Tracoe 320 Instrucciones De Uso página 3

Instructions for Use for TRACOE experc Set
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twist
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 follow instructions below.
The TRACOE experc Set consists of two components: The
TRACOE experc Dilation Set and a TRACOE Tracheostomy Tube
with minimally invasive inserter. Please find necessary information on
the general description, functional description, intended use, patient
population, indications and technical description in their respective
instructions for use.
1. Intended Use & Indications for Use
Intended Use: TRACOE experc Dilation Set for Percutaneous Tra-
cheostomy is intended for performing a percutaneous dilation tra-
cheotomy, applying the Ciaglia technique with a Seldinger guide
wire. TRACOE twist tracheostomy tubes are indicated for providing
tracheal access for airway management. It may be used for up to 29
days.
Indications: This medical device is indicated for cases where
access to the respiratory tract is required by means of a percutane-
ous dilation tracheotomy, with subsequent placement of a tracheos-
tomy tube.
2. General Description
A TRACOE experc Set twist consists of TRACOE experc Dilation Set
for Percutaneous Tracheostomy (REF 520) and one of the following
TRACOE twist Tracheostomy Tubes with minimally traumatic
inserter:
TRACOE experc Sets twist
REF 320: TRACOE twist Tracheostomy Tube, with cuff (REF 301-P)
REF 321: TRACOE twist Tracheostomy Tube, fenestrated, with cuff
(REF 302-P)
REF 322: TRACOE twist extract Tracheostomy Tube, with subglottic
suction line and cuff (REF 306-P)
REF 888-322: TRACOE twist extract Tracheostomy Tube, fenes-
trated, with subglottic suction line and cuff (REF 888-306-P)
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3. Procedure
1) Please read the Instructions for Use of both components (Dilation
Set and tracheostomy tube) together before performing the trache-
otomy.
2) Apply the TRACOE experc Dilation Set (REF 520) to create the
dilative tracheostoma.
Follow with application of the included TRACOE twist Tracheostomy
Tube.
4. Storage
Store the TRACOE products in their original packaging according to
the conditions displayed on the packaging.
5. Packaging
The product is provided sterile (with ethylene oxide) which allows
application under sterile conditions.
6. Disposal
Used products are to be disposed of in accordance with the valid
national regulations, waste management plans, or clinical proce-
dures governing biohazardous waste materials, e.g. the direct dis-
posal in a tear- and moisture-resistant and secure bag or container,
which is routed to the local waste disposal system for contaminated
medical products.
For further recommendations, contact your hygiene officer in health
facilities or the local waste management for homecare use.
7. General Terms and Conditions
The sale, delivery and return of all TRACOE products shall be
affected exclusively on the basis of the valid General Terms and
C o n d i t i o n s ( G T C ) , w h i c h a re a v a i l a b l e e i t h e r f ro m
TRACOE medical GmbH or on our website at www.tracoe.com.
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