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Beckman Coulter UniCel DxC 600 User Manual

Beckman Coulter UniCel DxC 600
498 pages
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A13914AF
April 2010
Instructions For Use
Volume 1
UniCel
®
DxC Synchron
®
Clinical Systems
For In Vitro Diagnostic Use
This manual is intended for
UniCel
®
DxC 600
UniCel
®
DxC 800
UniCel
®
DxC 600i
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, CA 92821

Table of Contents

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Beckman Coulter UniCel DxC 600 Specifications

General IconGeneral
TypeClinical Chemistry Analyzer
Sample TypesSerum, Plasma, Urine
Power Supply100-240 VAC, 50/60 Hz
Number of Tests100+
WeightApproximately 80 kg

Summary

Revision History

Safety Notice

Summary of Hazards

Summarizes hazards associated with the DxC System, including individual hazards for specific procedures.

Bar Code Reader Hazards

Warns against tampering with bar code reader housing due to laser hazard.

Biohazardous Materials Hazards

Advises observance of laboratory policies for handling infectious and pathogenic materials.

Hardware Symbols and Labels

Instrument Power Switch, ON

Describes the symbol indicating the analyzer power is ON when the switch is in the down position.

High Voltage Electric Shock Risk

Symbol indicates high voltage presence and risk of electric shock in the area.

Documentation Symbols

Alerts for Warning, Caution, Important, and Note

Explains the meaning and usage of WARNING, CAUTION, IMPORTANT, and NOTE symbols in documentation.

CHAPTER 1: System Description

System Components

Outlines the main components of the UniCel DxC System, including Sample Handling, Modular Chemistry, and others.

Sample Handling System

Describes the Sample Handling system, composed of racks, autoloader, shuttle, bar code reader, etc.

Modular Chemistry (MC) System

Details the Modular Chemistry system, comprising reagent storage, ratio pump, sample probe, flow cell, and reaction modules.

Cartridge Chemistry (CC) Reagent Handling System

Explains the Cartridge Chemistry Reagent Handling system, including reagent cartridges, carousel, probe, and mixer.

CHAPTER 2: Preparing Samples for Analysis

Preparing Samples for Analysis

Covers the process of preparing samples, including minimum volume requirements and sample rack compatibility.

How to Use Reserved Racks

Explains the usage of reserved racks for specific tests like HbA1c and IBCT, and their configuration.

CHAPTER 3: System Setup Options

Password Setup

Allows operators to assign user names, passwords, and privilege levels, enabling/disabling security for system functions.

Configuring the Chemistry Menu

Details how to install and configure tests from a list of available chemistries for display and selection.

Host Communications

Lists Host communications parameters, options, and default values for ASTM, LX20/DxC, and CX7 compatible systems.

CHAPTER 4: Reagent Load/Calibration

Reagent Load

Describes the process of loading reagents onto DxC systems and calibrating chemistries using the Reagent Load/Calibration screen.

System Calibration

Explains how system calibration is used to standardize sample analysis and when system calibration is required.

Request a Calibration

Provides instructions on how to calibrate DxC chemistries using bar code labels or assigned calibrator racks.

CHAPTER 5: Quality Control

Quality Control Program

Offers capabilities for monitoring system and chemistry performance through real-time analysis of control data using Westgard rules.

Define a Control

Guides users on defining controls, including control name, lot number, sample type, and chemistry selection.

Run Control Samples

Describes procedures for running control samples, with or without bar code labels, and with Auto Generation of Control enabled.

CHAPTER 6: Sample Programming and Processing

Identify Samples

Explains how samples can be identified using Sample ID, rack/cup position, or both, and how setup options affect cursor start and required fields.

Sample Programming and Processing

Details the process of programming samples, including test selection, sample description, and batch programming.

Clear Samples

Provides instructions on clearing sample programming information from the system when racks are no longer available or need reprogramming.

CHAPTER 7: Results Recall

Recall Results by Sample ID

Explains how to recall results by an individual Sample ID or a range of Sample IDs, and output options.

Display Recalled Results

Describes how to view recalled results on the screen, including navigating through pages and updating with new results.

Send Results to the Host

Details how to send results to the host computer, either whole groups of data or individual sample data.

CHAPTER 8: User Defined Reagents

User-Defined Reagent Setup

Guides users through defining user-defined reagents by specifying chemistry parameters, processing parameters, and error detection limits.

Chemistry Parameters

Covers defining a chemistry test name, allowable entries, and reaction types for user-defined reagents.

Error Detection Limits

Explains reagent blank, reaction, initial rate, and multipoint span limits for error detection in user-defined reagents.

CHAPTER 9: Maintenance

Maintenance Overview

Discusses the importance of performing maintenance by trained personnel for optimal performance and reducing service calls.

Twice Weekly Maintenance

Outlines procedures for cleaning sample/reagent probes, mixers, and flow cells twice weekly to prevent contamination.

Weekly Maintenance

Covers weekly maintenance tasks such as checking reagent levels, cleaning cuvette wiper and probes, and checking calibration span.

Monthly Maintenance

Details monthly tasks like replacing alkaline buffer, cleaning cup modules, cleaning mixers, and calibrating lamps/sensors.

CHAPTER 10: System Status and Commands

System Status

Provides a high-level summary of system temperatures, power, hydropneumatic, and ICS/Smart Module status in real-time.

Instrument Commands

Lists high-level system commands used to control the instrument and printer, including Home, Pause, Stop Print, and Shutdown.

Home

Explains the Home command for moving mechanical assemblies to a known position and priming the system, useful for recovering from motion errors.

Pause

Describes the Pause function to prevent new tests from starting without wasting sample or reagent, allowing interruption of samples in process.

CHAPTER 11: Utilities

Prime

Allows manual priming of entire subsystems or individual components to prepare them for system readiness.

Event Log

Provides a record of events and errors, useful for troubleshooting problems encountered while operating the instrument.

Backup/Restore

Offers the ability to store data to a diskette for later use or to restore previously backed-up data into the system.

CHAPTER 12: Troubleshooting Calibration and Result Errors

Calibration Errors

Describes calibration reports for various chemistries and explains fields used during calibration, including error flags.

MC Calibration

Details how the DxC system sets calibration based on two or four calibrator replicates for linear photometric chemistries.

Linear Calibration

Explains the calibration process for linear photometric chemistries, including back-to-back checks and calibrator range checks.

Common Error Messages and Corrective Actions

Lists common system error messages, their pop-up text, Event Log entries, descriptions, and recommended corrective actions.

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