Shenzhen BACKUP BELT 002 Ohjekirja

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Shenzhen
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BACKUP BELT 002
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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
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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