APPENDIX B. INFORMATION ON ACCESSORIES
D0716C-EN
APPENDIX B. INFORMATION ON ACCESSORIES
Information on the device or equipment
PAM-810/X – Accessory: Reusable connector for the AS300 aseptic
storage cabinet
Common name: MEDICAL AIR CONNECTOR FOR A STORAGE CABINET FOR THERMOLABILE ENDOSCOPES
Trade name: AS300 air connector
Nomenclature code: PAM-810/X (X corresponds to a connector model adapted for each brand and type of
endoscope)
LPPR Code (e.g. TIPS if applicable): not applicable to this product
Device description: Accessory for AS300: Assembly
composed of a silicone tube of various forms and
dimensions as well as polypropylene connection
pieces allowing connection of an endoscope to the
medical air supply device on the AS300 storage
cabinet.
Note: in order to avoid risk of cross contamination
between endoscopes, it is recommended that each
connector is dedicated to one particular endoscope.
Colour: Transparent/Opaque
Hardness: 60 +/- 5 Shore A
Density: 1.17 +/- 0.02 g/cm
2
Form: variable depending on endoscope model
Length (mm): variable depending on endoscope model
Single use: no
Texture: smooth
Food: yes, FDA certificate § 177.2600 and BfR XV
Origin: France
Device composition and accessories: Principal
component: Silicone elastomer type ST-EC-60-001
Secondary component: polypropylene barbed fittings
Latex: no
Phthalates (DHP): no
Product of animal or biological origin (nature, …): no
Radioactive products: no
Breaking strength: 10.5 N/mm
2
Elongation at break: 500 %
Tear resistance: 32.0 N/mm
Autoclavable product
Hot air resistance: 200°C
Steam resistance: 135°C
Good resistance to chemical contact detergents and
disinfectants
Means of device treatment
Before each use disinfection of the connector ends with a disinfectant wipe is required.
High level disinfection of the connector must be performed once a week. It is possible to sterilize the tubes
without their fittings.
Store connectors in their original packaging in a dry, clean area out of direct light (direct sun light and strong
artificial light).
NB: It is recommended to associate each connector to one endoscope.
Particular care: according to the criteria mentioned above.
Duration of validity: 2 years
Presence of temperature indicators if applicable: no.
User manual: At the end of manual or automated reprocessing according to national instructions in force:
Extend the connector on a sterile drape. Connect the tubing to the connectors for irrigation according to the
endoscope model. Place the endoscope in the AS300 cabinet and connect the tubing to the dedicated coupling.
Visually check that the air circulates freely, and the silicone tube is not kinked.
It is recommended to handle the endoscope wearing sterile gloves.
Labelling: individual marking with type and model
Precautions for use: check the integrity of connectors before use. Do not use connectors if damaged or pierced.
Contraindications: this product contains silicone that can cause allergies. Do not use if allergic to silicone.
Additional information on the product
Logistics information:
Protected unit: 1
Quantity (units) per package: 1
Unit packet: plastic bag
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