Before You Start Using Innovo; Indications For Use, Contraindications, Warnings, Precautions And Adverse Reactions Indications, Contra-Indications & Precautions - Atlantic Therapeutics Innovo Instrucciones De Uso

BEFORE YOU START USING INNOVO

Important:
To ensure that you use this product safely and effectively, please follow the safety information provided in this
instruction for use. INNOVO
instructions for use, the Quick Start Guide and on the website - www.myinnovo.com
INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS,
PRECAUTIONS AND ADVERSE REACTIONS
INDICATION FOR USE:
The INNOVO is a transcutaneous electrical stimulator indicated for treatment of stress urinary incontinence in
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adult females. The INNOVO
CONTRA-INDICATIONS:
• Do not use if you have an electronic implant (e.g. cardiac pacemaker or defibrillator) or suffer from any other
heart problem.
• Do not use if you have any conductive intra-uterine devices (IUD/Coil) or metal implants in the abdominal or
pelvic area, including hip and lumbar spine.
• Do not use if you are pregnant. The safety of powered muscle stimulators for use during pregnancy has not
been established.
• Do not use in close proximity (e.g. 1 meter) to shortwave or microwave therapy equipment, as this may
produce instability in the controller's output.
• Do not use if wearing the device necessitates placement over areas at which drugs/medicines are
administered by injection (short term or long term) e.g. hormone treatment.
WARNINGS:
• For use by adults only.
• The long-term effects of chronic electronic stimulation are unknown.
• Simultaneous connection of a patient to high-frequency surgical equipment may result in burns at the site of
the electrodes and possible damage to the controller.
• The product must not be used with any other product which delivers electrical current to the body (e.g.
interferential or another muscle stimulator).
• Stimulation should not be applied across or through the head, directly on the eyes, covering the mouth, on
the front of the neck, (especially the carotid sinus), or from electrodes placed on or across the chest and the
upper back or crossing over the heart.
• Stimulation applied near the thorax may increase the risk of cardiac fibrillation (cardiac arrhythmias), due to
the introduction of electrical current into the heart.
• Do not use if you have cancer in the region of application of the device or in the pelvis, epilepsy or are under
medical supervision for cognitive dysfunction.
• Apply stimulation only to normal, intact, clean, healthy skin.
• Do not apply over areas of skin which lack normal sensation.
• Do not apply stimulation over open wounds or rashes, or over swollen, red, infected, or inflamed areas or
skin eruptions (e.g. phlebitis, thrombophlebitis, varicose veins), or areas that have underwent recent surgery.
• Avoid any recent scars, broken or inflamed skin, areas of infection or susceptibility to acne, thrombosis or
other vascular problems (e.g. varicose veins), or any parts of the body where feeling is limited.
• The product should not be used while sleeping.
• Do not apply stimulation while driving, operating machinery, cycling or during any activity involving exercise in
which electrical stimulation can put you at risk of injury.
• Do not apply stimulation when in or near water, including a bathtub, shower, hot tub or swimming pool.
• Do not apply stimulation in the presence of electronic monitoring equipment (e.g. cardiac monitors, ECG
alarms), which may not operate properly when the electrical stimulation controller is in use.
• Wireless communication equipment such as wireless home network devices, mobile phones, cordless
telephones, base stations and walkie-talkies of between 1W to 10W can affect this equipment and should be
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should only be set-up and operated according to the instructions laid out in this
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is indicated for prescription use only.
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