Atos TRACOE Twist Plus Instructions For Use

Tracoe Medical GmbH
Reichelsheimer Straße 1 / 3
55268 Nieder-Olm | Germany
info-tracoe@atosmedical.com
www.atosmedical.com
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Atos and the Atos Medical logo
are trademarks of Coloplast A/S.
Contents
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SK – SLOVENSKY ������������������������������������������������������������������������������������������������������������������������������� 2
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EN - ENGLISH
Instructions for Use for
Tracoe Twist Plus Spare Inner Cannulas
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.
Tracoe Twist Plus spare inner cannulas must only be used in combination with the corresponding
Tracoe Twist Plus tracheostomy tubes. Please read the corresponding instructions for use carefully.
They are part of the described product and must be available at all times.
1. Intended Use & Indications for Use
Tracoe Twist Plus spare inner cannulas are indicated for use only in combination with Tracoe Twist
Plus tracheostomy tube. They may be used up to 29 days.
The product is intended to be used only in combination with Tracoe Twist Plus outer cannulas of
the corresponding size. For the application refer to the instructions for use for the Tracoe Twist Plus
tracheostomy tubes.
For information on Clinical Benefit, Patient Population, Clinical Use, Intended User and Indica-
tions for Use please refer to the instructions for use of the respective Tracoe Twist Plus tracheos-
tomy tube.
Single Patient Use and Useful Life: The Tracoe Twist Plus inner cannula is for single patient use
with a useful life of 29 days. The device can be cleaned and reinserted 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 inner cannula for more than 29 days may result in material safety and bio-
compatibility issues.
2. General Description
The Tracoe Twist Plus spare inner cannulas are made of polypropylene.
The standardized 15 mm connector is permanently attached to the proximal end of the inner can-
nulas.
Image 1
The non-fenestrated models have a white locking ring and are available in packs of 3 (REF 521),
10 (REF 521-X) or 30 (REF 521-XXX) units.
The fenestrated models have a blue locking ring and are available in packs of 3 (REF 523) or 10
(REF 523-X) units.
The inner cannulas are radiopaque due to material specifications and are categorized as MR Safe.
Supplementary Products:
• Products, which can be used in combination with the Twist Plus tracheostomy tubes are listed
in section "Supplementary Products" of the IFU for the respective tracheostomy tube.
3. MRI Safety Information
All Tracoe inner cannulas are classified as "MR Safe"
Caution: Before using the Tracoe Twist Plus inner cannula in MRI, check the MR capability of the
respective Tracoe Twist Plus tracheostomy tube.
4. Contraindications
For the application refer to the instructions for use for the Tracoe Twist Plus tracheostomy tubes.
5. General Precautions
• When the product is used together with other medical devices, follow their respective instructions
for use. Contact the manufacturer if there are any questions, or if assistance is required.
• Safety precautions must be taken in case of complications during the described procedures, in order
to provide immediate ventilation through alternative airways, (e.g. trans laryngeal intubation, laryngeal
mask). This is recommended to be based on the respective applicable guidelines and standards for
patients with difficult airways, e.g. Practice Guidelines for Management of the Difficult Airway
(American Society of Anesthesiologists, 2013).
• It is strongly recommended that a ready-to-use spare tube and several inner cannulas are kept at
the patient's bedside. Store the spare devices under clean and dry conditions.
• It is also recommended keeping an emergency spare device at the bedside in case of an
unplanned tracheostomy tube change, e.g. due to complications, a collapsed tracheostoma or sim-
ilar. The emergency spare device should be one or two sizes smaller than the device in use.The
product should be inspected for integrity and function prior to use/insertion. If the product is dam-
aged, it should be replaced with a new product.
• The sterile packaging and the outer packaging should be inspected for damage prior to opening.
If the packaging is damaged or has been unintentionally opened, the device should not be used.
• During mechanical ventilation and frequent changes of the patient's position or manipulation of
the tube, the inner cannula may become separated from the outer cannula. Therefore, check the
connection of the inner cannula regularly.
• When changing the inner cannula, always ensure that the inflation line of the cuff is not posi-
tioned between the inner and outer cannulas as it may get trapped and damaged.
• Improper storage conditions may result in product or sterile barrier damage.
6. Warnings
• Do not use this product if the sterile packaging or the outer packaging have been compromised/
damaged, e.g. open edges, holes in packaging etc.
• Reprocessing (including re-sterilisation) is not allowed, this may influence the material and
function of the product. The products are single use only.
• Modifications of Tracoe products are not allowed. Tracoe will not be responsible for modified
products.
• Do not turn the 15 mm connector, as this may cause the rotation of the inner cannula inside the
outer cannula. It may lead to interruption of the air supply or dislocation of the tracheostomy tube.
Use the locking ring to loosen and re-lock the inner cannula.
• Never use fenestrated inner cannulas for ventilation.
• Regularly check that all connections are secure to prevent an inadvertent disconnection of the
tube from external equipment and ensure efficient ventilation.
• Keep the 15 mm connector clean and dry.
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2025-02 801618 2.0 / EN, SK