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Beckman Coulter UniCel DxC Synchron 800 User Manual

Beckman Coulter UniCel DxC Synchron 800
510 pages
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© Copyright 2005 Beckman Coulter, Inc.
BECKMAN COULTER, INC. • 4300 N. Harbor Blvd., Fullerton, CA 92835 U.S.A.
A13914-AB
October 2005
UniCel
®
DxC Synchron
®
Clinical Systems
Instructions For Use
For In Vitro Diagnostic Use Only
This manual is intended for
UniCel
®
DxC 600
UniCel
®
DxC 800
Beckman Coulter Ireland, Inc.
Mervue Business Park,
Mervue Galway,
Ireland 353 91 774068
REPEC
®

Table of Contents

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Beckman Coulter UniCel DxC Synchron 800 Specifications

General IconGeneral
TypeClinical Chemistry Analyzer
ThroughputUp to 800 tests per hour
Sample CapacityUp to 120 samples
System TypeRandom Access
Sample TypeSerum, Plasma, Urine
Power Requirements200-240 VAC, 50/60 Hz
Reagent CapacityUp to 48 reagents
ConnectivityLIS (Laboratory Information System) Interface
Operating Temperature15°C to 30°C
Operating Humidity20-80% (non-condensing)

Summary

CHAPTER 1 General Information

Manual Conventions

Explains the printed and visual cues used to guide the user in responding to printed directions.

How to Use this Manual

Describes the manual format, including modular units and procedure tables.

Summary of Hazards

Summarizes hazards associated with the DxC System, including bar code reader, biohazardous materials, and electric shock hazards.

Summary of Precautions

Lists precautions for operating the DxC System, covering sensors, filters, buffers, calibrators, and bar code labels.

Symbols and Labels

Lists and describes symbols and labels used on the DxC Systems components, including power switches and connectors.

CHAPTER 2 System Description

System Components

Details the major components of the UniCel DxC System, including Sample Handling, Modular Chemistry, and others.

Theory of Operation

Explains the microprocessor-controlled, random access analyzers and their operational theories.

Cartridge Chemistry: Calibration Theory

Describes calibration principles for cartridge chemistries, including endpoint, first-order, and non-linear types.

Modular Chemistry: Calibration Theory

Explains calibration for modular chemistries, including error detection and methodology.

Cartridge Chemistry: Principles of Measurement

Explains spectrophotometric methods and Beer's Law as principles of measurement for cartridge chemistries.

CHAPTER 3 Preparing Samples for Analysis

Sample Programming and Processing

Details identifying samples, selecting tests, describing samples, and programming how to run them.

Prepare Samples

Covers minimum sample volume requirements and sample rack compatibility.

How to Use Reserved Racks

Provides guidance on recommended use of reserved racks and when not to use them.

Bar Code Labeling

Explains the use of bar code labels for sample identification and processing accuracy.

Adding Tests or Rerunning a Sample

Describes how to add tests to an existing sample program or rerun a sample.

Procedure for Clearing Samples

Outlines the steps to clear sample programming, rack/position, or by date/time.

CHAPTER 4 System Setup Options

Password Setup

Allows assigning user names, passwords, and privileges, and managing system security.

Auto Serum Index/ORDAC

Covers enabling/disabling automatic overrange detection and correction (ORDAC) and serum index functions.

Configuring the Chemistry Menu

Explains how to configure the chemistry menu, including adding, deleting, and defining print names.

Reportable Ranges Setup

Details setting analytical, instrument printable, and operator-defined reportable ranges.

Reference/Critical Ranges Setup

Allows defining normal and critical ranges for analytes by age group, gender, and sample type.

Bar Code Setup

Covers enabling/disabling sample bar code modes, types, and parameters.

Reserved Racks/Obstruct Detect

Manages CTS option, obstruction detection, and assigning reserved racks for specific sample types.

System Configuration

Allows changes to hardware configuration, data logger IP, and Ethernet addresses.

Chemistry Update

Explains how to load new versions of chemistry database software, updating or adding chemistries.

CHAPTER 5 Reagent Load/Calibration

Reagent Load

Describes how to load reagents onto the DxC 800/600 systems and calibrate chemistries.

System Calibration

Explains system calibration to standardize sample analysis, covering required conditions and options.

Calibration Failure Messages

Details pop-up messages and explanations for calibration failures in CC and MC subsystems.

Within-Lot Calibration

Covers multiple reagent loads of the same lot number without recalibrating each cartridge.

Calibration Override

Allows overriding a failed calibration to obtain results based on the failed calibration factors.

Chemistry Bypass

Permits continuation of analysis of other programmed tests after a calibration failure.

Calibrator Set Point Modifications

Allows editing programmed calibrator set points to alter chemistry provided it meets specific criteria.

Slope Offset Adjustment

Details adjusting the slope (m) or y-intercept offset (b) of the regression equation for results calculations.

CHAPTER 6 Quality Control

Quality Control Program

Provides capability for monitoring system and chemistry performance through real-time control data analysis.

Determination of QC Flags

Explains the Z-score method for standardizing measurements and flagging results based on deviations.

Accuracy and Precision Flags

Details Westgard rules utilized for evaluation of QC data, including 1-2S, 1-3SD, and 2-2S rules.

Defining a Control

Allows operators to define up to 100 controls, specifying name, lot number, QC file number, and sample type.

Control ID Assignments

Covers defining up to eight bar codes (control IDs) per control for sample programming and processing.

Running Control Samples

Describes how to run control samples with or without bar code labels, including auto generation.

Editing a Control Definition

Details editing assigned mean, SD, constituent code, and bar code IDs of a previously defined control.

Reviewing a Control Definition

Explains how to review control definitions from current or archived QC data.

Archive QC

Covers archiving control definition, log, and results to a floppy disk for data review and modification.

CHAPTER 7 Sample Programming

Prior to Programming

Details verifying rack status and sample carousel status before programming and assignment.

Identifying Samples

Explains sample identification using Sample ID or rack/cup position, including limitations and valid characters.

Selecting Tests

Describes manual test selection methods, including panels, configuration numbers, and chemistry buttons.

Programming Functions

Covers entering dilution factors and programming Manual Overrange Detection and Correction (ORDAC).

Batch Programming

Details programming multiple samples with identical parameters, including identification and status.

CHAPTER 8 Results Recall

Recalling Results by Sample ID

Allows recalling patient and control results by individual or range of Sample IDs, with output options.

Recalling Results by Rack and Position

Enables recalling results by rack number and position, with options for series and range entry.

Recalling Results by Patient ID

Allows recalling results by Patient ID, with output options for viewing, printing, or sending to host.

Displaying Recalled Results

Details how to view recalled results on the screen, including navigating pages and updating data.

Critical Result Rerun Editing

Describes deleting one of two results for a sample rerun with Critical Result Rerun.

Printing Recalled Results

Explains how to print recalled results in default or multi-sample report formats.

Sending Results to the Host

Covers recalling and sending whole data parcels or individual results to the host computer.

Statistical Summary Report

Allows generating a report with mean, Standard Deviation, and Coefficient of Variation for selected samples.

CHAPTER 9 User Defined Reagents

Requirements and Precautions

Outlines minimum operating parameters and precautions for using User-Defined Reagent feature.

User-Defined Reagent Setup

Guides through defining and editing user-defined reagents, including parameters and limits.

Chemistry Parameters

Covers defining test names, reaction types, units, precision, reaction direction, and math models.

Wavelength Selection

Explains selecting primary and secondary wavelengths for measuring analyte absorbance.

Determination of Extinction Coefficients

Provides methods for determining molar absorptivity or extinction coefficient 'e' for analysis wavelengths.

Exit Check Criteria

Specifies parameter requirements for correctness, completeness, and consistency of chemistry protocols.

User Defined Reagent Removal

Details the process of clearing a user-defined reagent from the system and chemistry menu.

CHAPTER 10 Maintenance

Maintenance Overview

Provides an overview of maintenance for optimal performance and reduced service calls.

Weekly Maintenance

Covers routine checks and cleaning tasks performed weekly for optimal system performance.

Monthly Maintenance

Details tasks performed monthly, including reagent replacement and module cleaning.

Two-Month Maintenance

Covers replacement of CTS blade/wick and cleaning/changing air filters.

Three-Month Maintenance

Includes replacement of syringe plungers and priming procedures.

Four-Month Maintenance

Details cleaning of MC reagent lines, cups, and stir bars.

Six-Month Maintenance

Covers replacing Calcium and Potassium electrode tips, and the glucose sensor.

As-Needed/As-Required Maintenance

Provides procedures for maintenance tasks performed on an as-needed basis for system performance.

CTS Wick Replacement Procedure

Details replacement of the Cap Piercer wick and blade assembly for CTS systems.

CHAPTER 11 System Status and Commands

System Status

Provides a high-level summary of system status, including temperatures, power, and components.

Status-Cycle Count

Approximates instrument usage and aids in estimating maintenance frequencies or component failure.

Temperatures

Shows actual temperatures of components, valid ranges, and indications of out-of-limit parameters.

Power Subsystems

Displays status of power supplies, voltage, peltiers, and fans, highlighting warnings or errors.

Hydropneumatics Subsystem

Shows status of reservoirs, canisters, and sumps, including air/vacuum pressures and DI water resistivity.

ICS/Smart Modules

Monitors power to Smart Modules and their communication ability, indicating errors or warnings.

Cuvette Water Blank Status

Shows absorbance values for cuvettes from water blank tests, indicating clean or dirty status.

CTS Tracking

Ensures sample tubes are pierced only once, operating on networked DxC instruments.

Instrument Commands

Lists high-level system commands for controlling instrument and printer operations.

Home

Moves mechanical assemblies to a known position and primes the system for recovery or standby.

Pause

Prevents new tests from starting without wasting sample or reagent, pausing MC, CC, or both sides.

Stop Print

Stops print requests in the queue, useful for preventing multiple print requests or large reports.

Shutdown

Places the system into a safe state for reset or power off, closing system files to prevent data corruption.

System Power On/Boot

Describes the boot-up sequence, including hardware diagnostics, module booting, and system priming.

Enable/Disable Modules

Allows enabling or disabling individual subsystems, MC side, or CC side for operation or error conditions.

Unload All

Removes all sample racks from the sample carousel to the offload track when instrument is in Standby or Stopped.

CHAPTER 12 Utilities

Prime

Permits manual request for priming entire subsystems or individual components for system readiness.

Maintenance

Provides routine instrument cleaning and part replacement for optimal performance.

Event Log

Records events and errors for troubleshooting, allowing viewing, printing, or copying to disk.

Copying to Disk

Details copying Events to a disk, creating a file for word processing or sending to Beckman Coulter.

Clearing Events

Removes unwanted event information from selected classes or the entire Event Log.

Alignment/Diagnostics/PVTs

Includes tests for confirming instrument problems, adjusting components, and assessing performance.

Backup/Restore

Enables storing data to a floppy disk for backup and restoring previously backed-up data.

Touch Screen Calibration

Adjusts the system for correct screen touch selection, especially after monitor movement or installation.

CHAPTER 13 Troubleshooting Calibration and Result Errors

Troubleshooting Calibration Errors

Covers calibration reports, error flags, and checks for linear, non-linear, and MC calibrations.

MC Calibration

Details MC calibration using calibrator levels, including checks like back-to-back, range, and DAC.

Linear Calibration

Explains linear calibration based on replicates, including checks for back-to-back, range, and span.

Non-Linear and Multipoint Calibrations

Describes calibration for non-linear chemistries, including checks for curve fitting and multipoint spans.

Result Errors

Explains how reactions are checked against parameter limits and how errors are flagged.

Error Codes and Definitions

Provides descriptions for various error codes and their meanings in result reporting.

Common Error Messages and Corrective Actions

Lists common system error messages, pop-up text, event log entries, and corrective actions.

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