Download Roche Elecsys 2010 User Guide PDF

TitleRoche Elecsys 2010 User Guide
TagsBarcode Assay Immunoassay Calibration Technology
File Size18.4 MB
Total Pages504
Table of Contents
                            Operator's Manual
Elecsys® 2010
	Revision History
	Table of Contents
	Preface
	How to use this manual
	Conventions used in this manual
	Reference Guide
		Table of Contents
		1. Introduction
			1.1 Introduction
			1.2 The Elecsys 2010 Immunoassay System
			1.3 General Overview
				General
				Warranty
				Using the Operator's Manual
				Manual Set-up
				Analyzer Installation
				Service
				Customer Training
				Test Specific Information
				Ordering Information
			1.4 Product Labeling
				Reagent Kits (Reagent Packs)
				Reagent Kit Box Labels
				Reagent Bar Code Label
				Package Insert
				Product Information Sheet
				Calibrator Kits
				Calibrator Bar Code Cards
				Calibrator Bar Code Labels
				Control Kits
				Control Bar Code Cards
				Control Bar Code Labels
			1.5 Potential Hazards and Safety Precautions
				Chemical
				Electrical
				Mechanical
				Biohazardous Materials
				Visual Cues
				Warning Stickers
				Potential Hazards and Safety Precautions
				Additional Precautions
			1.6 Approvals
		2. System Description
			2.1 Introduction
				The Control Unit
				The Analyzer Unit
				Sample/Reagent Area
				Consumables Area
				Measuring Area
				Operation Switch
			2.2 Control Unit Components
				Touchscreen
				Keyboard
				Floppy Disk Drive
				Data Disk
				External Printer
				Host Interface
			2.3 Sample/Reagent Area Components
				Sample Disk
				Rack Sampler
				Sample/Reagent (S/R) Probe
				Bar Code Reader
				Bar Code Card Reading Station
				Reagent Disk
				Reagent Cap Open/Close Mechanism
				Microparticle Mixer
				Probe/Mixer Rinse Station
				Sample/Reagent (S/R) Pipettor
			2.4 Consumables Area Components
				Gripper
				Cup Disposal Opening
				Pipetting Station
				System Water Container
				Liquid Waste Container
				Solid Waste Tray and Liner
			2.5 Measuring Area Components
				Incubator
				Sipper Probe
				Sipper Pipettor
				System Reagents (ProCell and CleanCell)
				Detection Unit
			2.6 Power Components
				Operation Switch
				Circuit Breaker
				Rack Circuit Breaker
			2.7 Technical Data
				Instrument Dimensions
				Electrical
				Environmental Conditions
				Noise Level (DIN 43635)
				Water Supply
				Liquid Waste
				Throughput Rate
				Sampling System
				Reagent System
				Incubation System
				Measuring System
				Control System
		3. Mechanical Theory
			3.1 Introduction
				Test Protocols
				General Assay Sequence
				Operation Flow in Analysis
			3.2 Detailed Assay Sequence
				Preoperation Steps
				First Incubation
				Microparticle Preparation
				Microparticle Aspiration and Dispense
				Second Incubation
				Measurement Process Preparations
				Measurement Process
				Signal Detection and Conversion
				Automatic Analyzer Cycles
			3.3 Dilution Steps
				Pretreatment Steps
			3.4 Analyzer Status Conditions
		4. ECL Technology
			4.1 Introduction
				ECL Assay Principles
				Use of the Ruthenium Complex
				The ECL Reaction at the Electrode Surface
				ECL Signal Generation
				ECL Measuring Cell
				Advantages of ECL Technology
		5. Test Principles
			5.1 Competitive Test Principle
			5.2 Competitive Principle
			5.3 Sandwich Principle
			5.4 Bridging Principle
		6. Calibration
			6.1 Reagent Calibration
				Master Calibration
				Lot Calibration
				Reagent Pack Calibration
				Calibration Stability
				Calibration Assessment and Quality Criteria
			6.2 Calibration of Quantitative Assays
				Rodbard Function
				Linear Calibration Function
				Linear Reciprocal Calibration Function
			6.3 Calibration of Qualitative Assays
				Result Calculation for Qualitative Assays
	Software Guide
		Table of Contents
		1. Operating Basics
			1.1 Introduction
			1.2 The Screen
			1.3 The Keyboard
			1.4 Software Structure - Disk System
			1.5 Software Structure - Rack System
		2. INVENTORY
			2.1 INVENTORY Screen
			2.2 REAGENT DETAILS Pop-up Window
			2.3 REAGENT DETAILS Pop-up Windows for Diluent and Pretreatment
			2.4 SYSTEM REAGENT DETAILS Pop-up Window
			2.5 MANUAL INPUT Pop-up Window
			2.6 DISK NUMBER CONFIRMATION Pop-up Window
			2.7 ALARM Pop-up Window
		3. ORDERS
			3.1 ORDERS Screen
			3.2 DELETE SAMPLE CONFIRMATION Pop-up Window
			3.3 SELECT CALIBRATOR Pop-up Window
			3.4 SELECT CONTROL Pop-up Window
			3.5 DILUTION FACTOR Pop-up Window
			3.6 POSITION SEARCH Pop-up Window
		4. RESULTS
			4.1 RESULTS Screen
			4.2 FILTER SELECTION Pop-up Window
			4.3 DOCUMENT SETUP Pop-up Window
			4.4 DELETE DOCUMENT SAMPLES CONFIRMATION Pop-up Window
			4.5 RESULT DETAILS Pop-up Window for a Sample
			4.6 RESULT DETAILS Pop-up Window for a Control
		5. QC
			5.1 QC Screen (Quality Control)
			5.2 CONTROLS Pop-up Window
			5.3 QC CHART OVERVIEW Pop-up window
		6. STATUS
			6.1 STATUS Screen
			6.2 SAMPLE POSITION STATUS Pop-up Window
			6.3 SAMPLE SCAN CONFIRMATION Pop-up Window
			6.4 OPEN REQUESTS Pop-up Window
		7. UTILITY
			7.1 UTILITY Screen
			7.2 CONTROL DEFINITION 1 Screen
				7.2.1 CONTROL DEFINITION Pop-up Window
			7.3 CONTROL DEFINITION 2 Screen
				7.3.1 CONTROL DEFINITION DETAILS Pop-up Window
				7.3.2 ADD CONTROL Pop-up Window
				7.3.3 DELETE CONTROL CONFIRMATION Pop-up Window
			7.4 CALIBRATION DATA Screen
				7.4.1 CALIBRATION DATA DETAILS Pop-up Window
			7.5 TEST CONDITIONS Screen
				7.5.1 TEST DETAILS Pop-up Window
			7.6 MESSAGE HISTORY Screen
				7.6.1 PRINT MESSAGE HISTORY Pop-up Window
			7.7 INTERFACE SETUP Screen
				7.7.1 INTERFACE SETUP CONFIRMATION Pop-up Window (Communication)
			7.8 INSTRUMENT SETUP Screen
				7.8.1 SETUP OF DATE/TIME Pop-up Window
			7.9 SAMPLE DISK MODE SETUP Screen
				7.9.1 CONFIRMATION Pop-up Window (SAMPLE DISK MODE SETUP)
			7.10 PRINTOUT CONFIGURATION Screen
			7.11 DOCUMENTATION SETUP Screen
			7.12 INITIAL BLANKCELL Screen
			7.13 KEEP FUNCTION SETUP Screen
			7.14 MAINTENANCE Screen
				7.14.1 SYSTEM RESET Pop-up Window
				7.14.2 MEASURING CELL PREPARATION Pop-up Window
				7.14.3 SIPPER PIPETTOR PRIME Pop-up Window
				7.14.4 S/R PIPETTOR PRIME Pop-up Window
				7.14.5 LIQUID FLOW CLEANING Pop-up Window
				7.14.6 L. AND A. RESET ALL Pop-up Window
				7.14.7 RACK CLEAR Pop-up Window
				7.14.8 FINALIZATION MAINTENANCE Pop-up Window
				7.14.9 FDD CLEANING Pop-up Window
				7.14.10 FD WRITE Pop-up Window
				7.14.11 Maintenance Windows for Service Personnel
			7.15 TEMPERATURE MONITOR Screen
			7.16 VOLTAGE MONITOR Screen
			7.17 RETRY FUNCTION SETUP Screen
			7.18 ASSAY PERFORMANCE CHECK Screen
			7.19 AUTOMATIC ADJUSTMENT Screen
			7.20 MECHANISM CHECK Screen
			7.21 SERVICE Screen
		8. Reports
			8.1 Overview of Options
			8.2 INVENTORY Report
			8.3 Work List
			8.4 TEST RESULTS Report
			8.5 RESULTS Report
			8.6 QC RESULTS Report
			8.7 STATUS Report
			8.8 CONTROL DEFINITION Report
			8.9 CALIBRATION DATA Report
			8.10 TEST CONDITIONS Report
			8.11 MESSAGE HISTORY Report
	Users Guide
		Table of Contents
		1. General Troubleshooting
			1.1 Introduction
			1.2 Immunoassay Troubleshooting
			1.3 General Instrument Troubleshooting
		2. Data Alarms
			2.1 Data Alarms Table
			2.2 Data Flags
			2.3 Special Data Flags
		3. Instrument Alarms
			3.1 General Description
			3.2 List of Alarms
		4. Maintenance
			4.1 Maintenance Procedure Overview
			4.2 Clean S/R Probe
			4.3 Finalization Maintenance
			4.4 Clean Incubator and Aspiration Station
			4.5 Clean Sipper Probe
			4.6 Clean Rinse Stations for R/S Probe, Mixer and Sipper Probe
			4.7 Perform Liquid Flow Cleaning
			4.8 Cleaning Floppy Disk Drive
			4.9 Clean Distilled Water Container
			4.10 Clean Liquid Waste Container
			4.11 Clean ProCell/CleanCell Compartments
			4.12 Clean Reagent Disk and Compartment
			4.13 Empty Solid Waste
			4.14 Replace Pinch Valve Tubing (PM Visit)
			4.15 Replace Pipettor Seals (PM Visit)
			4.16 Other As Needed Maintenance Procedures
			4.17 Extended Power OFF Recommendations
		5. Spare Parts
			5.1 Spare Parts Overview
			5.2 Accessory and User Replaceable Parts
	Tutorial Guide
		Table of Contents
		1. Overview
			1.1 Overview of Options
		2. Daily Operation
			2.1 Power ON
				Check Data Disk
				Power the Printer ON
				Power the Analyzer ON
				Log On
			2.2 Inventory Checks
				Check System Reagents
				Check System Water Container
				Check Liquid Waste Container
				Check Solid Waste Tray
				Check Assay Cups and Tips
				Load New Reagents
				What's Next?
			2.3 Delete Open Requests
				What's Next?
			2.4 Initiate Calibration/Control Measurement
				Prepare Calibrators and Controls
				Perform Bar Code Card Scan
				Load the Sample Disk/Racks and Program Calibration
				Placement of 13 mm Sample Tubes
				Loading Sample Tubes on the Sample Rack
				Loading Sample Tubes on the Sample Disk
				Test Selection and Orders for Roche Controls
				Test Selection and Orders for Non-Roche Controls
				Print a Work List (Optional)
				Initiate Operation
				What's Next?
			2.5 Calibration Validation
				Calibration Status
				Questionable Calibrations
				What's Next?
			2.6 Routine Sample Measurements - Disk System
				Patient Programming for Interfaced, Bar coded Samples
				Patient Programming for Interfaced, Non-Bar coded Samples
				Patient Programming for Non-Interfaced, Bar coded Samples
				Patient Programming for Non-Interfaced, Non-Bar coded Samples
				What's Next?
			2.7 Routine Sample Measurements - Rack System
				Patient Programming for Interfaced, Bar coded Samples
				Patient Programming for Interfaced, Non-Bar coded Samples
				Patient Programming for Non-Interfaced, Bar coded Samples
				Patient Programming for Non-Interfaced, Non-Bar coded Samples
				What's Next?
			2.8 Sample Tracking - Disk System
			2.9 Sample Tracking - Rack System
			2.10 Measurement of Additional Routine Samples
				Continuous Loading Using the Single Disk Mode
				Continuous Loading Using the Multiple Disk Mode
				Continuous Loading Using the Rack System
			2.11 Dilutions
				Predilution of Samples
				Procedure for Automatic Dilution by the Analyzer
			2.12 STAT Test Selections - Disk System
				STAT Patient Programming for Interfaced, Bar coded or Non-Bar coded Samples
				STAT Patient Programming for Non-Interfaced, Bar coded or Non-Bar coded Samples
			2.13 STAT Test Selections - Rack System
				STAT Patient Programming for Interfaced, Bar coded Samples
				STAT Patient Programming for Non-Interfaced, Bar coded and Non-Bar coded Samples
				STAT Patient Programming for Interfaced, Non-Bar coded Samples
			2.14 Results
				Viewing Patient Results
				Filtering Patient Results
				Blocking Patient Results
				Document Patient Results by Printing
				Document Patient Results by Uploading
				Document Patient Results by Printing/Uploading
				Saving Patient Sample Results
			2.15 Post-Operation Data Management
				Review Results
				Delete Documented Samples
			2.16 Daily Maintenance
				Clean the S/R Probe
				Finalization Maintenance
				Analyzer Power OFF Recommendations
		3. How to...
			3.1 How to Manually Select Calibration for a Reagent Pack
				Single Assay/Single Lot; Multiple Reagent Packs
			3.2 How to Manually Select a Calibrator
			3.3 How to Define Roche (Bar coded) Controls
			3.4 How to Define Non-Roche (Non-Bar coded) Controls
			3.5 How to Order a Control for a Particular Reagent Pack (MQR)
			3.6 How to Change a Control Target or Range
				Roche Controls
				Non-Roche Controls
			3.7 How to Delete a Single Open Request
			3.8 How to Delete Open Requests - Disk System
			3.9 How to Delete Open Requests - Rack System
			3.10 How to Manually Upload Results
				To upload a SINGLE result
				To upload MULTIPLE results
			3.11 How to Change Expected Values
			3.12 How to Print Message History
			3.13 How to Change Printout Configuration
			3.14 How to Change the Sample Disk Mode
	Glossary
		Numbers
		A
		B
		C
		D
		E
		F
		G
		H
		I
		L
		M
		N
		O
		P
		Q
		R
		S
		T
		U
		W
	Index
		Symbols
		A
		B
		C
		D
		E
		F
		G
		H
		I
		K
		L
		M
		N
		O
		P
		Q
		R
		S
		T
		U
		V
		W
                        
Document Text Contents
Page 1

DVR40b.eps


Elecsys® 2010

Operator's Manual
Software Version 06.03

Page 253

Roche Diagnostics Elecsys® 2010 Immunoassay System – A4 Format User Guide V 4.0. 2-5


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Data Alarms Table

Page 503

Register.eps


Roche Diagnostics Elecsys® 2010 Immunoassay System – A4 Format Index V 4.0. 13

Index

Troubleshooting, general ........................................................................................................................................... UG: 1-1
Troubleshooting, immunoassay ............................................................................................................................... UG: 1-3
Troubleshooting, instrument ..................................................................................................................................... UG: 1-5

U

Upload results .............................................................................................................................................................. TG: 3-19
User replaceable parts ............................................................................................................................................... UG: 5-2
UTILITY .............................................................................................................................................................................. SG: 7-1

V

Validity (instrument alarm) ......................................................................................................................................UG: 3-77
Viewing patient results ............................................................................................................................................. TG: 2-56
VOLTAGE MONITOR .................................................................................................................................................. SG: 7-49

W

Warning (alarm code) ................................................................................................................................................. UG: 3-4
Warning stickers ......................................................................................................................................................... RG: 1-13
Warranty ........................................................................................................................................................................... RG: 1-5
Waste solution ............................................................................................................................................................. RG: 1-14
Water supply ................................................................................................................................................................. RG: 2-22
Work list ........................................................................................................................................................................... SG: 8-4

RG = Reference Guide TG = Tutorial Guide
SG = Software Guide UG = User's Guide

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