Elise 2 Pelvic Floor Exerciser & Toner - from UK

• Elise 2 is an easy-to-use, rechargeable pelvic floor exerciser with a range of clinically tested programs - providing relief from stress, urge and mixed incontinence as well as improving sexual wellbeing.
• An elegant slim-line design will easily blend itself into your daily life, not interfering with your day-to-day activities. A safe, drug-free, non-surgical solution, the Elise 2 Pelvic Floor Exerciser provides freedom from the use of containment pads and can help incontinence sufferers return to a normal lifestyle.
• Our pelvic floor exerciser can be used with a vaginal probe or electrode pads. The device sends a gentle stimulation to the pelvic floor which strengthens your muscles and allows you to regain control. Training of this muscle group is what improves incontinence (bladder weakness) problems, becoming a long-term solution for an issue that may be affecting your daily life.
• The Elise 2 replacement leads have different connectors depending on model number, please make sure you are choosing the same leads as the ones originally supplied with your kit or the leads will not work.  

WARNING AND CAUTIONS:

CONTRAINDICATIONS

• Do NOT use if you are or may be pregnant. It is not known whether TENS may affect foetal development.
• Do NOT use with optional electrode pads if you have a pacemaker (or if you have a heart rhythm problem) or with any electronic medical devices. Using this unit with electronic medical devices may cause erroneous operation of the device. Stimulation in the direct vicinity of an implanted device may affect some models.
• Do NOT use in the first 6 weeks following a pelvic surgery or vaginal childbirth. Stimulation may disrupt the healing process.
• Do NOT use if you have symptoms of active urinary tract infection, vaginal infections, or localized lesions. Introducing the probe may irritate sensitive tissue.
• Do NOT use if you have poor sensation in the pelvic region. You may not be able to control the intensity of stimulation safely.

WARNINGS

• Do NOT use if you are unable to properly insert the vaginal or anal probe. If you have a severe prolapse, or if any discomfort occurs when inserting the probe, consult your healthcare professional before use.
• Do NOT use when driving, operating machinery, or similar actions needing muscular control. Loose electrode pads, damaged leads, or sudden changes in contact may cause brief involuntary muscle movements.
• Do NOT use to mask or relieve undiagnosed pain. This may delay diagnosis of a progressive condition.
• Do NOT use if you have, in the area being treated: active or suspected cancer or undiagnosed pain with a history of cancer. Stimulation directly through a confirmed or suspected malignancy should be avoided as it may stimulate growth and promote spread of cancer cells.
• Do NOT use optional electrodes on the front of the neck. Stimulation on the front of the neck can affect your heart rate or cause contraction of the throat.
• Do NOT use optional electrodes across the chest. Very strong stimulation across the chest may cause an extra heartbeat and/or rhythm disturbances to your heart, which could be lethal.
• Do NOT use while simultaneously connected to high frequency surgical equipment as it may result in burns at the site of stimulator electrodes and possible damage to the stimulator.
• Do NOT use Elise 2 in close proximity (e.g. 1 m) to a shortwave or microwave as this may produce instability in the stimulator output.
• Do NOT use electrodes near the thorax as this may increase the risk of cardiac fibrillation.
• Do NOT use any charger other than the one supplied. Use of other chargers could be hazardous.
• Do NOT use the device whilst charging.

CAUTIONS

• Caution should be used if you have a bleeding disorder as stimulation may increase blood flow to the stimulated region.
• Caution should be used if you have suspected or diagnosed epilepsy as electrical stimulation may affect seizure threshold.
• Caution should be observed when using the device at the same time as being connected to monitoring equipment with body worn electrode pads. It may interfere with the signals being monitored.
• 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 lead wires - risk of strangulation in infants.
• Caution should be observed when using the Elise 2 at high strength settings. Prolonged use at high settings may cause muscle injury or tissue inflammation.
• Caution Not intended for use in an oxygen rich environment.
• Caution Not intended for use in conjunction with flammable anaesthetics or flammable agents.
• Caution The patient is an intended operator.
• Caution Do not service and maintain the device while in use.
• Caution Maintenance and all repairs should only be carried out by an authorized agency. The manufacturer will not be held responsible for the results of maintenance or repairs by unauthorized persons.
• If necessary, we will provide circuit diagrams, component part lists or other information that will assist authorized service personnel to repair the device.
• Caution The operator should not touch the patient at the same time when touching the battery output.
• Caution Keep away from pets and pests.
• Caution: Interconnect this device with other equipment may damage this device or unintended output may be delivered to end user.
• 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.

TO KEEP YOUR DEVICE IN GOOD WORKING ORDER, OBSERVE THE FOLLOWING ADDITIONAL CAUTIONS

• Caution: Do not immerse your device in water or place it close to excessive heat such as a fireplace or radiant heater or sources of high humidity such as a nebulizer or kettle as this may cause it to cease to operate correctly.
• Caution: Keep the device away from sunlight, as long-term exposure to sunlight may affect the rubber causing it to become less elastic and crack.
• Caution: Keep the device away from lint and dust, as long-term exposure to lint or dust may affect the sockets or cause the battery connector to develop a bad contact.
• Caution: Temperature & Relative Humidity of storage: -10°C–+60°C, 15%-75% R.H. Temperature & Relative Humidity of transportation: -10°C–+60°C, 15%-75% R.H.
• Caution: There are no user serviceable parts. Do not attempt to open or modify the unit. This may affect the safe operation of the unit and will invalidate the warranty.

PROBE CAUTIONS

• Caution: The Elise 2 vaginal probe is intended for single patient use only. Do not share your Elise 2 probe with anyone else. 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 Elise 2’s muscle stimulation.
• Caution: Do not use this device with vaginal probe or anal probe other than those recommended by the manufacturer in section 17. Electrodes with smaller surface area may cause tissue irritation.

DO NOT PLACE OPTIONAL ELECTRODE PADS

• On skin, which does not have normal sensation. If the skin is numb too great a strength may be used, which could result in skin inflammation.
• On broken skin. The electrode pads could encourage infection.

ELECTRODE PADS CAUTION

• Caution: Do not ignore any allergic reaction to the electrode pads: If a skin irritation develops, stop use immediately, as this type of electrodes may not be suitable for you. Alternative electrode pads specially made for sensitive skin are available (see E-696-SS).
• Caution: Do not use this device with leads or electrode pads other than those recommended by the manufacturer. Performance may vary from specification. Electrodes with smaller surface area may cause tissue irritation.
• Caution: Do not use high intensity settings if electrodes are smaller than 50x50mm.
• The electrode pads supplied are reusable but for single patient use. The adhesive is a peelable hydrogel (water based).
• Note: You may safely use the stimulator during menstruation, although it may be a little less comfortable.