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2. Particular attention should be taken to ensure the inside of the tube, and as appropriate the
subglottic suction line (REF 470-P, REF 471-P), are thoroughly rinsed.
3. For removal of residual debris TRACOE approved brushes or swabs can be used, see "Supple-
mentary Products".
4. Alternatively, the TRACOE tube clean cleaning kits (see "Supplementary Products") can be used
in accordance to their respective instructions for use.
5. After cleaning, rinse the tube with potable or distilled water.
6. If the tube is not visually clean after rinsing then:
•
repeat rinsing until it is visibly clean, or
•
repeat the cleaning using the TRACOE cleaning kits, or
•
safely dispose of the tracheostomy tube.
7. All areas of the tube and obturator should be inspected, in adequate light, to ensure the device
is free of contaminants and encrustations.
8. Following the cleaning process, place the tube and obturator on a clean lint-free dry towel and
air dry in an area free of airborne contaminants.
9. The tube and obturator are considered dry when there is no visual evidence of residual water.
Please check, that the inner of the cuff is dry.
10. Finally, a visual and functional inspection prior to re-insertion should be performed to verify that
the tube and obturator are not damaged (also see chapter "Preparation").
Caution:
•
The tracheostomy tube and obturator should be cleaned immediately after removal from
the stoma to prevent drying of soil and contaminants.
•
When cleaning, take care not to damage the cuff or the inflating line.
•
The frequency of cleaning must be defined by the physician but must not exceed the
allowed frequency.
•
Maximum allowed cleaning frequency is once a day, otherwise biocompatibility and mate-
rial stability could be impaired.
•
The tubes must never be cleaned using agents or procedures which are not specified in this
instruction.
•
The tracheostomy tube is single patient use, therefore, it must be returned to the same
patient.
•
Failure to clean the device properly can result in damage to the tube, an increase in air
resistance due to obstructions, or irritation/inflammation of the tracheal stoma.
•
Since the upper respiratory tract is never free from microorganisms, even in healthy individ-
uals, we do not recommend the use of disinfectants.
•
The minimally traumatic inserter and guiding catheter are single-use and not allowed to be
cleaned and reused.
10.
Storage
a)
Store the TRACOE products in their original packaging according to the conditions dis-
played on the packaging.
b)
Store cleaned tracheostomy tubes in a clean covered container, within a clean and dry
location and away from sunlight. Re-insert the tracheostomy tube as soon as possible. Improper
storage conditions may result in tube damage or contamination. Do not store the cleaned devices
for more than 29 days from first use.
11.
Packaging
The product is provided sterile (with ethylene oxide) which allows application under sterile condi-
tions. TRACOE tracheostomy tubes do not require a sterile environment during normal use
or cleaning.
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