Elecsys® 2010

Operator's Manual
Software Version 06.03
Elecsys® 2010

Revision History
Manual Version Revision Date Changes
1.0 November 1996 Reference Guide
Software guide
User's Guide
Tutorial Guide
2.0 March 1998 Reference Guide
Software guide
User's Guide
Tutorial Guide
Short Guide
3.0 November 1998 Short Guide
3.0 April 1999 Reference Guide
Software guide
User's Guide
Tutorial Guide
3.2 November 2002 Reference Guide
Software guide
User's Guide
Tutorial Guide
Short Guide
3.21 June 2003 Reference Guide
Revision Page added
Not published!
4.0 July 2003 Change to A4 Format
Revision History Table updated
Introduction added
Graphic colors updated
Operator's Manual V 3.2 used as base for
translation
Software Version V 06.03

Language Order Number

English 11706420001
French 11706420080
Italian 11706420050
Portuguese 11706420046
Spanish 11706420036

2 Roche Diagnostics Elecsys® 2010 Immunoassay System – A4 Format Additional Information and Revision History V 4.0.
 Elecsys® 2010

Edition Notice
Elecsys 2010 Operator’s Manual
This manual is for users of the Elecsys 2010 analyzer.
Every effort has been made to ensure that all the information contained in this manual is correct at the
time of printing. However, Roche Diagnostics GmbH reserves the right to make any changes necessary
without notice as part of ongoing product development.
Any customer modification to the instrument will render the warranty or service agreement null and void.
For warranty conditions, refer to the analyzer purchase agreement. Contact your local Roche Diagnostics
representative for further information.
Software updates are done by Roche Diagnostics representatives.
Intended use
This operator’s manual is intended to be used as an instructional aid in the performance of tasks related
to the operation and general maintenance of the instrument. The manual contains detailed descriptions of
instrument features and general operational concepts, specifications, theory of operation, function and
use of controls, operating techniques, emergency procedures, product labeling and maintenance proce-
dures.
Copyrights
©2003, Roche Diagnostics GmbH. All rights reserved.
Trademarks
The following trademarks are acknowledged:
Roche and Roche logo are registered trademarks of the Roche group.
Instrument approvals
Our instruments meet the protection requirements laid down in IVD Directive 98/97/EC and the European
Standard prEN591. Furthermore, our instruments are manufactured and tested according to the international
standards EN 61010-1/ IEC 61010-2-081/ IEC 61010-2-101.
Compliance is demonstrated by the following marks:

Complies with the IVD directive 98/79/EC.

Issued by Underwriters Laboratories, Inc. (UL) for Canada and the US.

Contact addresses
Manufacturer:
Hitachi High-Technologies Corporation
24-14,Nishi-Shinbashi, 1-chome, Minato-ku
Tokyo, 105-8717
JAPAN

Authorized Representative:
Roche Diagnostics GmbH
Sandhofer Straße 116
D-68305 Mannheim
Germany

Roche Diagnostics Elecsys® 2010 Immunoassay System – A4 Format Additional Information and Revision History V 4.0. 3
Elecsys® 2010

Table of Contents

Revision History 1 1.4 Software Structure – Disk System 1-7

Table of Contents 3 1.5 Software Structure – Rack System 1-8
Preface 5
2. Inventory 2-1
How to use this manual 6
2.1 INVENTORY Screen 2-2
Conventions used in this manual 7
2.2 REAGENT DETAILS Pop-up Window 2-5
2.3 REAGENT DETAILS Pop-up Windows
Reference Guide Part A for Diluent and Pretreatment 2-7
1. Introduction 1-1 2.4 SYSTEM REAGENT DETAILS Pop-up
1.1 Introduction 1-2 Window 2-8
1.2 The Elecsys 2010 Immunoassay System 1-3 2.5 MANUAL INPUT Pop-up Window 2-9
1.3 General Overview 1-5 2.6 DISK NUMBER CONFIRMATION
1.4 Product Labeling 1-7 Pop-up Window 2-10
1.5 Potential Hazards and Safety 2.7 ALARM Pop-up Window 2-11
Precautions 1-12 3. Orders 3-1
1.6 Approvals 1-17 3.1 ORDERS Screen 3-2
2. System Description 2-1 3.2 DELETE SAMPLE CONFIRMATION
2.1 Introduction 2-2 Pop-up Window 3-5
2.2 Control Unit Components 2-4 3.3 SELECT CALIBRATOR Pop-up Window 3-6
2.3 Sample/Reagent Area Components 2-6 3.4 SELECT CONTROL Pop-up Window 3-7
2.4 Consumables Area Components 2-14 3.5 DILUTION FACTOR Pop-up Window 3-8
2.5 Measuring Area Components 2-17 3.6 POSITION SEARCH Pop-up Window 3-9
2.6 Power Components 2-20 4. Results 4-1
2.7 Technical Data 2-21 4.1 RESULTS Screen 4-2
3. Mechanical Theory 3-1 4.2 FILTER SELECTION Pop-up Window 4-4
3.1 Introduction 3-2 4.3 DOCUMENT SETUP Pop-up Window 4-5
3.2 Detailed Assay Sequence 3-5 4.4 DELETE DOCUMENT SAMPLES
3.3 Dilution Steps 3-12 CONFIRMATION Pop-up Window 4-6
3.4 Analyzer Status Conditions 3-13 4.5 RESULT DETAILS Pop-up Window
for a Sample 4-6
4. ECL Technology 4-1
4.6 RESULT DETAILS Pop-up Window
4.1 Introduction 4-2
for a Control 4-7
5. Test Principles 5-1
5. QC 5-1
5.1 Competitive Test Principle 5-2
5.1 QC Screen (Quality Control) 5-2
5.2 Competitive Principle 5-2
5.2 CONTROLS Pop-up Window 5-4
5.3 Sandwich Principle 5-4
5.3 QC CHART OVERVIEW Pop-up Window 5-5
5.4 Bridging Principle 5-6
6. Status 6-1
6. Calibration 6-1
6.1 STATUS Screen 6-2
6.1 Reagent Calibration 6-2
6.2 SAMPLE POSITION STATUS Pop-up
6.2 Calibration of Quantitative Assays 6-5
Window 6-6
6.3 Calibration of Qualitative Assays 6-7
6.3 SAMPLE SCAN CONFIRMATION
Pop-up Window 6-7
Software Guide Part B 6.4 OPEN REQUESTS Pop-up Window 6-8
1. Operating Basics 1-1 7. Utility 7-1
1.1 Introduction 1-2 7.1 UTILITY Screen 7-3
1.2 The Screen 1-2 7.2 CONTROL DEFINITION 1 Screen 7-4
1.3 The Keyboard 1-4 7.3 CONTROL DEFINITION 2 Screen 7-6

4 Roche Diagnostics Elecsys® 2010 Immunoassay System – A4 Format Additional Information and Revision History V 4.0.
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7.4 CALIBRATION DATA Screen 7-11 4.5 Clean Sipper Probe 4-7
7.5 TEST CONDITIONS Screen 7-24 4.6 Clean Rinse Stations for R/S Probe,
7.6 MESSAGE HISTORY Screen 7-27 Mixer and Sipper Probe 4-8
7.7 INTERFACE SETUP Screen 7-29 4.7 Perform Liquid Flow Cleaning 4-10
7.8 INSTRUMENT SETUP Screen 7-30 4.8 Cleaning Floppy Disk Drive 4-12
7.9 SAMPLE DISK MODE SETUP Screen 7-32 4.9 Clean Distilled Water Container 4-12
7.10 PRINTOUT CONFIGURATION Screen 7-33 4.10 Clean Liquid Waste Container 4-14
7.11 DOCUMENTATION SETUP Screen 7-35 4.11 Clean ProCell/CleanCell Compartments 4-15
7.12 INITIAL BLANKCELL Screen 7-36 4.12 Clean Reagent Disk and Compartment 4-16
7.13 KEEP FUNCTION SETUP Screen 7-36 4.13 Empty Solid Waste 4-17
7.14 MAINTENANCE Screen 7-38 4.14 Replace Pinch Valve Tubing (PM Visit) 4-18
7.15 TEMPERATURE MONITOR Screen 7-49 4.15 Replace Pipettor Seals (PM Visit) 4-20
7.16 VOLTAGE MONITOR Screen 7-49 4.16 Other As Needed Maintenance
7.17 RETRY FUNCTION SETUP Screen 7-50 Procedures 4-26
7.18 ASSAY PERFORMANCE CHECK Screen 7-51 4.17 Extended Power OFF Recommendations 4-26
7.19 AUTOMATIC ADJUSTMENT Screen 7-52
5. Spare Parts 5-1
7.20 MECHANISM CHECK Screen 7-53
5.1 Spare Parts Overview 5-2
7.21 SERVICE Screen 7-54
5.2 Accessory and User Replaceable Parts 5-2
8. Reports 8-1
8.1 Overview of Options 8-2 Tutorial Guide Part D
8.2 INVENTORY Report 8-2
1. Overview 1-1
8.3 Work List 8-4
1.1 Overview of Options 1-2
8.4 TEST RESULTS Report 8-6
8.5 RESULTS Report 8-9 2. Daily Operation 2-1
8.6 QC RESULTS Report 8-10 2.1 Power ON 2-3
8.7 STATUS Report 8-12 2.2 Inventory Checks 2-5
8.8 CONTROL DEFINITION Report 8-14 2.3 Delete Open Requests 2-12
8.9 CALIBRATION DATA Report 8-16 2.4 Initiate Calibration/Control
8.10 TEST CONDITIONS Report 8-20 Measurement 2-13
8.11 MESSAGE HISTORY Report 8-21 2.5 Calibration Validation 2-21
2.6 Routine Sample Measurements –
Disk System 2-25
User Guide Part C 2.7 Routine Sample Measurements –
1. General Troubleshooting 1-1 Rack System 2-33
1.1 Introduction 1-2 2.8 Sample Tracking – Disk System 2-37
1.2 Immunoassay Troubleshooting 1-3 2.9 Sample Tracking – Rack System 2-39
1.3 General Instrument Troubleshooting 1-5 2.10 Measurement of Additional Routine
Samples 2-43
2. Data Alarms 2-1 2.11 Dilutions 2-46
2.1 Data Alarms Table 2-2
2.12 STAT Test Selections – Disk System 2-50
2.2 Data Flags 2-3
2.13 STAT Test Selections – Rack System 2-53
2.3 Special Data Flags 2-13
2.14 Results 2-5
3. Instrument Alarms 3-1 2.15 Post-Operation Data Management 2-61
3.1 General Description 3-2 2.16 Daily Maintenance 2-62
3.2 List of Alarms 3-6
3. How to... 3-1
4. Maintenance 4-1 3.1 How to Manually Select Calibration
4.1 Maintenance Procedure Overview 4-2 for a Reagent Pack 3-2
4.2 Clean S/R Probe 4-3 3.2 How to Manually Select a Calibrator 3-3
4.3 Finalization Maintenance 4-5 3.3 How to Define Roche (Bar coded)
4.4 Clean Incubator and Aspiration Station 4-5 Controls 3-5

Roche Diagnostics Elecsys® 2010 Immunoassay System – A4 Format Additional Information and Revision History V 4.0. 5
Elecsys® 2010

3.4 How to Define Non-Roche 3.11 How to Change Expected Values 3-21
(Non-Bar coded) Controls 3-8 3.12 How to Print Message History 3-22
3.5 How to Order a Control for a 3.13 How to Change Printout Configuration 3-23
Particular Reagent Pack (MQR) 3-11 3.14 How to Change the Sample Disk
3.6 How to Change a Control Target Mode 3-24
or Range 3-12
3.7 How to Delete a Single Open Request 3-16 Glossary Part E
3.8 How to Delete Open Requests –
Glossary 1-1
Disk System 3-17
3.9 How to Delete Open Requests –
Index Part F
Rack System 3-18
3.10 How to Manually Upload Results 3-19 Index 1-1

6 Roche Diagnostics Elecsys® 2010 Immunoassay System – A4 Format Additional Information and Revision History V 4.0.
 Elecsys® 2010

Preface
The Roche Diagnostics Elecsys 2010 Immunoassay System is a fully automated, random access, software-
controlled system for immunoassay analysis. It is available as both a disk system and a rack system. The
differences between the two configurations are detailed throughout this operator's manual.
The Elecsys 2010 analyzer was designed for both quantitative and qualitative in vitro determinations using
a wide variety of tests. Both disk and rack systems have a throughput per hour of approximately 86 tests.
The Elecsys 2010 analyzer can be placed on a bench top, thus saving space in the laboratory environment.
Handling of the system is easy; potential for manual errors is reduced to a minimum. All assay reagent,
calibrator and control information is automatically entered into the software by bar codes.
The system consists of the analyzer, which performs all functions required for fully automated sample and
assay processing, and a control unit, which controls the analyzer through the user software. This entirely
automated process begins with the recording of patient samples - provided that they are in bar code-
labeled tubes - up to the electrochemiluminescent detection and results transmission.
Data transmission to and from the analyzer, results evaluation, documentation, and quality control are
performed automatically by the software. Furthermore, the software is responsible for the management of
data between a connected laboratory information system (LIS) and the 2010 analyzer. Several Elecsys
analyzers can be centrally controlled when integrated with the Laboratory System Manager (LSM)
designed by Roche Diagnostics (note that the Laboratory System Manager (LSM) is not available to US
customers).
An outstanding feature of the analyzer system is the touchscreen and easy to use software.

o
● Keep this manual in a safe place to ensure that it is not damaged and remains available for use.
● This Operator's Manual should be easily accessible at all times.

Roche Diagnostics Elecsys® 2010 Immunoassay System – A4 Format Additional Information and Revision History V 4.0. 7
Elecsys® 2010

How to use this manual

The general table of contents at the beginning of each guide and the subject index located in the back of
the guide, provide points of quick correlation for cross referencing. Pictorials are repeated as necessary to
minimize page flipping and references are made between sections to point out specific guide information.
You should not operate the instrument until you are thoroughly familiar with the information in this
manual.
The manual is divided into the following four guides:
Reference Guide (Part A):
This book provides general information about Roche Diagnostics (e.g., ordering reagents and contacting
technical support), an introduction to the analyzer, instrument specifications, precautions and warnings,
mechanical and chemistry methodology theory.
Software Guide (Part B):
This book describes in detail the software on the analyzer. A basic organisation as well as detailed menu/
screen displays are provided. Reports from the analyzer are also found in this book.
User's Guide (Part C):
This book contains general troubleshooting, data and instrument alarms, maintenance and a spare parts
list.
Tutorial Guide (Part D):
This book provides a basic overview of the system, daily operational procedures and a "How to…" section
(i.e., instructions on most tasks the average operator is required to perform).
The manual also contains a Glossary (Part E) and an Index (Part F).
Where to find Information:
Interactive CD-ROM
The Interactive CD-ROM available with your manual contains five language versions of the information in
this manual in PDF file format (English, French, Italian, Spanish and Portuguese). You will need to have
Adobe Acrobat Reader installed on your PC to be able to view and print the PDF files. If you order the short
guide you will also receive the CD-ROM.
Short Guide
Also available with this manual is the Short Guide. This small document is designed to complement your
operator's manual. The Short Guide tells you exactly what is necessary to operate the analyzer, without the
level of detail found in the Tutorial Guide. Please refer to the Tutorial Guide of your operator's manual for
additional operational details.

Customer Information:
Customer Training
Contact your local Roche service representative for questions regarding Elecsys 2010 analyzer training.
Test Specific Information
Information specific to a particular chemistry test can be found in the chemistry package insert and/or
product information for that method (note that product information sheets are not available in the USA).
Contact Customer Service
Contact your local Roche service representative for further information regarding the Elecsys 2010
analyzer service agreement.

8 Roche Diagnostics Elecsys® 2010 Immunoassay System – A4 Format Additional Information and Revision History V 4.0.
 Elecsys® 2010

Ordering Information
Replacement parts, consumable materials, reagents, calibrators and controls should be ordered from
Roche Diagnostics. When ordering, please use the Roche Diagnostics catalog number and reference
name for each item. Contact your local Roche service representative for the detailed ordering list.
If you order the Short Guide you will also receive an interactive CD-ROM containing five language
versions of the information in this manual in PDF file format.
Conventions used in this manual
Visual cues are used to help locate and interpret information in this manual quickly. This section explains
formatting conventions used in the manual.
Symbols
The following symbols are used:

Symbol Used for

● Bullet

o Note

d Caution

% Warning

Disk system specific

Rack system specific

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Elecsys® 2010

10 Roche Diagnostics Elecsys® 2010 Immunoassay System – A4 Format Additional Information and Revision History V 4.0.