Configurations Of The Polaris ® Valve; Measurement Unit And Calibration Of Operating Pressures; Case Of Classical Valves (Without Siphonx ® ) - Sophysa POLARIS SPV-SX Notice D'emploi

— - to unlock the valve,
— - to adjust the operating pressure by rotating the
Magnet.
Clockwise rotation increases the operating pressure of the
valve, while counter-clockwise rotation reduces it.
NOTE
If a valve is pre-connected to a SiphonX
siphon device, when adjusting take into account the fact
®
that the SiphonX adds up to 200 mmH
operating pressure.
NOTE
Do not attempt to turn the Magnet if it is not centered in the
Locator, or if it is not completely inserted into the Locator.
Unlocking of the valve rotor could be compromised.
A green marker pointing to the pressure values in the
Locator reading area and the "clicks" produced when the
Magnet rotates make it possible to determine the
successive operating pressures set by the Magnet.
Removing the Magnet activates the automatic re-locking
of the valve rotor due to the mutual attraction of the two
mobile micro-magnets.
PRECAUTIONS
Always take the Magnet out off the Locator vertically. This
ensures optimum locking of the rotor in its new position.
Failure to remove the Magnet from the Locator vertically
risks changing the selected position and/or causing
incorrect locking of the rotor.
Do not store or handle the Magnet near any device likely to
be affected by a powerful magnetic field.
Do not place the Magnet close to a powerful magnetic field
(e.g. MRI). It could become a dangerous projectile or its
performance could be affected.
Handle the Magnet with care near metallic objects (e.g.
hospital furniture). They could be violently attracted.
5. Configurations of the Polaris
®
The Polaris adjustable pressure valve is available in 4
different pressure ranges, each of which offers 5 pressures
(cf. §3 - Table of Pressure Ranges).
®
The Polaris valves in the " standard " pressure ranges
(30-200 mmH O) are available in 3 models :
2
— without a reservoir (SPV),
— with an integrated reservoir of the antechamber type
(SPVA),
— with an integrated reservoir of the burr hole type
(SPVB).
These 3 models are available as the valve alone or as a
complete kit which includes a ventricular catheter, and a
preconnected peritoneal catheter (Figures 1 & 2).
®
The Polaris valves in the " special " pressure ranges
(10-140, 50-300, and 80-400 mmH
models :
— without a reservoir (SPV-140, SPV-300 and SPV-400)
— with an integrated reservoir of the antechamber type
(SPVA-140, SPVA-300 and SPVA-400).
8 – ENGLISH
®
gravitational anti-
O to the valve
2
®
valve
O) are available in 2
2
These "special pressure" valves are not available as
complete kits; only the valve is available.
The standard pressure Polaris
SPVB), as well as the special low pressure valves
(SPV-140 and SPVA-140), are also available with a
®
SiphonX "gravitational"
connected downstream of the valve.
®
SiphonX makes it possible to add additional resistance to
the operating pressure of the Polaris
depends on the position of the patient (cf. §6 - Table of
Operating Pressures for Polaris
®
SiphonX ).
The 5 corresponding models (SPV-SX, SPVA-SX, SPVB-
SX, SPV140-SX and SPVA140-SX) are only available as the
valve alone form (with pre-attached anti-siphon device) and
are not available as complete kits.
Sophysa offers a complete range of ventricular and distal
radio-opaque catheters which allow the CSF to flow to the
valve and from the valve to the peritoneum or right atrium
respectively, depending upon the type of shunt chosen by
the neurosurgeon.
®
A complete Polaris shunt system must consist of a
ventricular catheter, a Polaris
(atrial or peritoneal).
®
Each Polaris valve
Identification Card (PIC) and traceability labels.
The surgeon is responsible for filling in this Patient
Identification Card and giving it back to the patient.
6. Measurement Unit and Calibration of
Operating Pressures
The pressures mentioned are in mmH
1 mmH O corresponds to 9.807 Pa or 0.074 mmHg.
2
The valves are calibrated on the basis of a flow rate of 10
ml/h.
Each valve is tested individually: the measurement
concerns the upstream pressure of a 10 ml/h flow of water
passing through the valve and the Sophysa proximal and
distal catheters.
The calibration is performed disregarding the resistance of
the catheters.
6.1. CASE OF CLASSICAL VALVES (WITHOUT
®
SIPHONX )
Thus the pressures given on the valve labels correspond to
the resistance of the valve alone.
The catheters add their own resistance to the shunt.
The reservoirs are not considered to have any particular
resistance.
The calibration of Polaris
tolerance of -10/+15 mmH
®
valves (SPV, SPVA and
anti-siphon device,
®
valve. This resistance
®
valves with pre-attached
®
valve and a distal catheter
is packaged with a
O.
2
®
valves is performed with a
O on the measured pressures.
2
pre-
Patient