Tracoe Silcosoft 360 Instructions D'utilisation page 17

tube and the 15 mm connector.
• The 15 mm connector (6) provides a smooth surface for con-
EN
necting the tracheostomy tube to external devices e.g. for mechanical
ventilation.
H O Cuff Models:
2
• The silicone cuff (4) is inflated with sterile water, and located on
the distal end of the tracheostomy tube and. It is directly connected
to the inflation line (5), which is incorporated into the neck flange (3).
• The proximal end of the inflation line includes a pilot balloon
(5a), an incorporated self-sealing check valve (5b), with a female Luer
connector (5c).
Disconnect Wedge:
• The plastic disconnect wedge (8) is a tool to disconnectfacili-
tate disconnection of external devices from the 15 mm connector of the
tracheostomy tube.
• The disconnect wedge slides between the female 15 mm con-
nector of the external device and the male 15 mm connector of the
tracheostomy tube to easily separate the devices, see Image 3.
Neck Strap:
• The neck strap (9) is a soft strip of padded fabric that wraps
around the patient's neck.
• The ends of the strap include hook and loop fasteners that are
inserted through the eyelet holes of the neck flange (3) to secure the
tracheostomy tube position.
3. MRI Safety Information
Non-clinical testing has demonstrated the TRACOE silcosoft tracheos-
tomy tube is MR Conditional. A patient with this device can be safely
scanned in an MR system meeting the following conditions:
• Static magnetic field of 1.5 Tesla (T) or 3.0 Tesla (T).
• Maximum spatial field gradient of 1900 gauss/cm (19 T/m).
• Maximum MR system reported, whole body averaged specific
absorption rate (SAR) of 2 W/kg and a maximum whole head specific
absorption rate (SAR) of 3.2 W/kg
• Quadrature driven transmit body coil only.
• The neck flange (3) must be secured in place with the neck
strap (9).
• For tubes with H
secured to the skin with medical tape, away from the area of MR diag-
nostic interest.
In non-clinical testing, the image artifact caused by the tube extends
(radially) up to 19 mm from the TRACOE silcosoft tracheostomy tube
(non-cuffed) when imaged with a gradient echo pulse sequence and
a 1.5T MR system, and up to 28 mm when imaged with a spin echo
pulse sequence in a 3.0T MR system.
10
O Cuff only: The check valve (5b) must be
2