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BIOTRONIK CardioMessenger, Preliminary Manual

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BIOTRONIK CardioMessenger Preliminary Manual Download Page 3

2

Accessories  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Frequently Asked Questions  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Technical Terms and Abbreviations  . . . . . . . . . . . . . . . . . . . . . . . . 21

Cardio Report   . . . . . . . . . . . . . . . . . . . . . . . . . . 21

GSM   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Home Monitoring   . . . . . . . . . . . . . . . . . . . . . . . 21

BIOTRONIK Service Center   . . . . . . . . . . . . . . . 21

SMS   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

US Regulatory Requirements  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

FCC RF Exposure Requirements  . . . . . . . . . . . 23

Legal Considerations  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Electromagnetic compatibility  . . . . . . . . . . . . . 25

Warranty   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

Technical Data  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

General information  . . . . . . . . . . . . . . . . . . . . . 26

Permissible environmental conditions  . . . . . . 26

CardioMessenger remote unit  . . . . . . . . . . . . . 26

CardioMessenger charging station  . . . . . . . . . 27

Rechargeable battery (integrated) . . . . . . . . . . 27

Power supply  . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Appendix   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Summary of Contents for CardioMessenger

Page 1: ...Preliminary Manual for CardioMessenger FCC ID QRICM02 1 BIOTRONIK GmbH Co...

Page 2: ...ore using the Cardio Messenger 9 Where should I put the CardioMessenger 9 How do I plug in the CardioMessenger 10 The CardioMessenger traffic light system 10 Turning on the CardioMessenger 11 Turning...

Page 3: ...21 SMS 21 US Regulatory Requirements 22 FCC RF Exposure Requirements 23 Legal Considerations 24 Electromagnetic compatibility 25 Warranty 25 Technical Data 26 General information 26 Permissible enviro...

Page 4: ...to be updated or if your therapy plan needs to be changed If necessary your physician will contact you about making an appointment for a follow up examination For Home Monitoring to work your implant...

Page 5: ...or ICD with the Home Monitoring function Conventions used in this technical manual Note Provides additional information on the features of the CardioMessenger and how to operate it Caution If these in...

Page 6: ...cessories Belt clip1 Carrying strap2 Belt carrying case3 The CardioMessenger works like a cell phone and transmits the information received from the implant as a short message SMS via a mobile telepho...

Page 7: ...Maintain a minimum distance between the patient device and your implant Like a cellular phone the CardioMessenger device can temporarily interfere with your implant if it is too close to it To avoid i...

Page 8: ...Messenger The charging station with the appropriate power supply unit type FW 7555 M 06 Other accessories can increase the interference emit ted and the device s susceptibility to interference Caution...

Page 9: ...or Electronic Article Surveillance EAS Systems Equipment such as retail theft prevention systems may interact with the implanted device Patients should be advised to walk directly through and not to r...

Page 10: ...lant and CardioMessenger is not less than 20 centimeters 7 inches and not more than 2 meters 6 feet Place the device on a solid base so that it cannot fall Keep the CardioMessenger from being exposed...

Page 11: ...of the charging station After connecting the charging station the light will be illuminated and the charging station will then be operational The CardioMessenger traffic light system Your CardioMesse...

Page 12: ...ellow When the light flashes yellow there is a prob lem with charging the CardioMessenger If the light is continuously yellow the CardioMessenger is charg ing Green When the light is green the CardioM...

Page 13: ...ged Place the CardioMessenger in the charging station The charging process will start immediately During the charging process the battery monitor light of the CardioMessenger will be yellow If the bat...

Page 14: ...r is receiving and transmitting implant data The data are received and transmitted automatically at specific intervals determined by your doctor so that you do not have to monitor data transmission Wh...

Page 15: ...network If the CardioMessenger is close to your bed and gen erally cannot establish a connection to the GSM net work contact your physician Continuous illumination Turn the CardioMessenger on and off...

Page 16: ...15 How Do I Use the CardioMessenger Then turn the CardioMessenger on as usual If only the yellow light is illuminated after five minutes the CardioMessenger may be defective Talk with your physician...

Page 17: ...ansmission can be activated by a special magnet pacemaker patients only This is done by placing the magnet directly over the implant Your doctor will explain this to you if how and when it is nec essa...

Page 18: ...CardioMessenger does not need to be serviced at regular intervals by a technician Note Before each use inspect the CardioMessenger charging station power supply unit and cable and make sure they are n...

Page 19: ...rdioMessenger infrequently or do not need the clip to wear it you can remove the clip Press the holder and slide it downwards away from the antenna and remove the clip To reattach the clip slide the h...

Page 20: ...happens if the CardioMessenger device fails Does this affect my implant No your implant will continue to function as usual If the CardioMessenger stops working it cannot receive any information from y...

Page 21: ...centimeters 7 inches What should I do when I want to travel Consult your physician beforehand and inform him or her of your travel plans You can take the Cardio Messenger everywhere and plug it in wh...

Page 22: ...tion are equipped with a transmitter that sends messages over a specific frequency to a mobile patient device These messages are then transmitted via a cellular network to the BIOTRONIK Service Center...

Page 23: ...ference that may be caused by such aids including interference that may cause undesired operation This transmitter shall be used only in accordance with the FCC rules governing the Medical Implant Com...

Page 24: ...sories 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 en...

Page 25: ...arameters of the built in transmitter have been carefully selected to ensure that interference with other services as well as with the data transmission of the implant is unlikely Furthermore BIOTRONI...

Page 26: ...this it car ries the following approval mark IMEI Number 350030 95 xxxxxx x Electromagnetic compatibility Note The CardioMessenger is protected from disturbances resulting from electromagnetic interfe...

Page 27: ...spheric pressure 700 hPa to 1060 hPa Shipping and storage Storage temp 20 C to 25 C 4 F to 77 F for 2 years with battery 20 C to 70 C 4 F to 158 F without battery Shipping temp 20 C to 50 C 4 F to 122...

Page 28: ...e battery integrated Model Lithium ion LP 103463 AR Dimensions WxHxD Approx 34 x 63 x 10 2 mm Weight Approx 45 g Operating voltage 3 7 V nominal Charge voltage 4 2 V DC Max charging current 1 5 C 2700...

Page 29: ...rding to CISPR 11 Group 1 The CardioMessenger must trans mit electromagnetic energy to ful fill the function for which it was in tended Nearby electronic devices can be affected Radiofrequency emitted...

Page 30: ...y to interference Test level ac cording to IEC 60601 1 2 Conformance level Guidelines for the electro magnetic environment Conducted RF interfer ence according to IEC 61000 4 6 3 Veff 150 kHz to 80 MH...

Page 31: ...rbances bursts according to IEC 61000 4 4 2 kV for power cables Same as the test level The quality of the supply voltage should correspond to that in a typical business and or hospital Power surges ac...

Page 32: ...r W Safe distance m Safe distance m Safe distance m 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters whose maximum nominal output is not indicated in t...

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