BIOTRONIK CardioMessenger Smart Technical Manual
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BIOTRONIK CardioMessenger Smart Technical Manual

Patient device for the biotronik home monitoring system
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CardioMessenger
Patient device for the
BIOTRONIK Home Monitoring
system
Technical Manual
404202
Revision: J (2019-01-29)
®
Smart

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Summary of Contents for BIOTRONIK CardioMessenger Smart

  • Page 1 ® CardioMessenger Smart Patient device for the BIOTRONIK Home Monitoring system Technical Manual 404202 Revision: J (2019-01-29)
  • Page 2 Specifications subject to modification, revision and improvement. ® All product names in use may be trademarks or BIOTRONIK SE & Co. KG registered trademarks held by BIOTRONIK or the Woermannkehre 1 respective owner. 12359 Berlin / Germany Tel +49 (0) 30 68905-0...
  • Page 3 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. The CardioMessenger collects the information and transmits it to the BIOTRONIK Service Center (4) as encoded messages via a mobile connection (3).

  • Page 4: First Steps

    CardioMessenger's resistance to electromagnetic interference. The product package includes the CardioMessenger (1) with power supply brick (2), the quick reference guide (3) and the technical manual (4). ® Smart CRM // BIOTRONIK Home Monitoring ® CardioMessenger ® Smart Gebrauchsanweisung Technical Manual Manual técnico...
  • Page 5 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: •...
  • Page 6 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 •...

  • Page 7: How Do I Use The Cardiomessenger

    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.

  • Page 8: How Do I Turn Off The Cardiomessenger

    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).
  • Page 9 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.
  • Page 10 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.

  • Page 11: Call Back Function

    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.

  • Page 12: Error Resolution

    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.
  • Page 13 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.
  • Page 14 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.
  • Page 15 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).
  • Page 16 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.

  • Page 17: Maintenance

    Handling Maintenance Maintenance The CardioMessenger is intended for continuous, automatic operation. Once correctly installed, ongoing maintenance typically is not required.
  • Page 18 The CardioMessenger and all the parts from the package can be returned to your physician. Your physician will return all parts to BIOTRONIK. BIOTRONIK ensures disposal in accordance with the national versions of the European guideline 2012/19/EC on waste electrical and electronic equipment (WEEE 2).

  • Page 19: Precautionary Measures

    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). Please observe the following safety-relevant notes: •...
  • Page 20 Low Power Active Medical Implants (CEPT/ERC REC 70-03). BIOTRONIK is legally obligated to inform you that the radio service does not have exclusive use of the assigned frequencies and that the transmission of device data is not permitted to interfere with other radio services.
  • Page 21 This device is registered with the Federal Communications Commission under the following number: FCC ID: QRICMSMART (CardioMessenger Smart 3G) and FCC ID: QRI-CMSMART4GNA (CardioMessenger Smart 4G).
  • Page 22 The operation is subject to the following two conditions: (1) The device must not cause interference and (2) the device must handle any interference received, including interference that may cause undesired operation. The CardioMessenger is registered at Industry Canada under the following identification: IC 4708A-CMSMART (CardioMessenger Smart 3G)

  • Page 23: Electromagnetic Compatibility

    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.

  • Page 24: Warranty

    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...

  • Page 25: Technical Data

    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 •...
  • Page 26 Appendix Technical Data GlobTek GTM96180-1107-2.0 • Input voltage: 100–240 V AC at 50–60 Hz • Output voltage: 5 V DC; 2,2 A • Power cord type: micro USB-B Battery (integrated) • Type: Lithium-ions...

  • Page 27: Symbols On The Device

    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)

  • Page 28: Legend For The Label

    This device contains material that requires special waste disposal according to the environmental protection guidelines. The European Directive 2012/19/EC on waste electrical and electronic equipment (WEEE 2) must be observed. Return devices that are no longer used to BIOTRONIK. CE mark Device Contents...
  • Page 29 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.
  • Page 30 Appendix Electromagnetic Emitted Interference Electromagnetic Emitted Interference Electromagnetic Emitted Interference according to IEC 60601-1-2 EN 55011 (CISPR 11) Group 1 Conducted interference emis- Class B sions Radiated emission 7.2.1 IEC 61000-3-2 Not applicable Harmonic distortion (harmonic See EN 61000-3-2 Section 7, currents in the mains supply) power consumption < 75 W 7.2.2 IEC 61000-3-3...

  • Page 31: Resistance To Electromagnetic Interference

    Appendix Resistance to Electromagnetic Interference Resistance to Electromagnetic Interference Electromagnetic Resistance to Interference according to IEC 60601-1-2 IEC 61000-4-2 ± (2, 4, 8) 15 kV air discharge Electrostatic discharge (ESD) 8.9/8.10 IEC 61000-4-3 10 V/m 80 MHz – 2.7 GHz 80% AM 1 kHz Electromagnetic fields Other measurements see table 9 (IEC 60601-1-2 8.10)

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