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4.
Keeping the Magnet as centered as possible, turn it until
it reaches the axis corresponding to the desired pres-
sure.
5.
Remove the Magnet vertically to keep the proper orien-
tation of the rotor.
6.
Check the setting using the Compass and Locator or
with an X-ray.
10.3. Specific case of valves implanted upside down
Upside-down implantation (but with the flow direction re-
spected) will be recognizable on X-ray.
NOTE
For a valve implanted on the skull, the radiopaque
dot(s) should be either pointing toward the patient's
nose (if the valve is implanted on their right side) or
pointing away from their nose (if the valve is implanted
on their left side).
If the valve is implanted upside down, setting is possible but
must be performed using the following sequence:
1.
Position the Locator in the opposite direction of the flow
(arrow towards the inlet connector).
2.
Center the Locator-Compass assembly using the target
of the Compass.
3.
Carry out the reading and then the adjustment in ac-
cordance with the steps described in Section 8.2. Read-
ing and/or changing the valve pressure after implantation
(p. 13), using the symmetrical indication on the Locator.
4.
Check the new adjustment by X-ray examination.
10.4. Reading of valves implanted in conditions other
than those recommended
The implantation of a valve not performed under the recom-
mended conditions may lead to a Compass reading of a
pressure value inconsistent with the patient's medical record
or clinical status.
In this case, X-ray examination will dispel any doubts as it
provides absolute proof of the correct adjustment of the
valve and the correct direction of its implantation.
11. Storage
CAUTION
Due to the power of its magnetic field, the Magnet must
be stored in its shielded case when it is not being used.
CAUTION
Do not expose the adjustment kit to temperatures high-
er than 50°C (122°F). The function of the Magnet could
be adversly altered.
CAUTION
Do not store the adjustment kit close to a source of
magnetic fields to preserve the ability of the magnet to
function properly.
Keep all the components of the adjustment kit together in
their original shielded case after use, or when stored.
Store the shielded case in a cool, dry place away from light.
The products are designed to withstand a storage tempera-
ture up to 50 °C (122 °F).
12. Processing of the products after use
12.1. Products return
To return a faulty product, contact a Sophysa representative
to obtain the explanatory return form to be provided.
Do not do anything to the product so that its condition dur-
ing analysis is as representative as possible.
Return all the components of the adjustment kit in its original
shielded case.
12.2. Products elimination
CAUTION
The Magnet contains components that must be dis-
posed of properly. Failure to do so may lead to environ-
mental pollution.
Clean the product carefully (see Section 7. Cleaning and dis-
infection procedure (p. 11)) and send the product back to
Sophysa for proper elimination, in its original shielded case.
13. Monitoring of the product safety
As part of its continual improvement program, Sophysa asks
its customers to inform it and the legal authority of the coun-
try of any unexpected and serious problems that occur with
the product.
14. Warranty
The performance and safety of the adjustment kit is ensured
only with the Sophy range of valves, designed, tested and
manufactured by Sophysa.
Sophysa warrants the performance and safety of this medi-
cal device under the normal conditions of the intended use
of the device, adapted to its intended purpose and use, and
in accordance with these Instructions for Use.
The medical device must be stored and transported in an en-
vironment and under conditions that also comply with the in-
formation in these Instructions for Use. These storage and
transport conditions have been tested and validated by So-
physa. Thus, Sophysa does not grant any other express or
implicit guarantee as for the good conservation and the safe-
ty of the product in other premises than its own which would
not respect these conditions. Likewise, no express or implicit
guarantee is granted by Sophysa as to the suitability of the
product for the use which will be made of it, or its adaptation
to a particular use, except within the indications and the in-
tended purpose of the product, or when it has been trans-
formed, modified or repaired except within the instructions of
Sophysa.
Under no circumstances, Sophysa can be held responsible
in case of damages, for any incident and/or complication, re-
sulting from damage or prejudice arising directly or indirectly
from the unsuitable use of the device and/or a use of the de-
vice which fail to conform or the non-respect of its condi-
Page 17 of 76
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