INDICATION FOR USE:
The
INNOVO®
is a transcutaneous electrical stimulator indicated for treatment of stress urinary incontinence in adult
females. The INNOVO
®
is indicated for prescription use only.
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. 1meter) 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:
• 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.
• 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.
• Do not use in close proximity to shortwave or microwave therapy equipment which may produce instability in the
stimulator output.
• 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
kept a distance of least 2.3 to 7.3 metres away from the controller.
• Use this controller only with the Shorts leads and accessories recommended by the manufacturer.
• For hygiene reasons the Shorts are for single person use. To prevent cross-infection and Shorts should not be
shared with other people.
• Always ensure that the charger/power supply is positioned so that it is easy to unplug the power supply from the
socket.
• To isolate this equipment from the mains, the charger/power supply plug should be removed from the socket.
• Do not attach any cables or connectors to INNOVO
®
, other than those supplied by Atlantic Therapeutics Ltd.
Never connect any computer leads to the controller.
• 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.
• Avoid areas of injury or restricted movement (e.g. fractures or sprains).
• Avoid placing the electrodes directly over metal implants.
• For use by adults only.
• Keep the product away from children due to the risk of strangulation, and the risk of small parts which may be
broken off and cause a choking hazard.
• For all users, including those with impaired sensory capabilities, the controller should not be handled at any time
during the charge cycle. If the charge cycle is terminated early, please do not handle the controller for at least 1
hour, as surfaces may be hot.
• Once the battery is fully charged, let the unit cool down for a couple of minutes as the battery heats up during
charging.
• Do not touch the electrodes, connectors or lead pins with your fingers while the stimulation session is in
progress
• The Shorts or treatment cable must not be connected to other objects.
• This product can deliver current densities in excess of 2mA/cm2 when used at a high intensity. The size, shape,
and type of electrodes may affect the safety and effectiveness of electrical stimulation.
• Do not touch the electrodes, connectors or lead pins with your fingers while the stimulation session is in
progress.
• You should only run one full treatment session per day to reduce the potential for muscle fatigue. An effective
treatment should not cause undue discomfort.
• Do not place your hand(s) inside the shorts while the stimulation session is in progress.
PRECAUTIONS:
• Although compliant with applicable EMC requirements, this device may still interfere with more sensitive
equipment, please move away or switch off.
• It is advised that you empty your bladder before starting a treatment session.
• Always check the product leads before use and do not use if they are damaged in any way.
• Caution should be used over the menstruating uterus.
• Keep this device out of the reach of pets, pests and Children.
Please wait before using your INNOVO
®
until:
• At least six months after the birth of your baby or until you stop lactating.
• The heavy days of your menstruation period have finished.
Please consult with your prescribing practitioner before using INNOVO
®
if:
• You have any serious illness or injury not mentioned in this guide.
• You have an underlying neurological condition e.g. Multiple Sclerosis or Parkinson’s disease
• You have a tendency to hemorrhage, following acute trauma or fracture.
• You take insulin for diabetes.
• You suffer from muscle or joint problems, including pelvic pain or a paravaginal defect.
• You suffer with suspected or diagnosed heart disease.
• You underwent a recent surgical procedure and where muscle contraction may disrupt the healing process.
To reposition the belt or GelPads during a session:
• To reposition the Shorts during a session: Always pause the device before adjusting the position of the Shorts
POSSIBLE ADVERSE REACTIONS:
• A small number of isolated skin irritations have been reported by people using muscle stimulation devices,
including skin allergies, burns under the electrodes, a prolonged reddening of the skin and acne.
NOTE that some reddening of the skin can appear under the electrode during and for a short time after a
session.
• If allergic reactions last for several hours, you should stop using the product as this product may not be
suitable for you.
• On very rare occasions, first-time users of Neuromuscular Electrical Stimulation have reported feeling
light-headed or faint. In this event, we recommend that you switch off the controller and sit down until you are
feeling better. You may then resume the treatment, however it is recommended that you use position B or C to
begin with.
• Use of muscle stimulation devices at a high intensity can be associated with minor and transient discomfort.
Ensure you used your INNOVO
®
at a level which is comfortable to you. An effective treatment should not
cause undue discomfort.
• You should stop using the product and should consult your prescribing practitioner if you experience adverse
reactions or if in any doubt about using the device.
IMPORTANT:
• The safety information provided in this Instruction Manual must be followed.
• The product should only be set-up and operated according to the instructions laid-out in this manual.
• Atlantic Therapeutics will not accept responsibility if the guidelines and instructions supplied with this product
are not followed.
VALIDITY
This instruction manual is intended for the correct application of the product. The information and technical data
contained in this document relates to the INNOVO
®
muscle stimulator provided with instructional manual which
is proprietary to Atlantic Therapeutics Ltd. and may be used and disseminated only for the purpose of and to the
exact specifically authorized writing by the company. Each INNOVO
®
controller is assigned a unique serial
number, which is located on the back of the controller.
RESTRICTIONS
The sale and/or operation of this equipment is subject to law in various countries. Compliance with the legislation
rests with the importer, dealer or user of the equipment as appropriate.
Contact your local careline (see page cover) if:
• Your product is not working correctly. Do not use it in the meantime.
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