YYU104450Lower Limb Prosthesis Force Measurement Transmitter

User Manual 2 SECTION iPec s ™ LAB / U ser Ma nu a l DECLARATION De c l aration I PECS LAB / M O DEL: 104441-01 F CC ID: XXXYYYYYYYYY Y I C : XXXXX-YYYYYYYYY Y M inimum S ystem Requirements f or S o f tware Installation  R ecommended 300 MHz or higher I ntel ® Pe n t i um ® / C eleron ® f amily, or compatible processor  Mi c r osoft ® Wi n do w s ® XP with S ervice Pack 3; Windows ® Vi sta; o r Wi n do w s 7  1 28 MB o f RAM or hi g her  1 G B of available hard-disk space  8 00 x 600, S u p er V G A or hi g her-resolution monito r  C D-R O M/DVD drive or U S B port I ntended User s This User Manual is intended f or use with the iPec s T M Lab S ystem f or clinical research by researchers and students. Technical Suppor t C ontact Colle g e Park Industries at 800-728-7950 or 586-294-7950 M-F 8:30-5:30 EST. Email: techsu pp ort@colle g e- p ark.com Le g end of Symbols W arn i ng: D angerous operat i ons t h at may d amage t h e d ev i ces or causes persona l i n j ury . C aution: O p erations ma y cause the device/software to not o p er- ate norma ll y an d/ or cause i n j ury. No t e : I mportant cons id erat i ons. This device com p lies with p ar t 15 of the FCC Rules and with RSS-210 of Industr y Canada. O p eration is sub j ect to the followin g t wo conditions: (1) this device ma y not cause harmful inter ference, and (2) this device must accept any inter ference received, including inter fer-ence t h at may cause un d es i re d operat i on. Note: Chan g es or modifi cations not ex p ressivel y a pp roved b y the p art y res p onsible for com p liance could void the user ’s authorit y to o p erate the e q ui p ment. The term “IC:” before the radio cer tifi cation number onl y si g nifi es that Industr y Canada technical s p eci- fi ca ti o n s w e r e m e t. USB connection for use with limited power source only. Must be connected to host com- p uter cer tifi ed for com p liance with IEC 6 0 95 0-1 or e q uivalent. 3 SECTION iPec s ™ LAB / U ser Ma nu a l CONTENTS C ont e nt s 0 1 System O verview iPecs Lab System 5 F eatu r es 6 Pr e -in sta ll at i o n C h ec kli st 7 Se n so r Co n t r o l s 8 S ensor Input/ O utput 9 S pecifi cations 10 0 2 S o f tware Installation Wi n d ows ® X P 12 Wi n do w s ® Vi sta / 7 1 4 0 3 U S B Driver Installation Wi n do w s ® XP 17 Wi n d ows ® Vi sta / 7 18 0 4 Hardware I nstallation C harging the iPecs Lab S ensor 21 Assembling Mounting Adapters to the S ensor 21 Using the S ensor Fixture 2 2 E n d os k e l eta l Ali gnment 23 U s i ng t h e T est i ng D ummy 23 Zeroing the S ensor Prior to Data C ollection 24 0 5 Software O verview S tartup 2 6 Basic O perations 2 7 Pairing the S ensor and D C M 2 7 S etting S ystem Preferences 29 C h a nn e l Pr e f e r e n ces 30 Displaying C hannel Values 30 0 6 R ecording Dat a Streaming Data to File 3 2 Streaming File Playback 3 3 0 7 Uninstalling S o f tware Wi n do w s ® X P 35 Wi n do w s ® Vi sta / 7 3 6 0 8 Uninstalling U S B Driver Wi n d ows ® X P 38 Wi n do w s ® Vi sta / 7 3 9 0 9 S ystem Calibration C alibration for External Data Acquisition 41 C alibration Procedure 42 10 Troubleshooting G uide Possible S ystem Issues 4 7 Frequently Asked Q uestions 48 E nv i ronmenta l U se 4 9 I n te n ded Use 4 9 System Overview 01 5 SECTION iPec s ™ LAB / U ser Ma nu a l 01 02 03 04 0506 07 08 09 10 i Pecs™Lab System After four y ears of develo p ment and with the su pp ort of a NIH g rant, it is our p leasure to introduce y ou to the iPecs Lab Sy stem from C olle g e Park Industries. Unlike an y device on the market toda y , t he iPecs Lab Sy stem is a p ortable research tool that p rovides a ccurate measurements of 3-axis forces and moments ex p erienced by a l ower li m b p rost h es i s user – i n an y env i ronment, w i t h out wires or the need for additional lab equi p ment. C onfi g uration and installation of the iPecs Lab sensor is to be p erformed b y a researcher or clinician trained in the a pp lication of p rosthetics. The iPecs Lab S y stem consists of the sensor, DCM ( Data Collection Module ) and iPecs Lab software for PCs. The followin g document g ives detailed instructions for the o p era- t ion of this s y stem, software installation and use. System O vervie w 6 SECTION iPec s ™ LAB / U ser Ma nu a l 01 02 03 04 0506 07 08 09 10 Featuresi Pecs Lab S ensor Thi s sensor h ouses t h e e l ectron i c com p onents requ i re d to d etect a nd measure the forces and moments actin g on the device and residual li m b . DCM ( Data Collection Module ) The sensor communicates with the PC software throu g h this m o d u l e w hil e o p erat i n g i n w i re l ess mo d e . i Pecs Lab S o f tware This is an inter f ace between the sensor and the researcher. It g ra phi ca lly re p resents t h e d ata co ll ecte d by t h e sensor to a id a nal y sis and has user-confi g urable p arameters to aid research. System O vervie w 7 SECTION iPec s ™ LAB / U ser Ma nu a l 01 02 03 04 0506 07 08 09 10 Pre-installation ChecklistA Protective carr y in g case ( not s h own ) B i Pecs Lab sensor C i Pecs Lab D C M (data collection module) D i Pecs Lab software ( not s h own ) E C onnection p rotocol and cables for iPecs Lab DCM F Flash memor y -to-com p uter USB p ort ada p te r G AC ada p te r 1 ( not s h own ) H 6ft U S B-A to U S B-B cable I 6ft USB-A to USB-5 p in mini-B cable J Micro S D card , 2 G B ( not s h own ) K ( 2 ) 4- h o l e ma l e a d a p ter s 2 L ( 2) 4-hole female rotatable ada p ters 2 M ( 16) M6x14mm mountin g fastener s 2 ( not s h own ) N 4mm h ex k e y O Se n so r fi x tu r e ( not s h own ) O p tional Accessories  T est i n g D umm y  Additional endoskeletal ada p tive com p onents and fasteners 2  A nnua l ca lib rat i on pl an 1 Use only the supplied A C adapter. 2 Colle g e Park Industries re q uires that y ou use onl y the su pp lied endoskeletal ada p tive components and fasteners for attachment to a prosthesis. C ontact C ollege Park to purchase additional components and f asteners…

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November 22, 2010 Federal Communications Commission Equipment Approval Services P.O. Box 358315 Pittsburgh, PA 15251-5315 Re: Certification for College Park Transceiver Model/PN(s): 104450-01 FCC ID: YYU104450 IC: 9356A-104450 Please find enclosed application materials for certification of College Park Transceiver. We tested it and found it to comply with FCC Part 15. If there are any questions regarding the application or testing performed, please contact me at the above address or call 734-483-4211, fax 734-647-2106, or e-mail [email protected]. Sincerely, Valdis V. Liepa Research Scientist

Re: Certification for College Park Transceiver FCC ID: YYU104450 IC: 9356A-104450 REQUEST FOR CONFIDENTIALITY Pursuant to FCC 47 CRF 0.457(d) and 0.459 and IC RSP-100, Section 10, College Park requests that a part of the subject application be held confidential. College Park has spent substantial effort in developing this product and it is one of the first of its kind in industry. Having the subject information easily available to "competition" would negate the advantage they have achieved by developing this product. Not protecting the details of the design will result in financial hardship. Type of Confidentiality Requested Exhibit Short Term Permanent (1) ID Label & Location Short Term Permanent (3) External Photos Short Term Permanent 1 (4) Block Diagram Short Term Permanent (5) Schematics Short Term Permanent (7) Test Setup Photos Short Term Permanent (8) User’s Manual Short Term Permanent (9) Internal Photos Short Term Permanent (10) Parts List & Placement Short Term Permanent (11) RF Exposure Short Term Permanent (12) Description of Operation 1. Block Diagram includes internal oscillator frequency information that the manufacturer considers to be proprietary. Permanent Confidentiality: College Park requests the exhibits listed above as permanently confidential be permanently withheld from public review. Short-Term Confidentiality (FCC Only): College Park requests the exhibits selected above as short term confidential be withheld from public view for a period of 45 days from the date of the Grant of Equipment Authorization and prior to marketing. If there are any questions regarding this request, please contact me at the above address or call 734-483-4211, fax 734-647-2106 or e-mail [email protected]. Sincerely, Valdis V. Liepa, Research Scientist University of Michigan

IPECS LAB - DCM MODEL: 104441-01 S/N: iF00100 INPUT: 5V 250mA MAX FCC ID: YYU104441 IC: 9356A-104441 MADE IN THE USA This device complies with part 15 of the FCC Rules and with RSS-210 of Industry Canada. 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. Note: Changes or modications not expressively approved by the party responsible for compliance could void the user's authority to operate the MADE IN THE USA IPECS LAB MODEL: 104450-01 S/N: iP00100 INPUT: 5V 250mA MAX FCC ID: YYU104450 IC: 9356A-104450 iP00100 iP00100 200% 200% MADE IN THE USA IPECS LAB MODEL: 104450-01 S/N: iP00100 INPUT: 5V 250mA MAX FCC ID: XXXYYYYYYYYYY IC: XXXXX-YYYYYYYYYY IPECS LAB - Hardware Regulatory Labels / 078-A-101102

The iPECS Sensor is a Force/Moment sensor that transmits strain gauge information at a high data rate over a 2.4 GHz wireless link. On the iPEC sensor is a three button keypad that indicates battery status, allows the user to turn on the sensor, zero the sensor, and reset the sensor. Also included on the sensor is a mi ni‐USB port used for charging the built in 3.7 VDC lithium ion battery and for upgrading the firmware on the unit as well as a manufacturer proprietary interface connector. Sensor operating frequency is software selected by the laboratory technician and set over the wir eless networ k from a DCM unit. The iPECS sensor is a com mercial (Class A) product intended for and sold to research facilities to aid in the design and fitting of prosth etic limbs.

University of Michigan Radiation Laboratory FCC Part 15, IC RSS-210/Gen - Test Report No. 417124-590 Page 1 of 13 The University of Michigan Radiation Laboratory 3228 EECS Building Ann Arbor, MI 48109-2122 Tel: (734) 764-0500 Fax: (734) 647 -2106 Measured Radio Frequency Emissions From College Park iPECS Se nsor FCC ID: YYU104450 IC: 9356A-104450 Test Report No. 417124-590 November 22, 2010 Copyright © 2010 For: College Park Industries, Inc. 17505 Helro Drive, Fraser, MI 48026 Contact: Michael Leydet [email protected] Phone: (586 ) 294-7950 Fax: (586) 294 -0067 Testing supervised by: Measurements made by: Joseph D. Brunett Report Approved by:__________________________ Valdis V. Liepa Test report written by: Joseph D. Brunett Research Scientist Summary Tests for compliance with FCC Regulations, CFR 47, Part 15 and with Industry Canada RSS-210/Gen, were performed on a College Park, FCC ID: KSME1007830, IC: 2004A-E1007830. This device under test (DUT) is subject to the rules and regulations as a Transceiver. In testing completed on May 5, 2009, the DUT tested met the allowed specifications for fundamental radiated emissions by 16.3 dB. Band edge and restricted band radiated emissions met the specified limit by more than 1.4 dB. Emissions from digital circuitry met the FCC Class A emissions limits by more than 19.9 dB. AC mains power emissions meet the allowed specifications for conducted emissions by 15.3 dB. University of Michigan Radiation Laboratory FCC Part 15, IC RSS-210/Gen - Test Report No. 417124-590 Page 2 of 13 Table of Contents 1. Introduction ...................................................................................................................................... 3 2. Equipment Used ............................................................................................................................... 3 3. Device Under Test ........................................................................................................................... 4 3.1 Description & Block Diagram .............................................................................................. 4 3.2 Variants & Samples .............................................................................................................. 4 3.3 Modes of Operation .............................................................................................................. 4 3.4 Exemptions ........................................................................................................................... 4 3.5 EMC Relevant Modifications ............................................................................................... 4 4. Emissions Limits .............................................................................................................................. 5 4.1 Radiated Emissions Limits .................................................................................................... 5 4.2 Power Line Conducted Emissions Limits ............................................................................. 5 5. Measurement Procedures ................................................................................................................. 6 5.1 Semi -Anechoic Chamber Radiated Emissions ...................................................................... 6 5.2 Outdoor Radiated Emissions ................................................................................................. 6 5.3 Radiated Field Computations ................................................................................................ 6 5.4 Indoor Power Line Conducted Emissions ............................................................................. 6 5.5 Supply Voltage Variation ...................................................................................................... 7 6. Test Results ...................................................................................................................................... 7 6.1 Radiated Emissions ............................................................................................................... 7 6.1.1 Peak to Average Ratio ....................................................................................................... 7 6.1.2 Emission Bandwidth ......................................................................................................... 7 6.1.3 Supply Voltage and Supply Voltage Variation ................................................................. 7 6.2 Conducted Emissions ............................................................................................................ 7 University of Michigan Radiation Laboratory FCC Part 15, IC RSS-210/Gen - Test Report No. 417124-590 Page 3 of 13 1. Introduction This College Park Transceiver was tested for compliance with FCC Regulations, Part 15, adopted under Docket 87-389, April 18, 1989 as subsequently amended, and with Industry Canada RSS-210/Gen, Issue 7, June 2007. Tests were performed at the University of Michigan Radiation Laboratory Willow Run Test Range following the procedures described in ANSI C63.4-2003 "Methods of Measurement of Radio- Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz". The Site description and attenuation characteristics of the Open Site facility are on file with FCC Laboratory, Columbia, Maryland (FCC Reg. No: 91050) and with Industry Canada, Ottawa, ON (File Ref. No: IC 2057A-1). 2. Equipment Used The pertinent test equipment commonly used in our facility for measurements is listed in Table 2.1 below. The middle column identifies the specific equipment used in these tests. The quality system employed at the University of Michigan Radiation Laboratory Willow Run Test Range has been established to ensure all equipment has a clearly identifiable classification, calibration expiry date, and that all calibrations are traceable to national standards.…

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