Compex Mini Manual de usuario

VERSION 1.0

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

EnvironmentalConditionforTransportand 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

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

EMS:

To stimulate healthy muscles in order to help improve and facilitate muscle performance. To be used

to help improve muscle tone and ﬁrmness, and to aid in strengthening muscles in the arms, abdomen,

legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions

or diseases.

It is also intended to help temporarily increase local blood circulation in the healthy muscles of lower

extremities.

TENS / RELIEF:

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist,

back, arm, and leg, due to strain from exercise or normal household and work activities.

It is also intended to aid in symptomatic relief and management of chronic, intractable pain and relief

of pain associated with arthritis.

CONSULT ACCOMPANYING DOCUMENTS

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

»WARNING: Use carefully. May cause serious burns. Do not use over sensitive skin areas or areas

with poor circulation. The unattended use of this device by children or incapacitated persons may be

dangerous. To reduce the risk of buns, electric shock, and ﬁre, this device must be used in accordance

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 patient’s chest contralaterally, because the introduction of electri-

cal current into the chest may cause rhythm disturbances to the patient’s heart, which could be lethal.

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 conductive medium, or

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.

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 manufac-

turer.

»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.

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.

Consult instructions for use

Caution, consult accompanying documents

Use by date

Date of manufacture

Batch code

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

SAFETY WARNING

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; handle with care

Keep away from rain

Product packaging is able to be recycled

Non-sterile

ENVIRONMENTAL CONDITION FOR TRANSPORT AND STORAGE

1) This product needs special precautions regarding electromagnetic compatibility (EMC) and needs to

be installed and put into service according to the EMC information provided, and this unit can be affected

by portable and mobile radio frequency (RF) communications equipment.

Keep away from rain

Product packaging is able to be recycled

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