Implantation Technique - Sophysa POLARIS SPV-140 Gebrauchsanweisung

Figure 13
P :
RECAUTION
W
HEN READING THE POSITION OF THE PRESSURE SETTING
OTHER FERROMAGNETIC OBJECT IS NOT WITHIN A RADIUS OF
A FALSE READING IS NOT INDUCED BY THE INFLUENCE OF AMBIENT MAGNETIC FIELDS
Checking can also be performed visually, without using the Polaris® adjustment kit,
as the rotor is visible through the valve and the blister pack.
Figure 14
7) Recording the operating pressure chosen for the implantation
Note the pressure value read in Step 6 on the Polaris® Patient Identifi cation Card (PIC).

Implantation Technique

Implantation of a Polaris® valve must take account of current aseptic neurosurgical
practices.
The implantation of a shunt including a Polaris®valve may be performed in several
ways.
The surgeon will choose the technique depending upon his experience and
the clinical status of the patient.
The fi nal implantation of the device must satisfy the conditions for optimal drainage
of the CSF.
The surgeon must select the implantation area taking into account the fact that
the valve is a potential source of artifacts when an MRI examination is performed
(cf. §7 - Behavior during Magnetic Resonance Imaging (MRI)).
P :
RECAUTION
D
O NOT PERFORM THE IMPLANTATION OF A SHUNT WITHOUT HAVING A REPLACEMENT SHUNT SYSTEM
.
AVAILABLE IN CASE IT IS REQUIRED
, M
MAKE SURE THAT THE AGNET OR ANY
0.5 C
M AROUND THE OMPASS SO THAT
.
W :
ARNING
D
O NOT CARRY OUT AN ADDITIONAL TEST BEFORE IMPLANTATION
. A
CALIBRATED AND CHECKED NY PRE
.
INFECTION
Ventricular Catheter
- Introduce the catheter into the ventricle using the introducing stylet supplied
for this purpose.
- If necessary, adjust the implantation depth of the ventricular catheter with
the right angle adapter supplied. Position it in the axis of the burr hole.
- Purge the catheter of air with the CSF.
- If necessary, check that the reservoir is properly fi lled, and then clamp.
- Connect and delicately ligate the catheter to the inlet connector of the
valve (or that of the reservoir for valve models with integrated reservoirs).
Check that the arrow located on the upper surface of the valve is correctly
oriented in the direction of the fl ow. The clamp can then be released.
W :
ARNING
E
NSURE THAT THE ARROW ON THE UPPER SURFACE OF THE VALVE IS CORRECTLY ORIENTED IN
:
THE DIRECTION OF THE FLOW ASSEMBLY OF THE VALVE IN THE OPPOSITE DIRECTION WOULD PREVENT
.
ANY DRAINAGE
P :
RECAUTION
D
UE TO THE FRAGILITY OF THE SILICONE
FOR LIGATING THEM ONTO CONNECTORS IS NOT RECOMMENDED
CUTTING OR PIERCING THE CATHETERS
Valve
P :
RECAUTION
P ®
OLARIS MODELS MUST BE IMPLANTED ON A BONY SURFACE
8 .
THAN MM THICK
T
HE SELECTED IMPLANTATION SITE MUST BE SUFFICIENTLY UNENCUMBERED TO FACILITATE DETECTION
L
OF THE VALVE BY THE OCATOR WHEN ADJUSTMENTS ARE MADE LATER
,
AROUND THE VALVE AWAY FROM THE EAR AND THE NECK
I
F THESE PRECAUTIONS ARE NOT OBSERVED
EVEN BE IMPOSSIBLE TO MAKE AN ADJUSTMENT
L M
OCATOR OR THE AGNET MOVING THE ROTOR INSUFFICIENTLY
- Purge the valve of air. To prevent any risk of introducing an air bubble,
it is recommended that the valve be left to fi ll directly with the patient's
CSF. In the majority of cases, the valve fi lls immediately.
However, in patients with low intracranial pressure or if the valve is set to a high
pressure, the valve may not fi ll spontaneously.
In this case:
place a piece of catheter on the outlet connector and slowly aspirate the CSF
using a syringe fi tted with a Luer connector
or even:
press the dome of the reservoir to allow the CSF to fi ll the valve (case of SPVA
and SPVB type models).
P :
RECAUTION
D
O NOT FILL OR PURGE THE VALVE WITH ANY LIQUID OTHER THAN THE PATIENT
(WFI)
FOR INJECTION BEFORE IMPLANTATION TO AVOID ANY RISK OF DEPOSITS IN THE VALVE
COULD LEAD TO AN OBSTRUCTION IN THE SHUNT SYSTEM OR A BLOCKAGE IN THE VALVE MECHANISM
- Check that the valve is correctly fi lled with CSF and there are no air bubbles
inside the valve. If this is not the case, continue to purge. The presence of air
bubbles could cause a signifi cant change to the operating pressure initially
chosen.
- Check that the arrow on the upper surface of the valve is visible and correctly
oriented in the direction of the CSF fl ow.
12
:
EACH VALVE HAS BEEN INDIVIDUALLY
-
OPERATIVE PRESSURE TESTS WILL INCREASE THE RISK OF
,
USING METALLIC FORCEPS FOR INSERTING CATHETERS AND
. T
HIS WOULD CREATE A RISK OF
.
, -
UNDER SUB CUTANEOUS TISSUE LESS
(
SPACE OF AT LEAST
).
,
THERE MAY BE DIFFICULTIES WITH ADJUSTMENT OR IT MAY
,
DUE TO POOR LOCALIZATION OF THE VALVE BY THE
.
4
CM ALL
' CSF
S OR WATER
,
WHICH
.