Cleaning The Mri Support; Introduction; Prerequisites; Cleaning Procedure - Sophysa PRESSIO Notice D'utilisation

Figure 2. Assembly of the MRI Support

7. Cleaning the MRI Support

NOTE
The MRI Support is not for single use. No sterilization is
required.
CAUTION
Do not use the MRI Support if there is any soiling or
visible residues on the external surface of the device.

7.1. Introduction

The MRI Support is delivered clean, but not disinfected.
Clean the MRI Support before first use and between each
patient, as described here.
WARNING
Do not clean the MRI Support when in use on the pa-
tient.
WARNING
Do not sterilize, immerse, autoclave or soak the MRI
Support in a liquid. Its performance could be affected.
NOTICE
Do not use solvents or cleaning agents which could
damage the MRI Support, such as:
– cleaning agents based on phenols,
– cleaning by boiling,
– cleaning by hot air/steam,
– acetone, ammonia, benzene, bleaching agent, chlor-
ine, chlorine water, water above 60°, paint solvents,
trichloroethylene.
For more information, contact Sophysa Customer Serv-
ice at contact@sophysa.com, or contact your local dis-
tributor.

7.2. Prerequisites

1. Put on gloves and keep them throughout the procedure.
2. Take pre-soaked wipes with 70% isopropyl alcohol (IPA).

7.3. Cleaning procedure

The purpose of this procedure is to remove any soiling and
visible residues on the external surface of the MRI Support.
NOTE
Do not put excessive pressure on the product labels.
Page 8 of 44
1. Clean the MRI Support for at least 1 minute using pre-
soaked wipes with 70% isopropyl alcohol (IPA), to re-
move any visible residues.
2. Inspect the MRI Support.
If residues remain, take a new pre-soaked wipe with
70% isopropyl alcohol (IPA) and wipe the surfaces
again.
NOTE
If residues persist after multiple cleanings, stop us-
ing the device and send it back to Sophysa for re-
placement.

7.4. Inspection

After each cleaning procedure, visually inspect the MRI Sup-
port for any damage. Make sure that:
– markings are still visible on the device,
– both parts of the MRI Support are properly assembled,
– no crack can be found,
– there is no missing plastic part.

8. Using the MRI Support

CAUTION
The Pressio Monitor (PSO-3000), Pressio 2 Monitor
(PSO-4000), Catheter Extension Cable (PSO-EC20 and
PSO-EC30) and the pressure (PSO-MCxx) and temper-
ature (PSO-MCT-Y) cables are considered to be MR Un-
safe (not MRI compatible) and must not be exposed to
an MRI environment. Consequently, the Catheter must
be disconnected from the Monitor before any MRI ex-
amination.
CAUTION
Do not use the MRI Support if the device is not properly
assembled or if it is not properly placed behind the pa-
tient's head. See Section 8.1. Preparation for the MRI
examination (p. 8).

8.1. Preparation for the MRI examination

Step 1. Once the patient is installed on the MRI table, place
the MRI Support on the table itself (the foot of the support in
contact with the table) and place the MRI Support as close
as possible to the patient's head (Figure 3).
Figure 3. Positioning of the MRI Support
Step 2. Move the MRI Support so that it is placed in the cen-
ter of the table (Figure 4).