Users Manual Part 1

Operator’s Manual i
Contents
1 Safety Information .................................................................................................................. 1 - 1
1.1 Labels and Symbols on the System ............................................................................... 1 - 1
1.2 Safety-related Symbols and Messages ........................................................................... 1 - 8
1.2.1 General Safety Messages ..................................................................................... 1 - 8
1.2.2 Analyzer Transportation and Installation-related Safety Messages .................... 1 - 9
1.2.3 Safety Messages Related to Reagents, Controls, and Calibrators ..................... 1 - 10
1.2.4 Maintenance-related Safety Messages .............................................................. 1 - 10
1.2.5 Laser Warning ................................................................................................... 1 - 11
1.2.6 Network Security ............................................................................................... 1 - 12
2 Using This Manual ................................................................................................................. 2 - 1
2.1 Overview ........................................................................................................................ 2 - 1
2.2 Who Should Read This Manual ..................................................................................... 2 - 1
2.3 How to Find Information ............................................................................................... 2 - 1
2.4 Conventions Used in This Manual ................................................................................. 2 - 2
3 Understanding Your System .................................................................................................. 3 - 1
3.1 Intended Use .................................................................................................................. 3 - 1
3.2 Test Parameters .............................................................................................................. 3 - 1
3.2.1 Blood Sample Test Parameters, Histograms, and Scattergrams ......................... 3 - 2
3.3 Description ..................................................................................................................... 3 - 4
3.3.1 Structure and Components .................................................................................. 3 - 4
3.3.2 Modules and Components ................................................................................... 3 - 5
3.3.3 Accessories .......................................................................................................... 3 - 8
3.4 Overview of Software Interfaces ................................................................................... 3 - 9
3.5 Reagents, Controls and Calibrators .............................................................................. 3 - 12
3.5.1 Reagents ............................................................................................................ 3 - 12
3.5.2 Controls and Calibrators .................................................................................... 3 - 13
4 Understanding the System Principles ................................................................................... 4 - 1
4.1 Overview ........................................................................................................................ 4 - 1
4.2 WBC Measurement ........................................................................................................ 4 - 1
4.2.1 SF CUBE Cell Analysis Technology .................................................................. 4 - 1
4.2.2 Derivation of WBC-Related Parameters ............................................................. 4 - 3
4.3 Hemoglobin Concentration Measurement ..................................................................... 4 - 4
4.3.1 A Test Model Using the Colorimetric Method ................................................... 4 - 4
4.3.2 Derivation of HGB .............................................................................................. 4 - 5
4.4 RBC/PLT Measurement ................................................................................................ 4 - 5
4.4.1 Sheath Flow Impedance Method ......................................................................... 4 - 5
4.4.2 SF CUBE Cell Analysis Technology .................................................................. 4 - 5
4.4.3 RBC-Related Parameters ..................................................................................... 4 - 6
4.4.4 PLT-Related Parameters ...................................................................................... 4 - 6
4.4.5 Reticulocyte Parameters ...................................................................................... 4 - 7
4.5 Wash .............................................................................................................................. 4 - 7