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Summary of Contents for Compex Mini

  • Page 1 V E R S I O N 1 . 0...
  • Page 3: Table Of Contents

    TABLE OF CONTENTS Introduction..................................4 Indications for Use................................4 Safety Warning................................4 Contraindications................................5 Warnings..................................5 Precautions..................................6 Adverse Reactions.................................8 Symbol and Title................................8 Environmental Condition for Transport and Storage....................10 How the Device Works..............................14 Setup....................................15 Operating Instruction..............................16 Performance Specifications............................20 Electrode Maintenance...............................20 Trouble Shooting................................21 Recommended Use Positions.............................22 Contact Information..............................25...
  • Page 4: Introduction

    INTRODUCTION Compex Mini delivers electric pulses generated to the user’s skin through the electrodes. The portable ® and compact device has 6 modes of different pulse frequencies, covering Electrical Muscle Stimulation (EMS) and Transcutaneous Electrical Nerve Stimulation (TENS). It includes operating elements of ON/ OFF button, intensity increase, intensity decrease, mode selection button, and can be attached and detached to the electrode through the connector and lead wire.
  • Page 5: Safety Warning

    SAFETY WARNING CONTRAINDICATIONS » Do not use this device on persons who have a cardiac pacemaker, implanted defibrillator, or otherim- planted metallic or electronic devices because this may cause electric shock, burns, electrical interference, or death. » Do not use this device on patients whose pain syndromes are undiagnosed. WARNINGS »...
  • Page 6: Precautions

    SAFETY WARNING » Since the effects of stimulation of the brain are unknown, stimulation should not be applied across the head, and electrodes should not be placed on opposite sides of head. » Stimulation should not be applied over swollen, infected, or inflamed areas or skin eruptions, e.g., phlebitis, thrombophlebitis, varicose veins, etc.
  • Page 7 SAFETY WARNING » Do not apply stimulation of this device in the following conditions: • Contralaterally across the chest because the introduction of electrical current into the chest may cause rhythm disturbances to the heart, which could be lethal; • over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins);...
  • Page 8: Adverse Reactions

    SAFETY WARNING ADVERSE REACTIONS » ➢ You may experience skin irritation and burns beneath the stimulation electrodes applied to the skin; check skin under electrodes frequently. » You should stop using the device and should consult with your physicians if you experience adverse reactions from the device.
  • Page 9 SAFETY WARNING Catalogue number Serial number Manufacturer Temperature limitation Humidity limitation Non-sterile MR Unsafe - keep away from magnetic resonance imaging (MRI) equipment Fragile, handle with care...
  • Page 10: Environmental Condition For Transport And Storage

    SAFETY WARNING Keep away from rain Product packaging is able to be recycled ENVIRONMENTAL CONDITION FOR TRANSPORT AND STORAGE Normal working ambient temperature: 10~40°C Normal working ambient humidity: 30~85% Store and transport ambient temperature: -10 ~50°C Store and transport ambient humidity: 30~90% Fragile;...
  • Page 11 SAFETY WARNING SAFETY WARNING Do not use other devices that emit electromagnetic fields, near the unit. This may result in incorrect operation of the unit. Caution: This machine should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, this machine should be observed to verify normal operation in the configuration in which it will be used.
  • Page 12 SAFETY WARNING GUIDANCE AND MANUFACTURE’S DECLARATION – ELECTROMAGNETIC IMMUNITY The device is intended for use in the electromagnetic environment specified below. The user should assure that it is used in such an environment. IMMUNITY TEST IEC 60601 TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT – LEVEL LEVEL GUIDANCE...
  • Page 13 SAFETY WARNING SAFETY WARNING 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. Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
  • Page 14: How The Device Works

    SAFETY WARNING For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
  • Page 15: Setup

    SETUP Remove the 2 devices and accessories from the box. The accessories include electrodes, lead wires and a USB cable. The USB cable should be used to charge both units. There are two devices included. The device marked “1” on its side is the master device, and the device marked “2” is the affiliation device. The master device and the affiliation device are paired as received.
  • Page 16: Operating Instruction

    OPERATING INSTRUCTION The following Operating Instructions are used to guide the operation. The step-by-step details are listed below: STEP 1 – Check the battery power of the device The devices comes with rechargeable batteries and can be used as received. If the battery icon is flashing when turned on, it means the battery is running out of power.
  • Page 17 OPERATING INSTRUCTION STEP 4 - Press the “ON/OFF” to turn on the power ON / OFF Press and release the ON/OFF button to turn on the device, indicated by the yellow LED indicators on and beeping once (0.5 second). STEP 5 - Select one of the stimulation modes After the device is on, press and release the ON/OFF button to change the 6 programs: The Program change...
  • Page 18 OPERATING INSTRUCTION Recommended Practice: • Start from the lowest intensity and gradually adjust the intensity to a comfortable level. Duration for each skin area is based on the preset timer for each program. Frequency is 2 times per day per skin area. Consult with your physician for longer and more frequent uses.
  • Page 19 OPERATING INSTRUCTION As shown above, the device can be operated independently by pressing its three buttons (ON/OFF button, intensity increase button, and intensity decrease button). Alternatively, the phone application interface provides a secondary operation method to wirelessly realize the functions mentioned above. At any time you can switch to manually operate the device itself by pressing its three buttons to deal with any safety issues that may arise.
  • Page 20: Performance Specifications

    If the electrode no longer contacts well with your skin, it is time to replace it. If needed, you can use a damp and clean cloth to wipe electrodes between uses. Electrodes can be ordered at www.compex.com...
  • Page 21: Trouble Shooting

    Device does not turn on • Check if battery is low and needs to be charged. Electrodes are not sticky • The pads will lose adhesiveness over use. Visit www.compex.com for replacements. Skin turns red • Stop use. • If problem persists, contact your physician.
  • Page 22: Recommended Use Positions

    RECOMMENDED USE POSITIONS SHOULDERS ARMS BACK LEGS BUTTOCKS FEET ABDOMEN Never apply electrodes on the throat or both sides of the neck, where the carotid sinus nerves are located.
  • Page 23 During the warranty period, defective items will be repaired or replaced at no charge. Any evidence of misuse, abuse, alterations, or externally caused damage the warranty is invalid. For more information, please contact Compex ®...
  • Page 24 FCC STATEMENT This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may cause undesired operation.
  • Page 25: Contact Information

    CONTACT INFORMATION Distributed by DJO ® 877.266.7398 DJO, LLC 1430 Decision Street • Vista, CA 92081 Manufactured by JKH www.compex.com...

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