A-A-51581A
Open-cell foam elastomers are prohibited. The resuscitator, including listed components, shall be capable of being sterilized repeatedly using cold chemical disinfectant liquid(s), and using ethylene oxide or by steam autoclaving at temperatures up to 134oC.
All materials shall be inherently corrosion resistant or treated for corrosion resistance.
The face mask shall be sized to fit a medium size adult face. It shall have a soft rim which seals effectively and conforms well to facial anatomy. The mask shall be transparent clear or have a transparent (clear) center section. It shall have 22/15 mm connectors which shall be in accordance with ASTM Standard F-920, General Requirements.
The patient valve shall prevent rebreathing of the patient’s exhaust gas, shall permit spontaneous breathing when ventilating bag is not being operated, shall direct bag pumped gas to the patient, and shall resist jamming despite temperature extremes, presence of debris, moisture or supplemental oxygen inflow as great as 10 LPM. The valve shall be transparent and have a standard 22/15 mm connector, at the face mask end, which shall be in accordance with ASTM Standard F-920. It shall be easy to disassemble/assemble and clean and its components shall be designed/sized to prohibit incorrect assembly. The valve dead space shall not exceed 12 ml.
The ventilator bag shall be single hand operable and capable of performing as specified when operated by a hand which has maximum values listed below:
a. Hand length (wrist joint to tip of longest finger) - - 6.32 in.
b. Hand breath (across finger joints in palm) - - - 2.72 in.
c. Hand grip strength (momentary hold, females) - - 39 lbs.
The ventilator bag shall have a minimum volume of 1000 ml and be capable of delivering 1000 ml per squeeze when operated at a rate of 50 cycles per minute by a hand no greater than listed above. The bag shall be provided with one-way valve for ambient gas admission.
The pressure limiting system shall be either a single component such as a relief valve or a design feature of combined components such as double ventilator bag (actual ventilator bag inside a pressure control bag). It shall sense the down-stream pressure (lung pressure) and shall allow as much, but no more than, 70 cm H20 (± 10 cm H20) pressure to be delivered. Shall provide an audible or visible warning if activated. Shall provide a means by which the limiting system may be over-ridden. Shall fully comply with ASTM F 920 Standard.
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