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STANDARDS

The Compex Wireless USA complies with current medical standards�

The Compex Wireless USA also complies with the IEC 60601-1 standard on general safety requirements for
electro-medical devices, the IEC 60601-1-2 standard on electromagnetic compatibility, the IEC 60601-2-10
standard on particular safety requirements for nerve and muscle stimulators, and the IEC 60601-1-11 standard
for use in the home environment�

The Compex Wireless USA Docking Station is used to charge the remote control and stimulation modules� It
complies with the IEC 60950-1 standard on general safety requirements for information technology equipment
and the following standards for electromagnetic compatibility: IEC 61000-3-2, IEC 61000-3-3, CISPR 22, and
CISPR 24�

INFORMATION ABOUT ELECTROMAGNETIC COMPATIBILITY (EMC)

The Compex Wireless USA is designed to be used in typical domestic approved environments in accordance
with the safety standard EMC EN 60601-1-2�

The Compex Wireless USA is designed to support anticipated disturbance originating from electrostatic
discharge, magnetic fields for the power supply or radiofrequency emitters�

However, it is not possible to guarantee that the stimulator will not be affected by powerful RF fields (radio
frequency) originating from other sources�

For more information about electromagnetic emission and immunity, please contact Compex�

PATENTS

The Compex Wireless USA incorporates several innovations with patents pending�

HOW TO GET HELP

For Customer assistance or to order a hardcopy of the User Manual at no charge, please contact:

COMPEX PRODUCT SUPPORT

Toll Free: 877-266-7398 (877-COMPEX8)
Fax: 1-760-734-1959
E-Mail: Service@ShopCompex�com

Website: www�ShopCompex�com

Address:
DJO, LLC
1430 Decision Street
Vista, CA 92081

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Summary of Contents for Wireless USA

Page 1: ...E N G L I S H USER MANUAL IFU_WIRELESS_2 indd 1 6 10 15 10 45 AM ...

Page 2: ... 11 Accessories 13 4 INTRODUCTION 14 How does Electrostimulation Work 14 Motor Nerve Stimulation EMS 14 Benefits of Electrostimulation 15 5 SAFETY GUIDE 16 Who Should Not Use the Compex Wireless USA 16 Where Never to Apply Electrodes 17 Precautions When Using Electrodes 19 6 OPERATION 20 Preliminary Settings 20 First Use 20 Device Function 22 How to Access Favorites 22 How to Access Programs 24 Ho...

Page 3: ...ergies 39 Progression in the Levels 40 8 TROUBLESHOOTING 41 9 DEVICE MAINTENANCE 45 Warranty 45 Maintenance 45 Storage Transport and Use 45 Disposal 45 10 TECHNICAL SPECIFICATIONS 46 General Information 46 Neurostimulation 46 RF Data 47 Standards 49 Information About Electromagnetic Compatibility EMC 49 Patents 49 How to Get Help 49 Description of Device Markings 50 Explanation of Symbols 51 Outpu...

Page 4: ...roper 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 www ShopCompex com website to establish an appropriate training pla...

Page 5: ...eath 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 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 MAT...

Page 6: ... 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 energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will n...

Page 7: ...ranging from 30 75 Sudden temperature changes can cause condensation to build up inside the stimulator To prevent this allow it to reach ambient temperature before use Electrodes should not be shared with other persons Each person should have their own set of electrodes otherwise undesirable skin reactions may occur Self adhesive electrodes should be replaced if they no longer stick firmly to the ...

Page 8: ...instances people of a nervous disposition may experience a vasovagal reaction This is of psychological origin and is connected with a fear of the muscle stimulation as well as surprise at seeing one of their muscles contract without having intentionally contracted it themselves A vasovagal reaction causes heart to slow down and blood pressure to drop which can make you feel weak and faint If this ...

Page 9: ...cts manufactured by other companies The use of other accessories or cables may result in increased emissions or decreased immunity of the Compex Wireless DANGER Stimulus delivered by the waveforms of this device in certain configurations will deliver a charge of 25 microcoulombs μC or greater per pulse and may be sufficient to cause electrocution Electrical current of this magnitude must not flow ...

Page 10: ...s These excitations of motoneurones are transmitted to the muscle fibers via the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work Depending on the parameters of the electrical impulses pulse frequency duration of contraction duration of rest total session duration different types of muscle work can be imposed on the stimulated muscles The Compex W...

Page 11: ...ems or unable to express yourself OSTEOSYNTHESIS EQUIPMENT The presence of osteosynthesis equipment metallic equipment in contact with the bone pins screws plates prostheses etc is not a contraindication for the use of Compex Wireless USA programs The electrical currents of the Compex Wireless USA are specially designed to have no harmful effect on osteosynthesis equipment ADVERSE REACTIONS Skin i...

Page 12: ...y of the selected channels D Confirm button E Plug for the docking station connector MODULE A On Off button press briefly to turn on press and hold down to turn off Flashing green LED Ready Flashing yellow LED In stimulation B Groove for winding the cable 3 CONTENTS COMPEX WIRELESS USA Note You are strongly advised to carefully read the safety precautions and contraindications described at the sta...

Page 13: ...WIRELESS USA DOCK A Remote control charging connector B Notch to open the lid of the docking station C Location for positioning the modules to be recharged D Charger plug E N G L I S H 12 IFU_WIRELESS_2 indd 12 6 10 15 10 45 AM ...

Page 14: ...Compex Lanyard 5529028 1 Remote Control Protection Sleeve 001094 1 Performance Electrodes 2 X 2 Compex 11 9119 2 Performance Electrodes 2 X 4 Compex 11 9120 2 Performance Electrodes 2 X 4 Compex Rectangular 1 Snap 11 9123 2 Only use this device with electrodes battery Docking Station and accessories recommended by Compex Compex Wireless USA users can purchase electrodes for their device via phone ...

Page 15: ...hanical response muscular twitch The latter constitutes the basic requirement for muscular contraction This muscular response is completely identical to muscular work controlled by the brain In other words the muscle cannot distinguish whether the command comes from the brain or from the stimulator The parameters of the Compex Wireless USA programs number of impulses per second contraction time re...

Page 16: ...involve the greatest possible number of muscular fibers The number of fibers working depends on the stimulation energy The maximum tolerable energy should therefore be used The user controls this aspect of stimulation The higher the stimulation energy the greater the number of muscular fibers that are working and therefore the more significant the progress achieved To maximize results DJO LLC reco...

Page 17: ...guinal hernia 7 Do you suffer from cancer 8 Are you pregnant 9 Do you suffer from cardiac problems or diseases 10 Do you have painful or afflicted joints 11 Do you have muscle spasms 12 Do you have atrophied muscles 13 Do you have painful muscles 14 Do you need muscle reeducation 15 Do you have any joint showing a decrease in its range of motion If you answer Yes or Maybe or I don t know to one or...

Page 18: ...SAFETY GUIDE WHERE NEVER TO APPLY ELECTRODES On the head or any area of the face On the neck or any area of the throat E N G L I S H 17 IFU_WIRELESS_2 indd 17 6 10 15 10 45 AM ...

Page 19: ...t and back sides or lateral sides On or in the vicinity of skin lesions or eruptions of any kind wounds swelling burns irritation eczema etc Over the abdominal region during menstruation periods On skin areas lacking of normal sensation E N G L I S H 18 IFU_WIRELESS_2 indd 18 6 10 15 10 45 AM ...

Page 20: ...f any oil and dry it before attaching the electrodes Attach the electrodes in such a way that their entire surface is in contact with the skin For obvious reasons of hygiene each user must have his her own electrode set Do not use the same electrodes on different people Never use a set of adhesive electrodes for more than 15 sessions as their bonding power deteriorates over time and optimal contac...

Page 21: ... operating language selection display contrast setting adjusting backlighting and volume setting To change any of these settings bring up the settings screen by navigating to the settings icon and selecting settings by pushing the center button on the remote control FIRST USE When using the device for the first time the following steps must be followed 1 Select language 2 Turn on all modules in or...

Page 22: ...nd recognized by the remote control a check appears on the module When all modules are paired all check marks appear Note This pairing procedure is to be performed only once E N G L I S H 21 IFU_WIRELESS_2 indd 21 6 10 15 10 45 AM ...

Page 23: ... automatically be removed from the list of favorites 1 SELECT A FAVORITE 2 SELECT ELECTRODE PLACEMENT A B A A Select the desired electrode placement B Confirm your selection C Return to the previous step A B A C DEVICE FUNCTION The following screens are generic examples but they work in the same way regardless of the device that you have A Select the Favorites menu B Confirm your selection A Selec...

Page 24: ...ick the electrodes to your skin The module is attached to the electrode from the side Slide the module onto the electrode s snap until it clips into place 4 TURN ON THE MODULES To launch the program see the section entitled Start a stimulation program A Confirm your selection B Return to the previous step B A E N G L I S H 23 IFU_WIRELESS_2 indd 23 6 10 15 10 45 AM ...

Page 25: ...TEGORY 2 SELECT A PROGRAM A Select the desired program B Confirm your selection C Return to the previous step A Select the Program menu B Confirm your selection A Select the desired program category B Confirm your selection C Return to the previous step A B A A B A C A B A C Muscle Relaxation E N G L I S H 24 IFU_WIRELESS_2 indd 24 6 10 15 10 45 AM ...

Page 26: ...o the electrode s snap until it clips into place 5 TURN ON THE MODULES To launch the program see the section entitled Start a stimulation program A Confirm your selection B Return to the previous step A Select the desired electrode placement B Confirm your selection C Return to the previous step A B A C B A Muscle Relaxation E N G L I S H 25 IFU_WIRELESS_2 indd 25 6 10 15 10 45 AM ...

Page 27: ... inducing powerful muscle contractions enabling the training cycle to be selected PROGRESSION IN THE LEVELS In general it is not advisable to go through the different levels quickly with the intention of reaching level 5 as fast as possible In fact the different levels correspond to progress with electrostimulation The goal is to progress through the electrical intensities and then through the lev...

Page 28: ...ound Turns the Sound function on ON or off OFF Contraction Sound Turns the contraction arrival warning sound on ON or off OFF Set Time Allows you to set the time on the device Set Date Allows you to set the date on the device Pair a new module Enables a new module to be paired to the remote control Reset to factory settings Enables the device to be re set and return to the basic settings Favorites...

Page 29: ... electrode placement selected As soon as a sufficient number of modules is turned on a small arrow appears on the right of the screen STIMULATION ALWAYS STARTS AT 000 A B A Contraction phase B Warm up phase C Active rest phase E Relaxation phase F Number of contractions performed Total number of contraction G Guiding message H Help message A B C E D F G A Return to the previous step A Confirm your...

Page 30: ...ion energy With a lower current intensity there are fewer working fibers With a higher current intensity the number of working fibers is increased For programs involving powerful muscular contractions you must therefore use maximum stimulation energies up to 999 always at the limit that you can endure in order to recruit the maximum number of fibers A Select the channels on which to act When a cha...

Page 31: ... with a relaxation phase MUSCLE RELAXATION RECOVERY TYPE PROGRAM These programs consist of a single phase and have no contraction active rest cycle These are recovery muscle relaxation pre warmup programs During this type of program frequency variations can occur A Work phase A A Warm up phase B Active rest phase C Relaxation phase D Contraction phase E Number of work phase cycles completed total ...

Page 32: ... the interruption END A STIMULATION PROGRAM At the end of the session a screen with a check mark appears Pressing on any button returns you to the Main menu To turn off the device hold down the remote control s On Off button for 2 seconds This will also result in turning off all modules Depending on the program maximum and average intensities statistics may appear A Skip the current phase or exit ...

Page 33: ...OCKING STATION Connect the AC adapter supplied with your device to the docking station and then plug it into a power outlet It is strongly recommended that you fully charge the remote control batteries and modules before first use in order to improve its performance and life expectancy A Module battery level B Remote control battery level A B E N G L I S H 32 IFU_WIRELESS_2 indd 32 6 10 15 10 45 A...

Page 34: ...MPEX WIRELESS USA In order to do so place the remote control on its connector Then place the modules in the slots provided for this purpose To do so place the A pod without the On Off button the green one in the figure in the location indicated in green and the other pod B in the location indicated in blue Do the same for the other modules A B E N G L I S H 33 IFU_WIRELESS_2 indd 33 6 10 15 10 45 ...

Page 35: ...te control s screen As soon as the remote control and modules are fully charged they go into standby mode Note About Battery Shelf Life If the device is not used for an extended period we recommend that you charge the batteries to 50 of their capacity every 3 months You should also store the device containing the batteries in a cool and dry environment A Remote control battery charging B Module ch...

Page 36: ...preparations to establish or improve basic muscle endurance It is designed to increase the average intensity of muscle effort that must be maintained over a long period It is most appropriate for athletes engaged in endurance sports such as marathon triathlon cycling etc RESISTANCE The Compex Resistance program imposes an average high power working level on muscle fibers This working level is main...

Page 37: ...wing To ensure a progressive approach in the muscle stimulation training you are strongly advised not to use this program without having previously worked through a cycle of sessions using the Strength program SPECIALIZED MUSCLE TRAINING PROGRAMS The Compex Wireless USA also offers five special muscle training programs Their objective is to prepare muscles for activity explosive motions or to faci...

Page 38: ...s applicable to sports that require shorter efforts basketball soccer football PRE WARMUP The Compex Pre Warmup program helps muscles to get ready and should be used before training sessions and before competitions The twitches increases blood flow warm the muscle tissue and speed all the reactions necessary for the most efficient muscular contraction COMPETITION RECOVERY The Compex Recover Plus p...

Page 39: ...er of training sessions per week you should do and the number of weeks you should use a muscle training program ELECTRODE POSITIONS For optimal results use the electrode positions recommended by Compex To do this refer to the pictures and pictograms shown on the Remote Stimulator Each stimulation module has two pods A positive pole power on off pod A negative pole smooth top connection A different...

Page 40: ...action which could create cramp pains and serious stiffness after the session For example when stimulating the quadriceps the user should be in a seated position with the ankles fixed with straps to prevent extension of the knees For other types of programs for example the Training Recovery Active Recovery program which do not involve powerful muscular contractions position yourself as comfortably...

Page 41: ...ll be the fibers that are going to progress But the speed of progress of these fibers and their ability for handle increasing training loads depend on the program and level used the number of sessions per week the length of these sessions and on intrinsic factors specific to each individual The simplest and most usual procedure is to start with level 1 and raise the level after 3 to 6 training ses...

Page 42: ...electrodes MODULE OUT OF RANGE The remote control displays the out of range symbol and an arrow flashing on the channel where the problem was detected in this case channel 1 Check to make sure that the module and the remote control are less than 7 2 meters away from each other Make sure you are not in an isolated area with no obstacle to reflect the signal from the remote control Make sure you are...

Page 43: ... 2 meters away from each other The LED is still red Ensure the module is charged Try to restart the remote control and modules If despite this the LED is still red contact customer service provided and approved by Compex The LED does not turn on Ensure the module is charged If despite this the LED still does not turn on contact customer service provided and approved by Compex E N G L I S H 42 IFU_...

Page 44: ...t THE MODULE WILL NOT PAIR WITH THE REMOTE CONTROL At the time of first use if the remote control is unable to pair all modules an error message may appear Ensure that the module is charged and repeat the pairing step If despite this the message returns contact customer service provided and approved by Compex STIMULATION DOES NOT PRODUCE THE USUAL SENSATION Check that all settings are right and ch...

Page 45: ...be replaced Change the positioning of the electrodes slightly THE DEVICE IS NOT WORKING Ensure that the remote control and modules are charged Try to restart the remote control and modules If despite this the device still does not work contact customer service provided and approved by Compex E N G L I S H 44 IFU_WIRELESS_2 indd 44 6 10 15 10 45 AM ...

Page 46: ...es If your stimulator contains parts that appear to be worn or faulty please contact the closest Compex customer service center STORAGE TRANSPORT AND USE STORAGE AND TRANSPORT USE TEMPERATURE 4 F to 113 F 20 C to 45 C 32 F to 104 F 0 C to 40 C MAXIMUM RELATIVE HUMIDITY 75 30 to 75 ATMOSPHERIC PRESSURE from 700 hPa to 1060 hPa from 700 hPa to 1060 hPa Do not use in areas at risk of explosion DISPOS...

Page 47: ...and individually adjustable channels electrically insulated from one another Impulsion form constant rectangular current with compensated impulses to eliminate any direct element of continuous current to avoid any residual polarisation from the skin Maximum impulse intensity 120 mA Impulse intensity increments manual adjustment of stimulation intensity from 0 to 999 energy by minimum increments of...

Page 48: ...d as maximum output power Effective emission power 4 4 dBm Data rate 2 Mbps Quality of service requirement 2 meter range between remote and stimulation modules WIRELESS SECURITY MEASURES Device identification 32 bits shared only with other Compex Wireless USA devices Data integrity checks Each data frame protected by a 16 b length CRC Acknowledgement Each point to point communication is acknowl ed...

Page 49: ...come is that all stimulation modules will stop stimulation Interference from other RF wireless and mobile communication devices is possible Refer to Table 4 for recommended distances between Compex Wireless USA and other RF devices FCC REQUIREMENTS This device complies with Part 15 of the FCC Rules Operation is subject to the following 2 conditions This device may not cause harmful interference Th...

Page 50: ...The Compex Wireless USA is designed to be used in typical domestic approved environments in accordance with the safety standard EMC EN 60601 1 2 The Compex Wireless USA is designed to support anticipated disturbance originating from electrostatic discharge magnetic fields for the power supply or radiofrequency emitters However it is not possible to guarantee that the stimulator will not be affecte...

Page 51: ...device with built in power supply and BF Type parts Class II Device with internal electric power Refer to Instruction Manual Booklet Website www ShopCompex com The On Off button is a multifunction button On Off two stable positions Waiting or on standby for a part of the unit Stop turns system off ETL Classified C US 3184356 Canadian product safety standards This device complies with UL Std 60601 ...

Page 52: ... equal to or greater than 12 5 mm 0 5 po IP02 IP02 on the carrying case means Protected from the ingress of water droplets from a shower of rain Reference Batch number OUTPUT WAVEFORM Biphasic rectangular impulse with electrical mean equal zero net zero DC All electrical specifications are given for an impedance of 500 1000 ohms per channel Channels Four independent and individually adjustable cha...

Page 53: ...2 Group 1 Complies The Compex Wireless USA uses RF energy only for its internal operation Consequently its RF emissions are very low and are unlikely to interfere with any adjacent electrical device RF Emissions Stimulation mode CISPR 11 Charging mode CISPR 22 Class B Class B The Compex Wireless USA is suitable for use in any establishment including a private dwelling and a place connected directl...

Page 54: ...ot Applicable Line to Earth CISPR24 COMPLIANCE LEVEL The quality of the power supply should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in U for 25 cycles 5 UT 95 dip in U for 5 sec 5 UT 95 dip in UT for 0 5 cycl...

Page 55: ...50 kHz to 80 MHz 3 Vrms 150 kHz to 80MHz CISPR24 COMPLIANCE LEVEL d 1 2 P Radiated RF IEC 61000 4 3 3 V m 80 MHz to 1 GHz 3 V m 1 GHz to 2 5 GHz 3 V m 3 V m d 4 P 80 MHz to 800 MHz d 6 7 P 800 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m a Field strengths fr...

Page 56: ...DING TO THE FREQUENCY OF THE TRANSMITTER M CISPR 11 FROM 150 KHZ TO 80 MHZ D 1 2 P FROM 80 MHZ TO 800 MHZ D 4 P FROM 800 MHZ TO 2 5 GHZ D 6 7 P 0 01 0 12 0 4 0 67 0 1 0 38 1 26 2 11 1 1 2 4 6 7 10 3 8 12 6 21 1 100 12 40 67 In the case of whose maximum output power is not shown in the table above the recommended spacing of d meters m can be calculated using the appropriate equation for the transmi...

Page 57: ...rts or labor furnished by anyone other than the Company the selling dealer or a service technician certified by the Company Defects or damage caused by labor furnished by someone other than the Company the selling dealer or a certified Company service technician Any malfunction or failure in the Product caused by product misuse including but not limited to the failure to provide reasonable and req...

Page 58: ... any person or representative to create for it any other obligation or liability in connection with the sale of the Product Any representation or agreement not contained in the warranty shall be void and of no effect The Foregoing Warranty is in lieu of all other Warranties expressed or implied including any Warranty or Merchantability or Fitness For a Particular Purpose E N G L I S H 57 IFU_WIREL...

Page 59: ...P N 4525520_RevA 2015 DJO LLC E N G L I S H 58 IFU_WIRELESS_2 indd 58 6 10 15 10 45 AM ...

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