TensCare mynd User manual

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Dear Customer,
Thank you for choosing Mynd. TensCare
stands for high-quality, thoroughly tested
products for the applications in the areas
of gentle electrotherapy, muscle toning,
continence management and pain relief
during labour.
Please read these instructions for use
carefully and keep them for later use, be
sure to make them accessible to other
users and observe the information they
contain.
Best regards,
Your TensCare Team

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CONTENTS
1. INTENDED USE ................................. 5
2. CONTRAINDICATIONS, WARNINGS
& CAUTIONS............................................... 5
3. PROGRAMMES ............................. 12
3.1. PROGRAMME SETTINGS............... 12
3.2. GEL PAD ADVICE ......................... 13
4. CONTENT....................................... 14
5. UNIT INFORMATION ...................... 14
5.1. CONTROLS .................................... 14
5.2. OPERATING INSTRUCTIONS ......... 15
6. SETTING UP AND USING MYND ... 17
6.1. CHARGING THE BATTERY............. 17
6.2. PREPARING FOR SESSION ............ 20
6.3. TREATMENT SESSION..................... 23
6.4. AFTER YOUR TREATMENT SESSION23
7. CLEANING & STORAGE ............... 24
8. EMC ............................................... 24
9. DISPOSAL OF WASTE ELECTRICAL
AND ELECTRONIC PRODUCTS (WEEE)... 25
10. ACCESSORIES ............................... 26
11. WARRANTY.................................... 27
12. TROUBLESHOOTING ..................... 29
13. GENERAL SPECIFICATION............ 31

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SYMBOLS USED
TYPE BF APPLIED PART: 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.
Medical Device

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Manufacturer Symbol
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
Importer symbol
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.

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1. INTENDED USE
MYND 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. There is currently no
evidence of effectiveness for users under
the age of 18.
2. CONTRAINDICATIONS,
WARNINGS & CAUTIONS
In this manual:
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.
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.

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Notes are used to provide
clarification or recommendation.
CONTRAINDICATIONS:
Do not use if you have unresolved brain
or facial injuries.
Do not use MYND 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 MYND if you have a cardiac
pacemaker, implanted defibrillator, or
other implanted metallic or electronic
device. Such use could cause electric
shock, burns, electrical interference, or
death.
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 MYND session, wait an hour before
undertaking an activity that requires
concentration. You may experience
drowsiness or lack of concentration.

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Do not place electrode pads on broken
skin. The electrode pads could
encourage infection.
Do not use MYND in close proximity (less
than 1 meter) to short wave or
microwave therapy equipment as it may
produce instability in MYND output.
It can be dangerous to connect MYND
with devices not described in this user
manual.
Keep away from children under 5 years of
age. Long charging cable - risk of
strangulation in infants.
Do not use simultaneously with high
frequency hospital
diagnostic/therapeutic equipment.
Doing so may result in burns at the site of
the electrodes and possible damage to
device.
Stimulation should not be applied directly
on the eyes, covering the mouth, on the
front of the neck (especially the carotid
sinus), or from electrodes placed on the
upper back or crossing over the heart.
Do not apply stimulation across your
chest because the introduction of
electrical current into the chest may
cause rhythm disturbances to your heart,
which could be lethal.
This device is only used for forehead
surface skin. Do not use the device for
any purpose other than this intended use.

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CAUTIONS:
Do not ignore any allergic reaction to the
electrode pads: If a skin irritation
develops, stop using MYND, 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 MYND could be
painful.
Caution should be used if you have a
bleeding disorder as stimulation may
increase blood flow to the stimulated
region.
Not intended for use in an oxygen rich
environment.
Not intended for use in conjunction with
flammable anaesthetics or flammable
agents.
The patient is an intended operator and
should control the device.
Do not service and maintain the device
while in use with a patient.
Changing the gel is the only
maintenance the patient should perform.
Maintenance and all repairs should only
be carried out by an authorized agency.
The manufacturer will not be held
responsible for the results of maintenance
or repairs by unauthorized persons.

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If necessary, we will provide circuit
diagrams, component part lists or other
information that will assist authorized
service personnel to repair the device.
Degraded gel pads can negatively
impact performance or cause other
problems.
SIDE EFFECTS
•Intolerance to the paresthesia
caused by electrical stimulation
•Intolerance to the sensation of
pressure on the forehead, dental
pain, cervical pains and tension-
type headache during the session
•Arousal and sleep changes
•Vomiting and nausea at the end of
stimulation
•Increased tinnitus during the session
•Mild pain over one eyebrow,
numbness at the back of the head,
feeling of abrupt electrical
variation.
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 intensity (see section
‘5.2 Operating Instructions’ for instructions
on how to reduce the intensity).
Headache after Programme 2:
Very rarely you may experience
a headache after using

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Programme 2. This is short-lived but may
make use of Programme 2 difficult for
some users. Note there are currently no
reports to suggest use of Programme 1
can result in the user experiencing
headaches. However, if any discomfort
occurs, user should consider the advice
listed below regarding side effects.
Neck pain: At the start of
treatment you may tense your
neck muscles when you are
using MYND, 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.
IF ANY OF THE SIDE EFFECTS BECOME
UNACCEPTABLE, PLEASE STOP USING THE
DEVICE IMMEDIATELY.
IF SIDE EFFECTS CONTINUE AFTER YOU
HAVE STOPPED USING THE DEVICE, PLEASE
CONSULT A HEALTHCARE PROFESSIONAL.
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

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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. Keep out of
the reach of children pets and pests.
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: There are no user serviceable
parts. Do not attempt to open or modify
the device. This may affect the safe
operation of the unit and will invalidate
the warranty.
Caution: Silicone and backside gels on
the surface of the device may come into
contact with the patient or operator. If
allergic to these materials, avoid contact
and discontinue use.

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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 MYND, feel
painful.
Programme 1 - Treatment
Maximum intensity
(across a load
resistance of 500 Ω)
20 mA (Peak)
Pulse frequency
110 Hz
Pulse width
200 μs
Pulse duration
200 μs
Session duration
60 minutes
Programme 2 - Prevention
Maximum intensity
(across a load
resistance of 500 Ω)
20 mA (Peak)
Pulse frequency
55 Hz
Pulse width
200 μs
Pulse duration
200 μs
Session duration
20 minutes

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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.
•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.

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4. CONTENT
The pack contains:
1 x MYND unit
3 x Reusable gel pads
1 x Headband
1 x Charging cable
1 x Travel case
1 x Mirror
1 x Instruction manual
1 x Quickstart guide
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 1 second. 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, the intensity will
gradually decrease and the device
switches 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
MYND 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. MYND has two
pre-set programmes.

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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 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.

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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 20mA is sufficient to
have a therapeutic effect, even if you
feel like this intensity has become
tolerated.
INTENSITY LEDS
The unit has 40 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
LEDs will automatically turn off after no
buttons have been pressed for 3 seconds.
6. SETTING UP AND USING
MYND
6.1. CHARGING THE BATTERY
MYND is powered by a built-in
rechargeable Li-ion battery. A separate

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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.
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.
Note: The device cannot be
used while being charged.
Note: Charging voltage: DC 5V,
charging current: 60mA.

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Battery Life
The battery life will last approximately 22
hours in normal use at 50% of the
maximum output.
Battery life at 100% output intensity is
approximately 18 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 and
immediately seek medical attention.