EmbaGYN is an pelvic floor exerciser designed specifically for the treatment of urinary incontinence. EmbaGYN is clinically proven for the rehabilitation and strengthening of weak pelvic floor muscles in the treatment of stress and mixed incontinence.

The patient should use EmbaGYN in the mode recommended by their medical adviser. EmbaGYN is “clinically proven” for stress incontinence and stress portion of mixed incontinence.

EmbaGYN should always be used as recommended by your medical adviser. Patients in clinical study conducted by Everett Labs noticed improvement within a few weeks. It is important to stay compliant to EmbaGYN during treatment.

It depends on your schedule. In studies conducted by Everett Laboratories, women typically used EmbaGYN at night before going to sleep.

The EmbaGYN Trainer should be inserted with one silver plate on the left and the other on the right hand side, in the same way you would insert a tampon. The trainer will naturally position itself with the widest part of the flange vertically and the curved edges of the flange pointing up. The trainer flange should remain outside of the vagina at all times.

In order to turn EmbaGYN on, press and hold the ON button for 3 seconds until the screen turns on and a beep is heard.

The EmbaGYN Pelvic Floor Exerciser produces a gentle electrical stimulation. The sensation is different for each specific program.

Stress Incontinence: You should feel a strong sensation of “tightening or lifting”. The stimulation lasts five seconds and then stops for ten seconds. Continue to increase the intensity until it is as high as you can comfortably stand.

The level of stimulation goes down so that muscles get to relax after the brief period of stimulation.

Check if Embagyn is inserted properly or if the LEADS indicator is on. Increase level of stimulation if it is too low.

It depends on individual needs and preferences. Use of lubricant helps in insertion of the exerciser.

EmbaGYN monitors the contact between you, the trainer, and the EmbaGYN control unit. Lack of connectivity will trigger the “LEADS” alarm in the control unit. If this happens to you, try the following:

- Change the position of the trainer in your vagina.
- Change the position of your body.
- Add lubricant to the EmbaGYN trainer in order to improve contact.

For your convenience, EmbaGYN has a built in feature that starts a new session at half the strength of your last session. This is to ensure that the body has adequate time to get used to the stimulation `by starting at lower levels.

EmbaGYN is designed to turn off after a completed session in order to protect your pelvic floor muscles from being overworked.

The EmbaGYN trainer should be cleaned with warm soapy water. Do not immerse the trainer under water.

EmbaGYN trainer is intended strictly for one person’s use. Do not share EmbaGYN with anyone.

The patient daily diary should be used along EmbaGYN treatment to record all your leakage episodes, as well as EmbaGYN sessions. This will help you and your medical adviser keep a record of your progress.

Contraindications:

Should not be used if you have any of the following conditions:

• If you have a heart pacemaker or a heart rhythm problem.
• If you are pregnant or trying to become pregnant.
• If you have been diagnosed or treated for cervical or any pelvic cancer.
• If you have or have had epilepsy.
• While driving or during any activity in which involuntary muscle contractions may put the user at undue risk of injury.
• If you have:
  • An active urinary tract infection.
  • Recent history of vaginal bleeding between menstrual periods.
  • Infections or lesions in the area of electrode placement.
  • Diminished sensory perception.
  • Inability to understand the directions of use or operate the device correctly.
  • History of urinary retention or post-void residual volume greater than 200 cc.

Warnings:

Review the followingwarnings before using:

• The patient should discontinue use and immediately consult the clinician if irritation, pain or unusual bleeding occurs.
• Keep out of reach of children.
• Do not use in water (for example, while bathing) or device may shock user. This equipment is not rated for use while immersed or under dripping water.
• Do not use simultaneously with high frequency hospital diagnostic/therapeutic equipment. Doing so may result in burns at the site of the electrodes and possible damage to the device.
• Do not carry batteries in a pocket, purse, or any other place where the terminals could become short circuited,(e.g. by way of a coin or paper clip). Intense heat could be generated and injury mayresult.
• The longterm effects of chronic electrical stimulation are unknown.
• Do not use with products other than those recommended by Everett Laboratories.

If any discomfort occurs when inserting the trainer consult your medical adviser.

Precautions

Review the followingprecautions before using:

• It is not recommended to use device while under the influence of alcohol or other substances, such as sleeping pills or tranquilizers, which could affect the patient's ability to operate the system correctly.
• Removing or inserting the electrode while the system is on could result in discomfort.
• Use while operating hazardous equipment, machinery or motorized vehicles could cause abrupt changes in stimulation which can startle the patient and create a hazard.
• Do not use in close proximity (e.g. qft.) to transmitting cellular (wireless) telephones or two-way radios. This equipment may produce instability in the stimulatory output. Sudden unexpected changes in output could startle the patient and create a hazard.
• Use while sleeping is not recommended.
• The patient should discontinue use and consult a clinician if a significant change in the stimulation sensation occurs without changing the intensity settings. It is normalto feel a difference in sensation when changing positions during stimulation.
• Caution should be used following recent surgical procedures when muscle contraction may disrupt the healing process.