Bladder weakness is not a normal part of the aging process, nor should it be simply accepted as a normal part of life after childbirth. Bladder weakness is a treatable condition and shouldn't simply be 'managed' through the use of containment pads. A safe, drug-free, non-surgical solution, the Perfect PFE Pelvic Floor Exerciser provides freedom from the use of containment pads and can help sufferers return to a more normal lifestyle.
The Perfect PFE Pelvic Floor Exerciser is simple and easy to use, with digital controls and 4 preset programs which have been clinically tested to provide long-term relief from incontinence.
The Perfect PFE sends a gentle stimulation to your pelvic floor through a vaginal probe, working your pelvic floor muscle for you and enabling you to develop your own muscle control.
The Perfect PFE also has an extra programme for the relief of Chronic Pelvic Pain from conditions such as Vulvodynia, Symphasis Pubis, or Interstitial Cystitis, allowing you to regain control of times of your life that would usually be hindered by pain.
The Perfect PFE can also be used with an anal probe for the improvement of symptoms of bladder weakness in men, and of faecal incontinence, please contact us for more information.
• 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.
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 perfect PFE 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 perfect PFE 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.
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 cord - risk of strangulation in infants.
Caution should be observed when using the perfect PFE 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: should be observed when using the Perfect PFE at high strength settings. Perfect PFE has a Yellow LED light on output socket which means the output will exceed 10 mA (R.M.S) or 10 V (R.M.S) averaged over any period of 1 sec. 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.
Caution: The perfect PFE vaginal probe is intended for single patient use only. Do not share your perfect PFE 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 perfect PFE’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.
Caution: Do not use this device with vaginal probe or anal probe other than those recommended by the manufacturer in section 18. 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 using TENS, 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.
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: -25°C–+70°C, 0%--93% R.H. Temperature & Relative Humidity of transportation: -25°C–+70°C, 0%--93% R.H.
Caution: There are no user serviceable parts. Do not attempt to open or modify the TENS unit. This may affect the safe operation of the unit and will invalidate the warranty.