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Roche Cedex Bio - User Manual

Roche Cedex Bio
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For use in quality control/manufacturing process only.
Cedex Bio Analyzer
Operator’s Manual
Software Version 2.3

Table of Contents

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Roche Cedex Bio Specifications

General IconGeneral
ManufacturerRoche Diagnostics
Power Requirements100-240 V AC, 50/60 Hz
Measurement RangeDepends on the parameter measured
ConnectivityUSB, Ethernet
WeightApproximately 60 kg
Operating Temperature15-30°C
Operating Humidity20% to 80% non-condensing
Sample TypesSerum, plasma, urine, CSF
TypeAutomated Clinical Chemistry Analyzer
SoftwareProprietary Roche software for instrument control, data management, and quality control

Summary

Document Information

Edition Notice

Information about the analyzer's intended use, optimizations, and development.

Intended Use

Describes the analyzer's purpose for determining chemical and biochemical parameters.

Copyrights

Copyright statement.

Trademarks

Lists acknowledged trademarks.

Safety

Safety Classification

Explains symbols and their meanings for hazardous situations.

Safety Information

Essential information to read and understand before operating the analyzer.

Transport Warnings

Warns about potential injury from heavy loads during analyzer transport.

Electrical Safety

Covers electrical shock hazards and grounding requirements for safe operation.

Optical Safety

Warns about the danger of eye damage from intense LED light during operation.

Mechanical Safety

Warns about personal injury from contact with analyzer mechanisms.

Analyzer Covers and Operation

Emphasizes keeping covers closed and following instructions for safe operation.

Biohazardous Materials

Warns about infection risks when handling biohazardous materials.

Waste and Reagent Safety

Warns about infection risks from waste and injury from reagents/solutions.

Installation and Environmental Safety

Warns about risks associated with incorrect installation and environmental conditions.

Power Interruption and Electromagnetic Devices

Warns about data loss from power issues and analyzer malfunction due to EMI.

Approved Parts and Third-Party Software

Warns against using non-approved parts or software to prevent malfunction.

Operator Qualification and Fatigue

Stresses the need for trained operators and taking breaks to prevent fatigue.

Sample Contamination and Spillage

Warns about incorrect results from sample carryover, contaminants, or spillage.

Data Security

Discusses unauthorized access and data loss risks from malicious software.

Disposal Recommendations and Legal Liability

Provides guidance on proper disposal and outlines user responsibility for features.

Safety Labels

Lists and explains safety labels found on the analyzer.

Location of Safety Labels

Shows where safety labels are located on the analyzer components.

Introduction to the Analyzer

Overview

Describes the analyzer's intended use, features, and operational requirements.

Principles of Operation

Explains the absorption photometry measuring method and sample analysis process.

User Interface

Details the touchscreen layout, tabs, buttons, and global action buttons.

Wizards

Explains how wizards guide users through tasks, simplifying operation.

Daily Operation Overview

Provides an overview of routine tasks for system preparation and monitoring.

Hardware Overview

Details covers, panels, components, fluid systems, and connections.

Software Overview

Explains software features like screen layout, navigation, and key screens.

Hardware Components

Covers and Panels

Shows removable panels and lids for accessing analyzer parts.

LEDs and Color Indicators

Explains the meaning of LED colors for system status and user actions.

Main Components

Illustrates and describes the primary hardware components of the analyzer.

Fluid System Components

Details the fluid system, including rinse station, probe, and fluid containers.

Reagent Handling Components

Describes the rotor, reagent disk, and reagent cooler for reagent management.

Cuvette Handling Components

Explains cuvette segments, handling, and the cuvette ring.

Barcode Scanner

Explains the use of the hand-held barcode scanner for data input.

Printer

Describes the built-in thermal printer and its operation.

Absorbance Photometer

Details the absorbance photometer and its wavelengths.

Connectors

Illustrates and labels various input/output connectors on the analyzer.

Fuses

Locates and identifies the analyzer's mains and low voltage fuses.

Technical Specifications

Lists physical dimensions, power requirements, environmental conditions, and throughput.

Software and User Interface

Software Introduction

Explains how to operate the analyzer using the touchscreen and introduces wizards.

Screen Layout and Display Items

Details screen layout, tabs, buttons, and other display items.

Color Concept and Navigation

Explains color coding and how to navigate between screens.

Working with the User Interface

Covers adjusting touchscreen, scrolling, expanding lists, typing, and filtering.

Printing Information

Guides on how to print information from various screens.

Online Help System

Describes how to access and use the context-sensitive online help feature.

Messages and Alarm Monitor

Explains how messages and alarms are displayed and how to react to them.

Key Screens Overview

Describes key screens like Overview, Workplace, Utilities, and their functions.

Special Operations

Deleting Sample Orders and Results

How to delete sample orders and results outside the normal routine.

Calibration Operations

Covers deleting calibration results and setting up calibration schedules.

Deleting QC Results

How to delete QC results outside the normal daily routine.

Lot Handling

Explains viewing, defining, and managing lot data for calibrators, controls, and reagents.

Exporting Data

Guides on exporting database, results, and log files to external media.

Importing Data

Details importing application data, software, database, certificates, and mixing rules.

Preparing and Assigning Tests

Guides on preparing new disks, assigning tests to tabs, and managing inventory.

Printer and Reagent Cooler Maintenance

Instructions for refilling printer paper and removing condensation water.

Probe and Fluid Container Management

Guides on replacing the probe and connecting/disconnecting fluid containers.

Touchscreen Adjustment and Cleaning

Instructions for adjusting and cleaning the touchscreen interface.

Configuration Settings

Introduction to Configuration

Explains how to define the system's working environment and user responsibilities.

Application Management

Covers importing, installing, activating/deactivating, preparing, and deleting applications.

Processing Order and Ratio Applications

Defines test processing order and how to manually define ratio applications.

Profiles and Control Definitions

Explains defining profiles, adding/removing tests, and control definitions.

Calibrator Definitions and Lot Handling

Guides on defining calibrator lots and handling lot data.

Application Definition Guides

Provides reference for application definitions like version, code, and general settings.

Calibration and Control Definitions

Explains calibration parameters and control definitions for ISE and general use.

Calculation and Result Conversion

Details calculation definitions, ratio applications, and result unit conversion.

System and Host Definitions

Covers workflow, host communication settings, and result handling.

User Management and Access Rights

Explains defining users, managing access rights, and deleting users.

Data Analysis Methods

Photometric Measurement Principles

Explains calculations and checks for photometric measurements.

Absorbance Calculations and Checks

Details absorbance calculations, blank correction, and volume correction.

Rate Calculations and Checks

Explains rate calculations, calculation models, and reaction direction.

Quantitative Calibration Modes

Explains different calibration modes like Linear Interpolation and Linear Regression.

Result Calculation Methods

Details result calculation for various modes and associated checks.

Corrections for Results

Explains volume correction, compensation, and correlation corrections.

Quality Control Methods

Explains QC process, methods, precision criteria, and control checks.

ISE Measurement Principles

Explains calculations and checks used in electrolyte measurements.

ISE Calibration Procedures

Details slope calculation, range checks, and Sol 1 factor checks for ISE.

ISE Results Calculation

Explains calculation of concentration and associated checks for ISE measurements.

General Maintenance

Overview of Maintenance

Explains maintenance importance, scheduling, intervals, and ensuring smooth operation.

Performing Maintenance Actions

Guides on how to perform maintenance actions, checking due dates, and interpreting colors.

Maintenance Actions and Intervals

Lists maintenance actions and their recommended frequencies.

Probe Cleaning and Maintenance

Step-by-step guide to deproteinize and manually clean the probe.

Fluid System and Container Maintenance

Instructions for priming fluid system and cleaning water/waste containers.

Water Inlet Filter Replacement

Instructions for replacing the water inlet filter.

Housing Cleaning and Disinfection

Step-by-step guide to clean and disinfect the analyzer housing.

Database Cleanup

Restores the database to optimum condition, typically for performance issues.

Photometer Lamp Replacement

Guides on how to replace the photometer lamp.

Contacting Service Representative

Explains how to initiate preventive maintenance by contacting service.

Air;Water Calibration

Guides on performing air/water calibration for the absorbance photometer.

Degasser Fluid Sensor Initialization

How to initialize the degasser fluid sensor for proper fluid detection.

Rotor and Heating Channel Cleaning

Instructions for cleaning the rotor and heating channel.

Database Recovery

How to recover the database if an error damaged its structure.

Troubleshooting

Messages and Alarms

Explains how to use and react to system messages and alarms.

Result Flags

Lists and explains result flags, their meanings, and recommended actions.

Dealing with Exceptional Situations

Provides guidance on handling common exceptional situations and error messages.

Reacting to Messages

Guides on how to react to error messages and provide information to service representatives.

Detailed Procedures for Troubleshooting

Provides detailed steps for common troubleshooting tasks like printer issues and fuse changes.

ISE Operation

Daily Operation of ISE Unit

Overview of routine tasks for processing tests using the ISE unit.

Safety Information for ISE Operation

Lists safety information relevant to ISE operation.

Preparing the System for ISE

Guides on preparing the system, including external fluid containers and ISE status.

Calibrations and QC for ISE

Explains how ISE calibrations and QC handling are integrated.

Defining Orders for ISE

Explains the process of defining orders for ISE sample analysis.

Monitoring ISE Analysis Progress

Guides on monitoring the progress of ISE analysis and checking analyzer status.

Validating ISE Sample Results

Explains how ISE result handling is integrated with the main analyzer.

Main Calibration and QC for ISE

Explains the periodic main calibration and QC handling for ISE electrodes.

Finishing the Shift for ISE Unit

Describes end-of-shift activities specific to the ISE unit.

Replacing ISE Fluid Bottles

Guides on replacing ISE fluid bottles, including status interpretation.

Replacing ISE Electrodes

Guides on replacing ISE electrodes, including tools and safety.

Cleaning the ISE Tower

Instructions for cleaning the ISE tower, both automatically and manually.

ISE Maintenance

Introduction to ISE Maintenance

Provides an overview of specific ISE maintenance actions.

ISE Maintenance Actions and Intervals

Lists ISE maintenance actions and their recommended frequencies.

Safety Information for ISE Maintenance

Lists safety warnings relevant to ISE maintenance procedures.

Daily Prepare Actions for ISE

Guides on performing daily prepare actions for the ISE unit.

Activating ISE Electrodes

Steps to activate electrode surfaces with Activator for correct potentials.

Conditioning ISE Tubing

Instructions for conditioning ISE tubing with Activator for proper fluid flow.

Initializing ISE Reference Solution Sensor

How to initialize the sensor for proper detection of air in ISE tubing.

Priming ISE Reference and Calibrator

Ensures no traces of previous solutions remain in tubing to prevent drift.

Electrode Service Procedures

Guides on cleaning, etching, deproteinizing, and activating electrodes.

Cleaning the ISE Tower Automatically

Instructions for automatically cleaning the ISE tower.

Cleaning the ISE Tower Manually

Guides on manually cleaning the ISE tower.

Initializing the ISE Unit

How to initialize the ISE unit using Activator for sensors and pump action.

Replacing ISE Pump Tubing

Guides on replacing the ISE pump tubing to ensure proper pump action.

Replacing ISE Unit Tubing

Instructions for replacing ISE unit tubing due to abrasion from valve action.

Deactivating the ISE Unit

How to deactivate the ISE unit for extended non-use periods to save fluids and reduce wear.

ISE Troubleshooting

Introduction to ISE Troubleshooting

Emphasizes understanding procedures and observing actions for troubleshooting.

ISE Unit Status Information

Explains how the user interface informs about unit status via LEDs, buttons, and messages.

Messages and Safety

Explains how messages are generated and lists safety information relevant to troubleshooting.

List of ISE Flags

Lists general and ISE-specific flags alphabetically with meaning and actions.

Reacting to Error Messages

Guides on how to react to specific error messages related to ISE unit operations.

Glossary

Glossary Terms A-I

Defines technical terms used in the manual starting with letters A through I.

Glossary Terms L-R

Defines technical terms used in the manual starting with letters L through R.

Glossary Terms S-W

Defines technical terms used in the manual starting with letters S through W.

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