DISCLAIMERS AND WARNINGS
To ensure that you use this product safely and effectively, please follow the safety information provided.
INNOVO® should not be used if:
- you have a cardiac pacemaker, implanted defibrillator or any implanted electronic device.
- you have a suspected or diagnosed heart condition, without consulting a clinician first.
- you are pregnant.
- you have any implanted metal devices in the abdominal or pelvic areas including an Intrauterine Device (IUD).
- you have epilepsy or are under medical supervision for cognitive dysfunction.
- wearing the product necessitates placement over areas at which drugs/medicines are administered by injection.
Please wait before using INNOVO® until:
- at least six weeks after the birth of your baby (consult a clinician first).
- at least three months after having a Caesarean section (consult a clinician first).
- the heavy days of your period have finished.
• 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 gel pads placed on the chest and the upper back or crossing over the heart.
• Application of gel pads near the thorax may increase the risk of cardiac fibrillation.
• Do not apply stimulation across the chest, because the introduction of electrical current into the chest may cause rhythm disturbances to the heart, which could be lethal.
• 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).
• Do not apply stimulation over, or in proximity to, cancerous lesions.
• Apply stimulation only to normal, intact, clean, healthy skin.
• 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 apply stimulation when in the bath or shower.
• Do not apply stimulation while driving, operating machinery, cycling or during any activity in which electrical stimulation can put you at risk of injury.
• 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 garments, leads, gel pads, and accessories recommended by the manufacturer.
• 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.
• Simultaneous connection to high frequency surgical equipment may result in burns at the site of the stimulator gel pads and possible damage to the stimulator.
• The product must not be used with any other product which delivers electrical current to the body (e.g. interferential or another muscle stimulator).
• Some users may experience skin irritation or hypersensitivity due to the electrical stimulation or the electrical conductive medium.
• Users with suspected or diagnosed heart disease should follow precautions recommended by their clinician.
• Users with suspected or diagnosed epilepsy should follow precautions recommended by their clinician.
• Use caution if you have a tendency to bleed internally, such as following an injury or fracture.
• Use caution following recent surgical procedures when stimulation may disrupt the healing process.
• Use caution if stimulation is applied over areas of skin which lack normal sensation.
• Due to the risk of strangulation, and the risk of small parts which may be broken off and cause a choking hazard, keep the product away from children.
• Keep this product out of the reach of pets or pests.
• The size, shape, and type of gel pads may affect the safety and effectiveness of electrical stimulation and recording.
• The long-term effects of electrical stimulation are unknown.
• Using stimulation gel pads which are too small or incorrectly applied could result in discomfort or skin burns.
• You should contact the manufacturer of this electrical stimulator if you do not know if the gel pads you have can be used with this stimulator.
• Gel pads and garments should not be shared with other people. To prevent cross-infection, each person should have their own set of gel pads and garments.
• Replace the gel pads if they no longer stick to your skin properly. See section on caring for your gel pads for further information.
• Although compliant with applicable EMC requirements, this product may still interfere with more sensitive equipment, please move away or switch off the controller if necessary.
• Once the treatment has ceased, always remember to switch off the controller.
• If in doubt, always seek medical advice.
• When repositioning gel pads during treatment, always pause or stop the controller first.
• This product can deliver current densities in excess of 2mA/cm2 when used at a high intensity with small gel pads.
• Do not touch the gel pads, connectors or lead pins with your fingers while the stimulation session is in progress.
Always pause or switch off the controller before handling the gel pads.
• It is advised that you use the toilet before starting a treatment session.
• Always check the product leads before use and do not use if they are damaged in any way.
• A small number of isolated skin reactions have been reported by people using muscle stimulation products, including allergies, a prolonged reddening of the skin and acne.
• On very rare occasions, first-time users of NMES 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.
• You should stop using the product and should consult your clinician if you experience adverse reactions.
• You should only run one full treatment session per day to reduce the potential for muscle fatigue. A treatment session is defined as 30 minutes of treatment, even if this is broken down into shorter 10- or 15-minute sessions.
• An effective treatment should not cause undue discomfort.
• 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 Ltd will not accept responsibility if the guidelines and instructions supplied with this product are not followed.
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 Bio-Medical Research Ltd. and may be used and disseminated only for the purpose of and to the exact specifically authorised writing by the company. Each INNOVO® controller is assigned a unique serial number, which is located on the back of the controller.