Paingone Qalm User manual

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QUICKSTART GUIDE
STEP ONE: Before use ensure to
clean your forehead with a
damp cloth and soapy water.
STEP TWO: Remove the
coloured plastic liner from the
gel and dispose of it.
STEP THREE: Apply the sticky
gel on the device and then
remove the clear plastic liner.
STEP FOUR: Place the device
on your forehead 1cm above
the eyebrows.

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STEP FIVE: Press and hold the
power button for 3 seconds to
switch the device on.
STEP SIX: To change the
programme, press and
release the power button.
STEP SEVEN: Regulate the
output intensity with the
increase and decrease
buttons.
STEP EIGHT: After use re-apply
the clear plastic liner to the
gel pads and store the device
in the travel case.

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Contents
1. INTENDED USE .......................................................................................6
2. CONTRAINDICATIONS, WARNINGS & CAUTIONS.............................6
3. PROGRAMMES .....................................................................................9
3.1. PROGRAMME SETTINGS ...........................................................9
3.2. GEL PAD ADVICE......................................................................9
4. CONTENT............................................................................................ 10
5. UNIT INFORMATION ........................................................................... 10
5.1. CONTROLS.............................................................................. 10
5.2. OPERATING INSTRUCTIONS ................................................... 11
6. SETTING UP AND USING QALM ........................................................ 12
6.1. CHARGING THE BATTERY ...................................................... 12
6.2. PREPARING FOR SESSION ..................................................... 14
6.3. TREATMENT SESSION .............................................................. 15
6.4. AFTER YOUR TREATMENT SESSION ........................................ 16
7. CLEANING & STORAGE .................................................................... 16
8. EMC .................................................................................................... 16
9. DISPOSAL OF WASTE ELECTRICAL AND ELECTRONIC PRODUCTS
(WEEE)............................................................................................................ 17
10. ACCESSORIES .............................................................................. 17
11. WARRANTY................................................................................... 18
12. TROUBLESHOOTING..................................................................... 19
13. GENERAL SPECIFICATION ........................................................... 20

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SYMBOLS USED
Attention! Please follow the instructions in the user’s instructions
for use.
TYPE BF EQUIPMENT: Equipment providing a degree of protection
against electric shock, with isolated applied part. Indicates that
this device has conductive contact with the end user.
This symbol on the unit means “Refer to instructions for use”.
Temperature Limitation: indicates the temperature limits to which
the medical device can be safely exposed.
Lot Number: indicates the manufacturer’s batch code so that
the batch or lot can be identified.
Humidity Limitation: indicates the humidity limits to which the
medical device can be safely exposed.
Serial Number: indicates the manufacturer’s serial number so
that a specific medical device can be identified.
Do not dispose in household waste.
Catalogue Number: indicates the manufacturer’s catalogue
number so that the device can be identified.
Atmospheric Pressure: indicates the atmospheric limits to which
the medical device can be safely exposed.
Manufacturer Symbol

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Date of Manufacture: indicates the date which the medical
device was manufactured. This is included within the serial
number found on the travel case, either as “E/Year/Number”
(YY/123456) or “E/Month/Year/Number” (MM/YY/123456).
CE Mark
This medical device is indicated for home use.
This medical device is not water resistant and should be
protected from liquids.
The first number 2: Protected against access to hazardous parts
with a finger, and the jointed test finger of 12 mm ø, 80 mm
length, shall have adequate clearance from hazardous parts,
and protected against solid foreign objects of 12.5 mm ø and
greater.
The second number 2: Protected against vertically falling water
drops when enclosure is tilted up to 15˚. Vertically falling drops
shall have no harmful effects when the enclosure is tilted at any
angle up to 15˚ on either side of the vertical.
Notes are used to provide clarification or
recommendation.
A Warning is used when failure to follow the instructions
may result in serious injury or death.
A Caution is used when failure to follow the instructions
may result in a minor or moderate injury, or damage to
the device or other property.
A Contraindication is used when a device should not be
used because the risk of use clearly outweighs any
foreseeable benefits and may result in serious injury or
death.
IP22
0197

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1. INTENDED USE
QALM is a medical
device designed to be
used in the home
healthcare environment for the
treatment and prevention of
frequent episodic and chronic
migraine headaches.
It is suitable for use by all who
can control the device and
understand the instructions.
It may be used by a child from
the age of 8 if supervised by an
adult, but there is currently no
evidence of effectiveness for
users under the age of 18.
Do not use the device for any
purpose other than this intended
use.
2. CONTRAINDICATIONS,
WARNINGS &
CAUTIONS
CONTRAINDICATIONS:
Do not use if you have
unresolved brain or
facial injuries.
Do not use QALM on
any other areas apart
from the forehead. Use on the
chest or neck may affect heart
or implanted devices and may
affect epileptic seizure
threshold. May also affect body
worn monitoring devices.
Do NOT use if you have,
in the area being
treated: active or suspected
cancer or undiagnosed pain
with a history of cancer.
Stimulation directly through a
confirmed or suspected
malignancy should be avoided
as it may stimulate growth and
promote spread of cancer cells.
WARNINGS:
After a QALM session,
wait an hour before
undertaking an activity
that requires concentration.

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You may experience drowsiness
or lack of concentration.
Do not place electrode
pads on broken skin.
The electrode pads
could encourage infection.
Do not use QALM in
close proximity (less
than 1 meter) to short
wave or microwave therapy
equipment as it may produce
instability in QALM output.
It can be dangerous to
connect QALM with
devices not described
in this user manual.
WARNING: Do not
modify this equipment
without authorization of
the manufacturer.
CAUTIONS:
Do not ignore any
allergic reaction to the
electrode pads: If a skin
irritation develops, stop
using QALM, as a small number
of users may have an adverse
reaction to the gel
Trigeminal neuralgia
and Ophthalmic
shingles make facial
nerves hypersensitive, so use of
QALM could be painful.
Caution should be used
if you have a bleeding
disorder as stimulation
may increase blood flow to the
stimulated region.
Strong electromagnetic
fields (electro-surgery/
microwave cookers/
mobile phones) may affect the
correct operation of this unit. If it
appears to behave unusually,
move it away from these
devices.
SIDE EFFECTS
Discomfort during
treatment: A small
portion of users may
find the stimulation to be very
uncomfortable. This feeling
usually goes away as you
become used to it. However, for
some patients this discomfort
remains. If so the patient should
reduce the intesity.
Headache after
Programme 2: Very
rarely you may
experience a headache after
using Programme 2. This is short-
lived but may make use of

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Programme 2 difficult for some
users.
Neck pain: At the start
of treatment you may
tense your neck
muscles when you are using
QALM, and this can lead to an
aching neck. If this happens, try
resting your head on a pillow
during treatment.
Note: Electrode pads
supplied have no
measurable latex
content.
TO KEEP YOUR DEVICE IN GOOD
WORKING ORDER, OBSERVE THE
FOLLOWING ADDITIONAL
CAUTIONS:
Caution: Do not
immerse your device in
water or place it close
to excessive heat such as a
fireplace or radiant heater or
sources of high humidity such as
a nebulizer or kettle as this may
cause it to cease to operate
correctly.
Caution: Keep the
device away from
sunlight, as long-term
exposure to sunlight may affect
the rubber causing it to become
less elastic and crack.
Caution: Keep the
device away from lint
and dust, as long-term
exposure to lint or dust may
affect the socket
Caution: Temperature
& Relative Humidity of
storage: -10°C to +60°C,
15% to 75% R.H. Temperature &
Relative Humidity of
transportation: -10°C to +60°C,
15% to 75% R.H.
Caution: Do not
attempt to open or
modify the device. This
may affect the safe operation of
the unit and will invalidate the
warranty.

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3. PROGRAMMES
3.1. PROGRAMME
SETTINGS
Programme 1 is designed to
treat migraine attacks and has a
duration of 60 minutes. It should
be applied when the migraine is
already present or, preferably,
when the first signs of the next
migraine attack are felt.
Note: Some migraine
patients develop
Allodynia with their
migraine attacks. This makes any
skin stimulation, including QALM,
feel painful.
Programme 2 is designed to
prevent migraines and will last
for 20 minutes. This programme
should be used once a day.
Regular use helps to reduce the
frequency of migraine attacks.
3.2. GEL PAD ADVICE
•Gel pads are reusable but for
single patient use.
•In order to get the best
conductivity through the gel
pads, always make sure they
are in good condition and
sticky.
•Make sure you clean the
forehead before use.
•After use, always replace the
clear plastic liner on top of
the gel pads on the device.
Keep the device and gel
pads in the travel case.
•Replace the gel pads when
they lose their adhesion.
Programme 2 - Prevention
Maximum
intensity
17 mA
Pulse frequency
55 Hz
Pulse width
200 μs
Pulse duration
200 μs
Session
duration
20 minutes
Programme 1 - Treatment
Maximum
intensity
17 mA
Pulse frequency
110 Hz
Pulse width
200 μs
Pulse duration
200 μs
Session
duration
60 minutes

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•A bad connection can
cause discomfort and
irritation of the skin.
•The shelf life of an unopened
packet of gel pads is 2 years.
This can be affected by very
high temperatures or very
low humidity.
4. CONTENT
The pack contains:
1 x QALM unit
3 x Reusable gel pads
1 x Headband
1 x Charging cable
1 x Travel case
1 x Mirror
1 x Instruction manual
5. UNIT INFORMATION
5.1. CONTROLS
ON/OFF
PROGRAMME SELECTOR
INTENSITY DOWN
INTENSITY UP
INTENSITY LEDS

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5.2. OPERATING
INSTRUCTIONS
ON/OFF
To turn the unit ON,
press the ON/OFF button of the
unit and hold for 3 seconds. You
will hear a long beep and the
white LED lights will switch on.
The unit will turn OFF
automatically when the session
is complete (60 minutes in
programme 1 and 20 minutes in
programme 2). A long beep will
indicate the end of the session
and the device switching off.
If you wish to manually turn the
unit OFF, press and hold the
ON/OFF button for 3 seconds.
You will hear a long beep (1
second) and the white LEDs light
will switch off.
Note: Always check unit
is OFF before applying
or removing the QALM
device from the forehead.
Note: Always clean the
forehead before using
the device.
PROGRAMME CONTROL
The ON/OFF button is also the
programme select button.
QALM has two pre-set
programmes.
Every time the unit is switched
on, the programme 1 is
automatically selected. If you
wish to change to programme 2
press and release the ON/OFF
button. Programme 2 selection
will be indicated by two short
beeps.
To change back to programme
1, press and release the ON/OFF
button. A single beep will
indicate programme 1 has been
selected.
Every time a new programme is
selected, the strength level is
reverted to zero. This is a safety
feature to alleviate any sudden
feeling of a surge, as each
programme gives a different
sensation.
STRENGTH CONTROLS
The buttons marked ˄, ˅are the
strength controls.
To increase the intensity in steps
of 0.5 mA press and release the
˄button. To increase

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automatically, press and hold
the ˄button (fast increase in
steps of 0.5 mA). To decrease
the intensity in steps of 0.5 mA
press and release the ˅button.
To decrease automatically,
press and hold the ˅button (fast
decrease in steps of 0.5 mA).
A short beep will be heard with
each press of the strength
controls.
When using the strength
controls, reaching maximum or
minimum intensity will be
indicated by three quick beeps.
You may feel nothing over the
first few stages of increase.
Continue pressing until the
sensation is strong but
comfortable. Further increases
during use may be necessary if
your body becomes used to the
sensation. Note that the
maximum intensity of 17mA is
sufficient to have a therapeutic
effect, even if you feel like this
intensity has become tolerated.
INTENSITY LEDS
The unit has 34 levels of strength.
The strength level will be
indicated by the three LEDs on
the bottom of the device. Each
LED gets brighter as the intensity
increases. The minimum and
maximum intensities are as
follows:
Minimum intensity –one dim LED
Maximum intensity –three bright
LEDS
6. SETTING UP AND
USING QALM
6.1. CHARGING THE
BATTERY
QALM is powered by a built-in
rechargeable Li-ion battery. A
separate charging cable with
universal USB plug is included in
the kit.
When the battery is low, the
central LED will flash white. This
would start about 4 hours before
the battery is empty (4 hours on
stand-by).
Warning: Use only the
charging cable
supplied. Use of other
chargers could be hazardous
and will negate the warranty.

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To charge the battery:
Connect the USB cable to a
mobile phone or tablet
charging socket or PC USB port.
Whilst the battery is charging,
the central LED light will flash
white slowly and repeatedly.
The device will take
approximately 2-2.5 hours to
charge.
When the battery is fully
charged, the white LED light will
stop flashing and remain turned
on.
Note: To minimise the
reduction in battery
capacity the device
should be recharged yearly,
regardless of usage.
Battery Life
The battery life will last
approximately 30 hours.
Battery Warnings
This product is equipped with a
Lithium-ion battery. Battery is
fixed inside the device and so
device warnings also apply to
the battery. Failure to follow
these instructions could cause
the lithium-ion battery to leak
acid, become hot, explode or
ignite and cause injury and /or
damage.
Do not pierce, open,
disassemble or use in a
humid and / or
corrosive environment.
Do not expose to
temperatures above 60
° C (140F).
Do not put, store or
leave near heat
sources, in direct
sunlight, in a high temperature
location, in a pressurized
container or in a microwave
oven.
Do not immerse in
water or seawater and
do not apply to wet
skin.
Do not short circuit.
If battery leakage occurs and
comes in contact with the skin or
eyes, wash thoroughly with lots
of water.
Disposal: Always dispose of
batteries responsibly according
to local government guidelines.
Do not throw batteries onto a
fire. Risk of explosion.

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6.2. PREPARING FOR
SESSION
1) Before use ensure to clean
your skin with a damp cloth and
soapy water. Leaving your
forehead slightly damp may
allow for better adhesion and
stimulation from the device.
Note: Do not use make-up
removal products to clean
your forehead as these
leave a greasy film on the skin.
2) For first use, remove one of the
gel pads from its foil packaging.
3) Remove the yellow plastic
liner from the gel pads and
apply to the rear of the QALM
device.
4) Remove the clear plastic liner
from the rear of the device. Be
careful to ensure the gel pads
remain stuck to the device.
5) Place the clear plastic liner
back in the travel case. The
yellow liner can be disposed of.
6) Place the device in the centre
of your forehead, roughly 1 cm
above the eyebrows.

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The gel pads are reusable.
However, over time they will
become less adhesive. When
this happens remove the gel
pads currently on the device
and apply new gel pad.
A fabric headband is included
with your QALM device. This is
provided for your convenience
and can be used to help keep
the device held firmly in place,
but its use is optional.
Note: The number of
applications for each
gel pad will vary
depending on the user’s skin
condition.
Note: Gel pads are for
single patient use.
Warning: Ensure that
QALM is switched OFF
before applying and
removing the device.
6.3. TREATMENT SESSION
1) Press and hold the ON/OFF
button on the device for 3
seconds to switch the unit on.
2) Select the desired
programme. Programme 1 will
always be the default
programme once powering on
the device. If you wish to
change to programme 2 press
and release the ON/OFF button.
You will hear two short beeps.
3) To increase the intensity in
steps of 0.5 mA press and
release the ˄button. To increase
automatically, press and hold
the ˄button (fast increase in
steps of 0.5 mA).
Note: If the sensation is
uncomfortable, reduce
the intensity.

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6.4. AFTER YOUR
TREATMENT SESSION
The unit will turn off
automatically when treatment
session is complete.
1) To check that the unit is
OFF, use the mirror
provided and ensure the
white LED light is switched
off. If it is not, hold down
the ON/OFF button to
switch off. Remove the
device from your forehead
by gently peeling the
device by the outer edges.
2) Re-apply the clear plastic
liner on the gel pads and
store the device in the
travel case. This will help
retain the stickiness of the
gel.
When not being used, the
device must ALWAYS be kept in
the travel case.
7. CLEANING &
STORAGE
Clean the device at least once
a week by wiping with a damp
cloth and a solution of mild soap
and water. Be careful to avoid
contact with silver electrodes.
Wipe dry.
•Do not immerse your QALM
device in water.
•Do not use any other
cleaning solution other than
soap and water.
Storage life
•Storage life of an unopened
pack of self-adhesive gel
pads is 2 years. This may be
affected by very high
temperatures or very low
humidity.
•The unit has no fixed shelf
life.
8. EMC
Wireless communications
equipment such as wireless
home network devices, mobile

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phones, cordless telephones
and their base stations, walkie-
talkies can affect this equipment
and should be used no closer
than 30cm (12 inches) to any
part of the device.
(Note. As indicated in 5.2.1.1(f)
of IEC 60601-1-2:2014 for ME
EQUIPMENT).
Note: For hospital use,
full EMC advice tables
are available on
request.
9. DISPOSAL OF
WASTE ELECTRICAL
AND ELECTRONIC
PRODUCTS (WEEE)
One of the provisions of the
European Directive 2012/19/EU
is that anything electrical or
electronic should not be treated
as domestic waste and simply
thrown away. To remind you of
this Directive all affected
products are now being marked
with a crossed-out wheelie bin
symbol, as depicted below.
To comply with the Directive,
you can return your old Qalm
unit for disposal (postage not
covered). Please return in an
envelope or padded bag with
the unit enclosed to Tower
Health, Unit 24 Wilford Business
and Industrial Park, Ruddington
Lane, Nottingham, NG11 7EP.
10. ACCESSORIES
Expected Service Life
•The machine will often last
for more than 5 years but is
warrantied for 2 years.
Accessories (charging
cable, gel pads, travel
case, headband and
mirror) are not covered by
the warranty.
•The number of applications
for each gel pad will vary
depending on the user’s skin
condition and humidity.
Replacement electrode pads
and charging lead are

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available from your supplier or
distributor (see back cover for
contact details).
Replacement electrode pads
and charging lead are
available from our UK distributor
Tower Health, by telephone
using a credit or debit card, or
through the Tower Health
website. Replacement parts
may be ordered from Tower
Health at www.tower-
health.co.uk or 0800 953 1666.
11. WARRANTY
This warranty refers to the unit
only. It does not cover, gel pads,
charging cable, travel case,
headband or mirror.
PRODUCT WARRANTY
INFORMATION
This product is warranted to be
free from manufacturing
defects for 2 years from date of
purchase.
This warranty is void if the
product is modified or altered, is
subject to misuse or abuse;
damaged in transit; lack of
responsible care; is dropped; if
the unit has been immersed in
water; if damage occurs by
reason of failure to follow the
written instructions for use
booklet enclosed; or if product
repairs are carried out without
authority from TensCare Ltd.
Our goods come with warranties
that cannot be excluded under
the UK consumer Law. You are
entitled to have the goods
repaired or replaced if the
goods fail to be of acceptable
quality.

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12. TROUBLESHOOTING
If your QALM device is not working properly, please check the following:
Problem
Possible causes
Solution
The white LEDs
do not turn on
Flat battery.
Charge battery. See section
6.1.
No sensation
Intensity is not strong
enough.
Increase strength.
Sudden change
in sensation
If you disconnect and re-
connect a few minutes
later, the signal should feel
a lot stronger.
Always return strength to zero
or turn the device off before
removing the device from the
forehead.
If the above review has failed to resolve your problem, or to report
unexpected operation or events or provide feedback call our UK
distributor, Tower Health, for advice.
Contact Tower Health customer service on 0800 953 1666. Staff are
trained to assist you with most issues you may have experienced, without
the need to send your product in for service.