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Compex Compex mini Handleiding

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Version 1.0
COMPEX MINI
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EN
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EN
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
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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. One end of the lead
wire is connected to the device and the other end of the lead wire is connected to the electrode pad.
INDICATIONS FOR USE
Transcutaneous Electrical Nerve Stimulation (TENS) for relief of pain associated with muscle strain,
chronic pain and arthritis pain.
Electrical Muscle Stimulation (EMS) to improve and facilitate muscle performance.
CONSULT ACCOMPANYING DOCUMENTS
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SAFETY WARNING
CONTRAINDICATIONS
»Do not use this device on persons who have a cardiac pacemaker, implanted defibrillator, or other
implanted metallic or electronic devices because this may cause electric shock, burns, electrical
interference, or death.
»Do not use this device on people whose pain syndromes are undiagnosed.
»Not to be used by children or incapacitated persons.
WARNINGS
»Use carefully. May cause serious burns. Do not use over sensitive skin areas or areas with poor
circulation. To reduce the risk of burns, electric shock, and fire, this device must be used in accor-
dance with the instructions.
»Do not crush the device and its electrodes and avoid sharp folds.
»Carefully examine the device and its electrodes, and do not use if they show any sign of
deterioration.
»Do not tamper with this device and its electrodes in any way. There are no user serviceable parts. If
for any reason they do not function satisfactorily, return to the authorized service center at address
given.
»The long-term effects of chronic electrical stimulation are unknown.
»Stimulation should not be applied over the carotid sinus nerves, particularly in persons with a
known sensitivity to the carotid sinus reflex. Carotid sinus is located on both sides of the neck.
»Stimulation should not be applied over the front 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 over the neck can also cause adverse effects on heart
rhythm or blood pressure.
»Do not apply stimulation across the user’s chest contralaterally, because the introduction of
electrical current into the chest may cause rhythm disturbances to the user’s heart, which could be
lethal.
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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.
»Stimulation should not be applied over, or in proximity to cancerous lesions.
PRECAUTIONS
»Caution should be used for persons with suspected or diagnosed heart problems.
»Caution should be used for persons with suspected or diagnosed epilepsy.
»Caution should be used if you have any of the following:
• if you have a tendency to bleed internally following an injury;
• if you recently had surgery, or have ever had surgery on your back;
• if areas of skin lack normal sensations, such as skin that is numb.
»Consult with your physician before use over the menstrual uterus.
»You may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical
conductive medium. The irritation can usually be reduced by using an alternate electrode placement.
»Do not use this device while driving, operating machinery, or during any activity in which involuntary
muscle contractions may put the user at undue risk of injury.
»Keep this device out of reach of children.
»Do not use this device in high humidity areas such as a bathroom.
»Stop using this device at once if you feel discomfort, dizziness or nausea, and consult your physician.
»Do not attempt to move the electrodes while the device is operating.
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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);
• in the presence of electronic monitoring equipment (e.g., cardiac monitors, ECG alarms);
• on children or incapacitated persons.
»Be aware of the following:
• consult with your physician before using this device;
• this device is not effective for pain associated with Central Pain Syndromes, such as headaches;
• this device is not a substitute for pain medications and other pain management therapies;
• this device is a symptomatic treatment and, as such, suppresses the sensation of pain that
would otherwise serve as a protective mechanism;
• stop using the device if the device does not provide pain relief;
• use this device only with the electrodes, and accessories recommended for use by the
manufacturer.
»Store the device away from high-temperature and direct-sunlight. Storage outside of stated
storage temperature may result in measurement error or device malfunction.
»Do not share the use of the electrodes with others; electrodes are intended for single person use.
»Do not use the device while it’s charging.
»This device contains a lithium battery. If overheating of the device occurred during the charging,
stop the charging or operation immediately and contact customer support.
»Dispose of this battery-containing device according to the local, state, or federal laws.
»Skin burns may occur, and check the skin under the electrode periodically.
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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.
SYMBOL AND TITLE
Information essential for proper use shall be indicated by using the corresponding symbols. The
following symbols may be seen on the device and labeling.
CE mark with notify body number
Symbol for “authorized representative in
the european community”
Consult instructions for use
Caution, consult accompanying
documents
Use by date
Date of manufacture
Batch code
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SAFETY WARNING
Catalogue number
Manufacturer
Temperature limitation
Humidity limitation
Non-sterile
MR Unsafe - keep away from magnetic
resonance imaging (MRI) equipment
Fragile, handle with care
Keep away from rain
Product packaging is able to be recycled
… 9 …

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