Q6AXMHG0575ActiGait� Heel Switch

1 23 456 78 1: ActiGait® Heel Switch 2: ActiGait® Belt Loop 3: ActiGait® Body Clip 4: ActiGait® Belt Clip 5: ActiGait® Control Unit 6: ActiGait® Antenna 7: ActiGait® Heel Sock 8: ActiGait® Antenna Fixture 9: ActiGait® Charger (model FW7711/0.7) incl. plugs 10: ActiGait® Charger Cable 9a9b9c9d 9 10 ActiGait® Implantable Drop Foot Stimulator User Manual 2 1. Introduction ......................................3 2. Intended Use ....................................3 2.1 Medical Purpose ....................................3 2.2 Application.............................................3 2.3 Qualification of Clinician ..........................3 2.4 Follow up Schedule ................................3 3. Indications/Contraindications ....4 3.1 Indications ............................................4 3.2 Contraindications ...................................4 4. Warnings and Precautions ...........5 4.1 Safety precautions .................................5 4.2 Warnings ...............................................5 4.3 General cautions ...................................7 4.4 Potential Risks/Side effects .....................9 5. Service Information ......................11 5.1 Scope of Delivery .................................11 5.2 Service ................................................11 6. Description of the ActiGait® .......12 6.1 The ActiGait® Implant ...........................13 6.2 The ActiGait® .......................................14 7. How ActiGait® works ...................15 7.1 The Control Unit ...................................16 7.1.1 The On/Off Button .............................17 7.1.2 The Stimulation Intensity Buttons .........18 7.1.3 The Mute Button ................................19 7.1.4 The Pairing Button .............................21 7.1.5 The Control Unit Battery Indicator ........22 7.1.6 The Heel Switch Battery Indicator ........23 7.1.7 Training Mode Indicator ......................25 7.1.8 Mute Indicator ...................................27 7.1.9 Stimulation Intensity Indicators ............27 7.2 Putting On the Control Unit ....................27 7.2.1 The Belt Clip .....................................28 7.2.2 The Belt Loop ....................................28 7.2.3 The Body Clip ...................................29 7.3 Putting On the Antenna Fixture ...............30 7.4 Putting On the Antenna .........................33 7.5 The Heel Switch ...................................35 7.5.1 The Heel Sock ...................................36 7.5.2 Heel Switch Feedback........................37 7.6 The Charger ........................................38 7.6.1 Charging the Control Unit ...................39 7.6.2 Travel Kit for Charger .........................41 7.7 Audio Signals and Warnings ..................42 7.7.1 Warnings ..........................................42 7.7.2 Audio Signals ....................................43 8. Lights and Audio Signals............43 8.1 How to Interpret the Light Indicators .......44 8.2 How to Interpret the Audio Signals .........46 9. Troubleshooting for ActiGait® ...49 10. Warranty .........................................51 11. Expected lifetime .......................52 12. Cleaning, Storage and Disposal ...........................................52 12.1 Cleaning ............................................52 12.2 Storage.............................................53 12.3 Disposal ............................................53 13. Available Articles .......................53 14. Technical Data ..............................55 14.1 ActiGait® Control Unit..........................55 14.2 ActiGait® Belt Clip ..............................56 14.3 ActiGait® Belt Loop .............................56 14.4 ActiGait® Body Clip ............................57 14.5 ActiGait® Antenna ..............................57 14.6 ActiGait® Antenna Fixture .....................58 14.7 ActiGait® Heel Switch ..........................58 14.8 ActiGait® Heel Sock ............................59 14.9 19.9 ActiGait® Charger Cable ..............59 14.10 ActiGait® Charger .............................60 14.11 ActiGait® Implant ..............................61 14.11.1 X-Ray Identification .........................62 15. Classification ................................62 16. List of symbols .............................63 16.1 Ingress Protection ...............................65 17. Declaration of Conformity .......65 3 1. Introduction This manual describes the use of the ActiGait® and is directed towards individuals with an ActiGait® Implant. The manual is to be used as an information resource and an instruction manual. The term “User” defines individuals who have an ActiGait® Implant and thereby are users of the ActiGait®. For clinicians the Clinician Manual (647G805=GB) is available 2. Intended Use 2.1 Medical Purpose The ActiGait® is solely to be used as treatment in patients having a drop foot follow- ing an upper motor neuron lesion. 2.2 Application The ActiGait® system is a partially implantable medical device for treatment of drop foot which activates the muscles of the lower leg during walking. The system is intended for use by persons suffering from paralysis of the ankle dorsiflexor muscles caused by damage to the central nervous system. The largest group of potential users are persons with hemiplegia as a consequence of stroke. The system will not function for people with drop foot caused by peripheral nerve damage. 2.3 Qualification of Clinician The selection of users for ActiGait®, setup and adjustment are done by clinicians such as medical doctors, physiotherapists or equivalent. To be able to program and adjust the ActiGait®, the clinician must have obtained a certificate on usage of the Clinical Station software following training by Otto Bock 2.4 Follow up Schedule It is recommended that the ActiGait® is activated 1-3 weeks after implantation, as the wound healing must be finished first. The user should thereafter be followed close…

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Neurodan A/S Sofiendalsvej 85 DK-9200 Aalborg SV. Denmark Tlf: +45 70 27 22 97 Fax: +45 70 27 22 17 ActiGait® Heel Switch FCC ID: Q6AXMHG0575

June 22, 2012 Neurodan A/S Sofiendalsvej 85 DK-9200 Aalborg SV. Denmark Tlf: +45 70 27 22 97 Fax: +45 70 27 22 17 ID Label and Label location: ActiGait® Heel Switch FCC ID: Q6AXMHG0575 Actual size:

Neurodan A/S Sofiendalsvej 85 DK-9200 Aalborg SV. Denmark Tlf: +45 70 27 22 97 Fax: +45 70 27 22 17 Internal Photos: ActiGait® Heel Switch FCC ID: Q6AXMHG0575 Top side January 16, 2012 z Page 2 Bottom side

Ref.-Nr.QuantitySAP-NumberValue BT11XETT1183CR2032/F4N C1-C2, C6, C8-C9, C116XETT0666100nF C31XETT06681NF C41XETT117947UF C7, C10, C15, C194XETT1126330PF C12-C132XETT06528.2PF C141XETT11280.5PF C171XETT112915PF C181XETT10292.2NF IC11XETT1125MSP430F2274IRHA IC21XETT1131CC2500 L11XETT1130LDB212G4010C-001 L4-L52XETT11324.7NH L61XETT1141600E/100MHZ R11XETT065956K R21XETT03161M R71XETT0859470K R101XETT031747K X21XETT113326MHZ Department of Documentation Otto Bock Healthcare Products GmbH Ident.: FO-226 Version: V4 Approval see Link A A B B C C D D E E F F G G H H I I J J 77 66 55 44 33 22 11 Protective note ISO 16016: Passing on as well as duplication of this document, utilisation and communication of his contents are forbidden, untill expressly permits. Offences oblige to compensation. All rights for the case the patent, utility model or taste pattern registration reserve. VersionDraughtsm. Leopold Oecker Creationdat. 29.04.2011 Projektnr. PK00120039B Boardmark. ETT1055-D 5 Sheet 9 of 9 Bill of material Assemb MUG1019

Test report no.1026496-6 Rev. B Page2 (16 ) Revision History Rev.DateOrder#Description A2011-03 -311026496First release B2012-06 -081026496Marker delta method for band-edge added Test report no.1026496-6 Rev. B Page3 (16 ) CONTENTS Page 1CLIENT INFORMATION..................................................................................................................4 2EQUIPMENT UNDER TEST(EUT)................................................................................................. 4 2.1IDENTIFICATIONOF THEEUTACCORDING TO THE MANUFACTURER/CLIENT DECLARATION...........4 2.2TEST SIGNALS................................................................................................................................. 4 3TEST SPECIFICATIONS...................................................................................................................5 3.1STANDARDS....................................................................................................................................5 3.2ADDITIONS,DEVIATIONS AND EXCLUSIONS FROM STANDARDS AND ACCREDITATION.....................5 3.3TEST FACILITY................................................................................................................................5 3.4TEST SET-UP....................................................................................................................................5 3.5TEST CONDITIONS...........................................................................................................................5 4TEST SUMMARY...............................................................................................................................6 5RADIATED OUTPUT POWER .........................................................................................................7 5.1MEASUREMENT SET-UP...................................................................................................................7 5.2TEST PROTOCOL..............................................................................................................................7 5.3LIMIT..............................................................................................................................................7 6SPURIOUS EMISSIONS (RADIATED)............................................................................................8 6.1MEASUREMENT UNCERTAINTY.......................................................................................................8 6.2TEST EQUIPMENT............................................................................................................................8 6.3MEASUREMENT SET-UP...................................................................................................................9 6.4TEST GRAPHS, TXMODE...............................................................................................................10 6.5TEST PROTOCOL, TXMODE...........................................................................................................13 7OCCUPIED BANDWIDTH..............................................................................................................14 7.1TEST EQUIPMENT..........................................................................................................................14 7.2TEST PROTOCOL............................................................................................................................14 8BAND EDGE......................................................................................................................................15 8.1TEST EQUIPMENT..........................................................................................................................15 8.2TEST PROTOCOL............................................................................................................................15 PHOTO OF THE EUT..............................................................................................................................16 Test report no.1026496-6 Rev. B Page4 (16 ) 1CLIENT INFORMATION The EUT has been tested by request of Company:Neurodan A/S Sofiendalsvej 85 DK-9200 Aalborg SV Denmark Name of contact:Eigil Myrhoj Nielsen 2EQUIPMENT UNDER TEST(EUT) 2.1Identificationof the EUT according to the manufacturer/client declaration Equipment:Medical device for treatment of dropfoot Type/Model:ActiGait,HES Brand name:ActiGait Serial number:Unmarked Manufacturer:NeurodanA/S Frequencyrange:2401MHz(one channel) Frequency agile or hopping:YesNo Antenna:Internal antennaExternal antenna Antenna connector:None , i nternal antennaYes Antenna gain:< 0dBi Rating RF output power:0 dBm Duty cycle:- Type of modulation:MSK 2.2Test signals 1.Continous TX with modulation (01010101...) 2.Continous TX without modulation Test report no.1026496-6 Rev. B Page5 (16 ) 3TEST SPECIFICATIONS 3.1Standards FCC 47 CFR part 15 (2010) Subpart B– Unintentional radiators FCC 47 CFR part 15 (2010) Subpart C– Intentional Radiators; §15.249 Operation within the bands 902-928 MHz, 2400– 2483.5 MHz, 5725– 5850 MHz and 24.0– 24.25 GHz RSS-Gen, Issue 3 (December 2010): General Requirements and Information for the Certification of Radiocommunication Equipment RSS-210, Issue 8 (December 2010): Low Power Licence-Exempt Radio communicationDevices (All Frequency Bands): Category I Equipment. Measurements methods according to ANSI C63.4-2009- Methods of Measurements of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz and ANSI C63.10 -2009- StandardforTesting Unlicensed Wireless Devices 3.2Additions, deviations and exclusions from standards and accreditation No deviations or exclusions have been made from standards and accreditation. 3.3Testfacility Measurements were performed at Intertek Semko AB, located in Stockholm, Sweden 3.4Test set-up The EUT was connected toa measuring instrumentby cable if not otherwise specified in the r…

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1(1) TEST SET-UP PHOTOS – XMHG0575 Radiated spurious emission