Compex Wireless USA User Manual

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USER MANUAL

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TABLE OF CONTENTS

It is strongly recommended to read these instructions and the contraindications and safety measures carefully before using your stimulator.

1. FOREWORD �� 3

2. ABOUT COMPEX WIRELESS USA ��4

Precautionary Instructions ��4

Caution ��5 Warning ��6

Danger �� 8 Indications for Use �� 9 Contraindications �� 9 Adverse Reactions ��10

3. CONTENTS ��11 Compex Wireless USA ��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 How to Access Settings ��26 Start a Stimulation Program ��28 Charging ��32

Battery Level Indication ��32

Programs ��35

Endurance ��35 Resistance ��35

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TABLE OF CONTENTS

Strength �� 36 Explosive Strength �� 36 Specialized Muscle Training Programs �� 36

Potentiation �� 36 Training Recovery ��37 Pre-Warmup ��37 Competition Recovery ��37 Muscle Relaxation ��37

7. OPERATIONAL GUIDELINES �� 38 Usage Guidelines�� 38 Choosing the Appropriate Muscle Work Program �� 38 Planning Stimulation Sessions �� 38 Electrode Positions �� 38 Stimulation Positions �� 39 Adjusting Stimulation Energies �� 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 Output Waveform ��51

11. WARRANTY �� 56

It is strongly recommended to read these instructions and the contraindications and safety measures carefully before using your stimulator.

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1. 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 www.ShopCompex.com

website to establish an appropriate training plan.

The www.ShopCompex.com website helps you take your ﬁrst steps with the device.

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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�

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�

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�

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�

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• 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 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 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 not occur in a particular installation� If this equipment does cause harmful interference 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 an outlet on a circuit different from that to which the receiver is connected – Consult the dealer or an experienced radio/TV technician for help

• Some persons may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium (gel)� The irritation can usually be reduced by using an alternative conductive medium or electrode placement�

• This device should be used only with the leads, electrodes and accessories recommended for use by the manufacturer�

• Caution should be used for users with suspected or diagnosed heart problems�

CAUTION

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• The Compex Wireless USA should not be used while driving, operating machinery, or during any activity in which involuntary muscle contractions may put the user at undue risk of injury�

• The effects of stimulation of the brain are unknown� Therefore, stimulation should not be applied across the head and electrodes should not be placed on the opposite sides of the head�

• Caution should be used for patients with suspected or diagnosed epilepsy�

• Caution should be used in the presence of a tendency to hemorrhage following acute trauma or fracture, following recent surgical procedures when muscle contraction may disrupt the healing process, over a menstruating or pregnant uterus and over areas of skin which lack normal sensation�

• Do not allow any foreign bodies (soil, water, metal, etc�) to penetrate the device, the battery compartment and the charger�

• Do not use the device in water of in a humid atmosphere (sauna, hydrotherapy,etc�)�

• This unit should be operated in temperatures between 32 °F and 104 °F (0 °C and 40 °C), atmospheric pressures between 700 and 1060 hPa and Relative Humidity 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 skin�

• Always use the charger provided by DJO, LLC to recharge the batteries�

• IMPORTANT! Changes or modiﬁcations not expressly approved by DJO, LLC could void the user’s authority to operate the equipment�

WARNING

• The Compex Wireless USA should not be used adjacent to or stacked with other equipment, and if adjacent or stacked use is necessary, the unit should be observed to verify normal operation in the conﬁguration in which it will be used�

• Use only accessories that are specially designed for the Compex Wireless USA� Do not use accessories manufactured by other companies on the Wireless USA� DJO, LLC is not responsible for any consequence resulting from using products manufactured by other companies� The use of other accessories or cables may result in increased emissions or decreased immunity of the Wireless USA�

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• Long term effects of chronic electrical stimulation are unknown�

• Safe use of electrotherapy during pregnancy has not been established�

• Stimulation should not be applied over the anterior neck or mouth� Severe spasm of the laryngeal and pharyngeal muscles may occur and the contractions may be strong enough to close the airway or cause difﬁculty in breathing�

• Stimulation should not be applied transthoracically in that the introduction of electrical current into the heart may cause cardiac arrhythmia�

• Stimulation should not be applied over swollen, infected, and inﬂamed areas or skin eruptions, e�g�, phlebitis, thrombophlebitis, varicose veins, etc�

• The user must keep the device out of the reach of children�

• Do not disconnect any stimulation cables during a session while the stimulator is switched on� Switch the stimulator off ﬁrst�

• Never connect stimulation cables to an external power supply� There is a risk of electric shock�

• Never recharge the stimulator without ﬁrst disconnecting the stimulation cables�

• Never carry out an initial stimulation session on a person who is standing� The ﬁrst ﬁve minutes of stimulation must always be performed on a person who is sitting or lying down� In rare 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 does occur, all that is required is to stop the stimulation and lie down with the legs raised until the feeling of weakness disappears (5 to 10 minutes)�

• Never allow movement resulting from muscular contraction during a stimulation session� You should always stimulate isometrically; this means that the extremities of the limb in which a muscle is being stimulated must be ﬁrmly ﬁxed, so as to prevent the movement that results from contraction�

• Do not use the Compex Wireless USA if you are connected to a high- frequency surgical instrument as this could cause skin irritation or burns under the electrodes�

• Never use the Compex Wireless USA or the charger if it is damaged (case, cables, etc�) or if the battery compartment is open� There is a risk of electric shock�

• Disconnect the charger immediately if the Compex Wireless USA “bleeps” continuously, if there is abnormal heating or smell, or if smoke comes from the charger or the Compex Wireless USA�

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• Do not recharge the battery in a conﬁned space (carrying case, etc�)� There is a risk of ﬁre or electric shock�

• Do not use the stimulator at altitudes of over 9,842 feet (3,000 meters)�

• Stimulation should not be applied over the carotid sinus nerve particularly in patients with a known sensitivity to the carotid sinus reﬂex�

• Stimulation should not be applied transcerebrally�

• Stimulation should not be applied over, or in proximity to, cancerous lesions�

• DO NOT operate this unit in an environment where other devices that intentionally radiate electromagnetic energy, such as RFID equipment, are being used in an unshielded manner� Fixed, portable and mobile RF communications equipment can affect Medical Electrical Equipment� RFID equipment can, for example, be Anti-Theft equipment in stores� In case of doubt about the presence of RFID equipment in the vicinity of the device, DO NOT use the Compex Wireless USA device�

• Only use accessories that are speciﬁcally designed for the Compex Wireless USA� Do not use accessories manufactured by other companies with the Compex Wireless USA device� DJO,LLC is not responsible for any consequence resulting from using products 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 through the thorax because it may cause a cardiac arrhythmia�

• Users with an implanted neurostimulation device must not be treated with or be in close proximity to any shortwave diathermy, microwave diathermy, therapeutic ultrasound diathermy or laser diathermy anywhere on their body� Energy from diathermy (shortwave, microwave, ultrasound and laser) can be transferred through the implante neurostimulation system, can cause tissue damage, and can result in severe injury or death� Injury, damage or death can occur during diathermy therapy even if the implanted neurostimulation system is turned “off�”

• Handle, clean and dispose of components and accessories that have come in contact with bodily ﬂuids according to National, Local and Facility rules, regulations and procedures�

• Explosion hazard if the Compex Wireless USA is used in the presence of ﬂammable anesthetics mixture with air, oxygen, or nitrous oxide�

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INDICATIONS FOR USE

The Compex Wireless USA is intended to stimulate healthy muscles in order to improve or facilitate muscle performance� It is to be used by adults only�

The Compex Wireless USA is not intended for adjunctive therapy in the treatment of medical diseases and conditions of any kind� None of the Compex Wireless USA stimulation programs are designed for injured or disease afﬂicted muscles� Its use on such muscles is contraindicated� The work imposed on the muscles by the Compex Wireless USA programs is deﬁnitely not suitable for rehabilitation and physiotherapy�

The Compex Wireless USA electrical impulses allow the triggering of action potentials on motoneurones of motor nerves (excitations)� 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 Wireless USA may therefore be considered a technique of muscle training�

CONTRAINDICATIONS

Never use the Compex Wireless USA on:

• Painful muscles

• Atrophied muscles

• Muscles with spasms

• Muscles associated with a limb with a painful or afﬂicted joint

Do not use the Compex Wireless USA:

• For muscle reeducation

• To prevent or retard disuse atrophy

• To prevent venous thrombosis

• To maintain or increase range of motion

• For muscle spasms

• For blood ﬂow deﬁciencies

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Do not use the Compex Wireless USA if you have one or more of the following medical conditions:

• This device must not be used on persons with cardiac pacemakers, deﬁbrillators, or other implanted

metallic or electronic devices.

• Cardiac demand pacemakers

• Epilepsy

• Following acute trauma or fracture

• Following recent surgical procedures

• Critical ischemia of lower limbs

• Abdominal or inguinal hernia

• Cancerous lesions

• Pregnancy (do not use on abdominal region)

• Serious arterial circulation problems in lower limbs

• Sensitivity problems 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 irritation and burns beneath the electrodes have been reported with the use of powered muscle stimulators�

• Headache and other painful sensations have been reported during or following the application of electrical stimulation applied to the head, face, and near the eyes�

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DEVICE DESCRIPTION

REMOTE CONTROL

A On/Off button (press brieﬂy to turn on, hold

down for more than 2 seconds to turn off)

B 4 buttons for the selection/deselection of

the stimulation channel

C Multifunction pad (up-down-left-right) to

navigate the interface and increase or decrease the level of stimulation intensity 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 start of this manual prior to using your stimulator�

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A

B

C

D

E

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DEVICE DESCRIPTION

COMPEX 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

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ACCESSORIES

REFERENCE QUANTITY

Remote Control 00300 1

Modules 001062 4

Docking Station 002000 1

Instructions on USB Stick 13-8851 1

Electrode Placement Guide 4525534 1

Quick Tips Sheet 4884430 1

Quick Start Guide 885742 1

Carry Case 680042 1

Remote Control Protection Sleeve 5529029 1

Wireless Desktop Adapter 5v 3�5A 649028 1

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 by dialing Toll Free 1-877-266-7398 or shop online at www�ShopCompex�com�

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4. INTRODUCTION

HOW DOES ELECTROSTIMULATION WORK?

The principle of electrostimulation is to stimulate nerve ﬁbers by means of electrical impulses transmitted by electrodes� The electrical pulses generated by Compex Wireless USA stimulator are high quality pulses offering safety, comfort and efﬁciency�

The motor nerves, to stimulate a muscular response� The quantity and the beneﬁts obtained depend on the stimulation parameters and this is known as electro- muscular stimulation (EMS)�

MOTOR NERVE STIMULATION (EMS)

In voluntary activity, the order for muscular work comes from the brain, which sends a command to the nerve ﬁbers in the form of an electrical signal� This signal is then transmitted to the muscular ﬁbers, which contract� The principle of electrostimulation accurately reproduces the process observed during a voluntary contraction� The stimulator sends an electrical current impulse to the nerve ﬁbers, exciting them� This excitation is then transmitted to the muscular ﬁbers causing a basic mechanical 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, rest time, total program time) subject the muscles to different types of work, by stimulating different types of muscle ﬁbers� In fact, different types of muscular ﬁbers may be distinguished according to their respective contraction speed: slow, intermediate and fast ﬁbers� Fast ﬁbers will obviously predominate in a sprinter, while a marathon runner will have more slow ﬁbers� With a good knowledge of human physiology and a perfect mastery of the stimulation parameters of the various programs, muscular work can be directed very precisely towards the desired goal (muscular reinforcement, increased blood ﬂow, ﬁrming up, etc�)�

Electrical pulse

Excitation

Motor nerve

Stimulated

muscle

Transmission of

the excitation

Elementary mechanical response – Twitch

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BENEFITS OF ELECTROSTIMULATION

Electrostimulation is a very effective way to make your muscles work:

• with signiﬁcant improvement of different muscular qualities

• without cardio-vascular or mental fatigue

• with limited stress on the joints and tendons. Electrostimulation thus allows a greater quantity of work by

the muscles compared with voluntary activity.

TTo be effective, this work must 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 recommends that you complement your electrostimulation sessions with other efforts, such as:

• regular exercise

• proper and healthy nutrition

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5. SAFETY GUIDE

WHO SHOULD NOT USE THE COMPEX WIRELESS USA Check the following list of 15 questions:

QUESTIONS YES/NO

1

Are you equipped with a cardiac pacemaker, deﬁbrillator, or other implanted metallic or electronic device?

2 Are you epileptic?

3 Have you recently been victim of an acute trauma (less than 6 months)?

4 Have you recently been subject to a surgical procedure (less than 6 months)?

5 Do you have blood ﬂow deﬁciency in your lower limbs?

6 Do you have an abdominal or inguinal 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 more questions, do not use the device and contact Compex Product Support, DJO, LLC for more information�

If you have 15 “No” answers, you can use the Compex Wireless USA�

Compex Product Support – Toll Free: 877-266-7398 (877-COMPEX8)

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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

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SAFETY GUIDE

WHERE NEVER TO APPLY ELECTRODES

• On both sides of the thorax simultaneously (front 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.

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PRECAUTIONS WHEN USING ELECTRODES

CAUTION

• Only use electrodes supplied by DJO, LLC� Other electrodes may have electrical properties that are unsuitable for the Compex Wireless USA stimulator�

• Do not use electrodes with a surface <16 cm² (2�94 in²), as there will be a risk of suffering a burn injury� Caution should always be exercised with current densities > 2mA/cm² (12�9 mA/in²)�

• Always turn off the stimulator before moving or removing any electrodes during a session�

• Do not place the electrodes in water�

• Do not apply solvents of any kind to the electrodes�

• For best results, wash and clean the skin of 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 contact is very important for both user comfort and efﬁcacy�

• Some people with very sensitive skin may experience redness under the electrodes after a session� Generally, this redness is completely harmless and disappears after 10 to 20 minutes� Never start another stimulation session in the same area, however, if the redness is still visible�

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6. OPERATION

PRELIMINARY SETTINGS

Before using the unit for the ﬁrst time, you should select the working language of the device which is displayed on the options screen� Follow the instructions below� Afterwards, for the greatest comfort, the Compex Wireless USA offers you a number of setting options (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 order to pair them with the remote control�

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Once a module is turned on and 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�

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HOW TO ACCESS FAVORITES

The Favorites menu displays the last programs used� You need only to have one program in the Favorites menu to become directly accessible after turning on the device�

The programs done will automatically be placed in the Favorites menu� The Favorites menu can contain up to 9 programs� If new programs are done, the old ones will 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 Select the desired favorite program B Conﬁrm your selection C Return to the previous step

A

B

A

C

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The placement of electrodes selected during the program appears� It is possible to scroll through other electrode placements�

3. CONNECT THE MODULES TO THE ELECTRODES

Stick 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

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HOW TO ACCESS PROGRAMS

For more information on programs, connect to: www�ShopCompex�com

The Programs menu displays the program categories�

1. SELECT A CATEGORY

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

B

A

C

A

B

A

C

Muscle Relaxation

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3. SELECT ELECTRODE PLACEMENT

4. CONNECT THE MODULES TO THE ELECTRODES

Stick the electrodes to your skin The module is attached to the electrode snap from the side� Slide the module onto 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

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A

B

A

A Select the Settings menu B Conﬁrm your selection

A Select the desired setting B Conﬁrm your selection C Return to the previous step

C

A

B

A

HOW TO ACCESS SETTINGS

The Settings menu enables certain elements to be conﬁgured such as backlighting, volume, language, etc� Some settings are not available in all devices�

1. SELECT A SETTING

Levels: Turns the Levels function on (ON) or off (OFF)

The Levels function is for people who are already accustomed to electrostimulation and want to perform several training cycles� If the Levels function is turned on (ON) an additional screen will appear for certain programs (programs 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 levels� The more numerous the muscle ﬁbers you stimulate, the more numerous will be the ﬁbers that are going to progress� But the speed of progress of these ﬁbers and their aptitude for operating at a higher rating 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�

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The simplest and most usual procedure is to start with level 1 and raise the level when changing to a new stimulation cycle�

At the end of a cycle, you may either start a new cycle at the next level up or do some maintenance at the rate of 1 session�

Power Saving: Turns the Power Saving mode function on (ON) or off (OFF)� Decreases the intensity and the backlighting time�

Sound: 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 deleted, Objectives cleared, Default settings)�

System info: Enables information related to the device to be viewed�

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START A STIMULATION PROGRAM

Before beginning any stimulation program, you must turn the modules on�

To turn on the modules, press their respective On/Off button� As soon as the module is turned on, its battery level appears on the screen� Turn on the number of modules desired according to the 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 selection and start the program

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Increase the stimulation intensities on the selected channels�

By default, all of the channels are active at the beginning of the session� To deselect a channel, simply press the corresponding button�

In this case only channel 1 is active� Any change of intensity will only be performed on channel 1�

ADJUSTING STIMULATION ENERGIES

In a stimulated muscle, the number of recruited ﬁbers depends on the stimulation 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 channel is

active the LED button emits a strong blue light�

B Pause

C Increase or decrease the stimulation intensities on the

selected channels

A

C

B

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CONTRACTION/ACTIVE REST PROGRAMS

• Endurance

• Resistance

• Strength

• Explosive Strength

These programs always begin with a warm-up phase� After this warm-up phase, a contraction cycles phase followed by active rest occurs (the number of cycles depends on the program) and when all cycles are completed, the program ends 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 number of work phase cycles in the program

A

B

E

D

C

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PAUSE AND CONTINUE A STIMULATION PROGRAM

By pressing on the central button of the remote control or on the On/Off button of one of the modules during the stimulation, the device goes into pause� At this point it is possible to skip the current phase or exit the program�

Depending on the program, maximum and average intensities statistics may appear�

Note: The session restarts with intensities equal to 80% of those used prior to 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 the

program

B Resume the stimulation session

C Exit the program and return to the previous step

C BA

A Average stimulation intensity

B Maximum stimulation intensity

A

B

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CHARGING

BATTERY LEVEL INDICATION

Module battery levels appear just prior to launching the stimulation session� The remote control battery level is always visible in the top right corner�

CONNECT THE DOCKING 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

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CHARGE THE REMOTE CONTROL AND THE MODULES

At the end of the stimulation session, it is strongly recommended that you store the remote control and modules in the docking station to charge the elements�

COMPEX 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

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The pod without the On/Off button must ﬁt on the small connectors� A magnet as well as the small vertical mark on the hull of the pod helps to position the pod correctly in its slot� When it is positioned correctly you should hear a click�

When a module is placed on the docking station it appears on the remote 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 charging

C Module charged

D No module present

BC

A

D

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PROGRAMS MUSCLE STIMULATION TRAINING PROGRAMS

Note: For the 4 basic workout programs: Endurance, Resistance, Strength, Explosive Strength, we advise you to consult the training planner on our website www�ShopCompex�com�

The Compex Wireless USA provides four muscle stimulation training programs� They correspond to the type of muscle performance the athlete wishes to improve or maintain� These training programs are:

• Endurance

• Resistance

• Strength

• Explosive Strength

Each of these four training programs offers ﬁve different working levels that enable the amount of work to be gradually increased�

ENDURANCE

The Compex Endurance program imposes an average medium working level on muscle ﬁbers� This working level is maintained over a long period (40 minutes per session)� The Endurance program particularly activates the aerobic metabolism of the ﬁbers during the stimulation session� The purpose is to increase the time the muscle is able to maintain a medium level of working power or the average power level the muscle is able to maintain durations of 1 to 5 (7) minutes� The program may be used in most physical 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 maintained over a short period (12 minutes per session)� The Resistance program activates the anaerobic metabolism of muscle ﬁbers during the stimulation session and induces the production of lactic acid� It is intended to increase the time the muscle is able to maintain a high power working level (close to its maximum) or the average power working level the muscle is able to maintain for a short duration� It is designed for sporting activities, which are characterized by a need for intense (close to the maximum) efforts to be maintained or repeated to approach the limit of muscle exhaustion� Sports requiring this type of effort are, for example, the 400 and 1600 meters, one-kilometer cycle races and 200 and 400 meters swimming� It is appropriate for many other sports based on duration, such as cycling, which makes repeated demands on muscle resistance�

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STRENGTH

The Compex Strength program imposes a high and instantaneous power working level on muscle ﬁbers during tetanic contractions� These contractions are separated by long periods of rest� The result is an average medium power working level (+ 20 minutes)� This program is intended to increase the maximum strength of muscle contraction, which is carried out isometrically or dynamically� It is speciﬁcally designed for sports characterized by a need for maximum but very brief strength contractions lasting 5-60 seconds� Weight lifting is a typical sport of this kind since a set of 10 repetitions will take ~30 seconds to complete� This program is also appropriate for any type of sports requiring a gain in strength on a speciﬁc muscle (cycling, short distance running, soccer, etc�)�

EXPLOSIVE STRENGTH

The purpose of the Compex Explosive Strength program is to increase the speed with which maximum muscle strength can be supplied� It is designed to improve performance in sporting activities of very brief duration such as jumps, sprints and throwing� 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 facilitate recovery after active muscle training and competition:

• Potentiation

• Pre-Warmup

• Muscle Relaxation

• Training Recovery

• Competition Recovery

POTENTIATION

The Compex Potentiation program produces the physiological muscular phenomenon known as “Twitch potentiation”� A speciﬁc system of stimulation increases the amplitude and the speed of the elementary muscle twitch response of muscle ﬁbers, more particularly of fast ﬁbers� A potentiated muscle gains in velocity and reaches its maximum strength more easily and rapidly� This program is recommended before performing a sprint, a jump or a throw� Applied brieﬂy just before the beginning of a competition, it offers immediate, well potentiated muscle ﬁbers and an optimal level of performance to basketball, soccer or volleyball players�

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TRAINING RECOVERY

The Compex Active Recovery cool-down program produces muscle twitches at a very low frequency� Those twitches act like a muscle relaxation and induce an increase in blood ﬂow� They are responsible for a faster reduction of the lactic acid blood level (much better than mere rest) and accelerate the exchanges between muscle ﬁbers and blood� Consequently, the stimulated muscles recuperate better from fatigue and the athlete has a feeling of relaxation and muscle lightness� This type of cool- down program is recommended after hard training sessions and competitions� It is particularly useful after sports requiring long duration efforts, combining endurance and resistance (cycling, marathon, triathlon, mountain-bike, etc�)� The same is 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 program is a sub-set of the Active Recovery program that produces the lower frequencies for inducing gentle muscle contractions and to increase in blood ﬂow and generate endorphins-the bodies natural analgesic� This program should be used after training sessions and competitions�

MUSCLE RELAXATION

The Compex Muscle Relaxation program produces gentle muscle twitches to facilitate recovery from muscle fatigue and to help recover muscle strength after training sessions and competitions�

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7. OPERATIONAL GUIDELINES

USAGE GUIDELINES

The usage guidelines presented in this section should be considered as general rules� For all programs, it is recommended that you read carefully the usage information and advice presented in the Operation section� You should use the shopcompex�com web site to establish an appropriate training plan� The shopcompex� com web site helps you with your ﬁrst steps with the device�

CHOOSING THE APPROPRIATE MUSCLE WORK PROGRAM

The choice of a program determines the kind of work that is imposed on the stimulated muscles� Based on your knowledge about sport training, you can choose the program that is appropriate to your needs� Please go on the shopcompex�com web site as it offers an advanced interactive way to establish an appropriate work program� With just a few answers to basic questions, the “Training Planner” will determine which is the most appropriate program for you�

PLANNING STIMULATION SESSIONS

The Training Planner (shopcompex�com) will determine the number 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 electrode must be connected to each pole�

Depending on the characteristics of the current, efﬁcacy can be optimized in certain programs by placing the electrode connected to the positive pole (positive pod connection) “strategically”� When working with a muscle stimulation program (program involving muscle contractions), it is important to place the positive electrode on the motor point of the muscle�

It is crucial to choose the right size electrodes (large or small) and correctly position these on the muscle group you want to stimulate to ensure the efﬁcacy of the program� Therefore, always use the size of electrodes shown in the pictures� Unless you have other speciﬁc medical instructions, always follow the placement directions in the pictures�

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DJO, LLC disclaims all responsibility for consequences arising from electrodes placed in other positions� See the Safety Guide section of this manual to more information on where not to apply electrodes�

STIMULATION POSITIONS

This position will vary depending on the position of the electrodes, the muscle group you wish to stimulate, and the program you are using� For programs involving powerful muscular contractions, the muscle should always be stimulated in an isometric fashion� When ﬁrst becoming familiar with the device and the effects of the programs� You must therefore ﬁx the extremities of your limbs securely� In this way, you provide maximum resistance to the movement and prevent any shortening of the muscle during the contraction, 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 as possible�

ADJUSTING STIMULATION ENERGIES

In a stimulated muscle, the number of recruited ﬁbers depends on the stimulation 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 (range = 1 to 999), always at the limit that you can endure, in order to recruit the maximum number of ﬁbers�

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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 levels� The more numerous the muscle ﬁbers you stimulate, the more numerous will 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 sessions (a cycle)�

At the end of a cycle, you may either start a new cycle at the next level up or do some maintenance at the rate of 1 session�

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8. TROUBLESHOOTING

ELECTRODE FAULT

The remote control displays the symbol of an electrode and a disconnected module and an arrow ﬂashes on the channel in question (in this case, channel 1)�

• Ensure that the electrodes are properly connected to the module.

• Check to see if electrodes are old, worn and/or if contact is poor: try using new 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 in an area that enables the signal to be reﬂected from the remote control.

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BEHAVIOR OF THE MODULE’S LED

The LED alternately ﬂashes green and red: the module is out of range or not recognized by the remote control�

• Ensure the remote control is on.

• Ensure that the module and the remote control are less than 6’ 5” (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.

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MODULE UNCHARGED

During the stimulation a module may be uncharged� In this case the symbol for an uncharged battery appears and an arrow ﬂashing on the channel where the problem was detected (in this case, channel 1)�

• Stop the stimulation and recharge the uncharged module.

• Abandon the uncharged module and continue the stimulation session without it.

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 check electrodes are properly positioned.

• Change the positioning of the electrodes slightly.

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STIMULATION CAUSES DISCOMFORT

• Electrodes lose their adhesive capacity and no longer provide adequate contact with skin.

• Electrodes are worn and must 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.

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9. DEVICE MAINTENANCE

WARRANTY

See the warranty card, enclosed�

MAINTENANCE

Your stimulator does not require any calibration or periodic maintenance� Use a soft cloth and solvent-free alcoholbased detergent to clean your device� Use as little liquid as possible to clean the device� Do not dismantle the stimulator or the charger because they contain high voltage components which could cause electrocution� This must be carried out by Compex-approved technicians or repair services� 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�

DISPOSAL

Batteries must be disposed of in accordance with national current regulations� Any product bearing the WEEE label (a bin crossed out with a cross) must be separated from household waste and recycled as electronic waste�

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10. TECHNICAL SPECIFICATIONS

GENERAL INFORMATION

Remote control battery: Rechargeable 3�7[V] / ≥ 1,500[mAh] lithium polymer (LiPo) battery�

Module battery: Rechargeable 3�7[V] / ≥ 450[mAh] lithium polymer (LiPo) battery�

Compex Wireless USA docking station: Only 5[V] / 3�5 [A] AC power adapters bearing reference number 64902X can be used to recharge your device�

NEUROSTIMULATION

All the electrical speciﬁcations are supplied for an impedance from 500 to 1000 ohms per channel�

Outputs: four independent 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 0�25 mA�

Duration of impulses: from 300 to 400 μs�

Maximum quantity of electricity per impulse: 96 microcoulombs (2 x 48 μC, compensated)�

Typical impulse rise time: 3 μs (20%-80% of maximum current)�

Frequency of impulses: 1 to 120 Hz�

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RADIO FREQUENCY WIRELESS INFORMATION

Radio Frequency Wireless technology is used in the Compex Wireless USA for communication between the remote control and the stimulation modules�

RADIO FREQUENCY WIRELESS DESCRIPTION

WIRELESS PROTOCOL CHARACTERISTICS

Frequency band 2�4 GHz ISM

Protocol type Proprietary frequency hopping

Channels 6 channels

Channel width 2 MHz

Frequency modulation GFSK

Frequency deviation ± -320 kHz

EIRP

Measured max -6�2 dBM (0 dBM conﬁgured 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 acknowledged

Out of range behavior

- Stimulation modules stop stimulation automatically when out of range from remote control�

- Remote control stops entire network stimulation when it detects one module out of range�

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RADIO FREQUENCY WIRELESS DESCRIPTION - CONTINUED

COEXISTENCE WITH OTHER COMPEX WIRELESS USA DEVICES

Compex Wireless USA wireless protocol is designed to allow coexistence with at least 3 other Compex Wireless USA devices�

Each Compex Wireless USA remote control and module is assigned a unique ID� Before initial use, the remote is paired with the 4 stimulation modules in its network�

Designed for coexistence with wireless products in the same RF band�

- Bluetooth (IEEE 802�15�1)

- Wi-Fi (IEEE 802�11)

Utilizes established coexistence principles to miniize cross-talk with other wireless devices�

- FDMA (Frequency Division Multiple Access)

- TDMA (Time Division Multiple Access)

Interference from other devices

- If all Compex Wireless USA RF channels are saturated by emissions from other devices, the failsafe outcome 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�

- This device must accept any interference received, including the interference that may cause undesired operation�

Remote Control FCC ID 2AD2U-REMHHTFT24

Modules FCC ID 2AD2U-NMESTNSMOD

IC REQUIREMENTS

This device complies with industry Canada’s licence-exempt RSSs� Operation is subject to the following 2 conditions:

- This device may not cause harmful interference�

- This device must accept any interference, including interference that may cause undesired operation of the device�

Remote Control IC 12752A-REMHHTFT24

Modules IC 12752A-NMESTNSMOD

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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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DESCRIPTION OF DEVICE MARKINGS

The markings on the Compex Wireless USA are your assurance of its conformity to the highest applicable standards of medical equipment safety and electromagnetic compatibility� One or more of the following markings may appear on the device:

The stimulator is a Category II 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� 60601-1 and is certiﬁed to CAN/CSA Std� C22�2 No� 601�

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EXPLANATION OF SYMBOLS

See the instructions

Manufacturer’s name and address and date of manufacture

This device must be separated from household waste and recycled as electronic waste

Protect from sunlight

Store in a dry place

Non-ionizing radiation

IP20

On the unit means: Protected against solid bodies with a diameter 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 channels that are electrically isolated from each other and earthed�

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TABLE 1: RECOMMENDATIONS AND DECLARATION BY THE

MANUFACTURER CONCERNING ELECTROMAGNETIC EMISSIONS

The Compex Wireless USA is intended for use in the electromagnetic environment speciﬁed below� The customer or the user of the Compex Wireless USA should assure that it is used in such an environment�

EMISSIONS

TEST

COMPLIANCE

ELECTROMAGNETIC

ENVIRONMENT – GUIDANCE

RF Emissions

Stimulation mode:

CISPR 11

Charging mode:

CISPR 22

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

The Compex Wireless USA is suitable for use in any establishment, including a private dwelling and a place connected directly to the low voltage mains supply which powers residential�

Harmonic Emissions

IEC 61000-3-2

Class A

Voltage Fluctuations/ Emission Oscillations

IEC 61000-3-3

Complies

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TABLE 2: RECOMMENDATIONS AND DECLARATION BY THE

MANUFACTURER CONCERNING ELECTROMAGNETIC IMMUNITY

The Compex Wireless USA is designed for use in the electromagnetic environment stipulated below� The customer or the user of the Compex Wireless USA must ensure that it is used in this recommended environment�

IMMUNITY

TEST

IEC 60601

TEST LEVEL

COMPLIANCE

LEVEL

ELECTROMAGNETIC

ENVIRONMENT –

GUIDANCE

Electrostatic

discharge (ESD)

IEC 61000-4-2

±6 kV at the contact

±8 kV in air

±6 kV at the contact

±8 kV in air

Floors must be wood, concrete, or ceramic tile� If ﬂoors are covered with synthetic material, the relative humidity should be at a minimum of 30%�

Electrical fast

transient/burst

IEC 61000-4-4

±2 kV for power supply

lines

±1 kV for input/output

lineS

±1 kV for power supply lines

Not Applicable (I/O lines)

CISPR24 COMPLIANCE

LEVEL

The quality of the power supply should be that of a typical commercial or hospital environment�

Surge (1)

IEC 61000-4-5

±1 kV differential mode

±2 kV common mode

±1 kV differential mode

Not 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 cycle

<5% UT (>95% dip in UT)

for 1 cycle

40% UT (60% dip in UT)

for 10 cycles

70% UT (30% dip in U)

for 25 cycles

<5% UT (>95% dip in U)

for 5 sec

CISPR24 COMPLIANCE

LEVEL

The quality of the power supply should be that of a typical commercial or hospital environment� If the Compex Wireless USA user requires continuous operation during mains power cuts, we recommend that the Compex Wireless USA is powered by a UPS�

Power frequency

(50/60Hz)

magnetic ﬁeld

IEC 61000-4-8

3 A/m

Stimulation mode: 3 A/m

Charging mode: N/A

No components subject to

magnetic ﬁeld

Magnetic ﬁelds at the mains frequency should be at the level of a representative site located in a typical commercial or hospital environment�

Note: UT is the a�c� mains voltage prior to application of the test level�

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TABLE 3: RECOMMENDATIONS AND DECLARATION BY THE

MANUFACTURER CONCERNING ELECTROMAGNETIC IMMUNITY

The Compex Wireless USA is designed for use in the electromagnetic environment stipulated below� The customer or the user of the Compex Wireless USA must ensure that it is used in this recommended environment�

IMMUNITY

TEST

IEC 60601

TEST LEVEL

COMPLIANCE

LEVEL

ELECTROMAGNETIC ENVIRONMENT

– GUIDANCE

Portable and mobile RF communications equipment should be used no closer to any part of the Compex Wireless USA, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter�

recommended separation distance:

Conducted RF IEC 61000-4-6

3 Vrms

150 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

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 from ﬁxed RF transmitters, as determined by an electromagnetic site survey b , should be less than the compliance level in each frequency range c� Interference may occur in the vicinity of equipment marked with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies� Note 2: These guidelines may not apply in all situations� Electromagnetic propagation is affected by absorption and reﬂection from structures, objects and people�

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TABLE 4: RECOMMENDED SPACING BETWEEN A PORTABLE AND

MOBILE COMMUNICATION APPLIANCE AND THE COMPEX WIRELESS USA

The Compex Wireless USA is designed for use in an electromagnetic environment in which radiated RF waves are controlled� The buyer or user of the Compex Wireless USA can contribute to preventing electromagnetic interference by maintaining a minimum distance between RF portable and mobile communication appliances (transmitters) and the Compex Wireless USA according to the table of recommendations below and according to the maximum output power of the telecommunication appliance�

MAXIMUM TRANSMITTER

OUTPUT POWER

W

SPACING ACCORDING 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 transmitter frequency, where P is the maximum output power of the transmitter in watts (W) as set by the transmitter manufacturer�

Note 1: At 80 MHz and at 800 MHz, the spacing for high frequency amplitude is applied�

Note 2: These guidelines may not be appropriate for some situations� Electromagnetic wave propagation is modiﬁed by absorption and reﬂection due to buildings, objects, and persons�

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11. WARRANTY

DJO, LLC (“Company”), warrants that the Compex Wireless USA (“Product”) is free of defects in material and workmanship� This warranty shall remain in effect for two years (24 months) from the date of original consumer purchase� If this Product fails to function during the two year warranty period due to a defect in material or workmanship, at the Company’s option, the Company or the selling dealer will repair or replace this Product without charge within a period of thirty days from the date on which the Product is returned to the Company or the dealer�

All repairs to the Product must be performed by a service center certiﬁed by the Company� Any modiﬁcations or repairs performed by unauthorized centers or groups will void this warranty�

The warranty period for accessories is 90 days� Accessories include Pods and Power Supply�

This Warranty Does Not Cover:

Replacement parts 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 required maintenance or any use that is inconsistent with the Product User Manual�

Company shall not be liable in any event for incidental or consequential damages�

Some locations do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation or exclusion may not apply to you�

To obtain service from Company or the selling dealer under this warranty:

1� A written claim must be made within the warranty period to the Company or the selling dealer. Written

claims made to the Company should be sent to:

DJO, LLC 1430 Decision Street Vista, CA 92081-8553 USA Phone: 1-877-266-7398 (877-COMPEX8)

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2� The Product must be returned to the Company or the selling dealer by the owner.

This warranty gives you speciﬁc legal rights and you may also have other rights which vary from location to location�

The Company does not authorize 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.

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P/N: 4525520_RevA

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Compex Wireless USA User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual