CPAP Bench Test Protocol V1.

0, 21/3/20

BENCH TEST PROTOCOLS

Conversion factors:
From cm H2O to Pa: x98.1
From L/min to m^3/s: x60,000

Figure 1- Bench test setup

BASIC FUNCTIONAL TEST

1.0 Oxygen Supply Pressure

TEST 1: Oxygen supply should be at 4 +/- 0.25 bar

2.0 Initial No Flow Leak Test

2.1 Connect device to oxygen supply and flow meter as Figure 1 with 10cm H20
PEEP valve
2.2 Close all valves of the flow generator (clockwise)

TEST 2: Verify flow output is < 0.3 L/min

3.0 Minimum Oxygen Available Test

3.1 Open on/off valve and flow control valve fully (anti-clockwise)
3.2 Verify FiO2 valve is fully closed (clockwise)

TEST 3.1: Verify oxygen percentage is < 32%

3.3 Adjust flow control valve to achieve flow rate of 60 +/- 3 L/min

TEST 3.2: Verify oxygen percentage is <36%

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 CPAP Bench Test Protocol V1.0, 21/3/20

4.0 Maximum Oxygen Available Test

4.1 Open FiO2 valve to maximum (anti-clockwise)
4.2 Adjust flow control valve to achieve flow rate of 60 +/- 3 L/min

TEST 4: Verify oxygen percentage is >95 %

5.0 Final No Flow Leak Test

5.1 Close all valves of the flow generator (anti-clockwise)

TEST 5: Verify flow output is < 0.3 L/min

PERFORMANCE TEST

6.0 Oxygen Available Test

6.1 Close all valves of the flow generator and place PEEP valve as per TABLE 1 and
Figure 1 (5, 10 or 15cm H20)
6.2 Open on/off valve fully (anti-clockwise)
6.3 Verify FiO2 valve is fully closed (clockwise)
6.4 Adjust flow control valve to achieve flow rates in TABLE 1 (40, 60, 80, 100 or 120
L/min)

TEST 6: Verify oxygen percentage meets value in TABLE 1 +/- 2 %

TABLE 1
Oxygen Available [%]
PEEP Valve
Flowrate [L/min]
5cm H20 10cm H2O 15cm H2O
40 +/- 2 30.8 33.0 34.4
60 +/- 3 29.2 30.6 31.6
80 +/- 4 28.4 29.4 30.0
100 +/- 5 28.2 29.0 29.5
120 +/- 6 28.2 29.0 29.2

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 CPAP Bench Test Protocol V1.0, 21/3/20

7.0 Maximum Flow Versus Pressure

7.1 Close all valves of the flow generator and place PEEP valve as per TABLE 2 and
Figure 1 (5, 10 or 15cm H20)
7.2 Open on/off valve fully (anti-clockwise)
7.3 Verify FiO2 valve is fully closed (clockwise)
7.4 Open flow control valve fully (anti-clockwise)

TEST 7: Verify flowrate meets values in TABLE 2

TABLE 2
Maximum Flowrate [L/min]
PEEP Valve
5cm H20 10cm H2O 15cm H2O
156 +/- 15 144 +/- 14 132 +/- 13

8.0 Oxygen Consumption

8.1 Close all valves of the flow generator and place 10cm H2O PEEP valve as per
Figure 1
8.2 Place additional flow meter between oxygen supply and oxygen input on flow
generator
8.3 Open on/off valve fully (anti-clockwise)
8.4 Adjust flow control valve to achieve flow rates in TABLE 3 (40, 60, 80, 100 or 120
cm H20)
8.5 Adjust FiO2 valve to achieve patient oxygen concentration in TABLE 3 (30, 50,
70 or 100%)

TEST 8: Verify Oxygen consumption flowrate meets values in TABLE 3

TABLE 3
Oxygen Supply Consumption at 10cm H20 [L/min]
Flowrate Patient Oxygen Concentration [%]
[L/min] 30 +/- 2 50 +/- 2 70 +/- 2 100 +/- 2
40 +/- 2 6 +/- 0.5 18 +/- 1 24 +/- 2 40 +/- 4
60 +/- 3 8 +/- 0.5 24 +/- 2 36 +/- 3 60 +/- 6
80 +/- 4 10 +/- 1 30 +/- 3 50 +/- 5 78 +/- 7
100 +/- 5 12 +/- 1 40 +/- 4 62 +/- 6 100 +/- 10
120 +/- 6 14 +/- 1 46 +/- 4 74 +/- 7 118 +/- 11