TVF-L300-FS-V20Foot Sensor

User's Guide Part No: B0001002 Rev 1 II User Guide Copyright © 2006 NESS Ltd. All rights reserved. No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or translated into any language or any computer language, in any form or by any third party, without the prior written permission of NESS Ltd. Trademarks NESS is a trademark of NESS Ltd. NESS L300™ is a trademark of NESS Ltd. Disclaimer NESS Ltd. shall not be liable for any injury or damage suffered by any person, either directly or indirectly, as a result of the unauthorized use or repair of NESS Ltd's products. NESS Ltd. does not accept any responsibility for any damage caused to its products, either directly or indirectly, as a result of use and/or repair by unauthorized personnel. Environmental Policy Service personnel are advised that when changing any part of the NESS L300™, care should be taken to dispose of those parts in the correct manner; where applicable, parts should be recycled. When the lifecycle of the NESS L300™ has been completed, the product should be discarded according to the laws and regulations of the local authority. For more detailed information regarding these recommended procedures, please contact your local or regional NESS L300™ distributor. NESS is committed to continuously seeking and implementing the best possible manufacturing procedures and servicing routines. Conformity Certification Caution: Federal law restricts this device to sale by or on the order of a physician. Manufacturer NESS Ltd. 19 Ha'haroshet St., Keidar Center, P.O. Box 2500, Ra'anana, 43654, Israel Tel: (972) 9-748-5738 Fax: (972) 9-748-5740, Email: [email protected], Website: www.nessltd.com European Distributor Ness Europe B.V, Zadelmakerstraat 53 2984 CC Ridderkerk, The Netherlands Tel: 31-180-481600 Fax: 31-180-463152 Email: [email protected] Website: www.ness.nl U.S. Distributor Bioness Inc. 25134 Rye Canyon Loop Suite 300 Santa Clarita, California 91355 Tel: (800) 211-9136 Fax: (661) 362-4851 Email: [email protected] Website: www.bionessinc.com III Contents 1. Introduction to your NESS L300™................................................ 1 Indications For Use........................................................................... 1 Advanced Technology in Rehabilitation ............................................ 1 For Your Health and Safety ............................................................... 2 2. General Overview of your NESS L300™.............................................. 7 Components of the NESS L300™.................................................... 7 The Orthosis..................................................................................... 8 Indicator lights on the RF Stim Unit ............................................ 9 The Foot Sensor............................................................................... 10 The Control Unit................................................................................ 11 Control Unit Buttons.................................................................... 12 Control Unit Display and Audio Indication................................... 13 3. Operating Modes............................................................................. 15 Standby Mode................................................................................... 15 Gait Mode.......................................................................................... 15 Training Mode ................................................................................... 15 4. Daily Use of your NESS L300™..................................................... 17 Activating and Using the System...................................................... 17 Positioning the Orthosis on your leg................................................. 18 IV Taking the Orthosis off....................................................................... 22 Operating the Control Unit.................................................................22 5. Care and Maintenance.................................................................... 25 Batteries............................................................................................ 25 Low Battery Warning ........................................................................ 25 Charging the Batteries...................................................................... 26 Replacing the Batteries.................................................................... 29 Replacing Electrodes........................................................................ 31 Cleaning your NESS L300™............................................................ 35 6. Replacing and Installing System Components............................ 37 Replacing and Registering Components........................................... 37 Removing and Installing the RF Stim Unit......................................... 39 Placing a Foot Sensor in your Shoe................................................. 40 7. Accessories.................................................................................... 43 8. Troubleshooting............................................................................. 45 9. Specifications................................................................................. 49 10. List of Symbols................................................................................ 55 V List of Figures Figure 1: NESS L300™ System Components .......................................7 Figure 2: The Orthosis ........................................................................... 8 Figure 3: The Foot Sensor ...................................................................10 Figure 4: The Control Unit ...................................................................11 Figure 5: Recommended Knee Angle for Orthosis Application ............18 Figure 6: Placing the Orthosis on the Leg ........................................... 1…

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NESS Ltd. FCC ID:TVF-L300-FS-V20 Page 1 of 1 Block diagram

March 19, 2006 American TCB 6731 Whittier Ave Suite C110 McLean, VA 22101 USA Subject: Request for confidentiality for the functional stimulation device (control unit) transceiver, model name NESS 300 Foot Sensor, FCC ID:TVF-L300-FS-V20 Dear Gentlemen, In regards the exhibits submitted in support of the application for certification, please classify the following as confidential under the provision of 47 CFR 0.459: 1) Schematic diagram, file “Schematics_16891_FS“(1 page). The above material contains trade secrets or technical data which NESS Ltd. deems to be proprietary. Therefore this information would customarily be guarded from competitors and cannot be accessible to the general public

NESS Ltd. FCC ID:TVF-L300-FS-V20 Date: March 2006 Page 1 of 5 EXTERNAL PHOTOGRAPHS This document contains 4 photographs NESS Ltd. FCC ID:TVF-L300-FS-V20 Date: March 2006 Page 2 of 5 Photograph No.1 NESS 300 Foot Sensor (FS) general view NESS Ltd. FCC ID:TVF-L300-FS-V20 Date: March 2006 Page 3 of 5 Photograph No.2 Foot sensor (FS) front view NESS Ltd. FCC ID:TVF-L300-FS-V20 Date: March 2006 Page 4 of 5 Photograph No.3 Foot sensor (FS) rear side view NESS Ltd. FCC ID:TVF-L300-FS-V20 Date: March 2006 Page 5 of 5 Photograph No.4 Foot sensor (FS) rear side view with battery cover removed

NESS Ltd. FCC ID:TVF-L300-FS-V20 Page 1 of 2 LABEL LOCATION The label shown below is affixed on the rear panel of the unit. NESS Ltd. FCC ID:TVF-L300-FS-V20 Page 2 of 2 Label location on the Foot Sensor rear panel, FCC ID:TVF-L300-FS-V20

NESS Ltd. FCC ID:TVF-L300-FS-V20 Date: March 2006 Page 1 of 5 INTERNAL PHOTOGRAPHS This document contains 4 photographs NESS Ltd. FCC ID:TVF-L300-FS-V20 Date: March 2006 Page 2 of 5 Photograph No.1 NESS 300 Foot Sensor (FS) internal view NESS Ltd. FCC ID:TVF-L300-FS-V20 Date: March 2006 Page 3 of 5 Photograph No.2 Foot sensor printed circuit board NESS Ltd. FCC ID:TVF-L300-FS-V20 Date: March 2006 Page 4 of 5 Photograph No.3 Foot sensor printed circuit board, second side NESS Ltd. FCC ID:TVF-L300-FS-V20 Date: March 2006 Page 5 of 5 Photograph No.4 Foot sensor printed circuit board, antenna close view

Application Notes for Wireless Headsets Compact Reach Xtend TM Chip Antenna Ref: AN_FR05-S1-N-0-102 January 2005 Page 1 2005 © FRACTUS Compact Reach Xtend TM Bluetooth ® , 802.11b/g WLAN Chip Antenna Application Notes: Wireless Headsets Antenna Part Number: FR05-S1-N-0-102 Optimised Antennas for Wireless Devices Application Notes for Wireless Headsets Compact Reach Xtend TM Chip Antenna Ref: AN_FR05-S1-N-0-102 January 2005 Page 2 2005 © FRACTUS TABLE OF CONTENTS NOTES________________________________________________________________________2 QUICK REFERENCE GUIDE________________________________________________________3 PCB RECOMMENDED CONFIGURATIONS_____________________________________________3 Configuration 1 (40x20 mm PCB)_____________________________________________4 Configuration 2 (30x20mm PCB)______________________________________________6 Configuration 3 (circle PCB – 40 mm diameter)__________________________________8 Configuration 4 (60x15mm PCB)_____________________________________________10 HOW TO BUY FROM YOUR LOCAL DISTRIBUTOR______________________________________12 NOTES The products described in this document are protected worldwide by at least one of the following Patents and Patent Applications owned by Fractus: WO0154225, WO0122528, PCT/EP01/10589, PCT/EP02/07837, US60/613394, US60/627653 and PCT/EP02/07836. All information contained within this document is property of Fractus and is subject to change without prior notice. Information is provided “as is” and without warranties. It is prohibited to copy or reproduce this information without prior approval. Application Notes for Wireless Headsets Compact Reach Xtend TM Chip Antenna Ref: AN_FR05-S1-N-0-102 January 2005 Page 3 2005 © FRACTUS QUICK REFERENCE GUIDE Technical Features Frequency range 2400-2500 MHz Radiation Efficiency > 70% Peak Gain > 1 dBi VSWR < 2:1 Polarization Linear Weight 0.1 g Temperature -40 to + 85ºC Impedance 50Ω Dimensions 7x3x2 mm Note : Results measured in a reference evaluation board of 41x23 mm described in the following section For further information related to the standard features of the Compact Reach Xtend Chip Antenna please refer to the User Manual. PCB RECOMMENDED CONFIGURATIONS Compact Reach Xtend has been designed to purposely minimise product integration efforts and optimise device performance. This document provides integration and mounting recommendations for the use of the Compact Reach Xtend Chip Antenna for wireless headset devices. Standard PCBs within this document were obtained through market research to provide you with the most accurate results. Size reduction and cost are the key drivers for the wireless headset market. Based on the importance of PCB space for component allocation, the recommended configurations are designed to provide the best performance using a minimum clearance area (PCB area without ground plane) for the antenna. These Application Notes provide you with both the performance of the headset PCB with standard plastic housing and the performance of the headset mounted on the user’s ear. Following the instructions in this guide, you will ̧ reduce your product development and manufacturing costs ̧ increase your device performance Please contact your sales representative at Richardson Electronics if you require additional information on antenna integration or optimisation on your industrial design. 3 mm 7 mm 2 mm Front View Back View FRACTUS S.A. [email protected] Tel: +34 935442690 Fax: +34 935442691 RICHARDSON ELECTRONICS Refer to the last page of this document for contact information of your locall sales agent. Application Notes for Wireless Headsets Compact Reach Xtend TM Chip Antenna Ref: AN_FR05-S1-N-0-102 January 2005 Page 4 2005 © FRACTUS CONFIGURATION 1 (40X20 MM PCB) Figure 1. PCB Dimensions and Clearance Dimensions. Letter Meas. A 7.00 B 3.00 C 1.50 D 0.20 E 2.60 F 3.60 G 3.00 H 0.50 I 4.75 J 1.50 All dimensions are in millimetres. Figure 2. Antenna Footprint A 40 C 10 B 20 D 6 All dimensions are in mm Soldering pads, feed point and feeding line Antenna Clearance (PCB without ground plane) Zone occupied by the antenna PCB ground-plane B C D A Antenna Feeding Line PCB PCB Application Notes for Wireless Headsets Compact Reach Xtend TM Chip Antenna Ref: AN_FR05-S1-N-0-102 January 2005 Page 5 2005 © FRACTUS VSWR, Radiation Patterns, Gain and Efficiency Peak Gain 1.5 dBi Gain Average Gain -2.3 dBi Peak Efficiency 75 % Efficiency Average Efficiency 70 % 2.2 2.3 2.4 2.5 2.6 2.7 2.8 1 1.5 2 2.5 3 3.5 4 VSWR Frequency (GHz) Free Space Talking Position Measurement conditions: ß ABS Plastic housing (distance to the antenna: 0 mm). ß 2 element matching network. φ x z y θ y z x PCB 00 3030 6060 9090 120120 150150 180 -30 -25 -20 -15 -10 -5 0 5 00 3030 6060 9090 120120 150150 180 -30 -25 -20 -15 -10 -5 0 5 Azimuth Cut cut φ = 0º 00 3030 6060 9090 120120 150150 180 -30 -25 -20 -15 -10 -5 0 5 cut φ = 90º Note: Gain and efficiency values within the 2,5-2,6 GHz band (free space). Application Notes for Wireless Headsets Compact Reach Xtend TM Chip Antenna Ref: AN_FR05-S1-N-0-102 January 2005 Page 6 2005 © FRACTUS CONFIGURATION 2 (30X20MM PCB) Figure 3. PCB Dimensions and Clearance Dimensions. Letter Meas. A 7.00 B 3.00 C 1.50 D 0.20 E 2.60 F 3.60 G 3.00 H 0.50 I 4.75 J 1.50 All dimensions listed in millimetres. Figure 4. Antenna Footprint A 30 C 10 B 20 D 6 All dimensions are in mm Soldering pads, feed point and feeding line Antenna Clearance (PCB without ground plane) Zone occupied by the antenna PCB ground-plane B C D A Antenna Feeding Line PCB PCB Application Notes for Wireless Headsets Compact Reach Xtend TM Chip Antenna Ref: AN_FR05-S1-N-0-102 January 2005 Page 7 2005 © FRACTUS VSWR, Radiation Patterns, Gain and Efficiency Peak Gain -0.3 dBi Gain Average Gain -3.9 dBi Peak Efficiency 45 % Efficiency Average Efficiency 41 % Measurement conditions: ß ABS Plastic housing (distance to the antenna: 0 mm). ß 2 element matching network. φ x z y θ y z x PCB Azimuth Cut…

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March 15 th, 2006 NESS L300 Foot Sensor – Duty Cycle declaration Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 We the undersigned, hereby certify that NESS L300 Foot Sensor’s (FS) transmitter (FCC ID: TVF-L300-FS-V20) operates in Duty Cycle (DC) not larger than 6% per channel (Measured on any 100 mS period). The Duty Cycle calculation is based on the following data: ! Heel events messages - 1. Maximal number of events transmitted in each 100 mS period - 1 2. Message transmission time - < 3mS 3. Retransmissions – 2 ! Status information is transmitted as part of one of the aforementioned messages. Hence: () [sec] ssions][retransmi][sec/eventevent][heel [FS] 0.1 20.0031 DC ×× = DC [FS] < 6% 20*log 10 (DC [FS] ) < -24 dB Sincerely, Amit Dar R&D and Clinical manager

March 15 th , 2006 NESS L300 Foot Sensor Unit Transceiver - operational description (FCC ID: TVF-L300-FS-V20) The NESS L300 system comprised of 3 transmitters: Foot sensor (FS), Stimulator (STM) and Control Unit (CU). The Foot sensor transmitter is responsible for: 1. Transferring detected heel events information from the foot sensor to the stimulator. 2. Transferring status information from the foot sensor to the stimulator (mostly hardware faults and low battery status) The RF link characteristics are: • Operating band: 2400.0 ñ 2483.5 MHz ISM band. • Channels used : 2 (Main and auxiliary) • Modulation: 2-FSK • Data throughput: 250 Kbps • Effective Isotropic Radiated Power: ≤ 0dBm • Antenna: 2.4 GHz chip antenna • Packet based communication • Wireless protocol: Proprietary

Ness Ltd. FCC ID:TVF-L300-FS-V20 Date: March 2006 Page 1 of 1 RF exposure evaluation according to FCC CFR 47 part 15, §15.247(e)(i) The foot sensor is a portable device. No SAR evaluation required if a transmitter power is below the following threshold: Tunable range, GHz Flow Fhigh Center of tunable band, GHz 60/f SAR limitation, mW 2.401 2.482 2.441 24.6 Maximum measured transmitter power: Pout conducted, mW Maximum antenna gain, dBi Pout EIRP, mW 0.44 1.5 0.62 Threshold for no SAR evaluation is 24.6 mW, maximum measured Tx power is 0.44 mW – conducted and 0.62 mW- EIRP. Conclusion: No SAR evaluation is required since the maximum transmitter output power, both conducted and radiated, is below FCC threshold.

Hermon Laboratories Ltd. P.O.Box 23, Binyamina 30500, Israel Tel. +972 4628 8001 Fax. +972 4628 8277 E-mail: [email protected] Page 1 of 88 Report ID: NESRAD_FCC.16891_FS.doc Date of Issue: 3/16/2006 Electrical TEST REPORT ACCORDING TO: FCC part 15 subpart C, §15.247 and subpart B FOR: NESS Ltd. Transceiver Trade mark: NESS L300 Model: foot sensor (FS) This report is in conformity with ISO/ IEC 17025. The A2LA logo endorsement applies only to the test methods and the standards that are listed in the scope of Hermon Laboratories accreditation. The test results relate only to the items tested. This test report shall not be reproduced in any form except in full with the written approval of Hermon Laboratories Ltd. Report ID: NESRAD_FCC.16891_FS.doc Date of Issue: 3/16/2006 Page 2 of 88 Table of contents 1 Applicant information..................................................................................................................................................... 3 2 Equipment under test attributes .................................................................................................................................... 3 3 Manufacturer information .............................................................................................................................................. 3 4 Test details.................................................................................................................................................................... 3 5 Tests summary.............................................................................................................................................................. 4 6 EUT description............................................................................................................................................................. 5 6.1 General information....................................................................................................................................................... 5 6.2 Operating frequencies ................................................................................................................................................... 5 6.3 Changes made in the EUT ............................................................................................................................................ 5 6.4 Transmitter characteristics ............................................................................................................................................ 6 7 Transmitter tests according to 47CFR part 15 subpart C requirements ........................................................................ 7 7.1 Minimum 6 dB bandwidth .............................................................................................................................................. 7 7.2 Peak output power ...................................................................................................................................................... 11 7.3 Field strength of spurious emissions ........................................................................................................................... 16 7.4 Peak spectral power density ....................................................................................................................................... 60 7.5 Radiated emission measurements .............................................................................................................................. 66 8 APPENDIX A Test equipment and ancillaries used for tests....................................................................................... 70 9 APPENDIX B Measurement uncertainties................................................................................................................... 72 10 APPENDIX C Test facility description ......................................................................................................................... 73 11 APPENDIX D Specification references ....................................................................................................................... 73 12 APPENDIX E Abbreviations and acronyms................................................................................................................. 74 13 APPENDIX F Test equipment correction factors ......................................................................................................... 75 Report ID: NESRAD_FCC.16891_FS.doc Date of Issue: 3/16/2006 Page 3 of 88 1 Applicant information Client name: NESS Ltd. Address: 19, Haíharoshet street, Raíanana 43654, Israel Telephone: +972 9748 5738 Fax: +972 9748 5740 E-mail: [email protected] Contact name: Mr. Eyal Lasko 2 Equipment under test attributes Product type: Transceiver Trade mark: NESS L300 Model(s): Foot sensor (FS) Receipt date 2/26/2006 3 Manufacturer information Manufacturer name: NESS Ltd. Address: 19, Haíharoshet street, Raíanana 43654, Israel Telephone: +972 9748 5738 Fax: +972 9748 5740 E-Mail: [email protected] Contact name: Mr. Eyal Lasko 4 Test details Project ID: 16891 Location: Hermon Laboratories Ltd. P.O.Box 23, Binyamina 30500, Israel Test started: 2/26/2006 Test completed: 3/14/2006 Test specification(s): FCC part 15 subpart C, ß15.247 (DTS) and subpart B Test suite: FCC_15.247_DTS_without_RF_connector (5/3/2004 5:43:35 PM, modified) Report ID: NESRAD_FCC.16891_FS.doc Date of Issue: 3/16/2006 Page 4 of 88 5 Tests summary Test Status Transmitter characteristics Section 15.247(a)2, 6 dB bandwidth Pass Section 15.247(b)3, Peak output power Pass Section 15.247(b)5, RF exposure Pass, refer to attached application documents Section 15.247(c), Radiated spurious emissions Pass Section 15.247(d), Peak power density Pass Section 15.207(a), Conducted emission Not required Unintentional emissions Section 15.107, Conducted emission at AC power port Not required Section 15.109, Radiated emission Pass Tes…

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NESS Ltd. FCC ID:TVF-L300-FS-V20 Date: March 2006 Page 1 of 5 SETUP PHOTOGRAPHS This document contains 4 photographs NESS Ltd. FCC ID:TVF-L300-FS-V20 Date: March 2006 Page 2 of 5 Photograph No.1 Setup for spurious emission field strength measurements in 30 MHz to 1 GHz range in the anechoic chamber NESS Ltd. FCC ID:TVF-L300-FS-V20 Date: March 2006 Page 3 of 5 Photograph No.2 Setup for spurious emission field strength measurements in the anechoic chamber, close view NESS Ltd. FCC ID:TVF-L300-FS-V20 Date: March 2006 Page 4 of 5 Photograph No.3 Setup for carrier field strength, peak power density, spurious emission measurements at the OATS above 1000 MHz NESS Ltd. FCC ID:TVF-L300-FS-V20 Date: March 2006 Page 5 of 5 Photograph No.4 Setup for spurious emission measurements at the OATS above 1000 MHz