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

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.


Instructions for use