|
Filter performance – (must be ≥ X % efficient)
|
≥ 95%
|
≥ 94%
|
≥ 95%
|
≥ 94%
|
≥ 94%
|
≥ 95%
|
|
Test agent
|
NaCl
|
NaCl and paraffin oil
|
NaCl
|
NaCl
|
NaCl and paraffin oil
|
NaCl
|
|
Flow rate
|
85 L/min
|
95 L/min
|
85 L/min
|
95 L/min
|
95 L/min
|
85 L/min
|
|
Total inward leakage (TIL)*– tested on human subjects each performing exercises
|
N/A
|
≤ 8% leakage (arithmetic mean)
|
≤ 8% leakage (arithmetic mean)
|
≤ 8% leakage (individual and arithmetic mean)
|
≤ 8% leakage (arithmetic mean)
|
Inward Leakage measured and included in User Instructions
|
|
Inhalation resistance – max pressure drop
|
≤ 343 Pa
|
≤ 70 Pa (at 30 L/min) ≤ 240 Pa (at 95 L/min) ≤ 500 Pa (clogging)
|
≤ 350 Pa
|
≤ 70 Pa (at 30 L/min) ≤ 240 Pa (at 95 L/min)
|
≤ 70 Pa (at 30 L/min) ≤ 240 Pa (at 95 L/min)
|
≤ 70 Pa (w/valve) ≤ 50 Pa (no valve)
|
|
Flow rate
|
85 L/min
|
Varied – see above
|
85 L/min
|
Varied – see above
|
Varied – see above
|
40 L/min
|
|
Exhalation resistance - max pressure drop
|
≤ 245 Pa
|
≤ 300 Pa
|
≤ 250 Pa
|
≤ 120 Pa
|
≤ 300 Pa
|
≤ 70 Pa (w/valve) ≤ 50 Pa (no valve)
|
|
Flow rate
|
85 L/min
|
160 L/min
|
85 L/min
|
85 L/min
|
160 L/min
|
40 L/min
|
|
Exhalation valve leakage requirement
|
Leak rate ≤ 30 mL/min
|
N/A
|
Depressurization to 0 Pa ≥ 20 s
|
Leak rate ≤ 30 mL/min
|
Visual inspection after 300 L/min for 30 s
|
Depressurization to 0 Pa ≥ 15 s
|
|
Force applied
|
− 245 Pa
|
N/A
|
− 1180 Pa
|
− 250 Pa
|
N/A
|
− 1470 Pa
|
|
CO2 clearance requirement
|
N/A
|
≤ 1%
|
≤ 1%
|
≤ 1%
|
≤ 1%
|
≤ 1%
|
