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Tracoe experc Set twist - Products for Single-Patient Use; Useful Life of the Tracheostomy Tube; Composition and Disposal; Indications

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ATTENTION: The TRACOE
®
experc tracheostomy
s
ets REF 320, 321, 322, 888-322, 330, 331, 332,
8
88-332, 420, 421, 422, 423, 424 and 425 contain
medical single-use products together with a tra-
cheostomy tube, which is intended for one patient
only.
Products for Single-Patient Use: The tracheostomy
tube contained in the tracheostomy set is a medical
product, which is only intended for one patient. Mul-
tiple uses for one and the same patient are permitted.
Useful Life of the tracheostomy tube: The manu-
facturer recommends that TRACOE
®
twist, TRACOE
®
vario and TRACOE
®
twist plus tracheostomy tubes
should not be used for more than 29 days. Even tubes
that exhibit only minor damage must be replaced.
Frequent replacement of the tracheostomy tubes, in
particular the inner tube, is recommended and should
be supervised by the responsible doctor.
Composition/Disposal: All products described
above consist of materials which are internationally
approved for medical use and contain no latex. Dis-
posal may only occur with the valid national regula-
tions for waste materials.
ATTENTION: Percutaneous tracheostomy should
only be carried out by doctors or under the instruc-
tion and supervision of doctors who are trained and
experienced in this technique. The intervention is
usually carried out by two people. One person car-
ries out the intervention while the second person
administers the anaesthetic, monitors the patient and
also has the responsibility for the bronchoscopic
control throughout the procedure.
Storage: The products must be stored in a cool
and dry location. Temporary storage for 30 days
at +50 °C is possible. Protect the product from
sunlight and extreme cold.
Contents of the TRACOE
®
experc Dilation Set
REF 520 (see Fig. 1):
1. Scalpel
2. Syringe
3. Puncture cannula (14 gauge)
with Teflon catheter
4. Guide wire (kink-resistant NiTiNOL)
with inserter
5. Short dilator 14 CH/FR
6. Guiding catheter with safety stop
7. TRACOE
®
experc dilator
with hydrophilic coating
(slides easily after moistening)
8. 4 swabs
TRACOE
®
Tube Set twist with Atraumatic Inserter
f
or Percutaneous Tracheostomy:
1
. TRACOE
®
t
wist tracheostomy tube with
2 inner cannulas and an atraumatic inserter
(see Fig. 2a)
2. Obturator, perforated
3
. Neck strap
4. Sterile lubricating gel 2.7 g
5. Recannulation tube
6. REF 321/REF 888-322 also contains an occlu-
sion cap for the fenestrated inner tube with a
1
5 mm connector.
7. REF 322/REF 888-322 contains in addition 2 con-
nectors for connection to the suction devices.
TRACOE
®
twist plus/TRACOE
®
vario Tube Sets with
Atraumatic Insertion System for Percutaneous
Tracheostomy:
1. TRACOE
®
twist plus with 2 inner cannulas/
TRACOE
®
vario tracheostomy tube, each with
atraumatic insertion system (consisting of
inserter and guiding catheter with radiopaque,
collapsible silicone sleeve; see Fig. 2b + 2c)
2. Obturator
3. Neck strap
4. Sterile lubricating gel 2.7 g
5. REF 331 also contains an occlusion cap for the
fenestrated inner cannula with 15 mm connector
6. REF 332/REF 888-332, REF 422 and REF 425
contain in addition 2 connectors for connec
tion to the suction devices.
Sizes: The following table indicates which types are
available in which size.
The sizes correspond to the internal diameter of the
tube in millimetres.
For further details please see the Ordering Informa-
tion and the enclosed instructions for use for the
tubes used.
1. Indications
The TRACOE
®
experc sets for percutaneous tracheo-
stomy are used for the subcricoidal insertion of a
tracheostomy tube into the trachea. Dilation takes
place in one step according to the Ciagla method
using a Seldinger guide wire.
6
TRACOE percutan
Type
REF
Size
twist
twist plus
vario
(without subglottal suction line)
vario
(with subglottal suction line)
320, 321, 322, 888-322
330, 331, 332, 888-332
420, 421, 423, 424
422, 425
07, 08, 09
07, 08, 09, 10
07, 08, 09
08, 09
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