Introduction; Intended Use - TensCare Sure+ Instrucciones De Uso

1. INTRODUCTION

Device Description & Principles of
Design
Bladder leakage and incontinence are
common problems for both women and
men, affecting their long-term health.
Exercising the pelvic floor muscles is
recognised as the way of preventing
and treating symptoms of incontinence
and pelvic floor weakness.
The Sure+ is a powered muscle
stimulator used for strengthening the
pelvic floor muscles.
It sends a gentle stimulation (similar to
your natural nerve impulses) direct to
your pelvic floor muscles through a
vaginal probe with stainless steel
electrodes. These signals make your
pelvic floor muscles contract. If you
have forgotten how to contract them,
are having trouble getting muscle
response, or simply want to bring back
the condition of your pelvic floor
muscles, the Sure+ can work them for
you to build up their strength and help
you to develop your own muscle
control. It perfectly complements pelvic
floor exercises.
Additionally, the Sure+ offers drug-free
relief from period pain.
Period Pain (Dysmenorrhoea) is a
widespread problem which affects 40-
90% of women. Period pain can have a
real impact on quality of life, leading to
absences from work and school.
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 Sure+ provides
conditions such as:
• Urinary and faecal incontinence:
including stress, urge and mixed
types as well as post prostatectomy
urinary incontinence
Additionally, it may help improve
sexual intimacy by toning the pelvic
floor muscles.
• Period pain: primary menstrual pain
(dysmenorrhoea)
menstrual pain due to conditions
such as endometriosis, fibroids or
pelvic inflammatory disease.

2. INTENDED USE

Sure+ is a medical device
designed to be used in the
home healthcare environment
to treat symptoms of urinary and/or
faecal incontinence
symptoms of primary menstrual pain
(dysmenorrhoea); and is suitable for
use by all who can control the device
and understand the instructions.
The Sure+ 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 intended use.
Warning: Not suitable for use
in children without medical
supervision.
6
relief from
in men.
and secondary
as well as