The MetaNeb® System User Manual (174432 REV 7) 31
Technical Specification for Performance—Breathing Simulator
CLASSIFICATION AND STANDARDS
TECHNICAL SPECIFICATION FOR PERFORMANCE—BREATHING
SIMULATOR
The performance checks shown on page 32 were measured by use of a
breathing simulator.
WARNING:
Due to excessive restriction of valves in the Controller, reduced
performance levels may result when gas supply pressures
< 50 psi (345 kPa) are used.
For these checks, we used a compressed gas supply of 50 to 55 psi
(345 to 379 kPa) and the Breathing Simulator settings shown here:
Technical and Quality Assurance ISO 13485
EN60601-1
EN13544-1
FDA Medical Device Equipment
Classification
Class II
Classification According to Medical Device
Directive 93/42/EEC
IIa
Breathing Simulator Settings
Lung Resistance 20 cmH2O/l/s
Lung Compliance 50 mL/cmH2O
Breath Rate 20 bpm
Effort Amplitude 25 cmH2O
Target Volume 500 mL
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