SJ3MHG0482Remote Control for low limp hightech prostheses

3C98-1/3C88-1 C-Leg® Knee Joint System Instructions for Use.......................................................... 2 © Otto Bock HealthCare · 647H215=GB Ž 07.06/1 Ž PDF Ž Printed in Germany 3 Table of Contents tion................................................................................................24 1.1Medical purpose......................................................................................................................24 1.2Field of application ..................................................................................................................24 1.3Operational conditions.............................................................................................................25 1.4Qualification of the prosthetist .................................................................................................25 1.5Safety instructions ...................................................................................................................25 .....................................................................................................27 2.1Connecting the tube adapter .................................................................................................27 2.2Bench alignment with the alignment tool (e.g. with LASAR Assembly)......................................28 2.2.1Checking the socket after bench alignment..............................................................................29 2.3Torque values of the screw connections ..................................................................................30 2.4Charging the C-Leg ® knee joint system ...................................................................................31 2.5 Static alignment optimization (with LASAR Posture).................................................................32 2.6BionicLink/optional: Serial data cable......................................................................................33 2.7C-Soft .....................................................................................................................................33 2.7.1C-Soft in the Otto Bock Data Station (back folded page) ........................................................34 2.7.2Otto Bock C-Soft (back folded page) ......................................................................................34 2.8Optional: Parameter settings with foam cover and C-Soft........................................................35 2.9Remote control and switching into 2 nd mode ............................................................................35 2.9.1Switching modes with the remote control .................................................................................36 2.9.2Configuration of the standing mode and the 1 st mode with remote control ................................36 2.9.3Changing the battery of the remote control ..............................................................................37 2.9.4Optional: Switching between 1 st mode and 2 nd mode without the remote control ......................38 2.10Finalizing the prosthesis...........................................................................................................38 2.11Important user instructions.......................................................................................................38 3Additional Information............................................................................................................40 3.1Service intervals ......................................................................................................................40 3.2Damage events .......................................................................................................................40 3.3Technical information...............................................................................................................40 3.3.1Symbols on the joint.................................................................................................................40 3.3.2Symbols on the remote control.................................................................................................40 3.4Transport.................................................................................................................................40 3.5Warranty .................................................................................................................................40 3.6Liability ....................................................................................................................................41 3.7Declaration of conformity .........................................................................................................41 4 Explanation of symbols used in these Instructions for Use Information: Important information about the fitting, use, patient instructions and the product. Attention/Caution: Warning signal for possible technical damages / Warning signal for possible risk of accident or injury. Note: Reference to another instructions for use. Recommended accessories for prosthetists: 710D4Torque Wrench 710Y2=5Hex Bit 743L100LASAR Posture(647H189 Instructions for Use) 743L200 / 743L300LASAR Assembly(647H193 Instructions for Use) 60X3BionicLink(647G192 Instructions for Use) 4X180C-Soft(647G268 Instructions for Use) Information: Before using the C-Leg®, please read these Instructions for Use thoroughly! Please pay special attention to the safety instructions! The patient must be taught how to handle, care for and operate his/her prosthesis properly. Please see the following sections: 1.3 Operational conditions, 1.5 Safety instructions, 2.4 Charging the C-Leg® knee joint system, 2.9 Remote control and switching into2 nd mode, 2.11 Important user instructions, 3.1 Service intervals, 3.3 Technical information, 3.6 Liability 1.1 Medical purpose The C-Leg® knee joints 3C98-1 and 3C88-1 are to be used exclusively for the…

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ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20606-0591-C-1 Page 1 of 12 Appendix A. Pictures Transmitter ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20606-0591-C-1 Page 2 of 12 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20606-0591-C-1 Page 5 of 12 Receiver

LF - Remote Control, FCC ID: SJ3MHG0482 FCC ID Label Location The FCC ID label is realized using a laser marker on the bottom side of the case. (The shown photograph has a blank FCC ID field, because the label was made before the definition of the FCC ID)

ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH TEST - REPORT FCC RULES PART 15 / SUBPART C IC RSS 210 FCC ID: SJ3MHG0482 IC: 5496A-MHG0482 Test report no.: G0M20606-0591-C-1 Certificate 1983-01 ELECTRONIC TECHNOLOGY SYSTEMS STORKOWER STRASSE 38C, D-15526 REICHENWALDE B. BERLIN DR. GENZ GMBH PHONE +49-33631-888 00 FAX +49-33631-888 660 ETS Dr. Genz GmbH, Germany Registration number: G0M20606-0591-C-1 Page 1 of 21 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH TABLE OF CONTENTS 1 General information 1.1 Notes 1.2 Testing laboratory 1.3 Details of approval holder 1.4 Application details 1.5 Test item 1.6 Test standards 2 Technical test 2.1 Summary of test results 2.2 Test environment 2.3 Test equipment utilized 2.4 Test Procedure 3 Test Results 3.1 Spurious emissions radiated 3.2 AC power line conducted emissions ETS Dr. Genz GmbH, Germany Registration number: G0M20606-0591-C-1 Page 2 of 21 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH 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 complexity of the technical specifications, however, means that full and thorough testing is impractical for both technical and economic reasons. Futhermore, there is no guarantee that a test sample which has passed all the relevant tests conforms to a specification. Neither is there any guarantee that such a test sample will interwork with other genuinely open systems. The existence of the tests nevertheless provides the confidence that the test sample posseses the qualities as maintained and that is performance generally conforms to representative cases of communications equipment. The test results of this test report relate exclusively to the item tested as specified in 1.5. The test report may only be reproduced or published in full. Reproduction or publication of extractes from the report requires the prior written approval of the ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH. Tester: 05.09.2006 K. Damm Date ETS-Lab. Name Signature Technical responsibility for area of testing: 05.09.2006 N. Kaspar Date ETS Name Signature ETS Dr. Genz GmbH, Germany Registration number: G0M20606-0591-C-1 Page 3 of 21 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH 1.2 Testing laboratory 1.2.1 Location ELECTRONIC TECHNOLOGY SYSTEM DR. GENZ GMBH (ETS) Storkower Straße 38c D-15526 Reichenwalde b. Berlin Germany Telefon : +49 33631 888 00 Telefax : +49 33631 888 660 1.2.2 Details of accreditation status ACCREDITED TESTING LABORATORY DAR-REGISTRATION NUMBER: DAT-P-201/96 A CCREDITED COMPETENT BODY DAR-REGISTRATION NUMBER: BPT-ZE-026/96-00 FCC FILED TEST LABORATORY REG. NO. 96970 A2LA Accredited Certification No.1983-01 BLUETOOTH QUALIFICATION TEST FACILITY (BQTF) Accredited by Bluetooth Qualification Review Board I NDUSTRY CANADA FILED TEST LABORATORY REG. NO. IC 3470 1.2.3 Test location, where different from ETS Name: ETS Product Service AG Street: Storkower Str. 38c Town: 15526 Reichenwalde b. Berlin Country: Germany Telephone: + 49 33631 888-00 Telefax:: + 49 33631 888-660 E-mail: [email protected] ETS Dr. Genz GmbH, Germany Registration number: G0M20606-0591-C-1 Page 4 of 21 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH 1.3 Details of approval holder Name : Otto Bock Healthcare Products GmbH Street : Kaiserstr. 39 Town : 1070 Vienna Country : Austria Telephone : +43 1 5233786 645 Fax : +43 1 523 22 64 Contact : Herr Hubert Egger Telephone : +43 1 5233786 645 1.4 Application details Date of receipt of application : 19.06.2006 Date of receipt of test item : 19.06.2006 Date of test : 05.09.2006 1.5 Test item Description of test item : Remote control Type identification : MHG 0482 Brand Name: Remote Control C-leg Serial number : Test sample without serial number. Transmitting frequency : 114,8 kHz Transmitter 114.8 kHz Receiver Operation mode : simplex Voltage supply : 3 V DC Antenna : Integral antenna Photos : see Annex Manufacturer: (if applicable) Name : Otto Bock Healthcare Products GmbH Street : Kaiserstr. 39 Town : 1070 Vienna Country : Austria Additional information : This application consists of a transmitter and a separate receiver. Both are tested and documented in this report. ETS Dr. Genz GmbH, Germany Registration number: G0M20606-0591-C-1 Page 5 of 21 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH 1.6 Test standards Technical standard : FCC RULES PART 15 / SUBPART C § 15.209 : IC RSS 210 Issue 6 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 2.5 were ascertained in the course of the tests … performed. 2.2 Test environment Temperature : 23 ° C Relative humidity content : 20 ... 75 % Air pressure : 86 ... 103 kPa Details of power supply : 3.0 V DC ETS Dr. Genz GmbH, Germany Registration number: G0M20606-0591-C-1 Page 6 of 21 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH 2.3 Test equipment utilized No. Test equipment Type Manufacturer ETS 0001 ESD Gun SESD 30000 Schlöder ETS 0002 Test receiver ESVP R & S ETS 0003 Diode Power Sensor NRV-Z2 R & S ETS 0004 Spektrum- and Network-Analyzer FSMS 26 R & S ETS 0005 RF amplifier matrix RSU-ETS-CTR6 ETS ETS 0006 HP-Filter H1G04G01 Microwave ETS 0007 Horn antenna AT 4004 ar ETS 0008 Antenna Loop antenna Siemens ETS 0011 Antenna (van Veen/Frame) HM020Z3 R & S ETS 0012 Biconical Antenna HK 116 R & S ETS 0013 LPD Antenna HL 223 R & S ETS 0014 Log Periodical Antenna HL 025 R & S ETS 0015 Log Periodical Antenna HL 025 R & S ETS 0016 Precision antenna kit VHAP Schwarzbeck ETS 0017 Precision antenna kit UHAP Schwarzbeck ETS 0018 Horn antenna BBHA 9120 D Schwarzbeck ETS 0019 Horn antenna BBHA 9120 D Schwarzbeck ETS 0020 Antenna DP 21 MEB ETS 0021 Antenna DP 3 MEB ETS 0022 Antenna SAS-200/ 521 A.H. Systeme+D65 ETS 0023 Antenna DP 1 MEB ETS 0024 Antenna mast AF 2 MEB ETS 0025 Antenna mast AF 2 MEB ETS 0026 Tripod Heinrich Deisel ETS 0027 Tripod …

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ETS Dr. Genz GmbH, Germany Registration number: G0M20606-0591-C-1 Appendix B ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH Appendix B Spurious Emissions radiated, Transmitter Transmitter spurious radiated H-field according to FCC part 15 EUT:Remote Control Manufacturer:OTTO BOCK heathcare Products GmbH Operating Condition:Unom: 3 VDC (battery), T=23°C Test Site:ETS Operator:Mr. Pflug Test Specification:Ant.: loop antenna HFH2-Z2 (300+30m) Comment:model: MHG 0482 (114.8 kHz) -80 -60 -40 -20 0 20 40 50 Level [dBμV/m] 9k20k 30k50k100k200k400k1M2M 3M5M10M30M Frequency [Hz] Marker: 114.8 kHz 16.59 dBμV/m -- MES MHG0482_pre PK MES MHG0482_pre AV LIM FCCpart15_9_30000kHz LIM FCCpart15_9_30000kHz Page 1/1 05.09.2006 09:23 MHG0482 Spurious emissions Field Strength Tx according to FCC RULES PART 15, SUBPART C EUT:Remote Control Manufacturer:OTTO BOCK heathcare Products GmbH Operating Condition:Unom: 3 VDC (battery), T=23°C Test Site:ETS Operator:Mr. Pflug Test Specification:Ant.: loop antenna HFH2-Z2 (300+30m) Comment:model: MHG 0482 Freq: 114.800kHz, Emax: 16.46dBμV/m, RBW: 200Hz -80 -60 -40 -20 0 20 40 50 Level [dBμV/m] 111k112k113k114k115k116k117k Frequency [Hz] Marker: 114.8 kHz 16.46 dBμV/m -- MES MHG0482_pre AV LIM FCC_15209_loop generelle limits Page 1/1 05.09.2006 11:18 MHG0482 ETS Dr. Genz GmbH, Germany Registration number: G0M20606-0591-C-1 Appendix C ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH Appendix C Spurious Emissions radiated, Receiver Receiver spurious radiated H-field according to FCC part 15 EUT:Remote Control Manufacturer:OTTO BOCK heathcare Products GmbH Operating Condition:Unom: 3 VDC (battery), T=23°C Test Site:ETS Operator:Mr. Pflug Test Specification:Ant.: loop antenna HFH2-Z2 (300+30m) Comment:model: MHG 0482 -80 -60 -40 -20 0 20 40 50 Level [dBμV/m] 9k20k 30k50k100k200k400k1M2M 3M5M10M30M Frequency [Hz] MES MHG0482_pre PK MES MHG0482_pre AV LIM FCCpart15_9_30000kHz LIM FCCpart15_9_30000kHz Page 1/1 05.09.2006 09:41 MHG0482 ETS Dr. Genz GmbH, Germany Registration number: G0M20606-0591-C-1 Appendix D ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH Appendix D AC power line conducted emissions

ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20606-0591-C-1 Page 7 of 12 Test Setup Transmitter ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20606-0591-C-1 Page 8 of 12 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20606-0591-C-1 Page 9 of 12 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20606-0591-C-1 Page 10 of 12 Test Setup Receiver ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20606-0591-C-1 Page 11 of 12 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20606-0591-C-1 Page 12 of 12