BIOTRONIK SE and KG CM08V-1 Patient Device User Manual 362453 D GA CM II S TLine US indd

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Date Submitted	2008-05-27 00:00:00
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CardioMessenger ®II-S TLine
Transmitter for BIOTRONIK Home Monitoring®
362453_D_GA_CM_II-S_TLine_US.ind1 1
Technical Manual
17.04.08 16:29:59
© 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
BIOTRONIK GmbH & Co. KG
Woermannkehre 1
12359 Berlin · Germany
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@biotronik.com
www.biotronik.com
362453_D_GA_CM_II-S_TLine_US.ind2 2
17.04.08 16:30:00
Call back light (yellow, page 22)
Operating light (yellow/green, page 21)
Slot for the brief instructions guide (page 20)
Use only original power supply units (page 16)
Connections for the landline (page 9 - 14)
Connection for the power supply (page 16)
362453_D_GA_CM_II-S_TLine_innen_1 1
05.05.08 15:00:47
CM _II-S_TLine.book Page 1 Tuesday,M ay 6,2008 12:56 PM
Content
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Operate . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
How Home Monitoring works. . . . . . . . . . . 3
Check lights . . . . . . . . . . . . . . . . . . . . . . . 21
Check the completeness of the delivery . . . 5
Call back function . . . . . . . . . . . . . . . . . . . 22
Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Switching Off the System. . . . . . . . . . . . . 23
Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Debugging . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Connection to the landline . . . . . . . . . . . . . 8
Cleaning, maintenance, and disposal . . . . 28
Connection to the power supply. . . . . . . . 16
Precautionary measures . . . . . . . . . . . . . . 30
Self-test . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Insert brief instructions guide . . . . . . . . . 20
Technical data . . . . . . . . . . . . . . . . . . . . . . . 37
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
CardioMessenger II-S TLine
362453--D
CM _II-S_TLine.book Page 2 Tuesday,M ay 6,2008 12:56 PM
CM _II-S_TLine.book Page 3 Tuesday,M ay 6,2008 12:56 PM
Introduction
Dear patient:
How Home Monitoring works
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.
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
transmits it to the
CardioMessenger II-S TLine
Introduction
CM _II-S_TLine.book Page 4 Tuesday,M ay 6,2008 12:56 PM
BIOTRONIK Service Center (4) as encoded
messages via a landline 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.
Introduction
CM _II-S_TLine.book Page 5 Tuesday,M ay 6,2008 12:56 PM
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:
Telephone cable
CardioMessenger II-S TLine
Technical manual with brief instructions guide
Power supply unit with electricity cable and DC
plug
CardioMessenger II-S TLine
Warning!
Use the CardioMessenger only if it is
undamaged. Return a damaged
CardioMessenger to your physician.
Check the completeness of the delivery
CM _II-S_TLine.book Page 6 Tuesday,M ay 6,2008 12:56 PM
Warning!
Use only the original parts included (for
details, see "Technical data", page 37).
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:
Check the completeness of the delivery
CM _II-S_TLine.book Page 7 Tuesday,M ay 6,2008 12:56 PM
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.
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.
2 Do not expose the CardioMessenger to
temperatures exceeding 40 °C (104 °F). 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 (50°F).
Please take the following into consideration:
CardioMessenger II-S TLine
2 Protect the CardioMessenger against water
and high humidity. Do not place it in the
bathroom.
Setup
CM _II-S_TLine.book Page 8 Tuesday,M ay 6,2008 12:56 PM
Connection
Connection to the landline
The CardioMessenger transmits the Home
Monitoring data via landline.
2 Method B
The CardioMessenger is operated with a
telephone wall jack to which no other device
is connected.
There are two ways to connect the
CardioMessenger to the landline:
2 Method A
CardioMessenger and telephone are
operated using the same telephone wall
jack.
In both cases, you can use your phone as
usual.
Note
The CardioMessenger has been designed
for use with an analog landline. Correct
operation cannot be ensured if using a
digital landline. If you are unsure what kind
of landline you are using, please contact
your telephone provider.
Connection
CM _II-S_TLine.book Page 9 Tuesday,M ay 6,2008 12:56 PM
Method A
To operate both the CardioMessenger and
the telephone using one telephone jack
To operate CardioMessenger and telephone
together in one telephone wall jack, proceed as
follows:
1. On the back side of the CardioMessenger:
Remove the sealing plug from phone inlet 1.
Phone inlet 1 is labeled
with the following
symbol:
2. Unplug the telephone cable from the
telephone wall jack.
CardioMessenger II-S TLine
Connection
CM _II-S_TLine.book Page 10 Tuesday,M ay 6,2008 12:56 PM
3. Connect the free end of the telephone cable
to phone inlet 1 of the CardioMessenger.
The telephone is now connected to the
CardioMessenger.
10
Connection
4. Remove the sealing plug from phone inlet 2.
Phone inlet 2 is
labeled with the
following symbol:
CM _II-S_TLine.book Page 11 Tuesday,M ay 6,2008 12:56 PM
5. Take the supplied telephone cable and
connect one end to phone inlet 2.
6. Connect the other end of the supplied
telephone cable to the telephone wall jack.
7. Check the telephone connection. Lift and
listen to the receiver. The usual dialing tone
should be audible.
CardioMessenger II-S TLine
Connection
11
CM _II-S_TLine.book Page 12 Tuesday,M ay 6,2008 12:56 PM
The telephone and CardioMessenger are now
connected to the landline.
As a next step, connect the CardioMessenger
to the power supply (see "Connection to the
power supply", page 16).
12
Connection
CM _II-S_TLine.book Page 13 Tuesday,M ay 6,2008 12:56 PM
Method B
Operate the CardioMessenger using an
available wall jack.
To operate the CardioMessenger in a
telephone wall jack to which no other devices
are connected, proceed as follows:
1. On the back side of the CardioMessenger:
Remove the sealing plug from phone inlet 1.
Phone inlet 1 is
labeled with the
following symbol:
CardioMessenger II-S TLine
Connection
13
CM _II-S_TLine.book Page 14 Tuesday,M ay 6,2008 12:56 PM
2. Take the supplied telephone cable and
connect one end to phone inlet 1.
14
Connection
3. Connect the other end of the supplied
telephone cable to the telephone wall jack.
CM _II-S_TLine.book Page 15 Tuesday,M ay 6,2008 12:56 PM
The CardioMessenger is now connected to the
landline.
As a next step, connect the CardioMessenger
to the power supply (see "Connection to the
power supply", page 16).
CardioMessenger II-S TLine
Connection
15
CM _II-S_TLine.book Page 16 Tuesday,M ay 6,2008 12:56 PM
Connection to the power supply
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 37).
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:
16
Connection
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:
CM _II-S_TLine.book Page 17 Tuesday,M ay 6,2008 12:56 PM
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.
CardioMessenger II-S TLine
Connection
17
CM _II-S_TLine.book Page 18 Tuesday,M ay 6,2008 12:56 PM
Self-test
The CardioMessenger automatically conducts
a self-test after being connected.
At first, both
lamps on the front
side of the
CardioMessenger
illuminate yellow
for a short while.
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.
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.
18
Connection
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. For details on the subject of
"Debugging", see page 24.
CM _II-S_TLine.book Page 19 Tuesday,M ay 6,2008 12:56 PM
If you are operating CardioMessenger and
telephone using one telephone wall jack
(variant A), the readily connected
CardioMessenger looks as follows:
CardioMessenger II-S TLine
If you are operating the CardioMessenger on a
free telephone wall jack (variant B), the readily
connected CardioMessenger looks as follows:
Connection
19
CM _II-S_TLine.book Page 20 Tuesday,M ay 6,2008 12:56 PM
Insert brief instructions guide
Attached to the back cover of this technical
manual is a removable instructions guide.
3. Insert the brief instructions guide into the
slot on the left side into the housing of the
CardioMessenger.
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.
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. For details on the subject of "Call
back function", see page 22.
20
Connection
CM _II-S_TLine.book Page 21 Tuesday,M ay 6,2008 12:56 PM
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. For details on the subject of
"Debugging", see page 24.
CardioMessenger II-S TLine
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".
Operate
21
CM _II-S_TLine.book Page 22 Tuesday,M ay 6,2008 12:56 PM
Call back function
Perform call back
With the aid of the call back light, your
physician can ask you to call him. He can turn
this light on via the landline. The light will then
blink yellow for a maximum time of 3 days.
Call your physician as soon as you realize that
the call back light is blinking.
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.
22
Operate
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 20).
CM _II-S_TLine.book Page 23 Tuesday,M ay 6,2008 12:56 PM
Turn off the call back light
Switching Off the System
To turn off the call back light, disconnect the
CardioMessenger briefly from the main supply.
The CardioMessenger does not have an on/off
switch. To turn off the CardioMessenger,
disconnect it 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.
1. Remove the power plug from the wall
outlet.
The operating control lamp will turn out. The
CardioMessenger is switched off.
The CardioMessenger performs the self-test.
Afterwards, the operating light will illuminate
green and the call back light will no longer be
blinking.
Note
For details on the subject of "Connection to
the power supply", see page 16.
CardioMessenger II-S TLine
Operate
23
CM _II-S_TLine.book Page 24 Tuesday,M ay 6,2008 12:56 PM
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 (For details
on the subject of "Call back function", see page 22.); no
malfunction
Yellow blinking
Error type B (both lights blink yellow): Repeat the selftest, see next page for further details
Off
Error type A: Check the power supply, see next page
Green illumination
The CardioMessenger is ready for use;
no malfunction
Yellow blinking
Error type B (both lights blink yellow): Repeat the selftest, see next page for further details
Yellow illumination
Error type C (only this light illuminates): Check the
landline connection, see next page for further details
Operating
light
24
Debugging
CM _II-S_TLine.book Page 25 Tuesday,M ay 6,2008 12:56 PM
Error type A:
Check the power supply
Error type B
Repeat the self-test
The operating light is off. CardioMessenger is
not ready for use.
Both lights blink yellow. The CardioMessenger
has not concluded the self-test. It is not yet
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.
CardioMessenger II-S TLine
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 selftest 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.
Debugging
25
CM _II-S_TLine.book Page 26 Tuesday,M ay 6,2008 12:56 PM
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 landline 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. Make sure that the one end of the telephone
cable is properly inserted into the telephone
wall jack.
2. Make sure that the other end of the
telephone cable is properly inserted into
phone inlet 1 on the back of the
CardioMessenger.
3. Check whether the telephone line is
available by lifting and listening to the
receiver. You should be able to hear the
normal dial tone.
4. Remove the power supply unit from the wall
outlet.
5. Reconnect it.
26
Debugging
CM _II-S_TLine.book Page 27 Tuesday,M ay 6,2008 12:56 PM
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.
Note
The CardioMessenger has been designed
for use with an analog landline. Correct
operation cannot be ensured if using a
digital landline. If you are unsure what kind
of landline you are using, please contact
your telephone provider.
If the operating light remains continuously
illuminated yellow, contact your physician.
CardioMessenger II-S TLine
Debugging
27
CM _II-S_TLine.book Page 28 Tuesday,M ay 6,2008 12:56 PM
Cleaning, maintenance, and disposal
Cleaning
Maintenance
2 Keep the CardioMessenger clean and away
from dirty or dusty environments.
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).
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.
28
Cleaning, maintenance, and disposal
In continuous operation, the longevity of the
contained button cell corresponds to the
longevity of the CardioMessenger.
CM _II-S_TLine.book Page 29 Tuesday,M ay 6,2008 12:56 PM
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).
CardioMessenger II-S TLine
Cleaning, maintenance, and disposal
29
CM _II-S_TLine.book Page 30 Tuesday,M ay 6,2008 12:56 PM
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!
The device must be located outside the
patient's vicinity if the intended user is to be
introduced to the device in the hospital.
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:
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 37).
30
Precautionary measures
Caution!
Federal (U.S.A.) law restricts this device to
sale by, or on the order of, a physician (or
properly licensed practitioner).
CM _II-S_TLine.book Page 31 Tuesday,M ay 6,2008 12:56 PM
Caution!
Protect the CardioMessenger from:
– Water and high humidity
– Temperatures above 40 °C (104 °F) (for
example from direct sunlight and strong
halogen spotlights)
– Temperatures below 10 °C (50 °F)
– Solvents, acids, detergents, and lyes
Caution!
The CardioMessenger may only be opened
and repaired by authorized trained
personnel.
CardioMessenger II-S TLine
Precautionary measures
31
CM _II-S_TLine.book Page 32 Tuesday,M ay 6,2008 12:56 PM
32
Precautionary measures
CM _II-S_TLine.book Page 33 Tuesday,M ay 6,2008 12:56 PM
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
harmful interference, and (2) this device must
accept any interference received, 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.
1) Federal Communications Commission for Medical Implant Communications Service
CardioMessenger II-S TLine
Guidelines
33
CM _II-S_TLine.book Page 34 Tuesday,M ay 6,2008 12:56 PM
The FCC ID number for the CardioMessenger
is QRICM08V-1.
The ACTA ID number for the cable modem is
AU7MMO1BMT5656SMI for the
CardioMessenger II-S/1 and AU7MDO4B2456
for the CardioMessenger II-S/2.
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 conjunction 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 interference in a residential installation. This equipment generates, uses and can radiate radio
frequency energy and, if not installed and used
34
Guidelines
in accordance with the instructions, may cause
harmful interference to radio communications.
However, there is no guarantee that interference will not occur in a particular installation.
If this equipment does cause harmful interference 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 following measures:
— Reorient or relocate the receiving antenna.
— Increase the separation between the equipment and receiver.
— 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.
CM _II-S_TLine.book Page 35 Tuesday,M ay 6,2008 12:56 PM
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: 4708ACM08V1.
The cable modem is registered at Industry
Canada with the following number: IC: 125A0015 or 125A-0008.
The term "IC:" before the certification/
registration 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, meteorologicalsatellite, and earth exploration-satellite
services and must accept any interference
received, including interference that may
cause undesired operation.
CardioMessenger II-S TLine
Guidelines
35
CM _II-S_TLine.book Page 36 Tuesday,M ay 6,2008 12:56 PM
Electromagnetic compatibility
Warranty
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.
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.
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.
36
Guidelines
CM _II-S_TLine.book Page 37 Tuesday,M ay 6,2008 12:56 PM
Technical data
General
CardioMessenger
2 Operating mode: Continuous operation
2 Dimensions (WxHxD):
approx. 203 x 136.5 x 80 mm
Permissible Environmental Conditions
2 MICS: Modulation FSK
2 Operating temperature: +10°C (50°F) to +40
C (104°F)
2 MICS frequencies: 402–405 MHz,
9 channels, 300 kHz frequency range
2 Storage and transport temperature:
-10°C (14°F) to + 60°C (140°F)
2 MICS transmission power: 25 µW EIRP
2 Relative humidity:
30% to 75% (non-condensing)
Telephone cable
2 Atmospheric pressure: 700 hPa to 1060 hPa
2 Type: VK-117
2 Length: approx. 2.5 m (8.2 ft)
2 Outlet: Rj-11
CardioMessenger II-S TLine
Technical data
37
CM _II-S_TLine.book Page 38 Tuesday,M ay 6,2008 12:56 PM
Power supply unit
or:
2 Type: FRIWO MMP 15 FW7555O/05
2 Type: Nordic Power (SAC) SA110D-05
2 Dimensions (WxHxD):
approx. 51.5 x 87.5 x 34 mm
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 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 Input voltage:
100–240 V ~ 50–60 Hz 300 mA
2 Output voltage:
5 V DC ± 5 %, 2.4 A/12 W
2 Output voltage:
5.1 V DC ± 5 %, 2 A/10.2 W
2 Safety class: II
2 Safety class: II
Technical manual
2 Technical manual with brief instructions
guide CardioMessenger II-S TLine
38
Technical data
CM _II-S_TLine.book Page 39 Tuesday,M ay 6,2008 12:56 PM
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 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
Interference of harmonics according
to IEC 61000-3-2
Class A according to IEC 61000-3-2
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.
Voltage fluctuations/flicker emissions according to
IEC 61000-3-3
Complies
CardioMessenger II-S TLine
Appendix
39
CM _II-S_TLine.book Page 40 Tuesday,M ay 6,2008 12:56 PM
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.
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 P
Radiated RF interference according
to IEC
61000-4-3
3V/m
80 MHz to 2.5 GHz
Same as test level
D= 1,17 P for 80 to 800 MHz
D= 2,34 P 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.
40
Appendix
CM _II-S_TLine.book Page 41 Tuesday,M ay 6,2008 12:56 PM
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.
CardioMessenger II-S TLine
Appendix
41
CM _II-S_TLine.book Page 42 Tuesday,M ay 6,2008 12:56 PM
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
immunity to noise
Test level according
to IEC 60601-1-2
Conformance
level
Guidelines for the electromagnetic environment
Discharge of static electricity (ESD)
± 6 kV contact 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%.
Same as the test
level
The quality of the supply voltage should correspond to that in a
typical business and/or hospital.
Same as the test
level
The quality of the supply voltage should correspond to that in a
typical business and/or hospital.
±8 kV air discharge
According to IEC 610004-2
Rapid transient electrical disturbances/bursts
± 2 kV for
power supply lines
According to IEC 610004-4
± 1 kV for input/output
lines
Surge
±1kV normal mode
voltage
According to IEC 610004-5
42
Appendix
± 2 kV common mode
voltage
CM _II-S_TLine.book Page 43 Tuesday,M ay 6,2008 12:56 PM
Checking
immunity to noise
Test level according
to IEC 60601-1-2
Conformance
level
Guidelines for the electromagnetic environment
Voltage dips, brief interruptions and fluctuations in the supply
voltage
‹ 5% UT for
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.
Same as the test
level
The magnetic field strength should correspond to the typical
value in business and hospital environments.
According to IEC 610004-11
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)
Magnetic field at the
supply frequencies (50/
60 Hz)
3A/m
According to IEC 610004-8
Comment: UT is the mains alternating voltage before applying the test levels.
CardioMessenger II-S TLine
Appendix
43
CM _II-S_TLine.book Page 44 Tuesday,M ay 6,2008 12:56 PM
Recommended separation distances between portable and mobile RF communications
equipment and the CardioMessenger
Transmission frequency
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
Equation
D= 1,17 P
D= 1,17 P
D= 2,34 P
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
1.17
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.
44
Appendix
CM _II-S_TLine.book Page 45 Tuesday,M ay 6,2008 12:56 PM
Index
Ambient conditions . . . . . . . . . . . . . . . . . . 37
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Bedside table . . . . . . . . . . . . . . . . . . . . . . . . 7
BIOTRONIK Service Center . . . . . . . . . . 4,21
Blinking . . . . . . . . . . . . . . . . . . . . . . . . 22,24
Brief instructions guide . . . . . . . . . . . . 20,22
Broken CardioMessenger . . . . . . . . . . . . . 30
Call back function . . . . . . . . . . . . . . . . . . . 22
Call back light . . . . . . . . . . . . . . . . . . . 18,22
Call your physician . . . . . . . . . . . . . . . . . . 22
Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Check the landline connection . . . 11,18,26
Check the telephone connection . . . . . . . 11
Checking the power supply . . . . . . . . . . . . 25
Clean it . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
CardioMessenger II-S TLine
Connection to the landline . . . . . . . . . . 8,19
Connection to the power supply . . . . 16,19
Damaged CardioMessenger . . . . . . . . . 5,30
DC plug . . . . . . . . . . . . . . . . . . . . . . . 5,23,38
Debugging . . . . . . . . . . . . . . . . . . . . . . . . . 24
Defective CardioMessenger . . . . . . . . . . . 30
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Distance to the implant . . . . . . . . . . . . . . . 7
Electricity cable . . . . . . . . . . . . . . . . 5,16,23
Electromagnetic Compatibility . . . . . . . . 36
Electromagnetic emitted interference . . 39
Green light . . . . . . . . . . . . . . . . . . . 18,21,24
Guidelines Canada . . . . . . . . . . . . . . . . . . 35
Guidelines USA . . . . . . . . . . . . . . . . . . . . . 33
Index
45
CM _II-S_TLine.book Page 46 Tuesday,M ay 6,2008 12:56 PM
Home Monitoring . . . . . . . . . . . . . . . . . . . . . 3
Hospital . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Illumination . . . . . . . . . . . . . . . . . . . . . . . . . 24
Implant . . . . . . . . . . . . . . . . . . . . . . . . . . . 3,7
Landline connection . . . . . . . . . . . . . . . . . . . 4
Light 1 . . . . . . . . . . . . . . . . . . . . 18,21,22,24
Light 2 . . . . . . . . . . . . . . . . . . . . . . . . . . 18,24
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . 28
Operate . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Operating light . . . . . . . . . . . . . . . . 18,21,24
Original parts . . . . . . . . . . . . . . . . . . . . . 5,37
Outlet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
46
Index
Package Contents . . . . . . . . . . . . . . . . . . . . 5
Perform call back . . . . . . . . . . . . . . . . . . . 22
Phone inlet 1 . . . . . . . . . . . . . . . . . . . . . 9,13
Phone inlet 2 . . . . . . . . . . . . . . . . . . . . . . . 10
Physician call back light . . . . . . . . . . . . . . 24
Physician's phone number . . . . . . . . . 20,22
Port for power connection . . . . . . . . . . . . 16
Power connection port . . . . . . . . . . . . . . . 16
Power supply unit . . . . . . . . . . . . . . 5,16,38
Precautionary measures . . . . . . . . . . . . . . 30
Ready-for-service status . . . . . . . . . . . . . 21
Recommended separation distances . . . 44
Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Safety instructions . . . . . . . . . . . . . . . . . . . 30
Sealing plug . . . . . . . . . . . . . . . . . . . 9,10,13
Self-test . . . . . . . . . . . . . . . . . . . . . . . . 18,25
Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Suitable installation location . . . . . . . . . . . 7
CM _II-S_TLine.book Page 47 Tuesday,M ay 6,2008 12:56 PM
Switch off the system . . . . . . . . . . . . . . . . 23
Switching on the system . . . . . . . . . . . 21,23
Technical data . . . . . . . . . . . . . . . . . . . . . . 37
Telephone cable . . . . . . . . . . 5,10,11,14,37
Telephone wall jack . . . . . . . . 8,9,11,13,14
Transmitter of the implant . . . . . . . . . . . 3,7
Turn off the call back light . . . . . . . . . . . . 23
Unsuitable installation location . . . . . . . . . 7
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
Yellow light . . . . . . . . . . . . . . . . . . . 18,22,24
CardioMessenger II-S TLine
Index
47

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