Compex Tens / Heat User manual

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TENS / HEAT

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TABLE OF CONTENTS
Introduction....................................................................................................................................................................4
Indications for Use........................................................................................................................................................4
Safety Warning..............................................................................................................................................................5
Contraindications...........................................................................................................................................................5
Warnings..........................................................................................................................................................................5
Precautions.....................................................................................................................................................................6
Adverse Reactions.........................................................................................................................................................8
Symbol and Title............................................................................................................................................................8
Environmental Condition for Transport and Storage..................................................................................................9
Electromagnetic Compatibility..................................................................................................................................10
How the Device Works................................................................................................................................................14
Device Description.......................................................................................................................................................15
Operating Instruction..................................................................................................................................................16
Performance Specifications......................................................................................................................................21
Cleaning and Maintenance.........................................................................................................................................21
Trouble Shooting..........................................................................................................................................................22
Contact Information....................................................................................................................................................23

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INTRODUCTION
Compex Tens / Heat delivers electric pulses and heat to the user’s body areas such as knee and back
through the conductive silver pads. The portable and compact device has multiple modes of different
pulse frequencies, covering Transcutaneous Electrical Nerve Stimulation (TENS) and Electrical Muscle
Stimulation (EMS). It includes operating elements of ON/OFF button, intensity increase button, intensity
decrease button, mode button, timer button, and heat/temperature button, and can be attached and
detached to a wrap with conductive silver pads through magnetic connectors.
INDICATIONS FOR USE
To be used for temporary relief of pain associated with sore and aching muscles due to strain from
exercise or normal household and work activities.
It is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain
associated with arthritis.
To stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for
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 temporarily increase local blood circulation in the healthy muscles of lower ex-
tremities.

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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 interfer-
ence, 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 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 the wrap and avoid sharp folds.
»Carefully examine the device and the wrap, and do not use if they show any sign of deterioration.
»Do not tamper with this device and the wrap 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 patients with a known
sensitivity to the carotid sinus reflex.
»Stimulation should not be applied over the 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 should not be applied transthoracically in that the introduction of electrical current into
the heart may cause cardiac arrhythmias.
»Stimulation should not be applied transcerebrally.

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»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
»Safety of stimulation use during pregnancy has not been established.
»Caution should be used for patients with suspected or diagnosed heart problems.
»Caution should be used for patients 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.
»Caution should be used in the presence of the following:
- When there is a tendency to hemorrhage following acute trauma or fracture;
- Following recent surgical procedures when muscle contraction may disrupt the healing process;
- Over the menstruating or pregnant uterus; and
- Over areas of the skin which lack normal sensation.
»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 while sleeping.
»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.

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»Do not attempt to move the conductive silver pads 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;
- the device is not a substitute for pain medications and other pain management therapies;
- the 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; and,
- use this device only with the conductive silver pads, and accessories recommended
for use by the manufacturer
»Keep the device away from high-temperature and direct-sunlight place.
»Do not share the use of the conductive silver pads with others.
»Do not use the device while it’s charging.
»The device contains the lithium battery. If overheating of the device occurred during the
charging, stop the charging or operation immediately and report to the seller.
»Dispose of the battery-containing device according to the local, state, or federal laws.
»Skin burns may occur, and check the skin under the conductive silver pads periodically.

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ADVERSE REACTIONS
»You may experience skin irritation and burns beneath the conductive silver pads applied to the skin;
»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 Manufacturer
Caution, consult
accompanying documents
Temperature limitation
Use by date Humidity limitation
Date of manufacture Non-sterile
Batch code Fragile, handle with care
Catalogue number Keep away from rain
Serial number Product packaging is
able to be recycled
Type BF applied Part

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ENVIRONMENTAL CONDITION FOR TRANSPORT AND STORAGE
Store and transport ambient temperature: -10 ~50°C (14~122°F)
Store and transport ambient humidity: 30~90%
Fragile; handle with care
Keep away from rain
Non-sterile
Product packaging is able to be recycled
TEMPERATURE LIMITATION
10
°C
40
°C
TEMPERATURE LIMITATION
-10
°C
50
°C
30%
85%
30%
90%
Normal working ambient temperature: 10~40°C (50~104°F)
Normal working ambient humidity: 30~85%

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GUIDANCE AND MANUFACTURE’S DECLARATION – ELECTROMAGNETIC EMISSION
The device is intended for use in the electromagnetic environment specified below. The customer of the user of the device 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.
RF emission
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Class A The device is suitable for use in all estab-
lishments, including domestic establish
public low-voltage power supply network
that supplies buildings used for domestic
purposes.
Voltage fluctuations/ flicker emissions
IEC 61000-3-3
Complies
ELECTROMAGNETIC COMPATIBILITY
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. 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 adjacent to or stacked with other equipment and that if adjacent
or stacked use is necessary, this machine should be observed to verify normal operation in the configuration in
which it will be used.

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GUIDANCE AND MANUFACTURE’S DECLARATION – ELECTROMAGNETIC EMISSION
The device is intended for use in the electromagnetic environment specified below. The customer of the user of the device 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, concrete or ceramic tile. If floor are
covered with synthetic material, the relative humidity should
be at least 30%.
Electrical fast
transient/
burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/
output lines
±2kV for power
supply lines
Main power quality should be that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
± 1 kV line(s) to
line(s)
± 2 kV line(s)
to earth
±1 kV differential
mode
Main power quality should be that of a typical commercial or
hospital environment.
Voltage
dips, short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-
4-11
<5% UT (>95% dip in
UT) for 0.5 cycle
40% UT (60% dip in UT)
for 5 cycles
70% UT (30% dip in UT)
for 25 cycles
<5% UT (>95% dip in
UT) for 5 sec
<5% UT (>95% dip in
UT) for 0.5 cycle
40% UT (60% dip in
UT) for 5 cycles
70% UT (30% dip in
UT) for 25 cycles
<5% UT (>95% dip in
UT) for 5 sec
Main power quality should be that of a typical commercial or
hospital environment. If the user of the device requires contin-
ued operation during power nterruptions, it is recommended
that the device be powered from an uninterruptible power
supply or a battery.
Power
frequency
(50Hz/60Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m Main power quality should be that of a typical commercial or
hospital environment. If the user of the device requires contin-
ued operation during power interruptions, it is recommended
that the device be powered from an uninterruptible power
supply or a battery.
NOTE UT is the a.c. mains voltage prior to application of the test level.

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GUIDANCE AND MANUFACTURE’S DECLARATION – ELECTROMAGNETIC IMMUNITY
The device is intended for use in the electromagnetic environment specified below. The customer or the user of the device should
assure that it is used in such an environment.
Immunity test IEC 60601 test
level
Compliance level Electromagnetic environment - guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 Vrms
3 V/m
Portable and mobile RF communications equipment should
not be used near any part of the device, including cables,
than the recommended separation distance calculated from
the equation applicable to the frequency of the transmitter.
Recommended separation distance
d= 1,2 P
d= 1,2 P 80 MHz to 800 MHz
d= 2,3 P 80 MHz to 2,5 GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation distance
in metres (m).
Field strengths from fixed RF transmitters, as determined by
an electromagnetic site survey, a) should be less than the
compliance level in each frequency range. b)
Interference may occur in the vicinity of equipment marked
with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.
a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured
field strength in the location in which the device is used exceeds the applicable RF compliance level.

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observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as
re-orienting or relocating the device.
b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS
EQUIPMENT AND THE DEVICE.
The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer
or the user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output
power of the communications equipment.
Rated maximum output
power of transmitter (W)
Separation distance according to frequency of transmitter (m)
150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
11.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be
estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, w and people.

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HOW THE DEVICE WORKS
The device has multiple modes, covering TENS and EMS. If you are using the device for the first time, it is
recommended that you start with the default Mode 1, which combines different pulse frequencies. Some
modes are particularly effective for certain users, but you may need to select the mode that is best for
you. You may need to try a few modes before finding the one that suits you the best. The best choice of
modes may vary from one user to another, in spite of having the same type of symptom.
PULSE FREQUENCY (HZ) MODE DESCRIPTION INTENDED USE
Mode 1 Combination of Mode 2-8 Combination of below Pain relief and muscle stimulation with combined
pulse rates
Mode 2 69 Hz Pulse on for 3.4 second and off
for 1.6 second Pain relief with a pulse rate of 69 Hz
Mode 3 12.5-55.5 Hz Pulse on for 20 second and off
for 1 second Muscle stimulation with variable pulse rate
Mode 4 1.2 Hz Pulse on every 0.85 second Pain relief with a pulse rate of 1.2 Hz
Mode 5 100 Hz Pulse on for 10 second and off
for 2.5 second Pain relief with a pulse rate of 100 Hz
Mode 6 100 Hz Pulse on for 20 second and off
for 1 second Pain relief with a pulse rate of 100 Hz and longer on time
Mode 7 20 Hz Pulse on for 5 second and off
for 1 second Muscle stimulation with a fixed pulse rate of 20 Hz
Mode 8 160 Hz Pulse on for 10 second and off
for 2 second Pain relief with a pulse rate of 160 Hz

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DEVICE DESCRIPTION
Remove the device and accessories from the packaging. The accessories include a USB cable used for
charging, and a wrap with conductive silver pads.
INTENSITY INCREASE
HEAT LEVEL
INTENSITY DECREASE
MODE CHANGE
TIMER CHANGE
BATTERY INDICATOR
CHARGING PORT ON / OFF: HOLD 2 SEC.
USE ON/OFF BUTTON TO
LOCK SCREEN
MICRO USB TO USB CHARGER

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OPERATING INSTRUCTION
The following steps are used to guide the device operation, and the details about each step are listed
in the following table.
01 Charge control unit before first use
02 Lightly dampen conductive silver pads with water
03 Apply brace to body part
NOTE: Skin should be clean. Remove sweat and lotions prior to use
04 Connect control unit to brace
05 Turn control unit on (Hold 2 sec.)
06 Select program
07 Change simulation time
08 Adjust stimulation intensity
09 Adjust heat level
10 Turn control unit off when done
NOTE: Intensity + button only works when device is attached to wrap and wrap is in contact with skin.

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1ST STEP – Charge control unit before first use
The control unit comes with a built-in rechargeable battery, and can be
used as received. If the battery icon on the turned-on control unit keeps
flashing, it means the battery is running out. Charge the control unit
with the enclosed USB cable. The battery icon flashes during charging,
and becomes solid when the control unit is charged fully.
2ND STEP - Dampen wrap pads for best results
Lightly dampen conductive silver pads with clean water
3RD STEP - Apply to the body part
Apply wrap to the body part using velcro strap/s to secure in place
4TH STEP - Connect control unit to the brace
Apply control unit to brace using magnets to secure connectors. Connect
gold magnets to gold connectors, and silver magnets to silver connectors.
The screen should be right reading from the user looking down.
5TH STEP - Turn control unit on
Hold On/Off button for 2 seconds to turn on device. Front display
panel will light-up, indicating the device is on. Press the On/Off button
once to lock/unlock the screen buttons. When buttons are locked, no
adjustments can be made. Hold On/Off button for 2 seconds to turn
off the device.
CONTROLL UNIT
ON/OFF BUTTON
MAGNETS
USB CABLE

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6TH STEP - Select program
There are eight stimulation modes. Press the “M” button to select a
desired pulse mode. The mode selected will be shown on the display.
7TH STEP - Change simulation time
Default timer is set to 30 min. Press the “T” button to select a desired
time (30, 40, 50, 60, 10 and 20 min) interval. The time selected will be
shown on the display screen.
8TH STEP - Adjust stimulation intensity
Press and release the “+” button to increase the intensity, and the “-”
button to decrease the intensity. The device will beep and the intensity
level will flash with each change.
Note: With the increase of intensity (20 total levels), you may experi-
ence sensations like tingling, vibration, pain, etc. Therefore, gradually
increase the intensity, and stop increasing when a comfortable level
is reached.
9TH STEP – Adjust heat level
Press the HEAT +/- button to select desired level of heat.
10TH STEP - Turn control unit off when done.
When the countdown timer is up, the device will turn off automatically.
The device can also be turned off by holding the On/Off button,
indicated by the display light turning off. OFF / ON
T = TIMER CHANGE
M = MODE CHANGE
+ = INTENSITY INCREASE
- = INTENSITY DECREASE
HEAT + / - =
HEAT OFF, LEVEL 1, LEVEL 2

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When using the device for the first time, we recommend starting from the default Mode 1, which
combines the different frequencies. If you use one of the specific TENS or EMS modes, please refer to
the following for details.
USE AS TENS
The control unit includes the following TENS frequencies, 69Hz (Mode 2), 1.2 Hz (Mode
4), 100Hz (Modes 5 and 6), and 160Hz (Mode 8). For treatment, place the wrap and conductive silver
pads at the site of pain, and connect the device to the wrap.
For arthritis pain, inflammation of the joints, place the conductive silver pads on or near the area of
the arthritis pain. The TENS mode of the device generates electrical pulses that are sent through the
conductive silver pads for pain relief.
USE AS EMS
The control unit also includes the EMS frequencies, 13-56Hz (Mode 3) and 20Hz (Mode 7). For treatment,
place the wrap and conductive silver pads where you desired muscle firming and strengthening, and
connect the device to the wrap. Then select modes 3 or 7.
The EMS modes can also help temporarily increase local blood circulation in healthy muscles through the
conductive silver pads, when they’re positioned on the extremity.

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Recommended Practice for Both TENS and EMS:
• Start from the lowest intensity and gradually adjust the intensity to a comfortable level at a scale
from from 1 to 20.
• Good skin care is important for a comfortable use of device. Be sure the treatment site is clean of
dirt and body lotion.
CONDUCTIVE WRAP
The conductive wrap accessory is connected to the control unit through its magnentic connectors.
The wrap accessory holds the conductive silver pad material that will be in contact with the skin. The
electrical stimulation will be delivered to the body through these pads.