Tracoe Silcosoft 360 Instructions D'utilisation page 15

Instructions for Use for
®
TRACOE
EN
Neonates / Infants and Children
Note:
• Please read the instructions for use carefully. They are part of the
described product and must be available at all times. For your own and
your patients' safety, please observe the following safety information.
•
the (foldout) illustrated pages at the beginning of these instructions. The
numbers and letters in brackets refer to the respective illustrations and
product components of the tracheostomy tube. The symbols and icons
used are explained on pages 1 – 5.
1. Indications for Use / Intended Use
The TRACOE silcosoft tracheostomy tube is intended to provide direct
airway access for a tracheotomized patient up to 29 days. It may be
reprocessed for single patient use up to 7 times.
Patient population: Neonates, infants, children, and adolescents.
2. General Description
TRACOE silcosoft is a silicone tracheostomy tube which provides an
artificial airway to the lower respiratory tract for neonates, infants,
children, and adolescents.
The TRACOE silcosoft tracheostomy tube is provided in a sterile blis-
ter pack together with an obturator, a fabric neck strap and a discon-
nect wedge. The silicone tracheostomy tube is radiopaque, and wire
reinforced. It is available in different diameters and lengths, and in
cuffed or uncuffed models. The cuffed model is provided with the cuff
deflated and flush with the tube. The obturator is made of plastic or
metal depending on the type of tube (please see Table 1 on the fold-
out pages).The appropriate diameter and length of the tube is to be
determined by the physician.
For insertion, the neck is extended with the tracheostoma open and
free of obstruction. The tracheostomy tube (with the obturator inside),
is inserted directly into the tracheostoma until the neck plate is in
contact with the skin surface. Once in place, the obturator is immedi-
ately removed and when applicable, the cuff is filled with sterile water.
With the tracheostomy tube in position it is secured in place with
a neck strap.
The TRACOE silcosoft is intended for single patient use up to 29 days
and may be reprocessed 7 times. The frequency of reprocessing is
based on the physician's care instructions. The device is applicable
for mechanically ventilated or spontaneously breathing patients in
8
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silcosoft Tracheostomy Tubes for
The illustrations to which the text refers can be found on