QRISAFESYNCSafeSync Module

Revision: D (2011-04-26) 11-D-xx © by BIOTRONIK SE & Co. KG Alle Rechte vorbehalten. Technische Änderungen vorbehalten BIOTRONIK SE & Co. KG Woermannkehre 1 12359 Berlin · Germany Tel +49 (0) 30 68905-0 Fax +49 (0) 30 6852804 [email protected] www.biotronik.com SafeSync Module Erweiterungsmodul für Programmiergeräte zur drahtlosen Kommunikation Cardiac Rhythm Management External Devices Gebrauchsanweisung 380184--D_GA_SafeSyncModule_de_Cover_2011-04-xx.indd 1-223.05.2011 12:28:48 Table of Contents3 Table of Contents Table of Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 About the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 About this Technical Manual . . . . . . . . . . . . . . . . . . . . . . 8 Safety During Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Intended Medical Use . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Required Expertise . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Residual Risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 General Safety Instructions. . . . . . . . . . . . . . . . . . . . . . 13 Electromagnetic Interference. . . . . . . . . . . . . . . . . . . . 14 Operating Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Maintenance, Care and Disposal . . . . . . . . . . . . . . . . . 18 Startup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Device Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 Transportation and Setup . . . . . . . . . . . . . . . . . . . . . . . 23 Connections and Cables . . . . . . . . . . . . . . . . . . . . . . . . 24 Unit Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 Technical Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Scope of Delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Electromagnetic Compatibility in Compliance with EN 60601-1-2:2007 . . . . . . . . . . . . . . . . . . . . . . . . 38 Legend for the Label . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 Symbols on the Device. . . . . . . . . . . . . . . . . . . . . . . . . . 44 Directories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 List of Keywords. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 4Table of Contents Introduction5 1Introduction Introduction1380184-DDoc-classECM--SafeSync Module What's in this chapter? This chapter contains the following topics: TopicPage About the Device6 About this Technical Manual8 6Introduction About the Device General descrip- tion The SafeSync Module can be connected to the ICS 3000 and Renamic programmers and permits: A wandless telemetry connection (SafeSync RF telemetry) between the programmer and devices with the BIOTRONIK SafeSync function and Optional communication with networks via the cellular phone network or WLAN (depending on the software version of the programmer). Devices with the BIOTRONIK SafeSync function are equipped with a special transmitter and receiver (1). This sends all the relevant information to the SafeSync Module (2), which then forwards the infor- mation to the programmer (3). The device also receives all information that the programmer forwards to the SafeSync Module for transmission. Fig. 1:SafeSync function principle It is used during the implantation procedure and follow-up of implantable pacemakers and ICDs (implantable cardioverter-defibrillators) with the BIOTRONIK SafeSync function. Primary function The device extends the programming devices of BIOTRONIK to include the following functions: FunctionPurpose BIOTRONIK SafeSync function Wandless telemetry connection (SafeSync RF telemetry) for interrogating, testing and programming pacemakers and ICDs with the BIOTRONIK SafeSync function Introduction7 Other functions (depending on the software version of the programmer) The device extends the programming devices of BIOTRONIK to include the following functions: FunctionPurpose Data transferExporting the follow-up data in hospital or private practice networks Update functionDownloading the latest, approved software version for the programmer from BIOTRONIK 8Introduction About this Technical Manual Objective This technical manual provides the user with all the safety information required to use the device. The following topics are covered in this manual: Device startup Target group This technical manual is intended for physicians and trained medical personnel who are familiar with the following: The use of implantable pulse generators and ICDs The risks and possible complications associated with using these systems Additional requirements include: Medical knowledge: - Basic medical knowledge of the therapy applied - Training in the handling and programming of implantable pulse generators and ICDs Technical knowledge: - Ability to work with a PC - Ability to use software-controlled medical devices Other technical manuals To ensure the safe and correct use of the device, you must follow these additional instructions: The technical manual for the programmer Technical software manual for programming the intended implantable pulse generator / ICD Technical manual for the intended implantable pulse generator / ICD Safety During Use9 2Safety During Use Safety During Use2380184-DDoc-classECM--SafeSync Module What's in this chapter? This chapter contains the following topics: TopicPage Intended Medical Use10 Required Expertise11 Residual Risk12 General Safety Instructions13 Electromagnetic Interference14 Operating Conditions16 Maintenance, Care and Disposal18 10Safety During Use Intended M…

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Test Report No.: G0M21010-3780-T-47 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Appendix A Photos EUT FRONT EUT BACK Page 29 of 123 Test Report No.: G0M21010-3780-T-47 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany EUT SIDE VIEW EUT WITHOUT FRONT CASE Page 30 of 123

Test Report No.: G0M21010-3780-INTERN PICTURES Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany PCB WLAN MODULE FRONT EUT MAIN PCB WLAN MODULE BACK Test Report No.: G0M21010-3780-INTERN PICTURES Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany EUT MAIN PCB GSM MODULE FRONT EUT MAIN PCB GSM MODULE BACK Test Report No.: G0M21010-3780-INTERN PICTURES Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany EUT MAIN PCB WITHOUT SHIELDINGS FRONT

EUROFINS PRODUCT SERVICE GMBH Testing Cert #1983.01 TEST - REPORT FCC RULES PART 15 / SUBPART B IC RSS-GEN ISSUE 2 SafeSync Module ECM Test report no.: G0M21010-3780-C-3 Eurofins Product Service GmbH Storkower Str. 38c, 15526 Reichenwalde, Phone +49-33631-888 0 Germany Fax +49-33631-888 660 Test Report No.: G0M21010-3780-C-3 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany TABLE OF CONTENTS 1 General Information 3 1.1 Notes 3 1.2 Operator: 5 1.3 Testing laboratory 6 1.3.1 Location 6 1.3.2 Details of accreditation status 6 1.3.3 Test location, where different 6 1.4 Details of applicant 7 1.5 Application details 7 1.6 Test item 7 1.6.1 Description of test item 7 1.6.2 Manufacturer (if different from applicant in point 1.4) 8 1.6.3 Frequency behavior 8 1.7 Test standards 8 2 Technical test 9 2.1 Summary of test results 9 2.2 Test environment 9 2.3 Test results 10 2.4 Test equipment utilized 11 2.4.1 Conducted Emission 12 2.4.2 Spurious Emission 13 2.5 Test protocols 14 3 Normative references 26 Annex A : Pictures 28 Page 2 of 30 Test Report No.: G0M21010-3780-C-3 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany 1 General Information 1.1 Notes The purpose of conformity testing is to increase the probability of adherence to the essential requirements or conformity specifications, as appropriate. The tests were carried out and passed in accordance to the standards: FCC part 15B IC RSS-Gen Issue 2 The results of this test report relate exclusively to the item tested as specified in chapter “Description of test item” and are not transferable to any other test items. Eurofins Product Service GmbH is not responsible for any generalisations and conclusions drawn from this report. Any modification of the test item can lead to invalidity of test results and this test report may therefore be not applicable to the modified test item. The test report may only be reproduced or published in full. Reproducing or publishing extracts of the report requires the prior written approval of the Eurofins Product Service GmbH. This document is subject to the General Terms and Conditions and the Testing and Certification System of Eurofins Product Service GmbH, available on request or accessible at www.pt.eurofins.com . Page 3 of 30 Test Report No.: G0M21010-3780-C-3 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Important Notes: Proper labeling is required for each device. Devices shall be labeled in accordance with labeling requirements pursuant to section 15.19 and section 2.1074 of the FCC rules. Devices subject to a Declaration of Conformity shall be uniquely identified by the responsible party. This identification shall not be of a format which could be confused with the FCC Identifier required on certified, notified type accepted or type approved equipment. The responsible party shall maintain adequate identification records to facilitate positive identification for each device. The user manual or instruction manual shall included also a warning statement that changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. Reference Section 15.21 Furthermore information to the user regarding to the interference potential of the device and about simple measures that can be taken to correct interference is required. Reference Section 15.105 The responsible party must warrant that each unit of equipment marketed under a Declaration of Conformity is identical to the unit tested and found acceptable with the standards and that the records maintained by the responsible party continue to reflect the equipment being produced under the Declaration of Conformity within the variation that can be expected due to quantity production and testing on a statistical basis. Page 4 of 30 Page 5 of 30 Test Report No.: G0M21010-3780-C-3 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany 1.3 Testing laboratory 1.3.1 Location EUROFINS PRODUCT SERVICE GMBH STORKOWER STR. 38c D- 15526 REICHENWALDE B. BERLIN GERMANY Telephone: + 49 33631 888-00 Telefax: + 49 33631 888-660 1.3.2 Details of accreditation status 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 3470A 1.3.3 Test location, where different Name : ./. Street : ./. Town : ./. Country : ./. Telephone : ./. Fax : ./. Page 6 of 30 Test Report No.: G0M21010-3780-C-3 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany 1.4 Details of applicant Name : BIOTRONIK SE & Co. KG Street : Woermannkehre 1 Town : 12359 Berlin Country : Germany Telephone : 030/68905-1213 Contact : Herr Wolfgang Buske Telephone : 030/689054440 1.5 Application details Date of receipt of application : 18.10.2010 Date of receipt of test item : 18.10.2010 Date of test : 18 - 19.10.2010 1.6 Test item 1.6.1 Description of test item Type of product : SafeSync Module Type identification : ECM Hardware Version : HW0000_0002_0000 Software Version : C_1_X_X Photos : Please find in Annex. Power supply : 5VDC (supplied via USB-Bus) Antenna type : internal antenna Additional information : ./. Page 7 of 30 Test Report No.: G0M21010-3780-C-3 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany 1.6.2 Manufacturer (if different from applicant in point 1.4) Name : BIOTRONIK SE & Co. KG Street : Woermannkehre 1 Town : 12359 Berlin Country : Germany 1.6.3 Frequency behavior Highest clock Frequency 500MHz < f < 1000MHz 1.7 Test standards FCC part 15B IC RSS-Gen Iss…

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EUROFINS PRODUCT SERVICE GMBH RADIO TEST - REPORT EUROPEAN STANDARD EN 301 839 FCC RULES PARTS 95 Subpart I IC RADIO STANDARDS RSS-243 FCC ID:QRISAFESYNC IC ID:4708A-SAFESYNC SafeSync Module ECM TEST REPORT NUMBER : G0M21010-3780-T-47 Eurofins Product Service GmbH Storkower Str. 38c, 15526 Reichenwalde, Phone +49-33631-888 0 Germany ́ Fax +49-33631-888 660 Test Report No.: G0M21010-3780-T-47 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany TABLE OF CONTENT 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 2 Technical test 7 2.1 Summary of test results 7 2.2 Test environment 7 2.3 Test Information 8 2.4 Test equipment utilized 9 2.5 Test results 10 3 Transmitter parameter 11 3.1 Frequency error 11 3.2 Emission bandwidth 12 3.3 Effective radiated power (e.r.p.) 13 3.4 Spurious emissions 14 3.5 Frequency stability under low voltage conditions 15 3.6 Unwanted radiation 16 3.7 Conducted Measurements AC power line 19 4 Receiver parameter 20 4.1 Spurious radiation 20 4.2 Monitoring system threshold power level 21 4.3 Monitoring system bandwidth 22 4.4 Scan cycle time 23 4.5 Minimum channel monitoring period 24 4.6 Channel access 25 4.7 Discontinuation of MICS session 26 4.8 Use of pre-scanned alternate channel 27 4.9 Radiated emission 28 Annex A Photos 29 Annex B Measurement diagrams “20dB Emission bandwidth” 37 Annex C Measurement diagrams “Occupied bandwidth” 44 Annex D Measurement diagrams “Radiated power” 51 Annex E Measurement diagrams “Transmitter spurious emissions, Europe” 62 Annex F Measurement diagrams “Transmitter spurious emissions, FCC” 75 Annex G Measurement diagrams “Band edge emissions” 100 Annex H Measurement diagrams “AC power line conducted emissions” 103 Annex I Measurement diagrams “Receiver spurious emissions, Europe” 106 Annex J Measurement diagrams “Receiver spurious emissions, Canada” 115 Page 2 of 123 Page 3 of 123 Test Report No.: G0M21010-3780-T-47 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 66 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 from Eurofins Name: ./. Street: ./. Town: ./. Country: ./. Telephone: ./. Fax: ./. Page 4 of 123 Test Report No.: G0M21010-3780-T-47 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 (0)30 68905 1213 Fax: +49 (0)30 68905 5409 Contact Herr Gunnar Börsch Telephone: +49 (0)30 68905 1213 1.4 Application details Date of receipt of application: 18.10.2010 Date of receipt of test item: 18.10.2010 Date of test: 21.10.2010 – 26.10.2010 1.5 Test item Description of test item: SafeSync Module Type identification: ECM Hardware Version: QM Plan 376502 vom 27.10.2010 Software Version: C_1_X_X Frequency range: 402MHz – 405MHz Antenna: internal Antenna gain: 0dBi Photos: see Annex Page 5 of 123 Test Report No.: G0M21010-3780-T-47 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany Manufacturer: Name: BIOTRONIK SE & Co. KG Street: Woermannkehre 1 Town: 12359 Berlin Country: Germany 1.6 Test standards Technical standard : EN 301 839-1 V1.3.1 : 2009-10 EN 301 839-2 V1.3.1 : 2009-10 FCC Part 95 Subpart I : : 2009-10 RSS-243 Issue 3 : 2010-02 FCC Part 15 : 2009-10 Page 6 of 123 Test Report No.: G0M21010-3780-T-47 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: 18 ... 25 o C Relative humidity content 20 ... 75% Air pressure: 860 ... 1030hPa Details of power supply: 100 - 240VAC / 50-60Hz Extrem conditions parameters: Voltage EN V nom :5VDC (supplied via USB-Bus) V min :- V max :- Voltage FCC/IC V nom :5VDC (supplied via USB-Bus) V min :- V max :- Temperature T nom :25°C T min :10°C T max :40°C Page 7 of 123 Test Report No.: G0M21010-3780-T-47 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany 2.3 Test Information Test monitoring test’s are performed using out-of-operation region disturbances. These Out-of-operation – region disturbances are generated by: a.) RF disturbing signals or fields … b.) Simulation by frequency administration commands ⌧ The manufacturer declares that the device SafeSync Module ECM uses transceiver diversity operation. The EUT contains two sperated transceivers and antennas. Each transceiver uses one antenna exclusively. Ther- fore all RF-Parameters are measured for both transceivers. The monitoring parameters are primarily deter- mined by firmware settings of the device and are only verified for one of the transceivers. The manufactuer declares that a supply voltage variation up to ±10% on the AC side only results in a non significant voltage variation less than ±1% for the voltages internally used by the device. To that end only temperature variation has been tested. All the tests acc. EN 301 839 and the monitoring tests acc. EN and FCC/IC are done only at an operating frequency of 403,65 MHz (app. middle of band). Page …

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Test Report No.: G0M21010-3780-T-47 Eurofins Product Service GmbH Storkower Str. 38c, D-15526 Reichenwalde, Germany TEST SETUP : RADIATED EMISSIONS TEST SETUP : CONDUCTED EMISSIONS Page 36 of 123