2AD2U-NMESTNSMODThe Compex Wireless USA simulation module set is composed of 4 independent simulation modules that are controlled via the remote control by a wireless connection

English|Español|Français Insert image of Compex Wireless USA with Modules USER MANUAL INSTRUCTIONS TABLE OF CONTENTS Forward ......1 About Compex Wireless USA ......2 Precautionary Instructions ......2 Cautions. . . . . . . . . . . 3-5 Warnings . . . . . . . . . . 6-8 Dangers. . . . . . . . . . . 9 Indications for Use . . . . . . . . . . . 10 Contraindications . . . . . . . . . . . 10-11 Adverse Reactions . . . . . . . . . . 11 Contents ......12 Compex Wireless USA ......12-13 Accessories ......14 Introduction ......15 How Does Electrostimulation Work? ......15 Motor Nerve Stimulation (EMS) ......15 Benefits of Electrostimulation ......16 Safety Guide ......17-20 Who should not use the Compex Wireless USA ......17 Where never to apply electrodes ......18-19 Precautions when using electrodes ......20 Operation ......21 Preliminary Settings ......21 First Use ......21-22 Device Function ......23 Select a Program. ......25 Select Electrode Placement ......26 Turn on Modules ......26 How to Access Settings ......27 Start a Simulation Program ......29 Battery Level Indication ......34 Charging ......34-36 Programs ......37 Endurance ......37 TABLE OF CONTENTS Resistance ......37 Strength ......38 Explosive Strength ......38 Specialized Muscle Training Programs ......38 Potentiation ......38 Training Recovery ......39 Pre-Warmup ......39 Competition Recovery ......39 Muscle Relaxation ......39 Operational Guidelines. ......40-42 Usage Guidelines ......40 Choosing the Appropriate Work Program. ......40 Planning Stimulation Session ......40 Electrode Positions ......40 Stimulation Positions ......41 Adjusting Stimulation Energies ......42 Progression in the Levels ......42 TROUBLESHOOTING ......43-45 DEVICE MAINTENANCE ......46 Maintenance......46 Storage/Transport and Use ......46 Disposal ......46 Technical Specifications ......47 General Information ......47 Neurostimulation ......47 RF Data ......48 Standards ......50 Information about Electromagnetic Compatibility (EMC) ......50 Patents ......50 How to Get Help ......51 Specifications ......52 Description of Device Markings ......52 Output Waveform ......54 Output Specifications ......55 Warranty ......62 1 English Foreword This manual has been written for the owners and operators of the Compex® Wireless USA. It contains general instructions for operation, precautionary instructions, and maintenance recommendations. In order to obtain maximum life and efficiency from your Compex Wireless USA, and to assist in the proper operation of the unit, read and understand this manual thoroughly. The specifications put forth in this manual were in effect at the time of the publication. However, changes to these specifications may be made at any time without obligation on the part of DJO, LLC. Before starting any program, you should become acquainted with the shopcompex.com website to establish an appropriate training plan. The shopcompex.com website helps you take your first steps with the device. 2 About Compex Wireless USA PRECAUTIONARY INSTRUCTIONS The precautionary instructions found in this section and throughout this manual are indicated by specific symbols. Understand these symbols and their definitions before operating this equipment. The definitions of these symbols are as follows: Caution Text with a “CAUTION” indicator will explain possible safety infractions that could have the potential to cause minor to moderate injury or damage to equipment. Warning Text with a “WARNING” indicator will explain possible safety infractions that will potentially cause serious injury and equipment damage. Dangerous Voltage Text with a “Dangerous Voltage” indicator serves to inform the user of possible hazards resulting in the electrical charge delivered in certain program configurations of waveforms. BioHazardous materials Text with a “Biohazard” indicator serves to inform the user of possible hazards resulting in improper handling of components and accessories that have come in contact with bodily fluids. Danger Text with a “DANGER” indicator will explain possible safety infractions that are imminently hazardous situations that would result in death or serious injury. Explosion Hazard Text with an “Explosion Hazard” indicator will explain possible safety infractions if this equipment is used in the presence of flammable anesthetics. non-ionizing electromagnetic radiation Text with a “Non-Ionizing Electromagnetic Radiation” indicator informs the user of possible hazards resulting from elevated, potentially dangerous levels of non-ionizing radiation. Note: Throughout this manual, “NOTE” may be found. These Notes are helpful information to aid in the particular area or function being described. 3 English ABOUT Compex Wireless USA • Read, understand, and practice the precautionary and operating instructions found in this manual. Know the limitations and hazards associated with the treatment table. Observe any and all precautionary and operational decals placed on the unit. • DO NOT operate this unit in an environment where other devices are being used that intentionally radiate electromagnetic energy in an unshielded manner. Portable and mobile RF communications equipment can affect Medical Electrical Equipment. • This unit generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to other devices in the vicinity. However, there is no guarantee that interference will not occur in a particular installation. Harmful interference to other devices can be determined by turning this unit on and off. Try to correct the interference using one or more of the following: reorient or relocate the receiving device, increase the separation between the equipment, connect the unit to an outlet on a different circuit from that which the other device(s) are connected, and consult DJO, LLC for help. • NOTE: This equipment has been tested and found to comply with the limits for a Clas…

Text truncated - open the document above for the full version.

PHOTOS of COMPEX WIRELESS USA-MODULES Top photo of module Bottom photo of module Side view of Module “snapping” into electrode Another side view of module and electrode All four modules (pods) in action

PHOTOS of COMPEX WIRELESS USA-MODULES G9_MOD_NMESTENS1_PCB_V2 Bottom side G9_MOD_NMESTENS1_PCB_V2_ top side

This report is for the exclusive use of Intertek's Client and is provided pursuant to the agreement between Intertek and its Client. Intertek's responsibility and liability are limited to the terms and conditions of the agreement. Intertek assumes no liability to any party, other than to the Client in accordance with the agreement, for any loss, expense or damage occasioned by the use of this report. Only the Client is authorized to permit copying or distribution of this report and then only in its entirety. Any use of the Intertek name or one of its marks for the sale or advertisement of the tested material, product or service must first be approved in writing by Intertek. The observations and test results in this report are relevant only to the sample tested. This report by itself does not imply that the material, product, or service is or has ever been under an Intertek certification program. Non-Specific EMC Report Shell Rev. July 2013Page 1 of 34 DJO LLC 001602 EMC TEST REPORT Report Number: 102114950ATL-001 Project Number: G102114950 Report Issue Date: June 22, 2015 Product Designation:COMPEX Module Model tested: 001062 Standards: CFR47 FCC Part 15 Subpart C:2015 Section 15.205, 15.209, 15.215, 15.249 CFR47 FCC Part 15 Subpart B:2015 Section 15.109 Industry Canada RSS-210 Issue 8 December 2010, Annex A2.9 Industry Canada RSS-GEN Issue 4 November 2014 Tested by:Client: Intertek 1950 Evergreen Blvd, Suite 100 Duluth, GA 30096 USA DJO LLC 1430 Decision Street Vista, CA 92081 USA Report prepared byReport reviewed by Mary Sampson/Senior Project EngineerKrishna Vemuri/Senior Staff Engineer Intertek Report Number: G102114950ATL-001Issued: 06/22/2015 Non-Specific EMC Report Shell Rev. July 2013Page 2 of 34 DJO LLC 001062 1Introduction and Conclusion The tests indicated in section 2.0 were performed on the product constructed as described in section 4.0. The remaining test sections are the verbatim text from the actual data sheets used during the investigation. These test sections include the test name, the specified test Method, a list of the actual Test Equipment Used, documentation Photos, Results and raw Data. No additions, deviations, or exclusions have been made from the standard(s) unless specifically noted. Based on the results of our investigation, we have concluded the product tested complieswith the requirements of the standard(s) indicated. The results obtained in this test report pertain only to the item(s) tested. 2Test Summary SectionTest full nameResult 3Client Information 4Description of Equipment Under Test 5System Setup and Method 6 Fundamental Frequency Radiated Emissions (47CFR Part 15 Subpart C: 2015 Section 15.249 RSS-210 Issue 8 Dec 2010 Annex A2.9) Pass -- AC Mains Conducted Emissions (Battery Powered Device) N/A 7 Transmitter Spurious Radiated Emissions (47CFR Part 15 Subpart C: 2015 Section 15.249, 15.209, 15.205 RSS-210 Issue 8 Dec 2010 Annex A2.9) Pass 8 Duty Cycle (47CFR Part 15 Subpart A: 2015 Section 15.35(c) RSS-GEN Issue 4: Nov 2014 Section 6.10) Pass 9 20 dB Bandwidth (47CFR Part 15 Subpart C: 2015 Section 15.215 RSS-GEN Issue 4:Nov 2014 Section 6.6) Pass 10 Bandedge (Band Edge (47CFR FCC Part 15 Subpart C: 2015 Section 15.215(c), 15.249(d); RSS-210 Issue 8: Dec 2010 Annex A2.9) Pass 11 Digital Parts Emissions (47CFR Part 15 Subpart B: 2015 Section 15.109 RSS-GEN Issue 4:Nov 2014 Section 6.6 Pass 12 13 RF Exposure(47CFR Part 2 Subpart J:2015 Section 2.1091; RSS- 102 Issue 4 Mar 2010 Section 2.5.1) Revision History Pass Intertek Report Number: G102114950ATL-001Issued: 06/22/2015 Non-Specific EMC Report Shell Rev. July 2013Page 3 of 34 DJO LLC 001062 3Client Information This EUT was tested at the request of: Client:DJO LLC 1430 Decision Street Vista, CA 92081 USA Contact:Mark Stavro Telephone: (760) 734-3551 Fax:(760) 734-5694 Email:[email protected] 4Description of Equipment Under Test Manufacturer:DJO LLC 1430 Decision Street Vista, CA 92081 USA Equipment Under Test DescriptionManufacturerModel NumberSerial Number Wireless Professional Module DJO001062YOP013860 TX and RX mode testing Wireless Professional Module DJO001062YOP014435 RX mode testing Wireless Professional Module DJO001062YOP013793 RX mode testing Wireless Professional Module DJO001062YOP014434 RX mode testing Receive Date:10/15/2014 Received Condition:Good Type:Production Description of Equipment Under Test (provided by client) The Compex Wireless USA stimulation module set is composed of 4 independent stimulation modules that are controlled via the remote control by a wireless connection. Each module is composed of two “pods” (one battery “pod” and one stimulation “pod”) linked by an electrical connection cable. Two proprietary Compex Standard snap gel electrodes are also needed to connect each “pod” to the body. The modules are powered by a Lithium Polymer (LiPo) rechargeablH9•P$+EDWWHU\. Equipment Under Test Power Configuration Rated VoltageRated CurrentRated FrequencyNumber of Phases 3.7 VdcN/AN/AN/A Operating modes of the EUT: No.Descriptions of EUT Exercising 1Continuous transmission 2Idle Software used by the EUT: No.Descriptions of EUT Exercising 1Firmware version: 0301x779A712F Intertek Report Number: G102114950ATL-001Issued: 06/22/2015 Non-Specific EMC Report Shell Rev. July 2013Page 4 of 34 DJO LLC 001062 5System Setup and Method Cables IDDescriptionLength (m) ShieldingFerritesTermination AElectrical Connection0.18NoNo Battery Pod/Stimulation Pod Support Equipment DescriptionManufacturerModel NumberSerial Number None 5.1Method: Configuration as required by CFR47 FCC Part 15 Subpart C:2015 Sections 15.205, 15.209, 15.215, 15.249, Industry Canada RSS-210 Issue 8 December 2010, Annex A2.9, Industry Canada RSS-GEN Issue 4 November 2014, and ANSI C63.10-2013. 5.2EUT Block Diagram: For TX Mode, one module was used during testing. For RX mode, four modules were used during testing. A Stimulation Pod Battery Pod Intertek Report Number: G102114950ATL-001Issued: 06/22/2015 …

Text truncated - open the document above for the full version.