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
- 1. Manual1
- 2. Manual2
Manual2
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| Mirror Download [FCC.gov] | |
| Document ID | 946838 |
| Application ID | jh0RKPuKB3yGHRvNvg1Bpw== |
| Document Description | Manual2 |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | No |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 303.97kB (3799645 bits) |
| Date Submitted | 2008-05-27 00:00:00 |
| Date Available | 2008-05-27 00:00:00 |
| Creation Date | 2008-04-17 16:28:15 |
| Producing Software | Adobe PDF Library 7.0 |
| Document Lastmod | 2008-05-08 14:19:55 |
| Document Title | 362454_D_GA_CM_II-S_US.indd |
| Document Creator | Adobe InDesign CS2 (4.0) |
CardioMessenger ®II-S
Transmitter for BIOTRONIK Home Monitoring®
362454_D_GA_CM_II-S_US.indd 1
Technical Manual
17.04.08 16:28:16
© 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
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)
Slot for the brief instructions guide (page 12)
Use only original power supply units (page 9)
Connection for the power supply (page 9)
362449_D_GA_CM_II-S_innen_EN01.i1 1
29.04.08 16:08:35
CardioM essenger_II-S_en.book Page 1 Tuesday,M ay 6,2008 1:11 PM
Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . 3
Debugging . . . . . . . . . . . . . . . . . . . . . . . . . 16
How Home Monitoring works . . . . . . . . . 3
Cleaning, maintenance, and disposal . . . 19
Check the completeness of the delivery . . 5
Precautionary measures . . . . . . . . . . . . . 21
Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . 23
Connection . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Technical data . . . . . . . . . . . . . . . . . . . . . . 27
Self-test . . . . . . . . . . . . . . . . . . . . . . . . . 10
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Insert brief instructions guide . . . . . . . 12
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Operate . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Check lights . . . . . . . . . . . . . . . . . . . . . . 13
Call back function . . . . . . . . . . . . . . . . . 14
Switch off the system . . . . . . . . . . . . . . 15
CardioMessenger II-S
CardioM essenger_II-S_en.book Page 2 Tuesday,M ay 6,2008 1:11 PM
CardioM essenger_II-S_en.book Page 3 Tuesday,M ay 6,2008 1:11 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
CardioMessenger II-S
Introduction
CardioM essenger_II-S_en.book Page 4 Tuesday,M ay 6,2008 1:11 PM
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.
Introduction
CardioM essenger_II-S_en.book Page 5 Tuesday,M ay 6,2008 1:11 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:
Technical manual with brief instructions guide
CardioMessenger II-S
Power supply unit with electricity cable and DC
plug
CardioMessenger II-S
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
Check the completeness of the delivery
CardioM essenger_II-S_en.book Page 6 Tuesday,M ay 6,2008 1:11 PM
device's susceptibility to interference.
The label on the back side of the
CardioMessenger indicates the approved
power supply units:
Check the completeness of the delivery
CardioM essenger_II-S_en.book Page 7 Tuesday,M ay 6,2008 1:11 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.
At the same time is the distance to the
implant more than 20 centimeters and the
CardioMessenger has no influence on your
implant.
CardioMessenger II-S
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.
Setup
CardioM essenger_II-S_en.book Page 8 Tuesday,M ay 6,2008 1:11 PM
Please take the following also into
consideration:
2 Do not expose the CardioMessenger to
temperatures lower than 10 °C.
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 Protect the CardioMessenger against water
and high humidity. Do not place it in the
bathroom.
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.
Setup
CardioM essenger_II-S_en.book Page 9 Tuesday,M ay 6,2008 1:11 PM
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:
CardioMessenger II-S
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:
Connection
CardioM essenger_II-S_en.book Page 10 Tuesday,M ay 6,2008 1:11 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.
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.
10
Connection
CardioM essenger_II-S_en.book Page 11 Tuesday,M ay 6,2008 1:11 PM
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.
CardioMessenger II-S
Connection
11
CardioM essenger_II-S_en.book Page 12 Tuesday,M ay 6,2008 1:11 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. Details on "Call back function" can
be found on page 14.
12
Connection
CardioM essenger_II-S_en.book Page 13 Tuesday,M ay 6,2008 1:11 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. Details on "Debugging" can be found
on page 16.
CardioMessenger II-S
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
13
CardioM essenger_II-S_en.book Page 14 Tuesday,M ay 6,2008 1:11 PM
Call back function
Perform call back
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.
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.
14
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 12).
CardioM essenger_II-S_en.book Page 15 Tuesday,M ay 6,2008 1:11 PM
Turn off the call back light
Switch 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
Details on "Connection" can be found on
page 9.
CardioMessenger II-S
Operate
15
CardioM essenger_II-S_en.book Page 16 Tuesday,M ay 6,2008 1:11 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 (Details on
"Call back function" can be found on page 14.);
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 now 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
mobile connection, see next page
Operating
light
16
Debugging
CardioM essenger_II-S_en.book Page 17 Tuesday,M ay 6,2008 1:11 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
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
17
CardioM essenger_II-S_en.book Page 18 Tuesday,M ay 6,2008 1:11 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 mobile connection
Note
The connection check can take up to
15 minutes.
The operating light illuminates yellow
continuously (longer than 15 minutes). The call
back light is off. CardioMessenger cannot
connect to the BIOTRONIK Service Center.
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.
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.
18
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.
Debugging
CardioM essenger_II-S_en.book Page 19 Tuesday,M ay 6,2008 1:11 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.
In continuous operation, the longevity of the
contained button cell corresponds to the
longevity of the CardioMessenger.
2 Use a cloth wetted with water for cleaning.
However, avoid bringing the
CardioMessenger into direct contact with
water or solvents.
CardioMessenger II-S
Cleaning, maintenance, and disposal
19
CardioM essenger_II-S_en.book Page 20 Tuesday,M ay 6,2008 1:11 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).
20
Cleaning, maintenance, and disposal
CardioM essenger_II-S_en.book Page 21 Tuesday,M ay 6,2008 1:11 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!
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.
CardioMessenger II-S
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.
Precautionary measures
21
CardioM essenger_II-S_en.book Page 22 Tuesday,M ay 6,2008 1:11 PM
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.
22
Precautionary measures
CardioM essenger_II-S_en.book Page 23 Tuesday,M ay 6,2008 1:11 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
Guidelines
23
CardioM essenger_II-S_en.book Page 24 Tuesday,M ay 6,2008 1:11 PM
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 configuration 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 conjunction with any other antenna or transmitter.
24
Guidelines
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
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.
CardioM essenger_II-S_en.book Page 25 Tuesday,M ay 6,2008 1:11 PM
— 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
CardioMessenger II-S
Canada
The CardioMessenger is registered at Industry
Canada with the following number: IC: 4708ACM08V1.
The GSM modem is registered at Industry Canada with the following number: IC: 1090-FV1 or
1090-HQ1.
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.
Guidelines
25
CardioM essenger_II-S_en.book Page 26 Tuesday,M ay 6,2008 1:11 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.
26
Guidelines
CardioM essenger_II-S_en.book Page 27 Tuesday,M ay 6,2008 1:11 PM
Technical data
General
CardioMessenger
2 Operating mode: Continuous operation
2 Type: CardioMessenger II-S
Permissible Environmental Conditions
2 Dimensions (WxHxD):
approx. 203 x 136.5 x 80 mm
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
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)
CardioMessenger II-S
Technical data
27
CardioM essenger_II-S_en.book Page 28 Tuesday,M ay 6,2008 1:11 PM
Power supply unit
or:
2 Type: PowerBox PA 1010-050
2 Type: FRIWO MMP 15 FW7555O/05
2 Dimensions (WxHxD): approx. 70 x 39 x 25
mm
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 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 400 mA
2 Output voltage: 5 V DC ± 5 %, 2 A/10 W
2 Output voltage:
5 V DC ± 5 %, 2.4 A/12 W
2 Safety class: II
2 Safety class: II
28
Technical data
CardioM essenger_II-S_en.book Page 29 Tuesday,M ay 6,2008 1:11 PM
or:
Technical Manual
2 Type: Nordic Power (SAC) SA110D-05
2 Technical manual with brief instructions
guide CardioMessenger II-S
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:
5.1 V DC ± 5 %, 2 A/10.2 W
2 Safety class: II
CardioMessenger II-S
Technical data
29
CardioM essenger_II-S_en.book Page 30 Tuesday,M ay 6,2008 1:11 PM
30
Technical data
CardioM essenger_II-S_en.book Page 31 Tuesday,M ay 6,2008 1:11 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 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
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
Appendix
31
CardioM essenger_II-S_en.book Page 32 Tuesday,M ay 6,2008 1:11 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 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 P
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 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 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.
32
Appendix
CardioM essenger_II-S_en.book Page 33 Tuesday,M ay 6,2008 1:11 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
Appendix
33
CardioM essenger_II-S_en.book Page 34 Tuesday,M ay 6,2008 1:11 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 the
interference
resistance
Test level according
to
IEC 60601-1-2
Compliance
level
Guidelines for the electromagnetic environment
Electrostatic
discharge (ESD)
± 6 kV contact 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 %.
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
According to IEC 610004-4
Surges voltages
(Surges)
According to IEC 610004-5
34
Appendix
± 2 kV for
power supply lines
± 1 kV for input
and output lines
±1kV push-pull voltage
± 2 kV common mode
voltage
CardioM essenger_II-S_en.book Page 35 Tuesday,M ay 6,2008 1:11 PM
Checking the
interference
resistance
Test level according
to
IEC 60601-1-2
Compliance
level
Guidelines for the electromagnetic environment
Voltage drops, brief
interruptions and
fluctuations in the
supply voltage
‹ 5 % UT for
1/2 cycle
(› 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.
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
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)
3 A/m
According to IEC 610004-8
Comment: UT is the mains alternating voltage before applying the test levels.
CardioMessenger II-S
Appendix
35
CardioM essenger_II-S_en.book Page 36 Tuesday,M ay 6,2008 1:11 PM
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
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 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.
36
Appendix
CardioM essenger_II-S_en.book Page 37 Tuesday,M ay 6,2008 1:11 PM
Index
Ambient conditions . . . . . . . . . . . . . . . . . . 27
Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Bedside table . . . . . . . . . . . . . . . . . . . . . . . . 7
BIOTRONIK Service Center . . . . . . . . . . 4,13
Blinking . . . . . . . . . . . . . . . . . . . . . . . . 14,16
Brief instructions guide . . . . . . . . . . . . 12,14
Broken CardioMessenger . . . . . . . . . . . . . 21
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
CardioMessenger II-S
Damaged CardioMessenger . . . . . . . . . 5,21
DC plug . . . . . . . . . . . . . . . . . . . . . . . 5,15,28
Debugging . . . . . . . . . . . . . . . . . . . . . . . . . 16
Defective CardioMessenger . . . . . . . . . . . 21
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Distance to the implant . . . . . . . . . . . . . . . 7
Electricity cable . . . . . . . . . . . . . . . . . 5,9,15
Electromagnetic compatibility . . . . . . . . . 26
Electromagnetic Emissions . . . . . . . . . . . 31
Green light . . . . . . . . . . . . . . . . . . . 10,13,16
Guidelines Canada . . . . . . . . . . . . . . . . . . 25
Guidelines USA . . . . . . . . . . . . . . . . . . . . . 23
Home Monitoring . . . . . . . . . . . . . . . . . . . . 3
Hospital . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Index
37
CardioM essenger_II-S_en.book Page 38 Tuesday,M ay 6,2008 1:11 PM
Illumination . . . . . . . . . . . . . . . . . . . . . . . . . 16
Implant . . . . . . . . . . . . . . . . . . . . . . . . . . . 3,7
Light 1 . . . . . . . . . . . . . . . . . . . . 10,13,14,16
Light 2 . . . . . . . . . . . . . . . . . . . . . . . . . . 10,16
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . 19
Mobile connection . . . . . . . . . . . . . . . . . . . . 4
Operate . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Operating light . . . . . . . . . . . . . . . . 10,13,16
Original parts . . . . . . . . . . . . . . . . . . . . . 5,27
Outlet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Package Contents . . . . . . . . . . . . . . . . . . . . 5
Perform call back . . . . . . . . . . . . . . . . . . . . 14
Physician call back light . . . . . . . . . . . . . . 16
Physician's phone number . . . . . . . . . 12,14
38
Index
Port for power connection . . . . . . . . . . . . . 9
Power connection port . . . . . . . . . . . . . . . . 9
Power supply unit . . . . . . . . . . . . . . . 5,9,28
Precautionary measures . . . . . . . . . . . . . . 21
Ready-for-service status . . . . . . . . . . . . . 13
Recommended safe distance . . . . . . . . . . 36
Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Safety instructions . . . . . . . . . . . . . . . . . . . 21
Self-test . . . . . . . . . . . . . . . . . . . . . . . . 10,17
Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Suitable installation location . . . . . . . . . . . 7
Switch off the system . . . . . . . . . . . . . . . . 15
Switching on the system . . . . . . . . . . . 13,15
Technical data . . . . . . . . . . . . . . . . . . . . . . 27
Transmitter of the implant . . . . . . . . . . . 3,7
Turn off the call back light . . . . . . . . . . . . 15
CardioM essenger_II-S_en.book Page 39 Tuesday,M ay 6,2008 1:11 PM
Unsuitable installation location . . . . . . . . . 7
Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Yellow light . . . . . . . . . . . . . . . . . . . 10,14,16
CardioMessenger II-S
Index
39
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