Reading And/Or Changing The Operating Pressure Of A Polaris; Setting A New Pressure - Sophysa POLARIS SPV-SX Notice D'emploi

9.3.3. Peritoneal Catheter
1. Make a short peritoneal incision in the peri-umbilical
region.
2. Tunnel the distal catheter.
3. Connect the proximal end of the catheter to the valve
outlet connector and ligate it delicately.
4. Check the flow of CSF.
5. Adapt the length of the catheter.
6. Bury the distal end of the catheter in the peritoneal
cavity.
PRECAUTION
Due to the fragility of the silicone, using metallic forceps for
inserting catheters and for ligating them onto connectors
is not recommended. This would create a risk of cutting or
piercing the catheters.
9.4. READING AND/OR CHANGING THE
OPERATING PRESSURE OF A POLARIS
IMPLANTATION
Refer to §4 – Principle of the Polaris
and for more information, refer to the instruction for use of
the Adjustment Kit.
PRECAUTION
The operation scar and/or post-operative edema can make
positioning the Locator painful and inaccurate. This could
then cause difficulties in adjustment or even make it
impossible.
For the adjustment, the patient should be positioned such
that the valve implantation site is easy to access. Having
valve horizontal is recommended.
F 8 – R
IGURE ECOMMENDED POSITIONING OF THE PATIENT
9.4.1. Pressure reading only
9.4.1.1. Identification of the valve model (Step 1b)
Identify the reference and/or the pressure range for the
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Polaris valve to be adjusted: refer to the Patient
Identification Card or to the patient's medical record
(traceability label) and/or perform an X-ray examination of
the valve (cf. §9.5 - Post-operative X-ray control
examination).
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AFTER
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Valve Adjustment,
9.4.1.2. Choice of Locator reading area (Step 2b)
Refer to §4 – Principle of the Polaris
Locating Instrument.
On the Locator, display the pressure range of the valve
model identified in Step 1b.
9.4.1.3. Positioning the Locator (Step 3b)
Palpate the valve implantation site in order to determine
both the location and orientation of the valve.
The inlet and outlet connectors at each end of the valve
and the reservoir (if fitted) are the easiest components to
locate. Find these first.
Place the Locator on the implant site with its axis aligned
with that of the valve connectors, and with the green arrow
pointing in the direction of the CSF flow.
Center the Locator above the valve as well as possible:
locate the valve by palpating it through the cut-out in the
center of the Locator.
Press the Locator firmly against the valve so as to center
and immobilize the valve.
9.4.1.4. Positioning the Compass and Reading the
Pressure (Step 4b)
Refer to §4 – Principle of the Polaris
Reading Instrument.
Hold the Locator with one hand.
Place the Compass in the Locator using the guide pins:
align the lines on the Compass with the pressure values
engraved on the Locator.
On the Locator read the operating pressure shown by the
Compass needle.
9.4.1.5. Confirmation of the reading
In the recommended implantation conditions, X-ray
examination is optional because the pressure can be read
directly using the adjustment kit. However, X-ray
confirmation is recommended in the following cases:
— if there is a discrepancy between the pressure read in
Step 4b and the value read in Step 1b on the Patient
Identification Card (PC-SPV) and/or on the X-ray
performed for the valve model identification,
— if the valve has been implanted too deeply, under
subcutaneous tissue more than 8mm thick (cf. §9.3,
Implantation technique - Valve),
— if the user is not familiar with the use of the kit;
— after an MRI examination.

9.4.2. Setting a new pressure

Refer to §9.4.1 - Operating pressure setting after
implantation: READING ONLY, Steps 1b-4b.
9.4.2.1. Orientation of the Locator (Step 5b)
It is recommended that the positioning of Locator in
relation to the axis of the valve is fine-tuned as follows:
— Remove the Compass and insert the Magnet into the
Locator with the green marker on the Magnet facing
the initial position of the pressure setting.
— Slide Magnet back and forth quickly along the axis of
the valve rotor current position as just determined in
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Valve Adjustment-
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Valve Adjustment -
ENGLISH – 13