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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Compex Wireless USA User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual