Pressio Mri Support; Preamble; Intended Use; Indications - Sophysa PRESSIO Notice D'utilisation

CAUTION
Federal (USA) law restricts this device to sale by or on
the order of a physician.
Read the Instructions for Use carefully before using the

Pressio MRI Support.

If necessary refer to the Instructions for Use for the
Pressio ICP monitoring kit being used: PSO-PB, PSO-
PT, PSO-VT, PSO-PBT, PSO-PTT, PSO-VTT.

1. Preamble

These Instructions for Use detail all the information required
for the implementation, use and maintenance of the Pressio
MRI Support (PSO-MRI), hereinafter referred to as MRI Sup-
port.
Any request for information or modification relating to these
instructions should be sent to: Sophysa – 5, rue Guy Moquet
– 91400 Orsay – France.

2. Intended use

The MRI Support is intended to make it possible to position
Pressio Catheters in an optimum position for an MRI exami-
nation. It is indicated for use in patients implanted with a
Pressio range Catheter who require an MRI examination.

3. Indications

Patients implanted with a Pressio Catheter are those requir-
ing continuous monitoring of intracranial pressure (ICP), or
who are brain-injured with a risk of intracranial hypertension
and who cannot be evaluated clinically.
The MRI Support must be used in an hospital environment
equipped with an MRI room, by qualified personnel only
(such as nurses, radio operators or radiologists).
NOTE
The MRI support is not expected to provide any clinical
benefit. Potential risks associated with the use of the
MRI support could be mispositioning of the MRI sup-
port, lack of coiling or no coiling, and wrong dongle fix-
ing.

4. Contraindications

There are no medical contraindications to the use of the MRI
Support.

5. Description

NOTE
This product is a reusable device, it is not intended for
single use. It must be cleaned before first use and be-
tween each patient.
The MRI Support is packaged in a parcel containing the fol-
lowing items:
– The two unassembled MRI Support parts.
– The Instructions for Use of the MRI Support
When unpacking the parcel, check that it contains all these
items and that none of them have been damaged during
transport.
The MRI Support consists of two sub-assemblies delivered
unassembled:
– The foot (Figure 1a), intended to be placed on the exami-
nation table and making it possible to stabilize the MRI
Support assembly.
– The body of the support (Figure 1b) making it possible to
coil and fix the Catheter.
Figure 1. Description of the MRI Support

6. Assembling the MRI Support

CAUTION
The two sub-assemblies of the MRI Support must be
assembled before use. Once assembled, the MRI Sup-
port must no longer be dismantled.
To assemble the MRI Support proceed as follows:
1. Take the foot and body of the MRI Support out of their
packaging.
2. Check that neither part has been damaged during trans-
port.
CAUTION
If one or both sub-assemblies are damaged, do not
assemble the MRI Support. Contact Sophysa or
your local distributor.
3. Assemble the body of the MRI Support with its foot re-
specting the direction shown in Figure 2. The tab found
on the end of the body of the MRI Support (Point 1 -
Figure 2a) must be inserted up to the stop in the location
provided for this on the MRI Support foot (Point 2 - Fig-
ure 2a) until a "click" is heard.
4. Make sure that the MRI Support is correctly assembled
by checking that a slight traction on the body of the MRI
Support does not allow the assembly to come apart.
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