Prerequisites; Cleaning Procedure; Disinfection Procedure; Inspection - Sophysa PRESSIO 2 PSO-4000 Manual De Instrucciones

NOTICE
Do not use solvents or cleaning agents which could
damage the Monitor casing and the 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.

8.2. PREREQUISITES

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

8.3. CLEANING PROCEDURE

The purpose of this procedure is to remove any soiling and
visible residues on the external surfaces of the Monitor, in-
cluding the touchscreen, its cables and accessories.
NOTE
Do not put excessive pressure on the product labels.
1. Clean the components for at least 1 minute using pre-
soaked wipes with 70% isopropyl alcohol (IPA), to re-
move any visible residues.
Change the wipe between each component.
a. Carefully wipe the touch screen without excessive
pressure.
b. Thoroughly wipe the external surfaces of the Moni-
tor and the cables.
2. Inspect the components.
If residues remain, take a new pre-soaked wipe with
70% isopropyl alcohol (IPA) and wipe the surfaces
again.

9. Operating Information

CAUTION
The Monitor should only be used by trained and quali-
fied personnel.
CAUTION
The implantation of the Catheter should be performed
immediately after the Catheter is zeroed. It is therefore
essential to prepare for the implantation of the Catheter,
by referring to the Instructions for Use of the Catheter
kit to be used, before using the Monitor.
CAUTION
Prior to each patient, inspect the Monitor casing and all
the cables to ensure none of these components are
damaged.
CAUTION
If a message indicating a low battery level displays on
the touch screen when powering on, connect the Moni-
tor to mains power.
NOTE
Repeat this step until all visible residues are re-
moved from all components.
Let the components completely air dry for 1 hour before
using them again.
3. Disinfect the Catheter Extension Cable as described in
the following section.

8.4. 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.
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.

8.5. INSPECTION

After each cleaning or disinfection procedure, visually in-
spect the components for any damage.
Check the visual aspect of the cables before use.
Make sure that:
– there is no foreign body in the cable plug,
– electrical connections of the plug are not twisted,
– there are no visible cracks on the cable,
– cable markings are still visible.
The cables have an expected lifetime of 2 years in normal
use (disconnecting and reconnecting between each monitor-
ing). However, the results of the visual checks listed above
prevail. These visual checks will indicate whether or not the
cables can still be used.
WARNING
Catheters and the catheter extension cable are not pro-
tected against defibrillation and may be damaged as a
result.
Before defibrillation:
– Disconnect the catheter extension cable from the
Catheter.
– Withdraw the Catheter, if possible. If this is not possi-
ble, for safety reasons, replace the Catheter after de-
fibrillation to continue monitoring.
Frequently used features
Frequently used features of the Monitor include the following:
– Display of the mean ICP value, and systolic and diastolic
ICP values. See Section 5.4.2.1. Intracranial Pressure (ICP)
(p. 15).
– Display of the ICP curve. See Section 5.4.2.3. ICP Curve
(p. 15).
– Display of the ICT value. See Section 5.4.2.2. Intracranial
Temperature (ICT) (p. 15).
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