Tracoe 450-P Instrucciones De Uso página 27

The Minimally Traumatic Insertion System is single use only and is intended for the insertion of the
vario tracheostomy tube using the Seldinger technique. It can be used for percutaneous dilation
tracheostomy or when the tube is changed.
EN
The TRACOE vario XL models (REF 451-P, REF 461-P and REF 471-P) are indicated whenever the
standard tube length is insufficient, or when it is necessary to position the low-pressure cuff further
in the caudal direction (e.g. to stent tracheal stenosis).
The TRACOE vario extract tracheostomy tubes with subglottic suction line and cuff (REF 470-P
and REF 471-P) are predominantly used for patients producing large amounts of secretions and
for whom suctioning of the subglottic space is indicated.
The vario extract tracheostomy tube can be used for Above Cuff Vocalisation (ACV).
Single Patient Use and Useful Life: The TRACOE vario tracheostomy tube is for single patient
use with a useful life of 29 days. The device can be cleaned and re-placed in the same patient
during this time period.
The device should not be used for more than 29 days beginning from the initial opening of the
sterile barrier. This maximum period of use includes both patient and non-patient (e.g. cleaning)
use of the device.
Caution:
A prolonged use of the tracheostomy tube for more than 29 days may result in material safety and
biocompatibility issues.
2. General Description
The vario tracheostomy tube is made of PVC and provides an artificial airway to the lower respira-
tory tract.
The product includes a tracheostomy tube, a minimally traumatic insertion system (inserter, guiding
catheter with silicone sleeve), an obturator, a fabric neck strap, and lubricating gel which are sup-
plied together within a sterile bag. Adaptors for use with external suctioning devices are only
delivered with the subglottic suctioning models (REF 470-P, REF 471-P).
The vario tracheostomy tubes are available in different diameters and lengths. The tracheostomy
tubes, included with the minimally traumatic insertion system, are cuffed models which are provided
with the cuff deflated. The appropriate diameter and length of the tube is determined by the physician.
The tracheostomy tube is radiopaque, due to the incorporated metal spiral reinforcement
(REF 450-P, REF 451-P) or from a radiopaque strip available in non-reinforced (clear PVC) models
(REF 460-P, REF 461-P, REF 470-P, REF 471-P).
Clinical use of the device in an MR environment is dependent on the product specifications and is
described in chapter "MRI Safety Information".
The tracheostomy tube can be used in combination with medical devices that are approved for
invasive ventilation through a tracheostoma and are connected via a standard 15 mm connector.
The tracheostomy tubes with the subglottic suction line can be used with medical devices
approved for subglottic suction.
This product is supplied with an information card, including two detachable labels, which contain
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