CardioMessenger.book Page 1 Thursday, January 5, 2012 1:13 PM Contents Contents . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 How Do I Turn On the CardioMessenger? 28 What is Home Monitoring? . . . . . . . . . . . . 3 How Do I Turn Off the CardioMessenger? 29 Included Equipment . . . . . . . . . . . . . . . . . . 4 How Do I Charge the CardioMessenger? . 30 How Do I Use the CardioMessenger? . . . . 6 How Do I Turn Off the Charging Station? .
CardioMessenger.book Page 2 Thursday, January 5, 2012 1:13 PM Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . 40 USA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 FCC RF exposure requirements . . . . . . 41 UL classification . . . . . . . . . . . . . . . . . . 41 Canada . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Electromagnetic Compatibility . . . . . . . . . 43 Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Technical Data . . . . . . . .
CardioMessenger.book Page 3 Thursday, January 5, 2012 1:13 PM What is Home Monitoring? Dear Patient: You have received a BIOTRONIK pacemaker or implantable cardioverter-defibrillator (ICD) with Home Monitoring function. Home Monitoring pacemakers and ICDs are additionally equipped with a special transmitter. This transmitter automatically transmits medical and technical information to a mobile device, the CardioMessenger.
CardioMessenger.book Page 4 Thursday, January 5, 2012 1:13 PM Included Equipment The set comes equipped with the following components: 1. 2. 3. 4. 5. 6. 7.
CardioMessenger.book Page 5 Thursday, January 5, 2012 1:13 PM Before use, make sure that none of the components are visibly damaged and that all necessary components have been delivered to you. Caution! Never use the CardioMessenger if it has been damaged; return it to your physician.
CardioMessenger.
CardioMessenger.book Page 7 Thursday, January 5, 2012 1:13 PM Warning! The distance between the device and CardioMessenger must not be less than 20 centimeters (7 inches). Note: If the CardioMessenger is too close to a loudspeaker (or a radio alarm or TV), you may hear interference noises typical for mobile phones.
CardioMessenger.book Page 8 Thursday, January 5, 2012 1:13 PM How Do I Install the CardioMessenger? Insert the plug into a socket in your wall. Make sure you do not connect the CardioMessenger to a power outlet controlled by a light switch. Make sure that the socket to which the charging station is connected is easily accessible. This ensures that you can disconnect the power supply from the mains at any time. Arrange power cable carefully to reduce the risk of entanglement or strangulation.
CardioMessenger.book Page 9 Thursday, January 5, 2012 1:13 PM Now, insert the small plug of the power supply cable into the charging station. Arrange power cable carefully to reduce the risk of entanglement or strangulation. The port for the small plug is situated on the rear side of the charging station and is marked with the following symbol: Follow the instructions for use! Use only the original power supply that came with the CardioMessenger, see “Included Equipment” on page 4.
CardioMessenger.book Page 10 Thursday, January 5, 2012 1:13 PM Light 5 is situated on the front side of the charging station. The charging station is operational when this light is illuminated. If this light is not illuminated, please refer to “How Do I Resolve Problems?” on page 32.
CardioMessenger.book Page 11 Thursday, January 5, 2012 1:13 PM Telephone connection Version A You need a telephone connection so that your CardioMessenger can send the Home Monitoring data to your physician. Version B You may operate your CardioMessenger with your existing telephone sharing one single telephone socket (version A) or connect it directly to a free telephone socket (version B). Either way, your normal phone use remains unaffected.
CardioMessenger.book Page 12 Thursday, January 5, 2012 1:13 PM Note: The CardioMessenger is designed to operate with standard analog phone lines providing Plain Old Telephone Service (POTS). Compatibility with other phone lines or services (e.g., Voice over IP (VoIP) via analog or digital lines, cable TV phone lines or ISDN) is not guaranteed. In these cases compatibility testing at the patient’s home is recommended.
CardioMessenger.book Page 13 Thursday, January 5, 2012 1:13 PM Version A Unplug your telephone cable from your telephone socket in your wall. Remove the safety plug on port 1 on the rear side of the charging station. Keep the sealing plug of the telephone inlet out of the reach of children.
CardioMessenger.book Page 14 Thursday, January 5, 2012 1:13 PM Now insert the free end of your telephone cable into port 1 of the charging station.
CardioMessenger.book Page 15 Thursday, January 5, 2012 1:13 PM Take the telephone cable that came with the CardioMessenger, remove the second safety plug from port 2 of the charging station. Keep the sealing plug of the telephone inlet out of the reach of children. Plug one end of the telephone cable into port 2.
CardioMessenger.book Page 16 Thursday, January 5, 2012 1:13 PM Insert the other end of your telephone cable into the telephone socket in your wall. Arrange the telephone cable carefully toreduce the risk of entanglement or strangulation.
CardioMessenger.book Page 17 Thursday, January 5, 2012 1:13 PM Now, place the CardioMessenger into the charging station. The CardioMessenger should switch itself on immediately, unless the batteries are completely depleted. A brief tone will sound when the CardioMessenger is switched on. If the batteries are completely depleted, then the CardioMessenger first charges itself and then switches itself on later (approximately after 30 minutes).
CardioMessenger.
CardioMessenger.book Page 19 Thursday, January 5, 2012 1:13 PM Version B If you wish to set up the CardioMessenger close to a telephone outlet, but there is no telephone, you may connect the CardioMessenger directly to the telephone outlet. Please proceed as follows: Take the telephone cable that came with the CardioMessenger and remove the safety plug on port 1 on the rear side of the charging station. Keep the sealing plug of the telephone inlet out of the reach of children.
CardioMessenger.book Page 20 Thursday, January 5, 2012 1:13 PM Now insert one end of your telephone cable into port 1 of the charging station.
CardioMessenger.book Page 21 Thursday, January 5, 2012 1:13 PM Insert the other end of your telephone cable into the telephone socket in your wall. Arrange the telephone cable carefully toreduce the risk of entanglement or strangulation.
CardioMessenger.book Page 22 Thursday, January 5, 2012 1:13 PM Now, place the CardioMessenger in the charging station. The CardioMessenger should switch itself on immediately, unless the batteries are completely depleted. A brief tone will sound when the CardioMessenger is switched on. If the batteries are depleted, then the CardioMessenger first charges itself and then switches itself on later (approximately after 30 minutes). Additional information can be found in “Version B” on page 19.
CardioMessenger.
CardioMessenger.book Page 24 Thursday, January 5, 2012 1:13 PM How Do I Understand the Lights of the CardioMessenger? Your CardioMessenger has four lights and one light on the charging station. The lights numbered 1 – 3 represent the general functions of the CardioMessenger, light 4 is the battery monitor light, and light 5 shows the operational status of the charging station. Note: Whether or not the lights flash or are lit continuously, the operation of your device remains unaffected.
CardioMessenger.book Page 25 Thursday, January 5, 2012 1:13 PM Yellow flashing – When this light flashes yellow, your physician wants you to call. This situation may never occur. You will be informed by your physician if s/he will use this feature. Note: After you have switched the CardioMessenger off and on, this light will not flash anymore. However, please do not forget to call your physician.
CardioMessenger.book Page 26 Thursday, January 5, 2012 1:13 PM Green flashing – When the light single-flashes green repeatedly, the CardioMessenger is operating properly. This is the normal status. Green flashing – When the light double-flashes green repeatedly, the CardioMessenger is also operating properly. Additionally, there are messages stored that have to be transmitted to the Service Center.
CardioMessenger.book Page 27 Thursday, January 5, 2012 1:13 PM When this light is off but the Cardio- Messenger is in the charging station, please refer to “How Do I Resolve Problems?” on page 32. Red flashing – When the light flashes red, the CardioMessenger batteries are nearly depleted. Please place the CardioMessenger in the charging station. Yellow illumination – When the light is illuminated yellow, the CardioMessenger is charging.
CardioMessenger.book Page 28 Thursday, January 5, 2012 1:13 PM How Do I Turn On the CardioMessenger? As soon as you place the CardioMessenger in the charging station, it is automatically switched on. You certainly may also switch on the CardioMessenger when it is not placed in the charging station; the On/Off button is located on the right side of the CardioMessenger. Press the On/Off button of the CardioMessenger until you can feel slight resistance.
CardioMessenger.book Page 29 Thursday, January 5, 2012 1:13 PM When the self-test of the CardioMessenger has finished, light 3 flashes yellow. Now, the CardioMessenger will try to connect to the BIOTRONIK Service Center. After a successful connection to the Service Center, light 3 flashes green. Your CardioMessenger is now operational. In case light 3 does not flash green, please refer to “How Do I Resolve Problems?” on page 32.
CardioMessenger.book Page 30 Thursday, January 5, 2012 1:13 PM How Do I Charge the CardioMessenger? The CardioMessenger has to be charged when the battery monitor light (light 4) flashes red. If you wish to use the CardioMessenger in mobile operation, you should charge it every 24 hours. It is recommended that you charge the CardioMessenger before you use it for the first time. To do so, place the CardioMessenger in the charging station; the charging process will start immediately.
CardioMessenger.book Page 31 Thursday, January 5, 2012 1:13 PM However, if the battery monitor light (light 4) is off even though the CardioMessenger is in the charging station, there might be a problem. Please refer to “How Do I Resolve Problems?” on page 32 to find out how to resolve this problem. Note: In case the CardioMessenger has been stored outside the operational temperature, i.e., below 0°C (32°F) and above 40°C (104°F), the batteries discharge themselves much more quickly.
CardioMessenger.book Page 32 Thursday, January 5, 2012 1:13 PM How Do I Resolve Problems? Problems with your CardioMessenger are easy to identify, and they are ususally easy to resolve. Light 3 Yellow illumination – When this light is continuously illuminated yellow, the CardioMessenger was not able to end its self-test. Solution – Reset the CardioMessenger. If light 3 is still illuminated yellow, inform your physician.
CardioMessenger.book Page 33 Thursday, January 5, 2012 1:13 PM the system at the patient’s home may require installation of adapters and/or analog phone lines. Please contact your telephone service provider for information on the type of phone line that you have. Note: If you take the CardioMessenger out of the charging station, the battery monitor light will go out to save energy.
CardioMessenger.book Page 34 Thursday, January 5, 2012 1:13 PM How Do I Reset the CardioMessenger? You should reset your CardioMessenger by restarting it when light 3 is lit continuously in yellow and if this error could not be eliminated by turning the CardioMessenger off and on. The reset button is located on the back of the CardioMessenger, on the left towards the lower end of the belt clip.
CardioMessenger.book Page 35 Thursday, January 5, 2012 1:13 PM If the problem still exists, inform your physician. Note: Only reset the CardioMessenger if you have eliminated other sources of error. When resetting the CardioMessenger, you abruptly cut off the current and data might be lost. Also, please note when you have done a reset; this could be useful for future troubleshooting. 2 Use a soft cloth for cleaning. If necessary, this can be moistened with water or ethyl alcohol.
CardioMessenger.book Page 36 Thursday, January 5, 2012 1:13 PM Note: Before use, make sure the CardioMessenger, charging station, power supply and cable are not visibly damaged. If you find damage, consult your physician. If handled properly, the installed batteries should supply the CardioMessenger with 24 hours of power even after 500 charging cycles (which is at least two years).
CardioMessenger.book Page 37 Thursday, January 5, 2012 1:13 PM The carrying strap has a clip attached. Take the carrying strap and reattach the clip of the carrying strap. To do so, slide the clip upwards toward the antenna until the clip snaps in. Warning! When you use the clip with the carrying strap, make sure that the distance between the device and CardioMessenger is greater than 20 centimeters (7 inches).
CardioMessenger.book Page 38 Thursday, January 5, 2012 1:13 PM Safety Precautions – What Should I Watch out For? The CardioMessenger and its components are medical devices and therefore comply with strict requirements for their development, manufacture and testing. Warning! To avoid interference, maintain a minimum distance of 20 centimeters (7 inches) between the CardioMessenger and the device.
CardioMessenger.book Page 39 Thursday, January 5, 2012 1:13 PM Warning! Keep the sealing plugs of the telephone inlet out of the reach of children. – Intensive light sources (direct sunlight, strong halogen emitters) -Solvents, acids, detergents, and lyes Warning! Arrange power and telephone cables carefully to reduce the risk of entanglement or strangulation. Caution! Never use the CardioMessenger if it has been damaged; return it to your physician.
CardioMessenger.book Page 40 Thursday, January 5, 2012 1:13 PM Guidelines USA Your device 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) MedRadio. This device may not interfere with stations operating in the 400.150–406.
CardioMessenger.book Page 41 Thursday, January 5, 2012 1:13 PM the specifications of the manufacturer in compliance with FCC approval requirements. procedures specified in FCC/OET Bulletin 65 Supplement C (2001) and IEEE Std. 1528200X (Draft 6.5, January 2002). FCC RF exposure requirements UL classification This device has been tested for operation when worn on the body and meets the FCC RF exposure guidelines when used with BIOTRONIK accessories supplied or designated for this product.
CardioMessenger.book Page 42 Thursday, January 5, 2012 1:13 PM Canada The CardioMessenger is registered at Industry Canada. Depending on the embedded GSM modem this number is either IC: 4708A-CM06V1 or else 4708ACMII. The cable modem in the charging station is registered at Industry Canada. Depending on the embedded cable modem type the number is either IC: 125A-0015 or else IC: 125A-0008 or else 125A-0032.
CardioMessenger.book Page 43 Thursday, January 5, 2012 1:13 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.
CardioMessenger.
CardioMessenger.book Page 45 Thursday, January 5, 2012 1:13 PM 2 Interfaces: Serial infrared port and IrDA1.0 standard 2 MedRadio: Modulation FSK 2 MedRadio frequencies: 402 – 405 MHz, 9 channels, 300 kHz band width CardioMessenger Charging Station 2 Dimensions (WxHxD): 90 x 82 x 105 mm 2 Input voltage: 6 V DC / 1 A 2 Output voltage: 5.
CardioMessenger.book Page 46 Thursday, January 5, 2012 1:13 PM Rechargeable Battery (Integrated) 2 Type: Lithium ions (CGA 103460A) 2 Dimensions (WxHxD): approx. 36.5 x 64.5 x 12 mm 2 Operating voltage: 3.6 V (nominal) 2 Charging voltage: 4.1 V DC 2 Max. charging current: 2 A 2 Capacity: 1850 mAh or more Power Supply 2 Type: FW 7555M/06 2 Dimensions: 51.5 x 87.5 x 34 mm 2 Input voltage: 100 – 240 V AC at 50 – 60 Hz, 400 mA 2 Output voltage: 6 V DC / 2.
CardioMessenger.book Page 47 Thursday, January 5, 2012 1:13 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.
CardioMessenger.book Page 48 Thursday, January 5, 2012 1:13 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.
CardioMessenger.book Page 49 Thursday, January 5, 2012 1:13 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.
CardioMessenger.book Page 50 Thursday, January 5, 2012 1:13 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.
CardioMessenger.book Page 51 Thursday, January 5, 2012 1:13 PM Checking immunity to noise Test level according to IEC 60601-1-2 Conformance level Guidelines for the electromagnetic environment Voltage dips, 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.
CardioMessenger.book Page 52 Thursday, January 5, 2012 1:13 PM Recommended separation distances between portable and mobile RF communications equipment and the CardioMessenger Transmission frequency 150 kHz to 80 MHz 80 MHz 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 1.17 1.17 2.34 10 3.7 3.7 7.4 100 11.7 11.7 23.
