Potential Causes Of Adjustment Diffi Culties And Troubleshooting - Sophysa POLARIS SPV-140 Gebrauchsanweisung

N :
OTE
D M
O NOT ATTEMPT TO TURN THE AGNET IF IT IS NOT CENTERED ON THE
NOT COMPLETELY INSERTED INTO THE
.
COMPROMISED
P :
RECAUTION
A M
LWAYS REMOVE THE AGNET FROM THE
.
OF THE ROTOR IN ITS NEW POSITION
F M
AILURE TO REMOVE THE AGNET FROM THE
/
POSITION AND OR CAUSING INCORRECT LOCKING OF THE ROTOR
7) Confi rming the operating pressure setting
Checking is performed using the Compass in accordance with the procedure described
in Step 4.
Figure 25
Confi rmation can also be performed by X-ray.
In the recommended implantation conditions, because direct pressure readings are
possible with the adjustment kit, X-ray examination is optional. However, if the
information is to be placed in the patient record, an X-ray should be performed.
N :
OTE
S
ETTING THE CHOSEN OPERATING PRESSURE CANNOT ALWAYS BE PERFORMED AT THE FIRST ATTEMPT
I
T IS POSSIBLE THAT THE PROCEDURE WILL HAVE TO BE REPEATED ONE OR MORE TIMES
ENSURE THAT THE DESIRED PRESSURE SETTING IS OBTAINED
P :
RECAUTIONS
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
A P
DJUSTING THE PRESSURE USING A OLARIS
IS NOT FAMILIAR WITH THE USE OF THE KIT
X- .
BE CONFIRMED WITH AN RAY
I
T IS ADVISABLE TO MONITOR THE PATIENT CAREFULLY FOR
THE VALVE OPERATING PRESSURE SETTING
8) Recording the new operating pressure
Note the pressure value read in Step 7 on the Polaris® Patient Identifi cation Card
(PIC).

Potential Causes of Adjustment Diffi culties and Troubleshooting

Poor positioning of the Locator in relation to the center of the valve or incorrect
orientation of this Locator in relation to the axis of the connectors may lead to
an inaccurate or incorrect reading of the operating pressure on the Compass and/or
diffi culties in making adjustments with the Magnet.
Before anything else, check that the Locator is correctly positioned and oriented
above the valve (cf. Steps 3 "Positioning the Locator" and 5 "Orientation of
the Locator" in the §10 - Adjustment of a Polaris® Valve after implantation).
L
OCATOR
L . U
OCATOR NLOCKING OF THE VALVE ROTOR COULD BE
L . T
OCATOR VERTICALLY HIS ENSURES OPTIMUM LOCKING
L
OCATOR VERTICALLY RISKS CHANGING THE SELECTED
.
.
,
MAKE SURE THAT THE
0.5
M AROUND THE
®
ADJUSTMENT KIT REQUIRES EXPERIENCE
,
IT IS RECOMMENDED THAT THE PRESSURE ADJUSTMENT
24
HOURS FOLLOWING ANY CHANGE IN
.
P
RECAUTION
, I
OR IF IT IS T IS NECESSARY TO ENSURE THAT THE
ITS BASE IS ABSOLUTELY PARALLEL TO THE VALVE SURFACE
B -
EING OFF CENTER BY MORE THAN
CAUSE AN INCORRECT PRESSURE READING OR INCOMPLETE UNLOCKING OF THE ROTOR
IMPOSSIBLE FOR THE ROTOR TO ROTATE AND THUS THE PRESSURE TO BE CHANGED
Figure 26a
Figure 26b
.
,
IN ORDER TO
M
AGNET OR ANY
C
OMPASS SO THAT
. However, there may be other causes for diffi culties in adjustment:
- Excessively thick sub-cutaneous tissue above the valve (>8mm) caused,
. I
F THE USER
for example, by post-operative edema, a hematoma or cicatricial tissue would
make the localization of the valve inaccurate, thus causing complications in
the pressure adjustment procedure.
- The presence of debris or deposits inside the valve could also make adjustment
using the usual procedure diffi cult.
A special procedure may then be applied to facilitate the adjustment of the valve,
possibly using a fl uoroscopic examination:
A. 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 fi tted) are the easiest components to locate. Locate these fi rst.
B. Place the
adhering to the orientation of the valve, and centered as well as possible over
the valve.
Note the direction of the Compass needle, aligned on the axis of the rotor of
the implanted valve.
C. Remove the
the Magnet aligned with the direction of the rotor located in the previous step.
16
:
L
OCATOR IS CORRECTLY CENTERED ABOVE THE VALVE AND THAT
2
MM OR ANY INCLINATION IN RELATION TO THE VALVE COULD
Compass, without the Locator, directly onto the implant site,
Compass and place the Magnet directly onto the implant site, with
(F 26 & 26 ).
IGURES A B
,
MAKING IT
.