Preliminary Manual for CardioMessenger FCC ID: QRICM02-1 BIOTRONIK GmbH & Co.
1 Contents What is Home Monitoring? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 About This Technical Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 User group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Conventions used in this technical manual . . . 4 The CardioMessenger Set and Its Components . . . . . . . . . . . . . . . 5 Safety Precautions – What Should I Watch Out For? . . . . . . . . . . .
2 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 Frequently Asked Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Technical Terms and Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . 21 Cardio Report . . . . . . . . . . . . . . . . . . . . . . . . . . 21 GSM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Home Monitoring . . . . . . . . . . . . . . . . . . . . . . .
3 What is Home Monitoring? What is Home Monitoring? Dear Patient. You have received a BIOTRONIK pacemaker or implantable cardioverter-defibrillator (ICD) with a Home Monitoring function. The Home Monitoring feature provides your attending physician with messages recorded by your implant at regular intervals, giving him or her information about your heart’s status. Your implant has a small wireless transmitter.
4 About This Technical Manual About This Technical Manual User group The CardioMessenger is to be used by patients with a BIOTRONIK pacemaker or an implantable cardioverter-defibrillator (ICD) with the Home Monitoring function. Conventions used in this technical manual Note: Provides additional information on the features of the CardioMessenger and how to operate it. Caution! If these instructions are not observed, minor injury or equipment damage may occur.
5 The CardioMessenger Set and Its Components The CardioMessenger Set and Its Components The BIOTRONIK CardioMessenger will not restrict your routine activities.
6 Safety Precautions – What Should I Watch Out For? Safety Precautions – What Should I Watch Out For? The CardioMessenger and its components are medical devices and therefore comply with strict standards for their development, manufacture, and testing. Please observe the following safety instructions: WARNING! Turn off the CardioMessenger in locations where cell phones are prohibited, such as hospitals or airplanes.
7 Safety Precautions – What Should I Watch Out For? — Temperatures below -5°C (23°F) for the CardioMessenger — Barometric pressure below 700 and above 1060 hPa — Violent shocks or other strong mechanical influences — Strong sources of light (direct sunlight, strong halogen lamps) — Solvents, acids, detergents, and lyes — Handle the antenna with care. Caution! Never use the CardioMessenger if it has been damaged; return it to your physician.
8 Safety Precautions – What Should I Watch Out For? Electronic Article Surveillance (EAS) Systems Equipment such as retail theft prevention systems may interact with the implanted device. Patients should be advised to walk directly through and not to remain near an EAS system longer than necessary.
9 How Do I Use the CardioMessenger? How Do I Use the CardioMessenger? The following section describes how to operate and use the CardioMessenger. What must be done before using the CardioMessenger? Find a suitable place to put the CardioMessenger and charging station. The distance between your implant and the CardioMessenger should not be too close in order to prevent interference with implant operation. On the other hand, the distance should not be beyond the implant transmitter’s range.
10 How Do I Use the CardioMessenger? While resting at night, your implant data can be sent to the CardioMessenger and then transmitted to the BIOTRONIK Service Center. How do I plug in the CardioMessenger? Make sure that the local supply voltage lies within the permissible operating range of 100-240 Volts at 5060 Hz. If this is the case, insert the power supply cable plug into the socket. The power supply has a long cable with a small plug at the end. Connect this plug to the charging station.
11 How Do I Use the CardioMessenger? Yellow: An illuminated or flashing yellow light indicates a temporary stage. This occurs, for example, when the CardioMessenger is looking for a connection to the GSM network. When the yellow light is continuously lit, there is a problem. For further information, see the ”Troubleshooting” section on page 13. Green: When the green light flashes, it means that the CardioMessenger is operating properly.
12 How Do I Use the CardioMessenger? If this does not happen, please refer to the ”Troubleshooting” section on page 13. Turning off the CardioMessenger Press the CardioMessenger on/off button for approximately two seconds. You will hear a brief tone, and the yellow light will go out. The CardioMessenger is now switched off; no data can be received or transmitted. You can only turn the CardioMessenger back on after approximately five to six seconds.
13 How Do I Use the CardioMessenger? How do I know when the batteries are running low? When the CardioMessenger batteries are nearly empty, the battery monitor light will flash red. Place the CardioMessenger in the charging station. Charging will start immediately, which is indicated when the battery monitor light is illuminated yellow. When the batteries are completely charged, the battery monitor light will be green.
14 Note: How Do I Use the CardioMessenger? When the red light in the “traffic light” flashes, it does not indicate a problem. It means you must call your physician. Your physician will inform you if this feature is used. However, when the yellow light in the “traffic light” flashes or is continuously lit, there is a problem. Continuous flashing First turn the CardioMessenger on and off.
15 How Do I Use the CardioMessenger? Then turn the CardioMessenger on as usual. If only the yellow light is illuminated after five minutes, the CardioMessenger may be defective. Talk with your physician.
16 When Does My Implant Transmit Data? When Does My Implant Transmit Data? There are three times when your implant sends information. • Your implant is configured by your physician to periodically send messages at a specific time, usually while you are sleeping. • Your physician can also set your implant to automatically send a message when certain events occur. • Transmission can be activated by a special magnet (pacemaker patients only). This is done by placing the magnet directly over the implant.
17 How Do I Take Care of the CardioMessenger? How Do I Take Care of the CardioMessenger? Handle the CardioMessenger with care, so that you will be able to use it for a long time and so that BIOTRONIK can guarantee its proper operation: • Keep the device clean and away from dirty or dusty environments. • Use a soft cloth for cleaning. If necessary, the cloth can be moistened with water. Do not immerse the device in water. • Protect the device from direct contact with water.
18 Accessories Accessories You can wear your CardioMessenger in various ways: • With a clip on your belt (with or without the belt carrying case) • With the clip and the carrying strap. If you wear the CardioMessenger infrequently or do not need the clip to wear it, you can remove the clip. Press the holder and slide it downwards (away from the antenna) and remove the clip. To reattach the clip, slide the holder upwards toward the antenna.
19 Frequently Asked Questions Frequently Asked Questions What happens if I forget to recharge my CardioMessenger? If the CardioMessenger is not charged, it cannot receive any data from your implant and transmit them to the BIOTRONIK Service Center. There is no danger to your health, since the implant operates independently from your CardioMessenger. The data recorded by your implant will not get lost either; they will remain available to your physician during your next follow-up appointment.
20 Frequently Asked Questions The CardioMessenger can be comfortably attached to your belt and transported with and without the provided belt carrying case. You can also use a carrying strap. Additional information can be found in the ”Accessories” section on page 18. You can also carry it in a normal bag or a backpack. Please always remember that the distance between the implant and CardioMessenger should not be less than 20 centimeters (7 inches).
21 Technical Terms and Abbreviations Technical Terms and Abbreviations Cardio Report A report informing a physician of his or her patient's current therapy status; the report is based on the data sent by the implant. GSM Global System for Mobile Communications – digital telephone network. Home Monitoring Pacemakers and ICDs with the Home Monitoring function are equipped with a transmitter that sends messages over a specific frequency to a mobile patient device.
22 US Regulatory Requirements US Regulatory Requirements Your implant is equipped with a radio frequency (RF) transmitter for wireless communications to the patient device. These messages are transmitted via an RF assigned by the Federal Communications Commission's (FCC) Medical Implant Communications Service (MICS). The transmitter is authorized by rule under the Medical Implant Communications service (47 CFR Part 95) and must not cause harmful interference to stations operating in the 400.150 - 406.
23 US Regulatory Requirements FCC RF Exposure Requirements For body-worn operation, this phone has been tested and meets the FCC RF exposure guidelines when used with BIOTRONIK accessories supplied or designated for this product. Use of other accessories may not ensure compliance with FCC RF exposure guidelines.
24 Legal Considerations Legal Considerations Your implant transmits diagnostic data to the CardioMessenger via an 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). 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 implant data is not permitted to interfere with other radio services.
25 Legal Considerations In addition, the CardioMessenger contains a GSM modem (Motorola g18e) that establishes the connection to the cellular network at the frequencies of 900/ 1800 MHz and 1900 MHz. BIOTRONIK uses the modem in accordance with the manufacturer’s specifications and in compliance with regulatory requirements. The GSM modem has been evaluated and approved by an independent authority for its compliance with the statutory regulations.
26 Technical Data Technical Data General information Class of protection Degree of protection Operating mode II IP 30 Continuous operation Permissible environmental conditions During operation: Temperature: + 10°C to + 40°C (50°F to 104°F) while charging - 5°C to + 40°C (23°F to 104°F) while discharging Rel. humidity: Atmospheric pressure: 30% to 70% (non-condensing) 700 hPa to 1060 hPa Shipping and storage: Storage temp.
27 Bandwidth Technical Data 300 kHz Transmission frequencies 900/1800 MHz (not for US), 1900 MHz Transmission power Max. 1 Watt (1900 MHz); Max. 2 Watt (900/1800 MHz) CardioMessenger charging station Dimensions (WxHxD) Weight Input voltage Output voltage 90 x 82 x 105 mm Approx. 110 g 6 V DC / 1 A 5.2 V DC / 1 A Rechargeable battery (integrated) Model Dimensions (WxHxD) Weight Operating voltage Charge voltage Max. charging current Capacity Lithium ion (LP 103463 AR) Approx. 34 x 63 x 10.
28 Appendix Appendix Electromagnetic emitted interference according to IEC 601-1-2 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.
29 Appendix Susceptibility to electromagnetic interference according to IEC601-1-2 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.
30 Appendix Susceptibility to electromagnetic interference according to IEC 601-1-2 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.
31 Appendix Susceptibility to electromagnetic interference for devices that are not life-sustaining. Transmission frequency 150 kHz to 80 MHz 150 kHz to 800 MHz 800 MHz to 2.5 GHz Equation D = 1, 2 P D = 1, 2 P D = 2, 3 P Nominal output of the transmitter (W) Safe distance (m) Safe distance (m) Safe distance (m) 0.01 0.12 0.12 0.23 0.1 0.38 0.38 0.73 1 1.2 1.2 2.3 10 3.8 3.8 7.
