Description
A 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 and is not intended to be attached to an active medical device.
The device is single-patient and is supplied in a non-sterile version.
The device does not contain latex or phthalates.

Cleaning before use
Before using the device, wash it with lukewarm water and neutral soap, then rinse with physiological saline solution.
Do not use brushes for washing, but only soft sponges so as not to scratch the surface of the device.
Do not use alcohol, solvents, or 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 area. The device can be steam-sterilized in an autoclave for up to two consecutive cycles set at a temperature of 121 °C for 15 minutes.

Instructions for use
Bend the ring into an ellipse to facilitate its insertion. Pass the osteo-vaginal opening. Circle the cervix.
Use the device in compliance with all instructions given by competent medical personnel during insertion.
Never tamper with the device on your own initiative.
In case of any abnormal discomfort, contact medical personnel.

Components
100% food-grade silicone, latex-free and phthalate-free.

Warnings
Before unpacking, ensure that the packaging is intact and sealed inside the specially prepared polyethylene bag.
Before use, ensure that the device:
- is intact and undamaged (e.g., no cracks, dents, tears);
- has not changed color, developed uneven coloring, or has superficial mold, etc. In such cases, DO NOT USE and REPLACE IT IMMEDIATELY.
IMPORTANT! A whitish surface discoloration caused by the protective film of talc, or other equivalent product, used during the manufacturing process, is not an indication of poor storage (or a 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 attending medical personnel, subject to periodic checks. Strictly follow the instructions you receive from competent medical personnel.
- Continuous use of the Pessary device is permitted for a maximum of 6 months, after periodic evaluation by the gynecologist. For this period, the device is considered safe and effective if used according to the manufacturer's instructions for use. After 6 months of use, the device must be disposed of.
- If treatment requires a period longer than 6 months, a new Pessary must be used.
- The device must be cleaned before use.
- Use the device responsibly.
- Keep the device out of reach of children.

Contraindications
The use of the Pessary is contraindicated in the following conditions:
- declared allergy to silicone;
- compromised 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 single-patient.
- 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 continuously for more than 6 months.
- Do not use the device in combination with 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 vaginal creams or ovules based on estrogens, 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, moisture-free environment, not in direct contact with heat 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