Warranty - Codman HAKIM Bedienungsanleitung

3.
Remove the distal catheter at this time.
Note: The attachment of a distal catheter can alter the test results as
well as increase test time. This is not possible with unitized versions
of the CODMAN HAKIM Valve. Allot additional time for testing of
unitized versions.
4. Submerge the valve completely in the water bath. For the unitized
version, submerge the outlet of the distal catheter in the water bath to
obtain accurate results. Confirm that there are no bubbles attached to
the tip of the distal catheter and that the water bath does not obstruct
the tip of the catheter.
5. Adjust the stopcock to connect the syringe to the manometer
(Figure A-6 above) and refill the manometer to a height equal to the
opening pressure setting of the CODMAN HAKIM Valve plus 50 mm.
If the CODMAN HAKIM Valve is programmed to an opening pressure
of 120 mm H
is 120 mm + 50 mm = 170 mm (17 cm) (1176 Pa + 490 Pa = 1666
Pa). This procedure minimizes the possibility of inadvertently activating
the SIPHONGUARD Device during manometer testing.
6. Turn the stopcock to connect the manometer to the valve
(Figure A-7 above).
7. The water column in the manometer will start to fall. Allow the water
column to drop for 3–5 minutes or until a steady state is reached.
A steady state is defined as a change of less than 2 mm H
in a 2-minute period.
8.
For valves with SIPHONGUARD Device, an extended test time is
recommended in order to compensate for the possibility of a decreased
flow rate due to SIPHONGUARD Device activation. Allow the water
column to drop for 5–7 minutes or until a steady state is achieved.
9.
Read the resultant pressure.
Variations between the manometer closing pressure test result and the
CODMAN HAKIM Valve setting of as much as ±25 mm H
possible based upon the test method utilized. Expect the same device to
produce opening pressure results within ±10 mm H
setting utilizing an industry standard test method such as ASTM F647
or ISO 7197.

WARRANTY

Codman & Shurtleff, Inc. warrants that this medical device is free
from defects in both materials and workmanship. Any other express or
implied warranties, including warranties of merchantability or fitness,
are hereby disclaimed. Suitability for use of this medical device for
any particular surgical procedure should be determined by the user
in conformance with the manufacturer's instructions for use. There are
no warranties that extend beyond the description on the face hereof.
® CODMAN, SIPHONGUARD, and RICKHAM are registered trademarks of
DePuy Synthes Products, Inc.
® PROLENE is a registered trademark of Ethicon, Inc.
® HUBER is a registered trademark of Becton, Dickinson, and Co.
® EXCITE is a registered trademark of General Electric Company
® HAKIM is a registered trademark of Hakim USA, LLC and is used under license
by DePuy Synthes Products, Inc.
FRANÇAIS
INFORMATIONS IMPORTANTES
À lire avant utilisation
Valves programmables
CODMAN
Description
Les valves programmables CODMAN HAKIM comprennent un mécanisme
d'ouverture (figures 1 & 2) qui intègre un ressort plat en acier inoxydable
316L et dans lequel l'étalonnage s'effectue au moyen d'un montant et
d'un pivot télescopique micro-réglable. Le châssis de la valve est en
titane. La bille et le cône sont fabriqués en rubis synthétique. La pression
intraventriculaire se maintient à un niveau constant grâce à l'appui de la
bille sur le cône de la valve.
Le réglage de pression du ressort dans la valve d'admission est ajusté
sans invasion chirurgicale par l'intermédiaire d'un programmateur externe qui
active le moteur pas à pas dans le logement de la valve. Le programmateur
transmet au moteur un signal magnétique codé permettant 18 réglages
de pression, allant de 30 mm à 200 mm de H
de 10 mm (98 Pa). Les pressions opératoires de l'unité de valve ont été
déterminées pour un débit compris entre 15 et 25 ml de H
O (1176 Pa), the height of the fluid in the manometer
2
HAKIM
® ®
O (98 Pa) of the valve
2
O (294 à 1960 Pa) par paliers
2
14
O (20 Pa)
2
O (248 Pa) are
2
O par heure.
2