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Beckman Coulter IMMAGE 800 User Manual

Beckman Coulter IMMAGE 800
536 pages
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A11403AE
September 2016
Operations Manual
IMMAGE 800
Immunochemistry System
For In Vitro Diagnostic Use
Beckman Coulter, Inc.
250 S. Kraemer Blvd.
Brea, CA 92821 U.S.A.

Table of Contents

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Beckman Coulter IMMAGE 800 Specifications

General IconGeneral
TypeImmunochemistry Analyzer
Sample TypeSerum, Plasma, Urine, CSF
Sample CapacityUp to 120 samples
Power Requirements100-240 V AC, 50/60 Hz
Detection MethodNephelometry
Assay MethodologyRate
Test MenuSpecific Proteins
Reagent Capacity44 reagent positions

Summary

CHAPTER 1 General Information/Precautions and Hazards

Introduction

Provides a basic overview of the IMMAGE 800 Immunochemistry System and its intended use.

How to Use This Manual

Explains the scope of the manual and conventions used for guidance.

Safety Information

Covers warranty, service, precautions, hazards, and symbols for safe instrument operation.

CHAPTER 2 System Description

Hardware Components

Details the physical components of the IMMAGE 800 system.

Instrument Components

Describes key instrument parts like the Reagent Compartment and Reaction Module.

System Peripherals

Covers specifications and connections for the computer and printer.

Software Overview

Provides an introduction to the graphical user interface (GUI) and basic functions.

System Specifications and Characteristics

Details instrument specifications, power requirements, and environmental conditions.

CHAPTER 3 Theory of Operations

Principles of Methodologies

Explains the scientific principles behind Rate Nephelometry and Rate Turbidimetry.

Signal Measurement and Reaction Dynamics

Describes how light scatter signals are developed and measured during reactions.

Antigen Excess Testing

Explains the necessity and process of antigen excess (AGXS) testing.

Calibration

Details calibration curves and system calibration processes.

CHAPTER 4 System Power On/Off

System Power On

Provides instructions for the power-on sequence of the IMMAGE 800 system.

System Power Off

Outlines the recommended sequence for powering off the IMMAGE 800 system.

Database Recovery

Explains procedures for recovering files and databases after system errors or power outages.

CHAPTER 5 System Setup

System Software Configuration

Covers customization of system features for laboratory requirements.

Configuring the Chemistry Menu

Details how to define, clear, and insert chemistries into the menu.

Panel Setup

Explains how to define, edit, and delete chemistry panels.

Bar Code Setup

Covers enabling/disabling symbologies and setting bar code parameters.

Reference Interval Setup

Describes how to define, edit, and clear reference intervals and critical ranges.

Report Setup

Covers selecting report formats, defining headers, and disabling automatic printing.

Calculations Setup

Details available calculations, custom calculations, and enabling/disabling them.

Units Setup

Explains how to select units for reporting and restoring default units.

Host Communications Setup

Covers configuring parameters for laboratory information system (LIS) connection.

Default Setup

Defines default sample types, replicates, and post-run summary time search.

User-Defined Reagent Chemistry Setup

Guides through defining custom reagent chemistry protocols and parameters.

CHAPTER 6 Reagents/Calibration

Reagents

Covers reagent status, loading parameters, and managing buffers/diluents.

Calibration

Details the process of calibrating the system, including status and history.

CHAPTER 7 Sample Programming

Preparing for Programming/Running

Covers essential pre-run checks for sample racks, dilution segments, and reagents.

Programming a Sample

Guides on entering sample identification, test selection, and options.

Selecting Chemistry Tests by Panel

Explains how to select predefined panels or individual chemistries for analysis.

Selecting a Sample Type

Details how to select sample types like Serum, Plasma, or Urine.

Entering Patient Demographics

Covers the entry of patient information such as name, ID, and age.

Antigen Excess (AGXS) Testing

Explains how to enable or disable antigen excess testing for individual samples.

Linking/Unlinking Samples

Describes how to link samples for special calculations.

Programming a Control

Covers defining and programming control samples for quality assurance.

Programming a STAT

Details how to program samples for priority STAT analysis.

Loading and Starting a Run

Provides steps for loading samples and initiating a run.

Pausing a Run

Explains how to pause the system for sample loading or other operations.

Rerunning a Sample

Covers options for rerunning samples, including editing programs.

Requesting a Load List or Post-run Summary

Describes how to request lists of samples or summaries of pending/incomplete tests.

Clearing a Sample

Details procedures for clearing samples by ID or rack/position.

Routine Operation

Summarizes routine procedures for bar code and host computer capabilities.

CHAPTER 8 Results Recall

Overview

Discusses how to recall and print patient and control results.

Recalling Results by Sample ID

Provides steps to recall results using Sample ID.

Recalling Results by Rack and Position

Details how to recall results based on rack and position.

Recalling Results by Patient ID

Explains how to recall results using Patient ID or Control ID.

Recalling Results by Patient Name

Describes how to recall results using the Patient Name.

Recalling Results by Run Date/Time

Covers recalling results based on specific date and time ranges.

Printing Recalled Results

Provides instructions for printing recalled results in various formats.

CHAPTER 9 Quality Control

Overview

Summarizes the QC program, Westgard Rules, and available features.

QC Statistics and Rules

Explains QC rules like Z-score, 1-2S, 1-3S, and accuracy/precision flags.

Defining a Control

Details the minimum information required to save a control definition.

Editing a Control

Covers editing control information such as mean, SD, and Control ID.

Reviewing a Control Definition

Allows the operator to review, delete, or print control definitions.

Deleting a Control Definition

Provides steps to delete control definitions from various screens.

Displaying the QC File List

Explains how to display and print QC files by control name or file number.

QC Log

Displays results with interpretations and allows data point deletion.

Displaying QC Summaries

Details how to access and print cumulative QC data.

QC Chart (Levey-Jennings)

Shows QC results graphically relative to assigned mean and standard deviation.

QC Backup

Explains how to save control information and QC View data to a floppy diskette.

Restoring and Reviewing Backup Data

Covers reviewing archived QC data from a floppy diskette.

CHAPTER 10 Utilities

Overview

Divides utilities into Maintenance, Troubleshooting, and Replacing Parts sections.

Maintenance

Covers daily, monthly, and as-indicated maintenance procedures.

Recommended Tools and Supplies

Lists tools and supplies needed for maintenance procedures.

Maintenance Precautions

Provides essential safety precautions for performing maintenance.

Daily Maintenance Procedures

Details the scheduled daily checks and cleaning tasks.

As-Indicated Maintenance

Covers maintenance tasks performed as needed, such as replacing cuvettes.

Troubleshooting

Guides on diagnosing instrument problems and using error messages.

Event Log

Explains how to access, display, copy, clear, and print the system event log.

Callable Diagnostics

Provides procedures for identifying and isolating instrument malfunctions.

Alignment

Details procedures for aligning hardware components like probes and optics.

Backup/Restore

Covers storing and retrieving system data to floppy or hard disks.

CHAPTER 11 System Status/Instrument Commands

System Status/Instrument Commands

Overview of instrument status monitoring and commands.

Checking Dilution Segment Status and Clearing Dilution Segments

Covers checking and replacing dilution segments.

Checking Sample Carousel Status

Describes how to monitor sample status using colored indicators.

Checking the Instrument Status Monitor

Explains how to access and interpret instrument parameters.

Accessing Instrument Commands

Details accessing commands like Stop, Home, Pause, and Run.

APPENDIX A Instrument Codes

Introduction

Explains how instrument codes represent chemistry and conditions on reports.

Chemistry Codes

Lists the codes assigned to various chemistries.

Condition Codes

Provides the codes used to represent specific conditions on reports.

APPENDIX B Reports

Introduction

Introduces examples of reports generated by the IMMAGE 800 system.

Generated Reports

Lists the types of reports that can be generated by the system.

Glossary

Alphanumeric character

Defines alphanumeric characters as A-Z, a-z, 0-9.

Analyte

Defines an analyte as the component being measured in a test.

Antibody (Ab)

Defines antibody as a protein protecting against foreign substances.

Antigen (Ag)

Defines antigen as a foreign substance triggering an immune response.

Antigen excess (AGXS) testing

Defines AGXS testing as a test for unbound antibody after antigen reaction.

Assay

Defines an assay as a test for a single concentration determination.

Assigned mean

Defines assigned mean as the mean value defined for a control.

ASTM protocol

Defines ASTM protocol as a standardized computer interface specification.

Bar code card

Describes the card containing reagent or calibrator parameters for lot information.

Bar code reader

Defines the instrument device that scans and decodes bar codes.

Batch

Defines batch as a group of samples with identical programming, except Sample ID.

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