Tracoe Silcosoft 360 Instructions D'utilisation page 18

Tubes with H O Cuff: In non-clinical testing, the image artifact, caused
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by the check valve, extends (radially) up to 107 mm from the check
valve when imaged with a gradient echo pulse sequence and a 1.5T
MR system, and up to 113 mm when imaged with a spin echo pulse
sequence in a 3.0T MR system. Therefore, when MR imaging a tube
with the H O Cuff, it is recommended to tape the check valve to the
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patient's skin away from the area of interest.
Warning:
When used in MR Imaging:
• Securely fasten the tube, with the neck strap, to prevent possi-
ble movement while in the MR environment.
• Securely affix the check valve (5b) away from the area of inter-
est with standard medical tape to prevent movement within the MR
environment.
• MR image quality may be compromised if the area of interest is
close to the position of the tube and/or inflation valve.
4. Contraindications
• The TRACOE silcosoft tracheostomy tube cannot be used in
conjunction with heat emitting devices, e.g. lasers to prevent the tube
material from being damaged.
• The H O Cuff should not be inflated, when a speaking valve is
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used and vice versa.
5. General Precautions
• A spare tracheostomy tube should remain at the patient's bed-
side and available for replacement, as required. This device should be
clean and dry.
• Ensure that an alternative airway is always available.
• The disconnect wedge (supplied with the device) should remain
at the patient's bedside and be available to assist in the disconnection
of external devices, e.g. mechanical ventilation.
• The sterile packaging should be inspected for damage prior to
opening. If the packaging is damaged the device should not be used.
• The tracheostomy tube should be inspected for tube integrity
and function prior to use/insertion. Verify that the tube is free of
obstruction, H O Cuff material is not brittle or torn and can be inflated/
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deflated, absence of kinks, tears or cuts, stable connection between
the tube and the neck flange, etc. If the product is damaged, it should
be discarded and replaced with a new product.
• Do not use unnecessary force on the tracheostomy tube when
connecting to, or disconnecting from, external devices. This may result
in damage to the tracheostomy tube, decannulation and/or increased
air resistance. Always hold the tracheostomy tube at the base of the
15 mm connector (6) when disconnecting from external devices. If
external devices are tightly fixed, use the disconnect wedge (9) to
separate them from the 15 mm connector tube.
EN
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