Safety Information

Indications and Contraindications

Indications for Use
The Flyte System is intended for strengthening of the pelvic floor muscles to treat women with stress urinary incontinence.

Contraindications
Do not use Flyte® if you:

  • Are under 21 years of age.
  • Have given birth in the past 6 weeks.
  • Have had genitourinary or pelvic surgery in the past 6 weeks.
  • Have had vaginal surgery within the past 3 months.
  • Have experienced unusual or unexpected vaginal bleeding in the past 6 months.
  • Experience pain or a burning sensation when you urinate, which could indicate a urinary tract infection.
  • Experience vaginal discharge that has an odor, irritation, soreness, or itching, which could indicate a vaginal infection.
  • Have been diagnosed by your doctor with a severely dry (atrophic) vagina.
  • If you have a sensitivity or allergy to silicone.

Ask your doctor before using Flyte® if you:

  • Are pregnant.
  • Experience pain during sexual intercourse or when inserting a tampon or tampon-like device.
  • Often have trouble keeping in a tampon or tampon-like device.

Do not use Flyte®:

  • If insertion of the Flyte® wand causes excessive discomfort.
  • With a tampon, a tampon-like device, a diaphragm, a pessary, or other intravaginal product.
  • During sexual intercourse.
  • On rare occasions when the wand causes irritation.
  • For any reason other than its intended purpose.

 

Precautions, General Safety Info and Adverse Events

Precautions

  • Flyte® is not sterile. Please follow the cleaning instructions prior to use.
  • Use Flyte® only as described in this Instructions For Use.
  • Do not disassemble any component of Flyte®.
  • Do not use Flyte® if any component appears to be damaged.
  • Do not store or use Flyte® in excessively hot, cold, or humid environments.
    Please refer to “Technical Specifications” for approved operating temperature and humidity.
  • Do not share your Flyte® System with others. It is for individual use only.
  • Do not clean the wand in the dishwasher. The wand is not dishwasher safe.
  • Do not submerge the controller, the charging cable, the charging block, or the wand in water.
  • Let the wand dry before replacing it in the box.
  • No part of Flyte® is designed to be repaired or modified by the user. Attempting to repair or modify system components will void any applicable warranty and could lead to injury or further damage to components.

General Safety Information

  • Keep Flyte® out of reach from children.

Potential Adverse Events

  • As with all intravaginal devices, a foreign-body response (response of biological tissue to any foreign material in the tissue) may occur.
  • Tissue responses to the wand can include vaginal irritation or discharge, irritation to the urethra or other surrounding tissue, pain, and inflammation. If you experience these responses, you may need to stop using Flyte®.
  • Improper placement or use of the wand may cause temporary or permanent injury.

WARNING: Do not use a charging system other than the one provided with Flyte®. Use of the wrong charging system can damage Flyte®.

If you suspect that the integrity of any component of Flyte® has been compromised, please contact Pelvital.