Compex FUSE User manual

FUSE™
Lidocaine TENS with up to 4% Lidocaine
READ THE MANUAL BEFORE OPERATING THIS PRODUCT
Version: A0 (2019-6-6)

TABLE OF CONTENTS
Introduction 4
Indications for Use 4
Safety Warning 5
Contraindications 5
Warnings 5
Precautions 6
Adverse Reactions 8
Symbol and Title 9
Environmental Condition for Transport and Storage 10
How the Device Works 11
Setup 13
Operating Instruction 14
Performance Specifications 17
Cleaning and Maintenance 18
Trouble Shooting 18
Recommended Use Positions 19
Warranty 20
Electromagnetic Compatibility and FCC Compliance Statement 21
Contact Information 26

4 5
INTRODUCTION
Compex®Fuse™helps deliver electric pulses generated to the user’s skin through
the electrodes. The portable and compact device has multiple modes of different
pulse frequencies, covering Transcutaneous Electrical Nerve Stimulation (TENS) and
Powered Muscle Stimulation (PMS) that is also called Electrical Muscle Stimulation
(EMS) for over-the-counter use. It includes operating elements of ON/OFF button,
intensity increase/mode selection button, and intensity decrease/timer selection
button, and could be attached and detached to the electrode through the connectors or
the lead wire. When the lead wire is used, 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
OVER-THE-COUNTER USE:
TENS:
To be used to aid the 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 the symptomatic relief and management of chronic, intractable
pain and relief of pain associated with arthritis.
PMS:
To stimulate healthy muscles in order to help improve and facilitate muscle
performance. To be used to help the improvement of muscle tone and firmness, and for
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.
CONTRAINDICATIONS
• Do not use this device on persons 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 persons whose pain syndromes are undiagnosed.
WARNINGS
WARNING: Use carefully as directed and for external use only. May cause serious
burns. Do not use over sensitive skin areas or in the presence of 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 (Refer to the page of Recommended Use Positions for
details).
SAFETY WARNING
CAUTION, CONSULT ACCOMPANYING DOCUMENTS

6 7
• 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, because the introduction of
electrical current into the chest may cause rhythm disturbances to the patient’s
heart, which could be lethal.
• Do not allow contact with the eyes.
• 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.
• Do not use at the same time as other topical analgesics.
PRECAUTIONS
• Safety of stimulation use during pregnancy and breastfeeding has not been
established. Consult with your physician before use during pregnancy and
breastfeeding.
• 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 and electrodes out of reach of children and pets. If swallowed, get
medical help or contact a Poison Control Center right away.
• 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.
• Do not apply stimulation of this device in the following conditions:
– 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;

8 9
– stop using the device and consult with your physician if the device does not
provide pain relief;
– use this device only with the electrodes and accessories recommended for
use by the manufacturer. The electrodes may be packaged together with the
device or packaged separately as the replacement.
• 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.
• This device contains batteries. If overheating of the device occurred, stop the
operation immediately and contact customer support.
• Dispose of this battery-containing device according to the local, state, or federal
laws. Dispose of used electrodes in manner that always keeps product away from
children and pets.
• Skin burns may occur, and check the skin under the electrode periodically.
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 product and should consult with your physician if you
experience adverse reactions from the device and/or electrodes.
• You should stop using the device and should consult with your physician if condition
worsens, redness is present, irritation develops, symptoms persist for more than 7
days or clear up and occur again within a few days, or you experience signs of skin
injury, such as pain, swelling, or blistering where the product was applied.
Non-sterile
Consult instructions for use
MR Unsafe - keep away
from magnetic resonance
imaging (MRI) equipment
Caution, consult
accompanying documents
Fragile, handle with care
Keep away from rain
Use by date
Product packaging is able to
be recycled
Date of manufacture
Batch code
Catalogue number
Serial number
Manufacturer
Temperature limitation
Humidity limitation
LOT
REF
SN
CAUTION, Avoid injury.
Read and understand
owner’s manual before
operating this product
Type BF applied part
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.