CardioMessenger® Smart Patient device for the BIOTRONIK Home Monitoring system Technical Manual 404202 Revision: J (2019-01-29)
© BIOTRONIK SE & Co. KG All rights reserved. Specifications subject to modification, revision and improvement. ® All product names in use may be trademarks or registered trademarks held by BIOTRONIK or the respective owner. 0123 2015 BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin / Germany Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6852804 sales@biotronik.com www.biotronik.
1 Introduction Introduction Dear Patient: You have received a device with the additional Home Monitoring function by BIOTRONIK. How Home Monitoring works Your device (1) is equipped with a special transmitter which sends cardiac information to your CardioMessenger (2). This usually happens at night. The transmission power from your device is low and does not impair your health in any way. Its limited transmission range, however, requires the use of the CardioMessenger.
2 First Steps Check the Package Contents First Steps Check the Package Contents Your CardioMessenger is supplied ready for use, and you can operate it immediately by inserting the power plug into the wall outlet. However, prior to usage, check the CardioMessenger and its accessories for any visible damage and use only undamaged components. Return a damaged CardioMessenger to your physician. Use only the provided original power supply brick (see the technical data).
First Steps Where Do I Put the CardioMessenger? Where Do I Put the CardioMessenger? At night, the CardioMessenger should be placed close to your bed to ensure the nightly data transfer from the implanted device. The bedside table is therefore the best location for your CardioMessenger, as it usually meets the following conditions: • The CardioMessenger is placed on a solid base and cannot fall. • The distance to the implanted device is less than 2 m (6 feet).
First Steps How Do I Connect the CardioMessenger? How Do I Connect the CardioMessenger? Your CardioMessenger is already configured and is ready for use. You can operate it immediately by inserting the power plug into the wall outlet. Also consult the included quick reference guide. WARNING • Lay the power cord so that there is no risk of strangulation and nobody may stumble.
First Steps How Do I Use the CardioMessenger? How Do I Use the CardioMessenger? The CardioMessenger automatically receives the information from your device and transmits it to the BIOTRONIK Service Center. Attention Check once a day whether your CardioMessenger is switched on and ready for use.
First Steps How Do I Turn Off the CardioMessenger? How Do I Turn Off the CardioMessenger? Since the CardioMessenger contains a mobile ("cellular") module, you may need to switch off the CardioMessenger for safety reasons in areas where the use of mobile phones is prohibited (e.g., in an airplane). Such areas can be identified by the following or similar signs: Press and hold the blue key on the right of the CardioMessenger for two seconds until the display turns off.
3 The CardioMessenger Icons The CardioMessenger Icons The CardioMessenger has the following icons: Operation icon Call back icon See Call Back Function [Page 11] Information icon See Error Resolution [Page 12] The battery icon is always displayed with 1-3 bars according to the charging status. When the CardioMessenger is connected to the power supply brick and charging, a battery icon with a small power plug is displayed.
4 Functions Self-Test Functions Self-Test The CardioMessenger automatically conducts a self-test after being connected. All icons on the CardioMessenger are displayed. The CardioMessenger then checks the connection to the cellular phone network. The operation icon flashes and the battery icon is displayed. The connection test can take up to 15 minutes. Once the connection is established, the operation and battery icons remain permanently activated. The CardioMessenger is now ready for use.
Functions Call Back Function Call Back Function The call back function is an additional function that your physician can use in different ways. You will be informed by your physician if and how he or she will use this function. For example, your physician can use the call back icon to ask you for a call. Your physician can turn on the icon via the cellular phone network. It will then flash for a maximum of three days.
5 Error Resolution Error Type A - No Power Supply Error Resolution If your physician contacts you because device messages are not being received but your CardioMessenger was ready for use during the period in question, you should remove possible sources of electromagnetic disturbance from the immediate vicinity of the CardioMessenger.
Error Resolution Error Type B - Self-Test Failed Error Type B - Self-Test Failed All symbols are flashing, thast is the CardioMessenger is not ready for use. Repeat the self-test as the CardioMessenger did not finish it. 1. Disconnect the CardioMessenger from the power supply brick if relevant. 2. Press the blue key on the right side of the CardioMessenger for about two seconds. 3. Leave the CardioMessenger turned off for about thirty seconds. 4.
Error Resolution Error Type C - No Mobile Connection Error Type C - No Mobile Connection The information icon flashes and the battery icon is displayed. Check the mobile connection since the CardioMessenger cannot connect to the BIOTRONIK Service Center. 1. Press the blue key on the right side of the CardioMessenger for about two seconds. 2. Put the CardioMessenger in a place with better mobile reception. Make sure that the distance to the device is still less than 2 m (6 feet). 3.
6 Handling Charging Handling The CardioMessenger is intended primarily for continuous operation at home because it receives information from your implanted device once daily, usually at night, and forwards it to the BIOTRONIK Service Center. If handled properly, the installed battery should supply the CardioMessenger with 16 hours of power even after 500 complete charging cycles (which is at least two years). The CardioMessenger contains a mobile ("cellular") module.
Handling Cleaning Cleaning Keep the CardioMessenger clean and away from dirty or dusty environments. Use a soft, lint-free cloth for cleaning. Use a cloth slightly moistened with water for cleaning. However, avoid bringing the CardioMessenger into direct contact with water or solvents. Protect the CardioMessenger from direct contact with water. Unplug the CardioMessenger from the power supply brick before cleaning it with a damp cloth.
Handling Maintenance Maintenance The CardioMessenger is intended for continuous, automatic operation. Once correctly installed, ongoing maintenance typically is not required.
Handling Disposal Disposal Do not dispose of the CardioMessenger with your household trash. CardioMessenger and the associated power supply brick contain materials that must be correctly disposed of in accordance with environmental protection regulations. You may dispose of the CardioMessenger and its associated power supply brick as electronic waste in accordance with the applicable regulations if you no longer use it.
7 Precautionary Measures Precautionary Measures The CardioMessenger is a medical product and therefore complies with the strict requirements for the development, manufacturing, and testing of medical devices. Statutory regulations for electrical devices in hospitals require that the CardioMessenger and its accessories not be used in areas defined as patient environment (e.g., in the operating room).
8 Guidelines Telemetry Data for Europe Guidelines Telemetry Data for Europe Your device transmits diagnostic data to the CardioMessenger via a radio frequency (RF) assigned by the European Conference of Postal and Telecommunications Administration for the operation of Ultra Low Power Active Medical Implants (CEPT/ERC REC 70-03).
Guidelines Telemetry Data for the USA Telemetry Data for the USA This transmitter is authorized by rule under the Medical Device Radiocommunication Service (in Part 95 of the FCC Rules) and must not cause harmful interference to stations operating in the 400.150 to 406.000 MHz band in the Meteorological Aids (i.e.
Guidelines Telemetry Data for Canada Telemetry Data for Canada This device must not cause harmful interference to stations operating in the 400.150-406.000 MHz band in the Meteorological Aids (i.e., transmitters and receivers used to communicate weather data), the Meteorological Satellite, or the Earth Exploration Satellite Services and must accept interference that may be caused by such stations, including interference that may cause undesired operation.
Guidelines Electromagnetic Compatibility Electromagnetic Compatibility The CardioMessenger is protected from disturbances resulting from electromagnetic interference, electrostatic discharges, and other sources of interference – including interference induced by wiring. At the same time, interfering electromagnetic emissions from the CardioMessenger have been minimized. The CardioMessenger therefore meets the requirements of EN 60601-1-2 in every respect.
Guidelines Warranty Warranty WARNING The CardioMessenger and all original components by BIOTRONIK are not subject to warranty when modified, used other than intended, stored improperly, or transported incorrectly. • Never alter the CardioMessenger and the power supply brick and only use the original packaging for shipment.
9 Appendix Technical Data Appendix Technical Data General information on the CardioMessenger Smart and power supply bricks • Operating mode: continuous operation • Longevity: 6 years • IP 22 • Operating temperature: -5°C to +40°C • Storage and transport temperature: -20°C to +60°C • Store in a dry place: Relative humidity: 30% to 75% (non-condensing) • Atmospheric pressure: from sea level to approx.
Appendix Technical Data GlobTek GTM96180-1107-2.
Appendix Symbols on the Device Symbols on the Device The label icons on the CardioMessenger symbolize the following: Observe the technical manual (see Check the Package Contents [Page 4]) IP 22 Degree of protection against the ingress of solid objects and water Store in a dry place On and off key (standby) Port for micro USB connector
Appendix Legend for the Label Legend for the Label BIOTRONIK order number Serial number Manufacturing date Follow the instructions for use Storage temperature Air pressure limit Humidity limit TP2 Compabiltiy with telemetry protocol version 2 of BIOTRONIK Home Monitoring Transceiver frequency This device contains material that requires special waste disposal according to the environmental protection guidelines.
Appendix Legend for the Label Power supply brick Caution: US laws restrict this device to sale by or on the order of a medical practitioner.
Appendix Electromagnetic Emitted Interference Electromagnetic Emitted Interference Electromagnetic Emitted Interference according to IEC 60601-1-2 7.1 EN 55011 (CISPR 11) Group 1 Conducted interference emissions Class B Radiated emission 7.2.1 7.2.
Appendix Resistance to Electromagnetic Interference Resistance to Electromagnetic Interference Electromagnetic Resistance to Interference according to IEC 60601-1-2 8.9 IEC 61000-4-2 ± (2, 4, 8) 15 kV air discharge Electrostatic discharge (ESD) 8.9/8.10 IEC 61000-4-3 Electromagnetic fields 10 V/m 80 MHz – 2.7 GHz 80% AM 1 kHz Other measurements see table 9 (IEC 60601-1-2 8.10) 8.9 IEC 61000-4-4 Transient conducted surge voltages (EFT, bursts) 8.9 8.
