Important Safety Information
for Milli Users

RISKS

As with all battery powered electromechanical devices, there is a risk of electrical shock, battery leakage or burn. There is also a risk of tissue damage/abrasion, delay in treatment, irritation, reaction, user discomfort, and user inconvenience with the use of Milli.

Additionally, using Milli incorrectly or incorrectly identifying Milli as the correct treatment could result in prolonged symptoms and/or prolonged treatment. Contact a healthcare provider if prolonged or worsening symptoms occur.

CONTRAINDICATIONS

Women with active pelvic infections, or women who have open wounds in the tissue inside or surrounding the vagina should not use vaginal dilators. Pregnant women should refer to their physician for guidance prior to use.

WARNINGS

  • Prolonged use of Milli Vaginal Dilator may cause vaginal abrasion or ulceration.
  • If symptoms, such as bleeding, vaginal discharge, unpleasant odor, pain, or severe
    itching occur, stop use of the device and contact your healthcare provider.
  • Use of Milli adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, Milli and the other equipment should be observed to verify that they are operating normally.
  • Use of accessories, transducers and cables other than those specified or provided by the manufacturer of Milli could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
  • No modification of this equipment (the Milli Vaginal Dilator) is allowed.

PRECAUTIONS

  • Contact your physician if prolonged or worsening symptoms occur.
  • Milli is for single patient use only. Do not share your device with others.
  • Do not soak Milli’s handle or submerge Milli under water.
  • Use only water-based lubricant with Milli.
  • Do not bathe with Milli.
  • Do not use silicone-based lubricant with Milli.
  • Do not use if you have a sensitivity to silicone.
  • Do not use Milli if the silicone cover, device, or case is damaged.
  • Do not place Milli in the microwave, dishwasher, or refrigerator.
  • Do not store Milli near extreme heat or cold.
  • Do not wash Milli with products containing alcohol, acetone, or petroleum.
  • Do not squeeze, twist, or bend Milli’s wand.
  • Do not use Milli in body parts other than the vagina.
  • Do not force Milli into your vagina.
  • While inserted into the vagina at desired depth, but at least halfway, gradually increase the dilation diameter at a comfortable level.

INDICATIONS

The Milli Vaginal Dilator is a tool intended for controlled dilation of the vagina. It can be used for dilation for an examination (by your doctor), in preparation for a surgical procedure or to help relieve the symptoms of vaginismus (condition that involves tightening of the vaginal muscles) and related painful sex.