Adjusting The Pressure Prior To Implantation; Checking The Compatibility Between The Valve And Adjustment Kit; Displaying The Correct Pressure Range On The Locator; Positioning The Locator - Sophysa POLARIS Gebrauchsanweisung

CAUTION
Do not use an adjustment kit without previously check-
ing under the Locator that it corresponds to the valve
model used.
Overdrainage or underdrainage can result from taking a
reading and/or adjustment with a pressure range on the
Locator different from that of the implanted valve mod-
el.
Figure 2. Bottom of the Locator
The reference "PAK2-LI" and the sentence "Designed exclu-
sively for use with POLARIS
sure to use the Locator with the right valve model.

8.1. Adjusting the pressure prior to implantation

CAUTION
Do not unpack or implant the valve without previously
adjusting it to the initial operating pressure defined by
the neurosurgeon.
Before opening the sterile packaging, it is necessary to
adjust the rotor in the position that corresponds to the pres-
sure selected by the surgeon for the implantation.
The double sterile packaging for each Polaris valve includes
a housing specifically for adjusting the valve through the
packaging.
8.1.1. Checking the compatibility between the valve and
adjustment kit
1. Check the model and pressure range of the valve to be
adjusted against the label on the packaging.
2. Check under the Locator that it is compatible with the
valve model used:
– reference is PAK2-LI,
– sentence says "Designed exclusively for use with PO-
®
LARIS SPV series".
Page 12 of 82
®
SPV series" are there to make
8.1.2. Displaying the correct pressure range on the Loca-
tor
CAUTION
Do not use an adjustment kit without ensuring that the
pressure range visible on the Locator corresponds to
the valve model to be implanted.
1. Check that the pressure range displayed in the Locator
reading area corresponds to the previously identified
valve model.
2. If this is not the case, display the pressure range which
corresponds to the model of the valve to be implanted:
a. Hold the Locator with one hand.
b. Turn the rotating ring until a "click" is heard. This
click guarantees that a complete pressure range is
displayed.
c. Repeat the operation until the valve model used ap-
pears at the left end and the 5 pressures are visible.

8.1.3. Positioning the Locator

Position the Locator in the place provided on the shell of the
outer packaging, centered above the valve, with the arrow of
the Locator pointing in the direction of the CSF flow as
shown by the arrow on the valve.

8.1.4. Reading the pressure

1. Insert the Compass fully into the Locator.
Align the lines on the Compass with the pressure values
printed on the Locator, if this is not already the case.
2. On the Locator, read the pressure value shown by the
Compass needle.
NOTE
Reading of the pressure can also be performed visually
without using the adjustment kit, as the rotor and the
radiopaque points are visible through the valve and the
double sterile packaging.

8.1.5. Adjusting the pressure

1. Remove the Compass.
2. Align the mark of the Magnet with the pressure read in
the previous section, and slide the Magnet vertically into
the Locator without changing the orientation of the Mag-
net.
3. Turn the Magnet until it reaches the position chosen as
the pressure for the valve to be implanted.