Performance Of The Mri Examination; Uninstalling The Mri Support; Maintenance Of The Mri Support; Environmental Conditions, Storage And Shipping - Sophysa PRESSIO Notice D'utilisation

Figure 4. Centering of the MRI Support
WARNING
Make sure that the MRI Support is aligned compared to
the patient's head. Do not move the MRI support com-
pared to the patient's body axis.
Positioning the MRI Support in a different way may in-
duce heating of the Catheter higher than 2.2°C.
Step 3. Pass the non-implanted part of the Catheter via one
of the side notches found on the body of the MRI Support,
and then coil it. Depending on its length the Catheter may be
coiled up to 4 or 5 times around the MRI Support (see Figure
5).
CAUTION
When rolling the Catheter handle it with care to avoid
any excessive traction that could damage the Catheter.
CAUTION
When handling the Catheter avoid any liquid spray on
the connector as this may damage it.
Figure 5. Coiling the Catheter around the MRI Support
Step 4. Fix the Catheter dongle by clipping it laterally on the
circular part of the MRI Support (see Figure 6).
Figure 6. Fixing the dongle to the MRI Support
Step 5. Before starting the MRI examination make sure the
MRI Support is correctly centered and perpendicular to the
primary magnetic field. If this is not the case, adjust its posi-
tion.
WARNING
The MRI Support is not compatible with every Head
Coil. If the device is not compatible, opt for a manual
coiling of the Catheter. Take the non-implanted part of
the Catheter and coil it behind the top of the patient's
head, in 5 cm loops (up to 4 or 5 loops) and perpendic-
ular to the primary magnetic field.

8.2. Performance of the MRI examination

The MRI Support is MR Safe.
The MRI specifications are described in Intracranial Pressure
Catheter's Instructions for Use NT530, NT540, NT550.

8.3. Uninstalling the MRI Support

To remove the MRI Support proceed as follows:
1. Gently remove the Catheter dongle from the MRI Sup-
port.
2. Uncoil the Catheter carefully.
3. Remove the Catheter from the side notch of the MRI
Support.
4. Remove the MRI Support.
5. Clean the MRI Support following the indications in Sec-
tion 9. Maintenance of the MRI Support (p. 9).
6. Store the MRI Support according to the indications in
Section 10.2. Storage and shipping (p. 9).

9. Maintenance of the MRI Support

Clean the MRI Support after each use and check the integrity
of the device before using it on a new patient. Proceed to a
visual inspection of the device as detailed in Section 7.4. In-
spection (p. 8).
If any defect is found out, proceed to the MRI Support elimi-
nation (see Section 11. Processing the product after use (p.
10) ).
WARNING
The MRI Support must not be cleaned during use on a
patient or in the presence of the Catheter.
Respect the following instructions:
– Do not use solvents or cleaning agents which could dam-
age the MRI Support and/or its label. Refer to Section 7.
Cleaning the MRI Support (p. 8) for more information.
– Do not autoclave the MRI Support.
10. Environmental conditions, storage and
shipping

10.1. Environmental conditions

The MRI Support is designed to withstand a temperature be-
low 60°C.

10.2. Storage and shipping

The MRI Support must be stored away from impacts and
risks of dropping.
The device is designed to withstand the following conditions:
– Temperature:
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