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Beckman Coulter Navios User Manual

Beckman Coulter Navios
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773232AH
October 2015
Instruction For Use
Navios Flow Cytometer
CAROUSEL CL
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Beckman Coulter Ireland Inc.
Lismeehan
O’Callaghan’s Mills
Co. Clare, Ireland 353-65-683-1100

Table of Contents

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Beckman Coulter Navios Specifications

General IconGeneral
TypeFlow Cytometer
SoftwareNavios Software
Forward Scatter DetectorPhotodiode
Side Scatter DetectorPhotomultiplier tube (PMT)
Sample Flow RateAdjustable
Sorting CapabilityNo
Number of ParametersUp to 12
Laser ConfigurationUp to 3 lasers
Data Acquisition RateUp to 35, 000 events per second
ApplicationsImmunophenotyping, Cell Cycle Analysis, DNA Analysis
Weight136 kg

Summary

Revision Status

Safety Notice

Alerts for Warning, and Caution

Defines WARNING and CAUTION alert meanings for hazard identification.

Safety Symbols

Explains safety symbols used in the manual and their meanings, such as Biohazard and CE mark.

CHAPTER 1: Use And Function

System Components

Identifies and briefly describes the main components of the Navios Flow Cytometer system.

Options

Details available hardware options like printers and additional PMTs for system configuration.

Reagents And Quality Control Materials

Lists recommended reagents, sheath fluid, cleaning agent, and quality control materials.

CHAPTER 2: Installation

Delivery Inspection

Guides users on inspecting instrument cartons for damage upon delivery and filing claims if necessary.

Special Requirements

Outlines prerequisites for installation, including space, accessibility, and electrical input considerations.

System Connections

Details the interunit connections for power, signal cables, waste, and pneumatic tubing.

Installing Navios Software

Provides step-by-step instructions for installing the Navios software, including license agreement and folder selection.

CHAPTER 3: Operation Principles

Sample Flow

Explains the process of sample loading, tube handling, and hydrodynamic focusing.

Light Collection, Separation And Measurement

Details the methods for collecting forward scatter, side scatter, and fluorescent light signals.

Signal Processing

Describes voltage pulse signals, peak signal, integral signal, and time-of-flight signal processing.

Parameters

Explains parameters like TIME and RATIO, detailing their measurement and display.

Plot Display

Describes how sample analysis results are presented as graphs (plots) and the available plot types.

Regions

Explains how to create and assign regions for data analysis, gating, and autogating.

CHAPTER 4: Specifications

Instrument Specifications And Characteristics

Provides detailed technical specifications for the instrument's components like dimensions, lasers, sensors, and workstation.

Software Specifications

Outlines software features including data output, compatibility, reporting units, absolute count determination, and acquisition.

Performance Characteristics And Specifications

Carryover

Quantifies particle and fluorescence carryover between specimens and provides measurement details.

Acquisition Rate

Details the verified event rates for various parameters and the yield percentage measurement.

Data Acquisition Throughput

Discusses throughput based on variables like flow rate, data rate, and number of parameters collected.

Laser Characteristics

Covers day-to-day and within-day variations in laser signal intensity for alignment verification.

CHAPTER 5: System Overview

Navios Intended Use And System Description

Defines the intended use of the Navios system for qualitative and quantitative measurement for In Vitro Diagnostic use.

Cytometer Controls And Indicators

Identifies and explains the controls and indicators on the Navios Flow Cytometer and MCL.

Learning The Basic Operating Techniques

Offers guidance on learning basic operational techniques, including MCL carousels and bar-code labels.

Navios Software Shortcuts

Lists essential keyboard shortcuts, drag-and-drop functions, and toolbar button functions for Navios software.

Creating Protocols

Guides users on creating new protocols, setting parameters, and defining plots, regions, and gates.

Creating Regions

Explains how to create different types of regions (polygonal, rectangular, quadrant, linear) for data analysis.

Creating Gates

Details the process of creating gates, including AutoGate, converting polygonal regions, and automatic gate creation.

Creating Flowpages

Provides instructions and examples for creating and managing FlowPAGEs, including inserting elements and deleting objects.

Creating Panels

Guides users on creating panels using the Panel Wizard, including defining panel details and protocol settings.

Creating Worklists

Explains how to create and manage worklists, including before and after creation steps, and drag-and-drop functionality.

Using The System Help

Describes how to access and navigate the system help, including using the Contents, Index, and Search features.

CHAPTER 6: Daily Routine

Daily Startup

Outlines the essential steps for starting up the Navios system, including checks and powering on components.

Power the Computer and Cytometer OFF

Details the procedure for powering off the computer and Cytometer, including turning off peripherals.

Put The Cytometer In The Idle Mode

Explains how to put the Cytometer into idle mode for cleaning or reagent container tasks.

Extended Shutdown

Provides instructions for leaving the instrument in shutdown state for extended periods, including cleaning.

Cytometer Auto Startup

Explains how to configure the system for automatic startup and shutdown of the Cytometer.

CHAPTER 7: Quality Control

Instrument Setup

Guides on selecting and optimizing basic instrument configuration settings for reliable results.

QC Processes

Lists necessary QC materials for each quality control process.

Daily QC

Outlines the steps for performing daily quality control, including preparing samples and running wizards.

Autosetup Scheduler

Explains how to use the scheduler to select applications for efficient setup and QC monitoring.

Autosetup II Wizard

Guides through the automated application setup and QC monitoring process.

Application Definition Wizard

Describes defining applications, capturing instrument setup, lasers, parameters, and requirements.

CHAPTER 8: Running Samples

Sample Requirements

Specifies the minimum sample volume, preparation, and concentration needed for analysis.

Before Running Samples

Lists essential checks and configurations to perform before initiating sample runs.

Running Samples - MCL Automatic Mode

Details the procedure for running samples using the Multi-tube Carousel Loader in automatic mode.

Running Samples - MCL Manual Mode

Explains how to run samples using the MCL in manual mode, allowing tube location input.

Running Samples - Single Tube Mode

Guides on running samples individually through the MCL tube access door.

Data Review

Instructs on reviewing data displays, including light scatter, antibody staining, and gate/region boundaries.

CHAPTER 9: How To...

Software Procedures

Links to detailed procedures for creating protocols, regions, gates, flowpages, panels, and worklists.

Hardware Procedures

Provides links to procedures for cleaning MCL sample head, replacing probes, tubing, and optical filters.

CHAPTER 10: Using Navios Software

Multi-user Sign On

Details the process of signing on to the Navios software, including user administration and security settings.

Sign-on Administration

Covers managing user profiles, workgroups, and system administrator settings.

File Menu

Explains various operations within the File menu, such as creating protocols, saving files, and managing workspace preferences.

Edit Menu

Describes common editing functions like Undo, Redo, Cut, Copy, Paste, and Paste Special.

View Menu

Details how to manage views and toolbars, including Acquisition Manager, Resource Explorer, and plot arrangement.

Tools Menu

Outlines the functions available in the Tools menu, such as publishing results, AutoMATOR, and listmode playback.

Plots Menu

Explains different plot types and their customization options, including color dot plots, histograms, density plots, and prism plots.

Analysis Menu

Covers operations for analyzing data, including creating/modifying gates, regions, and color settings.

CHAPTER 11: Cleaning Procedures

Clean The Air Filters

Guides on locating, preparing, cleaning, and reinstalling air filters for the instrument.

Put The Cytometer In The Idle Mode

Explains how to put the Cytometer into idle mode for cleaning or reagent container tasks.

Remove The Reagent Containers

Details the process for removing reagent containers for cleaning or replacement.

Clean The Internal Sheath Fluid Container

Provides instructions for cleaning the internal sheath fluid container to prevent contamination.

Clean The Cleaning Agent Container

Guides on cleaning the cleaning agent container, including preparing solutions and rinsing.

Clean The Vacuum Trap

Details the procedure for cleaning the vacuum trap, including preparation and rinsing.

Power The Cytometer Only On/off

Explains how to power the Cytometer on or off independently of the computer.

CHAPTER 12: Replace/Adjust Procedures

Replace Reagents

Covers procedures for managing reagent containers, including capacity and replacement.

Replace The 10 L External Sheath Fluid Container

Details the steps for replacing the external sheath fluid container when the level is low or an error occurs.

Fill The Internal Sheath Fluid Container

Guides on filling the internal sheath fluid container, including preparation and cap handling.

Fill The Cleaning Agent Container

Provides instructions for filling the cleaning agent container when a warning or error message appears.

Empty The 20L Waste Container

Details the procedure for emptying the waste container, including safety precautions and disposal methods.

Replace The Sheath Fluid Filter

Explains when and how to replace the 0.2-μm sheath fluid filter.

Replace The Sample Probe And Sample Pickup Tubing

Guides on replacing the sample probe and pickup tubing when issues like bending, leaks, or erratic flow occur.

Replace The Mcl Sample Head

Provides instructions for replacing the MCL sample head when cleaning fails or errors occur.

Adjust The System Pressure

Details how to adjust system pressure if the gauge reading is outside the specified range.

Replace An Optical Filter

Covers replacing optical filters due to loss of signal or application requirements, including dichroic and bandpass filters.

CHAPTER 13: Troubleshooting

Precautions/Hazards

Outlines essential safety precautions related to laser radiation, electrical instrumentation, and hazardous substances.

Laser Warning Labels

Explains the location and meaning of CDRH-required warning labels concerning laser radiation exposure.

Maintenance Schedules

Refers to the Maintenance Log for cleaning and replacement schedules.

Cytometer Messages

Details how and where Cytometer messages appear and how to access and clear them.

Software Messages

Lists common Navios software messages, their probable causes, and recommended actions.

Level Sense Indicators

Explains the meaning of level sense indicators like Sheath Low and Waste Full.

Cytometer Control Window Cannot Be Viewed

Provides troubleshooting steps for when the Cytometer Control window is not visible.

APPENDIX A: Bar-code Specifications

Bar-code Sample Identification

Lists the four bar-code symbologies used for specimen identification and the importance of accurate reading.

Correct Placement Of The Bar-code Label

Provides guidelines on the correct placement of bar-code labels on tubes for accurate reading.

Bar-code Label Specifications

Covers label size, thickness, symbol dimensions, and print quality requirements.

Bar-code Error Rate

Discusses factors affecting bar-code error rates and recommends best practices for accuracy.

Bar-code Decoder

Explains the function of the MCL bar-code decoder and character encoding.

APPENDIX B: Maintenance And Service Logs

Maintenance Log

Details how to use the Maintenance Log to record daily and periodic maintenance tasks.

Service Log

Explains how to use the Service Log to record noted service conditions and actions taken.

References

Glossary

Index

Customer End User License Agreement

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