K-Patents PR-23 for K-Patents Appendix - Manual (Page 4)

Document/Revision No. IM-GB-PR23-ACP: Rev. 1.01 Effective: November 1, 2013
4
Appendix to the Instructions Manual PR-23
Section 6 Onsite Qualification Protocols and Records: Installation Qualification ..................... 33
6.1 Authorization and responsibilities ................................................................................ 33
6.1.1 Documents and procedures ............................................................................ 33
6.1.2 Authorized officiator ......................................................................................... 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 Qualification Summary Report .................................................................. 42
Section 7 Onsite Qualification Protocols and Records: Operational Qualification .................... 43
7.1 Individual module and system components check ...................................................... 43
7.2 Installation Qualification has been performed successfully ........................................ 43
7.3 Test procedure ............................................................................................................. 44
7.4 Authorized officiator ..................................................................................................... 44
7.5 System qualification ..................................................................................................... 45
7.6 Setting up the system components and devices ......................................................... 45
7.7 Instrument verification with Sample holder and Refractive Index Liquids ................... 46
7.8 Operational Qualification Summary Report ................................................................ 47
Section 8 Routine Operation Phase .................................................................................................. 49
Section 9 Preventive Maintenance..................................................................................................... 51
Section 10 Other Documentation ......................................................................................................... 53