Single Patient Use - Trudell Medical International AeroEclipse XL Manual De Instrucciones

• The effectiveness of this procedure has been proven using Korsolex
in combination with the Korsolex
5.2 STERILIZATION
Your nebulizer (excluding tubing) may be sterilized using the following validated procedures. If another
procedure is used, its effectiveness must be validated. Hospital hygiene standards should be followed.
• A validated sterilization process can only
be carried out on products once they have
been cleaned and disinfected following
instructions in Section 5.1.
• 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, the
NEBULIZER TOP
portion of the
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.
EN 8
†
basic 4% disinfectant (Bode Chemie, Hamburg).
should be positioned in the packaging so it is not bent or pressed into
† EndoCleaner 0.5% cleaning agent
WHITE CYLINDER