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Summary of Contents for BIOTRONIK CardioMessenger II-S
- Page 1 Technical Manual CardioMessenger II-S ® Transmitter for BIOTRONIK Home Monitoring ® 362454_D_GA_CM_II-S_US.indd 1 17.04.08 16:28:16...
- Page 2 © by BIOTRONIK GmbH & Co. KG BIOTRONIK GmbH & Co. KG All rights reserved. Specifications subject to Woermannkehre 1 modification, revision and improvement. 12359 Berlin · Germany 2008-D-05 Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6852804 ®...
- Page 3 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...
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Page 4: Table Of Contents
Call back function ....14 Switch off the system ....15 CardioMessenger II-S... - Page 5 Car di oM es s enger _I I - S_en. book Page 2 Tues day, M ay 6, 2008 1: 11 PM...
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Page 6: Introduction
(ICD) with the transmitter (1). Usually at night, the additional Home Monitoring function by transmitter sends daily information on your BIOTRONIK. With Home Monitoring, the state heart to the patient device, your of your heart's health and your implant are CardioMessenger (2). - Page 7 Car di oM es s enger _I I - S_en. book Page 4 Tues day, 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.
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Page 8: Check The Completeness Of The Delivery
Use only components which are undamaged. The delivery includes the following: Technical manual with brief instructions guide Warning! CardioMessenger II-S Use the CardioMessenger only if it is undamaged. Return a damaged CardioMessenger to your physician. Warning! Power supply unit with electricity cable and DC... - Page 9 Car di oM es s enger _I I - S_en. book Page 6 Tues day, 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...
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Page 10: Setup
CardioMessenger. 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 Setup... - Page 11 Car di oM es s enger _I I - S_en. book Page 8 Tues day, M ay 6, 2008 1: 11 PM Please take the following also into Do not expose the CardioMessenger to consideration: temperatures lower than 10 °C. Place the CardioMessenger in such a way Protect the CardioMessenger against water that the lights can easily be viewed during...
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Page 12: Connection
"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 Connection... -
Page 13: Self-Test
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. Connection... - Page 14 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...
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Page 15: Insert Brief Instructions Guide
Car di oM es s enger _I I - S_en. book Page 12 Tues day, M ay 6, 2008 1: 11 PM Insert brief instructions guide 3. Insert the brief instructions guide into the slot on the left side into the housing of the Attached to the back cover of this technical CardioMessenger. -
Page 16: Operate
The CardioMessenger automatically receives the information from your implant and Note transmits it to the BIOTRONIK Service Center. The functions of your implant are not Note affected at any time by the It indicates a malfunction if the operating... -
Page 17: Call Back Function
Car di oM es s enger _I I - S_en. book Page 14 Tues day, M ay 6, 2008 1: 11 PM Call back function Perform call back With the aid of the call back light, your Call your physician as soon as you realize that physician can ask you to call him. -
Page 18: Switch Off The System
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. CardioMessenger II-S Operate... -
Page 19: Debugging
Car di oM es s enger _I I - S_en. book Page 16 Tues day, 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... - Page 20 Next, the bedside lamp to the outlet and by turning CardioMessenger checks the connection to the the lamp on. BIOTRONIK Service Center. The operating If you do not find any errors, contact your light switches to green once the connection physician.
- Page 21 The operating light illuminates yellow CardioMessenger cannot get a connection to continuously (longer than 15 minutes). The call the BIOTRONIK Service Center in general, talk back light is off. CardioMessenger cannot to your physician. connect to the BIOTRONIK Service Center.
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Page 22: Cleaning, Maintenance, And Disposal
CardioMessenger. 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... - Page 23 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).
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Page 24: Precautionary Measures
CardioMessenger. The minimum distance details, see "Technical data", page 27). assures that the CardioMessenger does not Other equipment may impair proper influence your implant. functioning of the CardioMessenger and increase the emitted interference and the device's susceptibility to interference. CardioMessenger II-S Precautionary measures... - Page 25 Car di oM es s enger _I I - S_en. book Page 22 Tues day, 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: –...
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Page 26: Guidelines
Services and must accept any interference transmission from this transceiver will be free received, including interference that may from interference. cause undesired operation. 1) Federal Communications Commission for Medical Implant Communications Service CardioMessenger II-S Guidelines... - Page 27 Part 15 of the FCC IHDT56HQ1 for the CardioMessenger II-S/3 Rules. These limits are designed to provide and IHDT56FV1 for the CardioMessenger II-S/ reasonable protection against harmful inter- ference in a residential installation. This equip- The integrated GSM module comply with the...
- Page 28 This device may not interfere with stations Phone (800) 547-0394 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. CardioMessenger II-S Guidelines...
- Page 29 Warranty Note The CardioMessenger and all original compo- The CardioMessenger is protected from dis- nents by BIOTRONIK are not subject to war- turbances resulting from electromagnetic ranty when used improperly or stored and interference, electrostatic discharges, and transported incorrectly. Use only the original other sources –...
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Page 30: Technical Data
Car di oM es s enger _I I - S_en. book Page 27 Tues day, M ay 6, 2008 1: 11 PM Technical data General CardioMessenger Operating mode: Continuous operation Type: CardioMessenger II-S Dimensions (WxHxD): Permissible Environmental Conditions approx. 203 x 136.5 x 80 mm Operating temperature: +10 °C to +40 °C... - Page 31 Car di oM es s enger _I I - S_en. book Page 28 Tues day, M ay 6, 2008 1: 11 PM Power supply unit Type: FRIWO MMP 15 FW7555O/05 Type: PowerBox PA 1010-050 Dimensions (WxHxD): approx. Dimensions (WxHxD): approx. 70 x 39 x 25 51.5 x 87.5 x 34 mm DC plug output: DC plug output:...
- Page 32 Car di oM es s enger _I I - S_en. book Page 29 Tues day, M ay 6, 2008 1: 11 PM Technical Manual Type: Nordic Power (SAC) SA110D-05 Technical manual with brief instructions guide CardioMessenger II-S Dimensions (WxHxD): approx. 69 x 45 x 35 DC plug output: Outer diameter 5.5 mm (mass), Inner diameter 2.1 mm (plus)
- Page 33 Car di oM es s enger _I I - S_en. book Page 30 Tues day, M ay 6, 2008 1: 11 PM Technical data...
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Page 34: Appendix
Interference of harmonics according Class A according to intended for residential purposes. to IEC 61000-3-2 IEC 61000-3-2 Voltage fluctuations/ flicker Complies emissions according to IEC 61000-3-3 CardioMessenger II-S Appendix... - Page 35 Car di oM es s enger _I I - S_en. book Page 32 Tues day, 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.
- Page 36 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...
- Page 37 Car di oM es s enger _I I - S_en. book Page 34 Tues day, 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.
- Page 38 The magnetic field strength should correspond to the typical supply frequencies (50/ level value in business and hospital environments. 60 Hz) According to IEC 61000- Comment: U is the mains alternating voltage before applying the test levels. CardioMessenger II-S Appendix...
- Page 39 Car di oM es s enger _I I - S_en. book Page 36 Tues day, M ay 6, 2008 1: 11 PM Recommended separation distances between portable and mobile RF communications equipment and the CardioMessenger Transmission 150 kHz to 80 MHz 80 MHz up to 800 MHz 800 MHz to 2.5 GHz Frequency...
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Page 40: Index
Disposal ......20 BIOTRONIK Service Center ..4, 13 Distance to the implant . - Page 41 Car di oM es s enger _I I - S_en. book Page 38 Tues day, M ay 6, 2008 1: 11 PM Port for power connection ... . . 9 Illumination .
- Page 42 Warranty ......26 Yellow light ....10, 14, 16 CardioMessenger II-S Index...
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