Chapter 1

Introduction

Chapter 1 Introduction
Thank you for purchasing the Sysmex Flow Cytometer XF-1600. Please read this manual carefully before
operating this product, and keep it in a safe place for future reference.

Note:
• Data generated by the XF-1600 is not intended to replace professional judgment in the determination of
a diagnosis or in monitoring patient therapy.
• Operate the instrument as instructed. Reliability of test results cannot be guaranteed if there are any
deviations from the instructions in this manual. If the instrument fails to function properly as a result of
either a user's operation not specified in this manual or a user's utilization of a program not specified by
Sysmex, the product warranty will be void.

In vitro diagnostic medical device

Contact Addresses
1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan
Authorized representatives
Europe, Middle East and Africa
Bornbarch 1, 22848 Norderstedt, Germany
Tel +49 40 5 27 26-0 / Fax +49 40 5 27 26-100

Americas
577 Aptakisic Road, Lincolnshire, IL 60069, U.S.A.
Tel +1-224-543-9500 / Fax +1-224-543-9505
Asia-Pacific
9 Tampines Grande #06-18 Singapore 528735
Tel +65-6221-3629 / Fax +65-6221-3687
Ordering of consumables/supply parts/options
If you need to order consumables, accessories, or options, please contact your
authorized local Sysmex representative.
Service and maintenance
Please contact your authorized local Sysmex representative.

The system described in this manual is marked with the CE mark, which
confirms compliance with the applicable requirements of:
• Regulation (EU) 2017/746 on in vitro diagnostic medical devices
• Directive 2011/65/EU on the restriction of the use of certain hazardous
substances in electrical and electronic equipment and its related amending
directives including (EU) 2015/863 amending Annex II of Directive 2011/65/
EU

9/312
XF-1600 Instructions for Use