APPENDIX B. INFORMATION ON ACCESSORIES
D0716C-EN
Information on the device or equipment
Optional accessory: Single-use sheath for the AS300 aseptic storage
cabinet
Common name: SHEATH FOR STORAGE OF THERMOLABILE ENDOSCOPES IN A STORAGE CABINET
Trade name: aseptic sheath
References:
PAE-810/111 Length 0.90 m
PAE-810/111 Length 1.30 m
PAE-810/111 Length 1.70 m
PAE-810/111 Length 1.90 m
PAE-810/111 Length 2.40 m
LPPR Code (e.g. TIPS if applicable): not applicable to this product
Device description: Optional accessory for
AS300: Single use aseptic sheath that enhances
protection of the endoscope during its
introduction into or its removal from the AS300
storage cabinet. An individual packaging
enables easy manipulation at the end of the
disinfection procedure.
Colour: Transparent
Density: 0.92 - 0.93 g/cm
2
Form: cylindrical
Length (mm): 800 or 1750
Single use: yes
Texture: smooth
Food: no
Origin: France
Device composition and accessories: Principal
component: low-density polyethylene
Latex: no
Phthalates (DHP): no
Product of animal or biological origin (nature,
…): non
Ethylene oxide: resistant
Gamma rays: resistant
Radioactive products: no
Powder: no
Flocking: no
Means of device treatment
Gamma rays
Method: gamma 28.8 KGy to 33.7 KGy
Protect sheaths from heat (storage temperature: between 15°C and 25°C (59°F – 77°F)), from light (direct sun light
and strong artificial light), from humidity and ozone, and avoid contact with oxidizing cleaners.
Particular care: according to the criteria mentioned above.
Shelf life: 2 years
Presence of temperature indicators if necessary: no.
User manual: At the end of manual or automated reprocessing according to national instructions in force: open
the protective package and unfold the sheath on a sterile drape. Introduce the distal part of the endoscope into
the sheath up to the handle. Put the endoscope into the AS300 cabinet and attach the sheath to the dedicated
holder.
It is recommended to handle the endoscope wearing sterile gloves.
Labelling: + identification batch number
Precautions for use: check the integrity of packaging. Do not use the sterile sheath if the packaging is damaged or
pierced or if the expiry date has passed.
Contraindications: Do not use for any other purpose that its use in the AS300 cabinet.
Additional information on the product
Logistics information:
Protected unit: 1
Quantity (units) per package: 200
Unit packet:
Number of boxes per layer: 1
Number of protected units: 200
Volume of a box (m³): 0.14
Average weight of a box (Kg): 10
To Next Page
Loading...