Oxygen Concentrator User Manual
RESIDUAL RISKS
Potential Risk Residual Risk
Application of Line Voltage Usage without reading user manual
Voltage Leakage To User Failure to perform leakage tests and final checks
Electric Shock Failure to perform leakage tests and final checks
Magnetic Field/Radiation EMC test values are not declared in the manual
Ionized Radiation Energy Usage outside declared values
Non-Ionising Radiation Usage outside declared values
Heat Given By Device Intervention to the device out of service
Falling Inappropriate carrying of device
High Sound Emission Improper assemble and production
Titration Improper assemble and production
Stored Energy Sensor failure or manual adjustment
Acustic Energy Usage outside declared values
Not given O2 due to cannula Failure to comply with intended use
Gases formed by chemical wastes Non-compliance with given trainings
Medical Gases Non-compliance with given trainings
Additives Failure to comply with critical raw material instruction
Residue on the device Failure to read user manual
Bacteria, virus and other agents Non-compliance with trainings and instructions
Again or Cross Infection Usage of non-informed persons
Biocompatibility Product use without CE certificate
Contaminants Not paying attention to manual
Function error Failure of final checkings and malfunction of sensors
Model Difference Patient's failure to use appropriate device
Error due to lack of attention Not paying attention to manual
Causing memory weakness Failure to use appropriate device for report and
prescription
Damage due to misuse No training and not reading of manual
Lack of knowledge Failure to read the manual and rejection of training
Frequent violations Not reading the manual and wrong habits
Improper use of device acc. No training and not reading of manual
Error before device operation Failure to read the manual and not receive training
Long-term use errors Failure to read the manual and not receive training
Lack of side eff. and warnings Not paying attention to product labels and symbols
Deflagration Not reading the manual and not paying attention to
labels
Usage in extremely humid envr. Not paying attention to product labels
Usage in a dusty environment Use of untrained persons
Using on pregnants and children Usage of untrained persons and not reading manual
Water leakage into device Usage of untrained persons and not reading manual
Problems due to critical material Failure to follow instructions
Assemble Error Staff Carelessness
Plastic manufacturing failure Failure to act in accordance with the list
Adverse events Lack of knowing responsibilities and authorities
Recalls Lack of knowing responsibilities and authorities
Untraceability Hazırlanan form ve kayıtların tutulmaması
Usage out of intended purpose Failure to fill the inspection and test forms
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