Tracoe 450-P Instrucciones De Uso página 26

Instructions for Use
TRACOE vario Tracheostomy Tubes with
the Minimally Traumatic Insertion System
Note: Please read the instructions for use carefully. They are part of the described product and
must be available at all times. For your patients' and your own safety, please observe the following
safety information.
Fold out pages: The illustrations to which the text refers can be found on the (fold-
out) illustrated pages at the beginning of these instructions. The numbers indicate
product components and refer to the respective illustrations of the product. Symbols and icons
used with the product are explained in sections "General Description" and "Functional Description".
1. Intended Use and Indications for Use
TRACOE vario tracheostomy tubes are indicated for providing tracheal access for airway manage-
ment especially to those patients with unusual anatomy or patients with thick necks. They may be
used for up to 29 days.
Clinical Benefit: TRACOE vario tracheostomy tubes provide tracheal access to the lower respira-
tory tract. The cuffed models, when inflated, can be used to seal the airway (e.g. for mechanical
ventilation).
The tubes with subglottic suction line allow to remove the secretions that remain above the inflated
cuff.
The adjustable neck flange provides the option to vary the proximal length of the tube (e.g. for
patients with extended stoma channel).
The tracheostomy tubes with additional distal length (vario XL) can be used to position the
low-pressure cuff further in the caudal direction (e.g. to stent tracheal stenosis).
The 15 mm connector is a standardised component to which other airway management devices
(e.g. mechanical ventilator, cough assist, nebuliser etc.) can be connected.
Compared to the usage of an endotracheal tube the anatomical dead space is reduced and there
is less need for sedation when using a tracheostomy tube. The risk of long-term complications
associated with prolonged endotracheal intubation (e.g. vocal cord injuries, formation of granula-
tion tissue in the laryngeal area etc.) can be prevented when using a tracheostomy tube.
Patient Population: The product is intended for adults and adolescents (≥12 – 21 years).
Clinical Use: The product is intended for mechanically ventilated and self-breathing patients in
hospitals, pre-hospitals (EMS), extended care facilities, or outpatient clinics, or home care.
Intended User: The product can be used by medical staff trained in tracheostomy care or individ-
uals trained by professionals.
Indications for Use: The tracheostomy tube is indicated for patients where access to the lower
respiratory tract is required by means of a tracheostomy to secure the airway. TRACOE vario trache-
ostomy tubes are single-lumen tubes. Therefore, their application is recommended when there is no
acute danger of the tracheostomy tube becoming encrusted or displaced by viscous secretions.
The tracheostomy tube with a high-volume-low-pressure (HVLP) cuff seals the trachea to separate
the upper airways from the lower respiratory tract. Therefore, it allows efficient ventilation and
reduces influx of subglottic secretions into the lung.
EN
23