Roche Elecsys 1010 User manual

Elecsys® 1010
Operators Manual
Cat. No. 1705296001
The contents of this manual, including all graphics and photographs are the property of Roche Diagnostics. Information in this document is subject to change without notice. Roche Diagnostics shall not be liable for technical or editorial errors or omissions contained herein.
No part of this document may be reproduced or transmitted in any form or by any means, electronic or mechanical, for any purpose, without the express written permission of Roche Diagnostics.
Elecsys is trademark of a member of the Roche Group. All other trademarks are the property of their respective holders.
This manual was created by SCRIPTOR DOKUMENTATIONS SERVICE GmbH, Bielefeld, Germany, on behalf of Roche Diagnostics. Questions/comments regarding the content of this manual can be directed to your local Roche Diagnostics representative.
V 3.0 – Reference Guide
Roche Diagnostics Elecsys® 1010 Immunoassay System
Revised Manual Pages
Revised pages for this manual are provided by Roche Diagnostics when necessary. No part of this publication may be reproduced in any form or by any means without prior written permission.
Publication Date Pages Affected
Reference No.
Version Gamma Nov 1996 Reference Guide
Software Guide User’s Guide Tutorial Guide
Version 1.1 May 1997 Reference Guide
Software Guide User’s Guide Tutorial Guide
Version 2.0 Feb 1999 Reference Guide
Software Guide User’s Guide Tutorial Guide
Version 3.0 Jan 2000 Reference Guide
Software Guide User’s Guide Tutorial Guide
V 3.0 – Reference Guide
Reference Guide
Reference Guide
Reference Guide - Table of Contents
Table of Contents - Reference Guide
V 3.0 – Reference Guide 1
Roche Diagnostics Elecsys® 1010 Immunoassay System
1. Introduction 1-1
1.1 Manual Outline 1-2
1.2 The Elecsys 1010 Analyzer 1-3
1.3 Reagents, Calibrators and Controls 1-5
1.3.1 Reagent Kits (Reagent Packs) 1-6
1.3.2 Package Insert 1-7
1.3.3 Product Information Sheet 1-7
1.3.4 Calibrator and Control Kits 1-7
1.3.5 Reagent Bar Code Labels 1-8
1.3.6 Calibrator and Control Bar Code Labels 1-9
1.3.7 Calibrator and Control Bar Code Cards 1-9
1.4 Potential Hazards and Safety Precautions 1-10
1.4.1 Safety Notes 1-10
1.4.2 Accident Prevention 1-15
1.5 Approvals 1-17
2. System Description 2-1
2.1 Introduction 2-2
2.2 Control Unit 2-3
2.3 Sample/Reagent Disk 2-5
2.4 Sample/Reagent Arm 2-7
2.5 Incubator 2-9
2.6 Sipper Arm 2-10
2.7 Liquid System 2-11
2.8 Measuring Cell 2-13
2.9 Power Switch 2-15
2.10 Printer 2-15
2.11 Floppy Disk Drive 2-16
2.12 Interfaces 2-17
2.13 Technical Data 2-18
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Reference Guide - Table of Contents
3. Functional Sequence of Analysis 3-1
3.1 Introduction 3-2
3.2 General Analysis Sequence 3-4
3.3 Test Sequences 3-6
3.3.1 Test protocol 3-7
3.4 Example of an Analysis Process 3-8
3.4.1 Reagent 1, Reagent 2 and Sample Pipetting 3-10
3.4.2 First Incubation 3-13
3.4.3 Resuspension of the Microparticles 3-14
3.4.4 Microparticle Pipetting 3-15
3.4.5 Second Incubation 3-16
3.4.6 Measurement Stage 3-17
3.4.7 Measurement and Evaluation 3-20
3.4.8 Measurement Cell Cleaning and Preparation for the Next Measurement 3-20
4.
ECL
Technology 4-1
4.1
ECL
Technology 4-2
5. Test Principles for Immunoassays 5-1
5.1 Test Principles 5-2
5.1.1 Competitive Principle 5-2
5.1.2 Sandwich Principle 5-4
5.1.3 Bridging Principle 5-6
6. Calibration 6-1
6.1 Introduction 6-2
6.2 Calibration Concept of Elecsys 6-3
6.3 Laboratory Calibration 6-4
6.4 Stability of Calibrations on Elecsys 1010 6-5
6.5 Automatic Validation of Calibrations 6-6
6.6 Calibration of Quantitative Assays 6-9
7. Glossary 7-1
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1. Introduction
Header
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Roche Diagnostics Elecsys® 1010 Immunoassay System

1.1 Manual Outline

The Reference Guide is part of the Elecsys® 1010 Operators Manual, which also includes the Software Guide, Tutorial Guide, Users Guide and Short Guide.
The Reference Guide gives a comprehensive insight into the technical/theoretical operation of the Elecsys 1010 analyzer.
Chapter 1. Introduction
This chapter introduces the analyzer and describes the packaging concept for reagents, calibrators and controls. Important safety instructions are also provided in this section.
Chapter 2. System Description
This chapter describes in detail the individual components of the analyzer, their tasks and technical data.
Chapter 3. Functional Sequence of Analysis
This chapter describes the individual stages of the immunological analysis process on the analyzer.
Chapter 4.
Chapter 5. Test Principles
Chapter 6. Calibration
Chapter 7. Glossary
ECL
Technology
This chapter describes the fundamental principle of the electrochemiluminescent process.
This chapter describes the principles of the various immunoassay processes.
This chapter describes the validation criteria in theory, as well as the various calibration methods used on Elecsys 1010.
This chapter provides definitions of commonly used terms.
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The Elecsys 1010 Analyzer

1.2 The Elecsys 1010 Analyzer

The Elecsys 1010 analyzer is a fully automatic, run-oriented analyzer system for determination of immunological tests using the
e
lectrochemiluminescent process. All components and reagents for routine
analysis are integrated in or on the analyzer.
Operation of the analyzer is simple and intuitive. The reagents are stable and can be directly loaded onto the analyzer. The consistent use of bar-coded reagents greatly reduces the need for time-consuming manual entries in the daily routine. Additional automation can be achieved by connecting a laboratory EDP (host) system.
ECL/Origen
You can use serum and plasma samples in primary tubes, Hitachi standard cups, microcups or cups on primary sample tubes. Bar-coded sample tubes are recognized. Two STAT positions for STAT samples are also available.
Results are produced either qualitatively or quantitatively depending on the test. The typical test throughput is approximately 50 results per hour.
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Roche Diagnostics Elecsys® 1010 Immunoassay System
     
R1/R2 S/R probe rinse station
R3 Sipper probe rinse station
R4 Mixer rinse station
Sample/reagent disk
Incubator
Sipper arm
+ Sample/reagent arm (S/R probe and mixer)
Detection unit (measuring cell)
+ Positions for ProCell and CleanCell bottles
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1.3 Reagents, Calibrators and Controls

The reagent packs have a special 2D (two dimensional) bar code, which allows fully automatic registration and management of reagent information. Manual input or additional monitoring is not necessary. The ready-to-use, liquid reagents are loaded into one of the six positions on the sample/reagent disk. Reagents are available for analysis after their bar codes have been scanned.
Reagents, Calibrators and Controls
The handling of calibrators and Roche Diagnostics controls corresponds to that of reagents. Most calibrators are ready-to-use. Lyophilized controls and some calibrators must be prepared and transferred into the appropriate container. Calibrator and control information is stored on 2D bar code cards (see Chapter
1.3.7, Calibrator and Control Bar Code Cards).
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Roche Diagnostics Elecsys® 1010 Immunoassay System
1.3.1 Reagent Kits (Reagent Packs)
Reagent packs are ready-to-use and incorporate three bottles connected to each other:
The white bottle with a transparent lid contains suspended magnetic microparticles that act as the carrier material of the ruthenium-labeled complex during measurement.
The black bottle with a gray lid contains R1.
The black bottle with a black lid contains R2.
The test application, calibration data, control information, sample and reagent volumes, as well as special measurement conditions are contained in the reagent bar code and therefore do not have to be entered separately by the operator.
The following are examples of typical box labels for an Elecsys reagent kit. The large label contains the intended use statement, storage temperature, contents and catalog number of the kit. The smaller side box label contains the lot and expiration date of the kit as well as a bar code number. This bar code number is used for tracking purposes and is not used by the analyzer.
Catalog number
Kit lot number
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Reagents, Calibrators and Controls
1.3.2 Package Insert
Each reagent kit includes a package insert. This insert contains information required to perform the assay. Detailed information is contained in the product information sheet supplied separately.
1.3.3 Product Information Sheet
Each assay applied to this analyzer has a product information sheet that provides general information about the assay. Data contained in the product information sheets is more detailed than what is in the package insert. Instrument settings are encoded in reagent bar codes and not entered by the operator. This type of information, such as sample volume, reagent volume, etc., are found in the overview section of the product information sheet.
Product information sheets can be obtained from Roche Diagnostics as required.
1.3.4 Calibrator and Control Kits
In most cases, calibrators and controls for Elecsys reagents come packaged separately.
Each kit contains either bar-coded calibrator or bar-coded control vials ready for use on the analyzer. Most calibrators are in ready-to-use liquid form and require no further action other than to place them on the sample/ reagent disk when a calibration is necessary.
A few of the calibrators and controls are lyophilized in glass bottles and must be reconstituted before being transferred into plastic bar coded-labeled vials. (Empty bar coded-labeled vials are packaged in these kits with lyophilized calibrators and controls.) Reconstituted calibrators and controls can be stored in the plastic vials after transfer.
Calibrators and controls also have color-coded caps to assist you in identification. A white cap is a level one calibrator/control and a black cap is a level two calibrator/control. In the course of the year 2000, black and white color-coded caps for controls will be phased out in favor of beige/light brown (level one) and caramel/dark brown (level two).
Calibrator and control bar code cards are packed with calibrator and control kits, respectively (see Chapter 1.3.7, Calibrator and Control Bar Code Cards).
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Roche Diagnostics Elecsys® 1010 Immunoassay System
1.3.5 Reagent Bar Code Labels
Reagent packs have a bar code label that contains information required to run the assay. This information includes:
test number
lot number
master calibration curve parameters
(e.g. Rodbard parameters)
instrument settings
calibrator lot numbers and target values
expiration date
calibration frequency
The following information can be identified on each reagent bar code label:
 
kit catalog number reagent pack number reagent bar code number kit lot number expiration date.
The reagent bar code label is in a new format. The new symbology utilizes portable data files (PDF) and is called PDF417. Traditional linear bar codes serve as a link to a database that contains the appropriate information. PDF417 is a two dimensional (2D), stacked bar code that contains an actual entire data record. The large amount of data that can be encoded allows all instrument settings to be included, as well as the master calibration curve and additional information for the assay. It is from this master curve and from the operator 2-point calibration that the analyzer derives the update of the master calibration curve. For further information, refer to Chapter 6, Calibration.
Every PDF417 symbol (bar code) contains two error detection codewords that are used like the check digit in linear bar code symbologies to detect decode errors and verify that all data have been read and decoded accurately. Additionally, PDF417 provides error correction in the event that portions of symbol have been damaged, destroyed or are unreadable.
1
It is a combination of this error detection and error correction that ensures a reliable bar code. If the bar code cannot be read and the reagent lot has been previously used by the analyzer, the 15-digit number can be entered manually in the software.
1. Itkin S, Martell J. A PDF417 Primer: A Guide to Understanding Second Generation Bar Codes and Portable Data Files. Bohemia, NY: Symbol Technologies, Inc; 1992:17-18.
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Reagents, Calibrators and Controls
1.3.6 Calibrator and Control Bar Code Labels
Each calibrator and control bottle has a traditional linear bar code label that contains an identifier to link it to information encoded in the reagent bar code label and the calibrator or the control bar code card (see Chapters 1.3.5 and 1.3.7).
1.3.7 Calibrator and Control Bar Code Cards
Each calibrator and control kit comes with one or two 2D bar code cards. The following information is included but not limited to:
test number
calibrator/control lot number
control code (e.g., PCU1) (control card only)
lot number of the calibrator/control bar code label
information about which calibrator is to be used and the number of determinations (calibrator card only)
target values
control ranges (control card only)
expiration date.
Roche Diagnostics produces a factory master calibration for each calibration lot. The results are encoded into the corresponding reagent bar code. Scan the new bar code card when a new lot of calibrators or controls is used.
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Roche Diagnostics Elecsys® 1010 Immunoassay System

1.4 Potential Hazards and Safety Precautions

1.4.1 Safety Notes
To protect yourself from potential hazards, you must review all safety precautions and regulations concerning the handling of materials and the system's electrical and mechanical components.
The important safety notes in this manual are listed and classified below. Make yourself acquainted with the following visual cues and icons:
WARNING
$
Warning messages contain information which, if not followed, could cause serious personal injury and/or damage to the analyzer.
CAUTION
Caution messages contain information which, if not observed, could result in loss of data and/or damage to the analyzer.
Note
Notes contain important information about a topic in the text.
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Potential Hazards and Safety Precautions
Electricity
To avoid an electric shock DO NOT attempt to open the instrument panels and work in any electronic compartment.
Chemical
The operator is responsible for taking all necessary precautions against hazard associated with the use of clinical laboratory chemicals. Specific recommendations for each reagent used on the analyzer are found on the box label, package insert or product information sheet for each chemistry. Material Safety Data Sheets (MSDS) are available for Roche Diagnostics reagents.
Immediately remove any reagent spillage from the instrument.
Mechanical
As with any mechanical system, certain precautions must be taken when operating the instrument. DO NOT wear loose garments or jewelry that could catch in moving mechanisms. DO NOT put your hand into the pathway of any moving parts while the analyzer is operating. Operate the instrument with the cover down. DO NOT attempt mechanical repairs unless the instrument is in Stand-by or OFF.
Biohazardous Materials
As with all in vitro diagnostic equipment, patient samples and serum-based quality control (QC) products that are assayed on this system, as well as all waste from the waste container, should be treated as potentially biohazardous. All materials and mechanical components associated with the sampling and waste system should be handled according to your facilitys biohazard procedure. Use the personal protective equipment recommended by your facility when handling any of these components.
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Roche Diagnostics Elecsys® 1010 Immunoassay System
Safety Precautions During Operation
Samples
1. Treat all samples as potential biohazards. If sample spills on the instrument, use correct personal protective equipment (PPE-gloves, lab coat, etc.) and wipe off the spillage immediately.
2. Make sure that the sample does not contain any fibrin, dust or other insoluble contaminants. If insoluble contaminants are contained in the sample, correct measuring values may not be obtained.
Waste Solution and Solid Wastes
1. Avoid direct contact with waste solution and/or solid wastes. Both should be handled as potential biohazards.
2. Dispose of waste solution and/or solid wastes according to the relevant governmental regulations.
3. Consult the reagent manufacturer for information on the concentrations of heavy metals and other toxic constituents in each reagent.
4. $ WARNING
Do not add bleach to the liquid waste container. Bleach combined with the contents of the liquid waste could cause potentially harmful fumes.
Biohazardous Parts
1. Avoid direct contact with the sample/reagent probe, sipper probe and rinse station. Treat these areas as potentially biohazardous.
Reagents
1. Avoid direct contact with reagents. Direct contact may result in skin irritation or damage. Refer to the reagent kit box labels or package insert for specific instructions.
2. Avoid direct contact with CleanCell. Direct contact may result in skin irritation or damage. Refer to the CleanCell box label or package insert for specific instructions.
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Potential Hazards and Safety Precautions
Additional Precautions
Flammables
Avoid using dangerous flammables near the instrument. Fire or explosion may be caused by naked flames.
Accuracy/Precision of Measured Results
For proper use of the instrument, measure control samples and monitor the instrument during operation.
An incorrectly measured result may lead to an error in diagnosis, therefore posing a danger to the patient.
Application
The instrument is designed for clinical immunological test analysis using water­soluble samples and reagents.
Please note that other analyses may not be applicable to this instrument.
Operator Qualification
1. Operation should be conducted under the management of a technician who has undergone training at the facility specified by the sales agent.
2. For clinical tests, the instrument should be used under the management of a doctor or clinical inspector.
Operation and Maintenance
1. During operation and maintenance of the instrument, proceed according to the instructions and do not touch any parts of the instrument other than those specified.
2. Do not open the cover while the analyzer is running or operation will be stopped.
Installation Requirements
Installation is performed by a Roche Diagnostics representative. The customer is responsible for providing the necessary facilities as detailed in Section 2.13, Technical Data.
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Roche Diagnostics Elecsys® 1010 Immunoassay System
Restriction on Samples and Reagent Solutions
1. The assay cups, detection unit and liquid waste container are not guaranteed to be chemically resistant against organic solvents. Therefore, do not use organic solvents on these parts.
2. Avoid using samples and reagent solutions that are likely to adhere to the assay tips, assay cups, liquid waste container or detection unit.
Handling Reagent Solutions
Follow the manufacturers instructions for use of reagent solutions.
Loading Samples and Reagents
Be sure to load samples and reagents only into the specified positions on the instrument.
If sample or reagent is spilled, malfunction of the instrument may occur.
Sample/Reagent Disk
Never load new samples onto the sample/reagent disk during the scan process. When loading the sample/reagent disk, follow the instructions in the manual.
Microparticle Mixer
Be careful not to bend the microparticle mixer. A bent mixer could lead to inaccurate results.
Switching On the Instrument
After the analyzer has been switched off, wait approximately 10 seconds before switching it back on.
Instrument Unused for a Long Time
If the instrument will not be used for a long period of time, contact Technical Support. Different shutdown procedures are recommended depending upon the duration of inactivity. In addition, certain procedures require the assistance of a Roche Diagnostics service representative.
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Potential Hazards and Safety Precautions
1.4.2 Accident Prevention
Elecsys 1010 is a fully automatic analyzer designed according to the most up-to­date safety requirements. This ensures the highest possible protection for the operator from accidents and ensures correct functioning of the system.
Before using the Elecsys 1010, review the safety precautions described in this chapter to avoid operational interruptions and to protect you from potential hazards.
The following overview describes specific features for optimal analyzer and operator protection.
Operator Training
Roche Diagnostics provides system training after which an operator not only works with the Elecsys 1010 but is also familiar with the relevant safety aspects.
Stand-by Operation and Analyzer Preparation
(Stand-by = the analyzer has power, however, the motion functions of the individual components are disabled). In Stand-by mode, the tips of the S/R and sipper probe and the paddle of the microparticle mixer are stowed in their home positions in the rinse stations. Therefore, the operator cannot be injured by the probes.
The sample/reagent disk can be removed from the analyzer. Therefore, loading of samples, reagent packs, calibrators and controls can either be performed on the analyzer or away from the analyzer.
The consumable containers (CleanCell, ProCell, water and waste containers) are replaced or refilled in Stand-by mode.
When all the necessary substances have been loaded on the analyzer, the scan process can be started after closing the cover.
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Roche Diagnostics Elecsys® 1010 Immunoassay System
Analyzer Cover
The analyzer cover must be closed prior to starting a run. A run cannot be started when the cover is open. If the cover is opened during initialization, the analyzer stops immediately.
If the cover is opened during a run, the analyzer moves the probes and microparticle mixer to their home positions in the rinse stations within 2 seconds to prevent accidental contact. As a result, the run is stopped.
CAUTION
Opening the analyzer cover during a run may cause results to be lost.
STOP
Key
Press the STOP key to stop all operations that Elecsys 1010 is performing as soon as possible. This process is the same as that described for the analyzer cover.
STAT
Samples
STAT (Short Turn Around Time) samples can be placed on the analyzer in the
designated positions behind the control unit, even when the cover is closed and a run is being performed. Contact with the probes or microparticle mixer is not possible. To load STAT samples, the drawer is pulled forward to expose the STAT positions. There is a mechanical lock present when access is not permitted.
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1.5 Approvals

The Elecsys 1010 analyzer was manufactured and tested according to international standard IEC 1010-1, Safety requirements for electrical equipment for measurement, control and laboratory use, Part 1: General requirements. This international standard is equivalent to the national standard Underwriters Laboratories (UL) 3101-1.
The analyzer was tested and approved by the VDE and UL and received the following safety marks:
Approvals
C
U
®
U
V
D E
L
L
®
¨
geprufte Sicherheit
Issued by Association of German Electrical Engineers (VDE).
Issued by Underwriters Laboratories, Inc. (UL).
Issued by Underwriters Laboratories, Inc. for Canada as a Certification and Testing Organization by the Standards Council of Canada (SCC).
The analyzer complies with the European Union (EU) directive 89/336/EEC (Electromagnetic Compatibility).
VDE Testing and Certification Institute,
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2. System Description
Control Unit
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Roche Diagnostics Elecsys® 1010 Immunoassay System

2.1 Introduction

Elecsys 1010 is a fully automated routine and STAT analysis system for the determination of immunological tests using the ECL/Origen
e
lectrochemiluminescent process. The system measures samples in the form of serum and plasma. Depending on the test used, the results are produced either as quantitative or qualitative results.
Elecsys 1010 was designed to be placed on a table. The photograph below shows where the components for the daily routine are located on the analyzer. The analyzer has an interface for the connection of a laboratory An external printer and a PC-compatible keyboard can also be connected.
Water Container
EDP (host) system.
Incubator
Sample/ Reagent Disk
Printer/ Floppy Disk Drive
ProCell/ CleanCell
Waste Container
Control Unit
The system was designed to be powered on and operated 24 hours a day. Power the analyzer on with the cover down. After configuration run is complete, the analyzer goes into Stand-by and is ready for operation.
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2.2 Control Unit
The control unit is easily accessible from the front of the analyzer. It is used by the operator to enter the tasks that the analyzer is to perform.
The control unit is comprised of a keyboard, covered by a plastic protection cover and an
L
iquid Crystal).
Located around the LC display (to the right and below the display) are unlabeled keys, called soft keys, which point to the display. The functions of these keys change according to the screen displayed.
All keys with a fixed function [to the left (menu keys) and above the display (function keys)] are labeled accordingly. For example, pressing the SCAN key initiates a scan of bar code-labeled tubes and reagent packs loaded on the sample/reagent disk.
LC display (LC =

Control Unit

As an option, a PC-compatible keyboard can be connected for entering text and special characters. For this purpose, there is a 5-pin standard connector underneath and to the right of the control unit.
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Roche Diagnostics Elecsys® 1010 Immunoassay System
STAT
Sample Positions
The control unit is designed like a drawer, which when pulled out provides access to the two STAT positions. During a run, up to two
STAT samples at a time can be
loaded in primary tubes or when using a special adapter (supplied) in secondary cups.
Normally, access to both STAT positions is always possible. When the STAT key is pressed, the requests for one or both STAT samples can be entered.
When the STAT requests have been confirmed, the control unit is locked into position by the analyzer until all of the requested tests have been pipetted.
The control unit is then immediately unlocked so that further STAT samples can be processed during a run.
Note
A power failure during the pipetting of the STAT samples may lock the control unit. The locking device can be temporarily overridden by inserting a screwdriver below the control unit.
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