4. Personnel instructions and training4. Personnel instructions and training
According to Medical Devices Directive 93/42/EEC, the product user must ensure that all personnel handling the product
is provided with the operating instructions & performance data, given here below & included in appendix nr 1 & 2.
According to Medical Devices Directive 93/42/EEC, the product user must ensure that all personnel handling the product
is provided with the operating instructions & performance data, given here below & included in appendix nr 1 & 2.
The user shall ensure that all personnel handling the product at each operation are fully trained to carry out that
operation and are fully aware of the relevant requirements of this instruction for use. Trainees need to be supervised by
an experienced person.
The user shall ensure that all personnel handling the product at each operation are fully trained to carry out that
operation and are fully aware of the relevant requirements of this instruction for use. Trainees need to be supervised by
an experienced person.
Contact GCE if further information is required on GCE product training program.Contact GCE if further information is required on GCE product training program.
5. Product description5. Product description
The low pressure regulator mainly consists of, an inlet quick connector, a flow control head and a flow outlet user
connection Gas from the medical gas pipeline system entering through the inlet connector, then calibrated in the flow
control head and deliver to the user through the flow outlet user connection.
The low pressure regulator mainly consists of, an inlet quick connector, a flow control head and a flow outlet user
connection Gas from the medical gas pipeline system entering through the inlet connector, then calibrated in the flow
control head and deliver to the user through the flow outlet user connection.
Different flows can be selected by the flow control knob on the flow head. Refer to appendix Nr 1 to see features
available on your low pressure regulator.
Different flows can be selected by the flow control knob on the flow head. Refer to appendix Nr 1 to see features
available on your low pressure regulator.
5.1 Inlet quick connector (QC)5.1 Inlet quick connector (QC)
The low pressure regulator is fitted to the medical gas pipeline system terminal unit or to medical regulator by a gas
specific male probe.
The low pressure regulator is fitted to the medical gas pipeline system terminal unit or to medical regulator by a gas
specific male probe.
Refer to appendix Nr 1 to get information about quick coupler type on your low pressure regulator.Refer to appendix Nr 1 to get information about quick coupler type on your low pressure regulator.
5.2 Flow control head5.2 Flow control head
Different flows can be selected by the flow control knob on the flow head. Depending on product variant, the flow
control head may be fitted with a stop function in between maximum flow and zero position.
Different flows can be selected by the flow control knob on the flow head. Depending on product variant, the flow
control head may be fitted with a stop function in between maximum flow and zero position.
5.3 User outlet5.3 User outlet
The “flow outlet” user connection is the outlet from the flow control head normally with a push on hose fitting (hose
nipple) or threaded (for humidifier for instance)
The “flow outlet” user connection is the outlet from the flow control head normally with a push on hose fitting (hose
nipple) or threaded (for humidifier for instance)
This outlet is for supplying a gas flow (l/min) at atmospheric pressure directly to a patient, e.g. through a cannula or a facemask.This outlet is for supplying a gas flow (l/min) at atmospheric pressure directly to a patient, e.g. through a cannula or a facemask.
Refer to appendix Nr 1 to get information about flow outlet type on your low pressure regulator.Refer to appendix Nr 1 to get information about flow outlet type on your low pressure regulator.
•The product is not fitted with a pressure relief valve. The user must ensure that an over pressure
protection is in place on the medical gas supply pipeline (see requirement of ISO 7396-1) or on medical
regulator (see requirement of ISO 10524-1, 3).
•The flow outlet shall not be use for driving any medical device.
Note also that products colour (specially flow control knob bone) might not follow any gas colour coding.
6. Operations
6.1 Before use
Visual Inspection before fitting
•Check if there is visible external damage on the low pressure regulator (including product labels and marking). If
it shows signs of external damages, remove the low pressure regulator from service and identify its status.
•Visually check if the low pressure regulator or the whole package is contaminated; if needed, apply the cleaning
procedure according to cleaning procedure here under
•Check if the service or the disposal time has not been exceeded, using GCE or owner’s date coding system. If
service or disposal time has been exceeded, remove the low pressure regulator from service & suitably identify
its status
•Set flow control knob on ZERO position - until the flow control knob engages.
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