Tracoe Silcosoft 360 Instructions D'utilisation page 25

CAUTION:
• The device is single patient use; therefore the tube must be
EN
returned to the same patient.
9.3 Storage
a) Store the factory delivered tracheostomy tubes in their original
packaging in a dry location, away from sunlight until initial use.
b) Store reprocessed tracheostomy tubes in a clean covered con-
tainer or sterilization pouch, in a clean dry location, away from sun-
light. Re-insert as soon as possible.
c) Improper storage conditions may result in tube damage or con-
tamination. Do not store the reprocessed devices for more than 29
days or beyond the time limit defined by the sterilization pouch.
10. Packaging
TRACOE silcosoft is provided sterile (sterilized with ethylene oxide)
which allows the product to be inserted under sterile conditions, e.g. ini-
tial insertion in surgical suite (operating room). TRACOE silcosoft does
not require a sterile environment during normal use or reprocessing.
Sterility is only ensured if the sterile device packaging is intact and
sealed on all sides prior to initial use.
11. Disposal
Used products are to be disposed of in accordance with the valid
national regulations, or clinical procedures governing biohazardous
waste materials. Ensure the device has been rinsed and free of con-
taminant before disposal, see section 9.1.
12. Returns
Returned products, that have been used, will only be accepted subject
to prior consultation and if a completed decontamination certificate and
complaint report is enclosed. These forms are available either directly
from TRACOE medical or via the website www.tracoe.com.
13. General Terms and Conditions
The sale, delivery and return of all TRACOE products shall be affected
exclusively on the basis of the valid General Terms and Conditions
(GTC), which are available either from TRACOE medical GmbH or on
our website at www.tracoe.com.
18 18