SJ3MUG6081Serial Cable Replacement

GBGB BionicLinkModule Printed in Austria - 11.05 2 3 2 1 3 Attention: To be installed by trained staff only. 1 Intended Use The BionicLinkModule is used for a cordless configuration and diagnosis of other Otto Bock products. Its main purpose is the replacement of the currently used serial cables. It has a three wire serial interface. 2 Description and Function It uses Bluetooth® technology, because this technology allows an easy connection to a PC, a PDA or to a similar device. These devices either must have the Bluetooth® functionality incorporated or use an external Bluetooth® interface such as a USB dongle or a Compact Flash- or PC-Card. The BionicLinkModule is conceived as a modular device, which can be permanently built into other products of Otto Bock. Special Features of the BionicLinkModule are: •The module is very flat. •Onboard PCB antenna, to achieve a higher antenna efficiency compared to the wide spread ceramic antennas. The goal is to maximize the connection range without increasing the output power of the RF components. This avoids unnecessary spurious emissions and minimizes the power drain out of the battery of the prosthetic device. •One single LED indicator shows the user if the module is powered (LED is on) and if data is transmitted (LED flashing). 3 Technical Data Temperature Range: 0° - 60°C Supply Voltage Range: 3.5 – 4.7V Bluetooth Class II 4 Mounting Restrictions: •The module has to be mounted in a way to insure that the human tissue is held at a minimum distance as shown in figure (2) and (3). •The module has to be placed isolated from metal surfaces at a minimum distance of 1mm, as shown in figure (1). •It is forbidden to make any modifications, especially of the antenna. 4 Otto Bock Healthcare Products GmbH Kaiserstraße 39 · 1070 Wien · Austria Tel. (+43-1) 526 95 48 · Telefax (+43-1) 526 79 85 [email protected] · www.ottobock.at Otto Bock has been certified by the German Society for the Certifi- cation of Quality Assur- ance Systems (DQS) in accordance with DIN EN ISO 9001, Reg. No. 779 ( Management System). This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Modifications not expressly approved by Otto Bock could void the user’s authority to operate the equipment. NOTE: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. This product has a modular FCC approval according to FCC public notice DA 00-1407 (released: June 26 th , 2000) Industry Canada

ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20509-9814-C-1 Page 1 of 5 Appendix A. Pictures ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20509-9814-C-1 Page 2 of 5 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20509-9814-C-1 Page 3 of 5

BionicLinkModule, FCC ID: SJ3MUG6081 FCC ID Label Location The FCC ID label is realized using a laser marker on an adhesive labelling foil. The label is then placed on the frontside of the module PCB.

10 mm BionicLinkModule, FCC ID: SJ3MUG6081 FCC ID Label Sample Label Design The FCC ID label is realized using a laser marker on an adhesive labelling foil. The label is then placed on the frontside of the module PCB. Actual Realization

ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20509-9814-C-1 Page 1 of 5 Appendix A. Pictures ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20509-9814-C-1 Page 2 of 5 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20509-9814-C-1 Page 3 of 5

ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH TEST - REPORT FCC RULES PART 15 / SUBPART C FCC ID: SJ3MUG6081 Test report no.: G0M20509-9814-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: G0M20509-9814-C-1 Page 1 of 33 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 General Test Procedure 3 Test Results 3.1 Peak output power 3.2 Equivalent isotropic radiated power 3.3 RF exposure radiated emission 3.4 Antenna requirement 3.5 Out of band radiated emission 3.6 Transmitter radiated emissions in restricted bands 3.7 Spurious emissions (tx) 3.8 Carrier frequency separation 3.9 Number of hopping frequency 3.10 Time of occupancy 3.11 20 dB bandwidth 3.12 Band-edge compliance of RF emissions 3.13 Conducted measurement at (AC) power line ETS Dr. Genz GmbH, Germany Registration number: G0M20509-9814-C-1 Page 2 of 33 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. Furthermore, 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 possesses 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 extracts from the report requires the prior written approval of the ELECTRONIC TECHNOLOGY SYSTEMS DR. GENZ GMBH. Tester: 12.10.2005 M. Handrik Date ETS-Lab. Name Signature Technical responsibility for area of testing: 12.10.2005 N. Kaspar Date ETS Name Signature ETS Dr. Genz GmbH, Germany Registration number: G0M20509-9814-C-1 Page 3 of 33 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 66 1.2.2 Details of accreditation status A CCREDITED TESTING LABORATORY DAR-REGISTRATION NUMBER: TTI-P-G 126/96 ACCREDITED COMPETENT BODY DAR- REGISTRATION NUMBER: BPT-ZE-026/96 FCC FILED TEST LABORATORY REG. NO. 96970 BLUETOOTH QUALIFICATION TEST FACILITY (BQTF) A CCREDITED BY BLUETOOTH QUALIFICATION REVIEW BOARD INDUSTRY CANADA FILED TEST LABORATORY REG. NO. IC 3470 A2LA ACCREDITED Certificate Number 1983-01 1.3 Details of approval holder Name : Otto Bock Healthcare Products GmbH Street : Kaiserstr. 39 Town : 1070 Vienna Country : Austria Telephone : +43 1 5233786 Fax : +43 1 523 22 64 Contact : Herr Robert Hoffmann E-mail : [email protected] ETS Dr. Genz GmbH, Germany Registration number: G0M20509-9814-C-1 Page 4 of 33 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH 1.4 Application details Date of receipt of application : 13.09.2005 Date of receipt of test item : 13.09.2005 Date of test : 13.09.2005 1.5 Test item Description of test item : Serial Cable Replacement Type identification : BionicLinkModule Serial number : without Photos : See Appendix A Technical data Frequency band : 2.4GHz - 2.4835 GHz Frequency (ch A) : 2402 MHz Frequency (ch B) : 2441 MHz Frequency (ch C) : 2480 MHz Transmitter Vnom Vnom Power (ch A) : Conducted: -2.09 dBm Radiated: -- dBm Power (ch B) : Conducted: -2.05 dBm Radiated: -- dBm Power (ch C) : Conducted: -1.84 dBm Radiated: 1.06 dBm Power supply : 3.6V Operating mode : duplex Type of modulation : FHSS Antenna type : integral Antenna gain : 1.5 dBi ETS Dr. Genz GmbH, Germany Registration number: G0M20509-9814-C-1 Page 5 of 33 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH Host device : none Classification : Fixed Device Mobile Device (Human Body distance > 20cm) Portable Device (Human Body distance < 20cm) Manufacturer: (if applicable) Name : Otto Bock Healthcare Products GmbH Street : Kaiserstr. 39 Town : 1070 Vienna Country : Austria Additional information: The test sample is designed as Bluetooth device. Its pseudorandom hopping scheme, authentication, receiver parameters, synchronization procedure and other parameters are determined by Bluetooth Core Specification. According to attached declaration of manufacturer this device don’t work in master inquiry mode. So we have only one frequency hopping system and the hopping sequence of the master inquiry mode is not verified. ETS Dr. Genz GmbH, Germany Registration number: G0M20509-9814-C-1 Page 6 of 33 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH 1.6 Test standards Technical standard : FCC RULES PART 15 / SUBPART C § 15.247 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 : 25 o C Relative humidity content : 20 ... 75 % Air pressure : 86 ... 103 kPa Details of power supply : 3.6 V DC / Extreme conditions parameters: : test voltage - extreme min.: -- V (Vnom – 15%) max: -- V (Vnom + 15%) ETS Dr. Genz GmbH, Germany Registration number: G0M20509-9814-C-1 Page 7 of 33 ELECTRONIC TECHNOLOGY SYSTEMS DR.GEN…

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ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20509-9814-C-1 Page 4 of 5 ELECTRONIC TECHNOLOGY SYSTEMS DR.GENZ GMBH ETS Dr. Genz GmbH, Germany Registration number: G0M20509-9814-C-1 Page 5 of 5