The Sure PRO Pelvic Floor Exerciser is an easy-to-use, flexible pelvic floor exerciser with a wide range of preset and manual programs - providing relief from stress, urged and mixed incontinence as well as improving sexual wellbeing.
Pelvic floor exercisers are one of the most effective forms of continence management and provide a discreet, affordable and long-term solution for incontinence sufferers.
The Sure PRO has 12 preset and 3 manual programmes. In addition to the standard settings, it has special programmes for transcutaneous tibial nerve stimulation (TTNS) for urge incontinence.
The manual programmes can be adjusted by healthcare professionals to the specific needs of the patient.
If you require an anal probe, please place your order and then Contact Us with your order number. We will then replace the vaginal electrode with an anal probe.
• 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 electrodes near the thorax as this may increase the risk of cardiac fibrillation.
Do NOT use 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 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 Sure Pro 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 Sure Pro in close proximity (e.g. 1 m) to a shortwave or microwave as this may produce instability in the stimulator output.
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 charging cable - risk of strangulation in infants.
Caution should be observed when using the Sure PRO at high strength settings. Prolonged use at high settings may cause muscle injury or tissue inflammation.
Caution: should be observed when using the Sure pro at high strength settings. Sure pro 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.
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 Keep away from pets and pests.
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 Sure PRO vaginal probe is intended for single patient use only. Do not share your Sure PRO probe with anyone else. Improper treatment or cross-infection may occur.
Caution: This probe is intended for single orifice use only (intra-vaginal or intra-anal use). Improper treatment or cross-infection may occur.
Caution: It is important that the vaginal probe is cleaned before and 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 Sure PRO’s muscle stimulation.
Caution: Do not use this device with vaginal probe, anal probe or electrode pads other than those recommended by the manufacturer in section 18. Electrodes with smaller surface area may cause tissue irritation.
DO NOT PLACE THE 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.
• Over the eyes. This can affect sight or cause headaches.
• Across the forehead. The effects on patients subject to stroke and epilepsy are not known.
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.
• The electrode pads supplied are reusable but for single patient use. The adhesive is a peelable hydrogel (water based).
• In order to obtain the best conductivity through the electrode pads always ensure that they are in good condition and tacky.
• Before use make sure your skin is clean and dry.
• Peel the electrode pads from their protective plastic shield by holding and lifting one corner of the pad and pulling. Do not pull on the pigtail wire of the pad.
• After use always replace the electrode pads on the plastic liner and replace them in the re-sealable plastic bag.
• If the electrode pads dry out, then it is best to buy a replacement pack. In an emergency, it may be possible to restore some of the tackiness of the pad by adding a tiny drop of water on each pad and spreading around. If too much water is added, the electrode pad will become too soft. If that happens then it is suggested in order to try and re-establish some adhesiveness, to place them sticky side up in a refrigerator for a few hours. • In very hot weather the gel on the electrode pads may become soft. In such cases place them, still on their plastic liners and in their pouch into a fridge until they return to their normal condition.
• The electrode pads provided are latex-free.
• Replace the electrode pads when they lose their stickiness.
Poor connection may cause discomfort and skin irritation.
• Storage life of an unopened pack of electrode pads is 2 years. This may be affected by very high temperatures or very low humidity.
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 to + 60°C, 15% to 75% RH. Temperature & Relative Humidity of transportation: -10°C to + 60°C, 15% to 75%% RH.
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.
Caution: Interconnect this device with other equipment may damage this device or unintended output may be delivered to end user.