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