Table of contents
1 Identification .................................................................................................... 7
1.1 Product information ........................................................................................... 7
1.2 Manufacturer ..................................................................................................... 7
2 Introduction ..................................................................................................... 8
2.1 About this Operating Manual ............................................................................. 8
2.2 Typographical conventions ................................................................................ 9
2.2.1 Safety information .............................................................................................. 9
2.2.2 Text highlights ................................................................................................. 10
2.3 General conditions ........................................................................................... 11
2.4 CE compliance ................................................................................................ 11
2.5 Sysmex representatives .................................................................................. 12
2.6 Authorised distributors ..................................................................................... 12
3 Safety ............................................................................................................. 13
3.1 Intended Use ................................................................................................... 13
3.2 Prohibited use ................................................................................................. 13
3.3 Reasonably foreseeable misuse ...................................................................... 13
3.4 User definition ................................................................................................. 13
3.4.1 User qualification groups ................................................................................. 14
3.4.2 User Qualification Matrix .................................................................................. 14
3.5 Environmental conditions ................................................................................. 14
3.6 Prohibition and warning signs on the device .................................................... 15
3.7 Personal protective equipment ........................................................................ 15
3.8 General safety ................................................................................................. 16
3.9 Laser radiation hazards ................................................................................... 16
3.10 Electrical hazards ............................................................................................ 16
3.11 Alterations to the device .................................................................................. 16
4 Overview ........................................................................................................ 17
4.1 Device ............................................................................................................. 17
4.2 Components of the device ............................................................................... 19
4.2.1 Control elements ............................................................................................. 19
4.2.2 Computer interface ports ................................................................................. 19
4.2.3 Sheath Fluid and Waste bottle ......................................................................... 19
4.2.4 Sample port with electrodes ............................................................................ 20
4.2.5 Type plate........................................................................................................ 20
4.3 Scope of delivery ............................................................................................. 21
4.4 Scope of operation .......................................................................................... 21
4.5 Reagents ......................................................................................................... 22
4.6 Accessories and spare parts ........................................................................... 23
5 Transport and storage ................................................................................... 23
6 Installation ..................................................................................................... 24
6.1 Positioning the device ...................................................................................... 24