Single Patient Use - Trudell Medical International AeroEclipse Xl Manuel De L'utilisateur

• After cleaning/disinfection, pack the nebulizer disassembled into its three parts in sterilization
packaging (disposable sterilization packaging) conforming to DIN EN ISO 11607. Packaging size
should be no smaller than 70 mm x 120 mm.
NOTE: When placing the nebulizer
components in the sterilization packaging,
WHITE CYLINDER
the
NEBULIZER TOP
the packaging so it is not bent or pressed into
corners where it can become bent (as shown).
• The nebulizer components should then be
sterilized using the following sterilization
procedure.
5.2.1 RECOMMENDED PROCEDURE: STEAM STERILIZATION
Autoclave the reusable AEROECLIPSE* XL BAN following the autoclave manufacturer's instructions
preferably with fractionated pre-vacuum – in accordance with DIN EN 285 or DIN EN 13060 (type B).
Maximum sterilization and holding time:
A. 121°C (to be maintained for at least 20 minutes).
OR
B. 134°C (to be maintained for at least 3 minutes). Do not exceed a temperature of 137°C.
Ensure the nebulizer components do not come in contact with other materials, metal trays or
shelving in the autoclave and that nothing is placed on top of the device during reprocessing.
This method has been validated according to DIN EN ISO 17665-1.
NOTE: The reusable AEROECLIPSE* XL BAN may be autoclaved up to 150 times or for 6
months (whichever is first), but then it must be replaced. Visually inspect the nebulizer after each
cleaning cycle. Replace any damaged, misshapen or seriously discoloured parts.
CAUTION: Use of cleaning and disinfection procedures other than those listed above have not
been validated and may cause damage to the device.
5.3 STORAGE
Keep the sterilized nebulizer in a dry, dust-free place protected from contamination.

SINGLE PATIENT USE

When not cleaned according to the Hospital Instructions for Multiple Patient Re-Use, this device is
intended for single patient use (one patient only). The device should be replaced after 6 months or
immediately if components are cracked or the nebulizer does not function properly.
DISPOSAL
The nebulizer components used can be disposed of with domestic waste unless this is prohibited by the
disposal regulations prevailing in the respective member countries.
portion of the
should be positioned in
9 EN