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

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

CONTRAINDICATION

This device has not been tested for use with Pentamidine.

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.
AEROSOL CHARACTERISTICS
100
80
60
40
20
0
1 2
Aerodynamic Droplet Size (μm)
EN 10
5 L/min
3.5 L/min
3 4 5 6 7 8 9 10
0.8
5 L/min
0.6
0.4
0.2
0.0
0 2 4
Time (min.)
3.5 L/min
6 8 10