QRICMIIPatient Device

1 ContentsContents . . . . . . . . . . . . . . . . . . . . . . . . . . . 1What is Home Monitoring? . . . . . . . . . . . . 3Included Equipment . . . . . . . . . . . . . . . . . . 4How Do I Use the CardioMessenger? . . . . 6Where Should I Put the CardioMessenger? 6How Do I Install the CardioMessenger? . . 8 Telephone connection . . . . . . . . . . . . . 11Version A . . . . . . . . . . . . . . . . . . . . . . . . 13 Version B . . . . . . . . . . . . . . . . . . . . . . . . 19 How Do I Understand the Lights of the CardioMessenger? . . . . . . . . . . . . . . . . . . 24 Light 1 . . . . . . . . . . . . . . . . . . . . . . . . . . 24 Light 2 . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Light 3 . . . . . . . . . . . . . . . . . . . . . . . . . . 25 Light 4 . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Light 5 . . . . . . . . . . . . . . . . . . . . . . . . . . 27 How 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? . . . . . . . . . . 32 Light 3 . . . . . . . . . . . . . . . . . . . . . . . . . . 32 Light 4 . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Light 5 . . . . . . . . . . . . . . . . . . . . . . . . . . 33 How Do I Reset the CardioMessenger? . . 34How Do I Take Care of the CardioMessenger? . . . . . . . . . . . . . . . . . . . 35 How Do I Carry the CardioMessenger? . . 36Safety Precautions – What Should I Watch out For? . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 356845--PreJ CardioMessenger.book Page 1 T hursday, January 5, 2012 1:13 PM 2 Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . 40USA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 FCC RF exposure requirements . . . . . . 41UL classification . . . . . . . . . . . . . . . . . . 41 Canada . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Electromagnetic Compatibility . . . . . . . . . 43Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Technical Data . . . . . . . . . . . . . . . . . . . . . . 44General . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Permissible Environmental Conditions . . 44 During operation . . . . . . . . . . . . . . . . . . 44 Shipping and storage . . . . . . . . . . . . . . 44 CardioMessenger Remote Unit . . . . . . . . . 44CardioMessenger Charging Station . . . . . 45Rechargeable Battery (Integrated) . . . . . . 46Power Supply . . . . . . . . . . . . . . . . . . . . . . . 46 Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 CardioMessenger.book Page 2 T hursday, January 5, 2012 1:13 PM 3 What is Home Monitoring?Dear Patient:You have received a BIOTRONIK pacemaker or implantable cardioverter-defibrillator (ICD) with Home Monitoring function. Home Monitoring pacemakers and ICDs are additionally equipped with a special 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 transmis sion 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 T hursday, January 5, 2012 1:13 PM 4 Included 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 manual CardioMessenger.book Page 4 T hursday, January 5, 2012 1:13 PM 5 Before use, make sure that none of the components are visibly damaged and that all necessary components have been delivered to you. Caution! Never use the CardioMessenger if it has been damaged; return it to your physician.  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 T hursday, January 5, 2012 1:13 PM 6 How Do I Use the CardioMessenger?The following section describes: 2 How to optimize CardioMessenger placement 2 How to operate it 2 How 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:2 The distance to the device is less than 2 meters (6 feet), so that regular data transmission at night is guaranteed. 2 The distance to the device is more than 20 centimeters (7 in ches), so that the CardioMessenger does not interfere  with the device. 2 The CardioMessenger is placed on  a solid base and cannot fall. Please also consider the following:2 Do not expose the device to moisture or heat; exposure to direct sunlight and taking the device into the bathroom are not recommended. 2 The CardioMessenger should not be connected to a power outlet controlled  by a light switch. 2 Do not place the device next to a television set, microwave oven, or similar source of electromagnetic interference. CardioMessenger.book Page 6 T hursday, January 5, 2012 1:13 PM 7 Warning! The distance between the device and CardioMessenger must not be less than 20 centimeters (7 inches). No…

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Test Report No.: G0M-1106-1164-C-1 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Annex A Photos EUT FRONT EUT BACK Page 19 of 57

Test Report No.: G0M-1106-1164-C-1 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Annex A Photos EUT FRONT EUT BACK Page 19 of 57

Test Report No.: G0M-1106-1164-C-1 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany EUT OPEN EUT PCB TOP Page 20 of 57

EUROFINS PRODUCT SERVICE GMBH SAR TEST - REPORT SAR Compliance Test Report CardioMessenger II CM II with G24-L Test report no.: G0M-1106-1164-S-1_rev01 Eurofins Product Service GmbH Storkower Str. 38c, 15526 Reichenwalde, Phone +49-33631-888 0 Germany Fax +49-33631-888 660 Test Report No.: G0M-1106-1164-S-1_rev01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany TABLE OF CONTENTS 1 General information 3 1.1 Notes 3 1.2 Testing laboratory 4 1.3 Details of approval holder 4 1.4 Manufacturer 5 1.5 Application details 5 1.6 Test item 5 1.7 Test results 6 1.8 Test standards 6 2 Technical test 7 2.1 Summary of test results 7 2.2 Test environment 8 2.3 Test equipment utilized 8 2.4 Definitions 9 2.5 Measurement system description 10 2.6 Test system specification 15 2.7 Measurement procedure 16 2.8 Reference points 17 2.9 Test positions 19 2.10 Measurement uncertainty 20 3 Tissue and system verification 21 3.1 Tissue verification 21 3.2 System verification 21 4 Test Results 22 5 References 24 Annex A Calibration Certificates 25 Annex B Measurement plots 60 Annex C Pictures 69 Page 2 of 73 Page 3 of 73 Test Report No.: G0M-1106-1164-S-1_rev01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany 1.2 Testing laboratory 1.2.1 Location EUROFINS PRODUCT SERVICE GMBH Storkower Straße 38c D-15526 Reichenwalde b. Berlin Germany Telephone : +49 33631 888 00 Fax : +49 33631 888 660 1.2.2 Details of accreditation status DAR ACCREDITED TESTING LABORATORY DAR-REGISTRATION NUMBER: DAT-P-268/08 RECOGNIZED NOTIFIED BODY EMC REGISTRATION NUMBER: BNetzA-bS EMV-07/61 RECOGNIZED NOTIFIED BODY R&TTE REGISTRATION NUMBER: BNetzA-bS-02/51-53 FCC FILED TEST LABORATORY REG.-NO. 96970 A2LA ACCREDITED TESTING LABORATORY CERTIFICATE NO. 1983.01 BLUETOOTH QUALIFICATION TEST FACILITY (BQTF) ACCREDITED BY BLUETOOTH QUALIFICATION REVIEW BOARD INDUSTRY CANADA FILED TEST LABORATORY REG. NO. IC 3470 Statement: The tests documented within this report are carried out in accordance with the scope of accreditation of test laboratory Eurofins Product Service GmbH. 1.3 Details of approval holder Name : BIOTRONIK SE & Co. KG Street : Woermannkehre 1 Town : 12359 Berlin Country : Germany Telephone : +49 30 68905 1213 Fax : +49 30 68905 5409 Contact : Herr Gunnar Börsch Page 4 of 73 Test Report No.: G0M-1106-1164-S-1_rev01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany 1.4 Manufacturer: (if applicable) Name : BIOTRONIK SE & Co. KG Street : Woermannkehre 1 Town : 12359 Berlin Country : Germany 1.5 Application details Date of receipt of application : 09.06.2011 Date of receipt of test item : 09.06.2011 Date of test : 08.08.2011 - 10.08.2011 1.6 Test item FCC ID : QRICMII Description of test item : CardioMessenger II Type identification : CM II with G24-L Serial number : 47199999 Identical prototype Device category : PCT (Licensed Portable Transmitter Worn On Body) Technical data GSM / PCS Frequency range : GSM 850 / GPRS PCS 1900 / GPRS TX Frequency range : 824.2 - 848.8 MHz 1850.2 - 1909.9 MHz RX Frequency range : 869.2 - 893.8 MHz 1930.2 - 1989.8 MHz Max. radiated output power : 34.14 dBm (2.59 W) 26.08 dBm (0.41 W) Power supply : 3.7VDC (Lithium-Battery) Antenna Tx : integral Antenna RX : integral Additional information : Tx and Rx. antenna are the same. Page 5 of 73 Test Report No.: G0M-1106-1164-S-1_rev01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany 1.7 Test Results Max. SAR Measurement GSM (Body) : 1.41 W/kg (averaged over 1 gram) Max. SAR Measurement PCS (Body) : 1.47 W/kg (averaged over 1 gram) This EUT 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. 1528-2003, December 2003. 1.8 Test standards Standards : - IEEE Std. 1528-2003, December 2003 FCC Rule Part(s) : - FCC OET Bulletin 65, Supplement C, Edition 01-01 Page 6 of 73 Test Report No.: G0M-1106-1164-S-1_rev01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany 2 Technical test 2.1 Summary of test results Applicable Configuration Handset (Head) Handset (Body) Headset (Head) Body Worn Equipment X EUT complies with the RF radiation exposure limits of the FCC as shown by the SAR measurement results. These measurements are taken to simulate the RF effects exposure under worst-case conditions. The EUT complies with the requirements in respect to all parameters subject to the test. The test results and statements relate only to the item(s) tested. Please note that the absorption and distribution of electromagnetic energy in the body are very complex phenomena that depend on the mass, shape, and size of the body, the orientation of the body with respect to the field vectors, and the electrical properties of both the body and the environment. Other variables that may play a substantial role in possible biological effects are those that characterize the environment (e.g. ambient temperature, air velocity, relative humidity, and body insulation) and those that characterize the individual (e.g. age, gender, activity level, debilitation, or disease). Because innumerable factors may interact to determine the specific biological outcome of an exposure to electromagnetic fields, any protection guide shall consider maximal amplification of biological effects as a result of field-body interactions, environmental conditions, and physiological variables. [1] In case of multiple hotspots the secondary hotspots within 2 dB of the maximum SAR value will be recorded and displayed in the measurement plots. The secondary hotspots with a peak SAR value below 0.5 W/kg will not be measured by the system, due to the high margin to the limits. 2.2 Test environment Room temperature : 22.1 -…

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Eurofins Product Service GmbH Storkower Str. 38c, 15526 Reichenwalde, Phone +49-33631-888 0 Germany Fax +49-33631-888 660 EUROFINS PRODUCT SERVICE GMBH Testing Cert #1983.01 RADIO TEST- REPORT Compliance Test Report Medical Device Radiocommunication Service (MedRadio) FCC 47 CFR Part 95E & 95I & 15B RSS 243 Issue 3 & RSS Gen Issue 3 CardioMessenger II CM II with G24-L FCC ID: QRICMII IC: 4708A-CMII TEST REPORT NUMBER: G0M-1106-1164-C-1 Test Report No.: G0M-1106-1164-C-1 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany TABLE OF CONTENTS 1 General Information 3 1.1 Notes 3 1.2 Testing laboratory 4 1.3 Details of approval holder 5 1.4 Application details 5 1.5 Test item 5 1.6 Test standards 6 1.7 Additional information 6 1.8 Acronyms and Abbreviations 6 2 Technical test 7 2.1 Summary of test results 7 2.2 Test environment 7 2.3 Test equipment utilized 8 2.4 Sample emission level calculation 9 2.5 Test results 10 3 Transmitter parameters 11 3.1 Equivalent isotropic radiated power 12 3.2 Transmitter radiated spurious emissions 14 3.3 Receiver parameters 17 3.4 Receiver spurious emissions 17 Annex A Photos 19 Annex B Transmitter spurious emissions 22 Annex C Receiver spurious emissions 51 Page 2 of 57 Page 3 of 57 Test Report No.: G0M-1106-1164-C-1 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany 1.2 Testing laboratory EUROFINS PRODUCT SERVICE GMBH Storkower Strasse 38c D-15526 Reichenwalde b. Berlin Germany Telefon : +49 33631 888 00 Telefax : +49 33631 888 660 DAR ACCREDITED TESTING LABORATORY DAR-R EGISTRATION NUMBER: DAT-P-268/08 R ECOGNIZED NOTIFIED BODY EMC R EGISTRATION NUMBER: BNetzA-bS EMV-07/61 R ECOGNIZED NOTIFIED BODY R&TTE R EGISTRATION NUMBER: BNetzA-bS-02/51-53 FCC FILED TEST LABORATORY R EG.-NO. 96970 A2LA ACCREDITED TESTING LABORATORY C ERTIFICATE NO. 1983.01 B LUETOOTH QUALIFICATION TEST FACILITY (BQTF) A CCREDITED BY BLUETOOTH QUALIFICATION REVIEW BOARD I NDUSTRY CANADA FILED TEST LABORATORY R EG. NO. IC 3470 Test location, where different: Name : ./. Street : ./. Town : ./. Country : ./. Telephone : ./. Fax : ./. Page 4 of 57 Test Report No.: G0M-1106-1164-C-1 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany 1.3 Details of approval holder Name : BIOTRONIK SE & Co. KG Street : Woermannkehre 1 Town : 12359 Berlin Country : Germany Telephone : +49 30 68905 1213 Fax : +49 30 68905 5409 Contact : Herr Gunnar Börsch 1.4 Application details Date of receipt of application : 09.06.2011 Date of receipt of test item : 09.06.2011 Date of test : 30.06.2011 1.5 Test item Description of test item : CardioMessenger II Type identification : CM II with G24-L Hardware Version : CardioMessenger II (CE): DMR 356073 (with G24-L) CardioMessenger II LLT (CA): DMR 358226 (with G24-L) CardioMessenger II LLT (US): DMR 359592 (with G24-L) Software Version : 0.6X Equipment type : End product Technical data Frequency range : 402 - 405MHz Number of channels : 9 Channel spacing : 300kHz Assigned frequency band : 402 – 405MHz, Power limit: 25μW e.i.r.p. Tested frequencies : F 1 402.45MHz F 2 403.65MHz F 3 404.85MHz Antenna : integrated, antenna diversity Number of antennas : 2 Antenna gain(s) : 0dBi Duty cycle : N/A (LTB is used for channel selection) Spectrum access : LBT (Listen before transmit) Modulations : 2GSK Supply voltage : 3.7VDC (Lithium-Battery) Page 5 of 57 Test Report No.: G0M-1106-1164-C-1 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Manufacturer: (if applicable) Name : BIOTRONIK SE & Co. KG Street : Woermannkehre 1 Town : 12359 Berlin Country : Germany 1.6 Test standards Technical standard : FCC 47 CFR Part 95E, most current CFR (eCFR) Personal Radio Services, Technical Regulations FCC 47 CFR Part 95I, most current CFR (eCFR) Medical Device Radiocommunication Service (MedRadio) FCC 47 CFR Part 15B, most current CFR (eCFR) Unintentional Radiators IC RSS 243 Issue 3 February 2010 Medical Devices Operating in the 401-406MHz Frequency Band IC RSS Gen Issue 3 December 2010 General Requirements and Information for the Certification of Radio Apparatus 1.7 Additional information The GSM module also integrated into the device has been replaced. All former resuts except spurious emissions are considered unaffected by this modification. 1.8 Acronyms and Abbreviations EUT : Equipment under Test TX : Transmission RX : Reception RBW : Measurement Resolution Bandwidth Pol : Measurement Polarization e.i.r.p. : Equivalent isotropic radiated power T nom : Nominal Temperature T min : Minimum Temperature T max : Maximum Temperature V nom : Nominal Supply Voltage V min : Minimum Supply Voltage V max : Maximum Supply Voltage VDC : DC voltage N/A : Not applicable Page 6 of 57 Test Report No.: G0M-1106-1164-C-1 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany 2 Technical test 2.1 Summary of test results No deviations from the technical specification(s) were ascertained in the course of the tests performed. or The deviations as specified in 2.4 were ascertained in the course of the tests performed. 2.2 Test environment Temperature : 22 ... 26°C Relative humidity content : 20 ... 75% Air pressure : 86 ... 103kPa Extreme conditions parameters: V nom : 3.7VDC V min : -- V max : -- T nom : 25°C T min : -- T max : -- Other parameter: None Page 7 of 57 Test Report No.: G0M-1106-1164-C-1 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany 2.3 Test equipment utilized Measurement Equipment List No. Measurement device: Type: Manufacturer: Last Cal. Next Cal. ETS 0086 Semi-anechoic chamber AC1 Frankonia 09.12.2010 09.12.2012 ETS 0253 Spectrum Analyzer FSIQ26 Rohde & Schwarz 04.11.2010 04.11.2012 ETS 0030 Biconical Antenna HK 116 Rohde & Schwarz 10.02.2011 20.02.2012 ETS 0295 LPD Antenna HL 223 Rohde & Schwarz 09.02.2011 09.02.2012 ETS 0018 Horn Antenna BBHA 9120D Schwarzbeck 26.08.2010 26.08.2011 ETS 0432 Amplifier-Matrix 02.06.2010 02.06.201…

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