Tracoe Silcosoft 360 Instructions D'utilisation page 23

9. Cleaning, Reprocessing and Storage
Following the cleaning or reprocessing procedure, a visual inspection
EN
prior to re-insertion should be performed, see chapter 8.1.
CAUTION:
• Cleaning and reprocessing the device outside these guidelines,
or failure to clean the device properly can result in damage to the tube,
possible obstruction or increased air resistance and damage to the tra-
cheal mucosa, infection or irritation/inflammation of the tracheal stoma.
• Reprocessing / sterilization methods other than the ones
described in section 9.2 are not permitted, such as deep, pulse or
intermittent vacuum sterilization, EO, H
zation, or Dry Heat.
• To avoid recontamination after cleaning and disinfection, only
hold the tube at the base of the 15 mm connector and not at the inser-
tion end of the tube
9.1 Cleaning
Cleaning of the device is intended to remove any bodily fluids or
encrustation that may inhibit its clinical use.
The frequency of cleaning must be defined by the physician.
The tube (2) and obturator (1) must be cleaned before reprocessing
(see section 9.2), and/or reuse.
The following instruction for manual cleaning applies to all TRACOE
silcosoft models and sizes:
The tracheostomy tube should be cleaned immediately after removal
from the stoma to prevent drying of soil and contaminants.
To clean the tube and obturator, rinse the devices separately under
lukewarm (40 °C/104 °F) potable water at least for 3 minutes, until
they are visibly clean and free of contaminants/encrustations. Particu-
lar attention should be taken to ensure the inside of the tube is thor-
oughly rinsed. If encrustations are still present after rinsing, soak the
device in warm water (up to 65 °C/149 °F) up to 30 minutes and rinse
again. Repeat these steps as required until the tube is visually clean.
All areas of the tube and obturator should be inspected, in adequate
light, to ensure the device is free of contaminants and encrustations.
When cleaning, take care not to damage the H
Following the cleaning process, place the tube and obturator on a
clean dry towel and air-dry in an area free of airborne contaminants.
The tube and obturator are considered dry when there is no visual
evidence of residual water.
Following the drying process, the tube can be reinserted, or sterilized
with steam sterilization, see 9.2.2.
If, after cleaning, the tube and obturator will be disinfected with hot
water disinfection (9.2.1), drying is not required.
16
O and O , microwave sterili-
2 2 3
O Cuff.
2