Intended Use; Indications; Patient Populations; Environment Of Use - Sophysa SOPHY SAK Notice D'utilisation

WARNING
Read the Instructions for Use carefully before adjusting
the valve operating pressure.

1. Intended use

The Sophy Adjustment Kit is intended to read and change
the operating pressure of a Sophy valve in order to adapt to
the clinical need and evolution of the patient.

2. Indications

The Sophy Adjustment Kit is indicated for patients implanted
with a Sophy valve to treat hydrocephalus, subarachonoid
cysts, or idiopathic intracranial hypertension (IIH), also called
Pseudotumor cerebri.

3. Patient populations

The device can be used on patients of all ages, including
pre-term infants.

4. Environment of use

Post-operative follow-up is done at the hospital (consulta-
tion, imaging service, emergency room), clinic or doctor's of-
fice.
The device must only be used by a neurosurgeon. It is not in-
tended for use in a patient's home. Patients are never expec-
ted to use the device by themselves.

5. Contraindications

This device is not intended for any use other than those indi-
cated in these Instructions for Use.

6. Description

The rotor of the Sophy valve is fitted with a patented mag-
netic locking system made up of two mobile micro-magnets.
Changing the operating pressure of the Sophy valve is per-
formed through the skin via a magnetic field using an adjust-
ment kit made up of 3 parts:
– Locating instrument (hereinafter referred to as Locator),
– Reading instrument (hereinafter referred to as Compass),
– Setting instrument (hereinafter referred to as Magnet).
For simplicity, for the rest of these Instructions for Use, the
"operating pressure of the valve" will be referred to as "pres-
sure".
Figure 1. Sophy Adjustment Kit
Contains a Magnet, a Locator to adjust SM8 valves (SAK-
LI-1), a Compass, the present Instructions For Use and a
Quick Start Guide. An additional Locator (SAK-LI-2) can be
purchased in option to adjust SM3 valves.
The Sophy Adjustment Kit (hereinafter referred to as SAK) is
designed specifically for setting the pressure of the Sophy
valves.
It is not made with natural or synthetic latex.
The components of the SAK are packaged non-sterile in a
reusable box with magnetic shielding.
CAUTION
The SAK must not be used in an MRI environment.
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.

6.1. Locator

The Locator is used to locate the valve through the skin.
It is designed to work with Sophy valves regardless of their
pressure range (see Table 1 or Table 2 according to the valve
used).
It houses the Compass and the Magnet in turn.
The Locator is the only component to be in contact with the
patient's skin for a limited time (a few minutes) when check-
ing or adjusting the pressure. More rarely, it may also be in
contact with the scar tissue when used post-operatively,
though the scar is usually protected with a dressing.
Two Locators are available:
– SAK-LI-1 for the adjustment of SM8 valves,
– SAK-LI-2 for the adjustment of SM3 valves (optional).
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