Introduction; Prerequisites; Cleaning Procedure; Disinfection Procedure - Sophysa PRESSIO Notice D'utilisation

4.1. Introduction

The cables are delivered clean, but not disinfected.
Clean all the cables and then disinfect the Catheter Exten-
sion Cable before first use and between each patient, as de-
scribed below.
WARNING
Do not clean the Monitor or the Catheter, nor disinfect
the cables, when in use on the patient.
WARNING
Do not immerse, autoclave or soak the cables in a liq-
uid. Their performance (including drift and electrical
safety) could be affected.
NOTICE
Do not use solvents or cleaning agents which could
damage the Monitor cables, such as:
– cleaning/disinfection agents (based on phenols),
– cleaning/disinfection by boiling,
– cleaning/disinfection 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.

4.2. Prerequisites

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

4.3. Cleaning procedure

The purpose of this procedure is to remove any soiling and
visible residues on the cables.
NOTE
Do not put excessive pressure on the product labels.
1. Clean the cable surfaces for at least 1 minute using pre-
soaked wipes with 70% isopropyl alcohol (IPA), to re-
move any visible residues.
Thoroughly wipe all the cables, using a new wipe for
each cable.
2. Inspect the components.
If residues remain, take a new pre-soaked wipe with
70% isopropyl alcohol (IPA) and wipe the surfaces
again.
NOTE
Repeat this step until all visible residues are re-
moved from all components.
3. Disinfect the Catheter Extension Cable as described in
the following section.

4.4. Disinfection procedure

The purpose of this procedure is to remove any microorgan-
isms present on the Catheter Extension Cable.
1. Thoroughly wipe the Catheter Extension Cable. It must
remain visibly wet for at least 2 minutes.
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If needed, use additional wipes to ensure continuous 2
minutes of wet contact time.
2. Let the Catheter Extension Cable completely air dry for 1
hour before using it again.

4.5. Inspection

After each cleaning or disinfection procedure, visually in-
spect the cables for any damage. See Section 6. Mainte-
nance of the cables (p. 9).

5. Using the cables

NOTE
Pressio Cables should only be used by trained person-
nel in medical devices.
Check that neither part of the cable has been damaged dur-
ing transport.
CAUTION
If any part of the cable is damaged, do not use it. Con-
tact Sophysa or your local distributor.
WARNING
Check proper cables connection before using your
monitoring system. Bad connection could lead to the
wrong diagnosis and thus risk patient injury.

5.1. Catheter Extension Cable

The Catheter Extension Cable is supplied with every
PSO-4000 Monitor and is also available separately.
Figure 2. Connecting system
[6] Plug [7] Fixation clips [8] Dongle Inlet
The plug (6) connects to the Monitor. A guide pin and color
code (white) facilitate proper connection.
The fixation clips (7) are tied to the bed sheets, or to the pa-
tient's clothing. Proper use of these clips limits traction on
the implanted Catheter, and reduces the risk of Catheter dis-
connection.
The dongle inlet (8) connects to the Catheter. A guide pin
and color code (blue arrows) facilitate proper connection.
At the end of the cable, insert the Catheter until you reach
the blue line. The line on the Catheter dongle indicates the
point of complete insertion.
CAUTION
Do not allow any connectors to come into contact with
liquid.