Codman Hakim Bedienungsanleitung Seite 20

3. If necessary, adjust the height of the manometer to bring the water
level in the manometer to the same level as the fluid in the water
bath
Manometer Test Procedure
1. Reconnect the sterile valve to the sterile test apparatus It is
recommended that this step be performed under water in the water
bath to prevent the reintroduction of air bubbles into the valve
2.
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
3. 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
4.
Adjust the stopcock to connect the syringe to the manometer (Figure A-6)
and refill the manometer to a height equal to the opening pressure setting
of the Codman Hakim Valve plus 50 mm For example, a high pressure
Codman Hakim Precision Fixed Pressure Valve is preset to a pressure of
130 mm H 2 O (1274 Pa), so that the height of the fluid in the manometer
would be 130 mm + 50 mm = 180 mm (18 cm) (1274 Pa + 490 Pa = 1764 Pa)
This procedure minimizes the possibility of inadvertently activating the
SiphonGuard Device during manometer testing
5. Turn the stopcock to connect the manometer to the valve
(Figure A-7)
6.
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 2 O
(20 Pa) in a 2-minute period
7. 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
8.
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 2 O (248 Pa) are
possible based upon the test method utilized Expect the same device to
produce opening pressure results within ±10 mm H 2 O (98 Pa) of the valve
setting utilizing an industry standard test method such as ASTM F647 or
ISO 7197
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REASONABLE CARE IN THE SELECTION OF MATERIALS AND THE
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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
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