warranty
The CardioMessenger and all original compo-
nents by BIOTRONIK are not subject to war-
ranty when used improperly or stored and
transported incorrectly. Use only the original
packaging when shipping the device.
CardioM essenger_II-S_en.book Page 26 Tuesday, May 6, 2008 1:11 PM
CardioMessenger II-S Technical data 27
Technical data
General
2
Operating mode: Continuous operation
Permissible Environmental Conditions
2
Operating temperature: +10 °C to +40 °C
2
Storage and transport temperature:
-10°C to +60°C
2
Relative humidity:
30 % to 75 % (non-condensing)
2
Atmospheric pressure: 700 hPa to 1060 hPa
CardioMessenger
2
Type: CardioMessenger II-S
2
Dimensions (WxHxD):
approx. 203 x 136.5 x 80 mm
2
MICS: Modulation FSK
2
MICS frequencies: 402–405 MHz,
9 channels, 300 kHz frequency range
2
MICS transmission power: 25 µW EIRP
2
GSM: Modulation GMSK
2
GSM frequencies: 850 MHz, 900 MHz,
1800 MHz, 1900 MHz, frequency range
9.6 kHz
2
GSM transmission power: 2 Watts (850/900
MHz); 1 Watt(1800/1900 MHz)
CardioM essenger_II-S_en.book Page 27 Tuesday, May 6, 2008 1:11 PM
Technical data
28
Power supply unit
2
Type: PowerBox PA 1010-050
2
Dimensions (WxHxD): approx. 70 x 39 x 25
mm
2
DC plug output:
Outer diameter 5.5 mm (mass),
Inner diameter 2.1 mm (plus)
2
Input voltage:
100–240 V ~ 50–60 Hz 400 mA
2
Output voltage: 5VDC ± 5%, 2A/10W
2
Safety class: II
or:
2
Type: FRIWO MMP 15 FW7555O/05
2
Dimensions (WxHxD): approx.
51.5 x 87.5 x 34 mm
2
DC plug output:
Outer diameter 5.5 mm (mass),
Inner diameter 2.1 mm (plus)
2
Input voltage:
100–240 V ~ 50–60 Hz 400 mA
2
Output voltage:
5VDC ± 5%, 2.4A/12W
2
Safety class: II
CardioM essenger_II-S_en.book Page 28 Tuesday, May 6, 2008 1:11 PM
CardioMessenger II-S Technical data 29
or:
2
Type: Nordic Power (SAC) SA110D-05
2
Dimensions (WxHxD): approx. 69 x 45 x 35
mm
2
DC plug output:
Outer diameter 5.5 mm (mass),
Inner diameter 2.1 mm (plus)
2
Input voltage:
100–240 V ~ 50–60 Hz 300 mA
2
Output voltage:
5.1VDC ± 5%, 2A/10.2W
2
Safety class: II
Technical Manual
2
Technical manual with brief instructions
guide CardioMessenger II-S
CardioM essenger_II-S_en.book Page 29 Tuesday, May 6, 2008 1:11 PM
Technical data
30
CardioM essenger_II-S_en.book Page 30 Tuesday, May 6, 2008 1:11 PM
CardioMessenger II-S Appendix 31
Appendix
Electromagnetic emitted interference according to IEC 60601-1-2
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 emitted
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
CardioM essenger_II-S_en.book Page 31 Tuesday, May 6, 2008 1:11 PM
Appendix
32
Electromagnetic emitted interference according to IEC 60601-1-2
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 the
interference
resistance
Test level according
to
IEC 60601-1-2
Compliance 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
conducted RF
interference according
to
IEC 61000-4-3
3 V/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 80 MHz and at 800 MHz.
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
CardioM essenger_II-S_en.book Page 32 Tuesday, May 6, 2008 1:11 PM
CardioMessenger II-S Appendix 33
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.
CardioM essenger_II-S_en.book Page 33 Tuesday, May 6, 2008 1:11 PM
Appendix
34
Electromagnetic emitted interference according to IEC 60601-1-2
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 the
interference
resistance
Test level according
to
IEC 60601-1-2
Compliance
level Guidelines for the electromagnetic environment
Electrostatic
discharge (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.
If the floor is covered with 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
and output lines
Same as the test
level The quality of the supply voltage should correspond to that in a
typical business and/or hospital.
Surges voltages
(Surges)
According to IEC 61000-
4-5
±1kV push-pull 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.
CardioM essenger_II-S_en.book Page 34 Tuesday, May 6, 2008 1:11 PM
CardioMessenger II-S Appendix 35
Voltage drops, brief
interruptions and
fluctuations in the
supply voltage
According to IEC 61000-
4-11
‹ 5% U
T for
1/2 cycle
(› 95 % drop)
40 % UT for 5 periods
(60 % drop)
70 % UT for 25 periods
(30 % drop)
‹ 5% U
T 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
3 A/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 the
interference
resistance
Test level according
to
IEC 60601-1-2
Compliance
level Guidelines for the electromagnetic environment
CardioM essenger_II-S_en.book Page 35 Tuesday, May 6, 2008 1:11 PM
Appendix
36
Recommended separation distances between portable and mobile
RF communications equipment and the CardioMessenger
Transmission
Frequency 150 kHz to 80 MHz 80 MHz up to 800 MHz 800MHz to 2.5GHz
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 80 MHz and at 800 MHz.
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
CardioM essenger_II-S_en.book Page 36 Tuesday, May 6, 2008 1:11 PM
CardioMessenger II-S Index 37
Index
A
Ambient conditions . . . . . . . . . . . . . . . . . . 27
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
B
Bedside table . . . . . . . . . . . . . . . . . . . . . . . . 7
BIOTRONIK Service Center . . . . . . . . . . 4, 13
Blinking . . . . . . . . . . . . . . . . . . . . . . . . 14, 16
Brief instructions guide . . . . . . . . . . . . 12, 14
Broken CardioMessenger . . . . . . . . . . . . . 21
C
Call back function . . . . . . . . . . . . . . . . . . . 14
Call back light . . . . . . . . . . . . . . . . . . . 10, 14
Call your physician . . . . . . . . . . . . . . . . . . 14
Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Checking the mobile connection . . . . 10, 18
Checking the power supply . . . . . . . . . . . . 17
Clean it . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Connection . . . . . . . . . . . . . . . . . . . . . . . . . . 9
D
Damaged CardioMessenger . . . . . . . . . 5, 21
DC plug . . . . . . . . . . . . . . . . . . . . . . . 5, 15, 28
Debugging . . . . . . . . . . . . . . . . . . . . . . . . . 16
Defective CardioMessenger . . . . . . . . . . . 21
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Distance to the implant . . . . . . . . . . . . . . . 7
E
Electricity cable . . . . . . . . . . . . . . . . . 5, 9, 15
Electromagnetic compatibility . . . . . . . . . 26
Electromagnetic Emissions . . . . . . . . . . . 31
G
Green light . . . . . . . . . . . . . . . . . . . 10, 13, 16
Guidelines Canada . . . . . . . . . . . . . . . . . . 25
Guidelines USA . . . . . . . . . . . . . . . . . . . . . 23
H
Home Monitoring . . . . . . . . . . . . . . . . . . . . 3
Hospital . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
CardioM essenger_II-S_en.book Page 37 Tuesday, May 6, 2008 1:11 PM
Index
38
I
Illumination . . . . . . . . . . . . . . . . . . . . . . . . .16
Implant . . . . . . . . . . . . . . . . . . . . . . . . . . . 3, 7
L
Light 1 . . . . . . . . . . . . . . . . . . . .10, 13, 14, 16
Light 2 . . . . . . . . . . . . . . . . . . . . . . . . . .10, 16
M
Maintenance . . . . . . . . . . . . . . . . . . . . . . . .19
Mobile connection . . . . . . . . . . . . . . . . . . . .4
O
Operate . . . . . . . . . . . . . . . . . . . . . . . . . . . .13
Operating light . . . . . . . . . . . . . . . .10, 13, 16
Original parts . . . . . . . . . . . . . . . . . . . . .5, 27
Outlet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
P
Package Contents . . . . . . . . . . . . . . . . . . . .5
Perform call back . . . . . . . . . . . . . . . . . . . .14
Physician call back light . . . . . . . . . . . . . .16
Physician's phone number . . . . . . . . .12, 14
Port for power connection . . . . . . . . . . . . . 9
Power connection port . . . . . . . . . . . . . . . . 9
Power supply unit . . . . . . . . . . . . . . . 5, 9, 28
Precautionary measures . . . . . . . . . . . . . . 21
R
Ready-for-service status . . . . . . . . . . . . . 13
Recommended safe distance . . . . . . . . . . 36
Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
S
Safety instructions . . . . . . . . . . . . . . . . . . . 21
Self-test . . . . . . . . . . . . . . . . . . . . . . . . 10, 17
Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Suitable installation location . . . . . . . . . . . 7
Switch off the system . . . . . . . . . . . . . . . . 15
Switching on the system . . . . . . . . . . . 13, 15
T
Technical data . . . . . . . . . . . . . . . . . . . . . . 27
Transmitter of the implant . . . . . . . . . . . 3, 7
Turn off the call back light . . . . . . . . . . . . 15
CardioM essenger_II-S_en.book Page 38 Tuesday, May 6, 2008 1:11 PM
CardioMessenger II-S Index 39
U
Unsuitable installation location . . . . . . . . . 7
W
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Y
Yellow light . . . . . . . . . . . . . . . . . . . 10, 14, 16
CardioM essenger_II-S_en.book Page 39 Tuesday, May 6, 2008 1:11 PM

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