TensCare Sure PRO, Instructions For Use Manual, Page: 14 / 44

13
Caution Do not permit use by
persons unable to understand
the instructions or persons with
cognitive disabilities, i.e.; Alzheimer’s
disease or dementia.
Caution: Insertion of the
vaginal or anal electrode
makes it unsuitable for use in children
without clinical supervision
Caution: Keep away from
children under 5 years of age.
Long cord - risk of strangulation in
infants .
Caution should be observed
when using the Sure PRO at
high strength settings. Prolonged use at
high settings may cause muscle injury
or tissue inflammation.
Note: No serious or long term
adverse effects have been
reported. Mild adverse reactions are
very rarely reported, but these have
included muscular pain and cramps,
vaginal
tenderness, irritation and
bleeding, mild or short term urge or
faecal
incontinence, and tingling
sensation in legs. If you experience any
of these, stop use. When symptoms
have gone, try resuming at a lower
intensity setting.
PROBE CAUTIONS:
Caution: The Sure PRO
vaginal probe is intended for
single patient use only. Do not share
your
Sure PRO probe with anyone else.
Improper treatment or cross-infection
may occur.
Caution: This probe is
intended for single orifice use
only (intra-vaginal or intra-anal use).
Improper treatment or cross-infection
may occur.
Caution: It is important that the
vaginal probe is cleaned after
each use. Ineffective cleaning may lead
to irritation or infection.
Caution: Never insert or
remove vaginal probe unless
the control unit is powered OFF as
insertion or removal when stimulation is
active may cause discomfort or tissue
irritation.
Caution: If tissue irritation
occurs, discontinue treatment
immediately. Ask your healthcare
professional for advice before
continuing further treatment to prevent
injury.
Caution: Do not use a silicone
based lubricant on the metal
plates of the probe as it may decrease
the effectiveness of
Sure PRO
’s
muscle stimulation.
Caution: The stainless steel in
the probe’s metal plates contain
some Nickel. This could cause a
reaction if you have a Nickel allergy.
Alternative gold probe specially made
without Nickel is available (see X-VPG).
Use with caution if you have a
copper IUD. If discomfort
occurs, discontinue treatment
immediately and ask your healthcare
professional for advice.
There is a small
risk of stimulating the uterine wall if the
IUD is not correctly positioned.
Caution: Do not use this
device with vaginal probe, anal
probe or electrode pads other than
those
recommended by the
manufacturer in section 18. Electrodes
with smaller surface area may cause
tissue irritation.