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Nonclinical testing has demonstrated the TRACOE vario tracheostomy tube is "MR Conditional".
A patient with this device can be safely scanned in a MR system meeting the following conditions:
•
Static magnetic field of 1.5 Tesla (T) or 3.0 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 (normal operating mode) and a maximum whole head specific absorption rate (SAR) of
3.2W/kg.
•
Quadrature driven transmit body coil only.
•
The neck flange must be secured in place with the neck strap.
•
The check valve of the tracheostomy tube cuff must be secured to the skin with medical
tape, away from the area of MR diagnostic interest.
In non-clinical testing, the image artifact, caused by the check valve, extends (radially) up to 107 mm
from the check valve when imaged with a gradient echo pulse sequence and a 1.5 T MR system,
and up to 113 mm when imaged with a spin echo pulse sequence in a 3.0 T MR system. Therefore,
it is recommended to tape the check valve to the patient's skin away from the area of interest.
Warning:
When used in MR imaging:
•
Securely fasten the tube, with a metal-free neck strap, to prevent possible movement while
in the MR environment.
•
Securely affix the check valve away from the area of interest 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
inflation valve.
4.
Contraindications
Trachostomy Tubes:
•
Spiral-reinforced models (REF 450-P and REF 451-P) are "MR Unsafe" and must be out-
side the MR environment.
•
The tracheostomy tube cannot be used in conjunction with heat emitting devices, e.g. laser.
There is a risk of fire, also toxic gases may form, and the tube may get damaged.
•
Not suitable for patients with spasms, which may result in excessive axial forces > 15 N
(e.g. neurological spasticity).
•
The HVLP cuff should not be inflated, when a speaking valve or an occlusion cap is used
and vice versa.
•
Neonates, infants, and children (<12 years).
ACV use:
•
Patient with new tracheostoma (less than 7–10 days after surgical incision).
•
Obstructions in the upper airway that can inhibit the airflow and therefore phonation
capabilities.
•
Obstructions may lead to pressure rise in the trachea and therefore cause a risk of subcu-
taneous emphysema.
•
Patients with surgical emphysema or infections of the tracheal tissue.
•
Patients with unilateral or bilateral paralysis of the vocal cords in median position.
5.
General Precautions
•
When the product is used together with other medical devices, follow their respective instruc-
tions 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 proce-
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