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BIOTRONIK CardioMessenger, Предварительное руководство

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Contents

What is Home Monitoring?   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

About This Technical Manual . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

User group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Conventions used in this technical manual   . . . 4

The CardioMessenger Set and Its Components   . . . . . . . . . . . . . . . 5

Safety Precautions – What Should I Watch Out For?   . . . . . . . . . . . 6

Electronic Article Surveillance (EAS) Systems . 8

How Do I Use the CardioMessenger?  . . . . . . . . . . . . . . . . . . . . . . . . 9

What must be done before 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 off the CardioMessenger   . . . . . . . . . . 12

Charging the CardioMessenger  . . . . . . . . . . . . 12

How do I know when the batteries are running 
low?   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

How do I know that the CardioMessenger is 
receiving and transmitting implant data? . . . . 13

Troubleshooting   . . . . . . . . . . . . . . . . . . . . . . . . 13

Resetting  . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

When Does My Implant Transmit Data?  . . . . . . . . . . . . . . . . . . . . . 16

How Do I Take Care of the CardioMessenger?   . . . . . . . . . . . . . . . 17

343 851/A

Содержание CardioMessenger

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

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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