Description
Device used for the containment of uterine prolapse of grade II or higher.
Class IIb invasive device that penetrates the body through a natural orifice, it is not intended to be connected to an active medical device.
The device is for single patient use and is supplied in a non-sterile version.
The device does not contain latex and does not contain phthalates.

Cleaning before use
Before using the device, wash it with lukewarm water and neutral soap, then rinse with saline solution.
Do not use brushes for washing, only soft sponges to avoid scratching the device's surface.
Do not use alcohol, solvents, and acids to clean the device's surfaces or liquids that could damage the device.
After cleaning, do not leave the device unattended, but immediately place it in the vaginal site. The device can be sterilized in a steam autoclave for up to two consecutive cycles set at a temperature of 121 °C for 15 minutes.

How to use
Fold the ring into an ellipse to facilitate entry. Pass the osteo-vaginal opening. Encircle the cervix.
Use the device according to all instructions given by competent medical personnel at the time of insertion.
Never intervene on the device on your own initiative.
In case of any abnormal sensation of discomfort, contact medical personnel.

Components
100% food-grade silicone, without latex and phthalates.

Warnings
Before unpacking, ensure that the package is intact and sealed inside the specially prepared polyethylene bag.
Before use, ensure that the device:
- is intact and undamaged (e.g., presence of cracks, dents, tears);
- has not changed color, taken on uneven colors, does not have superficial mold, etc. In such cases, DO NOT USE and REPLACE IMMEDIATELY.
IMPORTANT! A whitish superficial coloration caused by the protective film of talc, or other equivalent product, used during the manufacturing process, is not a sign of poor storage (or damaged product).
- Any counterfeiting and/or improper use will be prosecuted according to law.
- Strictly adhere to the intended use of the device.
- The use of the device may be at the discretion of the treating medical personnel, subject to periodic checks. Strictly follow the instructions you receive from competent medical personnel.
- Continuous use of the Pessary device is allowed for a maximum of 6 months, subject to periodic evaluation by the gynecologist. For this period, the device is considered safe and effective if used according to the instructions for use provided by the manufacturer. After 6 months of use, the device must be disposed of.
- If the treatment requires a period longer than 6 months, a new Pessary must be used.
- Before use, the device must be cleaned.
- Use the device consciously.
- Keep the device out of the reach of children.

Contraindications
The use of the Pessary is to be excluded in the following conditions:
- declared allergy to silicone;
- impaired immune system;
- thromboembolic disorders;
- recurrent urinary tract infections;
- frequent vaginal infections;
- frequent vaginal bleeding;
- in the presence of abrasions or lesions of the vaginal mucosa.
- Do not reuse the device on another patient. This device is for single patient use.
- The use of the pessary is not allowed in pregnant or breastfeeding patients and in patients under 18 years of age.
- Do not use the device for a continuous period longer than 6 months.
- Do not use the device in combination or as part of other medical devices.
- Do not modify or alter the constituent parts and/or characteristics.
- The use of the pessary is not compatible with certain vaginal medications. In particular, the concomitant use of estrogen-based vaginal creams or ovules, spermicides, oily antifungals, oil-based lubricants, and topical antibiotics may alter the device material or increase the risk of irritation and infection.
- Do not use the device if the packaging is damaged.

Storage
To ensure proper long-term storage, it is recommended to always use the original packaging in conjunction with a dry and humidity-free environment, not in direct contact with heat radiating sources, protected from dust and harmful materials, and at a temperature preferably between 1 °C and 40 °C.
Avoid placing excessive weight loads on the device and do not subject it to stress.
Shelf life after opening: 60 months.

Code FOR.70.51760, FOR.70.51765, FOR.70.51770, FOR.70.51775, FOR.70.51780, FOR7051745, FOR.70.51750, FOR.70.51755, FOR.70.51785, FOR.70.51790, FOR.70.51795, FOR.70.517100