Demonstration Valve; Cleaning And Disinfection Procedure; Introduction; Prerequisites - Sophysa Sophy Notice D'utilisation

The Magnet is made up of a specific assembly of magnets
designed to enable the rotor to be unlocked and the pres-
sure of the Sophy valve to be adjusted.
To operate correctly, the Magnet must be properly centered
above the valve and aligned with the valve rotor.
The Magnet fits into the Locator.
It makes it possible to adjust the pressure by rotating the
Magnet.
[10] Red mark. Used to align the Magnet with the valve rotor
using the indication given by the Compass.
[11] Lateral lugs. Used to vertically guide the Magnet into the
internal grooves of the Locator.
[12] Handle.
CAUTION
Always remove the Magnet from the Locator vertically
to keep the proper orientation of the rotor.

6.4. Demonstration valve

A demonstration valve is supplied in the adjustment kit. It
provides training for adjusting the valve while displaying
changes in the position of the rotor during the adjustment
procedure.

7. Cleaning and disinfection procedure

7.1. Introduction

The adjustment kit is delivered clean, but the Locator is not
disinfected.
While the risk of infection is low (limited contact with the
skin, either healthy skin or scar tissue), clean all the adjust-
ment kit components and disinfect the Locator before first
use and between each patient, as described in this section.
CAUTION
Do not sterilize or immerse the adjustment kit compo-
nents. Irreversible alterations to the markings, distortion
of the plastic parts and/or demagnetization of the Mag-
net risk rendering the adjustment kit unusable.
CAUTION
Non-adherence to the disinfection rules described in
this section could induce a risk of microbial contamina-
tion.
NOTICE
Do not use solvents or cleaning/disinfectant agents
which could damage the kit components:
– phenol-based cleaning/disinfectant agents,
– cleaning/disinfection by boiling,
– cleaning/disinfection with hot air/steam,
– acetone, ammonia, benzene, bleach, chlorine, chlori-
nated water, water above 60°, paint thinners, tri-
chloroethylene.
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 residue from the external surfaces of the adjustment
kit components.
1. Clean the components for at least 1 minute using pre-
soaked wipes with 70% isopropyl alcohol (IPA), to re-
move any visible residue. Change the wipe between
each component.
2. Inspect the components.
If residue remains, 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 Locator as described in the following sec-
tion.

7.4. Disinfection procedure

The purpose of this procedure is to remove any microorgan-
isms present on the Locator.
WARNING
Disinfect the Locator before first use and between each
patient. Failure to do so may provoke an infection, lead-
ing to surgery.
1. Thoroughly wipe the Locator using pre-soaked wipes
with 70% isopropyl alcohol (IPA). It must remain visibly
wet for at least 2 minutes.
Take extra care when disinfecting the base of the Loca-
tor which is in contact with the patient's skin.
If needed, use additional wipes to ensure continuous 2
minutes of wet contact time.
2. Let the Locator completely air dry for 1 hour before us-
ing it again.

7.5. Inspection

After each cleaning and disinfection procedure, visually in-
spect the components for any damage. See Section 9.1. Vis-
ual checks (p. 15).
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