BIOTRONIK SE and KG CMII Patient Device User Manual CardioMessenger

BIOTRONIK SE & Co. KG Patient Device CardioMessenger

Contents

  • 1. User Man
  • 2. UserMan

User Man

1ContentsContents . . . . . . . . . . . . . . . . . . . . . . . . . . . 1What is Home Monitoring? . . . . . . . . . . . . 3Included Equipment . . . . . . . . . . . . . . . . . . 4How Do I Use the CardioMessenger? . . . . 6Where Should I Put the CardioMessenger? 6How Do I Install the CardioMessenger? . . 8Telephone connection . . . . . . . . . . . . . 11Version A . . . . . . . . . . . . . . . . . . . . . . . . 13Version B . . . . . . . . . . . . . . . . . . . . . . . . 19How Do I Understand the Lights of the CardioMessenger? . . . . . . . . . . . . . . . . . . 24Light 1 . . . . . . . . . . . . . . . . . . . . . . . . . . 24Light 2 . . . . . . . . . . . . . . . . . . . . . . . . . . 25Light 3 . . . . . . . . . . . . . . . . . . . . . . . . . . 25Light 4 . . . . . . . . . . . . . . . . . . . . . . . . . . 26Light 5 . . . . . . . . . . . . . . . . . . . . . . . . . . 27How Do I Turn On the CardioMessenger? 28How Do I Turn Off the CardioMessenger? 29How Do I Charge the CardioMessenger? . 30How Do I Turn Off the Charging Station? . 31How Do I Resolve Problems? . . . . . . . . . . 32Light 3 . . . . . . . . . . . . . . . . . . . . . . . . . . 32Light 4 . . . . . . . . . . . . . . . . . . . . . . . . . . 33Light 5 . . . . . . . . . . . . . . . . . . . . . . . . . . 33How Do I Reset the CardioMessenger? . . 34How Do I Take Care of the CardioMessenger? . . . . . . . . . . . . . . . . . . . 35How Do I Carry the CardioMessenger? . . 36Safety Precautions – What Should I Watch out For? . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38356845--PreJCardioMessenger.book Page 1 Thursday, January 5, 2012 1:13 PM
2Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . 40USA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40FCC RF exposure requirements . . . . . . 41UL classification . . . . . . . . . . . . . . . . . . 41Canada . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42Electromagnetic Compatibility . . . . . . . . . 43Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . 43Technical Data . . . . . . . . . . . . . . . . . . . . . . 44General . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44Permissible Environmental Conditions . . 44During operation . . . . . . . . . . . . . . . . . . 44Shipping and storage . . . . . . . . . . . . . . 44CardioMessenger Remote Unit . . . . . . . . . 44CardioMessenger Charging Station . . . . . 45Rechargeable Battery (Integrated) . . . . . . 46Power Supply . . . . . . . . . . . . . . . . . . . . . . . 46Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . 47CardioMessenger.book Page 2 Thursday, January 5, 2012 1:13 PM
3What 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 trans-mitter. This transmitter automatically transmits medical and technical information to a mobile device, the CardioMessenger. The CardioMessenger works like a cell phone and automatically transmits the information received from your device as encoded messages to the BIOTRONIK Service Center.The transmission power from your device is low so as to not impair your health in any way. Since the transmission range is short, the CardioMessenger is needed to send the information to the BIOTRONIK Service Center.At the Service Center, the data are processed and can be viewed only by your physician on a secured Internet site in the form of a comprehensive report called a Cardio Report. Your doctor can use this Cardio Report to decide whether your device settings need to be updated or if your therapy plan needs to be changed. Thus, Home Monitoring serves as a practical diagnostic aid.CardioMessenger.book Page 3 Thursday, January 5, 2012 1:13 PM
4Included EquipmentThe set comes equipped with the following components:1. Mobile unit2. Charging station3. Wall mounted power supply 4. Telephone cable5. Belt clip (already affixed)6. Carrying strap7. Patient manualCardioMessenger.book Page 4 Thursday, January 5, 2012 1:13 PM
5Before 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. Only use the following original BIOTRONIK devices, as other accessories can increase the interference emitted and the device's susceptibility to interference:– The CardioMessenger– The charging station with the wall mounted power supply (type: FW 7555 M/06)– The telephone cord (type: BIOTRONIK VK-117)CardioMessenger.book Page 5 Thursday, January 5, 2012 1:13 PM
6How Do I Use the CardioMessenger?The following section describes: 2How to optimize CardioMessenger placement2How to operate it2How it functions Where Should I Put the CardioMessenger?On your bedside table or close to your bed is a suitable place for your CardioMessenger since it generally fulfills the following conditions:2The distance to the device is less than 2 meters (6 feet), so that regular data transmission at night is guaranteed.2The distance to the device is more than 20 centimeters (7 inches), so that the CardioMessenger does not interfere with the device.2The CardioMessenger is placed on a solid base and cannot fall. Please also consider the following:2Do not expose the device to moisture or heat; exposure to direct sunlight and taking the device into the bathroom are not recommended.2The CardioMessenger should not be connected to a power outlet controlled by a light switch. 2Do not place the device next to a television set, microwave oven, or similar source of electromagnetic interference.CardioMessenger.book Page 6 Thursday, January 5, 2012 1:13 PM
7Warning! 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 7 Thursday, January 5, 2012 1:13 PM
8How Do I Install the CardioMessenger?Insert the plug into a socket in your wall. Make sure you do not connect the Cardio-Messenger 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.Now the green light on the upper side of the power supply should be illuminated; if not, please refer to “How Do I Resolve Problems?” on page 32.CardioMessenger.book Page 8 Thursday, January 5, 2012 1:13 PM
9Now, 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 9 Thursday, January 5, 2012 1:13 PM
10Light 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 10 Thursday, January 5, 2012 1:13 PM
11Telephone connectionYou need a telephone connection so that your CardioMessenger can send the Home Monitoring data to your physician. 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. Version AVersion BCardioMessenger.book Page 11 Thursday, January 5, 2012 1:13 PM
12Note: 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. Proper set up of the system at the patient’s home may require installation of adapters and/or analog phone lines. Please contact your telephone service provider for informa-tion on the type of phone line that you have.CardioMessenger.book Page 12 Thursday, January 5, 2012 1:13 PM
13Version AUnplug 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 13 Thursday, January 5, 2012 1:13 PM
14Now insert the free end of your telephone cable into port 1 of the charging station.CardioMessenger.book Page 14 Thursday, January 5, 2012 1:13 PM
15Take 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 15 Thursday, January 5, 2012 1:13 PM
16Insert 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 stran-gulation.CardioMessenger.book Page 16 Thursday, January 5, 2012 1:13 PM
17Now, 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 Cardio-Messenger 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). Additional information can be found in “How Do I Charge the CardioMessenger?” on page 30.CardioMessenger.book Page 17 Thursday, January 5, 2012 1:13 PM
18When you are finished, the connection should look like as follows:CardioMessenger.book Page 18 Thursday, January 5, 2012 1:13 PM
19Version BIf you wish to set up the CardioMessenger close to a telephone outlet, but there is no telephone, you may connect the Cardio-Messenger 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 19 Thursday, January 5, 2012 1:13 PM
20Now insert one end of your telephone cable into port 1 of the charging station.CardioMessenger.book Page 20 Thursday, January 5, 2012 1:13 PM
21Insert 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 stran-gulation.CardioMessenger.book Page 21 Thursday, January 5, 2012 1:13 PM
22Now, 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 Cardio-Messenger 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.book Page 22 Thursday, January 5, 2012 1:13 PM
23When you are finished, the connection should look like as follows:CardioMessenger.book Page 23 Thursday, January 5, 2012 1:13 PM
24How 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. Light 1 Off – This is the normal status.CardioMessenger.book Page 24 Thursday, January 5, 2012 1:13 PM
25Yellow 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 Cardio-Messenger off and on, this light will not flash anymore. However, please do not forget to call your physician.Light 2 This light will only be used during a follow-up visit and can be triggered via the device programmer ICS 3000. Your physician will find further information in the ICS 3000 manual.Note: Light 2 is not illuminated when your device transmits regular messages.This light may be illuminated or flash yellow, or flash green. Off – This is the normal status.Yellow illumination – When the light is illuminated yellow, the CardioMessenger is receiving a message. Please wait until the data transmission has finished (light flashing green) before you walk away from the CardioMessenger. Green flashing – When the light flashes green several times, the transmission of the message has been completed.Yellow flashing – However, when the light flashes yellow several times, the transmis-sion was not successful. Your physician will decide what to do next.Light 3 This light informs you about the normal operation of the CardioMessenger. CardioMessenger.book Page 25 Thursday, January 5, 2012 1:13 PM
26Green flashing – When the light single-flashes green repeat-edly, the CardioMessenger is operating properly. This is the normal status.Green flashing – When the light double-flashes green repeat-edly, the CardioMessenger is also operating properly. Additionally, there are messages stored that have to be transmitted to the Service Center.Yellow flashing – When the light double-flashes yellow repeatedly, there is no connection to the GSM network or modem and additionally the CardioMessenger has messages stored to be transmitted to the Service Center. For further information, see the “How Do I Resolve Problems?” on page 32. Yellow illumination – When the light is illuminated yellow, the CardioMessenger is performing a self-test. This test should last no longer than 10 seconds after the CardioMessenger has been switched on.Off – The CardioMessenger is switched off.Light 4 In the following, the four statuses of the battery monitor light are described as follows:Green Illumination – When the light is illuminated green, the CardioMessenger is fully charged. You may now use it in mobile operation for at least 24 hours. But the CardioMessenger can certainly also be kept in the charging station. Off – This is the normal status when the CardioMessenger is used in mobile operation.CardioMessenger.book Page 26 Thursday, January 5, 2012 1:13 PM
27When 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. Light 5 Green Illumination – This is the normal status when the charging station is connected to the power supply. If this is not the case, there might be an error. Additional information can be found in “How Do I Resolve Problems?” on page 32.CardioMessenger.book Page 27 Thursday, January 5, 2012 1:13 PM
28How 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 Cardio-Messenger until you can feel slight resistance. A brief tone will sound, the CardioMessenger will start its self-test, and light 3 will be illuminated yellow. You can now release the button.CardioMessenger.book Page 28 Thursday, January 5, 2012 1:13 PM
29When 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. Note: When the CardioMessenger has not been used for a long time or if it was stored below operational temperature, the battery can be completely depleted. In this case, the CardioMessenger switches itself on only after the battery has been charged for about 30 minutes.How Do I Turn Off the CardioMessenger?Press and hold the CardioMessenger On/Off button for at least two seconds. A brief tone will sound and light 3 will go out after a short period of time.The CardioMessenger is switched off; no data can be received or transmitted.Note: A switched-off or improperly functioning CardioMessenger does not affect the operation of your device. CardioMessenger.book Page 29 Thursday, January 5, 2012 1:13 PM
30How 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 Cardio-Messenger 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.During the charging process, the battery monitor light (light 4) of the CardioMessenger will be illuminated yellow. Once the CardioMessenger is charged, the battery monitor light is illuminated green. Charging usually takes no longer than three and a half hours. CardioMessenger.book Page 30 Thursday, January 5, 2012 1:13 PM
31However, 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. You should then first charge the Cardio-Messenger before attempting to use it. How Do I Turn Off the Charging Station?The charging station can remain perma-nently connected. This ensures that your CardioMessenger will always start charging as soon as you place it in the charging station.Disconnect the power cable plug from the socket to turn off the charging station. The charging station does not have a power switch.CardioMessenger.book Page 31 Thursday, January 5, 2012 1:13 PM
32How 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 Cardio-Messenger was not able to end its self-test. Solution – Reset the CardioMessenger. If light 3 is still illuminated yellow, inform your physician. You will find information on a reset in “How Do I Reset the Cardio-Messenger?” on page 34.Yellow flashing – When this light continu-ously flashes yellow, the CardioMessenger cannot connect to the Service Center.Solutions – Check if the charging station is connected to the power supply and if the cables from the charging station to the telephone wall outlet are loose. Check that the standard telephone line is not dead, i.e., the CardioMessenger is not blocked by other devices.Check if you are able to dial toll-free numbers with your telephone. If this is generally not possible, have this service set up for you by your telephone provider or inform your physician. 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. Proper set up of CardioMessenger.book Page 32 Thursday, January 5, 2012 1:13 PM
33the 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.Light 4 Off – When this light is off even though the CardioMessenger is in the charging station, proceed as follows: Solutions – Check if light 5 on the charging station is illuminated. Is this not the case, refer to the solutions described for light 5.If light 5 is illuminated, check whether the connecting parts on the CardioMessenger or on the charging station are easily accessible and not dirty.If light 4 is still off, inform your physician so that the device can be checked and the battery may be exchanged. Note: If you take the CardioMessenger out of the charging station, the battery monitor light will go out to save energy. Light 5 Off – If this light is off, proceed as follows: Solutions – Check that the plugs of the power cables are connected both to the outlet in the wall and to the power supply. Check that the green light of the power supply is illuminated. If this is not the case, either the power outlet is not being supplied with electricity or the power supply is defec-tive. Return a non-functioning power supply to your physician. CardioMessenger.book Page 33 Thursday, January 5, 2012 1:13 PM
34How 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 elimi-nated 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.Press the reset button (located on the back of the CardioMessenger) with a sharp object such as a ballpoint pen or the end of a straightened paper clip.CardioMessenger.book Page 34 Thursday, January 5, 2012 1:13 PM
35If 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. 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:2Keep the CardioMessenger clean and away from dirty or dusty environments.2Don't bend the antenna and don't hold the CardioMessenger by the antenna.2Use a soft cloth for cleaning. If necessary, this can be moistened with water or ethyl alcohol. Unplug the charging station before cleaning. Do not bring the mobile unit or the charging station into direct contact with water or other solvents.2Protect the CardioMessenger from direct contact with water. For example, wear it under your coat when it rains.2Don't turn on the CardioMessenger if it has been recently stored in a cold environment. Let it warm up slowly to room temperature, since the resulting condensed water may harm the elec-tronic circuit.Return the CardioMessenger to your physician if it no longer works.Maintenance at regular intervals is not necessary for the CardioMessenger. CardioMessenger.book Page 35 Thursday, January 5, 2012 1:13 PM
36Note: 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). If you feel the CardioMessenger is not lasting long enough during mobile opera-tion, ensure that it has been charged in the charging station for at least three and a half hours before mobile use. Additional information can be found in “How Do I Charge the CardioMessenger?” on page 30. If you find that the battery is always running low too soon, contact your physician. The physician will have a new battery installed.Note: When authorized personnel change the battery, they should also check the button cell. In particular, rechargeable lithium ion batteries should be disposed of by the manufacturer according to legal guidelines.How Do I Carry the CardioMessenger?You can wear your CardioMessenger in various ways: 2With the clip of the CardioMessenger on your belt2With the carrying strap If you don't need the clip or if you wish to attach the carrying strap, proceed as follows: Remove the clip by pressing the symbol with your thumb (see figure) and slide the clip downwards – away from the antenna.CardioMessenger.book Page 36 Thursday, January 5, 2012 1:13 PM
37The 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).Warning! Do not carry the CardioMessenger inside the breast pocket of your shirt or jacket, and do not place it directly on your skin.CardioMessenger.book Page 37 Thursday, January 5, 2012 1:13 PM
38Safety Precautions – What Should I Watch out For?The CardioMessenger and its components are medical devices and therefore comply with strict requirements for their develop-ment, manufacture and testing. Please observe the following safety instruc-tions, which are summarized below: Warning! Turn off the CardioMessenger in locations where cell phones are prohibited for safety reasons (such as in hospitals or airplanes). Such areas can be identified by the following or similar signs:Warning! To avoid interference, maintain a minimum distance of 20 centimeters (7 inches) between the CardioMessenger and the device. Like a cellular phone, the CardioMessenger device can temporarily interfere with your device if it is too close to it. Warning! Do not carry the CardioMessenger inside the breast pocket of your shirt or jacket, and do not place it directly on your skin.Warning! According to government regulations, the charging station of the CardioMessenger may not be operated within a distance of 1.5 m (5 feet) of a patient in a hospital environment. At home, this restriction does not apply.CardioMessenger.book Page 38 Thursday, January 5, 2012 1:13 PM
39Warning! Keep the sealing plugs of the telephone inlet out of the reach of children.Warning! Arrange power and telephone cables carefully to reduce the risk of entanglement or strangulation.Caution! Protect the CardioMessenger and charging station from:– Water and high humidity (e.g., in the bathroom)– Temperatures above 40°C (104°F)– Temperatures below -5°C (23°F) (mobile operation for CardioMessenger)– Barometric pressure below 700 hPa (corresponding to altitudes above 3000 m/10,000 feet)– Barometric pressure above 1060 hPa (corresponding to altitudes below sea level)– Violent shocks or other strong mechan-ical influences– Intensive light sources (direct sunlight, strong halogen emitters)-Solvents, acids, detergents, and lyesCaution! Never use the CardioMessenger if it has been damaged; return it to your physician.Before use, make sure that none of the components are visibly damaged and that all necessary components have been delivered to you. Additional information can be found in “Included Equipment” on page 4.Caution! The CardioMessenger must not be modified. It must only be opened and repaired by authorized trained personnel. The rechargeable batteries must only be exchanged by authorized trained personnel.Note: For proper operation, the Cardio-Messenger must be put into the charging station for at least three and a half hours each day.CardioMessenger.book Page 39 Thursday, January 5, 2012 1:13 PM
40Guidelines USAYour 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 400.150–406.000 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.Analog and digital voice communications are prohibited. Although this transceiver has been approved by the Federal Communica-tions Commission, there is no guarantee that it will not receive interference or that any particular transmission from this trans-ceiver will be free from interference.Depending on the embedded GSM modem the FCC ID number for the CardioMessenger is either QRICM06-1 or else QRICMII.Depending on the embedded cable modem type in the charging station the ACTA ID number of the cable modem is either AU7MM01BMT5656SMI or else AU7MD04B2456 or else AU7MMO1BMT5692SMI.The CardioMessenger, as well as the device itself, must conform to appropriate govern-ment standards and regulations.The CardioMessenger uses a GSM modem that connects to the mobile cellular telephone service at 850/1900 MHz. BIOTRONIK uses the modem according to CardioMessenger.book Page 40 Thursday, January 5, 2012 1:13 PM
41the specifications of the manufacturer in compliance with FCC approval require-ments.FCC RF exposure requirementsThis 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 desig-nated for this product. Use of other accesso-ries may not ensure compliance with FCC RF exposure guidelines. This EUT (Equipment Under Test) has been shown to be capable of compliance for localized specific absorption rate (SAR) for uncontrolled environment/ general population exposure limits specified in ANSI/ IEEE Std. C95.1-1992 and had been tested in accordance with the measurement procedures specified in FCC/OET Bulletin 65 Supplement C (2001) and IEEE Std. 1528-200X (Draft 6.5, January 2002).UL classificationThe CardioMessenger charger is classified by Underwriters Laboratories Inc. with re-spect to electric shock, fire, and mechanical hazards only in accordance with UL 60601-1 and CAN/CSA-C22.2 No 601.1-M90. The devices are denoted accordingly:CardioMessenger.book Page 41 Thursday, January 5, 2012 1:13 PM
42CanadaThe CardioMessenger is registered at Industry Canada. Depending on the embedded GSM modem this number is either IC: 4708A-CM06V1 or else 4708A-CMII.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.The term "IC:" before the certification/registration number only signifies that the Industry Canada technical specifications were met. Note: This device may not interfere with stations 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.In addition, the CardioMessenger contains a GSM modem (Motorola g24 or Motorola g24l) that establishes the connec-tion to the cellular network at the frequencies of 900/1800 MHz. BIOTRONIK uses the modem in accordance with the manufacturer’s specifications and in compliance with the approval require-ments.The GSM modem has been evaluated and approved by an independent authority for its compliance with the statutory regulations. As an indication of this, it carries the following approval mark(IMEI Number: 35726200-xxxxxx-x):CardioMessenger.book Page 42 Thursday, January 5, 2012 1:13 PM
43Electromagnetic CompatibilityNote: The CardioMessenger is protected from disturbances resulting from electromagnetic interference, electro-static discharges, and other sources – including interference induced by cables. Interfering emissions from the Cardio-Messenger have been minimized. The CardioMessenger therefore meets the requirements of EN 60601-1-2 in every respect.Warning! Other equipment, including portable and mobile RF radiocommu-nications equipment may interfere with the CardioMessenger, even if this equipment complies with CISPR emission requirements. However, this possible interference does not affect the device functionality. WarrantyThe CardioMessenger and all original com-ponents by BIOTRONIK are not subject to warranty when used improperly or stored and transported incorrectly. Use only the original packaging when shipping the device.CardioMessenger.book Page 43 Thursday, January 5, 2012 1:13 PM
44Technical DataGeneral2Class of protection: II2Operating mode: Continuous operationPermissible Environmental ConditionsDuring operation2Temperature: -5°C (23°F) to +40°C (104°F) (remote unit)0°C (32°F) to +40°C (104°F) (charging station)2Store in a dry place!Relative humidity: 30% to 75%(non-condensing)2Atmospheric pressure: 700 hPa to 1060 hPa2Altitude: Sea level up to 3000 m (10,000 feet)Shipping and storage2Temperature: -20°C (-4°F) to +60°C (140°F) 2Store in a dry place!Relative humidity: 30% to 75% (non-condensing)2Atmospheric pressure:700 hPa to 1060 hPaCardioMessenger Remote Unit2Dimensions (WxHxD): 60 x 132 x 45 mm2Charging voltage: 5,2 V DC / 0.8 A2Max. charge time: 3.5 hoursCardioMessenger.book Page 44 Thursday, January 5, 2012 1:13 PM
452Interfaces: Serial infrared port and IrDA1.0 standard2MedRadio: Modulation FSK2MedRadio frequencies:402 – 405 MHz, 9 channels, 300 kHz band width2MedRadio transmission power: 25 μW EIRP2GSM: Modulation GMSK2GSM frequencies: 850 MHz, 900 MHz, 1800 MHz, 1900 MHz, 9,6 kHz band width2GSM transmission power:0.8 Watt (850 MHz); 2 Watt (900 MHz); 1 Watt (1800/1900 MHz)CardioMessenger Charging Station2Dimensions (WxHxD): 90 x 82 x 105 mm2Input voltage: 6 V DC / 1 A2Output voltage: 5.2 V DC / 1 ACardioMessenger.book Page 45 Thursday, January 5, 2012 1:13 PM
46Rechargeable Battery (Integrated)2Type: Lithium ions (CGA 103460A) 2Dimensions (WxHxD):approx. 36.5 x 64.5 x 12 mm2Operating voltage: 3.6 V (nominal)2Charging voltage: 4.1 V DC2Max. charging current: 2 A2Capacity: 1850 mAh or morePower Supply2Type: FW 7555M/062Dimensions: 51.5 x 87.5 x 34 mm2Input voltage: 100 – 240 V AC at 50 – 60 Hz, 400 mA2Output voltage: 6 V DC / 2.1 ACardioMessenger.book Page 46 Thursday, January 5, 2012 1:13 PM
47AppendixElectromagnetic emitted interference according to IEC 60601-1-2The 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.Measuring the interference Compliance Guidelines for the Electromagnetic EnvironmentHigh-frequency interference according to CISPR 11Group 1 The CardioMessenger uses RF energy only for its internal function. Therefore, the HF interference is very low and not likely to cause any interference in nearby electronic equipment.High-frequency interference according to CISPR 11 Class B The CardioMessenger is suitable for use in all areas, including living space and those areas that are directly connected to a public power supply system that also supplies buildings intended for residential purposes.Interference of harmonics according to IEC 61000-3-2 Class A according to IEC 61000-3-2Voltage fluctuations/ flicker emissions according to IEC 61000-3-3CompliesCardioMessenger.book Page 47 Thursday, January 5, 2012 1:13 PM
48Electromagnetic emitted interference according to IEC 60601-1-2The 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.Testing resistance to interferenceTest level according to IEC 60601-1-2Conformance level Guidelines for the electromagnetic environmentConducted RF inter-ference according toIEC 61000-4-63Veff150 kHz to 80 MHz Same as test level The minimum distance of the CardioMessenger from portable and mobile radio devices, including the cables, should correspond to the recommended safe distance that is calculated according to the equation for the suitable transmission frequency. Recommended safe distance:D= 1,17Radiated RF inter-ference according to IEC 61000-4-33V/m80 MHz to 2.5 GHz Same as test level D= 1,17 for 80 to 800 MHzD= 2,34 for 800 MHz to 2.5 GHz with P as the nominal output of the transmitter in Watts (W) according to the information from the transmitter manufacturer, and d as the recommended safe distance in meters (m).The field strength of stationary transmitting devices should be measured on sitea and must be lower than the compliance level at all frequenciesb.Interference can be generated when the CardioMessenger is close to devices that have the following warning sign:Note: The higher frequency range applies at 80 MHz and at 800 MHz.Note: These guidelines may not be applicable in all cases. The spread of electromagnetic waves is influenced by absorption and reflection from buildings, objects, and humans.pppCardioMessenger.book Page 48 Thursday, January 5, 2012 1:13 PM
49a. 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. If the measured field strength in the location in which the CardioMessenger is used exceeds the applicable RF compliance level above, the 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 150 KHz to 80 MHz, ensure that field strengths are less than 3 V/m.CardioMessenger.book Page 49 Thursday, January 5, 2012 1:13 PM
50Electromagnetic emitted interference according to IEC 60601-1-2The 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.Checkingimmunity to noiseTest level according to IEC 60601-1-2Conformance levelGuidelines for the electromagnetic environmentDischarge of static electricity (ESD)According to IEC 61000-4-2± 6 kV contact discharge±8 kV air dischargeSame as the test level Floors should be made of wood or cement, or have ceramic tiles. When the floor consists of a synthetic material, the relative humidity must be at least 30%.Rapid transient elec-trical disturbances/burstsAccording to IEC 61000-4-4± 2 kV forpower supply lines± 1 kV for input/output linesSame as the test level The quality of the supply voltage should correspond to that in a typical business and/or hospital.SurgeAccording to IEC 61000-4-5±1kV normal mode voltage± 2 kV common mode voltageSame as the test level The quality of the supply voltage should correspond to that in a typical business and/or hospital.CardioMessenger.book Page 50 Thursday, January 5, 2012 1:13 PM
51Voltage dips, brief interruptions and fluctuations in the supply voltageAccording to IEC 61000-4-11‹ 5% UT for1/2 cycle(› 95% drop)40% UT for 5 periods(60% drop)70% UT for 25 periods(30% drop)‹ 5% UT for 5 s(› 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. An interruption in the supply voltage to the power supply unit will not impair the functioning of the CardioMessenger.Magnetic field at the supply frequencies (50/60 Hz)According to IEC 61000-4-83A/m Same as the test level The magnetic field strength should correspond to the typical value in business and hospital environments.Comment: UT is the mains alternating voltage before applying the test levels.Checkingimmunity to noiseTest level according to IEC 60601-1-2Conformance levelGuidelines for the electromagnetic environmentCardioMessenger.book Page 51 Thursday, January 5, 2012 1:13 PM
52Recommended separation distances between portable and mobile RF communications equipment and the CardioMessenger Transmission frequency150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHzEquation D= 1,17 : D= 1,17 : D= 2,34 :Rated power of transmitter (W)Safe distance (m) Safe distance (m) Safe distance (m)0.01 0.12 0.12 0.240.1 0.37 0.37 0.741 1.17 1.17 2.3410 3.7 3.7 7.4100 11.7 11.7 23.4For transmitters whose maximum nominal output is not indicated in the above table, the distance can be calculated using the equation in the column, where P is the maximum nominal output of the transmitter in Watts (W) according to the transmitter’s manufacturer.Note: The higher frequency range applies at 80 MHz and at 800 MHz.Note: These guidelines may not be applicable in all cases. The propagation of electromagnetic values is affected by absorption and reflection by structures, objects and people.pppCardioMessenger.book Page 52 Thursday, January 5, 2012 1:13 PM

UserMan

1ContentsContents . . . . . . . . . . . . . . . . . . . . . . . . . . . 1What is Home Monitoring? . . . . . . . . . . . . 3Included Equipment . . . . . . . . . . . . . . . . . . 4How Do I Use the CardioMessenger? . . . . 6Where Should I Put the CardioMessenger? 6How Do I Install the CardioMessenger? . . 8Telephone connection . . . . . . . . . . . . . 11Version A . . . . . . . . . . . . . . . . . . . . . . . . 13Version B . . . . . . . . . . . . . . . . . . . . . . . . 19How Do I Understand the Lights of the CardioMessenger? . . . . . . . . . . . . . . . . . . 24Light 1 . . . . . . . . . . . . . . . . . . . . . . . . . . 24Light 2 . . . . . . . . . . . . . . . . . . . . . . . . . . 25Light 3 . . . . . . . . . . . . . . . . . . . . . . . . . . 25Light 4 . . . . . . . . . . . . . . . . . . . . . . . . . . 26Light 5 . . . . . . . . . . . . . . . . . . . . . . . . . . 27How Do I Turn On the CardioMessenger? 28How Do I Turn Off the CardioMessenger? 29How Do I Charge the CardioMessenger? . 30How Do I Turn Off the Charging Station? . 31How Do I Resolve Problems? . . . . . . . . . . 32Light 3 . . . . . . . . . . . . . . . . . . . . . . . . . . 32Light 4 . . . . . . . . . . . . . . . . . . . . . . . . . . 33Light 5 . . . . . . . . . . . . . . . . . . . . . . . . . . 33How Do I Reset the CardioMessenger? . . 34How Do I Take Care of the CardioMessenger? . . . . . . . . . . . . . . . . . . . 35How Do I Carry the CardioMessenger? . . 36Safety Precautions – What Should I Watch out For? . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38356845--PreJCardioMessenger.book Page 1 Thursday, January 5, 2012 1:13 PM
2Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . 40USA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40FCC RF exposure requirements . . . . . . 41UL classification . . . . . . . . . . . . . . . . . . 41Canada . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42Electromagnetic Compatibility . . . . . . . . . 43Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . 43Technical Data . . . . . . . . . . . . . . . . . . . . . . 44General . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44Permissible Environmental Conditions . . 44During operation . . . . . . . . . . . . . . . . . . 44Shipping and storage . . . . . . . . . . . . . . 44CardioMessenger Remote Unit . . . . . . . . . 44CardioMessenger Charging Station . . . . . 45Rechargeable Battery (Integrated) . . . . . . 46Power Supply . . . . . . . . . . . . . . . . . . . . . . . 46Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . 47CardioMessenger.book Page 2 Thursday, January 5, 2012 1:13 PM
3What 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 trans-mitter. This transmitter automatically transmits medical and technical information to a mobile device, the CardioMessenger. The CardioMessenger works like a cell phone and automatically transmits the information received from your device as encoded messages to the BIOTRONIK Service Center.The transmission power from your device is low so as to not impair your health in any way. Since the transmission range is short, the CardioMessenger is needed to send the information to the BIOTRONIK Service Center.At the Service Center, the data are processed and can be viewed only by your physician on a secured Internet site in the form of a comprehensive report called a Cardio Report. Your doctor can use this Cardio Report to decide whether your device settings need to be updated or if your therapy plan needs to be changed. Thus, Home Monitoring serves as a practical diagnostic aid.CardioMessenger.book Page 3 Thursday, January 5, 2012 1:13 PM
4Included EquipmentThe set comes equipped with the following components:1. Mobile unit2. Charging station3. Wall mounted power supply 4. Telephone cable5. Belt clip (already affixed)6. Carrying strap7. Patient manualCardioMessenger.book Page 4 Thursday, January 5, 2012 1:13 PM
5Before 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. Only use the following original BIOTRONIK devices, as other accessories can increase the interference emitted and the device's susceptibility to interference:– The CardioMessenger– The charging station with the wall mounted power supply (type: FW 7555 M/06)– The telephone cord (type: BIOTRONIK VK-117)CardioMessenger.book Page 5 Thursday, January 5, 2012 1:13 PM
6How Do I Use the CardioMessenger?The following section describes: 2How to optimize CardioMessenger placement2How to operate it2How it functions Where Should I Put the CardioMessenger?On your bedside table or close to your bed is a suitable place for your CardioMessenger since it generally fulfills the following conditions:2The distance to the device is less than 2 meters (6 feet), so that regular data transmission at night is guaranteed.2The distance to the device is more than 20 centimeters (7 inches), so that the CardioMessenger does not interfere with the device.2The CardioMessenger is placed on a solid base and cannot fall. Please also consider the following:2Do not expose the device to moisture or heat; exposure to direct sunlight and taking the device into the bathroom are not recommended.2The CardioMessenger should not be connected to a power outlet controlled by a light switch. 2Do not place the device next to a television set, microwave oven, or similar source of electromagnetic interference.CardioMessenger.book Page 6 Thursday, January 5, 2012 1:13 PM
7Warning! 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 7 Thursday, January 5, 2012 1:13 PM
8How Do I Install the CardioMessenger?Insert the plug into a socket in your wall. Make sure you do not connect the Cardio-Messenger 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.Now the green light on the upper side of the power supply should be illuminated; if not, please refer to “How Do I Resolve Problems?” on page 32.CardioMessenger.book Page 8 Thursday, January 5, 2012 1:13 PM
9Now, 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 9 Thursday, January 5, 2012 1:13 PM
10Light 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 10 Thursday, January 5, 2012 1:13 PM
11Telephone connectionYou need a telephone connection so that your CardioMessenger can send the Home Monitoring data to your physician. 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. Version AVersion BCardioMessenger.book Page 11 Thursday, January 5, 2012 1:13 PM
12Note: 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. Proper set up of the system at the patient’s home may require installation of adapters and/or analog phone lines. Please contact your telephone service provider for informa-tion on the type of phone line that you have.CardioMessenger.book Page 12 Thursday, January 5, 2012 1:13 PM
13Version AUnplug 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 13 Thursday, January 5, 2012 1:13 PM
14Now insert the free end of your telephone cable into port 1 of the charging station.CardioMessenger.book Page 14 Thursday, January 5, 2012 1:13 PM
15Take 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 15 Thursday, January 5, 2012 1:13 PM
16Insert 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 stran-gulation.CardioMessenger.book Page 16 Thursday, January 5, 2012 1:13 PM
17Now, 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 Cardio-Messenger 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). Additional information can be found in “How Do I Charge the CardioMessenger?” on page 30.CardioMessenger.book Page 17 Thursday, January 5, 2012 1:13 PM
18When you are finished, the connection should look like as follows:CardioMessenger.book Page 18 Thursday, January 5, 2012 1:13 PM
19Version BIf you wish to set up the CardioMessenger close to a telephone outlet, but there is no telephone, you may connect the Cardio-Messenger 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 19 Thursday, January 5, 2012 1:13 PM
20Now insert one end of your telephone cable into port 1 of the charging station.CardioMessenger.book Page 20 Thursday, January 5, 2012 1:13 PM
21Insert 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 stran-gulation.CardioMessenger.book Page 21 Thursday, January 5, 2012 1:13 PM
22Now, 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 Cardio-Messenger 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.book Page 22 Thursday, January 5, 2012 1:13 PM
23When you are finished, the connection should look like as follows:CardioMessenger.book Page 23 Thursday, January 5, 2012 1:13 PM
24How 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. Light 1 Off – This is the normal status.CardioMessenger.book Page 24 Thursday, January 5, 2012 1:13 PM
25Yellow 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 Cardio-Messenger off and on, this light will not flash anymore. However, please do not forget to call your physician.Light 2 This light will only be used during a follow-up visit and can be triggered via the device programmer ICS 3000. Your physician will find further information in the ICS 3000 manual.Note: Light 2 is not illuminated when your device transmits regular messages.This light may be illuminated or flash yellow, or flash green. Off – This is the normal status.Yellow illumination – When the light is illuminated yellow, the CardioMessenger is receiving a message. Please wait until the data transmission has finished (light flashing green) before you walk away from the CardioMessenger. Green flashing – When the light flashes green several times, the transmission of the message has been completed.Yellow flashing – However, when the light flashes yellow several times, the transmis-sion was not successful. Your physician will decide what to do next.Light 3 This light informs you about the normal operation of the CardioMessenger. CardioMessenger.book Page 25 Thursday, January 5, 2012 1:13 PM
26Green flashing – When the light single-flashes green repeat-edly, the CardioMessenger is operating properly. This is the normal status.Green flashing – When the light double-flashes green repeat-edly, the CardioMessenger is also operating properly. Additionally, there are messages stored that have to be transmitted to the Service Center.Yellow flashing – When the light double-flashes yellow repeatedly, there is no connection to the GSM network or modem and additionally the CardioMessenger has messages stored to be transmitted to the Service Center. For further information, see the “How Do I Resolve Problems?” on page 32. Yellow illumination – When the light is illuminated yellow, the CardioMessenger is performing a self-test. This test should last no longer than 10 seconds after the CardioMessenger has been switched on.Off – The CardioMessenger is switched off.Light 4 In the following, the four statuses of the battery monitor light are described as follows:Green Illumination – When the light is illuminated green, the CardioMessenger is fully charged. You may now use it in mobile operation for at least 24 hours. But the CardioMessenger can certainly also be kept in the charging station. Off – This is the normal status when the CardioMessenger is used in mobile operation.CardioMessenger.book Page 26 Thursday, January 5, 2012 1:13 PM
27When 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. Light 5 Green Illumination – This is the normal status when the charging station is connected to the power supply. If this is not the case, there might be an error. Additional information can be found in “How Do I Resolve Problems?” on page 32.CardioMessenger.book Page 27 Thursday, January 5, 2012 1:13 PM
28How 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 Cardio-Messenger until you can feel slight resistance. A brief tone will sound, the CardioMessenger will start its self-test, and light 3 will be illuminated yellow. You can now release the button.CardioMessenger.book Page 28 Thursday, January 5, 2012 1:13 PM
29When 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. Note: When the CardioMessenger has not been used for a long time or if it was stored below operational temperature, the battery can be completely depleted. In this case, the CardioMessenger switches itself on only after the battery has been charged for about 30 minutes.How Do I Turn Off the CardioMessenger?Press and hold the CardioMessenger On/Off button for at least two seconds. A brief tone will sound and light 3 will go out after a short period of time.The CardioMessenger is switched off; no data can be received or transmitted.Note: A switched-off or improperly functioning CardioMessenger does not affect the operation of your device. CardioMessenger.book Page 29 Thursday, January 5, 2012 1:13 PM
30How 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 Cardio-Messenger 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.During the charging process, the battery monitor light (light 4) of the CardioMessenger will be illuminated yellow. Once the CardioMessenger is charged, the battery monitor light is illuminated green. Charging usually takes no longer than three and a half hours. CardioMessenger.book Page 30 Thursday, January 5, 2012 1:13 PM
31However, 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. You should then first charge the Cardio-Messenger before attempting to use it. How Do I Turn Off the Charging Station?The charging station can remain perma-nently connected. This ensures that your CardioMessenger will always start charging as soon as you place it in the charging station.Disconnect the power cable plug from the socket to turn off the charging station. The charging station does not have a power switch.CardioMessenger.book Page 31 Thursday, January 5, 2012 1:13 PM
32How 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 Cardio-Messenger was not able to end its self-test. Solution – Reset the CardioMessenger. If light 3 is still illuminated yellow, inform your physician. You will find information on a reset in “How Do I Reset the Cardio-Messenger?” on page 34.Yellow flashing – When this light continu-ously flashes yellow, the CardioMessenger cannot connect to the Service Center.Solutions – Check if the charging station is connected to the power supply and if the cables from the charging station to the telephone wall outlet are loose. Check that the standard telephone line is not dead, i.e., the CardioMessenger is not blocked by other devices.Check if you are able to dial toll-free numbers with your telephone. If this is generally not possible, have this service set up for you by your telephone provider or inform your physician. 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. Proper set up of CardioMessenger.book Page 32 Thursday, January 5, 2012 1:13 PM
33the 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.Light 4 Off – When this light is off even though the CardioMessenger is in the charging station, proceed as follows: Solutions – Check if light 5 on the charging station is illuminated. Is this not the case, refer to the solutions described for light 5.If light 5 is illuminated, check whether the connecting parts on the CardioMessenger or on the charging station are easily accessible and not dirty.If light 4 is still off, inform your physician so that the device can be checked and the battery may be exchanged. Note: If you take the CardioMessenger out of the charging station, the battery monitor light will go out to save energy. Light 5 Off – If this light is off, proceed as follows: Solutions – Check that the plugs of the power cables are connected both to the outlet in the wall and to the power supply. Check that the green light of the power supply is illuminated. If this is not the case, either the power outlet is not being supplied with electricity or the power supply is defec-tive. Return a non-functioning power supply to your physician. CardioMessenger.book Page 33 Thursday, January 5, 2012 1:13 PM
34How 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 elimi-nated 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.Press the reset button (located on the back of the CardioMessenger) with a sharp object such as a ballpoint pen or the end of a straightened paper clip.CardioMessenger.book Page 34 Thursday, January 5, 2012 1:13 PM
35If 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. 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:2Keep the CardioMessenger clean and away from dirty or dusty environments.2Don't bend the antenna and don't hold the CardioMessenger by the antenna.2Use a soft cloth for cleaning. If necessary, this can be moistened with water or ethyl alcohol. Unplug the charging station before cleaning. Do not bring the mobile unit or the charging station into direct contact with water or other solvents.2Protect the CardioMessenger from direct contact with water. For example, wear it under your coat when it rains.2Don't turn on the CardioMessenger if it has been recently stored in a cold environment. Let it warm up slowly to room temperature, since the resulting condensed water may harm the elec-tronic circuit.Return the CardioMessenger to your physician if it no longer works.Maintenance at regular intervals is not necessary for the CardioMessenger. CardioMessenger.book Page 35 Thursday, January 5, 2012 1:13 PM
36Note: 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). If you feel the CardioMessenger is not lasting long enough during mobile opera-tion, ensure that it has been charged in the charging station for at least three and a half hours before mobile use. Additional information can be found in “How Do I Charge the CardioMessenger?” on page 30. If you find that the battery is always running low too soon, contact your physician. The physician will have a new battery installed.Note: When authorized personnel change the battery, they should also check the button cell. In particular, rechargeable lithium ion batteries should be disposed of by the manufacturer according to legal guidelines.How Do I Carry the CardioMessenger?You can wear your CardioMessenger in various ways: 2With the clip of the CardioMessenger on your belt2With the carrying strap If you don't need the clip or if you wish to attach the carrying strap, proceed as follows: Remove the clip by pressing the symbol with your thumb (see figure) and slide the clip downwards – away from the antenna.CardioMessenger.book Page 36 Thursday, January 5, 2012 1:13 PM
37The 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).Warning! Do not carry the CardioMessenger inside the breast pocket of your shirt or jacket, and do not place it directly on your skin.CardioMessenger.book Page 37 Thursday, January 5, 2012 1:13 PM
38Safety Precautions – What Should I Watch out For?The CardioMessenger and its components are medical devices and therefore comply with strict requirements for their develop-ment, manufacture and testing. Please observe the following safety instruc-tions, which are summarized below: Warning! Turn off the CardioMessenger in locations where cell phones are prohibited for safety reasons (such as in hospitals or airplanes). Such areas can be identified by the following or similar signs:Warning! To avoid interference, maintain a minimum distance of 20 centimeters (7 inches) between the CardioMessenger and the device. Like a cellular phone, the CardioMessenger device can temporarily interfere with your device if it is too close to it. Warning! Do not carry the CardioMessenger inside the breast pocket of your shirt or jacket, and do not place it directly on your skin.Warning! According to government regulations, the charging station of the CardioMessenger may not be operated within a distance of 1.5 m (5 feet) of a patient in a hospital environment. At home, this restriction does not apply.CardioMessenger.book Page 38 Thursday, January 5, 2012 1:13 PM
39Warning! Keep the sealing plugs of the telephone inlet out of the reach of children.Warning! Arrange power and telephone cables carefully to reduce the risk of entanglement or strangulation.Caution! Protect the CardioMessenger and charging station from:– Water and high humidity (e.g., in the bathroom)– Temperatures above 40°C (104°F)– Temperatures below -5°C (23°F) (mobile operation for CardioMessenger)– Barometric pressure below 700 hPa (corresponding to altitudes above 3000 m/10,000 feet)– Barometric pressure above 1060 hPa (corresponding to altitudes below sea level)– Violent shocks or other strong mechan-ical influences– Intensive light sources (direct sunlight, strong halogen emitters)-Solvents, acids, detergents, and lyesCaution! Never use the CardioMessenger if it has been damaged; return it to your physician.Before use, make sure that none of the components are visibly damaged and that all necessary components have been delivered to you. Additional information can be found in “Included Equipment” on page 4.Caution! The CardioMessenger must not be modified. It must only be opened and repaired by authorized trained personnel. The rechargeable batteries must only be exchanged by authorized trained personnel.Note: For proper operation, the Cardio-Messenger must be put into the charging station for at least three and a half hours each day.CardioMessenger.book Page 39 Thursday, January 5, 2012 1:13 PM
40Guidelines USAYour 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 400.150–406.000 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.Analog and digital voice communications are prohibited. Although this transceiver has been approved by the Federal Communica-tions Commission, there is no guarantee that it will not receive interference or that any particular transmission from this trans-ceiver will be free from interference.Depending on the embedded GSM modem the FCC ID number for the CardioMessenger is either QRICM06-1 or else QRICMII.Depending on the embedded cable modem type in the charging station the ACTA ID number of the cable modem is either AU7MM01BMT5656SMI or else AU7MD04B2456 or else AU7MMO1BMT5692SMI.The CardioMessenger, as well as the device itself, must conform to appropriate govern-ment standards and regulations.The CardioMessenger uses a GSM modem that connects to the mobile cellular telephone service at 850/1900 MHz. BIOTRONIK uses the modem according to CardioMessenger.book Page 40 Thursday, January 5, 2012 1:13 PM
41the specifications of the manufacturer in compliance with FCC approval require-ments.FCC RF exposure requirementsThis 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 desig-nated for this product. Use of other accesso-ries may not ensure compliance with FCC RF exposure guidelines. This EUT (Equipment Under Test) has been shown to be capable of compliance for localized specific absorption rate (SAR) for uncontrolled environment/ general population exposure limits specified in ANSI/ IEEE Std. C95.1-1992 and had been tested in accordance with the measurement procedures specified in FCC/OET Bulletin 65 Supplement C (2001) and IEEE Std. 1528-200X (Draft 6.5, January 2002).UL classificationThe CardioMessenger charger is classified by Underwriters Laboratories Inc. with re-spect to electric shock, fire, and mechanical hazards only in accordance with UL 60601-1 and CAN/CSA-C22.2 No 601.1-M90. The devices are denoted accordingly:CardioMessenger.book Page 41 Thursday, January 5, 2012 1:13 PM
42CanadaThe CardioMessenger is registered at Industry Canada. Depending on the embedded GSM modem this number is either IC: 4708A-CM06V1 or else 4708A-CMII.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.The term "IC:" before the certification/registration number only signifies that the Industry Canada technical specifications were met. Note: This device may not interfere with stations 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.In addition, the CardioMessenger contains a GSM modem (Motorola g24 or Motorola g24l) that establishes the connec-tion to the cellular network at the frequencies of 900/1800 MHz. BIOTRONIK uses the modem in accordance with the manufacturer’s specifications and in compliance with the approval require-ments.The GSM modem has been evaluated and approved by an independent authority for its compliance with the statutory regulations. As an indication of this, it carries the following approval mark(IMEI Number: 35726200-xxxxxx-x):CardioMessenger.book Page 42 Thursday, January 5, 2012 1:13 PM
43Electromagnetic CompatibilityNote: The CardioMessenger is protected from disturbances resulting from electromagnetic interference, electro-static discharges, and other sources – including interference induced by cables. Interfering emissions from the Cardio-Messenger have been minimized. The CardioMessenger therefore meets the requirements of EN 60601-1-2 in every respect.Warning! Other equipment, including portable and mobile RF radiocommu-nications equipment may interfere with the CardioMessenger, even if this equipment complies with CISPR emission requirements. However, this possible interference does not affect the device functionality. WarrantyThe CardioMessenger and all original com-ponents by BIOTRONIK are not subject to warranty when used improperly or stored and transported incorrectly. Use only the original packaging when shipping the device.CardioMessenger.book Page 43 Thursday, January 5, 2012 1:13 PM
44Technical DataGeneral2Class of protection: II2Operating mode: Continuous operationPermissible Environmental ConditionsDuring operation2Temperature: -5°C (23°F) to +40°C (104°F) (remote unit)0°C (32°F) to +40°C (104°F) (charging station)2Store in a dry place!Relative humidity: 30% to 75%(non-condensing)2Atmospheric pressure: 700 hPa to 1060 hPa2Altitude: Sea level up to 3000 m (10,000 feet)Shipping and storage2Temperature: -20°C (-4°F) to +60°C (140°F) 2Store in a dry place!Relative humidity: 30% to 75% (non-condensing)2Atmospheric pressure:700 hPa to 1060 hPaCardioMessenger Remote Unit2Dimensions (WxHxD): 60 x 132 x 45 mm2Charging voltage: 5,2 V DC / 0.8 A2Max. charge time: 3.5 hoursCardioMessenger.book Page 44 Thursday, January 5, 2012 1:13 PM
452Interfaces: Serial infrared port and IrDA1.0 standard2MedRadio: Modulation FSK2MedRadio frequencies:402 – 405 MHz, 9 channels, 300 kHz band width2MedRadio transmission power: 25 μW EIRP2GSM: Modulation GMSK2GSM frequencies: 850 MHz, 900 MHz, 1800 MHz, 1900 MHz, 9,6 kHz band width2GSM transmission power:0.8 Watt (850 MHz); 2 Watt (900 MHz); 1 Watt (1800/1900 MHz)CardioMessenger Charging Station2Dimensions (WxHxD): 90 x 82 x 105 mm2Input voltage: 6 V DC / 1 A2Output voltage: 5.2 V DC / 1 ACardioMessenger.book Page 45 Thursday, January 5, 2012 1:13 PM
46Rechargeable Battery (Integrated)2Type: Lithium ions (CGA 103460A) 2Dimensions (WxHxD):approx. 36.5 x 64.5 x 12 mm2Operating voltage: 3.6 V (nominal)2Charging voltage: 4.1 V DC2Max. charging current: 2 A2Capacity: 1850 mAh or morePower Supply2Type: FW 7555M/062Dimensions: 51.5 x 87.5 x 34 mm2Input voltage: 100 – 240 V AC at 50 – 60 Hz, 400 mA2Output voltage: 6 V DC / 2.1 ACardioMessenger.book Page 46 Thursday, January 5, 2012 1:13 PM
47AppendixElectromagnetic emitted interference according to IEC 60601-1-2The 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.Measuring the interference Compliance Guidelines for the Electromagnetic EnvironmentHigh-frequency interference according to CISPR 11Group 1 The CardioMessenger uses RF energy only for its internal function. Therefore, the HF interference is very low and not likely to cause any interference in nearby electronic equipment.High-frequency interference according to CISPR 11 Class B The CardioMessenger is suitable for use in all areas, including living space and those areas that are directly connected to a public power supply system that also supplies buildings intended for residential purposes.Interference of harmonics according to IEC 61000-3-2 Class A according to IEC 61000-3-2Voltage fluctuations/ flicker emissions according to IEC 61000-3-3CompliesCardioMessenger.book Page 47 Thursday, January 5, 2012 1:13 PM
48Electromagnetic emitted interference according to IEC 60601-1-2The 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.Testing resistance to interferenceTest level according to IEC 60601-1-2Conformance level Guidelines for the electromagnetic environmentConducted RF inter-ference according toIEC 61000-4-63Veff150 kHz to 80 MHz Same as test level The minimum distance of the CardioMessenger from portable and mobile radio devices, including the cables, should correspond to the recommended safe distance that is calculated according to the equation for the suitable transmission frequency. Recommended safe distance:D= 1,17Radiated RF inter-ference according to IEC 61000-4-33V/m80 MHz to 2.5 GHz Same as test level D= 1,17 for 80 to 800 MHzD= 2,34 for 800 MHz to 2.5 GHz with P as the nominal output of the transmitter in Watts (W) according to the information from the transmitter manufacturer, and d as the recommended safe distance in meters (m).The field strength of stationary transmitting devices should be measured on sitea and must be lower than the compliance level at all frequenciesb.Interference can be generated when the CardioMessenger is close to devices that have the following warning sign:Note: The higher frequency range applies at 80 MHz and at 800 MHz.Note: These guidelines may not be applicable in all cases. The spread of electromagnetic waves is influenced by absorption and reflection from buildings, objects, and humans.pppCardioMessenger.book Page 48 Thursday, January 5, 2012 1:13 PM
49a. 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. If the measured field strength in the location in which the CardioMessenger is used exceeds the applicable RF compliance level above, the 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 150 KHz to 80 MHz, ensure that field strengths are less than 3 V/m.CardioMessenger.book Page 49 Thursday, January 5, 2012 1:13 PM
50Electromagnetic emitted interference according to IEC 60601-1-2The 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.Checkingimmunity to noiseTest level according to IEC 60601-1-2Conformance levelGuidelines for the electromagnetic environmentDischarge of static electricity (ESD)According to IEC 61000-4-2± 6 kV contact discharge±8 kV air dischargeSame as the test level Floors should be made of wood or cement, or have ceramic tiles. When the floor consists of a synthetic material, the relative humidity must be at least 30%.Rapid transient elec-trical disturbances/burstsAccording to IEC 61000-4-4± 2 kV forpower supply lines± 1 kV for input/output linesSame as the test level The quality of the supply voltage should correspond to that in a typical business and/or hospital.SurgeAccording to IEC 61000-4-5±1kV normal mode voltage± 2 kV common mode voltageSame as the test level The quality of the supply voltage should correspond to that in a typical business and/or hospital.CardioMessenger.book Page 50 Thursday, January 5, 2012 1:13 PM
51Voltage dips, brief interruptions and fluctuations in the supply voltageAccording to IEC 61000-4-11‹ 5% UT for1/2 cycle(› 95% drop)40% UT for 5 periods(60% drop)70% UT for 25 periods(30% drop)‹ 5% UT for 5 s(› 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. An interruption in the supply voltage to the power supply unit will not impair the functioning of the CardioMessenger.Magnetic field at the supply frequencies (50/60 Hz)According to IEC 61000-4-83A/m Same as the test level The magnetic field strength should correspond to the typical value in business and hospital environments.Comment: UT is the mains alternating voltage before applying the test levels.Checkingimmunity to noiseTest level according to IEC 60601-1-2Conformance levelGuidelines for the electromagnetic environmentCardioMessenger.book Page 51 Thursday, January 5, 2012 1:13 PM
52Recommended separation distances between portable and mobile RF communications equipment and the CardioMessenger Transmission frequency150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHzEquation D= 1,17 : D= 1,17 : D= 2,34 :Rated power of transmitter (W)Safe distance (m) Safe distance (m) Safe distance (m)0.01 0.12 0.12 0.240.1 0.37 0.37 0.741 1.17 1.17 2.3410 3.7 3.7 7.4100 11.7 11.7 23.4For transmitters whose maximum nominal output is not indicated in the above table, the distance can be calculated using the equation in the column, where P is the maximum nominal output of the transmitter in Watts (W) according to the transmitter’s manufacturer.Note: The higher frequency range applies at 80 MHz and at 800 MHz.Note: These guidelines may not be applicable in all cases. The propagation of electromagnetic values is affected by absorption and reflection by structures, objects and people.pppCardioMessenger.book Page 52 Thursday, January 5, 2012 1:13 PM

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