K-patents PR-23 for K-Patents Appendix Manual de usuario descargar pdf (Pagina 4)

Document/Revision No. IM-GB-PR23-ACP: Rev. 1.01 Effective: November 1, 2013

Appendix to the Instructions Manual PR-23

Section 6 OnsiteQualicationProtocolsandRecords:InstallationQualication ..................... 33

6.1 Authorization and responsibilities ................................................................................ 33

6.1.1 Documents and procedures ............................................................................ 33

6.1.2 Authorizedofciator ......................................................................................... 34

6.1.3 Execution ......................................................................................................... 34

6.2 System ......................................................................................................................... 34

6.2.1 Qualifying the system ...................................................................................... 34

6.2.2 Manufacturers and suppliers ........................................................................... 34

6.3 IQ Protocol ................................................................................................................... 35

6.3.1 Scope of delivery ............................................................................................. 35

6.3.2 Damage ............................................................................................................ 36

6.4 Documentation ............................................................................................................. 36

6.5 Operating environment ................................................................................................ 37

6.6 Installation .................................................................................................................... 37

6.7 Setting up the system components and devices ......................................................... 38

6.8 Electricalconnectionsandwiring ................................................................................ 39

6.9 Ethernet connection ..................................................................................................... 40

6.10 ComputercommunicationsoftwareFC-11 .................................................................. 40

6.11 Initialcheckandswitchingthedeviceon ................................................................... 40

6.12 InstallationQualicationSummaryReport .................................................................. 42

Section 7 OnsiteQualicationProtocolsandRecords:OperationalQualication .................... 43

7.1 Individual module and system components check ...................................................... 43

7.2 InstallationQualicationhasbeenperformedsuccessfully ........................................ 43

7.3 Test procedure ............................................................................................................. 44

7.4 Authorizedofciator ..................................................................................................... 44

7.5 Systemqualication ..................................................................................................... 45

7.6 Setting up the system components and devices ......................................................... 45

7.7 InstrumentvericationwithSampleholderandRefractiveIndexLiquids ................... 46

7.8 OperationalQualicationSummaryReport ................................................................ 47

Section 8 Routine Operation Phase .................................................................................................. 49

Section 9 Preventive Maintenance..................................................................................................... 51

Section 10 Other Documentation ......................................................................................................... 53

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K-patents PR-23 for K-Patents Appendix Manual de usuario Pagina 4