991-3003 Rev. 1.0
August 2013
4
Table of contents
Quick Guide ................................................................................................................................................................ 5
Installation Guide ....................................................................................................................................................... 6
Installation Overview ..................................................................................................................................................... 6
Minimum Computer Requirements and Preparations before Installation .................................................................... 6
Installing the NucleoView™ Software and NucleoCounter® Instrument ....................................................................... 6
Installing Licenses and Protocols .................................................................................................................................. 13
Software Upgrade ........................................................................................................................................................ 14
Installing a new NucleoCounter® Instrument .............................................................................................................. 14
Uninstall NucleoView™ Software ................................................................................................................................. 14
Validation with IQ, OQ and PQ protocols ...................................................................................................................14
Installation Qualification (IQ Test)................................................................................................................................ 15
Operation Qualification (OQ Test)................................................................................................................................ 16
Performance Qualification (PQ Test)............................................................................................................................ 17
Main Window ............................................................................................................................................................18
Menu Line ..................................................................................................................................................................... 20
Selecting a Protocol ...................................................................................................................................................22
Analysis Results .........................................................................................................................................................23
Browse Analysis Results ............................................................................................................................................25
File Browser ...............................................................................................................................................................27
File Properties ...........................................................................................................................................................28
Report Generator ......................................................................................................................................................29
Image Scaling .............................................................................................................................................................30
Image Overlay ...........................................................................................................................................................31
Next Analysis .............................................................................................................................................................32
Protocols ...................................................................................................................................................................33
Protocol Adaptation Wizard ......................................................................................................................................34
Plot Manager .............................................................................................................................................................35
Layout Editing ............................................................................................................................................................... 36
Plot Statistics ................................................................................................................................................................ 37
Row Window in Plot Manager ...................................................................................................................................... 37
Histogram Plot in Plot Manager ................................................................................................................................... 39
Large Histogram Plot in Plot Manager ......................................................................................................................... 40
Scatter Plot in Plot Manager ........................................................................................................................................ 42
Large Scatter Plot in Plot Manager ............................................................................................................................... 43
Plot Manager Gate Configuration ................................................................................................................................ 45
Compensation Window ................................................................................................................................................ 46
Export Data ...............................................................................................................................................................48
Options ......................................................................................................................................................................49
21 CFR Part 11 ...........................................................................................................................................................50
Requirements on the Microsoft Windows Computer System ..................................................................................... 50
NucleoView™ User Groups ........................................................................................................................................... 50
Approval ....................................................................................................................................................................... 51
Event Log ...................................................................................................................................................................... 51
License, Protocol and Documentation Installation .....................................................................................................52
Maintenance and Backup ..........................................................................................................................................53
NucleoView™ Software Maintenance .......................................................................................................................... 53
NucleoCounter® Instrument Maintenance .................................................................................................................. 53
How To ......................................................................................................................................................................54
How to Get Context Sensitive Help .............................................................................................................................. 54
How to Verify Correct Operation of the NucleoCounter® Instrument after Transportation ....................................... 54
Keyboard Shortcuts ...................................................................................................................................................55
Trouble Shooting .......................................................................................................................................................56
