Description
LATEX FREE PESSARY
Description
The LATEX FREE PESSARY device is a transparent silicone ring and is intended for the containment of uterine prolapse. It is indicated for women between the ages of 18 and 90. Use in pregnant or breastfeeding women and on pediatric patients is excluded.
The device must be prescribed and positioned exclusively by specialized and qualified medical personnel in the gynecological field, in public or private health and hospital facilities. The device is sterile and therefore its manipulation by medical personnel, before positioning, must take place according to aseptic procedures.
Medical staff are responsible for:
- prescribe the device;
- prescribe the most suitable device size for the patient;
- prescribe to the patient the time of continuous use of the device;
- prescribe the frequency of checks to which the patient must undergo;
- frequently check the positioning of the device as well as the condition of the application site.
How to use
The device is sterile and therefore its handling by medical personnel, before placement, must take place according to aseptic procedures.
Insert the pessary beyond the ostio-vaginal opening, bending the elliptical ring to facilitate entry. Insert the Device by circling the cervix.
Lubricating gel can be used to facilitate entry.
IMPORTANT: Make sure 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.
- Use of the device in conjunction with 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 longer than prescribed by medical personnel.
- Do not reuse and/or re-sterilize as the product is disposable. Reusing the device causes a high risk of bacterial contamination and cross infection.
- If the device is not intact or damaged, dispose of it immediately without using it.
- Any serious incidents occurring in relation to this medical device must be reported to the Manufacturer and to the Competent Authority of the country in which the user or patient is established.
- Do not use on patients with known silicone allergy or sensitivity.
- Do not use on women who are pregnant or breastfeeding and under 18 years of age.
- Do not use if you have pelvic infections or lacerations.
Conservation
To maintain the correct conservation of the device over time, we recommend always using 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.
Validity for intact package: 60 months.
Format
1 piece.
Available in sizes from 50 to 100 mm external diameter. Section diameter 12 mm.
The LATEX FREE PESSARY device is a transparent silicone ring and is intended for the containment of uterine prolapse. It is indicated for women between the ages of 18 and 90. Use in pregnant or breastfeeding women and on pediatric patients is excluded.
The device must be prescribed and positioned exclusively by specialized and qualified medical personnel in the gynecological field, in public or private health and hospital facilities. The device is sterile and therefore its manipulation by medical personnel, before positioning, must take place according to aseptic procedures.
Medical staff are responsible for:
- prescribe the device;
- prescribe the most suitable device size for the patient;
- prescribe to the patient the time of continuous use of the device;
- prescribe the frequency of checks to which the patient must undergo;
- frequently check the positioning of the device as well as the condition of the application site.
How to use
The device is sterile and therefore its handling by medical personnel, before placement, must take place according to aseptic procedures.
Insert the pessary beyond the ostio-vaginal opening, bending the elliptical ring to facilitate entry. Insert the Device by circling the cervix.
Lubricating gel can be used to facilitate entry.
IMPORTANT: Make sure 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.
- Use of the device in conjunction with 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 longer than prescribed by medical personnel.
- Do not reuse and/or re-sterilize as the product is disposable. Reusing the device causes a high risk of bacterial contamination and cross infection.
- If the device is not intact or damaged, dispose of it immediately without using it.
- Any serious incidents occurring in relation to this medical device must be reported to the Manufacturer and to the Competent Authority of the country in which the user or patient is established.
- Do not use on patients with known silicone allergy or sensitivity.
- Do not use on women who are pregnant or breastfeeding and under 18 years of age.
- Do not use if you have pelvic infections or lacerations.
Conservation
To maintain the correct conservation of the device over time, we recommend always using 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.
Validity for intact package: 60 months.
Format
1 piece.
Available in sizes from 50 to 100 mm external diameter. Section diameter 12 mm.
