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•
set flow control knob on ZERO position - ensure the flow control knob engages correctly,
For combination valves without flow head:
•
ensure that shut-off valve is turned off,
•
insert a quick-coupler probe in the combination valve quick-coupler (Refer to appendix Nr 2
to get information about connecting / disconnecting procedure of quick coupler type on your
product).
•
wait until the combination valve has completely been vented,
•
disconnect quick-coupler probe,
Only use genuine GCE filling adaptors. Contact GCE to get information about available
filling adaptor for your product.
Connect genuine GCE filling adaptor. Do not use excessive torque when connecting
EN
the filling adaptor.
GCE do not recommend using power drivers or impact drivers to connect filling adapter
(excessive force & shocks could result in damage to the filling port). Contact GCE to
ensure that the filling port features on your product are compatible with power drivers
or impact drivers.
Non GCE filling adaptors can damage the non-return valve in the filling port and impact
the safety of the product.
Medical Gas Package Filling
If the combination valve is used to dispense medical gases within the EC, only gases which
have been manufactured according to the requirement of Good Manufacturing Practice
(GMP), detailed in the EC Good Manufacturing Practice guide and defined in EC Directive
91/356EEC Annex 6 should be used. Further guidance can be found in EIGA document IGC
Doc 99/03/E Good Manufacturing Practice Guide for Medical Gases.
•
Prior to filling carry out checks (refer to appendix nr. 3 "Pre / Post filling checks").
•
During filling, the shut-off valve must be fully open.
•
After filling ensure that shut-off valve is closed. When turning off at the shut-off valve do not
use excessive force (Maximum recommended closing torque is 3 Nm).
•
The filling line (including the filling high-pressure hose) must be vented to disconnect the
filling adaptor).
•
Before to release the medical gas primary package for patient use, perform functional and
leak-tight checks Refer to appendix nr 3 "Pre/Post filling checks", which includes leak-tight
test according EIGA document IGC Doc 99/03/E Good Manufacturing Practice Guide.
A special attention should be paid to the following items:
•
pressure gauge functionality,
•
for combination valves fitted with a flow head, check that there is a gas flow at each setting
(for instance, by sound or special leak detector),
•
integrity of product label, gas label, anti-tamper label (depending on the type), flow marks
on flow control head,
•
presence of protective caps & plugs.
Do not use leak detection fluids containing ammonia or other substances which can
promote stress corrosion cracking in brass materials or can affect other materials.
On oxygen equipment use only leak detection fluids approved for use with oxygen
systems. Contact GCE if further information is needed on approved leak fluids for your
product.
If the relief valve opens, return the valve to GCE for service.
After completion of the functional and leak-tight checks, refit the filling port, pressure outlet and
flow outlet protection cap as soon as possible. Before refitting the caps ensure that they are
clean. Use only genuine GCE caps. If required, check that the anti-tamper label is in position.
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