BIOTRONIK SE and KG CM06-1 Patient Device User Manual Manual1

BIOTRONIK SE & Co. KG Patient Device Manual1

Manual1

CardioMessenger II®Transmitter for BIOTRONIK Home Monitoring®sbiotronikTechnical Manual356845_Cover_CMII_US.qxd 10.05.06 13:45 Seite 1
OverviewPhysician callback signal . . . . . . . . . . .Follow-up data transmission . . . . . . . .Ready (CardioMessenger II) . . . . . . . . .Battery monitor light . . . . . . . . . . . . . . .Ready (charging station) . . . . . . . . . . . .Data interfaceA view of the rear side of the device can befound on the back cover.356845_Cover_CMII_US.qxd 10.05.06 13:45 Seite 2
OverviewOn/off buttonRestartPower supply portTelephone jackBelt clip356845_Cover_CMII_US.qxd 10.05.06 13:45 Seite 3
BIOTRONIK GmbH & Co. KGWoermannkehre 112359 Berlin · GermanyTel +49 (0) 30 68905-0Fax +49 (0) 30 6852804BIOTRONIK, Inc.6024 SW Jean rd. Bldg. BLake Oswego, OR 97035Phone (800) 547-0394 (24-hr)Fax (503) 635-9936sales@biotronik.comwww.biotronik.com© by BIOTRONIK GmbH & Co. KGAll rights reserved. Specifications subject to modification, revisionand improvement.® CardioMessenger is a registered trademark ofBIOTRONIK GmbH & Co. KGsbiotronik356845/A/6D20356845_Cover_CMII_US.qxd 10.05.06 13:45 Seite 4
1ContentsWhat is Home Monitoring? . . . . . . . . . . . . 3Included Equipment . . . . . . . . . . . . . . . . . . 4How Do I Use the CardioMessenger? . . . . 6Where Should I Put the CardioMessenger? 6How Do I Install the CardioMessenger? . . 9Telephone Connection . . . . . . . . . . . . . 12Version A . . . . . . . . . . . . . . . . . . . . . . . . 13Version B . . . . . . . . . . . . . . . . . . . . . . . . 19How Do I Understand the Lights of the CardioMessenger? . . . . . . . . . . . . . . . . . . 25Light 1 . . . . . . . . . . . . . . . . . . . . . . . . . . 25Light 2 . . . . . . . . . . . . . . . . . . . . . . . . . . 26Light 3 . . . . . . . . . . . . . . . . . . . . . . . . . . 26Light 4 . . . . . . . . . . . . . . . . . . . . . . . . . . 27Light 5 . . . . . . . . . . . . . . . . . . . . . . . . . . 28How Do I Turn On the CardioMessenger? 29How Do I Turn Off the CardioMessenger? 30How Do I Charge the CardioMessenger? .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? . . . . . . . . . . . . . . . . . . . . . . . . . . . 38Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . 40USA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .40Canada . . . . . . . . . . . . . . . . . . . . . . . . . . . .41Electromagnetic Compatibility . . . . . . . . .42Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . 43CardioMessenger.book Page 1 Tuesday, May 2, 2006 5:05 PM
2Technical Data . . . . . . . . . . . . . . . . . . . . . . 44General . . . . . . . . . . . . . . . . . . . . . . . . . . . 44Permissible Environmental Conditions . . 44During Operation: . . . . . . . . . . . . . . . . . 44Shipping and Storage: . . . . . . . . . . . . . 44CardioMessenger Remote Unit . . . . . . . . 44CardioMessenger Charging Station . . . . 45Rechargeable Battery (integrated) . . . . . 45Power Supply . . . . . . . . . . . . . . . . . . . . . . . 45Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . 46CardioMessenger.book Page 2 Tuesday, May 2, 2006 5:05 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 transmitter. 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 implant as encoded messages to the BIOTRONIK Service Center.The transmission power from your implant 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 implant 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 Tuesday, May 2, 2006 5:05 PM
4Included EquipmentThe set comes equipped with the following components:1. Mobile unit2. Charging station3. Power supply unit4. Power supply cable5. Belt clip (already affixed)6. Carrying strap7. Patient manual8. Telephone cableCardioMessenger.book Page 4 Tuesday, May 2, 2006 5:05 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 appropriate power supply unit (type: FW 7555 M/06)- The power cord (type: BIOTRONIK NK-29, NK-30, or NK-31) - The telephone cord (type: BIOTRONIK VK-117)CardioMessenger.book Page 5 Tuesday, May 2, 2006 5:05 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 implant is less than 2 meters (6 feet), so that regular data transmission at night is guaranteed.2The distance to the implant is more than 20 centimeters (7 inches), so that the CardioMessenger does not interfere with the implant.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.Warning! The distance between the implant and CardioMessenger must not be less than 20 centimeters (7 inches). CardioMessenger.book Page 6 Tuesday, May 2, 2006 5:05 PM
7Note: 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 Tuesday, May 2, 2006 5:05 PM
8CardioMessenger.book Page 8 Tuesday, May 2, 2006 5:05 PM
9How Do I Install the CardioMessenger?Insert the power cable plug into a socket in your wall and the other end of the cable into the power supply. Make sure you do not connect the CardioMessenger to a power outlet controlled by a light switch.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 9 Tuesday, May 2, 2006 5:05 PM
10Now, insert the other end of the power supply cable (the end with the small plug) into the charging station. The port for the small plug is situated on the rear side of the charging station and is marked with the following symbol:Use only the original power supply unit that came with the CardioMessenger, see „Included Equipment" on page 4.CardioMessenger.book Page 10 Tuesday, May 2, 2006 5:05 PM
11Light 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 Tuesday, May 2, 2006 5:05 PM
12Telephone 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 12 Tuesday, May 2, 2006 5:05 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.CardioMessenger.book Page 13 Tuesday, May 2, 2006 5:05 PM
14Now insert the free end of your telephone cable into the inlet of the charging station.CardioMessenger.book Page 14 Tuesday, May 2, 2006 5:05 PM

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