Compex Knee Wrap for Pain Relief Manuale utente

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BACK AND KNEE PAIN RELIEF

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EN

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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. 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.

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SAFETY WARNING

CONTRAINDICATIONS

Do not use this device on people 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 people whose pain syndromes are undiagnosed.

WARNINGS

• 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.

• 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.

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PRECAUTIONS

• Safety of stimulation use during pregnancy has not been established.

• Caution should be used for people with suspected or diagnosed heart problems.

• Caution should be used for people 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;

• 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.

• 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.

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• 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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Consult instructions

for use

Catalogue number Humidity limitation

Caution, consult

accompanying documents

Serial number Non-sterile

Use by date Type BF applied Part Fragile, handle with care

Date of manufacture Manufacturer Keep away from rain

Batch code Temperature limitation

CE mark shows the

conformity to the Medical

Device Directive

Unrecyclable

IP22

IP code of the device

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.

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ENVIRONMENTAL CONDITION FOR TRANSPORT AND STORAGE

TEMPERATURE LIMITATION

5 °C

40 °C

Normal working ambient temperature: 5~40°C (41~104°F)

15 %

90 %

Normal working ambient humidity: 15~90%

-25 °C

70 °C

TEMPERATURE LIMITATION

Store and transport ambient temperature: -25~70°C (-13~158°F)

0 %

90 %

Store and transport ambient humidity: 0~90%

Fragile; handle with care

Keep away from rain

Non-sterile

Product packaging is able to be recycled

Atmospheric pressure: 70~106kPa

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GUIDANCE AND MANUFACTURE’S DECLARATION – ELECTROMAGNETIC EMISSION

The device is intended for use in the electromagnetic environment specied 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

establishments, including domestic establish

public low-voltage power supply network

that supplies buildings used for domestic

purposes.

Voltage uctuations/ icker emissions

IEC 61000-3-3

Complies

ELECTROMAGNETIC COMPATIBILITY

• 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.

• 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.

• Caution: This unit has been thoroughly tested and inspected to assure proper performance and

operation.

• Caution: This unit should not be used adjacent to or stacked with other equipment and that if

adjacent or stacked use is necessary, this unit 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 specied below. The customer of the user of the device should

assure that it is used in such an environment.

Immunity test

IEC 60601-1-2

test level

Compliance level Electromagnetic environment - guidance

Electrostatic

discharge

(ESD)

IEC 61000-4-2

±8 kV contact

±2 kV, ±4kV, ±8 kV,

±15 kV air

±8 kV contact

±2 kV, ±4kV, ±8 kV,

±15 kV air

Floors should be wood, concrete or ceramic tile. If oor 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

±2 kV for power supply

lines

±1 kV for input/output

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 line(s) to line(s)

± 2 kV line(s) to earth

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

0 % UT; 0.5 cycle

at 0°,45°,90°, 135°,

180°, 225°, 270°,

315°

0 % UT ; 1 cycle

70 % UT; 25/30 cycle

0% UT; 250/300

cycle

0 % UT; 0.5 cycle

at 0°,45°,90°, 135°,

180°, 225°, 270°,

315°

0 % UT ; 1 cycle

70 % UT; 25/30 cycle

0% UT; 250/300 cycle

Main power quality should be that of a typical commercial

or hospital environment. If the user of the device

requires continued 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 eld

IEC 61000-4-8

30 A/m 50Hz/60Hz 30 A/m 50Hz/60Hz

Main power quality should be that of a typical commercial

or hospital environment. If the user of the device requires

continued 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 specied 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 RMS outside the

ISM band, 6 V RMS in

the ISM and amateur

bands

10 V/m

80 MHz ¨C 2,7 GHz 80

% AM at 1 kHz

3 Vrms

150 kHz to 80 MHz

3 V RMS outside

the ISM band, 6 V

RMS in the ISM and

amateur bands

10 V/m

80 MHz ¨C 2,7 GHz

80 % AM at 1 kHz

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 xed 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 aected by absorption and reection from

structures, objects and people.

a Field strengths from xed 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 xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld

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, eld strengths should be less than 3 V/m.

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.

Test Frequency

(MHz)

Band

a

Service

a

Modulation

a

Maximum

Power (W)

Distance (M)

Immunity Test

Level (V/m)

385 380-390 TETRA 400. Pulse Modulation

b

18Hz 1.8 0.3 27

450 430-470 GMRS 460. FRS 460. FM

c

+5kHz sine 2 0.3 28

710

704-787 LTE Band 13. 17.

Pulse Modulation

b

217 Hz

0.2 0.3 9745

780

810

800-960

GSM 800/900.

TETRA 800. iDEN 820.

CDMA 850. LTE.

Nand 5.

Pulse Modulation

b

18 Hz

2 0.3 28

870

930

1720

1700-1990

GSM 1800. CDMA.

1900.

GSM 1900. DECT.

LTE Nand 1, 3.

4, 25; UTMS.

Pulse Modulation

b

217 Hz

2 0.3 28

1845

1970

2450 2400-2570

Bluetooth WLAN.

802.11 b/g/n.

RFID 2450.

LTE Band 7.

Pulse Modulation

b

217 Hz

2 0.3 28

5240

5100-5800 WLAN 802. 11 a/n.

Pulse Modulation

b

217 Hz

0.2 0.3 95500

5785

NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may

be reduced to 1m. The 1m test distance is permitted by IEC 61000-4-3.

a) For some services, only the uplink frequencies are included

b) the carrier shall be modulated using a 50% duty cycle square wave signal.

c) As an alternative to FM modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.

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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.

Accessories included in the package.

1x Tens unit controller

1x Wrap

1x USB line

1x Manual

1x Bottle

MICRO USB TO USB

CHARGER

INTENSITY INCREASE

HEAT LEVEL

INTENSITY DECREASE

MODE CHANGE

TIMER CHANGE

CHARGING PORT

BATTERY INDICATOR

ON / OFF: HOLD 2 SEC.

USE ON/OFF BUTTON TO

LOCK SCREEN

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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

Note: Connect gold magnets to gold connectors, silver magnets to silver connectors.

The screen should be legible from the user looking down.

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 rst use

CONTROL UNIT USB CABLE

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

ashing, it means the battery is running out. Charge the control unit with

the enclosed USB cable. The battery icon ashes 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

MAGNETS

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

ON/OFF BUTTON

Hold On/O button for 2 seconds to turn on device. Front display panel will

light-up, indicating the device is on. Press the On/O button once to lock/

unlock the screen buttons. When buttons are locked, no adjustments can

be made. Hold On/O button for 2 seconds to turn o the device.

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6th Step - Select program

M = MODE CHANGE

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

T = TIMER CHANGE

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

+ = INTENSITY INCREASE

- = INTENSITY DECREASE

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 ash with each change.

Note: With the increase of intensity (20 total levels), you

may experience 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

HEAT + / - =

HEAT OFF, LEVEL 1, LEVEL 2

Press the HEAT +/- button to select desired level of heat.

10th Step - Turn control unit o when done.

OFF / ON

When the countdown timer is up, the device will turn o

automatically. The device can also be turned o by holding

the On/O button, indicated by the display light turning o.

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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, 12.5-55.6Hz (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.

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.

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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.

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