The balloon and accessories are single use in order to:
- Reduce the risks of cross-contamination, infection, etc.
- Achieve its performance safely and effectively (insertion of the balloon)
- Simplify its use for practitioners (no cleaning, disinfection and sterilization procedures to be implemented by users)
- The balloon is punctured during removal
Consequently, the practitioner exposes himself to serious risks (see below) if he reuses this single use device.
- Single pouch polyurethane balloon
- Size of the balloon empty: Flat 110 mm disc
- Volume of inflation 700 ml liquid and air
BiocompatibilityDevice compatible with the human body (NF EN ISO 10993).
PackagingThe device is delivered NON-STERILE. The device is packaged in a peel-back sachet, heat sealed and packed in a case together with the following materials.
- Instructions for use of the medical device
- User manual
- Individual identification card
- Identification labels for the files
StorageTo be kept in a cool, dry place at ambient temperature.
Disposal of wasteAfter use all our products must be considered as medical waste carrying a risk of infection and related risks (D.A.S.R.I. in France).
It is ESSENTIAL that the procedure for sorting and disposal established in the user health establishment is followed.