Tracoe percutan experc Set vario 420 Instructions D'utilisation page 3

Instructions for Use for TRACOE experc Set vario
EN
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 insertion system. Please find necessary infor-
mation on the general description, functional description, intended
use, patient population, indications and technical description in their
respective instructions for use.
1. Intended Use and 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 vario tracheostomy tubes are indicated for providing
tracheal access for airway management especially to those patients
with unusual anatomy or patients with thick necks. 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 vario consists of TRACOE experc Dilation Set
for Percutaneous Tracheostomy (REF 520) and one of the following
TRACOE vario Tracheostomy Tubes with minimally traumatic inser-
tion system:
TRACOE experc Sets vario
REF 420: TRACOE vario Tracheostomy Tube, spiral-reinforced with
cuff (REF 450-P)
REF 422: TRACOE vario extract Tracheostomy Tube, with subglottic
suction line and cuff (REF 470-P)
REF 423: TRACOE vario Tracheostomy Tube, with cuff (REF 460-P)
TRACOE experc Sets vario XL
REF 421: TRACOE vario XL Tracheostomy Tube, spiral-reinforced
with cuff (REF 451-P)
3
REF 424: TRACOE vario XL Tracheostomy Tube, with cuff (REF 461-
P)
REF 425: TRACOE vario XL extract Tracheostomy Tube, with sub-
glottic suction line and cuff (REF 471-P)
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 vario 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
Conditions (GTC), which are available either from TRACOE medical
GmbH or on our website at www.tracoe.com.
EN
4