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Bypass/alarm system test
o
The user shall briefly disconnect one inlet gas to assure that the bypass/alarm system is functioning. With a single inlet gas
disconnected, the audible alarm shall sound and the analyzed O
oxygen was disconnected and 100% if the air inlet was disconnected.
•
Accuracy of Oxygen Concentration of Delivered Gas
o
With an accurately calibrated oxygen analyzer, the user shall analyze the O
60%, 70%, 80%, 90% and 100%.
Reverse Gas Flow Procedure
•
o
Reverse gas flow is inspected by supplying pressure to one of the gas supply inlets while a test hose is connected to the other
inlet with the free end submerged in clean water. If bubbles are detected, do not use the gas mixer.
Monthly
The following more extensive procedure shall be performed at least once a month, or more frequently as indicated or desired.
This procedure provides a means of determining if the gas mixer is functioning in accordance with the design specifications. This verification is
intended to be performed in the health care setting by qualified personnel.
The procedure shall be followed exactly as outlined. If the gas mixer fails to meet the established standards, it shall be removed from clinical
application until calibration and/or service is accomplished (see troubleshooting section or service manual)
CAUTION: Personnel responsible for daily and monthly performance verification testing shall keep accurate records of testing activities.
The performance verification process requires a simple configuration as diagramed below.
Connect the gas mixer to the inlet gases with independently adjustable pressure regulators (0 – 60 psig).
Connect a flowmeter to the gas mixer outlet (for models 3600 and 3601 only).
Direct the flow from the flowmeter to a reservoir (e.g., a bottle or tube) making sure that no room air is being entrained to dilute the mixture.
Place a calibrated O
2
Test for overall accuracy
Set both inlet pressures to 50 psig (344 kPa).
Set the flowmeter to 8 lpm for configurations with the following flowmeters: 0 – 10 lpm and 100-1000 ml/min, 1 –15 lpm, 0 – 16 lpm.
Set the flowmeter to 15 lpm for configurations with the following flowmeters: 2 – 20 lpm, 2 – 32 lpm, and 3 – 30 lpm.
Compare the O
analyzer readings at the following settings: 21%, 30%, 40%, 50%, 60%, 70%, 80%, 90% and 100%. Since the gas mixer has an
2
overall accuracy of ± 3% full scale and if the analyzer accuracy is within ± 1%, the FiO
analyzer probe within the reservoir.
Page 10 • P/N 100001-EU Rev. 31 (10/2024)
% shall indicate the O
2
% at the following settings: 21%, 30%, 40%, 50%,
2
Figure 2
comparisons shall agree within ± 4% points.
2
% of the single inlet gas, i.e., 21% if the
2
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