Compex LT Manual de usuario
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TABLE OF CONTENTS
Introduction....................................................................................................................................................................4
Indications for Use........................................................................................................................................................4
Safety Warning..............................................................................................................................................................4
Contraindications...........................................................................................................................................................4
Warnings..........................................................................................................................................................................4
Precautions.....................................................................................................................................................................5
Adverse Reactions.........................................................................................................................................................7
Symbol and Title............................................................................................................................................................8
Environmental Condition for Transport and Storage..................................................................................................9
Electromagnetic Compatibility....................................................................................................................................9
How the Device Works................................................................................................................................................14
Setup..............................................................................................................................................................................19
Operating Instruction..................................................................................................................................................20
Performance Specifications......................................................................................................................................20
Cleaning and Maintenance.........................................................................................................................................21
Trouble Shooting..........................................................................................................................................................21
RecommendedUsePositions......................................................................................................................................23
Contact Information....................................................................................................................................................24
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INTRODUCTION
Compex LT, a transcutaneous electrical nerve stimulation (TENS) pain management device delivers
electric pulses to the user’s body through electrodes to block and relieve pain. The portable and compact
device features 12 modes with differing frequencies to target fatigued and sore muscles and helps in
relieving aches and pains in various parts of the body such as the waist, shoulders, joints, hands and feet.
INDICATIONS FOR USE
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
SAFETY WARNING
CONTRAINDICATIONS
»Do not use this device on patients who have a cardiac pacemaker, implanted defibrillator, or other
implanted metallic or electronic device, because this may cause electric shock, burns, electrical
interference, or death.
»Do not use this device on patients whose pain syndromes are undiagnosed.
WARNINGS
»Do not apply stimulation over the patient’s neck because this could cause severe muscle spasms
resulting in closure of the airway, difficulty in breathing, or adverse effects on heart rhythm or blood
pressure.
»Do not apply stimulation across the patient’s chest, because the introduction of electrical current into
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the chest may cause rhythm disturbances to the patient’s heart, which could be lethal.
»Do not apply stimulation over, or in proximity to, cancerous lesions.
»Do not apply stimulation when the patient is in the bath or shower.
»If you have one of the following conditions, please consult with your physician before purchasing or
using this device.
»Acute disease, malignant tumor, infective disease, pregnant, heart disease, high fever, abnormal
blood pressure, lack of skin sensation or an abnormal skin condition, any condition requiring the active
supervision of a physician
PRECAUTIONS
»Do not use this device while driving.
»Do not use this device while sleeping.
»Do not use this device in high humidity areas such as a bathroom.
»Keep the device away from wet, high temperature and direct-sunlight.
»Keep this device out of reach of children.
»Stop using this device at once if you feel pain, discomfort, dizziness or nausea and consult your
physician.
»Do not attempt to move the electrode pads while the device is operating.
»Do not use the device around the heart, on the head, mouth, pudendum or blemished skin areas.
»Do not apply stimulation of this device in the following conditions:
»(1) Across the chest because the introduction of electrical current into the chest may cause rhythm
disturbances to the heart, which could be lethal.
»(2) Over painful areas. Please consult with your physician before using this device if you have
painful areas.
»(3) Over open wounds or rashes, or over swollen, red, infected, or inflamed areas or skin eruptions
(e.g., phlebitis, thrombophlebitis, varicose veins). Apply stimulation only to normal, intact, clean, healthy
skin.
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»(4) In the presence of electronic monitoring equipment (e.g., cardiac monitors, ECG alarms).
The electronic stimulator may not operate properly when the electrical stimulation device is in use.
»(5) While operating machinery, or during any activity in which electrical stimulation can put
you at risk of injury.
»(6) On children
BE AWARE OF THE FOLLOWING.
»(1) Consult with your physician before using this device. The stimulation of the device may:
»i. cause lethal rhythm disturbances to the heart in susceptible individuals
»ii. disrupt the healing process after a recent surgical procedure
»(2) The device is not effective for pain of central origin, including headache.
»(3) The device is not a substitute for pain medications and other pain management therapies.
»(4) The device has no curative value.
»(5) The device is a symptomatic treatment and, as such, suppresses the sensation of pain that
would otherwise serve as a protective mechanism.
»(6) The long-term effects of electrical stimulation are unknown.
»(7) The user may experience skin irritation, burns or hypersensitivity due to the electrical stim-
ulation or electrical conductive medium (gel).
»(8) The user has suspected or diagnosed epilepsy, the user should follow precautions recom-
mended by his or her physician.
»(9) Use caution if the user has a tendency to bleed internally, such as following an injury or
fracture.
»(10) Use caution if stimulation is applied over the menstruating or pregnant uterus.
»(11) Use caution if stimulation is applied over areas of skin that lack normal sensation.
»(12) Stop using the device if the device does not provide pain relief.
»(13) Use this device only with the leads, electrodes, and accessories that the manufacturer
recommends.
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(14) DO NOT SHARE THE USE OF THE ELECTRODE PADS WITH OTHERS.
(15) DO NOT USE THE DEVICE WHILE IT’S CHARGING.
(16) THE DEVICE CONTAINS THE LITHIUM BATTERY. IF OVERHEATING OF THE DEVICE OC-
CURRED DURING THE CHARGING, STOP THE CHARGING OR OPERATION IMMEDIATELY AND
REPORT TO THE SELLER.
(17) DISPOSE OF THE BATTERY-CONTAINING DEVICE ACCORDING TO THE LOCAL, STATE, OR
FEDERAL LAWS.
THE LONG-TERM EFFECTS OF ELECTRICAL STIMULATION ARE UNKNOWN.
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 THE HEAD.
THE SAFETY OF ELECTRICAL STIMULATION DURING PREGNANCY HAS NOT BEEN ESTABLISHED.
ADVERSE REACTIONS
»Patients may experience skin irritation and burns beneath the electrodes applied to the skin;
»Patients may experience headache and other painful sensations during or following the application
of electrical stimulation near the eyes and to the head and face.
»Patients should stop using the device and should consult with their physicians if they experience
adverse reactions from the device
THE ENVIRONMENTAL CONDITION FOR NORMAL WORKING, TRANSPORT, AND
STORAGE
»- Normal working ambient temperature: 5°C ~40°C
»- Normal working ambient humidity: 15% RH ~90% RH
»- Store and transport ambient temperature: -25°C ~70°C
»- Store and transport ambient humidity: 0% RH ~90% RH
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SYMBOL AND TITLE
Fragile; handle with care Type BF applied part
Keep away from water and rain CAUTION, Read manual before
operating this product
This way up Manufacturer
Product package recyclable Non-recyclable
Date of manufacture FDA 510(k) cleared
Serial number IP code of the device
Batch code
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ELECTROMAGNETIC COMPATIBILITY
AND FCC COMPLIANCE STATEMENT
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.
2) Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit. This may
result in incorrect operation of the unit.
3) Caution: This unit has been thoroughly tested and inspected to assure proper performance and
operation.
4) Caution: This machine should not be used in conjunction with other equipment.
GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSION
The device is intended for use in the electromagnetic environment specified below. The user should assure that it is used in such
an environment.
EMISSION TEST COMPLIANCE ELECTROMAGNETIC ENVIRONMENT – GUIDANCE
RF emissions
CISPR 11
Group 1 The device uses RF energy only for its internal function. Therefore, its
RF emissions are very low and are not likely to cause any interference
in nearby electronic equipment
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RF emission
CISPR 11
Class B The device is suitable for use in all establishments, including domestic
establishments and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic
purposes.
Harmonic emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
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 LEVEL COMPLIANCE LEVEL ELECTROMAGNETIC
ENVIRONMENT -
GUIDANCE
Electrostatic discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Floors should be wood, con-
crete or ceramic tile. If floors
are covered with synthetic
material, the relative humidity
should be at least 30%.
Electrical fast transient/burst ±2 kV for power supply lines
±1 kV for
Not applicable
(internal batte
Main power quality should be
that of a typical commercial or
hospital environment.
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