Polaris ® Adjustment Kit-2 (Pak2); Intended Use; Indications; Patient Populations - Sophysa POLARIS Gebrauchsanweisung

WARNING
Federal (USA) law restricts this device to sale by or on
the order of a physician.
CAUTION
Read these Instructions for Use carefully before adjust-
ing the valve operating pressure.

1. Intended use

The Polaris Adjustment Kit-2 is intended to read and change
the operating pressure of a Polaris valve in order to adapt to
the clinical need and evolution of the patient.

2. Indications

The Polaris Adjustment Kit-2 is indicated for patients implan-
ted with a Polaris valve to treat hydrocephalus, subaracho-
noid 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 Polaris valve is fitted with a patented mag-
netic locking system made up of two mobile micro-magnets.
Changing the operating pressure of the Polaris 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. Polaris Adjustment Kit-2
Contains a Magnet, a Locator, a Compass, the present In-
structions For Use and a Quick Start Guide.
The Polaris Adjustment Kit-2 (hereinafter referred to as PAK2)
is designed specifically for setting the pressure of the Polaris
valves.
It is not made with natural or synthetic latex.
The components of the PAK2 are packaged non-sterile in a
reusable box with magnetic shielding.
CAUTION
The PAK2 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 Polaris valves regardless of their
pressure range (see Table 1).
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.
Table 1. Table of pressures for Polaris valves
Valve model SPV-140
listed on the
Locator
References SPV-140,
concerned
SPV-140-SX,
SPVA-140,
SPVA-140-
SX
Radiographic 0 point
identification
of the model
SPV SPV-300 SPV-400
SPV, SPV-300 SPV-400
SPV-2010,
SPVA-300 SPVA-400
SPV-SX,
SPVA,
SPVA-2010,
SPVA-SX,
SPVB,
SPVB-2010
1 point 2 points 3 points
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