The MetaNeb® System Instructions for Use (174432 REV 10) 35
Specifications
Environmental Conditions for Transport and Storage
1
Environmental Conditions for Transport and Storage with Packaging
Environmental Conditions for Use
CLASSIFICATION AND STANDARDS
Condition Range
Temperature -13° to 158°F (-25° to 70°C)
ambient temperature
Relative humidity Up to 90% non-condensing
1. These conditions and values apply to a fully-assembled MetaNeb® System.
Condition Range
Temperature -40° to 158°F (-40° to 70°C)
ambient temperature
Relative humidity range 10% to 95% non-condensing
Atmospheric pressure 55 kPa to 106 kPa
Condition Range
Temperature 41° to 104°F (5° to 40°C) ambient
temperature
Relative humidity range 15% to 90% non-condensing
Atmospheric pressure 70 kPa to 106 kPa
Technical and Quality Assurance ISO 13485
EN13544-1
FDA Medical Device Equipment
Classification
Class II
Classification According to
Medical Device Directive
93/42/EEC
IIa
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