À Lire Avant Utilisation - Integra LifeSciences Codman HAKIM Mode D'emploi

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.
PRODUCT INFORMATION DISCLOSURE
INTEGRA LIFESCIENCES CORPORATION ("INTEGRA") HAS EXERCISED
REASONABLE CARE IN THE SELECTION OF MATERIALS AND THE
MANUFACTURE OF THESE PRODUCTS. INTEGRA WARRANTS
THAT THESE PRODUCTS SHALL CONFORM TO THE PRODUCT
LIMITED WARRANTY AS PROVIDED IN THE PRODUCT LABELING OR
APPLICABLE PRODUCT CATALOG. THIS WARRANTY IS EXCLUSIVE,
AND INTEGRA DISCLAIMS ALL OTHER WARRANTIES, WHETHER
EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED TO, ANY
IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE. INTEGRA SHALL NOT BE LIABLE FOR ANY
INCIDENTAL OR CONSEQUENTIAL LOSS, DAMAGE, OR EXPENSE,
DIRECTLY OR INDIRECTLY ARISING FROM USE OF THESE PRODUCTS.
INTEGRA NEITHER ASSUMES NOR AUTHORIZES ANY PERSON TO
ASSUME ANY OTHER OR ADDITIONAL LIABILITY OR RESPONSIBILITY
IN CONNECTION WITH THESE PRODUCTS.
Codman, SiphonGuard, and Rickham are registered trademarks of Integra
LifeSciences Corporation or its subsidiaries in the United States and/or other
countries.
PROLENE is a trademark of Ethicon, Inc.
EXCITE is a trademark of General Electric Company.
Hakim is a registered trademark of Hakim USA, LLC and is used under license.
FRANÇAIS
INFORMATIONS IMPORTANTES
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Valves programmables
CODMAN
Description
Les valves programmables CODMAN
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.
O (1176 Pa), the height of the fluid in the manometer
2
HAKIM
® ®
O (98 Pa) of the valve
2
® HAKIM ® comprennent un
13
O (20 Pa)
2
O (248 Pa) are
2