Tracoe Comfort Instructions D'utilisation page 7

EN
For the detailed cleaning steps please refer to the instructions for use
of the below cleaning kits.
The TRACOE Cleaning Kits 930-A or -B with the Cleaning Powder and
REF 931-A or -B with the Concentrated Cleaning Liquid allow the easy
cleaning and care of the tubes. These kits contain a cleaning tub with
a sieve insert, a cleaning agent, cleaning swabs and a cleaning brush.
All of the items from the kits are also available separately.
Important: After the tracheostomy tube has been cleaned and dried, a
small amount (approx. 1 drop) of the REF 902 Liquid Paraffin is applied
to the outside of the inner cannula and distributed with a fluff-free
cloth until a thin covering has been achieved. Then the inner cannula
is inserted into the outer cannula and pulled out and pushed back in
several times in order to further distribute the liquid paraffin.
Caution: Make sure that the applied amount of the liquid paraffin is
as small as possible. Never apply the oil to an extent that the liquid
paraffin escapes between the inner and outer cannula and enters the
trachea. There is a possibility, albeit small, that permanent overdosing
may result in oil pneumonia.
In many cases, the TRACOE comfort tube is used for out-of-hospital
applications and domestic care. In such cases, and due to the germ
range, which is different from that in hospitals, under normal circum-
stances simplified cleaning using a commonly available, domestic,
mild and pH-neutral agent is possible.
Caution: The tubes must not be cleaned with aggressive domestic
cleaning agents, cleaning agents for dentures or agents with a high
alcohol content because these agents can impair the functioning of
the products.
Caution: TRACOE comfort tracheostomy tubes must not be sterilised.
The tube must be checked after each cleaning and before the reinser-
tion. Even tubes that exhibit only minor damage must be replaced.
Disinfection
Since the upper airways are never free of germs even in healthy
people, we recommend that you abstain from using disinfectants.
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However, if disinfection seems necessary, you can access a
list of disinfectants on the website of TRACOE medical GmbH
(www.tracoe.com).
After disinfection, the tubes must be thoroughly rinsed with water in
drinking quality or with distilled water and dried.
Caution: Do not use any disinfectants, which release chloride, or
agents, which contain strong alkaline solutions or phenol derivatives.
You may thermally disinfect the tubes with a commonly available
mild agent with a neutral pH for 5 minutes at temperatures of up to
65 °C (≤ 65 °C) without using any chemical additives. This process
may result in an opaque staining, but the function of the product is
not impaired.
9. Useful Life
The tube is designed so that it can be reused for a patient several
times over a period of 29 days even after having been cleaned several
times during that period. In individual cases, the useful life heavily
depends on the patient's illness as well as the secretion and care of
the tracheostomy tube. The regular replacement of the entire tube
should be monitored by the physician in charge. If cared for at regular
intervals, the TRACOE comfort tracheostomy tubes can be used for
up to 6 months
10. Tube Info Card
Each TRACOE comfort tube contains a tube info card with detach-
able stickers on the front and back. These labels contain information
regarding the REF no., size, length and lot no. The tube info card
should be kept separately. This will make reordering easier, and the
tube info card is also essential in the event of a complaint when it must
be enclosed with the paperwork.
11. Storage
The products must be stored in a cool and dry place. Temporary
storage for ≤ 30 days at maximum +50 °C is possible. Protect the
product from sunlight and extreme cold.
12. Disposal
The TRACOE comfort tracheostomy tubes are made of plastic materi-
als that are globally approved for medical applications. They contain
EN
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