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;

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– 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.

10 11
TEMPERATURE
LIMITATION
10O
-10O
30%
30%
85%
90%
40O
50O
TEMPERATURE
LIMITATION
Normal working ambient temperature: 10~40°C
Store and transport ambient temperature: -10 ~50°C
Normal working ambient humidity: 30~85%
Store and transport ambient humidity: 30~90%
ENVIRONMENTAL CONDITION
FOR TRANSPORT AND STORAGE
HOW THE DEVICE WORKS
The device has multiple program modes of TENS and PMS. If you are using the device
for the first time, it is recommended that you start with the default Mode 1. Some modes
are particularly effective for certain users, but you may need to select both the mode
and the electrode position that are the best for you. You may need to try a few positions
and modes before finding the one that suits you the best. The best choice of modes
and positions may vary from one user to another, in spite of having the same type of
symptom.
Program name Timer (min) Frequency (Hz) Pulse Width (μs)
Mode 1 (combination
mode): PMS/TENS
30, 40, 50, 60, 10, 20 1.2-160 100
Mode 2: TENS 30, 40, 50, 60, 10, 20 62.5 100
Mode 3: PMS 30, 40, 50, 60, 10, 20 12.5-55.5 100
Mode 4: TENS 30, 40, 50, 60, 10, 20 1.2 100
Mode 5: TENS 30, 40, 50, 60, 10, 20 100 100
Mode 6: TENS 30, 40, 50, 60, 10, 20 160 100

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TECHNICAL INFORMATION
Model/type LidoTENS Weight 20g
Power supply Powered by a built-in
3.7V li-ion battery
Automatic shutoff 30 min
Waveform and wave
shape
Biphasic rectangular
wave pulse
Degree of protection
against electric shock
Type BF applied part
Pulse width 100µsec Type of protection against
electric shock
Internally powered
equipment
Pulse frequency 1-160Hz (Hz=stimulation
times per second)
Grade of waterproof IP22
Output Voltage Max. 70Vpp ±20%(at
500Ω)
Product warranty 1 year
Treatment time 30, 40, 50, 60, 10, 20 min Lifetime for electrode Storage for 2 years (no
use), Times of reusable:
30 times
Output intensity 0 to 20 levels, adjustable Mode of operation Continuous operation
Modes 6 auto modes Software version A0
Typical operation time of
Battery
If to use at the highest
level, the battery can be
used for about 150 min
after fully charged.
The time required for me
equipment to warm from
the minimum storage
temperature between
uses until it is ready for
intended use
30 min
Behaviour of me
equipment while the
rechargeable internal
electrical power source is
charging:
The indication light will
flash during charging
and will be still with full
capacity.
The time required for me
equipment to cool from
the maximum storage
temperature between
uses until it is ready for
intended use
15 min
Typical service life of
Battery
300 times of recharging Adapter for charging Please use output DC5V
and output current 0.3-
2.0A adapter for charging
Note: Not intended to be sterilized.
Not for use in an OXYGEN RICH ENVIRONMENT
SETUP
Unpack the box of the product, and take
the product and accessories out.
Accessories included in the package
1 TENS unit
1 electrode patch
1 USB cable
1 Manual
TENS Unit (Side View)
USB Cable
Electrode Pack

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OPERATING INSTRUCTION
The following Operating Instructions are used to guide the operation, and the details
about each step are listed in the following table.
1st Step – Check the battery power for the device
The device comes with a built-in rechargeable
battery, and could be used as received. The USB cable
included could be used to charge the device. The light
indicator on the device is flashing during charging,
and becomes solid when the device is charged fully.
Note: Use the UL- or ETL- certified adapter of 5V and
0.3-2A for the battery charging. Charge Device
2nd Step - Install the electrode onto the device
Snap the enclosed electrode onto the device through
the contact connectors. This should be done prior to
applying the device onto the skin of the treatment
area.
Electrode installation
3rd Step - Put the electrode-installed device on the
stimulation-needed body area
Carefully remove the protective cover film from the
electrode pad/patch, and avoid fingers contacting to
the sticky electrode gel. Place the electrode-installed
device onto the treatment area. Press down firmly
and ensure a full and firm contact to the body area of
treatment.
Note: Keep the skin clean before placing the
electrode patch-installed device and wash hands if
fingers contact to the sticky electrode gel. Place the device on the body area
4th Step - Press the “ON/OFF” to turn on the power
Hold the On/Off button to turn on the unit, illustrated
by the lit-up indicator on the front. On/Off
5th Step - Select one of the stimulation modes
Change the output stimulation modes by pressing and
holding the + button, and the mode change could be
seen on the flashing times of the light indicator.
Note: When the light indicator flashes once, it means
Mode 1; when the light indicator flashes twice, it
indicates Mode 2. Mode change
6th Step - Choose the stimulation time
The default timer is 30 min. Change the timer by
pressing and holding the - button, and the timer
change could be seen on the flashing times of the
light indicator.
Note: When the light indicator flashes once, it means
10min; when the light indicator flashes twice, it
indicates 20min. Timer change
7th Step - Adjust the stimulation intensity
Press and release the “+” button to increase the
stimulation intensity, and press and release the “-”
button to decrease the intensity.
Note: With the increase of intensity, you may
experience sensations like tingling, vibration, etc.
Therefore, gradually increase the intensity, and stop
increasing when a comfortable level is reached. Intensity change
8th Step - Stay with the stimulation
After the above mode, timer, and intensity are set, the
stimulation treatment provided by the device will last
until the device turns off.
Stay with the stimulation treatment
9th Step - Press the “ON/OFF” to turn off the power
after done
When the timer is up, the device will turn off
automatically. The device could be also turned off by
holding the On/Off button. The electrode patch/pad
could remain on the treatment area for up to 12 hours,
while the device turns off automatically or manually.
Note: When not in use, store the device and accessory
in a cool place, out of direct sunlight.
On/Off

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If using the device for the first time, you may start from the default Mode 1. And if you
expect to use the specific mode, please refer to the following for details.
USE AS TENS
The device could be placed directly on the treatment site where you are experiencing
pain (such as pain associated with sore and aching muscles and pain associated with
arthritis). For example, if the treatment site is on the calf, place the TENS device above
the pain site.
Arthritis involves inflammation on joints of the body, usually producing pain and
stiffness. The electrode is placed on or near the area of the arthritis pain. The TENS
mode of the device generates electrical pulses that are sent via the electrode for pain
relief.
USE AS EMS
The device could be placed directly on the body area where you are expecting the
muscle strengthening. For example, if the body area is the leg, place the device on the
leg site.
RECOMMENDED PRACTICE FOR BOTH TENS AND EMS:
• Start from the lowest intensity and gradually adjust the intensity to a comfortable
level. Duration is the preset timer (such as 30 minutes) for each skin area. Frequency
is 2 times per day per skin area. The electrode patch/pad could remain on the
treatment area for up to 12 hours per day, while the device is turned off automatically
or manually. Consult with your physician for longer and more frequent uses.
• Good skin care is important for a comfortable use of device. Be sure the treatment
site is clean of dirt and body lotion.
• Keeping the electrode in the storage bag after use will extend its lifespan. The
electrode pad is disposable and should be replaced when it loses the adhesiveness.
To purchase additional electrodes, please contact the seller.
The exact percentage of ingredients used in the electrode patch/pad is withheld as the
trade secret and may be disclosed as requested. Electrodes with a shelf life of 2 years
are intended for single person use, and could be reused and replaced. If the electrode
no longer contacts well with your body skin, it is time to replace it. If needed, you could
use a damp and clean cloth to wipe electrodes between uses. Please see the following
for the Use Direction, Removal and Storage of the electrode used for both TENS and
EMS.
USE DIRECTION
1. Clean skin thoroughly prior to each application of electrodes, which will not contact
well if any lotion, make-up, or dirt is left on the body skin.
2. Ensure the device is off before applying the electrode to it.
3. Apply the electrode-installed device firmly to the body skin.
REMOVAL AND STORAGE
1. Turn the device off before removing the electrode from the body skin.
2. Grab the edge of the electrode and remove from the body area.
3. When not in use and/or between each use, store the electrode in the re-sealable
bag, out of direct sunlight and out of reach of children and pets.
PERFORMANCE SPECIFICATIONS
Power Source 3.7V Battery
Number of Output Modes 6 preset modes
Timer Range (minutes) 10-60
Dimensions (mm) [L x W x D] 52 x 44 x 12 mm
Waveform Biphasic
Shape Rectangular
Maximum Output Voltage 70V@500Ω
Maximum Output Current 80mA@500Ω
Maximum Pulse Duration 100µSec
Maximum Frequency 160Hz

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CLEANING AND MAINTENANCE
Please use wipe to clean the device first, and then use the dry cloth to wipe it again.
The electrodes coming with the device are disposable, and should be replaced when
their adhesiveness becomes worse. Contact the seller for replacements.
TROUBLE SHOOTING
If your device is not operating properly, please check below for common problems and
suggested solutions. If the recommended action does not solve the problem, please
contact the seller.
STIMULATION IS WEAK OR NON-EXISTENT
• Be sure skin is clean and pads are firmly attached to skin.
• The battery is low and needs to be charged.
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. Please contact the distributor or dealer
for replacements.
SKIN TURNS RED
• Do not use the product if skin irritation or redness occurs.
• If problem persists, contact your physician.
RECOMMENDED USE POSITIONS
SHOULDERS BACK BUTTOCKS ABDOMEN
ARMS LEGS FEET
NEVER APPLY ELECTRODES ON THE THROAT OR BOTH
SIDES OF THE NECK, WHERE THE CAROTID SINUS NERVES
ARE LOCATED.