Elecsys e411 Operator's Manual

Operator’s Manual

Software Version 01-01

Revision history

Order numbers

Edition notice cobas e 411 analyzer Operator’s Manual

This manual is for users of the cobas e 411 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 procedures.

Copyrights © 2001-2006, Roche Diagnostics GmbH. All rights reserved.

Trademarks COBAS, COBAS C, COBAS E, ELECSYS, and LIFE NEEDS ANSWERS are trademarks of Roche.

All other trademarks are the property of their respective owners.

Instrument Approvals The cobas e 411 analyzer meets the requirements of Directive 98/79/EC of the European Parliament and the Council of the European Union (EU) on in vitro diagnostic medical devices. Furthermore, the cobas e 411 analyzer is manufactured and tested according to International Standard IEC 61010-1, 2nd edition, “Safety requirements for electrical equipment for measurement, control and laboratory use, Part 1: General requirements”. This International Standard is equivalent to the national standards Underwriters Laboratories (UL) 61010-1 2nd edition for the USA, and CAN/CSA C22.2 No. 61010-1:2004 for Canada. Compliance is demonstrated by the following marks:

Manual Version Template Version Revision date Changes

1.0 3.0

Language Order number

English 0490 5148 018 French 0490 5148 080 German 0490 5148 001 Italian 0490 5148 050 Portuguese 0490 5148 046 Spanish 0490 5148 036

Notice to the purchaser The purchase of this product allows the purchaser to use it solely for detection by ECL Technology for human in vitro diagnostic uses. No general patent or other license of any kind other than this specific right of use from purchase is granted hereby. This product may not be used by purchaser to conduct life science research or

development, patient self-testing, drug discovery or development or in any veterinary, food, water or environmental testing or use.

US Pat. 5,147,806; US Pat. 5,779,976; US Pat. 6,325,973; US Pat. 5,466,416; US Pat. 5,624,637; US Pat. 5,720,922; US Pat. 5,061,445; US Pat. 5,068,088; US Pat. 5,247,243; US Pat. 5,296,191, and corresponding patents in other countries.

Contact addresses

Manufacturer

Authorized Representative

Complies with the IVD directive 98/79/EC.

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

C ® US

Hitachi High-Technologies Corporation 24-14. Nishi-shimbashi. 1-chome. Minato-ku Tokyo. 105-8717 JAPAN

EC REP

Table of contents

Revision history 2

Contact addresses 3

Table of contents 5

Preface 7

Where to find information 7

Online Help system 8

Customer information 9

Conventions used in this manual 9

System description

Part

A

1 Safety information

Safety classifications A-5

Safety precautions A-5

System safety labels A-18

2 System overview

Overview of the cobas e 411 analyzer A-27

System components A-30

Analyzer unit A-30

Control unit A-34

Power components A-34

System specifications A-37

3 Control unit

Components A-55

Software basics A-60

4 Analyzer components

Overview of the analyzer components A-71 Sample/reagent area components A-72 Consumables area components A-89 Measuring area components A-97

Operation

Part

B

5 Overview

Operation Guide B-5

Disk and rack systems B-5

Software keyboard B-5 6 Daily operation Overview B-11 Pre-start inspection B-12 Pre-routine operation B-18 Routine operation B-31 Results B-81 Post-operation data management B-87

7 Special operation: How to…

Overview B-93 How to apply barcode labels to tubes and vials B-94 How to upload results manually B-96 How to select two or more samples in Data Review

B-98 How to archive sample data B-99

How to rerun a sample B-100

How to reset the system B-101 How to delete a single open request B-103 How to assign calibrator and control positions B-104 How to install and define Roche controls B-106 How to install and define non-Roche controls B-107 How to edit control values B-109 How to request standby bottle QC B-110 How to cancel a print job B-111 How to print a daily Alarm Trace report B-112 How to print a System Communication Trace report

B-113 How to change documentation settings B-114 How to program calculated tests B-115 How to change test settings B-116 How to change calibration settings B-118 How to change the sample disk mode B-119

Maintenance

Part

C

Every two weeks maintenance C-19 Every two months maintenance C-24

As needed maintenance C-30

Troubleshooting

Part

D

Contacting Technical Support D-8 Basic troubleshooting flow chart D-10 Immunoassay troubleshooting D-11 Instrument troubleshooting D-14 Chemistry troubleshooting D-24

10 Data alarms

Introduction D-33

List of data alarms D-34

Data alarms D-36

Data problems without an alarm D-48 Instrument problems without an alarm D-49

Appendix

Part

E

Glossary

Part

F

Index

Part

G

Notes

Part

H

Preface

The Roche Diagnostics cobas e 411 analyzer 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 cobas e 411 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 of approximately 85 tests per hour.

The cobas e 411 analyzer can be placed on a bench top, so 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 through the use of barcodes.

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 barcode labeled tubes—up to the electrochemiluminescence detection and results transmission.

Data transmission to and from the analyzer, results evaluation, documentation, and quality control are performed automatically by the software. Also, the software is responsible for the management of data between a connected Pre-Analytic Systems Manager (PSM)(1) and the cobas e 411 analyzer. Several cobas analyzers can be centrally controlled when integrated with the PSM.

This manual has detailed descriptions of cobas e 411 analyzer features and general operational concepts, specification functions and use of controls, operating techniques, emergency procedures, product labeling, and maintenance procedures.

Where to find information

The information you need to operate the cobas e 411 analyzer is supplied in several printed or online publications.

Operator’s Manual The Operator’s Manual contains information about safety, hardware, and operating the system, as well as maintenance and troubleshooting. A table of contents at the beginning of the book and each chapter, and an index at the end of this book help you to find information quickly.

Online Help The online Help contains a detailed description of the software of the cobas e 411 analyzer. In addition to the software description, the whole Operator’s Manual is included in the online Help. This makes it possible to retrieve information from both online Help and Operator’s Manual using the search functions available for

electronically stored documents.

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 Operator’s Manual.

COBI-CD The COBI-CD (Compendium of Background Information) provides you with background information about the technologies, test principles, their theory, and the calibration methods used by the cobas e 411 analyzer. The information can be read and printed using Adobe Acrobat Reader.

You cannot use the COBI-CD on the cobas e 411 system because the COBI-CD requires Adobe Acrobat Reader to be viewed correctly. Adobe Acrobat Reader is not installed on the control unit and such third-party software must not be installed.

Online Help system

The cobas e 411 analyzer provides online documentation in the form of context-sensitive Help. “Context-context-sensitive” means that wherever you are located in the software, choosing the Help feature displays Help text or a screen picture relating to that area of the software. The online Help offers a quick and convenient way to find information, such as explanations of screens and windows and how to perform particular processes.

a To display the online Help

1 You can display Help from any screen. However, if you wish to see Help information about a particular screen, display that screen on the monitor first.

2 Choose the ? button at the bottom left of the screen.

The Help window opens, usually displaying information concerning the current software screen or window.

3 If the Help information displayed initially does not answer your questions, use the contents, index, or search tab to locate more appropriate information.

Customer information

Customer training Contact your local Roche service representative for any questions or information regarding cobas e 411 analyzer system training and training material.

Contact customer service Contact your local Roche service representative for further information regarding the

cobas e 411 analyzer system service agreement.

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.

Conventions used in this manual

Visual cues help you to locate and interpret information in this manual. This section explains formatting conventions used in this manual.

Symbols The following symbols are used:

Symbol Used for

a Procedural step o List item e Cross-reference h Call up of screen Note Caution Warning

Laser radiation / optical safety

Biohazard

Disk system-specific

Abbreviations The following abbreviations are used: Abbreviation Definition A

ANSI American National Standards Institute C

CBT Computer Based Training

CCITT Comité consultatif international téléphonique et télégraphique (Consultative Committee on International Telegraph and Telephone)

CE Conformité Européenne

CLAS 2 Clinical Laboratory Automation System 2 CLIA Clinical Laboratory Improvement Amendments COBI-CD Compendium of Background Information CSA Canadian Standards Association

D

dBA decibel weighted against the A-frequency response curve. This curve approximates the audible range of the human ear.

DIL diluent

E

EC European Community

ECL electrochemiluminescence EMC electromagnetic compatibility

EN european standard

F

FIFO first in first out H

HCFA Health Care Financing Administration I

IEC International Electrical Commission IVD in vitro diagnostic directive K

KVA kilovolt-Ampere. Unit for expressing the power rating of AC electrical machinery.

L

LDL lower detection limit see analytical sensitivity LIS laboratory information system

LLD liquid level detection M

MSDS material safety data sheet N

NCCLS National Committee for Clinical Laboratory Standards P

PC/CC ProCell/CleanCell Q

Use of example screens This manual includes examples of screens from the cobas e 411 analyzer software. The equivalent screens might be different on your analyzer because the appearance of a screen depends on the specific configuration of an instrument and on the access level of the person operating it.

S

SD standard deviation

S/R sample/reagent

SVGA Super Video Graphics Adapter T

TPA tripropylamine

U

UL Underwriters Laboratories Inc. V

VDE Verband Deutscher Elektrotechniker (association of German electrical engineers)

1

Safety information . . . A-3

2

System overview . . . A-25

3

Control unit . . . A-53

4

Analyzer components . . . A-69

Safety information

Before operating the cobas e 411 analyzer, it is essential that you read and understand the warnings, cautions, and safety requirements contained in this manual.

The following safety precautions and instructions are intended for operators and also for anyone responsible for the management of the analyzer.

Safety classifications ... 5

Safety precautions ... 5

Warnings ... 5

Biohazards ... 11

Cautions ... 12

System safety labels ... 18

Analyzer unit ... 18

Positions of safety labels on the analyzer unit (disk system) ... 19

Positions of safety labels on the analyzer unit (rack system) ... 20

Positions of safety labels on the solid waste tray and Clean-Liner ... 21

Power supply ... 22

Circuit breaker ... 22

Rack sampler circuit breaker ... 23

Electromagnetic compatibility (EMC) ... 23

Peripheral device connections ... 23

Safety classifications

This section explains how precautionary information is formatted in the manual.

e Throughout this manual, safety icons are used to draw your attention to certain information. You should familiarize yourself with the following symbols, stickers, and icons: See System safety labels on page A-18.

Safety precautions

Pay particular attention to each of the following safety precautions. If these safety precautions are ignored, you may suffer serious or fatal injury.

Warnings

Warning

Indicates a possibly hazardous situation which, if not avoided, may result in death or serious injury.

Caution

Indicates a possibly hazardous situation which, if not avoided, may result in slight or minor injuries, or damage to equipment.

Biohazard

Indicates a possibly hazardous situation which, if not avoided, may result in infection.

Laser radiation/optical safety

Indicates a possibly hazardous situation which, if not avoided, may result in harm to your eyesight.

Air bubbles or films in system reagents

Perform a reagent prime after replacing the ProCell and CleanCell bottles back on the analyzer to ensure that there are no air bubbles or films in the fluid system.

Application

This instrument is designed for clinical immunological test analysis using water-soluble samples and reagents. Other analyses may not be applicable to this instrument. For clinical tests, the instrument should be used under the management of a doctor or clinical inspector.

Avoid use of bleach

Do not use bleach, SysClean, or alkaline disinfectant (pH > 9.5) to clean the liquid waste container. If such solutions are mixed with the contents of the liquid waste container, this could cause potentially harmful fumes.

Bent or damaged microbead mixer paddle

Do not bend the microbead mixer during cleaning. If the microbead mixer is damaged it will have to be replaced, as incorrect mixing may cause incorrect results.

Changing the Clean-Liner

o The system must be in Standby or switched off before continuing with this operation. o Do not touch the System Reset or Reagent Scan buttons, or switch on the analyzer, while

changing the Clean-Liner.

Circuit breakers and fuses

If any of the instrument circuit breakers trip or fuses blow, contact your Roche service representative before you try to operate the system again.

Contact with sample/reagent probe

Do not touch the sample/reagent probe until the analyzer enters S.Stop status as damage to the probe may result.

Take care not to damage the lower end of the sample/reagent probe during cleaning.

Contact with solutions

Avoid direct contact with reagents and cleaning solutions. Follow the package insert information for Roche Diagnostics reagents and cleaning solutions. Direct contact with these solutions may result in irritation or injury to the skin.

Correct use

Always follow the instructions in the Operator’s Manual, as failure to do so may result in a risk to your safety. Ensure that the Operator’s Manual is easily accessible at all times.

Damage to the measuring cell unit

Do not open the detection unit cover or service cover while the main circuit breaker is On. Otherwise, damage to the photomultiplier may result.

Disconnecting the power supply

To disconnect the analyzer from the supply source, the circuit breaker must be in the O (off) position and the power cord must be removed. Rack systems are provided with more than one power supply cord. All power supply cords must be removed to disconnect the equipment from the mains power supply.

Disposal of ProCell

Do not dispose of undiluted ProCell together with any strong alkaline solution, for example CleanCell.

Electrical safety precautions

Do not attempt to gain access to parts of the instrument marked with this label. Do not open the back cover or attempt to work in any electronic compartment. As with any electronic equipment, electric shock can occur. Installation, service, and repair must only be performed by authorized and qualified personnel.

Do not open the cover of the photomultiplier tube’s high voltage supply circuit board with the power switch or circuit breaker turned On. Touching the board may cause death or severe injury.

Environmental conditions

This analyzer is approved for indoor use only. Refer to the system specifications in the System overview chapter for details of the safe environmental operating conditions.

Flammables

Keep flammables away from the instrument when conducting maintenance or checks using alcohol. When using isopropyl alcohol or ethanol on or around the instrument, use no more than 20 mL at a time. Isopropyl alcohol and ethanol (70%) are flammable substances, and there is a danger of fire, explosion, or burns.

Handling of cleaning solutions (detergents)

Always wear protective (chemical-resistant) gloves and safety glasses when handling cleaning solutions. Roche Diagnostics cleaning solutions have corrosive properties. The handling of cleaning solutions with bare hands may result in injury to your skin, and failure to wear suitable eye protection may result in injury to your eyes.

Handling of reagents

o Avoid direct contact with reagents. Direct contact may result in irritation or injury to the skin. o Refer to the labels on the reagent boxes for specific handling instructions.

o Avoid direct contact with CleanCell. Direct contact may result in irritation or injury to the

skin. Refer to the Clean Cell box label for specific handling instructions.

o Do not use reagents that are expired. Otherwise, inaccurate data may be obtained.

o Do not store reagents at a temperature of less than 2°C as the microbeads should not be frozen. o Before loading reagents on the analyzer, ensure that they contain no bubbles, foam, or films as

these may cause pipetting volume shortage and deterioration in measurement accuracy.

Importance of maintenance

Provide the system with proper maintenance and care to ensure consistent and accurate functioning. Modifying or omitting the maintenance procedures may result in the loss of performance or reliability of the system, which are the responsibility of the operator.

Impurities in samples

Ensure that samples contain no insoluble impurities when loading on the instrument. Insoluble impurities such as fibrin, dust, or air bubbles in samples may cause pipetting volume shortage and deterioration in measurement accuracy.

Installation, removal from use, transportation, and disposal of the analyzer

Only trained Roche Support personnel, or similarly qualified personnel supervised by authorized service agents of Roche Diagnostics, are qualified to install, transport, and dispose of a cobas e 411 analyzer.

The customer is responsible for providing the necessary facilities. See the system specifications for details of the necessary facilities with suitable environmental conditions.

Instrument covers

o Close the top cover before starting operation. Take care not to pinch your fingers or hand. o Keep all covers closed and in place while the instrument is operating.

o When you close the rack sample cover, take care not to pinch your fingers or hand.

o Follow the procedures in the Operator’s Manual when opening the top cover for maintenance

and checks.

Instrument problems without alarms

Certain instrument problems may arise that the system does not monitor. If this is the case, no alarm is issued to alert the operator. Erroneous control measurements provide an important indicator of analyzer problems even when no alarms are issued. Such problems may include worn parts, air leaks in the syringe system, or reagent contamination. When you encounter these types of problems, you must decide whether to continue to process samples or to terminate the operation, depending on the possibility of causing damage to the system or reporting erroneous test results.

Manual assignment of sample containers

It is sometimes necessary to manually assign a vial or other sample or calibrator container to a rack or a specific sample disk position, for example, due to an unreadable barcode.

o Ensure that the position is not already assigned before manually assigning a position. o Do not manually assign calibrator vials with barcodes to racks or sample disks.

Refer to the Operator’s Manual or online Help for more details on making manual assignments.

Moving parts

Do not touch moving parts when the instrument is operating, and do not wear loose garments or jewelry that could catch in moving mechanisms. Otherwise, you may be injured or infected, or the instrument may be damaged.

Operation and maintenance

During operation and maintenance of the instrument:

o Follow the instructions.

o Do not touch any parts of the instrument other than those specified.

Operator qualification

Do not perform operation and maintenance unless you have been trained by authorized Roche Diagnostics personnel or processes. Carefully follow the procedures specified in the Operator’s Manual for the operation and maintenance of the system. Leave maintenance that is not described in the Operator’s Manual to trained Roche Technical Support personnel. Follow standard laboratory practices, especially when working with biohazardous material.

The operator is responsible for taking all necessary precautions against hazards 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.

Quality control measurement

An incorrectly measured result may lead to an error in diagnosis, therefore posing danger to the patient.

o Check that quality control measurements are within the specified range before accepting the

sample results. The frequency of quality control depends upon the system settings and your local legal requirements.

o Do not use reagents, calibrators, or controls that are expired. Otherwise, inaccurate data may

be obtained.

o Refer to package inserts for example assigned values and sample/control stability.

Rack line cover

Do not detach the cover. Because racks are moving at a high speed beneath the cover, you may be injured if you touch racks in the A-line and C-line during operation.

Replacing reagent packs

o The instrument must be in Standby before performing this operation.

o If you open the reagent rotor cover during operation, your fingers may be entangled in it and

cause you injury.

Replacing system reagents

Biohazards

Residual liquid in pinch valve tubing

When replacing the pinch valve tubing, take care to avoid contact with any residual liquid remaining in the old tubing. The liquid that flows through this tubing comes from the measuring cell and so is potentially biohazardous. Wear approved disposable gloves. If you get any of the liquid on your skin, wash it off immediately, apply disinfectant according to your own laboratory practices, and consult a physician.

Sample evaporation

If the sample has been on board for more than two hours, repeat the analysis with a fresh sample. Evaporation of samples that have been on board for more than two hours may lead to false results.

Biohazardous materials

Material of human or animal origin, and material from tissue cultures or in vitro cultures, must be treated as potentially biohazardous. Always wear suitable protective equipment such as approved disposable gloves, a fluid-resistant laboratory coat, and safety goggles, when handling biohazardous materials. Handle all biohazardous materials according to your facility's biohazard procedure. The following materials must be treated as potentially biohazardous materials and handled accordingly:

o All in vitro diagnostic equipment, pretreatment systems, patient samples, serum-based

calibrators, quality control (QC) products, and waste materials.

o Everything that comes into contact with these potentially biohazardous materials, such as

syringes, tubes, waste containers, reservoirs, S/R probe, sipper probe, rinse stations, and sample disk protective cover.

Cautions

Handling of waste

Contents of the waste solution reservoirs, and subsequently the water used to rinse the containers, are all potentially biohazardous. Contact with waste solution may result in infection.

o Handle all waste materials and mechanical components associated with the waste systems

according to your facility's biohazard procedures, and always wear adequate protective equipment.

o Immediately wash off with water any waste solution that comes into contact with your skin,

apply disinfectant according to your own laboratory practices, and consult a physician.

o Dispose of waste according to the appropriate local regulations for handling biohazardous

waste.

o If your system is installed with a direct drain option, follow all local, state, and federal

regulations for waste disposal.

o Take special care when disposing ProCell and CleanCell, as these may produce toxic gases.

When pouring waste down the drain, run the faucet (tap) continuously to ensure the waste is diluted with plenty of water.

o Always refer to the package inserts for details on particular warnings.

o Consult the reagent manufacturer for information on the concentrations of heavy metals and

other toxic constituents in each reagent.

Preventing infection

o Always wear approved protective equipment when operating or maintaining this system. o Protective equipment should include (but not be limited to) approved protective gloves, a

fluid-resistant laboratory coat, and safety goggles.

o Wear a face shield if there is a chance of splash or splatter.

o Take extra care when working with protective gloves because these can be pierced or cut by

sharp edges, which can lead to infection.

o When wiping probes, use several layers of gauze and wipe from the top down to reduce the risk

of puncturing your protective gloves or skin.

o If any biohazardous material is spilled on the instrument, wipe it up immediately, wash off any

residual material, and apply disinfectant.

o If you get any biohazardous material on your skin, wash it off immediately, apply disinfectant

according to your own laboratory practices, and consult a physician.

Aluminum parts

Do not use an acidic or an alkaline solution to clean the system reagent compartment or incubator. The compartment is made of aluminum and these solutions degrade the metal.

Approved parts

Use only parts and devices approved by the manufacturer. Use of non-approved parts or devices may result in instrument malfunction and incorrect results and may render the warranty null and void.

Avoid damage to motorized components

Switch off the analyzer power before manually moving any motorized components. If power is on, the motors are engaged and attempted movement may damage them.

Avoid damage to the probe

Do not bend the probe during cleaning, as this can crimp it. Be careful not to damage the tip of the probe. If the probe is damaged, it will have to be replaced.

Barcode reader window

Take care not to scratch or smear the barcode reader window.

Check digits in barcodes

Use only barcodes with check digits. Barcode scanning errors could potentially go undetected when a check digit is not used.

Continuous sample loading on sample disks

When loading additional samples on the sample disk after testing has begun, do not place a new sample in a position where measurement has not been completed for the sample previously assigned there. Otherwise, the new sample will be measured rather than the registered sample.

Cooling fan

Avoid touching the cooling fan of the detection unit while the analyzer is operating. Otherwise, personal injury may result. Do not touch the fan unless the circuit break of the analyzer is turned Off.

Data backup

If a momentary drop in power voltage occurs due to a power interruption or lightning, the control unit of the instrument may become faulty or the system software, application software, or data may be damaged. In addition, instrument malfunctions or operating errors may cause damage to result data or assay parameters. To prevent such losses, be sure to back up result data and assay parameters periodically.

Dry the incubator surface

Make sure that the incubator surface and its positions are dry or you may experience gripper problems when you resume operation.

Electromagnetic devices

Do not operate the following devices in the same room where the system is installed:

o Mobile/cellular telephones o Transceivers

o Cordless telephones

o Other electrical devices that may generate electromagnetic interference

Devices that emit electromagnetic radiation may cause the instrument to malfunction.

Loading and unloading racks and trays

Verify that the light on the rack sampler is green before you add a new rack or tray to the A-Line or remove a tray of processed samples from the C-Line while the analyzer is in operation. Otherwise, the instrument may be damaged or operation may stop. Do not add or remove single AssayCups and AssayTips to a tray when it is on the analyzer.

Loading and unloading the sample disk

Verify that sampling has stopped before you load additional samples on the sample disk, remove processed samples from the sample disk, or replace the sample disk while the analyzer is in operation. When sampling has stopped, raise the sample disk cover before changing samples. Otherwise, personal injury may result or the instrument may be damaged or operation may stop.

Loading samples and reagents

Loading STAT racks

When loading racks on the system from the STAT rack position, ensure the rack is inserted the right way around.

Memory problems

If any message from the operating system indicates a problem with the Flash memory, contact your Roche service representative.

Non-Roche controls

When measuring a non-Roche control, use only recommended sample tubes, on-tube, or cup-on-rack. Do not use the Roche control vials, as the system would register this as cup-on-tube and would not be able to pipette the control material.

Organic solvents

o Do not use organic solvents on the AssayCups, AssayTips, and waste solution flow path, as these

parts are not guaranteed to be chemically resistant against organic solvents.

o Do not use organic solvents, other than isopropyl alcohol or ethanol, for maintenance and

checkup.

Photosensors

o Take care not to scratch or smear the photosensors in compartment positions 2 and 3. o If the sensors become wet, use a cotton swab to dry them.

The sensors are rectangular windows located at the back of the compartment, just below the top edge. These sensors check for the presence of a ProCell/CleanCell bottle set.

Power interruption

Roche recommends that an uninterruptible power supply be used with this equipment. A momentary voltage drop or surge caused by power interruption or lightning may damage the control section of this instrument or corrupt the system software, application software, or data.

Reagent rotor

o Do not touch the reagent rotor or the reagent cover during operation. Otherwise, the

instrument may be damaged, or may stop running.

o Do not insert your fingers into the openings in the reagent rotor cover or into the opening of the

reagent cap open/close mechanism. Otherwise, personal injury may result.

o Check that the reagent rotor cover is locked on the reagent disk during operation unless you are

exchanging reagents. If the cover is kept open, the cooling efficiency and temperature control may be compromised and the reagents may deteriorate. Opening the cover during analysis also causes an instrument alarm and stops the instrument operation.

Reduced sample volume

A reduced residual volume may only be used with Hitachi standard cups (not with primary or secondary tubes).

Restrictions on samples

Do not use sample and cleaning or disinfectant solutions that are likely to adhere to the sample probe, reagent probes, or measuring channel.

Sample disk protective cover

Make sure that you lay down the sample disk protective cover before you start operation.

Sipper shield

o To open the sipper shield, push the white metal area at the top to release the latch. Do not pull

the sipper shield without releasing the latch in this way, otherwise the latch may be damaged.

o Do not open the sipper shield while the analyzer is in operation, otherwise the analyzer will

immediately stop processing and an alarm will be issued.

o Close the sipper shield after replacing a system reagent or performing maintenance, otherwise

the instrument will not operate.

Spillage

Wipe up any liquid spilled on the instrument immediately. Liquid spilled on the instrument may cause it to malfunction. Do not place any liquid on the analyzer except where recommended or requested in the Operator’s Manual or online Help.

Stop processing

Choosing the Stop button causes all sampling and sample processing to be stopped. Results from samples currently being processed are lost.

Switching on the instrument

After switching off the analyzer, wait for at least ten seconds before switching on again.

Third-party software

Do not install any party software products on the instrument’s control unit. Installing third-party software may result in incorrect behavior of the system. The installation and use on the instrument’s control unit of any third-party software is not approved or permitted by the manufacturer. Installing third-party software may invalidate your warranty.

Tubing and fittings

Do not crimp the replacement pinch tubing or damage the fittings during this operation.

Use of microcups

Microcups must not be used on the cobas e 411 analyzer.

Viewing the screen for long periods

Take a rest for 10 to 15 minutes every hour to relax your eyes and body. Avoid spending more than six hours per day looking at the monitor screen. Looking at the screen over long periods may tire your eyes or body.

System safety labels

Warning labels have been placed on the system to draw your attention to areas of potential hazards. The labels and their definitions are listed below, according to the area of the system where they are located.

Analyzer unit

If the labels are damaged, they must be replaced by Roche service personnel. Contact your local Roche representative for replacement labels. Some of the photos of the label may differ from those on your system, if they have changed since the photographs were taken for this manual.

Warning

The presence of this label on part of the analyzer indicates that there is a danger of hazardous situations nearby which may result in death or serious injury. Biohazard warning

The presence of this label on part of the analyzer indicates that there are potential biohazards nearby. The relevant laboratory procedures on safe use must be observed. Moving parts

This label identifies moving parts of the analyzer that you must not touch if you are to avoid injuring yourself or damaging the equipment.

Corrosive materials

This label indicates protective goggles and gloves should be worn when working within the vicinity of this label as there is a danger of coming into contact with corrosive or caustic material.

STAT rack orientation

CAUTION: When setting the STAT rack, confirm the direction of rack.

This label provides a caution that racks must be must be places in the STAT (Short Turn Around Time) position with the correct orientation. Placing the rack the wrong way round may cause damage to the instrument. Use SysWash

This label indicates that SysWash must be added to the distilled water with a SysWash to water dilution ratio of 100+1 when refilling the system water container.

Positions of safety labels on the analyzer unit (disk system)

Warning labels are attached to the instrument at the following positions:

Positions of safety labels on the analyzer unit (rack system)

Warning labels are attached to the instrument at the following positions:

Positions of safety labels on the solid waste tray and Clean-Liner

Warning labels are attached to the solid waste tray and Clean-Liner at the following positions.

Power supply

Circuit breaker

The following figure shows the circuit breaker and power cord. Electrical safety precautions

Do not attempt to gain access to parts of the instrument marked with this label. Do not open the back cover or attempt to work in any electronic compartment. As with any electronic equipment, electric shock can occur. Installation, service, and repair must only be performed by authorized and qualified personnel.

Disconnecting the power supply

To disconnect the analyzer from the supply source, the circuit breaker must be in the O (off) position and the power cord must be removed. Rack systems are provided with more than one power supply cord. All power supply cords must be removed to disconnect the equipment from the mains power supply.

Rack sampler circuit breaker

Electromagnetic compatibility (EMC)

The cobas e 411 analyzer fulfils the electromagnetic compatibility (EMC) requirements of EN 61326: 1997, +A1:1998, +A2:2001.

Peripheral device connections

All peripheral devices that are connected to the cobas e 411 analyzer must comply with safety standard IEC 60950 (UL 1950) for information technology equipment or with IEC 61010 (UL 3101) for laboratory instruments.

The following figure shows the rack sampler circuit breaker and power cord. A label warns that rack systems are provided with more than one power supply cord, because the rack sampler has a separate power supply. All power supply cords must be removed to disconnect the equipment from the mains power supply.

Figure A-5 Safety label location: rack sampler circuit breaker

Approved parts

Use only parts and devices approved by the manufacturer. Use of non-approved parts or devices may result in instrument malfunction and incorrect results and may render the warranty null and void.

System overview

This chapter provides an overview of the cobas e 411 analyzer system, system specifications, and product labeling.

Overview of the cobas e 411 analyzer ... 27 Disk and rack systems ... 28 Disk system ... 29 Rack system ... 29 System components ... 30 Analyzer unit ... 30 Analyzer unit: disk system ... 31 Analyzer unit: rack system ... 32 Control unit ... 34 Power components ... 34 Operation switch ... 35 Circuit breaker ... 35 Rack sampler circuit breaker ... 36 System specifications ... 37 Technical data ... 37 Instrument dimensions ... 37 Electrical ... 38 Environmental conditions ... 39 Noise level ... 39 Water supply ... 40 Liquid waste ... 40 Solid waste ... 40 Throughput rate ... 40 Sampling system ... 40 Residual volume (disk system) ... 42 Residual volume (rack system) ... 42 Reagent system ... 43 Incubation system ... 43

Control unit ... 44 Reagent kit box labels ... 45 Reagent packs ... 46 Reagent barcode label ... 46 Package inserts ... 47 Calibrator kits ... 48 Calibrator barcode cards ... 49 Control kits ... 50 Control barcode cards ... 51

Overview of the cobas e 411 analyzer

The Roche Diagnostics cobas e 411 Immunoassay System is an automated, random-access, multichannel analyzer for immunological analysis. It is designed for both quantitative and qualitative in vitro determination of a wide range of analytes by use of electrochemiluminescence (ECL) technology.

The cobas e 411 analyzer can be placed on a bench top, thereby saving space in the laboratory environment. All assay reagent, calibrator, and control information is automatically entered into the software by using barcodes, or downloaded over the cobas Link connection (if installed).

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. The process includes the recording of patient samples, the ECL detection, and the transmission of results.

The software controls data transmission to and from the analyzer, evaluates results, produces documentation, and implements quality control. Also, the software manages data between a connected Pre-Analytic Systems Manager (PSM)(1) and the

cobas e 411 analyzer. Several cobas e 411 analyzers can be centrally controlled when

integrated with the PSM.

The advantages of the system include the following:

o Easy operation by means of a color touchscreen. Very few manual entries are required.

o An integrated-barcode concept improves convenience and work flow. You do not have to identify individual samples manually if you use barcode-labeled tubes. Racks (on rack systems), reagent packs, and calibrator and control vials are barcode-labeled and are also read automatically.

o Automatic entry of test applications. Transfer of test parameters to the system using the reagent barcode label speeds the installation of new assays.

o Real-time monitoring of the analyzer allows the system to run unattended. Alarm messages notify the operator of any problems.

o Continuous access to samples avoids interruption of routine testing while ensuring that results will be available as quickly as possible.

o STAT (Short Turn Around Time) samples are prioritized and processed as soon as possible as the first priority, once the current operation has been completed. o Reagents are kept at a constant temperature (20 ± 3°C) on the analyzer, allowing

Disk and rack systems

The cobas e 411 analyzer is available as a disk system and as a rack system. The differences between the two configurations are detailed throughout this Operator’s Manual. Both systems have a throughput of approximately 85 tests per hour. To assist you in quickly identifying information that is specific to either the disk or rack system, one of the following symbols is present to the left of the text.

Applies to disk system only

Disk system

Rack system

The following figure shows a cobas e 411 analyzer disk system:

Figure A-6 cobas e 411 analyzer (disk system)

System components

This chapter provides an overview of the following main components and functional areas:

o Analyzer unit o Control unit o Power components

Analyzer unit

The analyzer unit on the disk system consists of the: o Sample/reagent area

o Consumables area o Measuring area o Operation switch

Analyzer unit: disk system

A Operation switch B Sample/reagent area C Measuring area

D Consumables and liquid waste area Figure A-8 Analyzer unit (disk system)

D

Analyzer unit: rack system

The only difference on the rack system is in the sample area. The sample disk is replaced by a rack sampler, as shown in the following figure:

A Rack sampler B Operation switch C Reagent area

D Measuring area E Consumables and liquid waste area F Main circuit breaker (hidden) Figure A-9 Analyzer unit (rack system)

E

B C D

A

A Rack sampler circuit breaker B C-Line

C B-Line (hidden) D A-Line

E STAT (Short Turn Around Time) position Figure A-10 Rack sampler D

B

C

E A

Control unit

The control unit is located at the top left of the analyzer and consists of the following components:

o Touchscreen monitor

o Connections located on the left side for data storage, an external printer, and a host interface.

e For further information, see Chapter 3 Control unit.

Power components

The power components include the following: o Operation switch

o Circuit breaker o Rack circuit breaker Figure A-11 Control unit

Operation switch

The operation switch is located on the lower left front side of the analyzer. Use the operation switch to switch off the analyzer in order to perform certain maintenance procedures or when the system is not in use for extended periods of time (for example, overnight). The operation switch also switches off the power to the touchscreen.

Provided that the circuit breaker is on, the reagent rotor and system reagent compartment temperatures are maintained while the operation switch is off.

Circuit breaker

The circuit breaker is located on the right side panel of the analyzer, above the power supply cord. The circuit breaker controls the power supplied to the temperature-controlled reagent compartments when the operation switch is off. The circuit breaker must be in the I (on) position whenever reagents are stored on the analyzer to maintain liquid in the measuring cell.

When connecting or disconnecting the host cable, power the analyzer off at the circuit breaker only.

A Operation switch

Figure A-12 Operation switch

A

Rack sampler circuit breaker

A Circuit breaker B Power cord

Figure A-13 Circuit breaker

A

B

There is a circuit breaker located on the left side of the rack sampler, above the rack sampler power cord. This controls power to the sampler unit. The circuit breaker should be kept in the I (on) position at all times. Use the operation switch to switch the rack system on and off.

For essential safety information, see Disconnecting the power supply on page A-7.

A Rack sampler circuit breaker B Rack sampler power cord Figure A-14 Rack sampler circuit breaker

A

System specifications

Technical data

A plate located on the right side of the analyzer displays the part number, serial number, and power requirements.

The following figure shows an example of the analyzer plate.

Instrument dimensions

The following table lists the dimensions of the cobas e 411 analyzer, for both the disk and rack systems:

Figure A-15 Analyzer plate example

Analyzer Height Depth Width Weight

31.4 in(a) 80 cm(a)

(43 in, 109 cm with top cover opened)

28.7 in 73 cm 47.2 in 120 cm 397 lbs 180 kg 31.4 in(a) 80 cm(a) (43 in or109 cm with top cover opened) 37.4 in(b) 95 cm(b) 67 in 170 cm 551 lbs 250 kg

(a) The height includes the touchscreen (b) The depth includes the STAT position Table A-1 Instrument dimensions

Electrical

The following table lists the power requirements and heat output of the cobas e 411 analyzer:

Installation requirements: The instrument complies with the safety requirements of IEC 61010-1, 2nd edition; IEC 61010-2-081, 1st edition; IEC 61010-2-101, 1st edition; UL 61010-1, 2nd edition; CAN/CSA C22.2 No. 61010-1:2004.

Pollution degree: 2 (IEC 61010-1) Overvoltage category: II (IEC 664)

The instrument complies with the electromagnetic compatibility (EMC) requirements of EN 61326: 1997, +A1:1998, +A2:2001.

The cobas e 411 analyzer must be connected to a three-wire power supply cord with a safety ground.

AC Cord Set ratings:

Countries requiring UL and CSA: 115 V 208 or 240 V Temperature rate Whole length Safety Standard

AC125V-15A /SJT type 3×14AWG AC250V-10A /SJT type 3×16AWG Minimum 60°C

2500±50 mm

UL817 / CSA C22.2 No.21

Europe

220 to 240 V Temperature rate Whole length Safety Standard

The AC Cord must be marked "HAR". AC250V-10A /3×1.16AWG

Minimum 60°C 2500±50 mm CENELEC HD21

Connector type to e411 inlet IEC320 / EN60320 type

Supply voltage/frequency: 100 - 240 V AC, 50/60 Hz single phase

The power supply voltage is automatically detected by the system.

Main supply voltage fluctuation: ±10% of nominal voltage (90 VAC to 264VAC) Power consumption:

1000 VA

1250 VA (Analyzer unit: 1000 VA; rack sampler unit: 250 VA)

Environmental conditions

The cobas e 411 analyzer is designed for indoor use only. The following table lists the range of acceptable environmental conditions under which cobas e 411 analyzers will reliably and accurately operate:

Noise level

The following table lists the acoustic noise levels generated by the cobas e 411 analyzer in various operating modes:

Heat generation (approximate):

2879 kJ/hresp. 688 kcal/hresp. 2730 Btu/h

3778 kJ/hresp. (Rack sampler unit: 899 kJ/hr resp) 903 kcal/hresp. (Rack sampler unit: 215 kcal/hr resp.) 3583 Btu/h (Rack sampler unit: 853 Btu/hr)

Table A-2 Electrical specifications

Temperature: Operation: 18 to 32°C

Storage and transport: -20 to 75°C Temperature variation: Maximum ±2°C/h

Humidity (indoor use only): Operation: 20 to 80% (non-condensing)

Storage and transport: 5 to 95% (non-condensing, <80% average per year)

Altitude: Operation up to 2000 m

Table A-3 Environmental conditions

Noise level requirement: IEC 61010-1: 2001 DIN 43635

Standby level: 60 dBA

Operation level (average): 63 dBA Operation level (maximum): 70 dBA

Water supply

The following table lists the requirements for the water supply:

Liquid waste

Solid waste

Throughput rate

Sampling system

The following table lists the specifications for the sampling system. Certain capacities vary between the disk and rack systems.

Water container: 3 L

Water requirements: < 10 µS/cm or > 0.1 megohm, bacteria-free (SysWash is added, with a dilution 100+1) Water consumption

(approximate):

3 L for 250 tests 12 mL/cycle

Table A-5 Water supply

Liquid waste container: Capacity: 4 L, with overflow detection.

Table A-6 Liquid waste

The liquid waste container is not installed if the direct drain option is used.

Disposable solid waste container: Capacity: 420 AssayCups and 680 AssayTips, or just1100 items.

Table A-7 Solid waste

Assay measurements: Up to 86 tests/hour

Sample/Reagent pipetter principle: Conductive disposable AssayTip handling Sample volume per test: 10 to 50 µL

Sample/Reagent pipetter precision: For 10 µL volumes, the coefficient of variance is < 1.2% at an ambient temperature of 18 to 25°C and < 2.4% at an ambient temperature of 25 to 32°C.

< 0.8% CV for 50 µL volumes.

Sample detection: Liquid level detection and clot detection Sample loading capacity:

30 positions for samples, controls, and calibrators

Rack tray: 15 racks with five positions each = 75 positions

Input buffer: 5 racks with five positions each = 25 positions

Total: 100 positions for samples, controls, and calibrators

STAT (Short Turn Around Time) capacity:

Any unoccupied position on the sample disk

STAT rack position at the front of the analyzer

Barcode symbologies: The barcode symbologies that can be read include the following: o PDF417 o NW7 (Codabar) o Code 39 o Code 128 o Interleaved 2 of 5

Assay tips: 360 AssayTips (3 trays, with 120 AssayTips/tray) Assay cups: 180 AssayCups (3 trays, with 60 AssayCups/tray) Sample cups: 2 mL (Standard) Hitachi cup; NO micro cups Primary sample tubes:

(external diameter x height)

13 x 75 mm 13 x 100 mm

16 x 75 mm 16 x 100 mm

Table A-9 Sampling system

Residual volume (disk system)

Residual volume (rack system)

The following table lists the residual volumes for the various sample container options. These figures apply to the disk system only.

Sample Container Tube height “Normal”

residual volume

“Reduced” residual volume

Standard Hitachi cup directly on the sample disk: — 200 µL 100 µL

Standard Hitachi cup on top of a primary sample tube (16 mm diameter): 75 mm 200 µL 150 µL Standard Hitachi cup on top of a primary sample tube (dia. = 16 mm): 100 mm 200 µL 150 µL

Primary sample tube (13 mm diameter): 75 mm 600 µL —

Primary sample tube (13 mm diameter): 100 mm 600 µL —

Primary sample tube (16 mm diameter): 75 mm 1000 µL —

Primary sample tube (16 mm diameter): 100 mm 1000 µL —

Calibrator/control vial: — 150 µL(a) —

Table A-10 Sample container residual volume (disk system)

(a) The distinction "Normal" or "Reduced" does not apply for the residual volumes of calibrator or control vials.

For essential safety information, see Reduced sample volume on page A-16.

Depending on sample volumes and type of vial (for example, primary sample tube or sample cup), the sample/reagent (S/R) probe can, when necessary, be lowered further to prevent air aspiration.

The following table lists the residual volumes for the various sample container options. These figures apply to the rack system only.

Sample Container Tube height “Normal”

residual volume

“Reduced” residual volume

Standard Hitachi cup directly on the sample disk: — 200 µL 100 µL

Standard Hitachi cup on top of a primary sample tube (ø = 16 mm): 75 mm 200 µL 100 µL Standard Hitachi cup on top of a primary sample tube (ø = 16 mm): 100 mm 150 µL 100 µL

Primary sample tube (ø = 13 mm): 75 mm 600 µL —

Primary sample tube (ø = 13 mm): 100 mm 600 µL —

Primary sample tube (ø = 16 mm): 75 mm 1000 µL —

Primary sample tube (ø = 16 mm): 100 mm 1000 µL —

Calibrator/control vial: — 150 µL(a) —

Table A-11 Sample container residual volume (rack system)

(a) The distinction "Normal" or "Reduced" does not apply for the residual volumes of calibrator or control vials.

Reagent system

Assay reagents The following table lists the specifications for the assay reagents:

System reagents The following table lists the specifications for the system reagents:

Incubation system

The following table lists the specifications for the incubation system:

Depending on sample volumes and type of vial (for example, primary sample tube or sample cup), the sample/reagent (S/R) probe can, when necessary, be lowered further to prevent air aspiration.

Reagent rotor temperature: 20°C ± 3°C

Reagent capacity: Up to 18 assays, 9 pretreatments, or 8 diluents in 18 reagent positions

R1/R2 consumption: 50 to 80 µL per reagent, dependent upon the assay Microbead consumption: 30 to 50 µL dependent upon the assay

Reagent detection: Liquid level detection

Positive reagent identification: Two-dimensional barcode (PDF417) Automatic dilution: Available up to 1:400 (for applicable assays) Evaporation protection: Reagent lids are automatically opened and closed Table A-12 Assay reagent system

Temperature: 28°C ± 2°C

Inventory control: Automatic based on counting (reagent rotor) or liquid level detection (ProCell/CleanCell)

ProCell consumption: Approximately 2 mL per cycle CleanCell consumption: Approximately 2 mL per cycle Table A-13 System reagent system

Incubator capacity: 32 AssayCups Volume of AssayCups: 200 µL Incubation temperature: 37.0°C ± 0.3°C Table A-14 Incubation system

Measuring system

The following table lists the specifications for the measuring system:

Control unit

The following table lists the specifications for the control unit:

e For further information, see Chapter 3 Control unit.

Measuring method: Integral measuring of an electrochemiluminescence signal Calibration mode: 2-point calibration

ProCell consumption Approximately 2 mL per cycle CleanCell consumption Approximately 2 mL per cycle

Cycle time: 42 s

Temperature: 28°C ±2°C Table A-15 Measuring system

Type: Integral PC unit with touchscreen monitor Data storage: Compact flash card

System interfaces: Standard PC ports (USB, ethernet, and serial) for other communication devices (remote access, cobas Link) Host interface: CCITT V. 24/RS-232-C (bidirectional)

The host should comply with the requirements of IEC (60950) External printer: Connection through a USB port

e For further information and a list of recommended printer models, see External printer on page A-58.

Touchscreen monitor: 39 cm (15 in) color TFT-LCD, XGA Operating system Microsoft Windows XP (embedded version) Table A-16 Control system

Reagent kit box labels

The reagent pack comes as part of a reagent kit. On each reagent kit box, a large label shows the intended use, storage temperature, contents, and catalog number of the kit. A smaller side box label shows the lot and expiration date of the reagent pack, as well as a barcode number. Both of these labels are shown in Figure A-16:

A Kit catalog number B Reagent Pack lot number

Figure A-16 Reagent box labels A

Reagent packs

The following figure shows an example of a reagent pack (e-pack) used on the

cobas e 411 analyzer.

Each reagent pack is a single ready-to use unit that consists of three bottles:

o A transparent bottle (with a transparent lid) containing suspended paramagnetic microbeads (M).

o A black bottle (with a gray lid) containing reagent 1 (R1) o A black bottle (with a black lid) containing reagent 2 (R2)

The reagent pack and reagent rotor are keyed to prevent you from placing reagents on the analyzer incorrectly.

Reagent barcode label

Reagent packs have a barcode label that contains information required to run the assay on the analyzer. This information includes, but is not limited to:

o Test number o Lot number

o Master calibration curve parameters (for example, Rodbard parameters) o Instrument settings

o Calibrator lot numbers and assigned values o Expiration date

o Calibration frequency Figure A-17 Reagent pack

The following information can be identified on each reagent barcode label:

Package inserts

Each reagent kit comes with a package insert, which provides detailed information required to perform the assay. This information includes, but is not limited to: o Intended use

o Test principle

o Reagent handling and stability o Calibration and QC information o Measuring range

o Dilution o Expected values.

A Test code B Kit catalog number

C Reagent volume within the package D Reagent pack number

E Storage temperature F Abbreviation for in vitro diagnostics

G Reagent pack lot number H Expiration date

I Reagent barcode number

Figure A-18 T4 reagent barcode label G E F A B C D I H

Calibrator kits

For most tests, calibrators for the Elecsys reagents can be ordered separately (for example, Elecsys FT3 or Troponin-T CalSet). Each kit contains barcoded calibrator vials. Some calibrators are in a ready to use liquid form and require no further action other than to place them on the sample disk or rack when a calibration is necessary. A few of the calibrators are lyophilized in glass bottles and must be reconstituted before being transferred into plastic barcode-labeled vials. (Empty barcode-labeled vials are packaged in these kits with lyophilized calibrators.) You can store

reconstituted calibrators in the plastic vials after transfer.

Calibrators also have color-coded caps to assist you in identification. A level 1 calibrator has a white cap, and a level 2 calibrator has a black cap.

Each calibrator bottle has a traditional linear barcode label that contains an identifier to link it to information encoded in the reagent barcode label and the calibrator barcode card.

Each calibrator kit contains calibrator barcode cards.

e For further information, see Calibrator barcode cards on page A-49. A Empty calibrator vials to be filled B Bottles containing calibrators to

be reconstituted according to the package inserts

C Calibrator barcode card D Package inserts

E Extra labels for calibrator aliquots that should be kept separately

Figure A-19 Calibrator kit

C

D

E A

Calibrator barcode cards

Each calibrator kit comes with a barcode card. This cards is in the PDF417 format and must be used with the corresponding calibrators. Information encoded in the calibrator barcode cards includes, but is not limited to:

o Test number

o Calibrator lot number

o Lot identifier to calibrator barcode labels

o What calibrators are to be used and their number of determinations o Target or assigned values

o Expiration date

Roche Diagnostics produces a factory master calibration for each calibration lot. The results are encoded into the corresponding reagent barcode. Scan the new barcode card when you use a new lot.