Chapter 1

1.1

Introduction

Intended purpose

The Sysmex Flow Cytometer XF-1600 is intended for use as an in vitro diagnostic device for immunophenotyping.
It is equipped with 10 fluorescence detection channels and two light scatter channels by means of a blue (488
nm) laser, a red (638 nm) laser, and a violet (405 nm) laser. It is to be used by healthcare professionals and
properly trained personnel in a laboratory environment. It is intended to be used to analyze human specimens
in conjunction with appropriate antibody reagents to generate information that will serve as an aid to diagnosis,
monitoring, or prognosis. The Sysmex Flow Cytometer XF-1600 works as an automated analyzer to provide
quantitative results. Manual review of the results and visual inspection of the plots is recommended.
For appropriate use of the product, refer to the instructions for use of the applicable reagents.

Caution
Diagnosis must be made using comprehensive judgment of all available information including but not
limited to immunophenotyping, pathological results, clinical symptoms, and patient history.

1.2

Overview of the system

The instrument consists of an analyzer and an Information Processing Unit (IPU).

1.3

About this manual

The following manual is provided with this instrument.
Type
Instructions for Use

Description
This manual explains how to operate the instrument.

Information
The English manual is provided with the instrument. For the translated most current version, please contact
your authorized local Sysmex representative.

1.3.1 Points to note about this manual
• You may not reproduce the contents of this manual in whole or in part without permission from Sysmex
Corporation.
• Images in this manual related to the product are for illustrative purposes only and may not exactly match the
product itself.
• While we have taken all possible precautions to ensure the quality of this manual, please contact your
authorized local Sysmex representative if you find any errors or omissions.

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XF-1600 Instructions for Use