W4P-SP-W03Wireless EMG Hip Module

Trigno TM Personal Monitor User’s Guide 1 TRIGNO TM Personal Monitor User’s Guide October 2011 Edition (DRAFT) PM-W02 Copyright © 2011 Delsys Incorporated Specifications and procedures outlined in this document are subject to change without notice. Delsys Logo, EMGworks and Myo- monitor are Registered Trademarks of Delsys Incoroporated. MAN-014-1-0 (DRAFT) 2 Table of Contents Important Information 3 Intended Use 3 Contraindications 3 Technical Service and Support 3 Warning and Precautions 4 Device Information 5 Disclaimer 7 Limited Warranty 7 System Requirements 7 Trigno TM Personal Monitor Overview 8 Trigno Sensor 8 Body-Worn Personal Monitor 8 Trigno Sensor Recharger 8 Trigno TM Personal Monitor User’s Guide 3 Important Information Intended Use The Trigno TM Wireless EMG Systems are designed for research, investigational and scholarship purposes only. Delsys® products are not intended for measurement purposes or for use in the treat- mentand diagnosis of humans. Rx ONLY Contraindications DO NOT USE on Patients with implanted electronic devices of any kind, including cardiac pace-makers or similar assistive devices, electronic infusion pumps, and implanted stimulators. DO NOT USE on irritated skin or open wounds. DO NOT USE on Patients with allergies to Silver. Technical Service and Support For information and assistance visit our web site at: www.delsys.com Contact us at: tel: (617)-236-0599 email: [email protected] 4 Consult all accompanying documents for precautionary state- ments and other important information. Consult accompanying user’s guide for detailed instructions. Keep the device dry. The presence of liquids may compromise the safety features of the device. Handle with care. Sensitive electronic device. Avoid static discharges. Do not oper- ate or store near strong electrostatic, electromagnetic, magnetic or radioactive fields. Interference from external sources may de- crease the signal-to-noise ratio or result in corrupted data. Connect only to Delsys-approved devices. Connecting a patient to high-frequency surgical equipment while using Delsys EMG systems may result in burns at the site of the EMG sensor contacts. Immediately discontinue device use if skin irritation or discom- fort occurs. Immediately discontinue device use if a change in the device’s performance is noted. Contact Delsys technical support for as- sistance. Warning and Precautions Trigno TM Personal Monitor User’s Guide 5 Delsys Inc. guarantees the safety, reliability, and performance of the equipment only if assembly, modifications and repairs are carried out by authorized technicians; the electrical installation complies with the appropriate requirements; and the equipment is used in accordance with the instructions for use. Device contains a Lithium-Polymer battery. Do not damage, crush, burn, freeze or otherwise mishandle the device. Recharge only with the approved power supply and recharger. Trigno Systems should be stored and operated between 5 and 50 degrees Celsius due to the presence of an internal Lithium Poly- mer rechargeable cell. Storing or operating the device, and conse- quently the cell, outside of this temperature range may compro- mise the integrity and the safety features of the cell. Device Information Complies with Requirements put forth by the Medical Device Directive 93/42/EEC. Class I device, Annex VII. Type BF device (IEC 60601-1). Isolated device, (Class II, IEC 60601-1) Do not dispose this product with house waste. Contact Delsys Inc. for instructions on responsibly disposing this device. This product should not be mixed with other commercial wastes. Date of Manufacturing (appears on device) Serial Number (appears on device) EMERGO EUROPE Molenstraat 15 2513 BH, The Hague The Netherlands Authorized Representative Manufacturer DELSYS INC. 650 Beacon St. Boston MA 02215 USA 6 FCC ID: W4P-SP-W03 (Trigno Body Worn Receiver) FCC ID: W4P-SP-W01 (Trigno Sensor) IC: 8138A-DST02 (Trigno Personal Monitor 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. This product complies with FCC OET Bulletin 65 radiation ex- posure limits set forth for an uncontrolled environment. 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. Pursuant to Part 15.21 of the FCC Rules, any changes or modi- fications to this product not expressly approved by Delsys Inc. might cause harmful interference and void the FCC authoriza- tion to operate this product. To reduce potential radio interference to other users, the antenna type and its gain should be so chosen that the equivalent isotro- pically radiated power (EIRP) is not more than that required for successful communication. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency en- erg y and, if not installed and used in accordance with the instruc- tions, may cause harmful interference to radio communications. There is no guarantee that interference,will not occur in a par- ticular installation. If this equipment does cause harmful inter- ference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: • Reorient or relocate the receiving antenna. • Increase the separation between the equipment and receiver. • Connect the equipment into outlet on a separate circuit.…

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Page 1 of 1 RP-6978L 12 East Devonwood SOLVING A WAVE OF EMI COMPLIANCE PROBLEMS Romeoville, IL 60446 June 29, 2011 Tel: (815) 293-0772 Page 1 of 1 Fax: (815) 293-0820 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Rd. Columbia, MD 21046 Industry Canada Certification and Engineering Bureau Ottawa, Ontario K2H 8S2 Canada Reference FCC ID: W4P-SP-W03 Reference IC: 8138A-DST02 Organization: Delsys, Inc.. Long Term Confidentiality Delsys, Inc. requests that the following materials be withheld from public inspection permanently under 47 C.F.R. 0.457 & 0.459: (1) Detailed Circuit Schematics of the EUT (2) Block Diagrams (3) EUT Description The EUT will have tamper-proof screws to prevent the end user from opening the product. The above materials contain proprietary and confidential information not customarily released to the public. The public disclosure of these materials provides unjustified benefits to its competitors in the market. They are considered confidential trade secrets Authorized Signature Joseph Strzelecki Senior EMC Engineer Radiometrics Midwest Corporation Authorized Agent for Delsys, Inc.

Authorized Agent: Radiometrics Midwest Corporation (815) 293-0772 – [email protected] External EUT Photographs Front View Side Views Authorized Agent: Radiometrics Midwest Corporation (815) 293-0772 – [email protected] Bottom View Top View Rear View Authorized Agent: Radiometrics Midwest Corporation (815) 293-0772 – [email protected] Power Supply Top of Power Supply Bottom of Power Supply

Authorized Agent: Radiometrics Midwest Corporation (815) 293-0772 – [email protected] ID Label/Location Drawing of label This is a plastic label with permanent adhesive. The following is the FCC and IC ID numbers of this product. FCC ID: W4P-SP-W03 IC: 8138A-DST02 Radiometrics Midwest Corporation (815) 293-0772 – [email protected] Label Location This shows the label location. The printing on the above label is not the actual text.

Authorized Agent: Radiometrics Midwest Corporation (815) 293-0772 – [email protected] Internal EUT Photographs Photograph of PCB with RF section Photograph of PCB with RF section Authorized Agent: Radiometrics Midwest Corporation (815) 293-0772 – [email protected] Photograph of PCB with RF section: Keypad and Display removed Photograph of Hip Module: Rear Cover removed Authorized Agent: Radiometrics Midwest Corporation (815) 293-0772 – [email protected] Photograph of Hip Module: Battery removed Photograph of PCB boards inside case

Radiometrics Midwest Corporation (815) 293-0772 – www.radiomet.com Page 1 of 21 Electromagnetic Compatibility Test Report Tests Performed on a Delsys, Inc. Wireless EMG Hip Module, Model DS-T02 Radiometrics Document RP-6978 Product Detail: FCC ID: W4P-SP-W03 IC: 8138A-DS T02 Equipment type: 2.4 GHz Transmitter Test Standards: US CFR Title 47, Chapter I, FCC Part 15 Subpart C FCC Part 15 CFR Title 47: 2009 Industry Canada RSS-210, Issue 8: 2010 as required for Category I Equipment This report concerns: Original Grant for Certification FCC Part 15.249 Tests Performed For: Test Facility: Delsys, Inc. 650 Beacon St., Floor 6 Boston, MA 02215 Radiometrics Midwest Corporation 12 East Devonwood Romeoville, IL 60446 Test Date(s): (Month-Day-Year) February 18 thru March 9, 2011 Document RP-6978 Revisions: Rev. Issue Date Affected Pages Revised By 0 June 15, 2011 1 June 29, 2011 22 Joseph Strzelecki 2 December 6, 2011 All Joseph Strzelecki 3 December 8, 2011 All Joseph Strzelecki RADIOMETRICS MIDWEST CORPORATION - EMC Test Report Testing of the Delsys, Inc., Model DS-T02, Wireless EMG Sensor System RP-6978 Rev. 3 Page 2 of 21 Table of Contents 1 ADMINISTRATIVE DATA ....................................................................................................................3 2 TEST SUMMARY AND RESULTS ......................................................................................................3 2.1 RF Exposure Compliance Requirements ......................................................................................3 3 EQUIPMENT UNDER TEST (EUT) DETAILS .....................................................................................3 3.1 EUT Description ............................................................................................................................3 3.1.1 FCC Section 15.203 & RSS-GEN Antenna Requirements.....................................................4 3.2 Related Submittals ........................................................................................................................4 4 TESTED SYSTEM DETAILS ...............................................................................................................4 4.1 Tested System Configuration........................................................................................................4 4.2 Special Accessories ......................................................................................................................5 4.3 Equipment Modifications ...............................................................................................................5 5 TEST SPECIFICATIONS AND RELATED DOCUMENTS ..................................................................5 6 RADIOMETRICS’ TEST FACILITIES ..................................................................................................5 7 DEVIATIONS AND EXCLUSIONS FROM THE TEST SPECIFICATIONS .........................................6 8 CERTIFICATION .................................................................................................................................6 9 TEST EQUIPMENT TABLE .................................................................................................................6 10 TEST SECTIONS ..............................................................................................................................6 10.1 AC Conducted Emissions ...........................................................................................................6 10.1.1 AC Conducted Emissions Test Results ................................................................................8 10.2 Time of Occupancy (Dwell Time) ..............................................................................................10 10.3 Occupied Bandwidth (20 dB) ....................................................................................................11 10.4 Band-edge Compliance of RF Conducted Emissions ...............................................................13 10.5 RF Radiated Emissions.............................................................................................................15 10.5.1 Radiated Emissions Field Strength Sample Calculation ....................................................16 10.5.2 Spurious Radiated Emissions Test Results........................................................................17 Notice: This report must not be reproduced (except in full) without the written approval of Radiometrics Midwest Corporation. RADIOMETRICS MIDWEST CORPORATION - EMC Test Report Testing of the Delsys, Inc., Model DS-T02, Wireless EMG Sensor System RP-6978 Rev. 3 Page 3 of 21 1 ADMINISTRATIVE DATA Equipment Under Test: A Delsys, Inc., Wireless EMG Sensor System Model: DS-T02, Serial Number: none This will be referred to as the EUT in this Report Date EUT Received at Radiometrics: (Month-Day-Year) Test Date(s): (Month-Day-Year) February 18, 2011 February 18 thru March 9, 2011 Test Report Written By: The Test Witnessed by: Joseph Strzelecki Senior EMC Engineer The Test was not Witnessed by Personnel from Delsys, Inc. Radiometrics’ Personnel Responsible for Test: Test Report Approved By Joseph Strzelecki Senior EMC Engineer NARTE EMC-000877-NE Chris W. Carlson Director of Engineering NARTE EMC-000921-NE 2 TEST SUMMARY AND RESULTS The EUT (Equipment Under Test) is a Wireless EMG Sensor Hip Modeule, Model DS-T02, manufactured by Delsys, Inc. The EUT consists of a Base and Sensor. The detailed test results are presented in a separate section. The following is a summary of the test results. Emissions Tests Results Environmental Phenomena Frequency Range FCC Section RSS-210 Section Test Result 20 dB Bandwidth Test 2400 to 2483 MHz 15.249 A2.9 Pass Radiated Emissions 30 MHz to 25 GHz 15.249 A2.9 Pass AC Conducted Emissions Test 0.15-30 MHz 15.207 RSS-Gen-e 7.2.2Pass 2.1 RF Exposure Compliance Requirements Because the power output is 9 mW, The EUT meets …

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Authorized Agent: Radiometrics Midwest Corporation (815) 293-0772 – [email protected] Test Setup Photographs Photographs of Radiated Emissions Test Setup Authorized Agent: Radiometrics Midwest Corporation (815) 293-0772 – [email protected] Authorized Agent: Radiometrics Midwest Corporation (815) 293-0772 – [email protected] Authorized Agent: Radiometrics Midwest Corporation (815) 293-0772 – [email protected] Photographs of Conducted Emissions Test Setup