Indications for use:

ELITONE is a non-implanted muscle stimulator designed to treat stress urinary incontinence in women. It applies stimulation to the pelvic floor muscles and surrounding tissues.

Contraindications:

Do NOT use if you have/are:

  • Pregnant or attempting to become pregnant. The safety of electronic muscle stimulators during pregnancy has not been established.
  • An electronic implant (e.g. cardiac pacemaker, implanted defibrillator) or suffer from heart problems.
  • Cancer, epilepsy, or cognitive dysfunction.
  • Pelvic floor surgery within the last six weeks.
  • Complete denervation of the pelvic floor.
  • History or symptoms of urinary retention, extra-urethral incontinence, or overflow incontinence.
  • Conductive intra-uterine devices (IUD/Coil) or metal implants in the abdominal or pelvic area, including the hip and lumbar spine.

Warnings / Precautions / Adverse Reactions / Notes:

  • Read all instructions prior to use. Failure to follow these directions may result in personal discomfort or injury, or damage to the device.
  • The long-term effects of chronic muscle stimulation are unknown.
  • The device is intended for indoor use only.
  • Exposure of the Controller to liquids may result in personal injury or damage to the device. Do not use while bathing, swimming, or otherwise submerged.
  • Consult your healthcare provider prior to use if you are fewer than six weeks postpartum or fewer than three months post-caesarean section.
  • If a tissue irritation, allergic reaction, or burn occurs beneath the GelPad, discontinue use immediately and contact your healthcare provider.
  • Some reddening of the skin, lasting for several hours, may occur under normal use.
  • Discontinue treatment and consult a healthcare provider if you feel light-headed or faint while using the device.
  • Use of equipment should be discontinued upon signs of treatment-related stress or discomfort.
  • The device should not be used while driving, operating machinery, or any other activity in which involuntary muscle contraction may put the user at risk.
  • Use only with ELITONE GelPads.
  • Use only with ELITONE GelPad Cable. Use with other cables could result in increased electromagnetic emissions or deceased electromagnetic immunity and result in improper operation.
  • The GelPad is for single person use. Reuse of the GelPad by another user could cause cross-infection of skin disease.
  • Only apply the GelPad as instructed. Applying the GelPad to or in proximity of the chest, neck, head, face, or eyes could result in serious injury.
  • Do not power on the device prior to applying the GelPad and connecting it to the Controller.
  • Only apply the GelPad to normal, intact, clean, healthy skin.
  • Do not place the GelPad over or in proximity to cancerous lesions, open wounds, rashes, recent scars, swollen, red infected or inflamed tissue, or skin that is susceptible to acne, thrombosis or other vascular problems.
  • Use caution if GelPad application area lacks normal sensation.
  • Replace the GelPad if it no longer sticks firmly to the skin.
  • Do not use GelPads or the GelPad Cable if they have visible damage.
  • Do not connect the GelPads or GelPad Cable to other objects.
  • Do not modify or attempt to repair this device.
  • Do not touch the gel, metal studs, or snaps with your fingers while the Controller is on.
  • Do not use more than once per day or at an intensity that exceeds your comfort level. Treatment should not cause undue discomfort or muscle fatigue.
  • Turn the Controller off before removing GelPad.
  • Keep device out of reach of children and pets. ELITONE is for use by adults only.
  • Do not attempt to use the device while it is charging or connected to the charging cable.
  • Do not use the product while sleeping.
  • Use the toilet before starting a treatment session.
  • Best results may be achieved by removing/trimming hair from the application site.
  • Do not use the device with any other product which delivers electrical current to the body (e.g. muscle stimulators, high frequency surgical equipment) as this could result in burns or other injury.
  • Do not apply stimulation in the presence of electronic monitoring equipment (e.g. cardiac monitors, ECG alarms), which may not operate properly when the device is in use.
  • Do not use in close proximity (e.g. 1 meter) to shortwave or microwave therapy equipment, as this may produce instability in the Controller’s output.
  • Wireless communication equipment such as wireless home network devices, mobile phones, cordless telephones, base stations, and walkie-talkies can affect this device. See the EMC Information section of this User Manual for additional information.

Consult your healthcare provider before using the device 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.
  • You have any doubt about using the device.

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