QRIBM2BioMonitor 2-AF, BioMonitor 2-S

B"oMon"tor 2Implantable card"ac mon"tor w"th Home Mon"tor"ngImplant"erbarer Herzmon"tor m"t Home Mon"tor"ngMon"tor card"aco "mplantable con Home Mon"tor"ngMon"teur card"aque "mplantable avec Téléc=rd"olog"e Techn&cal manual ,ebrauchsanwe&sung Manual técn&co Manuel t echn&que • en• de • es• fr ( ) BIOTRONIK SE & CoD K,Woermannkehre 112359 Berl&n L ,ermanyTel +49 (0) 30 68905U0Fax +49 (0) 30 6852804salesXb&otron&kDcomwwwDb&otron&kDcom 14UDUxxRev&s&on[  (2014U09U05) © BIOTRONIK SE & CoD K, All r&ghts reservedD Spec&_cat&ons sub`ect to mod&_cat&on, rev&s&on and &mprovementD® BIOTRONIK Home Mon&tor&ng and ProMRI are reg&stered trademarks of BIOTRONIK SE & CoD K, 01230681 2015 1 BioMonitor 2Implantable cardiac monitor with Home MonitoringTechnical manual for the deviceGA8HW_en_  8 [[ _BioMonitor 2_(ProMRI) I ndex GA8HW_en88mul_3786228E_BioMonitor8ProMRI Technical manual for the deviceBioMonitor Table of Contents Table of Contents Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2 Intended Medical Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2System Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Diagnostic Functions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 General Safety Instructions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 Operating Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4Possible Complications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Possible Risks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Implantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6 Implantation Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Follow8up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Patient Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7Replacement Indications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Explantation and Device Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9 Arrhythmia Detection Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Home Monitoring Parameter Settings. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Technical Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11 Mechanical Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Electrical Characteristics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Battery Data. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12Legend for the Label. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 2 1 Product Description Product Description1GA8HW_en88mul_3786228E_BioMonitor8ProMRITechn ical manual f or the deviceBioMonitorIntended Medical UseIntended useBioMonitor 2 is the name of an implantable cardiac monitor for the monitoring of heart rhythm. Its primary purpose is to provide early detection and diagnostics of symptoms of arrhythmias, such as atrial fibrillation and the causes of syncope, which can be mani8fested clinically.Form of diagnosisThe heart rhythm is continuously monitored; the possible detection types are atrial fibrillation, high ventricular rate, asystole, or bradycardia. Depending on the preset parameters, subcutaneous ECGs and other data are recorded.The patient can also initiate a recording of a subcutaneous ECG.BIOTRONIK Home Monitoring ® enables physicians to perform a multi8year diagnosis management at any time. Required expertiseIn addition to having basic medical knowledge, the user must be thoroughly familiar with the operation of the implantable cardiac monitor and the specified conditions for its use. Only qualified medical specialists having the special knowledge are permitted to implant the BioMonitor 2 and make diagnoses.Guidelines of cardiological societiesIt is recommended that the indications published by the German Cardiac Society (Deutsche Gesellschaft für Kardiologie, Herz8 und Kreislaufforschung) and the ESC (European Society of Cardiology) are observed. This also applies to the guidelines published by the Heart Rhythm Society (HRS), the American College of Cardiology (ACC), the American Heart Association (AHA), and other national cardiology associa8tions. Indications• Clinical symptoms or increased risk of cardiac arrhythmias • Temporary symptoms that may indicate cardiac arrhythmia ContraindicationsThere are no known contraindications.However, the particular patient's state of health determines whether a subcutaneous device will be tolerated long8term.System OverviewDevice familyBioMonitor 2 is a cardiac monitor.The device family consists of BioMonitor 28AF and BioMonitor 28S. Not all device types are available in ecvery country.PartsThe system consists of the following parts:• Device with electrode integrated in the header and insertion tool • Programmer • Current software version for the implanted device • Remote Assistant for the patient Cardiac monitorThese devices have a retrospective loop memory, which continuously records the last minutes o…

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External Photos page 1 Model No.: BioMonitor 2-AF Parylene Coated, BioMonitor 2-AF Silicone Coated BioMonitor 2-S Parylene Coated, BioMonitor 2-S Silicone Coated FCC ID: QRIBM2 IC: 4708A-BM2 Project No.: G0M-1406-3876

Test Report No.: G0M-1406-3876-TFC95IMR-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 1 of 79 FCC TEST REPORT FCC 47 CFR Part 95I Medical Device Radiocommunication Service (MedRadio) Industry Canada RSS-243 Medical Devices Operating in the 401 – 406 MHz Frequency Band Report Reference No. ..................... : G0M-1406-3876-TFC95IMR-V01 Testing Laboratory ......................... : Eurofins Product Service GmbH Address ............................................. : Storkower Str. 38c 15526 Reichenwalde Germany Accreditation ..................................... : A2LA Accredited Testing Laboratory, Certificate No.: 1983.01 FCC Filed Test Laboratory, Reg.-No.: 96970 IC OATS Filing assigned code: 3470A Applicant’s name ............................ : Biotronik SE & Co. KG Address ............................................. : Woermannkehre 1 12359 Berlin GERMANY Test specification: Standard ........................................... : 47 CFR Part 95E 47 CFR Part 95I 47 CFR Part 15C RSS-243, Issue 3, 2010-02 RSS-Gen, Issue 3, 2010-12 ANSI C63.4:2009 EN 301 839-1 V1.3.1:2009-10 Equipment under test (EUT): Product description Implantable Cardiac Monitor Model No. BioMonitor 2-AF Silicone Coated Additional Model(s) BioMonitor 2-AF Parylene Coated, BioMonitor 2-S Parylene Coated, BioMonitor 2-S Silicone Coated Brand Name(s) Biotronik Hardware version ASM-0206, Rev A Firmware / Software version RAM: 7447_30_0301 / UpROM:7300_20_0102 FCC-ID: QRIBM2 IC: 4708A-BM2 Test result Passed Test Report No.: G0M-1406-3876-TFC95IMR-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 3 of 79 Version History Version Issue Date Remarks Revised by 01 2014-09-24 Initial Release Test Report No.: G0M-1406-3876-TFC95IMR-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 4 of 79 REPORT INDEX 1 EQUIPMENT (TEST ITEM) DESCRIPTION 5 1.1 Photos - Equipment external 7 1.2 Photos - Equipment internal 8 1.3 Photos – Test setup 9 1.4 Photos – Auxiliary/Associated Equipment 10 1.5 Supporting Equipment Used During Testing 11 1.6 Test Modes 12 1.7 Test Equipment Used During Testing 13 1.8 Sample emission level calculation 14 1.9 Simulated human body 15 2 RESULT SUMMARY 16 3 TEST CONDITIONS AND RESULTS 17 3.1 Test Conditions and Results – Occupied Bandwidth 17 3.2 Test Conditions and Results – Emission Bandwidth 21 3.3 Test Conditions and Results – Frequency stability 25 3.4 Test Conditions and Results – Transmitter output power 27 3.5 Test Conditions and Results – Band-edge compliance 29 3.6 Test Conditions and Results – Transmitter unwanted emissions 31 3.7 Test Conditions and Results – Receiver spurious emissions 33 3.8 Test Conditions and Results – Discontinuation of MICS or MEDS session 35 ANNEX A Transmitter radiated power 38 ANNEX B Transmitter radiated spurious emissions 50 ANNEX C Receiver radiated spurious emissions 74 Test Report No.: G0M-1406-3876-TFC95IMR-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 5 of 79 1 Equipment (Test item) Description Description Implantable Cardiac Monitor Model BioMonitor 2-AF Silicone Coated Additional Model(s) BioMonitor 2-AF Parylene Coated, BioMonitor 2-S Parylene Coated, BioMonitor 2-S Silicone Coated Brand Name(s) Biotronik Serial number 91200433 Hardware version ASM-0206, Rev A Software / Firmware version RAM: 7447_30_0301 / UpROM:7300_20_0102 FCC-ID QRIBM2 IC 4708A-BM2 Equipment type End product Radio type Transceiver Number of Radios 1 Radio technology MedRadio (MICS) active medical implant Operating frequency range 402.45 - 405.85 MHz Assigned frequency band 402 - 405 MHz Main test frequencies F LOW 402.45 MHz F MID 403.65 MHz F HIGH 404.85 MHz Modulations FSK Emission designator F1D Number of channels 9 Channel spacing 300 kHz Spectrum access LBT/AFA (channel access controlled by ULP-AMI-P device outside the human body) Number of antennas 1 Antenna Type integrated Model wire antenna Manufacturer see Manufacturer Gain -27 dBi (Determined by measurements) Manufacturer Biotronik SE & Co. KG Woermannkehre 1 12359 Berlin GERMANY Test Report No.: G0M-1406-3876-TFC95IMR-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 6 of 79 Power supply V NOM 3.0 VDC V MIN 2.0 VDC V MAX 3.5 VDC Temperature T NOM 37 °C T MIN 25 °C T MAX 45 °C AC/DC-Adaptor Model N/A Vendor N/A Input N/A Output N/A Test Report No.: G0M-1406-3876-TFC95IMR-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 11 of 79 1.5 Supporting Equipment Used During Testing Product Type* Device Manufacturer Model No. Comments AE1 Programming Wand Biotronik PGH3000 EUT programming AE2 Telex USB Stick Biotronik Hermes 2D Companion device *Note: Use the following abbreviations: AE : Auxiliary/Associated Equipment, or SIM : Simulator (Not Subjected to Test) CABL : Connecting cables Test Report No.: G0M-1406-3876-TFC95IMR-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 12 of 79 1.6 Test Modes Mode # Description Unmodulated General conditions: EUT powered on. Radio conditions: Mode = standalone transmit Spreading = None Modulation = None Duty cycle = 100 % Power level = Maximum Modulated General conditions: EUT powered on. Radio conditions: Mode = standalone transmit Modulation = FSK Duty cycle = 100 % Power level = Maximum Monitoring General conditions: EUT powered on... EUT adjusted to monitoring conditions for companion device. Radio conditions: Mode = standalone transmit Modulation = FSK Duty cycle = normal Receive General conditions: EUT powered on. Radio conditions: Mode = standalone receive Modulation = FSK Test Report No.: G0M-1406-3876-TFC95IMR-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 13 of 79 1.7 Test Equipment Used During Testing Measurement Software Description Manufacturer Name Version EMC Test Softwar…

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Test Report No.: G0M-1406-3876-TFC209LP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 1 of 23 FCC TEST REPORT FCC 47 CFR Part 15C Industry Canada RSS-310 License exempt radio equipment Report Reference No. ..................... : G0M-1406-3876-TFC209LP-V01 Testing Laboratory ......................... : Eurofins Product Service GmbH Address............................................. : Storkower Str. 38c 15526 Reichenwalde Germany Accreditation ..................................... : A2LA Accredited Testing Laboratory, Certificate No.: 1983.01 FCC Filed Test Laboratory, Reg.-No.: 96970 IC OATS Filing assigned code: 3470A Applicant’s name ............................ : Biotronik SE & Co. KG Address............................................. : Woermannkehre 1 12359 Berlin GERMANY Test specification: Standard ........................................... : 47 CFR Part 15C RSS-310, Issue 3, 2010-12 RSS-Gen, Issue 3, 2010-12 ANSI C63.4:2009 Equipment under test (EUT): Product description Implantable Cardiac Monitor Model No. BioMonitor 2-AF Parylene Coated Additional Model(s) BioMonitor 2-AF Silicone Coated, BioMonitor 2-S Parylene Coated, BioMonitor 2-S Silicone Coated Brand Name(s) Biotronik Hardware version ASM-0206, Rev A Firmware / Software version RAM: 7447_30_0301 / UpROM:7300_20_0102 FCC-ID: QRIBM2 IC: 4708A-BM2 Test result Passed Test Report No.: G0M-1406-3876-TFC209LP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 3 of 23 Version History Version Issue Date Remarks Revised by 01 2014-09-24 Initial Release Test Report No.: G0M-1406-3876-TFC209LP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 4 of 23 REPORT INDEX 1 EQUIPMENT (TEST ITEM) DESCRIPTION 5 1.1 Photos – Equipment External 6 1.1 Photos - Equipment internal 7 1.2 Photos – Test setup 8 1.3 Supporting Equipment Used During Testing 9 1.4 Test Modes 10 1.5 Test Equipment Used During Testing 11 1.6 Sample emission level calculation 12 2 RESULT SUMMARY 13 3 TEST CONDITIONS AND RESULTS 14 3.1 Test Conditions and Results – Occupied Bandwidth 14 3.2 Test Conditions and Results – Fundamental field strength emissions 16 3.4 Test Conditions and Results – Receiver radiated emissions 18 ANNEX A Transmitter radiated spurious emissions 20 ANNEX B Receiver radiated spurious emissions 22 Test Report No.: G0M-1406-3876-TFC209LP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 5 of 23 1 Equipment (Test item) Description Description Implantable Cardiac Monitor Model BioMonitor 2-AF Parylene Coated Additional Model(s) BioMonitor 2-AF Silicone Coated, BioMonitor 2-S Parylene Coated, BioMonitor 2-S Silicone Coated Brand Name(s) Biotronik Serial number None Hardware version ASM-0206, Rev A Software / Firmware version RAM: 7447_30_0301 / UpROM:7300_20_0102 FCC-ID QRIBM2 IC 4708A-BM2 Equipment type End product Radio type Transceiver Radio technology custom Operating frequency range 64 kHz Frequency range F MID 64 kHz Modulations OOK Number of channels 1 Channel spacing None Number of antennas 1 Antenna Type integrated Model unspecified Manufacturer Biotronik SE & Co. KG Gain unspecified Manufacturer Biotronik SE & Co. KG Woermannkehre 1 12359 Berlin GERMANY Power supply V NOM 3.0 VDC (Lithium-Battery) V MIN N/A V MIN N/A AC/DC-Adaptor Model N/A Vendor N/A Input N/A Output N/A Test Report No.: G0M-1406-3876-TFC209LP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 9 of 23 1.3 Supporting Equipment Used During Testing Product Type* Device Manufacturer Model No. Comments AE1 Programming Wand Biotronik PGH3000 EUT programming AE2 Telex USB Stick Biotronik Hermes 2D Companion device *Note: Use the following abbreviations: AE : Auxiliary/Associated Equipment, or SIM : Simulator (Not Subjected to Test) CABL : Connecting cables Test Report No.: G0M-1406-3876-TFC209LP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 10 of 23 1.4 Test Modes Mode # Description Single General conditions: EUT powered by fully charged battery Radio conditions: Mode = standalone transmit Modulation = OOK Power level = Maximum Receive General conditions: EUT powered by fully charged battery Radio conditions: Mode = standalone receive Modulation = OOK Test Report No.: G0M-1406-3876-TFC209LP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 11 of 23 1.5 Test Equipment Used During Testing Measurement Software Description Manufacturer Name Version EMC Test Software Dare Instruments Radimation 2014.1.15 Occupied Bandwidth Description Manufacturer Model Identifier Cal. Date Cal. Due Spectrum Analyzer R&S FSP 30 EF00312 2014-02 2015-02 Field strength emissions Description Manufacturer Model Identifier Cal. Date Cal. Due Semi-anechoic chamber Frankonia AC 1 EF00062 2013-01 2015-01 Spectrum Analyzer R&S FSIQ26 EF00242 2014-03 2015-03 Biconical Antenna R&S HK 116 EF00012 2013-02 2016-02 LPD Antenna R&S HL 223 EF00187 2014-03 2017-03 LPD Antenna R&S HL 025 EF00327 2013-02 2016-02 Test Report No.: G0M-1406-3876-TFC209LP-V01 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Page 12 of 23 1.6 Sample emission level calculation The following is a description of terms and a sample calculation, as appears in the radiated emissions data table. The numbers used in the calculation are for example only. There is no direct correlation to the specific data taken for the product described in this document: Reading: This is the reading obtained on the spectrum analyzer in dBμV. Any external preamplifiers used are taken into account through internal analyzer settings. A.F.: This is the antenna factor for the receiving antenna. It is a conversion factor, which converts electric fields strengths to voltages, which can be measured directly on the spectrum analyzer. It is treated as a loss in dB. Cable losse…

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T-Sup Photo page 1 Model No.: BioMonitor 2-AF Parylene Coated, BioMonitor 2-AF Silicone Coated BioMonitor 2-S Parylene Coated, BioMonitor 2-S Silicone Coated FCC ID: QRIBM2 IC: 4708A-BM2 Project No.: G0M-1406-3876