Fresenius Medical Care AquaA, Instructions For Use Manual

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Chapter 15: Appendix
222 Fresenius Medical Care AquaA IFU-EN-US 06B-2021
AquaA Contents of the Medical Device Register
1 Instructions for Use
Monitoring
2 System monitoring
– Operational data acquisition reports
3 Microbiological and chemical monitoring
– Results of the microbiological analysis
– Results of the chemical analysis
– Sample collection plans
4 Disinfection
– Disinfection reports
– Disinfection plans
5 Settings reports
6 Service reports, Training records, Malfunctions
– Training records
– Service reports and documentation of modifications to the system options
– Reporting of incidences
– Documentation of malfunctions and repeated, identical operating errors
7 Technical Safety Checks (TSC) and revalidation
Validation phase
8 Installation qualification (IQ)
– Installation report
– Validation plan
9 Operational qualification (OQ)
– Disinfection report OQ
– Settings report OQ
– Training record OQ
– Sampling plan OQ
– Disinfection plan OQ
– Start-up report OQ
10 Performance qualification (PQ)
– Operational data acquisition report PQ
– Results of the microbiological analysis PQ
– Results of the chemical analysis PQ