Technical description
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
Furthermore, ENDALIS® has not demonstrated that its device is compliant with the basic requirements of Directive 93/42/CEE and its amendment 2007/47/CEE, if it is re-used.
Consequently, the practitioner exposes himself to serious risks (see below) if he reuses this single use device.
Characteristics
Balloon END T110
- Single pouch polyurethane balloon
- Size of the balloon empty: Flat 110 mm disc
- Volume of inflation 700 ml liquid and air
Biocompatibility
Device compatible with the human body (NF EN ISO 10993).
Packaging
The 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
Its microbiological cleanliness is controlled by the manufacturing conditions in the controlled atmosphere room (followed by a bioburden in each batch) and preventive treatment to ETO. Devices are delivered STERILE and are for SINGLE USE (they have CE marking from a different manufacturer to Laboratoire ENDALIS®).
Storage
To be kept in a cool, dry place at ambient temperature.
Disposal of waste
After 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.
