Description
The LATEX-FREE PESSARY device is a transparent silicone ring intended for the containment of uterine prolapse. It is indicated for women aged between 18 and 90 years. Use is excluded in pregnant or breastfeeding women and in pediatric patients.
The device must be prescribed and placed exclusively by specialized medical personnel qualified in the gynecological field, in public or private healthcare and hospital facilities. The device is sterile and therefore its handling by medical personnel, before placement, must take place according to aseptic procedures.
Medical personnel are responsible for:
- prescribing the device;
- prescribing the most suitable device size for the patient;
- prescribing to the patient the continuous use time of the device;
- prescribing the frequency of check-ups the patient needs to undergo;
- frequently checking the positioning of the device and the condition of the application site.

Instructions for use
The device is sterile and therefore its handling by medical personnel, before placement, must take place according to aseptic procedures.
Insert the pessary past the ostium-vaginal opening, bending the ring into an ellipse to facilitate entry. Insert the device by encircling the cervix.
Lubricating gel can be used to facilitate entry.
IMPORTANT: Verify that the device is inserted correctly.

Warnings
- Avoid contact with open flames and incandescent objects: they could damage the device.
- Avoid contact with sharp and/or pointed objects and tools that could damage the physical integrity of the device.
- Do not use in combination with other medical devices.
- The use of the device in conjunction with the use of localized medications must be approved by medical personnel.
- The device is single-use: once removed by medical personnel, it must be disposed of.
- Do not use for periods longer than those prescribed by medical personnel.
- Do not reuse and/or re-sterilize as the product is single-use. Reuse of the device carries a high risk of bacterial contamination and cross-infection.
- If the device is not intact or is damaged, dispose of it immediately without using it.
- Any serious incidents that have occurred in relation to this medical device must be reported to the Manufacturer and the Competent Authority of the country in which the user or patient is established.
- Do not use on patients with known allergy or sensitivity to silicone.
- Do not use on pregnant or breastfeeding women and those under 18 years of age.
- Do not use in the presence of pelvic infections or lacerations.

Storage
To ensure proper preservation of the device over time, it is advisable to always use the original packaging in a dry environment with temperatures between +1 °C and +40 °C, not in direct contact with heat sources, protected from dust and harmful materials.
Shelf life in intact packaging: 60 months.

Format
1 piece.
Available in sizes from 50 to 100 mm external diameter. Section diameter 12 mm.