Shenzhen BACKUP BELT 002 Ohjekirja

BACKUP BELT

USER MANUAL

BACKUP BELT

Model Number: 002

Manufacturer: SHENZHEN KENVOX TECHNOLOGY CO., LTD

Company Address: Bldg 3 Shangwei Industrial Zone,

Zhangkengjing, Guanlan, Shenzhen, China.

European Representative: Unikia AS

Adress: Karl Johans gate 13, 0154, Oslo, Norway

Contact Name: UNIKIA AS

Telephone number: +47 920 40 756

Email: [email protected]

Manual version 002

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Content

1. Parts & Controls 3

2. Introduction 3

3. Before use 4

4. Support functionality 4

5. TENS functionality 5

6. HEAT functionality 7

7. Removing the Backup Belt 8

8. Batteries & charging 8

9. Maintenance and storage 8

10. Technical Specifications 9

11. Safety information 10

12. Manufacturers Declaration 11

Parts & Controls

PARTS

1. Belt

a. Inner belts (right & left)

b. Belt backplate

c. Magnetic connectors

d. Tensioning belts (right & left)

2. Remote

3. Main unit

a. Electrode Area: Surface where

the gel pads are placed

b. Electronics housing

4. USB cable & Charger

5. Gel pads

6. Manual

CONTROLS

7. Main unit On/O

8. Main unit Indicator Light

9. Remote unit On/O

10. TENS On/“+” button

11. TENS O/“-“ button

12. HEAT On/O button

13. TENS signal light

14. HEAT signal light

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Introduction

Congratulations on your purchase of

the Backup Belt. It is a unique wireless

remote controlled pain relief device

incorporating active heating, structural

support and TENS technology to

specifically target back pain.

This innovative device is safe, drug-free,

easy to use, discreet and comfortable

to wear, and most importantly allows

you to control your pain to maintain an

active lifestyle.

This device is intended for relief of

chronic intractable pain. It can be used

at home.

Before use

Your Backup Belt has been designed

with the home user in mind. Please

consult the safety precautions and

contraindications in this manual prior

to use.

Before using the main unit the first time

please charge the main unit. Insert the

usb cable into the charger. Plug the

charger into the mains making sure

before that the charger is compatible

to the mains in your current location.

Then connect the main unit. The main

unit indicator light will flash green

every 5th second during charging. The

unit is fully charged after 10 hrs (2000

mAh).

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Support functionality

The support function of your Backup

Belt is completely analog and ready to

use. Put on the belt like this:

1. Make sure the belt is facing the

right way. The magnetic connectors

should face towards your body and

down.

2. The belt length can be adjusted by

moving the inner right & left belt

along the belt backplate, fastening

by means of the velcro. Max waist

diameter is 116cm.

3. To insert the main unit insert the

notch in the top of the main unit

into the matching tab on the belt

backplate. Then press main unit

through the opening allowing the

magnetic connectors on the main

unit & belt backplate to connect.

4. Hold the backplate with main unit

towards your lower back. If using

the optional gel pads see next

page for detailed instructions.

Grab the inner fastening belt and

wrap it around your body. Tighten

comfortably and fasten with the

Velcro. Right hand side goes over

the left hand side.

5. To tighten the supporting belt grab

both outer tensioning belts and pull

them until you feel you have desired

support. Fasten with the Velcro.

Right hand side goes over the left

hand side here too.

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TENS functionality

Before using the TENS functionality of

your Backup Belt you will need to Insert

the main unit in the belt and prepare

the device for a treatment. Optionally

apply the gel pads to the main unit.

APPLYING THE GEL PADS TO THE

MAIN UNIT

For added comfort you can chose to

use the gel pads. The backup belt can

be used without it but if your skin is

very dry you may experience some

discomfort in use if the belt is not fitting

tight against the body. The gel pads are

intended for single person use. They

will last, depending on skin type, oils,

and pH levels, approximately twenty

applications. Replace the gel pads when

they no longer adhere completely.

Follow these steps to apply the gel pads:

1. Trim, not shave, excessive hair on

the treatment area.

2. Wash the skin and dry completely

3. Separate the two gel pads.

4. Remove the film with print reading

“ELECTRODE” from the side being

applied to the electrode area. This

film is the smallest of the two. Do

not remove the protective liner on

the “skin side” yet.

5. Align the shape of the first gel pad

with the electrode area. Apply the

gel pad onto the electrode area

and firmly press across the entire

surface to ensure good adhesion.

6. Repeat steps 3 – 5 for the second

gel pad.

HOW DOES IT WORK

Tens treatment works in two ways.

It stimulates nerves that normally

carries pain signals thus “blocking”

these (“closing the pain gate”). It also

releases endorphins as if from exercise,

endorphins is the body`s “natural pain

killers”. The muscle contractions also

stimulate blood circulation.

TREATMENT RECOMMENDATIONS

• You can leave the device in position

for multiple treatments during the day.

It will automatically turn om after one

(1) hour of treatment. If no treatment is

active the unit will turn o completely

after 15 minutes.

• It is recommended you wait a

minimum of 30 minutes between

treatments.

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CONDUCTING A TENS TREATMENT

Always read the safety warnings before

conducting a treatment. Follow these

steps to conduct a treatment:

1. If using the gel pads, remove the

protective liners from the “skin side”

of the gel pads by slowly peeling the

liner diagonally from an inside corner

to the opposite outside corner.

Important! Avoid contact of the gel

pad with other objects. Contact with

other objects may aect the pads

adhesion properties. Save the liners

for storage of the device. Gel pad

may cause skin itching, redness and

swelling so test on skin first.

2. Align the center of the device over

the spine and place the device on

your back in the area of pain. If you

cannot place the device properly,

ask another person for assistance.

Important! Do not apply the gel

pads/electrodes directly over the

spine.

3. Press the On/O button on the main

unit. The LED will flash green for

10 seconds indicating the device is

ready for use.

4. Press the ON/OFF button on the

remote. Both signal lights will blink

twice to signal remote is on. Then

press the “+” button on the remote

control to begin the treatment. The

TENS signal light on the remote

will blink once to indicate signal is

sent from remote. Note: The LED on

the main unit will flash blue for 10

seconds to indicate TENS treatment

is activated.

5. Press the (+/-) buttons to increase

or decrease the intensity of the

stimulation until it is at a comfortable

level. There are 4 levels.

6. Press the ON/OFF button on the

remote control to stop the treatment

at any time. Both indicator lights

will blink twice to signal remote is

o. Treatment will automatically

stop after 1 hour of inactivity (not

pressing any buttons) - Alternatively

press the “-“ button several times to

reduce intensity and finally turn o

the treatment. Note: If a treatment is

stopped and restarted the treatment

will restart at the first stage, and will

run for a new full hour. Note: Turning

the remote o will also turn the main

unit o! To resume treatment both

main unit & remote must be turned

back on seperately

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HEAT functionality

CONDUCTING A HEAT TREATMENT

1. Make sure the main unit & remote

is on.

2. Press the HEAT button on the

remote. The heat signal light on

the remote will blink once to show

that a signal is sent to the main

unit.

3. The belt will start the heating and last

for 20 minutes before automatically

turning o. The main unit indicator

light will blink yellow for 10 seconds to

indicate a heat treatment has started.

The heating temperature is 42°C. It

will take a bit of time before you can

feel the heat after activation. The unit

will have enough battery for 8 full

HEAT treatments per full charge.

4. To stop the HEAT treatment before

the 20 minutes have passed simply

press the HEAT button on the

remote one more time. Alternatively

press and hold the remote ON/OFF

button to turn o both remote and

main unit instantly.

Removing the Backup Belt

1. After treatment, or when you want

to remove the device, loosen the

support belt, grasp the edge of the

device and gel pad to ensure the

gel pad does not stay on the skin (if

you are using the optional gel pad).

Slowly peel the device away from

the skin.

2. If you use the gel pads, align and

place the protective liners back on

the gel pads to prolong their useful

life. Ensure the pads are completely

covered. Important! Do not remove

the device until tens treatment has

stopped.

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Batteries & charging

When main unit recharge is needed

the main unit indicater will flash red:

Recharge with USB charger.

When the remote control is low on

battery no indications will light up if

buttons are pressed.

TO REPLACE THE REMOTE CONTROL

BATTERY:

1. Gently snap o the front cover

where the “+” & “—“ buttons are, you

will then see 2 screws.

2. Unscrew these to access the battery

on the back of the PCB.

3. Slide the old battery out, and slide

a new(1)CR2016E lithium battery

into the slot. Note: The (+) is facing

upward. The battery should be re-

placed once per year, dispose of the

used batteries in an orderly manner.

Reverse the process to close the

remote.

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Maintenance and storage

• Clean the device using a damp cloth

and mild soap. Gently wipe clean.

• The right & left inner belts can

be washed at 30 degrees. Do

NOT wash the belt backplate as it

contains electronics for the heating

functionality.

• Do not submerge the product in

liquid.

• The device should be operated,

transported and stored at

temperatures between 10° C

and 40° C, with relative humidity

between 30% - 85%, and

Atmospheric Pressure limitation of

500 hPa to 1060 hPa.

All values have +/- 10% tolerance.

• Store the device, remote control and gel pads in the original packaging when

not in use.

• If the device is not working properly, stop using immediately. Do not

disassemble or modify the device. Contact KENVOX Customer Service

• Enviromental conditions of transport and storage between uses: -25 °C without

relative humidity control; and +70°C at a relative humidity up to 93%,non-

condensing

• Enviromental operating conditions: A temperature range of +5°C to +40°C;

A relative humidity range of 15% to 93%, non-condensing; and an atmospheric

pressure range of 700 hPa to 1060hPa

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Technical Specifications

Channels: Single channel

Waveform: Asymmetric biphasic square pulse

Pulse Amplitude: 0 ~160 mA = 0 ~ 80 volts,

adjustable (at 500 ohm load)

Pulse Frequency: (Hz) 59

Pulse Width: (μs) 200

Timer Control: (mins) 20 mins for heat,

60 mins for tens

Power Supply: Lithium-polymer

rechargeable battery

Remote Control: One (1) CR2016E

Lithium battery

Size (D x W x H): 18 mm x 191 mm x 90 mm

Weight (including battery): Main unit 200g,

remote 17g

Safety Standards: CE, R&TTE, EN300220-2,

EN301489-3

EMC: EN60601-1-2

Safety: EN60601-1x

Made in China

WARRANTY

COMPANY SHALL NOT BE LIABLE

IN ANY EVENT FOR INCIDENTAL OR

CONSEQUENTIAL DAMAGES.

KENVOX (“Company”) warrants the

Backup Belt (“Product”) is free of

defects in materials and workmanship.

This warranty shall remain in eect as

per the legislation of the country in

which the unit was purchased.

SAFETY INFORMATION

INDICATIONS FOR USE

For temporary relief of pain associated

with sore and aching muscles in the lower

back due to strain from exercise or normal

household and work activities.

SAFETY CONTRAINDICATIONS Do not use

the TENS treatment on this device if you have

a cardiac pacemaker, implanted defibrillator,

or other implanted metallic or electronic

device. Such use could cause electric shock,

burns, or electrical interference or death.

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WARNING

• The device’s TENS treatment may

cause rhythmic disturbances to the

heart. Do not use the device across

or through your chest. If you are

susceptible to rhythm disturbances

of the heart, use of the device must

be done under the direction of a

physician.

• Use of the device’s TENS treatment

over your neck could cause muscle

spasms resulting in airway closure,

diiculty in breathing, adverse

eects on heart rhythm or blood

pressure. Do not use the device’s

TENS treatment over your neck

• Use of the device’s TENS treatment

when you are in the care of a

physician or have had medical or

physical treatment for your pain.

Consult with your physician before

using the device’s TENS treatment.

• Continued use of the device’s TENS

treatment when pain does not

improve, becomes more severe,

or lasts more than five days may

indicate a severe condition. Stop

using the device’s TENS treatment

and consult with your physician.

• Use of the device’s TENS treatment

on the following skin conditions

may cause a condition to become

worse. Do not use the device’s TENS

treatment over, or in proximity to,

these skin conditions: abnormal

skin, skin that is not intact,

uncleaned, unhealthy, open wounds,

rashes, swollen, red, infected,

inflamed areas, skin eruptions (e.g.,

phlebitis, thrombophlebitis, varicose

veins), or cancerous lesions.

• Electrical stimulation during

common activities may increase the

risk of injury. Do not use the device’s

TENS treatment when in the bath or

shower, sleeping, driving, operating

of machinery or any activity in

which electrical stimulation can put

you at risk of injury.

• Using the device around electronic

monitoring equipment (e.g., cardiac

monitors, ECG alarms) may cause

equipment malfunction. Do not

use this device around electronic

monitoring equipment.

• The eect, and safety, of using

the device on children, during

pregnancy, or use across the

head has not been evaluated or

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LIST OF COMMON FAULTS AND HANDLING

Common fault Handling method

1 Excess temperature Contact the manufacturer

2 Will not automatically

turn O after one (1)

hour

Ensure that the unit is turned on according to the

manual, then restart and restore original factory

settings. If the problem still persists, please feel

free to contact the manufacturer

3 Will not boot Contact the manufacturer

4 Battery is not

charging

Check whether the battery connection with the

adapter is damaged first, replace with a new one

if it is old and will not work. If the problem still

persists please contact the manufacturer

established and is unknown. Do not

use the device on children or let

children handle the device. Do not

use this device if you are pregnant,

or suspect that you are pregnant,

unless under the direction of your

physician. Do not apply the device

across your head.

• Users are forbidden to replace

the original factory accessories

and make changes to the original

product.

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PRECAUTION

• Using the device’s TENS treatment

when you have suspected or

diagnosed epilepsy or heart disease

may cause unexpected reactions.

Always consult your physician

before using the device’s TENS

treatment.

• Patient with implantable devices

should use with caution

• Using with the high frequency

surgical equipment at the same

time may cause burns or damage to

the device

• Operation close to short-wave or

microwave devices may cause the

ouput to be unstable.

• Use this product close to the heart

area can result in ventricular

fibrillation

• Do not use this device on the

head,eye,mouth,neck,chest and

upper back.

• The life expectancy of product is 3

years and the discarded main unit

should be handled so it does not

harm the environment

• Heating pad section can reach

a maximum temperature of 65

degrees Celsius if used in the

maximum operating temperatures.

If during use you feel the unit is

to hot remove immediately and

contact suppliers.

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Manufacturers Declaration

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS

The Backup Belt is intended for use in the electromagnetic environment specified below.

Emissions test Compliance Electromagnetic environment – guidance

RF emissions CISPR 11 Group 1 The Backup Belt uses RF energy only for its internal function. There-

fore, its RF emissions are very low and are not likely to cause any inter-

ference in nearby electronic equipment.

RF emissions CISPR 11 Class B The Backup Belt are suitable for use in all establishments including do-

mestic 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

Not applicable

Voltage fluctuations /

flicker emissions

IEC 61000-3-3

Not applicable

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GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY

The Backup Belt is intended for use in the electromagnetic environment specified below. The customer or the user of the

Backup Belt should assure that it is used in such an environment.

IEC 60601 test level Compliance level Electromagnetic environment – guidance

Electrostatic dis-

charge (ESD) IEC

61000-4-2

±6 kV contact

±8 kV air

±6 kV kontakt

±8 kV luft

Floors should be wood, concrete or ceramic tile. If

floors 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/ out-

put lines

Mains power quality should be that of a typical com-

mercial or hospital environment.

Surge

IEC 61000-4-5

±1 kV dierential mode

±2 kV common mode

±1 kV dierential mode

±2 kV common mode

Mains power quality should be that of a typical com-

mercial or hospital environment.

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GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY

Voltage dips, short

interruptions and

voltage variations on

power supply input

lines IEC 610004-11

<5 % U

T

(>95 % dip in U

T

) for

0.5 cycles

40 % U

T

(60 % dip in U

T

) for

5 cycles

70 % U

T

(30 % dip in U

T

) for

25 cycles

<5 % U

T

(>95 % dip in U

T

)

for 5 sec

<5 % U

T

(>95 % dip in U

T

) for

0.5 cycles

40 % U

T

(60 % dip in U

T

) for

5 cycles

70 % U

T

(30 % dip in U

T

) for

25 cycles

<5 % U

T

(>95 % dip in U

T

)

for 5 sec

Mains power quality should be that of a typical

commercial or hospital environment. If the user of

the Backup Belt requires continued operation during

power mains interruptions, it is recommended that

the Backup Belt be powered from an uninterruptible

power supply or a battery.

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GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY

The Backup Belt is intended for use in the electromagnetic environment specified below. The customer or the user of the

Backup Belt 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

150 kHz to 80 MHz

3 V/m

80 MHz to 2.5 GHz

Portable and mobile RF communications equipment should be

used no closer to any part of the Backup Belt, including cables,

than the recommended separation distance calculated from the

equation applicable to the frequency of the transmitter. Recom-

mended separation distance

d = 1.17 √P 150 kHz to 80 MHz | d = 1.17 √P 80 MHz to 800 MHz |

d = 2.33 √P 800 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, *should be less than the compliance

level in each frequency range. **

Interference may occur in the vicinity of equipment marked with

the following symbol:

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GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC IMMUNITY

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 reflection

from structures, objects and people.

*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 mea-

sured field strength in the location in which the Backup Belt is used exceeds the applicable RF compliance level above, the

Backup Belt should be observed to verify normal operation. If abnormal performance is observed, additional measures may

be necessary, such as re-orienting or relocating the Backup Belt .

** Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT

AND THE BACKUP RELIEF BELT

Recommended separation distances between portable and mobile RF communications equipment and the Backup Belt.

Separation distance according to frequency of transmitter m

Rated maximum output

power of transmitter W

kHz to 80 MHzd =1.17√P MHz to 800 MHzd =1.17√P

MHz to 2.5 GHzd =2.33√P

0.01 0.12 0.12

0.23

0.1 0.37 0.37 0.74

1 1.17 1.17 2.33

10 3.70 3.70 7.37

100 11.70 11.70 23.30

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 aected by absorption and

reﬂection from structures, object.

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Shenzhen BACKUP BELT 002 Ohjekirja

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