Introduction, Software packages, About this guide – Luminex xPONENT 3.1 Rev 2 (IVD) User Manual

Page 11: Chapter 1 introduction, Software packages about this guide, Chapter 1: introduction

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The Luminex system was developed to improve workflow and efficiency in the clinical
laboratory and in research and development. End users in the laboratory must run microtiter
plates using xMAP

®

-based assay kits developed for use with xMAP technology.

Software Packages

xPONENT

®

software has different levels of functionality:

• Allows you to perform analysis from IVD protocols and batches, review and print reports,

and perform Luminex system maintenance.

• Instrument Control - Allows the application to connect to and communicate with an

instrument identified by a specific serial number.

• Secure - Includes all of the Basic functionality, as well as administrator-controlled user

permission levels.

• 21 CFR Part 11 - Includes all of the Secure functionality as well as requiring electronic

signatures to perform certain tasks. Electronic signatures are listed in the system log.
Electronic signatures for batch functions are also listed in the batch audit log.

• Remote Web Monitoring - Allows you to view alerts and system status using a webpage.

• LIS - Includes the ability to communicate with an external Laboratory Information System

(LIS) database. The LIS edition allows the export of patient result data in ASTM file format
and the import of patient sample information in ASTM format

You will need an instrument control license to operate the instrument.

For more information on purchasing upgraded packages or to obtain specific package
documentation, contact your vendor.

About this Guide

The conventions in this document assume a basic familiarity with computers and a
knowledge of Microsoft

®

Windows

®

software. Commands are often available through more

than one method, such as from the toolbar and from menus that appear when right-clicking
an area of the screen. However, for ease of use the individual procedures in this manual
describe only one method for accessing commands.

Chapter 1: Introduction

1

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