Integra LifeSciences CODMAN HAKIM Precision Fixed Pressure Valves Mode D'emploi page 19

Zeroing the Manometer
1.
After refilling the manometer, turn the stopcock to connect the
manometer with the bath (Figure A-7).
Figure A-7
2. Allow the water column in the manometer to fall. The water column
should stop at the zero level of the manometer (Figure A-5).
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
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-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
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.
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OR IMPLIED, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED
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O (1274 Pa), so that the height of the fluid in the manometer
2
O (98 Pa) of the valve
2
11
O (20 Pa) in a
2
O (248 Pa) are
2