Oxygen Concentrator User Manual
Contunation of identified prolems Failure to perform corrective actions
Packaging Mistake Failure to comply with procedure
Labelling Mistake Failure to comply with instructions
Lack of operational instructions Failure to read user manual
Disposal of the device to trash Usage of untrained persons and not reading manual
Lack of warnings Not reading the manual, not paying attention to the
label
Software Failure Failure to perform final control tests
Processor Failure Failure of performing input checkings
Failure of the device Failure to act in acordance with user manual
Sensor Errors Failure to perform final checks
Device error after service Failure to act in accordance with the instruction
Failure of the device Failure to comply with instructions
Not enough oxygen for patient Usage of untrained persons and not reading manual
Encountered Problems Lack of risk assessment
Storage Concitions Failure to comply with requirements on product labels
RELATED DIRECTIVES
Medical Devices Directive 93/42 / EEC is taken as reference.
ELECTROMAGNETIC COMPATIBILITY
Foras OXY Oxygen Concentrator complies with the electromagnetic compatibility
limitations of the medical device directive 93/42/EEC. (En 55011 BF class and EN 60601-
1-2) IEC 60601-1-2 requirements for EMC have been completed.
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