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
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