TensCare OVA+ Instructions For Use Manual

Distributed by:

Period PainReliever

TensCare Ltd, PainAway House,
9 Blenheim Road, Longmead Business Park,
Epsom, Surrey KT19 9BE, UK

Tel: [phone]

www.tenscare.co.uk [e-mail]

Pub Ref.: I-OVAP-UK Rev 3.0 01/17

INSTRUCTIONS FOR USE

READ CAREFULLY BEFORE STARTING USE

CONTENTS

Introduction
Intended Use
Period Pain

Advantages of “Ova+”

How itWorks
Contraindications, Cautions &Warnings
Pain Relief programmes
Battery
Controls and Display
Contents of Pack
SettingUp and Using the “Ova+”
Placement ofPads
Application ofPads
Cleaning
Accessories
Disposal
EMCPrecautions
TechnicalSpecifications
Troubleshooting
Warranty

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QUICK STARTGUIDE

Connect the main unit

with electrodes using

the Y-cable

Place two electrodes on each

side of your lower tummy,

distance between the

electrodes should be over 3cm

Turn on the device by

pressing and holding

the “ “ button for 3

seconds

Select the programme

which works best for you

by pressing and holding

the “programmeME

SELECTOR” button

Regulate the output

intensity by pressing the

“ ”, or “ ” buttons

Keep pressing and

holding the “ ” button

for 3 seconds to turn

off the device

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2. INTENDED USE

This device has been designed to be
used in the home healthcare
environment to treat symptoms of

primary menstrual pain

(dysmenorrhoea).

The “Ova+" may also help to relieve the
pain of secondary menstrual pain due to
conditions such as endometriosis, fibroids
or pelvic inflammatory disease.

Do not use the device for any purpose
other than this intendeduse.

1. INTRODUCTION

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Period Pain (Dysmenorrhoea) is a
widespread problem which affects 40­90% of women. Period pain can have a
real impact on quality of life, leading to
absences from work and school.

The “Ova +” Period Pain Reliever offers

drug-free relief from period pain. If you
are unsure of the cause of the pain then
you should seek medical advice to
establish the cause and identify the
correct treatment.

The “Ova+” is a non-invasive small and
convenient unit that can be worn all day
under clothing to provide safe,
continuous, drug-free period pain relief
whilst maintaining a normal, active

lifestyle.

Painful periods are common in teenagers
and young adults.

Most women have some pain during
periods. The pain is often mild but, in about
5 in 10 women, the pain is severe enough to
affect day-to-day activities. The pain can be
so severe that they are unable to go to
school or work.

Period pain generally falls into two
categories: primary dysmenorrhea and

secondary dysmenorrhea.

Primary dysmenorrhoea has no specific

cause yet is the most common type of

painful periods affecting 9 out of 10 women.

It occurs where there is no underlying
problem of the womb (uterus) or pelvis. The
main symptom is a cramping type of pain in
the lower tummy (abdomen); it may in some
cases spread to the lower back, or to the top
of the legs. Pains are generally worst in the

first few years after starting your period, with

symptoms tending to improve with age or
after childbirth.

Secondary dysmenorrhoea is less common,
and is more likely to occur in women in their
30s and 40s. It is caused by a specific

underlying condition such as endometriosis
(when cells that normally line the uterus are

found at other sites in the body – usually the

ovaries and fallopian tubes). Again, the main

symptom is cramping pain in the lower tummy
during your periods. In some women with
secondary dysmenorrhoea the pain starts
several days before the period begins, and
lasts all the way through the period. (This is

uncommon with primary dysmenorrhoea). With

secondary dysmenorrhoea it is likely to have
other symptoms - forexample:

• Irregular periods.

• Bleeding between periods.

• Pains between periods.

• The bleeding becomes heavier than

previously.

• Vaginal discharge.

• Pain during sex.

• Pain in your backpassage(rectum).

Secondary dysmenorrhoea may occur as a

result of:

• Endometriosis/adenomyosis.

• Pelvic inflammatory disease.

3. PERIOD PAIN

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5. HOW IT WORKS

The “Ova+” can be an option for women
who prefer not to usemedication.

The “Ova+” causes muscles in the uterine

area to relax with a calming analgesic
effect.

By reducing menstrual pain, the “Ova+” can
help improve sense of wellbeing and allows
everyday activity to resumewhile it is worn.

The “Ova+” is non-invasive and drug-free,
therefore the risk of side effects is
considered to be low, and can be worn
comfortably while engaging in everyday
activities.

The “Ova+” is easy to useand very discreet.
Its small size makesit convenientto wear all

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4. ADVANTAGES OF “OVA+”

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day and this allows you to get on with your

everyday life, without period pain.

The “Ova+” uses T.E.N.S. to relieve pain.
T.E.N.S. stands for Transcutaneous
Electrical Nerve Stimulation. The “Ova+”
machine delivers small electrical pulses to

the body via electrode patches placed on

the lower abdomen. It works in three ways:

- It blocks pain signals from reaching the
brain through a mechanism called the
‘Pain Gate’.

- It stimulates the natural production of

endorphins which raise the thresholdfor

painperception.

- Finally, it helps to relax the contracted
muscles.

It is important to allow the “Ova+” time to

work. Each time a new programme or

position for the pads is selected allow the
“Ova+” to run for thirty minutes. If after that
time the relief is not sufficient, then try
another programme or pad position. Evenif
you obtain excellent relief it is still useful to
try othersettings.

• Fibroids when it is often associated

with heavy menstrual bleeding.

• Adhesions.

• Developmental abnormalities.

Consult your healthcare professional if you
are experiencing any of the above
symptoms.

6. CONTRAINDICATIONS, CAUTIONS & WARNINGS

Do NOT use if you are or may be pregnant;

or in the first 6-8 weeks after childbirth. It is
not known whether TENS may affect
foetal development.

WARNINGS:

Do NOT use when driving, operating

machinery, or similar actions needing
muscular control. Loose pads, damaged

leads, or sudden changes in contact may
cause brief involuntary muscle
movements.

Do NOT use to mask or relieve

undiagnosed pain. This may delay

diagnosis of a progressivecondition.

Do NOT use if you have poor sensation in
the pelvic region. You may not be able to

control the intensity of stimulation safely.

Do NOT use if you have, in the area
being treated: active or suspected cancer;
or have 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.

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In this manual:

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.

CONTRAINDICATIONS:

Do NOT use if you have a pacemaker (or

you have a heart rhythm problem) or with
any electronic medical devices. Using this

unit with electronic medical devices may
cause erroneous operation of the device.

Stimulation in the direct vicinity of an

implanted device may affect some models.
Stimulation on the front of the neck can
affect your heart rate. Very strong
stimulation across the chest may cause an
extra heartbeat.

CAUTIONS:

Caution should be used if you have

suspected or diagnosed epilepsy as
electrical stimulation may affect seizure
threshold.

Caution should be observed when using
the “Ova+” at the same time as being

connected to monitoring equipment with

body worn electrode pads. It may interfere
with the signals being monitored.

Caution should be used following recent
surgical procedures. Stimulation may
disrupt the healing process.

Caution. Simultaneous connection to high
frequency surgical equipment may result in
burns and damage to the stimulator.

Caution. 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.

Caution. Do not permit use by children
unable to understand the instructions or
persons with cognitive disabilities, i.e.;
Alzheimer’s disease or dementia.

DO NOT PLACE ELECTRODE PADS:

• On skin which does not have normal

sensation. If the skin is numb too great a

strength may be used, which could result in

skin inflammation.

• On broken skin. The pads could

encourage infection.

• On the front of the neck. This could

cause the airway to close, giving

breathing problems. May cause sudden

drop in blood pressure (vasovagal
response).

• Over the eyes. May affect eyesight or

cause headaches.

• Across the front of the head. Effect on

patients who have had strokes or seizures

is not known. May affect your sense
of balance. The effects of stimulation of
the brain are unknown.

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