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Operators Manual
Software Version 01-01
cobas e 411 analyzer
Revision history
Intended use This operators 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.
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:
Roche Diagnostics
2 Operators Manual Version 1.0
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Issued by Underwriters Laboratories, Inc. (UL) for Canada and the USA.
C US
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
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Table of contents
3 Control unit
Components A-55
Maintenance Part C
Software basics A-60
8 Maintenance
4 Analyzer components Overview C-5
Overview of the analyzer components A-71 Maintenance schedule C-8
Sample/reagent area components A-72 Maintenance log C-9
Consumables area components A-89 Daily maintenance C-12
Measuring area components A-97 Weekly maintenance C-15
Every two weeks maintenance C-19
Every two months maintenance C-24
Operation Part B As needed maintenance C-30
5 Overview
Operation Guide B-5
Troubleshooting Part D
Disk and rack systems B-5
Software keyboard B-5 9 Troubleshooting
Introduction D-5
6 Daily operation Alarms D-5
Overview B-11 Problem categories D-5
Pre-start inspection B-12 Contacting Technical Support D-8
Pre-routine operation B-18 Basic troubleshooting flow chart D-10
Routine operation B-31 Immunoassay troubleshooting D-11
Results B-81 Instrument troubleshooting D-14
Post-operation data management B-87 Chemistry troubleshooting D-24
Daily maintenance B-87
Switch off the analyzer B-88
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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
11 Appendix
Glossary Part F
Glossary F-3
Index Part G
Index G-3
Notes Part H
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Preface
Keep this manual in a safe place to ensure that it is not damaged and remains available for use.
The information you need to operate the cobas e 411 analyzer is supplied in several
printed or online publications.
Operators Manual The Operators 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 Operators Manual is
included in the online Help. This makes it possible to retrieve information from both
online Help and Operators Manual using the search functions available for
electronically stored documents.
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Short Guide Also available with this manual is the Short Guide. This small document is designed
to complement your Operators Manual. The Short Guide tells you exactly what is
necessary to operate the analyzer, without the level of detail found in the Operators
Manual.
The cobas e 411 analyzer provides online documentation in the form of context-
sensitive Help. 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.
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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.
Visual cues help you to locate and interpret information in this manual. This section
explains formatting conventions used in this manual.
Caution
Warning
Biohazard
Disk system-specific
Rack system-specific
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Abbreviation Definition
A
ANSI American National Standards Institute
C
CBT Computer Based Training
CCITT Comit consultatif international tlphonique et tlgraphique
(Consultative Committee on International Telegraph and Telephone)
CE Conformit Europenne
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
QC quality control
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Abbreviation Definition
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)
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.
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System description A
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.
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Table of contents
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Safety classifications
Safety classifications
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.
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
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.
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Safety precautions
Correct use
Always follow the instructions in the Operators Manual, as failure to do so may result in a risk to
your safety. Ensure that the Operators Manual is easily accessible at all times.
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Safety precautions
Disposal of ProCell
Do not dispose of undiluted ProCell together with any strong alkaline solution, for example
CleanCell.
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.
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Safety precautions
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 2C 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.
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Safety precautions
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 Operators Manual when opening the top cover for maintenance
and checks.
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.
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Safety precautions
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 Operators
Manual for the operation and maintenance of the system. Leave maintenance that is not described
in the Operators 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.
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Safety precautions
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.
Biohazards
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.
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Safety precautions
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.
Cautions
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.
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Safety precautions
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.
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.
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Safety precautions
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.
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.
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Safety precautions
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, cup-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.
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Safety precautions
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.
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.
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 Operators Manual or online Help.
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Safety precautions
Stop processing
Choosing the Stop button causes all sampling and sample processing to be stopped. Results from
samples currently being processed are lost.
Third-party software
Do not install any third-party software products on the instruments control unit. Installing third-
party software may result in incorrect behavior of the system. The installation and use on the
instruments control unit of any third-party software is not approved or permitted by the
manufacturer. Installing third-party software may invalidate your warranty.
Use of microcups
Microcups must not be used on the cobas e 411 analyzer.
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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.
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.
Analyzer unit
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.
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System safety labels
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System safety labels
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System safety labels
Figure A-3 Safety label location: solid waste tray and Clean-Liner
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System safety labels
Power supply
Circuit breaker
The following figure shows the circuit breaker and power cord.
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System safety labels
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.
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.
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.
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System safety labels
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Table of contents
System overview
This chapter provides an overview of the cobas e 411 analyzer system, system
specifications, and product labeling.
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Table of contents
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Overview of the cobas e 411 analyzer
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Overview of the cobas e 411 analyzer
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 Operators
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.
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Overview of the cobas e 411 analyzer
Disk system
Rack system
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System components
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
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Analyzer unit
A B C D
A Operation switch B Sample/reagent area C Measuring area
D Consumables and liquid waste area
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Analyzer unit
A B C D E
A Rack sampler B Operation switch C Reagent area
D Measuring area E Consumables and liquid waste area F Main circuit breaker (hidden)
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Analyzer unit
A
B
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Control unit
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
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Power components
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.
A Operation switch
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.
For essential safety information, see Disconnecting the power supply on page A-7.
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Power components
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.
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System specifications
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:
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System specifications
Electrical
The following table lists the power requirements and heat output of the cobas e 411
analyzer:
Main supply voltage fluctuation: 10% of nominal voltage (90 VAC to 264VAC)
Power consumption:
1000 VA
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System specifications
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:
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System specifications
Water supply
The following table lists the requirements for the water supply:
Water container: 3L
Liquid waste
The liquid waste container is not installed if the direct drain option is used.
Solid waste
Disposable solid waste container: Capacity: 420 AssayCups and 680 AssayTips, or just1100
items.
Throughput rate
Sampling system
The following table lists the specifications for the sampling system. Certain capacities
vary between the disk and rack systems.
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System specifications
Sample/Reagent pipetter precision: For 10 L volumes, the coefficient of variance is < 1.2%
at an ambient temperature of 18 to 25C and < 2.4% at
an ambient temperature of 25 to 32C.
< 0.8% CV for 50 L volumes.
Sample detection: Liquid level detection and clot detection
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
For essential safety information, see Check digits in barcodes on page A-13
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System specifications
The following table lists the residual volumes for the various sample container
options. These figures apply to the disk system only.
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.
For essential safety information, see Reduced sample volume on page A-16.
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System specifications
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 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:
Temperature: 28C 2C
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
Incubation system
The following table lists the specifications for the incubation system:
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Measuring system
The following table lists the specifications for the measuring system:
Control unit
The following table lists the specifications for the control unit:
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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:
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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 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
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A
B
D
E
F
G
H
I
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.
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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.
D
B
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.
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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.
e For additional information, refer to Reagent concept on the COBI-CD.
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Control kits
For most tests, controls for the Elecsys reagents come packaged separately (for
example, Elecsys PreciControl Universal). Each kit contains barcoded control vials for
use on the analyzer.
Most of the controls 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 controls.) You can store reconstituted controls
in the plastic vials after transfer.
Controls also have color-coded caps to assist you in identification. A level 1 control
has a light brown cap and a level 2 control normally has a dark brown cap. Read the
package insert to check the color of the caps on the level 1 and level 2 controls.
Each control bottle has a traditional linear barcode label that contains an identifier to
link it to information encoded in the reagent barcode label and the control barcode
card.
Control barcode cards come packed in each control kit. These cards are described in
more detail in the next section.
A
B E
C
D F
G
A Empty control vials to be filled with level 2 B Empty control vials to be filled with level 1
controls controls
C Bottles containing level 2 controls to be D Bottles containing level 1 controls to be
reconstituted according to the package reconstituted according to the package
inserts inserts
E Control barcode cards F Package inserts
G Extra labels for control aliquots that should
be kept separately
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Each control kit comes with barcode cards. These cards are also in the PDF417 format
and must be used with the corresponding controls. Information encoded in the
control barcode cards includes, but is not limited to:
o Test number
o Control lot number
o Control code (for example, PC U1)
o Lot identifier to control barcode labels
o Target or assigned values
o Control ranges
o Expiration date
Scan the new barcode cards when you use a a new control lot.
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Table of contents
Control unit
This chapter provides a detailed description of the control unit and its components
and an overview of the system software.
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Components
Components
Touchscreen monitor
The 39 cm (15 in) color touchscreen monitor is located on the top left of the analyzer
and is used to:
o Display information
o Navigate through the software
o Initiate instrument functions
You can use a stylus to operate the touchscreen.
You can tilt the touchscreen to provide the best viewing angle. To use the touchscreen,
choose the item you want to request or change on the screen by lightly touching it
with a finger or stylus. When touching the touchscreen, do not press hard as this
could cause damage. Instead, tap the screen lightly and then remove your finger or
stylus.
You can access all items within the software using the touchscreen. Choose the
required item (such as a menu bar, list box, text box, or button) to complete your task.
For example, to display the Data Review screen in the Workplace menu, choose
Workplace and then choose the Data Review tab.
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Software keyboard
The cobas e 411 analyzer software has an on-screen keyboard function. When you
touch a text box, a software keyboard pops up around the text box. The required
input determines whether the display is a full keyboard or numeric only.
Numeric keyboard
A B
Use the numeric keyboard to type numeric values, touching each field in turn to enter
the required values. When all the numeric entries are complete, choose Close to
return to the previous screen.
Choose the Full keyboard mode button (A) to switch from the numeric keyboard to
the full keyboard mode.
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Full keyboard
A B
Use the full keyboard to type alphabetical or numeric values, either touching the Tab
key or touching each field in turn to move between fields. You can either:
o Choose Close to return to the previous screen
o Move to the next text box either by choosing Tab or by touching the required box.
The software keyboard moves aside automatically from the selected text box.
Choose the Numeric keyboard mode button to switch from the full keyboard to the
numeric keyboard mode.
Keyboard transparency
You can control the transparency of the software keyboards by choosing the
Transparency button (B). This enables you to see what is behind the keyboard
without having to move or close it.
There are three transparency states:
o No transparency (default)
o Normal transparency
o Increased transparency
Each time you choose the Transparency button, the transparency button will move to
the next transparency state.
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Data storage
The system uses flash memory, memory cards, and CD-ROMs for data storage. There
is no mechanical hard drive; the Windows XP operating system is embedded.
The memory contains a number of data files necessary for the analyzer and the
software to work together. These files include the following:
o Reagent data
O Up to 300 reagent packs
o Sample data
O Up to 2000 test records (for routine samples, STAT samples, and controls)
o Calibration data
O Up to 160 calibrators
o QC data
O Up to 100 controls
o Parameter data
O Up to 305 application parameters
O Up to 20 operator IDs
O Analyzer serial number (entered by Roche Diagnostics service personnel
during software installation)
o Log data
O Up to 20000 daily alarm blocks
O Up to 1000 operator ID logs
O Up to 180 logs for each maintenance item
O Up to 10 MB host communication log
The data CD-ROM contains read-only data, including assay reference tables
containing information that is linked to data encoded in the reagent barcode (for
example, test number, test code, available units, and unit conversion factors)
External printer
The printers in the list above have been tested for use with the cobas e 411 analyzer and are
supported by Roche Diagnostics. You may be able to use an alternative USB printer that is not on
this list. However, Roche Diagnostics would be unable to provide support for use of any printer that
is not recommended for use with the cobas e 411 analyzer.
Connect the printer to the USB port marked PRINTER on the left side of the analyzer.
See the following figure for the location of this port.
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e For more information, see Reports in the Software description section of the online Help.
Service interface
The service port is used to connect an external storage device. This can be DVD-
RAM, or a removable USB service device if the data is to be backed up onto a PC.
Contact Roche Technical Support for information or assistance concerning the use of
this port.
Host interface
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Software basics
This section provides an overview of the system software, with a brief description of
the following screen elements:
o Status line
o Guidance prompt
o Main menu screens
o Menu tabs
o List boxes
o Text boxes
o Option buttons
o Buttons
o Windows
The main menus and online Help system are also described.
e For more information, see the Software description section of the online Help.
The screen representations shown in this chapter and throughout this manual are for illustrative
purposes only. The screens do not necessarily show valid results. Also, the availability and
appearance of any specific screen depends on the access level assigned to the operator.
The screen is divided into various areas. Some of these areas do not change, and some
differ according to the currently active function. Following is an example of a screen
showing the various areas.
B
C
A Status line B Online Help
C Guidance prompt (no message displayed) D Global buttons
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Status line
The status line displays the current operational mode, operator ID, date, and time.
The double status icon on the left changes colors to reflect the current operational
status of the system. The color codes, listed from lowest to highest priority, are:
Choose the status icon at any time to display the System Overview screen.
Guidance prompt
A Guidance prompt
In this area, the software explains how you can use a specific text box. When you select
a text box, the guidance prompt defines the information that you can enter. It may
also give an action to take, such as choosing a button or pressing a key.
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The graphical user interface used by the control unit consists of six main menu
screens:
o System Overview
o Workplace
o Reagent
o Calibration
o QC
o Utility
Through these screens all instrument functions are controlled. Access to some
screens, especially those of the Utility menu, is confined to the access level of the user.
e For more information, see User access levels in the Software description section of the
online Help.
System Overview
The System Overview screen is the central screen used for performing daily operation.
From here you can view the status of reagents, calibrations, and quality control. You
can also check the quantities of consumables available on the analyzer.
The System Overview screen consists of the following areas:
o Work Flow Guide
o Inventory area
o Main screen buttons
e For more information, see System Overview screen in the Software description section of
the online Help.
Workplace
The Workplace menu screen consists of two main tabs: Test Selection and Data
Review.
o Test Selection is used to enter and review test selections for a sample.
o Data Review is used to search, review, backup, delete, and send data to the host.
e For more information, see Workplace menu in the Software description section of the
online Help.
Reagent
The Reagent menu screen is used to view detailed reagent and consumables
information.
e For more information, see Reagent menu in the Software description section of the online
Help.
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Calibration
The Calibration menu screen consists of three tabs: Status, Calibrator, and Install.
They are used to request calibrations, define calibrators, and view calibration results.
e For more information, see Calibration menu in the Software description section of the
online Help.
QC
The QC menu screen consists of six tabs: Status, Run Status, Individual, Cumulative,
Control, and Install. Use these screens to install, view and edit controls, and to
evaluate and accumulate quality control results.
e For more information, see QC menu in the Software description section of the online
Help.
Utility
The Utility menu screen consists of four tabs: System, Maintenance, Application, and
Calculated Test. These screens are used to enter system settings, application
parameters, and access maintenance and service functions.
e For more information, see Utility menu in the Software description section of the online
Help.
Menu tabs
You can use the menu tabs to select screens and windows that are grouped together
and used to perform related tasks. The menu tabs are accessible from every screen
(but not from popup windows). This makes the software navigation within the
menus, and between menus, very easy.
The menu tabs are for the five menus: Workplace, Reagent, Calibration, QC, and
Utility.
List boxes
List boxes display a list of choices. If there are more choices than can fit in the box, a
scroll bar is displayed.
Touchscreen: Choose the item within the list box on the screen by touching it. If a
scroll bar is displayed next to the list box, you can touch the scroll bar above or below
the current display position, or touch the arrows on the scroll bar, to move up or
down the list to view the available item choices.
Software Keyboard: You can use the Arrow keys to move quickly through the list by
pressing the Arrow key that points in the required direction. The currently selected
choice is indicated by the selection cursor, which appears as a highlight. You can also
use the Home, End, Page Up, and Page Down keys of the full software keyboard to
move through the list. When the required item is highlighted, press Enter.
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Text boxes
A text box provides a place for you to type information on a screen. Some text boxes
are read-only and used to display information. Other text boxes may be unavailable
for you to enter information if the content of the text box is appropriate for the
current mode or configuration.
Move to a text box by touching it on the screen to choose it. The full or numerical
software keyboard will be displayed, depending on the entry field.
After you have typed in a text box, press Enter or Tab, or just touch the next field, for
your information to be accepted. Press Tab (full keyboard only) or touch the required
field to move the cursor to the next text box or option button.
Options buttons
Option buttons are used to select a particular function. Sometimes when an option is
selected, other option buttons or text boxes become available.
Choose an option by touching it on the screen. An option is selected when the
corresponding option button is colored light blue. If it is dark blue, the option is not
selected.
Buttons
Buttons are used for execution of functions, confirmation of entries and selections,
and displaying pop-up windows. The available buttons depend on the menu or tab
that is active.
The black triangle in the upper right-hand corner of a button indicates that choosing
this button displays another window. The black triangle in the lower left corner of a
button indicates that choosing this button performs the specified function and closes
the window.
Choose a button by touching it on the touchscreen.
Standard buttons
The following buttons are used throughout the software. These buttons are explained
below, and will not be explained again with each individual screen.
OK Choose this button to accept the changes and entries made in a window and to close
the window.
Cancel Choose this button to close the window without saving the changes and entries made
in a window
Yes Choose this button to accept the changes made in a window, perform the action of
the window (for example, Delete), and close the window.
No Choose this button to close the window without saving the changes made in a
window or without executing the function of the window (for example, Delete).
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Save Choose this button to save any changes made to the screen/window currently
displayed. When changes have been made, this button turns yellow.
Update Choose this button to update any changes made to the screen/window currently
displayed. When changes have been made, this button turns yellow.
Page Buttons Some screens have page buttons that can be used to display additional buttons to
display new screens. These page buttons are numbered (for example, x/3), to indicate
the page that you are on.
The page buttons only change the displayed buttons and not the entire appearance of the screen.
Global buttons
Use the global buttons to display screens that are used for specific functions. The
global buttons are accessible from every screen and are located on the right side of the
screen (except for the Help button which is located in the lower left corner of the
screen). The global buttons include: Stop, Logoff, S. Stop, Alarm, Print, Start, and
Help. The Stop, S. Stop, STAT Rack (rack systems only), and Start buttons are also the
system control buttons. You can select the global buttons using the touchscreen.
A Global buttons
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Windows
Confirmation Window Many functions require confirmation before they are performed (for example,
Delete).
Confirmation windows are used to confirm these functions. Choose Yes to confirm
the function and to close the confirmation window, or choose No to close the
confirmation window without carrying out the function.
Sample Range Start and Select Samples buttons on the Workplace > Data Review
screen are used to select consecutive or non-consecutive samples in the sample list.
Access to some screens, especially those of the Utility menu, is confined to the access
level of the user. Some screens are not accessible with the operator level logon, or can
not be edited. Some boxes can only be viewed at the administrator level logon.
e For more information, see User access levels in the Software description section of the
online Help.
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The cobas e 411 analyzer provides online documentation in the form of context-
sensitive Help. Context-sensitive means that wherever you are located within the
software, choosing the Help feature displays information relating to the current
screen or window. 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 ? Help button
To view online Help, choose the ?Help button at the bottom left of the screen.
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Analyzer components
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Overview of the analyzer components
The cobas e 411 analyzer components are located in the following areas:
o Sample/reagent area components, comprising:
o Sample disk
o Rack sampler
o Sample/Reagent (S/R) probe
o Barcode reader
o Barcode card reading station
o Reagent rotor
o Reagent cap open/close mechanism
o Microbead mixer
o Probe/mixer rinse station
o Sample/Reagent (S/R) pipetter
o Consumables area components, comprising:
o Gripper unit
o AssayCup disposal opening
o Pipetting station
o System water container
o Liquid waste container
o Solid waste tray and Clean-Liner
o Measuring area components, comprising:
o Incubator
o Sipper probe
o Sipper pipetter
o System reagents (ProCell and CleanCell)
o Detection unit
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Sample/reagent area components
The sample/reagent area, occupying the left half of the analyzer, consists of the
following components:
o Sample disk or rack sampler (rack system)
o Rack barcode reader (rack system)
o Sample/reagent (S/R) probe
o Barcode reader
o Barcode card reading station
o Reagent rotor
o Reagent cap open/close mechanism
o Microbead mixer
o Probe/mixer rinse station
o Sample/reagent (S/R) pipetter
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Sample disk
The sample disk has 30 positions for samples, calibrators, and controls. You may place
patient samples in either primary sample tubes or sample cups. Built-in adapters
allow intermixing of different-sized primary sample tubes.
e For details of sample tubes that may be used, see Sampling system on page A-40.
You may place sample cups [2 mL (Standard) Hitachi cups only] directly on the
sample disk or on top of 16 mm primary sample tubes.
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Rack sampler
The rack sampler consists of an A-Line, B-Line, C-Line, and STAT (Short Turn
Around Time) rack position.
A-Line
Specimens are placed in five-position racks and are loaded onto a tray. Once a tray has
been loaded, you can add additional racks to the tray one at a time during operation,
provided the tray indication light is green (on). If the light is out (off), the pusher arm
is preparing to move. The pusher arm, which is located at the far left of the A-Line,
pushes the racks forward and onto the B-Line.
The A-Line shown in the following figure, holds a tray that accommodates 15 racks at
one time.
Ouput
C-Line buffer
tray
indication
light
B-Line
5 racks 5 racks 5 racks 5 racks
A A-Line
Input
buffer
tray
indication
light
STAT
B C
A Tray indication light B Rack pusher arm C Input buffer (hidden)
Input buffer
The input buffer, shown in the following figure, has space for an additional five racks.
Therefore, added to the 15 racks on the A-Line, you can have a total of 20 racks
holding 100 specimens on board at any one time.
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Ouput
C-Line buffer
tray
indication
light
B-Line
5 racks 5 racks 5 racks 5 racks
Input
A-Line buffer
tray
indication
light
STAT
Figure A-33 Input buffer of the rack sampler
B-Line
The B-Line transports the racks to the rack barcode reader. Here each position in the
rack is scanned for a sample barcode. After the last position is scanned, the barcode
reader scans the rack ID. After the last specimen is sampled, the rack is transferred
through the output buffer onto the tray on the C-Line.
Output
C-Line buffer
tray
indication
light
B-Line
5 racks 5 racks 5 racks 5 racks
Input
A-Line buffer
A tray
indication
light
STAT
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Output buffer
Racks are off-loaded from the B-Line into the output buffer, shown in the following
figure. If there is no tray, up to five racks can enter the output buffer. At this point the
sampling procedure stops.
Output
C-Line buffer
tray
indication
light
B-Line
5 racks 5 racks 5 racks 5 racks
Input
A-Line buffer
tray
indication
light
STAT
Figure A-35 Output buffer with racks
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C-Line
When the sixth rack moves into the output buffer, a rack is pushed onto the tray on
the C-Line, shown in the following figure. You can remove the tray from the C-Line
any time the tray indication light is green (on). If the light is out (off), the system is
preparing to push a rack onto the C-Line tray.
Output
C-Line buffer
tray
indication
light
B-Line
5 racks 5 racks 5 racks 5 racks
Input
A-Line buffer
tray
indication
light
STAT
A
A Output buffer
You cannot remove single racks from the C-Line; you must remove an entire tray at
one time. If you remove the tray, the system continues to push racks into the output
buffer. If the buffer fills and there is no tray, the analyzer issues an alarm and stops
sampling racks.
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Output
C-Line buffer
tray
indication
light
B-Line
5 racks 5 racks 5 racks 5 racks
Input
A-Line buffer
tray
indication
light
STAT
A
A STAT position
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Racks
Sample cups, primary sample tubes, calibrator vials, or control vials are placed in
racks shown below. Each rack holds a maximum of five samples. Each tube slot
contains adapters that allow the rack to hold different sizes of primary sample tubes.
Each rack has a unique ID found on the barcode label on the back end of the rack.
This rack ID is read by the barcode reader and transferred to the system. It appears
both on the screens and on the reports.
A B C
A Rack ID barcode B Tray guide
C Slot for tube
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The sample/reagent probe is located on the back left wall of the analyzer and is
mounted on an arm (S/R arm) that moves horizontally between the sample disk or
rack and the pipetting station. The probe uses disposable AssayTips to avoid sample
carryover and has liquid level and clot detection for accurate pipetting. Liquid level
detection is accomplished by capacitance measurement. Clot detection is
accomplished by a pressure transducer.
Every new pipetting sequence uses a new AssayTip. For example, a TSH assay uses one
AssayTip for R1, R2, and the sample, and an additional new AssayTip for the
microbeads.
The AssayTip is washed externally at the rinse station between each aspiration step.
Additional AssayTips are used for sample dilutions or pretreatment.
A AssayTip
Barcode readers
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Sample/reagent area components
You can see the barcode reader on a rack system when the reagent rotor is removed.
To read barcode labels, the barcode reader rotates between the reagent rotor and the
barcode card reading station.
e For further information, see Barcode card reading station on page A-84.
You can see the barcode reader on a disk system when either the sample disk or
reagent rotor is removed.
e For the location of the barcode reader on a disk system, see Figure A-40 (viewed from the
sample disk side) and Figure A-41 (viewed from the reagent rotor side).
To read barcode labels, the barcode reader rotates between the sample and reagent
rotors and the barcode card reading station.
e For further information, see Barcode card reading station on page A-84.
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Sample/reagent area components
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Sample/reagent area components
On a disk system, the barcode reading station is located between the sample disk and
reagent rotor.
On a rack system, the barcode reading station is located to the back left of the reagent
rotor.
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Sample/reagent area components
Reagent rotor
The reagent rotor contains 18 positions for assays, diluent, or pretreatment reagents.
These 18 positions can be used in any combination. There are restrictions on the
maximum number of each type of reagent that can be placed on the disk.
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Sample/reagent area components
To prevent reagents from evaporating, and to promote ease of use, the reagent rotor
uses a reagent cap open/close mechanism during reagent pipetting. The mechanism is
located on the back wall of the reagent rotor compartment and emerges when
reagents need to be opened or closed. Caps are opened before pipetting or mixing the
specific reagent (for example, M, R1, or R2) and are closed when pipetting or mixing
for the specific reagent (for example, M, R1, or R2) is completed.
The reagent cap open/close mechanism is normally hidden beneath the cover of the reagent disk
and cannot be seen in use.
Microbead mixer
The mixer is used to mix the microbeads to ensure a homogeneous suspension before
aspiration. The mixer is located to the right of the reagent rotor. In its home position,
it occupies the space directly to the left of the S/R probe.
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Sample/reagent area components
The rinse station rinses the AssayTip or mixer externally with system water between
aspirations or before and after microbead mixing. The rinse station is located below
the S/R probe and mixer when the probe is in its Standby position and the mixer is in
its home position.
A
B
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The S/R pipetter is located on the back right of the analyzer. The pipetter is filled with
system water and uses positive displacement to aspirate and dispense from the S/R
probe.
A Sample/reagent pipetter
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Consumables area components
The consumables area is on the right of the analyzer and consists of the following
components:
o Three AssayTip trays
o Three AssayCup trays
o Gripper unit
o AssayCup disposal opening
o Liquid waste container
o Solid waste tray and Clean-Liner
o System water container
One AssayTip tray holds up to 120 AssayTips, and one AssayCup tray holds up to 60
AssayCups. Therefore, a total of 360 AssayTips and 180 AssayCups can be placed on
the analyzer.
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Gripper unit
z axis
B
A C
D
y axis
x axis
A Position 1 B Position 2
C Tray 3 D Tray 2
E Tray 1
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Pipetting station
A B C
D
A AssayTip positions 1-2 B AssayCup positions 3-5
C AssayTip eject station D AssayCup disposal opening
AssayCups are discarded through a disposal opening located directly to the left of the
incubator.
e See Figure A-52 on page A-91 for the location of the AssayCup disposal opening.
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Consumables area components
The system water container is located in front of the pipetters. It holds three liters of
distilled water plus SysWash which should be added to prevent bacterial growth and
avoid reagent carryover.
An alarm is issued when the system water container is empty. A float mechanism
sensor, located beneath the aspiration inlet, triggers the alarm on the Inventory
screen.
Removing the system water container during operation causes the analyzer to enter P. Stop status.
The liquid waste container is located in front of the ProCell and CleanCell reagents. It
holds four liters of waste and issues an alarm when it is approximately three-quarters
full. The alarm is triggered by a weight-sensitive mechanism that activates a
photosensor located in the compartment holding the container. An alarm is also
issued when the container is improperly positioned. This alarm is triggered by a plate
mechanism that activates a photosensor located at the front of the compartment.
Removing the liquid waste container during operation or an improperly positioned container
causes the analyzer to enter E. Stop status.
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The liquid waste container is not installed if the direct drain option is used.
Installation of the direct drain option or any container size change must be
undertaken by Roche service personnel, as there are software implications.
The direct drain is an optional system that routes the flow of the waste solution
directly into a prepared container, or the facility drainage. A reserve tank is provided
in front of the ProCell and CleanCell reagents to store the waste solution temporarily
if a problem arises with the flow.
A Tank inlet
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The tank can hold up to one Liter of waste solution, and the analyzer will enter S. Stop
mode when the liquid reaches a predetermined level. A tube extends from the right
side of the analyzer to the tank.
A
A Drain port
Flow stagnation, or leaks may occur if the drain tube is bent or pinched. Check the condition of the
drain tube every day.
Do not connect any extension to the drain tube. It may cause flow stagnation.
If the reserve tank gets full, the analyzer will enter S. Stop mode. Check if the drain tube is bent or
pinched, and ensure that it is correctly placed. If you cannot find the cause, or if the tube is clogged,
contact a Roche service representative. Do not try to unclog the drain tube.
Figure A-57 shows two examples of correctly installed drain tubes, running
horizontally or sloping downwards. The tube must not be bent, pinched, placed
above the level of the drain port, or form a U-bend along any part of its course.
Hands shown in photos and illustrations in the Operators Manual and online Help are to be
considered as hands covered with approved disposable gloves.
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The drain tube must not be placed as shown in the examples in Figure A-58. The tube
on the left runs upward from the drain port. The tube on the right is forming a U-
bend. In both cases, flow stagnation will occur.
A B
A Incorrect B Correct
Make sure that the end of the tube does not touch the liquid surface, as this may stop
the flow (see Figure A-59).
To prevent clogging in the flowpath, pour approximately 100mL distilled or deionized water into
the tank inlet after each day's operation. See Clean the Direct Drain Flowpath in the Maintenance
chapter.
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The solid waste tray and Clean-Liner is located behind the front access door on the
analyzer. Used AssayCups and AssayTips are discarded into the waste tray during
operation.
A disposable Clean-Liner is placed inside the solid waste tray. The Clean-Liner has a
sliding cover to reduce potential splashing and to prevent AssayTips and AssayCups
from falling out of the tray upon removal from the analyzer. The sliding cover must be
open during operation. The tray shakes periodically during operation so that used
AssayTips and AssayCups do not accumulate at one end of the tray.
An alarm is issued if the solid waste tray is full (a maximum of 1100 AssayTips and
AssayCups) or if the solid waste tray and Clean-Liner are missing. A photosensor
monitors the presence of a tray. The amount of solid waste in the tray is displayed in
the Inventory area of the System Overview screen.
e For further information, see:
Empty the solid waste on page C-42
Removing the solid waste tray during operation causes the analyzer to enter E. Stop status.
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Incubator
A B
A Incubator positions B Aspiration station
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Measuring area components
The sipper probe aspirates the reaction mixture into the measuring cell, and also
aspirates ProCell and CleanCell. It is located to the right of the incubator.
The sipper rinse station externally washes the sipper probe with system water between
measurements. When the sipper probe is in its Standby position, it is located directly
above the rinse station.
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Sipper pipetter
The sipper pipetter is located directly to the right of the sample/reagent pipetter,
behind the liquid waste container. It uses positive displacement of system water to
aspirate and dispense from the sipper probe.
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ProCell and CleanCell are located in bottles in the pipetter area, behind the liquid
waste container.
o ProCell is the buffer solution containing tripropylamine (TPA). ProCell bottles
are identified by white caps.
o CleanCell is the cleaning solution used to clean the measuring cell after
measurement. CleanCell bottles are identified by black caps.
Two bottles of each reagent are stored on the analyzer, temperature controlled at
28.0C 2.0C. The keyed shape of the reagent compartment ensures that the reagent
can only be placed in the proper position.
A transparent sipper shield is fitted to the pipetter area. The sipper shield must be
opened to gain access to the system reagent bottles. It is opened and closed by
applying pressure to the white metal area at the top until the latch is released or
engaged. The sipper shield should not be opened during operation, otherwise the
analyzer will immediately stop processing and an alarm will be issued.
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A B C
E FG H I
When starting from Standby, the sipper probe always attempts to first use ProCell and
CleanCell from bottle set 1. If the quantity is insufficient, bottle set 2 is used. When
starting from S. Stop or R. Stop, the bottle set in use when the analyzer was previously
in operation is pipetted.
The analyzer can operate with just one bottle of ProCell and one bottle of CleanCell
reagent, but they must be placed together either as bottle set 1 or as bottle set 2.
Detector unit
The detector unit receives the incubated reaction mixture aspirated from the sipper
probe.
e Information on the detector unit measuring cell is provided on the COBI-CD.
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Operation B
5 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3
6 Daily operation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-7
7 Special operation: How to . . . . . . . . . . . . . . . . . . . . . . . . . . . B-91
cobas e 411 analyzer 5 Overview
Table of contents
Overview
This chapter describes the Operation Guide, the disk and rack symbols, and the
software keyboard associated with the cobas e 411 analyzer.
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Operation Guide
Operation Guide
This Operation Guide contains quick reference procedures for operating the Roche
Diagnostics cobas e 411 Immunoassay Analyzer. This Operation Guide can be used
for training purposes. More detailed information can be found in the Reference
Guide, Software Guide and Users Guide.
In the Operation Guide, you will find:
o Daily operating procedures
o Daily maintenance procedures
o Tips and quick references to further subjects (How To...)
o Procedures for special tasks that are not usually part of the daily work flow.
The cobas e 411 analyzer is available as both a disk system and a rack system. The
differences between the two configurations are detailed throughout this operator's
manual.
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.
Software keyboard
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Table of contents
Daily operation
This chapter describes the everyday tasks that are required for running the
cobas e 411 analyzer. Common procedures that are performed as part of the daily
work flow are also described here.
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Overview
Overview
Daily operation encompasses the routine tasks that are required to prepare the
system, analyze samples and maintain the system. The layout of the System Overview
screen gives the operator an intuitive guide for the tasks required for routine
operation.
The sections in this chapter contain detailed descriptions explaining how to
accomplish various daily operational tasks. The following diagram gives an overview
of the daily operation process.
Pre-start inspection
Switch on
(Initialization and Standby)
Check alarm button
Pre-routine operation
Routine operation
Rerun Calibration and control
Assigned Routine or STAT(a) sampling
------------------------------------------------------
Results
Sampling Stop
(Finalization, Stop, and Standby)
Maintenance
Switch off
Additional maintenance
(a)
Short Turn Around Time
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Pre-start inspection
Pre-start inspection
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Result evaluation
m Print reports Data Review screen
m Review results Data Review screen
m Delete documented samples Data Review screen
Daily maintenance
m Clean the S/R probe (None)
m Perform Finalization maintenance (if needed) Finalization window
m Switch off Shutdown window
If the printer is not already on, switch it on. Check that the printer paper supply is
adequate.
e Refer to the appropriate printer documentation for details, as the analyzer may be used
with several printer models. For further information, and a list of recommended printers,
see External printer on page A-58.
When the analyzer is in service, leave the circuit breakers set to On so that the analyzer
continues to regulate the temperature of reagent rotor. Use only the operation switch
to switch on or off the analyzer at the start and end of the day. However, if you have
had to shut down the analyzer completely, you need to switch the circuit breakers
back on before switching on the analyzer.
When the system is switched on, it performs initialization before entering Standby
mode.
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Pre-start inspection
2 Switch on the rack transport system circuit breaker located on the left side of the
analyzer (rack systems only).
If the rack transport system circuit breaker is not turned on then a yellow pop up
window appears on the screen with the message: Line main power off .
Always keep the analyzer switched on at the circuit breaker. Power from the circuit breaker keeps
the reagent rotor temperature-controlled.
A small green light on the switch lights when the system is on, and the Logon
screen is displayed while the system performs initialization. During initialization,
the mechanisms are reset to their home positions.
2 After initialization is complete, ensure that the screen displays a Standby status.
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Pre-start inspection
1 Open the sipper shield by pressing the white metal area at the top, as shown in the
following figure, until the latch is released.
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Pre-start inspection
3 Close the sipper shield by applying pressure to the white metal area at the top until
the latch is engaged and you hear a click.
.
Do not open the sipper shield during a run, as the action will interrupt the run.
If the screen remains black when you switch on the analyzer, check the circuit breaker. If the circuit
breaker is off, switch it on. The analyzer should then power up.
2 Choose the Logon button on the window to log on and gain access to the software.
The Operator ID will be shown at the top of all screens, next to the date.
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Pre-start inspection
If an alarm has been issued, there is a sound warning and the Alarm global button
shows red or yellow. The Alarm button can open the Alarm screen from the first
screen that appears, even if no log on has been performed. The Alarm screen
identifies any system alarm conditions.
You can sort the list of alarms according to the criteria shown in the headers that
appear above the list. For example, if you choose Level, the system sorts the list
according to the severity of the alarms.
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Pre-routine operation
Pre-routine operation
Before you can start routine operation you must first prepare the system.
The System Overview screen has a central role within the cobas e 411 analyzer
software. From here you have an overview of the whole system at any time. This
screen displays the status of each reagent, the details of the reagents loaded, and
details of the inventory. You can access other windows by choosing the corresponding
button or area of the screen. You can use the Work Flow Guide to prepare the system
for daily routine operation.
You can open the System Overview screen from any screen by choosing the double
status icon in the top left corner of the screen. The colors of the two halves of this icon
show you the status of the host communication and the analyzer.
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The System Overview screen uses color to display the system status. The following
table gives the meaning of the color for each button in the Work Flow Guide area.
Reagent overview
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Pre-routine operation
Use the Reagent Overview area of the System Overview screen to view the status of the
consumables on board. Reagent Overview area consists of two sub-areas: the Reagent
area and the Inventory area.
Reagent Rotor Graphic Choosing a position segment of the reagent rotor section displays the Reagent Detail
window, with details of the reagent loaded in the chosen position. The color of the
segments of the Reagent Rotor graphic indicate the status of reagents, calibrators, and
controls.
Inner block: reagent pack Active Reagent pack currently in use for this test.
Warning Remaining tests in this reagent pack below yellow alarm level
(Utility > System (Page 2/3) > Reagent Level Check).
Caution No more reagent available for this assay on the analyzer, or no
diluent on the rotor, or no pretreatment.
Stand-by This is a standby reagent pack.
Zero tests, Used up The reagent pack has been used and is empty. There is still
reagent available in another reagent pack on the analyzer.
Free Pos. There is no reagent pack in this position.
Inventory area
This area displays the amount of system reagents, AssayCups, AssayTips, and solid
waste on the analyzer by means of seven bar-charts.
PC1/PC2 The blue bar indicates the amount of ProCell (PC) remaining, with a % figure below.
The PC1 column represents bottle 1 and PC2 bottle 2.
CC1/CC2 The blue bar indicates the amount of CleanCell (CC) remaining, with a % figure
below. The CC1 column represents bottle 1 and CC2 bottle 2.
Solid waste The gray bar indicates the amount of solid waste present in the solid waste container,
with the quantity displayed below (0=empty).
Vessel The blue bar indicates the amount of AssayCup trays remaining, with the quantity
displayed below.
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Tip The blue bar indicates the amount of AssayTip trays remaining, with the quantity
displayed below.
Use this window to view detailed information about the reagent loaded in the
position selected in the Reagent area of the System Overview screen.
Test The short name of the test for which the reagent pack is used.
Position The position the reagent pack occupies in the reagent rotor.
Reagent Lot No. The lot number of the current reagent pack.
Reagent Pack No. The sequence number of the current reagent pack.
Lot Expiration Date The expiration date of the current reagent pack lot.
First Registration Date and Time The date and time that the current reagent pack was first registered by the system.
No. of determinations This column displays the number of determinations remaining for the corresponding
reagent.
Last Calib Date (L-Calib) The date of the last lot calibration of the current reagent pack.
Last Calib Date (R-Calib) The date of the last reagent pack calibration of the current reagent pack
recommended at The recommended date for the next reagent pack calibration
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Pre-routine operation
The Work Flow Guide area at the top of the System Overview screen is a step-by-step
guide through the preventive action.
The Work Flow Guide area consists of six buttons: Maintenance, Sample Data Clear,
Reagent Load List, Calib/QC Load List, Parameter Download, and Sample Tracking.
The color of each button varies, depending on the status. Choosing these buttons,
displays screens and windows that enable users to take actions appropriate to the
situation.
Maintenance
Use Maintenance on the System Overview screen to perform maintenance actions.
Choosing Maintenance displays the Maintenance screen.
Use the Sample Data Clear button to delete the sample results. Sample Data Clear
deletes all records of the samples and moves QC data to the QC view. Regular backing
up is recommended. If your system is connected to a host, make sure that all data has
been uploaded before performing Sample Data Clear.
e See How to archive sample data on page B-99.
Sample clear
It is strongly recommended that a sample clear is performed daily.
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You can also print a Reagent Load List from the Reagent tab of the Print global screen.
You can also print a Calibration/QC Load List from the Reagent tab of the Print global screen.
Replace all required reagent packs and system reagents as indicated by the Reagent
Load List. Ensure that reagent packs have not exceeded their expiration date.
When you manually register a reagent pack, you must confirm that you have placed it in the correct
position.
For essential safety information, see Replacing reagent packs on page A-10.
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2 Place the required reagents in the reagent rotor, ensuring that the reagent packs
are correctly oriented in the rotor.
Reagents on the reagent rotor are stored in temperature controlled conditions. If you plan to run
assays that currently are not stored on the analyzer, you must allow them to reach reagent rotor
temperature (20 3C) before starting analysis.
3 Close the reagent rotor cover. The analyzer will not operate without the cover on
the disk.
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The reagent rotor cover is keyed. It must be properly oriented, so that the cover fits into the key,
before it can be closed.
4 Choose Scan Reagent on the System Overview screen to activate a reagent scan.
When the reagent scan is complete, the reagent rotor indicator on the System
Overview screen is updated to displays the status of each reagent pack placed on
the reagent rotor.
For essential safety information, see Replacing system reagents on page A-10.
2 Open the sipper shield by applying pressure to the white metal area at the top,
until the latch is released.
e For the location of the sipper shield, see Figure B-5 on page B-15.
Always replace ProCell and CleanCell bottles as sets. If you remove and replace a full (100%
volume) bottle from one of the system reagent compartment positions containing a photosensor, the
analyzer assumes that you have loaded a new bottle set, even if the bottle has been on the analyzer
for several hours or days. The analyzer consequently waits 15 minutes for temperature
equilibration, as is normal for a new bottle set.
If you need to load two new bottle sets of ProCell/CleanCell, load these new bottles as your first
inventory check. By the time you are ready to operate, the system reagents should be at the correct
temperature. If they are not, you will receive ProCell/CleanCell reagent temperature alarms.
e For further information on these alarms, refer to Data alarms on page D-31.
The bottles on the right (Set 1) are consumed first. If replacing the bottles on the right, move the
bottles from the left (Set 2) to the right. Then load the new bottles in the correct positions of Set 2.
3 Remove the empty ProCell and CleanCell bottles, indicated in the inventory area
on the System Overview screen, and replace them with a set of full bottles. Ensure
that each bottle is firmly in place in the correct position with the correct
orientation. Place ProCell only in the left hand position of each bottle set and
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Pre-routine operation
CleanCell in the right hand position. The keyed shapes of the reagent
compartment and reagent bottles ensure that the reagents are placed in the proper
position.
A B
C D E F
A Bottle set 2 B Bottle set 1
C ProCell position (bottle set 2) D CleanCell position (bottle set 2)
E ProCell position (bottle set 1) F CleanCell position (bottle set 1)
4 Close the sipper shield by applying pressure to the white metal area at the top until
the latch is engaged and you hear a click.
5 Close the instrument cover.
6 If a ProCell bottle with a new lot number was loaded, select Reagent and choose
the Inventory Set button. The Inventory Set pop-up window is displayed. Here
you can type in the lot number for each of the ProCell and CleanCell.
For essential safety information, see Air bubbles or films in system reagents on page A-5
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For essential safety information, see Avoid use of bleach on page A-6.
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For essential safety information, see Changing the Clean-Liner on page A-6.
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Pre-routine operation
4 Remove the Clean-Liner from the tray and dispose of it according to the waste
procedures that apply in your laboratory for potentially biohazardous material.
5 Place a fresh Clean-Liner in the tray.
6 Verify that the sliding door is open and that the opening is located at the back of
the tray.
7 Insert the tray into the analyzer and close the door.
The counter for the solid waste, which is located on the System Overview screen,
automatically resets to zero (0) when the tray is removed.
If you remove the solid waste tray for any reason you should discard the solid waste or replace the
Clean-Liner at the same time. The software counts the AssayTips and AssayCups used during the
course of operation. When the analyzer senses that the solid waste tray is removed, the counter
resets to 0 (zero), and starts counting as if the tray is empty.
1 Replace any empty AssayCup or AssayTip trays with full ones as required. Do not
add or remove single AssayTips or AssayCups.
2 Make sure that the trays are seated properly with the correct orientation. Trays are
keyed for proper placement.
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The level is checked and the inventory is automatically updated the next time the
system changes to another tray.
e For information on how you can also load AssayCups and AssayTips when the analyzer is
operating, see Loading consumables during operation on page B-79
Routine operation
After completing pre-routine operation, you are ready to start routine operation.
Routine operation involves procedures related to the following areas:
o Perform calibration and QC
o Validate calibration and control results
o Correct placement of 13 mm sample tubes on a sample disk
o Correct placement of 13 mm sample tubes on a rack
o Routine sample measurements: disk system
o Routine sample measurements: rack system
o Measurement of additional routine samples
o STAT test selections: disk system
o STAT test selections: rack system
o Dilution
o Sample tracking: disk system
o Sample tracking: rack system
o Loading consumables during operation
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2 Use QC materials to verify calibration as well as the precision and accuracy of the
instrument. Follow the regulatory requirements for your local area to establish
additional control runs for your laboratory.
3 Load calibrators and controls onto the sample disk.
For essential safety information, see Manual assignment of sample containers on page A-9.
2 Use QC materials to verify calibration as well as the precision and accuracy of the
instrument. Follow the regulatory requirements for your local area to establish
additional control runs for your laboratory.
3 Load calibrators and controls onto the racks and place the racks on the loader.
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For essential safety information, see Manual assignment of sample containers on page A-9.
1 Place one CalSet (vials Cal1 and Cal2) of open, barcode-labeled calibrator vials on
the sample disk. Ensure that both levels of calibrators are next to each other on the
sample disk.
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2 Place the CalSet vials and control vials correctly in their keyed positions on the
sample disk, as shown in the following figure, with the barcode facing outward.
3 Open each CalSet vial lid to the vertical position (see Figure B-22).
1 Place one CalSet (vials Cal1 and Cal2) of open, barcode-labeled calibrator vials on
the rack. Ensure that both levels of calibrators are next to each other on the rack.
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A
B
3 Open each CalSet vial lid to the vertical position as shown above.
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Activate QC test
If a new control lot is loaded, you will need to activate the required tests.
For essential safety information, see Instrument problems without alarms on page A-9.
For essential safety information, see Air bubbles or films in system reagents on page A-5.
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For essential safety information, see Manual assignment of sample containers on page A-9.
2 If the analyzer is running in the multiple sample disk mode, make sure that the
number in the Disk No. box reflects the sample disk currently loaded. Correct the
number if necessary.
When the calibrator barcode is scanned by the barcode reader, calibration is
automatically requested for the assay.
3 Choose Start. The monitor displays the previous screen and the calibration and
control run begins.
If automatic printout has been selected at Utility > System (Page 2/3) > Documentation Setup, the
Calibration Result report will be printed automatically when calibration is complete.
4 Remove calibrators and controls from the sample disk or rack when sampling is
complete. Close the lids of the calibrator and control vials and return them to the
refrigerator.
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If automatic printout has been selected for calibration and control samples on the
Documentation and Printer Setting window, the results will be printed automatically
when calibration is complete.
********************************************************************************************
Roche Diagnostics Immunoanalyzer cobas e 411 S/N 0703-37
********************************************************************************************
Calibration Result Operator-ID:Admin 2006-05-23, 12:35
------------------ -----------------
L Calibration was generated!
Test : TSH 0
Unit : ulU/ml
Reagent pack Lot no. : 139709
Reagent pack number : 32700
Reagent pack expiration date : 2006/07
L Calibration
L calibration date : 2005/12/14
Reagent pack no. for L Calib. : 32700
Calibrator Lot no. : 168530
Expiration date calibrator : 2006/04
Recalibration recommended at : 2006/01/11
RP Calibration
RP Calibration date : 2006/12/14
Reagent pack no. for RP Calib. : 32700
Calibrator Lot no. : 168530
Expiration date calibrator : 2006/04
Recalibration recommended at : 2005/12/21
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In the case of a rejected or failed calibration without a previous valid calibration, the instrument
stops test-specific sample pipetting (depending on the system settings), and it will be necessary to
perform a new calibration.
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2 Select the calibration to be checked in the Status list and choose the Calibration
Result button to display the Calibration Result window. This window is different
for quantitative and for qualitative assays.
3 Choose the Calibration Trace button to check the calibration trace. The
Calibration Trace window is displayed.
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Accumulate QC results
The results of controls measured are saved in the database and appear on the Data
Review screen as well as the QC > Individual screen. To ensure good quality statistical
data, it is important to accumulate these results regularly for the long-term quality
control data.
Take special care to place sample tubes correctly on the sample disk. This is especially
important for 13 mm tubes, which are narrower and more likely to tilt if placed
incorrectly. If the tubes are not correctly seated in an upright position on the sample
disk, the sample/reagent probe may attempt to sample outside the tube, causing
errors and incorrect results.
The following figure illustrates correct and incorrect placement of a sample tube on
the sample disk. The tube should be seated correctly in the grommet at the base of the
sample disk so that the tube is vertical.
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A B
D
C
A Correctly placed tube (bottom of tube seated B Incorrectly placed tube (bottom of tube not
in the grommet) seated in the grommet)
C Correctly placed tube (overhead view) D Incorrectly placed tube (overhead view)
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Take special care to place sample tubes correctly on the rack. This is especially import
for 13 mm tubes, which are narrower and more likely to tilt if placed incorrectly. If
the tubes are not correctly seated in an upright position on the rack, the sample/
reagent probe may attempt to sample outside the tube, causing errors and incorrect
results.
The following figure illustrates correct and incorrect placement of a sample tube on
the rack. The tube should be seated correctly in the rack so that the tube is vertical.
A B
C D
To improve the alignment of 13 mm tubes on the rack, Roche recommend that the
Roche Cup-Adapters (part name: CUP-ADAPTER FOR STANDARD RACK) is used.
Cup-Adapters are placed as an insert to the Standard Rack, as shown in the following
figure.
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The Roche Cup-Adapters should be used only for the sample tubes specified for use
with the cobas e 411 analyzer. Tubes with an outer diameter greater than 13mm should
not be used in combination with Cup-Adapters, because the barcode label might be
damaged.
e For details of the various sample tubes specified for use with the cobas e 411 analyzer,
see System specifications on page A-37.
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You can make a patient test selections at any time during operation.
For essential safety information, see Loading and unloading the sample disk on page A-14.
If you forget the Stop barcode when running in single disk mode, the disk turns continuously. If
calibrators or controls are present, they will be pipetted again.
If you forget the Stop barcode when running in multiple disk mode, the disk stops at position 30.
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a To start processing
Before starting a run, ensure that all necessary samples are on board and test
selections made.
1 Choose Start (global button).
2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
Check the following:
o The disk number displayed in the window is correct.
o The Host Communication setting is On (if a host connection is being used)
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process patient samples.
If the host does not answer within 15 seconds, the position is skipped and the disk advances to the
next position.
If you are using the batch mode for the analyzer-host-communication, make sure that all requests
are loaded from the host to the analyzer.
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For essential safety information, see Loading and unloading the sample disk on page A-14.
If you forget the Stop barcode when running in single disk mode, the disk turns continuously. If
calibrators or controls are present, they will be pipetted again.
If you forget the Stop barcode when running in multiple disk mode, the disk stops at position 30.
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a To start processing
Before starting a run, ensure that all necessary samples, calibrators and controls are
on board and test selections made.
1 Choose Start (global button).
2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process patient samples.
1 Place the barcoded samples on the sample disk. Make sure the barcodes are facing
out so the barcode reader scans them properly.
For essential safety information, see Loading and unloading the sample disk on page A-14.
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If you forget the Stop barcode when running in single disk mode, the disk turns continuously. If
calibrators or controls are present, they will be pipetted again.
If you forget the Stop barcode when running in multiple disk mode, the disk stops at position 30.
a To start processing
The first step is to do a sample scan.
1 Choose Sample Tracking.
2 Choose Sample Scan. Wait for the system to go to Standby.
3 Choose Workplace > Test Selection
4 Choose Start (global button).
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5 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
Check the following:
Disk number displayed in the window is correct.
Host Communication setting is On (if a host connection is being used)
6 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process patient samples.
When not using sample barcodes, you can either use a numeric sample ID or
alternatively type in characters using the software keyboard.
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2 Select the Routine option from the Sample area on the top left of the screen.
3 Type the disk number in the Disk No. text box.
4 Type the position number for the sample in the Pos. text box.
5 Type the sample number in the Sample ID text box if necessary.
6 Select the Pre-dilution button if the sample has already been diluted
7 Select the Normal or Reduced Sample Cup button.
8 Select the required dilution, if any, for the sample in the Sample Volume/Dilution
list box.
9 Select the test, combination of tests or test profiles for the sample in the test key
matrix. Selected tests and profile keys appear white.
10 Choose Save to save the test selection.
11 Place a stop barcode in the next open position on the disk.
If you forget the Stop barcode when running in single disk mode, the disk turns continuously. If
calibrators or controls are present, they will be pipetted again.
If you forget the Stop barcode when running in multiple disk mode, the disk stops at position 30.
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a To start processing
Before starting a run, ensure that all necessary samples, calibrators and controls are
on board and test selections made.
1 Choose Start (global button).
2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process patient samples.
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You can make patient test selections at any time during operation.
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a To start processing
Before starting a run, ensure that all necessary samples are on board and test
selections made.
1 Choose Start (global button).
2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process patient samples. As each barcode is
scanned, the analyzer queries the host and receives test requests for the sample.
The sequence number, rack ID, and rack position are assigned automatically
during this process.
In the System screen (Utility > System), the value for Barcode Setting Stat/Routine
must be set to No.
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a To start processing
Before starting a run, ensure that all necessary samples, calibrators and controls are
on board and test selections made.
1 Choose Start (global button).
2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
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3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process patient samples. As each rack position
is encountered, the host is queried to download the sample ID and test selections
to the analyzer.
You can only use a numeric sample ID when not using a host. This is because you
cannot perform a sample scan (as on the disk system); you must type all sample ID
numbers manually.
2 Select the Routine option from the Sample area on the top left of the screen.
3 Choose the Sample ID field to open the software keyboard. Type in the sample ID
of the sample in the Sample ID text box.
4 Select the Pre-dilution On button if the sample has already been diluted manually.
5 Select the Normal or Reduced button for Sample Cup.
6 Select the required dilution, if any, for the sample in the Sample Volume/Dilution
list box.
7 Select the test, combination of tests or test profiles for the sample in the test key
matrix. Selected tests and profile keys appear white.
8 Choose Save to save the test selection.
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It is not necessary to program a rack ID and position when the sample is barcoded.
a To start processing
Before starting a run, ensure that all necessary samples are on board and test
selections made.
1 Choose Start (global button).
2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process patient samples. As each barcode is
scanned, the analyzer queries the host and receives test requests for the sample.
The sequence number, rack ID, and rack position are assigned automatically
during this process.
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You can only use a numeric sample ID when not using a host.
In the System screen (Utility > System), the value for Barcode Setting Stat/Routine
must be set to No.
2 Select the Routine option from the Sample area on the top left of the screen.
3 Type the rack number in the Rack No. text box.
4 Type the position number for the sample in the Pos. text box.
5 Type the sample number in the Sample ID text box, if necessary.
6 Select the Pre-dilution check box if the sample has already been diluted.
7 Select the Normal or Reduced button for Sample Cup.
8 Select the required dilution, if any, for the sample in the Sample Volume/Dilution
list box.
9 Select the test, combination of tests or test profiles for the sample in the test key
matrix. Selected tests and profile keys appear white.
10 Choose Save to save the test selection.
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Before starting a run, ensure that all necessary samples are on board and test
selections made.
1 Choose Start (global button).
2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process patient samples.
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e If you wish to track samples, add patients during routine operation, or process a STAT
(Short Turn Around Time) patient sample, proceed to one of the following sections:
Sample tracking: rack system on page B-77
Measurement of additional routine samples on page B-60
STAT test selections: rack system on page B-67.
You can program additional routine samples at any time. When the analyzer starts
from Standby mode, the system always begins at position 1 on the disk and stops at
the position of the Stop barcode.
When the analyzer starts from Sampling Stop, the system remembers the last position
where the Stop barcode was and starts at that position.
For essential safety information, see Continuous sample loading on sample disks on page A-13.
For essential safety information, see Loading and unloading the sample disk on page A-14.
If you forget to place the Stop barcode on the disk, the disk turns continuously. If calibrators or
controls are present, they will be pipetted again.
1 2
3
4
5
6
7
STOP 8
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2 When the sample in position 4 is complete, add seven more samples to the disk.
Move the Stop barcode to position 15.
1 2
3
X X 4
X 5
X
6
7
8
9
10
11
STOP 12
13
14
15
All 14 samples have been pipetted. The analyzer goes into Sampling Stop when it
reaches the Stop barcode in position 15.
1 2
3
X X 4
X 5
X
X 6
X
X 7
X 8
X 9
X
10
X
X 11
STOP X
X 12
13
14
15
3 Add samples starting at position 15 (the previous position of the Stop barcode).
After choosing Start the system continues sampling past position 30 until it sees
the Stop barcode again (here in position 6).
30 1 2 3
29
28 4
27 5
26 6
25 STOP
24
23
22
21
20
19
18 17
16 15
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When the analyzer starts from Standby mode, the system always begins at position 1
on the disk and stops at the position of the Stop barcode.
The analyzer enters the sampling stop mode when it recognizes the Stop barcode or
reaches position 30 on the sample disk.
When the analyzer starts from sampling stop and the system has reached position 30,
the analyzer will begin again at position 1. If using multiple disks, you should change
the disk and type the new disk number on the Workplace > Test selection screen
before choosing Start.
For essential safety information, see Continuous sample loading on sample disks on page A-13.
For essential safety information, see Loading and unloading the sample disk on page A-14.
If you forget to place the Stop barcode on the disk, the disk stops at position 30.
Loading/unloading of racks
You can add single racks to the A-Line only when the tray indication light is green. When the light
is out, do not load racks onto the analyzer.
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B-Line
A green light
indicates that you
can remove or 5 racks 5 racks 5 racks 5 racks
replace a tray
Input
A-Line buffer
Tray
indication
light
STAT
Figure B-51 Tray indication lights
You can add racks during operation. When the rack system is in sampling stop mode,
choose Start to continue sampling.
You can make STAT (Short Turn Around Time) patient test selections when the
analyzer is in Operation, S. Stop, or Standby.
During STAT processing, the current sample finishes pipetting. The STAT samples are
pipetted next. When the STAT sampling is complete, the analyzer proceeds to the next
sample (the sample directly after where it had previously stopped) and resumes
pipetting routine samples.
Test selections must be made at the host system before a sample query from the analyzer.
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Use the Tab key on the full software keyboard or touch the required field to move the
cursor to appropriate fields.
2 Select the Stat option from the Sample area on the top left of the screen.
o In non-barcode mode the cursor moves to the Pos. text box. Go to step 3.
o In barcode mode the cursor moves to the Sample ID text box. Go to step 4.
3 Type in the position number of the sample in the Pos. text box.
For essential safety information, see Loading samples and reagents on page A-14.
For essential safety information, see Manual assignment of sample containers on page A-9.
7 Select the required dilution, if any, for the sample in the Sample Volume/Dilution
list box and press Tab.
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8 Select the test, combination of tests or test profiles for the sample in the test key
matrix. Selected tests and profile keys appear white.
9 Choose Save to save the test selection.
2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process STAT samples.
In the STAT mode, when the Test Selection screen is opened, an available disk
position is suggested by the software. You can override the position suggested by the
system.
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2 Select the Stat option from the Sample area on the top left of the screen.
3 Type in the position number of the sample in the Pos. text box.
For essential safety information, see Loading samples and reagents on page A-14.
For essential safety information, see Manual assignment of sample containers on page A-9.
7 Select the required dilution, if any, for the sample from the Sample Volume/
Dilution list box.
8 Select the test, combination of tests or test profiles for the sample from the test key
matrix. Selected tests and profile keys appear white.
9 Choose Save to save the test selection.
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2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process STAT samples.
You can make STAT (Short Turn Around Time) patient test selections when the
analyzer is in Operation, R. Stop, Standby, or Stop.
During STAT processing, the analyzer first finishes pipetting the current rack. The
samples in the STAT rack are pipetted next. When the STAT sampling is complete, the
analyzer proceeds to the next rack on the A-Line and resumes pipetting routine
samples.
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Refer to the label on the STAT rack position to ensure correct orientation of the rack.
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2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process STAT samples. As each barcode is
scanned, the analyzer queries the host and receives test selections for the sample.
The sequence number, rack ID, and rack position are assigned automatically
during this process.
If multiple STAT racks are necessary, you must choose Stat each time a STAT rack is loaded in the
STAT rack position.
Use the Tab key on the full software keyboard or touch the required field to move the
cursor to appropriate fields.
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3 Select the Stat option from the Sample area on the top left of the screen.
o In non-barcode mode the cursor moves to the Rack No. text box. Go to step 4.
o In barcode mode the cursor moves to the Sample ID text box. Go to step 6.
4 Type in the rack ID of the sample in the Rack No. text box.
5 Type in the position number of the sample in the Pos. text box.
For essential safety information, see Loading samples and reagents on page A-14.
For essential safety information, see Manual assignment of sample containers on page A-9.
9 Select the required dilution, if any, for the sample in the Sample Volume/Dilution
list box.
10 Select the test, combination of tests or test profiles for the sample in the test key
matrix. Selected tests and profile keys appear white.
11 Choose Save to save the test selection.
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For essential safety information, see Loading STAT racks on page A-15.
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2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process STAT samples.
If multiple STAT racks are necessary, you must choose Stat each time a STAT rack is loaded in the
STAT rack position.
Refer to the label on the STAT rack position to ensure correct orientation of the rack.
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2 Verify the settings on the Start Conditions screen. If the settings are not as
required, make the necessary adjustments.
3 Choose Start (on the Start Conditions screen). The system performs an initial
preparation process, and begins to process STAT samples. As each STAT rack
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position is encountered, the host is queried to download the sample ID and test
selections to the analyzer.
If multiple STAT racks are necessary, you must choose the Stat key each time a STAT rack is loaded
in the STAT rack position.
Dilution
Sample results that exceed the measuring range of the assay must be diluted and
measured again. Dilutions can be requested from the Workplace > Test Selection
screen and are performed automatically by the analyzer.
The Sample Volume/Dilution menu is activated only when both the following apply:
o The assays are encoded in the reagent barcode as being suitable for dilution.
o A bottle of suitable diluent is on the analyzer.
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After changes have been made on the Test Selection screen, the Save button turns
yellow.
4 Choose Save to save the entries. A predilution flag is added to the sample ID.
After measurement, the target sample is flagged Prediluted on the Test Review
screen and on the result report.
The results for prediluted samples are not calculated using the dilution factor. The operator must
calculate the final results for manually prediluted samples.
5 Choose Save. The test key button appears with the dilution rate you have just
specified.
When measurement starts, the sample is automatically diluted by the analyzer. When
calculating the final sample concentration, the software calculates the result based on
the selected dilution factor.
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Use the Sample Tracking window to monitor the progress of sample processing.
Empty (E) This sample position is empty (the sample position is light
gray).
Processing (P) The sample, control or calibrator in this position is in process
(all assays have been pipetted), but results are not yet ready.
The sample position is green.
Incomplete (I) At least one ordered request for the sample has a missing
value. The sample position is red.
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Occupied (O) The sample in this position is still being processed. The
sample position is blue.
Completed (C) The processing of the sample in this position has been
completed satisfactorily. The sample position is white.
Stop BC (S) This sample position contains a stop barcode. The sample
position is yellow.
Sample positions that contain a STAT sample appear red throughout the operation, even though
their actual status changes.
3 To obtain more detailed information on the result of a specific sample, select the
sample from the Sample disk information area on the right side, and then choose
the Show Result button. The Test Review window is displayed.
Use the Sample Tracking window to monitor the progress of sample processing.
e For further information see Sample Tracking window (rack system) on page E-18
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Thirty positions (six rows) are listed on the screen, each row representing a rack. To
the right of each row is the rack ID number. The upper right corner of each button
corresponds to a position on the rack. Each position also lists a status.
The status conditions are as follows:
Empty (E) This sample position is empty (the sample position is light
gray).
Processing (P) The sample, control or calibrator in this position is in process
(all assays have been pipetted), but results are not yet ready.
The sample position is green.
Incomplete (I) At least one ordered request for the sample has a missing
value. The sample position is red.
Occupied (O) The sample in this position is still being processed. The
sample position is blue.
Completed (C) The processing of the sample in this position has been
completed satisfactorily. The sample position is white.
Sample positions that contain a STAT sample appear red throughout operation, even though their
actual status changes.
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You can reload AssayCup and AssayTip trays during operation if you take suitable
precautions.
A
B
A Tray 3 B Tray 2
C Tray 1
When the AssayCup and AssayTip compartments are fully loaded, the analyzer begins
by using AssayCups and AssayTips from tray 1.
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When tray 1 is empty, the analyzer starts using tray 2, followed by tray 3.
When tray 3 is empty, the analyzer returns to tray position 1 to check if a new tray has
been loaded.
The analyzer indicates the current gripper position for AssayCups (Vessel) and
AssayTips (Tip) on the System Overview screen. In Figure B-69, the Inventory area
shows the gripper position markers at the tray 1 position for both AssayCups and
AssayTips. Trays 2 and 3 for both are full.
When the AssayCup and AssayTip compartments are only partly loaded, the analyzer
starts using AssayCups and AssayTips from the positions last in use during the
previous run. The AssayCup position may be different from the AssayTip position in
this case.
Table B-3 shows how you can use to Vessel and Tip symbols in the System Overview
screen to determine when you can safely load additional consumables at the tray
positions.
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Results
Results
You can evaluate control and patient results on printed reports or on the Workplace >
Data Review screen. All samples can be viewed, deleted, printed, or uploaded from
this screen.
As results are generated on the instrument, they are saved in the database located on
the control unit. The database stores up to 2000 results, depending upon the number
of orders in the system. Once the figure of 2000 documents is reached, the system
automatically deletes the oldest documented result. You can manually delete any
results, documented or undocumented, from the database to free additional space.
As soon as results are printed, uploaded or printed/uploaded, they are considered to
be documented (the documentation mode is defined in the Utility > System >
Documentation Setup window).
After documentation, an H appears at the top of the row. Partial sample results can
be viewed from this screen as soon they are made available by the system.
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Results
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Results
2 Choose Search to display the Sample Search window, used to search for a sample
in the database.
3 Select either the Sequence Number option to search for a sample by sequence
number, or the Sample ID option to search by sample number.
4 Type the sequence or sample number, depending on the option selected in the
previous step.
5 Choose Down to search the sample list of the Data Review screen downward from
the currently selected sample, or Up to search upward from the currently selected
sample, until you find the required sample.
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Results
6 Choose Cancel to close the Sample Search window and return to the Data Review
Screen. The chosen sample is highlighted.
Use this function to filter the type of samples you want to view, document or print.
The default filter setting is Off.
2 Enter filter criteria as required, and choose OK to save the selected filter criteria,
close the Filter window, and return to the Data Review Screen.
3 Select On in the Filter area of the Data Review screen to activate the filter. The
results are filtered according to the filter criteria you selected.
The Documentation and Printer Setting window enables you to select the desired
documentation output option and the items to print out automatically.
If you choose Upload, or Print/Upload, when the host communication set to Off on the Start
Conditions screen, an alarm is issued.
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Results
Print/Upload Send reports to the printer and also upload results to the host.
Not connected A printer is not connected to the system; reports will not be sent to the printer.
Calibration Sample Select On to enable, or No to disable automatic printing of the results from
calibration samples.
Control Sample Select On to enable, or No to disable automatic printing of the results from quality
controls.
STAT Sample Select On to enable, or No to disable automatic printing of the results from STAT
samples.
Routine Sample Select On to enable, or No to disable automatic printing of the results from routine
samples.
Results can be printed out from the Workplace > Data Review screen.
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Results
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Post-operation data management
Review results
You should review the results as they become available using the printout or on the
Workplace > Data Review screen. Use the Test Review window to check results in
more detail.
e For more information, see:
Results on page B-81
Samples are considered documented once they are printed out or uploaded to the
host.
Delete documented samples to free up additional space in the database. Filter settings
have no effect on this function.
Daily maintenance
Before the end of routine operation, it is important to ensure that all required
maintenance is performed. In addition to the routine daily maintenance, this could
also include other scheduled maintenance, for example, weekly and monthly
maintenance.
Perform the following tasks each day:
o Clean the sample/reagent probe
o Clean the sipper probe
o Finalization maintenance.
e For information about daily maintenance items to be performed, refer to your laboratory
maintenance schedule, Maintenance schedule on page C-8 and the Maintenance chapter.
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6 Daily operation cobas e 411 analyzer
Switch off the analyzer
After routine operation is finished and you have perform all the required
maintenance, you can switch off the analyzer.
Under normal circumstances it is not necessary to shut down the analyzer by turning
off the main circuit breaker. Keep the circuit breaker on the right of the analyzer on at
all times to maintain the temperatures in the reagent rotor and system reagent
compartments.
In the Sleep window, do not choose Shutdown unless you wish to shut down all of the analyzer
functions and components.
If choose Shutdown by mistake, turn off the main circuit breaker once, wait for at least ten seconds,
and then turn it on again to revive the analyzer.
After switching off the analyzer, close the lids on the ProCell and CleanCell bottles to
prevent evaporation of their contents.
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Switch off the analyzer
1 Open the sipper shield by applying pressure to the white metal area at the top, as
shown in the following figure, until the latch is released.
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Switch off the analyzer
3 Close the sipper shield by applying pressure to the white metal area at the top until
you hear the click of the latch engaging.
If the analyzer will remain switched off for longer than seven days, it is important
to prepare the system properly and to perform the correct shutdown maintenance.
Failure to observe these recommendations may result in damage to the measuring
cell.
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Table of contents
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Table of contents
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Overview
Overview
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How to apply barcode labels to tubes and vials
The size and placement of barcode labels on sample, calibrator, and control
containers must comply with certain specifications. The sample barcode reader may
fail to read any labels that do not conform to these restrictions.
a To apply barcode labels to sample tubes and calibrator and control vials
1 Ensure that the barcode label dimensions comply with Figure B-78.
A B
A Label width (16 mm minimum) B Barcode width (12 mm minimum)
C Quiet zone (5 mm minimum) D Barcode zone (50 mm maximum for
100 mm tubes; 38 mm maximum for
75 mm tubes)
E Quiet zone (5 mm minimum)
Figure B-78 Dimensions for barcode labels for tubes and vials
2 For sample tubes, position your barcode labels according to restriction shown in
Figure B-79. For calibrator and control vials, position your barcode labels
according to the restriction shown in Figure B-80.
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How to apply barcode labels to tubes and vials
A Upper margin: 12 mm minimum (for both 100 mm and 75mm sample tubes)
3 Press and smooth the labels to ensure that all the label edges adhere to the tubes or
vials.
Place all sample tubes upright and settled in their positions, with the barcode labels fully visible to
the barcode reader.
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How to upload results manually
If automatic uploading is switched off and the analyzer is connected to a host, you
must upload sample results manually. You can upload a single result or multiple
results at any time, and you can upload results more than once if necessary.
If automatic upload is activated, and the Utility > System > Review by Exception
window shows alarms listed as Exception Alarms on the right of the screen, you must
upload manually the results flagged with exception alarms.
The procedure is the same for both disk and rack systems.
e You can search for samples to upload manually using the Sample search facility.
For further information, see:
Sample tracking: disk system on page B-76
Sample tracking: rack system on page B-77
2 Select an individual sample to upload from the open requests (status O).
3 Select the result to upload from the Data Review list on the right of the screen.
e See How to select two or more samples in Data Review on page B-98
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How to upload results manually
The Send to Host window closes, and the system returns to the Workplace Data
Review window. The sample status changes to H (documented/sent to host) if all
results are sent to the host.
If you wish to validate the result before uploading, switch off Automatic Upload.
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How to select two or more samples in Data Review
The sample data displayed on the Data Review screen can be selected, for example,
when a printout of all sample results is not required.
To apply an analyzer function to specific data items from the complete sample data
set, select the items in the Data Review screen. The following procedure describes the
selection of some sample results for printing. The procedure is the same for both disk
and rack systems.
Choose QC View at Step 2 if you wish to display only the control results.
3 Select a sample from the list on the left of the screen. The selected sample is
highlighted in blue.
4 Choose Select. The Select button turns white, indicating that sample selection is
activated.
5 Select the next sample from the list. The selected sample is highlighted in blue (in
addition to the previous selection).
6 Choose Select.
7 Repeat steps 5 and 6 until all the samples required are selected.
8 Choose Print (global button). The Print window opens.
9 Choose Print in the Print window to confirm the print. The Print window closes.
To clear a complete selection, select any sample previously selected. The highlight will
disappear from all the samples.
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How to archive sample data
3 Select samples for which data is to be backed up, from the list on the left of the
screen.
4 Choose Backup Data. The Backup Data window is displayed.
If choosing External, ensure that the target device is connected and able to receive the data.
6 Type a folder name for the current backup in the Folder name box, and choose
OK.
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How to rerun a sample
a To rerun a sample
1 Choose Workplace > Data Review (see Figure B-81).
2 Select the sample required from the list on the left of the screen. The selected list is
highlighted in blue.
3 Choose Workplace > Test Selection. The selected sample ID and the tests
performed upon the sample will be displayed.
4 Choose Rerun from the Sample area of the screen.
5 Select the tests required for rerun. The selected test buttons will change to white
and the Save button changes to yellow when any test is selected.
6 Select the sample dilution from the list box on the right of the screen.
7 Choose Save. The Save button changes from yellow to blue, and the test buttons
change back from white to blue.
8 Choose Data Review (see Figure B-81). Note that the sample is now listed twice on
the left of the screen - once for the original tests and once for the rerun selection.
9 Place the sample on the instrument and choose Start (global button).
10 Choose Start (large button) in the Start Conditions window.
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How to reset the system
System reset is necessary following system alarm events that put the analyzer into P.
Stop or Stop status. Examples are:
o Interference with the gripper action.
o Malfunction of the cap open/close mechanism.
o Any movement of the pipetter shield away from the fully closed position during
operation.
Resetting the system returns mechanical parts to their home or standby positions. It
does not reset any of the line mechanisms on a rack system.
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How to reset the system
4 Choose Start. The system reset begins and the System Reset window closes.
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How to delete a single open request
You can delete single open requests from the Data Review screen. The procedure is the
same for disk and rack systems.
4 Confirm the deletion in the Delete Record window. The window closes
automatically and the selected sample is no longer listed in the Data Review
window.
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How to assign calibrator and control positions
Use the following procedure to assign a position to a calibrator or control if you are
using AssayCups without a barcode, or if the system cannot read the barcode.
The procedure is the same on both disk and rack systems.
The calibrator or control to be assigned must already be installed.
4 Select a calibrator from the list on the left of the screen, and a position for the
calibrator from the list on the right.
5 Choose Assign to assign the selected calibrator to the position selected. The
calibrator and the corresponding lot number appear on the right of the screen,
and the Assign button becomes inactive. The OK button turns yellow and remains
yellow until you save the changes in step 7. You can assign a calibrator to one
position only.
6 Repeat steps 4 to 5 to assign further calibrators.
7 Choose OK to save the changes when each of the desired calibrators has an
assigned position. The Position Assignment window closes.
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How to assign calibrator and control positions
5 Choose Assign to assign the selected control to the position selected. The control
and the corresponding lot number appear on the right of the screen, and the
Assign button becomes inactive. The OK button turns yellow and remains yellow
until you save the changes in step 7. You can assign a control to one position only.
6 Repeat steps 4 to 5 to assign further controls.
7 Choose OK to save the changes when each of the desired controls has an assigned
position. The Position Assignment window closes.
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How to install and define Roche controls
During the reading process the system status changes from Standby to BC card
scan. When scanning is complete, the list on the left of the QC > Install >
Individual screen shows the control and its lot number, and the system status
returns to Standby. The right of the screen displays the tests that are on board and
encoded in the control barcode, together with the reagent lot number, T.Mean,
and T.SD. The Active Test button color is green.
5 Select a test you wish to activate, and choose Active Test. The selected test name
displays a green highlight, the caption of Active Test button changes to Inactive
Test, and the button color changes to blue.
6 Repeat step 5 for every test you wish to activate.
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How to install and define non-Roche controls
4 Enter the control information into the Add Control fields using the software
keyboard. The Material Code for non-Roche controls must be in the range 64-78.
5 Choose OK to confirm the entries. The Add Control window closes.
6 Select the non-Roche control on the left of the screen.
7 Choose Edit. The Edit Control window opens.
8 Choose Test Assign. The Test Assign window opens.
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How to install and define non-Roche controls
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How to edit control values
4 Select the test to be edited, and enter the values given in the package into the
Individual T.Mean and T.SD fields.
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How to request standby bottle QC
5 Choose Update to transfer the entries to the list of tests. The Calculate button is
only active for tests that are set for QC violation.
6 Choose OK to confirm the changes to the control values. The Edit Control
window closes.
Stand by reagent packs currently on the analyzer require QC processing. All tests and
controls for standby reagent packs are displayed in the Stand By Bottle QC screen.
4 Choose a required test from the list. The chosen line is highlighted.
5 Choose Select. A tick and a change of background in the Selection column identify
the selected test.
6 Repeat steps 4 and 5 for any other selections required.
7 Choose OK to confirm the selection. The Stand By Bottle QC screen closes. The
chosen tests are now identified in the Selection column on the QC > Status screen.
To deselect manually selected standby bottle QC controls, navigate to the Stand By
Bottle QC screen, highlight the reagents required, choose Deselect, followed by OK to
confirm the deselection.
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How to cancel a print job
After you have requested the printout of a report from the analyzer, you might decide
that you wish to cancel your request. The cobas e 411 software does not provide an
option for canceling print jobs. Instead, you must cancel the print job by using the
options available on your printer. Consult your printers documentation to choose the
most appropriate procedure.
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How to print a daily Alarm Trace report
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How to print a System Communication Trace report
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How to change documentation settings
If the communication link with the host breaks down, the system displays a Host
Communication error and the host cannot document the results. In this event the
operator can change the settings to print out the results without uploading.
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How to program calculated tests
You can configure the system to divide the result of one test by the result of another
test to derive a third parameter of diagnostic significance.
Before programming ensure that the tests required for the calculation are registered
on the system.
This programming generates two test requests. If one test fails then the calculation will fail.
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How to change test settings
The following procedure describes how you can change various parameters that the
system records for a test. You can use it to change test units, expected values, dilution
ratios, and the User Test No.
4 Select a default dilution ratio from the list box. Refer to the reagent package insert
for the recommended dilution ratio.
5 Choose Save to confirm the dilution change.
6 Choose Utility > Application > Range.
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How to change test settings
7 Change the User Test No., the Unit, and the Expected Values as required.
The User Test No. defines the order of the test keys in Workplace > Test Selection.
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How to change calibration settings
You can change QC settings and calibration parameters. Changes are necessary for
QC violations, when calibration must be repeated because the controls are out of
range. If timeout calibration is set, the system will not recommend a calibration when
control test results are out of range. The default setting is always Timeout.
If the control is out of range, the system suggests QC Violation as a cause for calibration, showing
green in the Select column of the Status window (Calibration > Status).
If the control is repeated and the result is within range, the suggestion is removed.
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How to change the sample disk mode
Change the sample disk mode only when the analyzer is in Standby.
Complete all open requests before making the change, as data related to uncompleted
requests will be deleted during the process.
2 Choose Change in the Sample Rotor Mode area. The Sample Rotor Mode window
opens.
3 Select Single or Multiple to change the mode, and choose OK. A yellow
Confirmation window appears.
4 Choose Yes to change the mode. The yellow Confirmation window will close. The
OK button in the Utility > System screen changes to yellow.
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How to change the sample disk mode
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B-120 Operators Manual Version 1.0
Maintenance C
8 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3
cobas e 411 analyzer 8 Maintenance
Table of contents
Maintenance
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Table of contents
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Operators Manual Version 1.0 C-4
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Overview
Overview
Maintenance procedures
Each maintenance task section is divided into two parts: Introduction and Procedure.
The introduction provides important information about the procedure including the
following matters:
o Materials required
o Time required
o Precautions
The procedures provide step-by-step directions for performing the required
maintenance. Some maintenance tasks are divided into several procedures. You must
perform each procedure in the order specified, as well as following each step in the
correct order. Specific notes, precautions, warnings, and cautions are included in the
procedures when appropriate.
These maintenance recommendations are based on using the system eight hours per
day, five days per week. You may adjust your maintenance frequency based on your
laboratory's actual use. Scheduled maintenance follows the Recommended Scheduled
Maintenance table.
e See Maintenance log on page C-9.
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Operators Manual Version 1.0 C-5
8 Maintenance cobas e 411 analyzer
Overview
For essential safety information, see Operation and maintenance on page A-9.
Performing maintenance
Maintenance items
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Overview
This section lists all system-controlled maintenance items and a brief description of
their function.
System Reset Resets mechanical parts to their home or standby positions. A system reset is often
necessary if the analyzer is in a P. Stop or Stop status due to an alarm condition. This
button does not reset any of the line mechanisms on a rack system.
The system will stop during reagent scan or after a start if the PC/CC bottles have not
been manually opened. A reset must then be done because the sipper needle path is
blocked over the bottles. Close the sipper shield, select System Reset and choose Start.
Liquid Flow Cleaning Washes the sipper flow paths and the measuring cell with SysClean.
L. and A. Reset All (rack systems Initiates a complete system and line reset for the rack analyzer A-, B-, and C-lines, and
only) returns all analyzer mechanisms to their home or standby positions. An L. and A.
Reset All is often necessary if the analyzer is in a Stop or P. Stop status due to an alarm
condition.
Rack Clear Clears the B-line of any racks and transfers them to the C-line.
(rack system only)
Sipper Pipetter Prime Primes sipper flow paths with system water to purge them of air, for the specified
number of cycles.
S/R Pipetter Prime Purges the sample/reagent pipetter flow path of air for the specified number of cycles.
Measuring Cell Preparation Conditions the measuring cell for the specified number of cycles.
Finalization Maintenance Primes the system with water, and fills the measuring cell with ProCell. This allows
the analyzer to stand unused for several hours, such as when left overnight.
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8 Maintenance cobas e 411 analyzer
Maintenance schedule
Media Write Opens the Media Write window to select the internal or external target device for data
storage.
Measuring Cell Exchange Purges tubing. Also used by Roche service representatives.
Maintenance schedule
It is important that you keep to the recommended schedule for all maintenance
actions. You can find detailed descriptions of the maintenance tasks later in this
chapter.
Daily
Weekly
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cobas e 411 analyzer 8 Maintenance
Maintenance log
As needed
Maintenance log
Use the Maintenance log to record the dates when the maintenance tasks were
performed and the initials of the person who performed them.
For convenience, the cobas e 411 analyzer maintenance log is printed on two sheets.
You can make photocopies of both parts of the maintenance schedule sheet provided
on the following pages for your own records.
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Operators Manual Version 1.0 C-9
8 Maintenance cobas e 411 analyzer
Maintenance log
Serial Number______________Month______________Year__________
Daily 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
Clean: Sample/Reagent probe
Direct drain flow path (if fitted)
Check: Condensation inside compartments
Operator
Weekly 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
Clean: Sipper probe
Incubator and aspiration stations
Operator
As needed 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
Perform: Finalization maintenance
Clean: System water container
Liquid waste container or direct drain
Microbead mixer
ProCell and CleanCell compartments
Reagent rotor and compartments
Reagent compartment
Perform: Empty solid waste tray
Protect the measuring cell (extended shutdown)
Operator
For information about safety precautions and a detailed description of each maintenance action, see the cobas e 411 analyzer Operators Manual
Version 1.0.
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cobas e 411 analyzer 8 Maintenance
Maintenance log
Serial Number______________Month______________Year__________
Daily 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Clean: Sample/Reagent probe
Direct drain flow path (if fitted)
Check: Condensation inside compartments
Operator
Weekly 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Clean: Sipper probe
Incubator and aspiration stations
Operator
As needed 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31
Perform: Finalization maintenance
Clean: System water container
Liquid waste container or direct drain
Microbead mixer
ProCell and CleanCell compartments
Reagent rotor and compartments
Reagent compartment
Perform: Empty solid waste tray
Protect the measuring cell (extended shutdown)
Operator
For information about safety precautions and a detailed description of each maintenance action, see the cobas e 411 analyzer Operators Manual
Version 1.0.
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Operators Manual Version 1.0 C-11
8 Maintenance cobas e 411 analyzer
Daily maintenance
Daily maintenance
Record in the Maintenance log the dates when the maintenance tasks were carried out
and the initials of the person who performed them.
Dirt on the sample/reagent (S/R) probe may cause contamination and carryover, and
affect results. Clean this part daily to prevent contamination.
Materials Item
Gauze pads
Distilled or deionized water
70% isopropyl alcohol
Table C-7 Required materials
For essential safety information, see Avoid damage to motorized components on page A-13.
For essential safety information, see Avoid damage to the probe on page A-13.
2 Move the sample/reagent probe to an area where you can readily access it.
3 Wipe the outer surfaces of the sample/reagent probe and its tip with a gauze pad
soaked in distilled or deionized water.
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Daily maintenance
4 Inspect the probe. If any dirt is visible, wipe the outer surfaces with a gauze pad
soaked in 70% isopropyl alcohol, and a second wipe with a gauze pad soaked in
distilled or deionized water.
5 Switch on the analyzer.
The analyzer performs a start-up reset operation, and each mechanism returns to
its home or standby position.
If your analyzer is equipped with the direct drain system, crystallization from waste
solution in the flowpath could cause clogging. To prevent crystallization, clean the
flowpath after each day's operation.
Item
Syringe (minimum capacity 100 mL) with attached tubing
Distilled or deionized water (approximately 100 mL)
Table C-9 Required materials
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8 Maintenance cobas e 411 analyzer
Daily maintenance
A Tank inlet
If the tube is clogged, contact your Roche service representative. Do not try to unclog the tube
yourself.
Materials Item
Gauze pads
Table C-11 Required materials
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Weekly maintenance
Weekly maintenance
Record in the Maintenance log the dates when the maintenance tasks were carried out
and the initials of the person who performed them.
Dirt on the sipper probe may cause contamination and carryover, thereby affecting
results. Clean this part weekly to prevent contamination.
Materials Item
Gauze pads
Cotton swabs
70% isopropyl alcohol
Table C-13 Required materials
3 Open the sipper shield by applying pressure to the white metal area at the top,
until the latch is released.
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Weekly maintenance
For essential safety information, see Avoid damage to motorized components on page A-13.
For essential safety information, see Avoid damage to the probe on page A-13.
4 Move the sipper probe to an area where you can readily access it.
5 Wipe the outer surfaces of the sipper probe with a gauze pad soaked in 70%
isopropyl alcohol, followed by a wipe with a gauze pad soaked in distilled or
deionized water.
A
B
6 Close the sipper shield by applying pressure to the white metal area at the top until
the latch is engaged and you hear a click.
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cobas e 411 analyzer 8 Maintenance
Weekly maintenance
Spills on the incubator may cause gripper movement alarms. The incubator and
aspiration station should be cleaned regularly.
Materials Item
Gauze pads
Cotton swabs
Distilled or deionized water
Table C-15 Required materials
For essential safety information, see Avoid damage to motorized components on page A-13.
Roche Diagnostics
Operators Manual Version 1.0 C-17
8 Maintenance cobas e 411 analyzer
Weekly maintenance
7 Wet a cotton swab with distilled or deionized water and swab each of the 32
positions on the incubator, as well as the aspiration station.
A B C
A Wipe incubator surface B Swab incubator positions
C Aspiration station
8 Use a dry gauze pad to dry the incubator when you have finished cleaning.
Roche Diagnostics
C-18 Operators Manual Version 1.0
cobas e 411 analyzer 8 Maintenance
Every two weeks maintenance
Record in the Maintenance log the dates when the maintenance tasks were carried out
and the initials of the person who performed them.
The analyzer has one rinse station for the sample/reagent (S/R) probe and the
microbead mixer, and one for the sipper probe.
Contamination of the rinse stations can be responsible for carryover. To prevent
contamination, clean the rinse stations at least every two weeks.
Materials Item
Cotton swabs
Distilled or deionized water (approx 300 mL)
Syringe with attached tubing
70% isopropyl alcohol
Table C-17 Required materials
You may find it easier to use two syringes for this procedureone for aspirating liquid and the
other for refilling the rinse stations.
For essential safety information, see Avoid damage to motorized components on page A-13.
For essential safety information, see Avoid damage to the probe on page A-13.
2 Move the sample/reagent probe, the microbead mixer, and the sipper probe to an
area away from the rinse stations.
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Operators Manual Version 1.0 C-19
8 Maintenance cobas e 411 analyzer
Every two weeks maintenance
3 Aspirate the water out of the microbead mixer rinse station using a syringe with
tubing attached.
A B C D
A Microbead mixer B Microbead mixer rinse station
C Attached tube D Syringe
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C-20 Operators Manual Version 1.0
cobas e 411 analyzer 8 Maintenance
Every two weeks maintenance
4 Use a cotton swab soaked in 70% isopropyl alcohol to clean thoroughly the
microbead mixer rinse station and the sipper rinse stations.
5 Wipe the microbead mixer rinse station and the sipper rinse station again using a
fresh cotton swab soaked in distilled or deionized water.
6 Fill the syringe with distilled or deionized water, and refill the microbead mixer
rinse station. This should take approximately 50-100 mL of water.
7 Flush the sample/reagent probe and sipper rinse stations with water (50-100 mL).
8 Aspirate the water out of the microbead mixer rinse station again, by using the
syringe.
9 Refill the microbead mixer rinse station, and flush all the rinse stations with
distilled or deionized water again.
10 Switch on the analyzer at the operation switch.
The analyzer performs a start-up reset operation, and each mechanism
automatically returns to its home or standby position.
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Operators Manual Version 1.0 C-21
8 Maintenance cobas e 411 analyzer
Every two weeks maintenance
Contamination in the sipper system may degrade sample accuracy and precision, or
possibly block the measuring cell flow. To keep the sipper liquid flow clean and
maintain the integrity of the measuring cell, perform the following liquid flow
cleaning procedural steps in the correct order.
Planning Recommended frequency: Every two weeks or after 2500-3000 tests, whichever comes
first.
Operator time: Approximately 4 minutes.
System time: Approximately 17 minutes.
Precautions: Wear suitable protective gloves, plus eye and face protection.
Table C-18 Planning considerations
Materials Item
SysClean
SysClean adapter
Distilled or deionized water
Table C-19 Required materials
For essential safety information, see Handling of cleaning solutions (detergents) on page A-8.
For essential safety information, see Contact with solutions on page A-6.
For essential safety information, see Avoid use of bleach on page A-6.
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C-22 Operators Manual Version 1.0
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Every two weeks maintenance
A B
Figure C-11 SysClean adapter in the ProCell position of bottle set 1 (system reagent
compartment)
5 Remove the liquid waste container and clean it thoroughly with distilled or
deionized water. Replace the empty liquid waste container.
e For additional information on cleaning the liquid waste container, see Clean the liquid
waste container or direct drain (as appropriate) on page C-33.
6 Verify that ProCell and CleanCell bottles are correctly located in the other three
positions, with the lids open and adequate ProCell and CleanCell in the bottles.
7 Close the sipper shield.
8 Choose Utility > Maintenance.
9 Choose Maintenance from the Maintenance Type list.
10 Select Liquid Flow Cleaning from the Maintenance Items list.
11 Choose Select to display the Liquid Flow Cleaning window.
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Operators Manual Version 1.0 C-23
8 Maintenance cobas e 411 analyzer
Every two months maintenance
12 Type 1 in the Cycles text box and choose Start. Wait for the analyzer to return to
Standby.
13 Remove the liquid waste container and rinse it thoroughly with distilled or
deionized water. Return the liquid waste container to the analyzer.
e For additional information on cleaning the liquid waste container, see Clean the liquid
waste container or direct drain (as appropriate) on page C-33.
16 Return the ProCell bottle to its correct position in bottle set 1 in the system
reagent compartment.
17 Close the sipper shield.
Record in the Maintenance log the dates when the maintenance tasks were carried out
and the initials of the person who performed them.
Worn pinch valve tubing can allow liquid to leak out. Leakage will affect both the
accuracy of the pipetting volumes and the ability of the analyzer to properly clean the
measuring cell.
This maintenance task is divided into the following procedures:
o Procedure 1: To purge the tubing of liquid
o Procedure 2: To remove the tubing from the fittings
o Procedure 3 (optional): To replace a broken fitting
o Procedure 4: To prime the sipper
o Procedure 5: To prepare the measuring cell
Perform these procedures in the correct order.
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C-24 Operators Manual Version 1.0
cobas e 411 analyzer 8 Maintenance
Every two months maintenance
Materials Item
Pinch valve tubing
Tube joint B
Paper towels
Gauze pads
Table C-21 Required materials
It is highly recommended that you keep a spare Tube joint B on-site. There is a risk that this part
may be damaged during replacement of the Pinch valve tubing.
For essential safety information, see Residual liquid in pinch valve tubing on page A-11
For essential safety information, see Tubing and fittings on page A-17.
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Operators Manual Version 1.0 C-25
8 Maintenance cobas e 411 analyzer
Every two months maintenance
A E
B F
C G
D H
A Pinch valve (left side, sample/reagent probe) B Tubing (left side, sample/reagent probe)
C Fitting (sample/reagent probe) D Fitting (sample/reagent probe)
E Pinch valve (right side, sipper probe) F Tubing (right side, sipper probe)
G Fitting (sipper probe) H Fitting (sipper probe)
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C-26 Operators Manual Version 1.0
cobas e 411 analyzer 8 Maintenance
Every two months maintenance
4 Carefully remove the tubing from the fittings on the metal plate and discard.
There may still be some liquid in the tubing. The liquid that flows through this
tubing comes from the measuring cell and is potentially biohazardous. Use gauze
pads and paper towels to prevent spillage.
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8 Maintenance cobas e 411 analyzer
Every two months maintenance
A B
8 Carefully slide the ends of the tubing over each of the fittings in turn.
A B
A Fitting B Tubing
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C-28 Operators Manual Version 1.0
cobas e 411 analyzer 8 Maintenance
Every two months maintenance
It is only necessary to perform this procedure if any of the fittings are broken.
A
B
C
A Fitting B O-ring
C Valve block
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Operators Manual Version 1.0 C-29
8 Maintenance cobas e 411 analyzer
As needed maintenance
As needed maintenance
Record in the Maintenance log the dates when the maintenance tasks were carried out
and the initials of the person who performed them.
Finalization allows the module to stand unused for several hours (for example,
overnight). The system is primed with water, and the measuring cells are filled with
ProCell.
Before going into Standby mode, the system automatically performs finalization
maintenance. Finalization must be manually initiated if it was not performed
automatically (for example, due to an emergency stop), or did not complete (for
example, when an alarm is issued), or if the system stands unused for several hours.
If you choose S. Stop (Sample stop), finalization is bypassed and the analyzer goes
directly into Standby mode.
Planning Recommended frequency: Daily (if the analyzer does not automatically enter finalization
during the course of the day)
Operator time: Approximately 30 seconds
System time: Approximately four minutes
Precautions: None
Table C-22 Planning considerations
Materials None
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C-30 Operators Manual Version 1.0
cobas e 411 analyzer 8 Maintenance
As needed maintenance
Materials Item
Gauze pads
Cleaning brush
Distilled or deionized water
Paper towels
70% isopropyl alcohol
Table C-24 Required materials
Roche Diagnostics
Operators Manual Version 1.0 C-31
8 Maintenance cobas e 411 analyzer
As needed maintenance
5 Inspect the inside of the container and scrub away any visible dirt or
contamination using a large cleaning brush immersed in 70% isopropyl alcohol.
Rinse thoroughly with distilled or deionized water.
6 Remove the valve on the bottom of the system water container.
Figure C-20 Remove the valve from the system water container valve
7 Clean the valve with a wet brush, then rinse with distilled or deionized water. If
the valve appears to be dirty, use a brush immersed in 70% isopropyl alcohol to
clean the valve. Then, rinse thoroughly with distilled or deionized water.
8 Use a gauze pad to wipe and clean the aspiration inlet for the distilled or deionized
water supply.
9 Connect the valve to the container bottom and fill the container with distilled or
deionized water.
10 Add 35 mL of SysWash to the distilled or deionized water, pouring carefully to
avoid creating air bubbles. This gives a SysWash dilution of 1+100.
11 Dry the outside of the container with paper towels, attach the cap to the container,
and return the container to the analyzer.
A Aspiration inlet
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cobas e 411 analyzer 8 Maintenance
As needed maintenance
The liquid waste container must be checked and emptied as necessary. A full liquid
waste container causes an alarm and interrupts the operation of the analyzer. This
applies to the internal liquid waste container, and also to any external liquid waste
tank in cases where the optional direct drain arrangement is used.
Materials Item
70% isopropyl alcohol
Paper towels
Germicidal agent, pH 9 (optional)
Table C-26 Required materials
For essential safety information, see Avoid use of bleach on page A-6.
Roche Diagnostics
Operators Manual Version 1.0 C-33
8 Maintenance cobas e 411 analyzer
As needed maintenance
a To clean the liquid waste container for direct drain (if fitted)
1 Switch off the power to the analyzer or put the analyzer into Standby.
2 Remove the window plate (4 screws) to gain access to the container.
3 Empty the container and rinse it thoroughly with water. Keep paper towels at
hand to mop up any drips or spillages.
4 If the inside of the container appears to be dirty, rinse it with 70% isopropyl
alcohol. Follow with a thorough water rinse.
5 Wipe the outside of the container with a paper towel.
6 Use a paper towel to wipe the area around the container.
7 Optional step: Add the appropriate volume of a germicidal agent of pH 9 (as
directed in its product labeling) to the container.
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cobas e 411 analyzer 8 Maintenance
As needed maintenance
8 Position the drain tubing with no upwards slope or U-bend. See Analyser
Components - Direct drain system (optional).
9 Replace the container window plate.
Clean the microbead mixer when necessary. Check the microbead mixer periodically,
and remove visible dirt, for example red dots on the mixer arm or the paddle.
Impurities on the microbead mixer may cause problems and affect results.
Materials Item
Gauze pads
Distilled or deionized water
70% isopropyl alcohol
Table C-28 Required materials
For essential safety information, see Avoid damage to motorized components on page A-13.
For essential safety information, see Bent or damaged microbead mixer paddle on page A-6.
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Operators Manual Version 1.0 C-35
8 Maintenance cobas e 411 analyzer
As needed maintenance
A Mixer paddle
3 Wipe the outer surface of the microbead mixer paddle carefully, using a gauze pad
soaked in 70% isopropyl alcohol. Repeat with a new gauze pad soaked in distilled
water. Take care not to bend the mixer paddle during cleaning.
4 Switch on the power to the analyzer. The analyzer performs a start-up reset and
each mechanism returns to its home or standby position.
Clean the system reagent compartment whenever necessary to remove any liquid or
residue spilled from the ProCell and CleanCell reagents.
Materials Item
Gauze pads
Cotton swabs
Distilled or deionized water
70% isopropyl alcohol
Table C-30 Required materials
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cobas e 411 analyzer 8 Maintenance
As needed maintenance
3 Open the sipper shield by applying pressure to the white metal area at the top,
until the latch is released.
e For the location of the sipper shield, see Figure C-5 on page C-16.
For essential safety information, see Avoid damage to motorized components on page A-13.
4 Move the sipper arm manually as far to the left as the arm will allow.
5 Remove all four ProCell and CleanCell reagent bottles from their compartments.
6 Wipe the sipper shield with a damp gauze pad and repeat with a dry gauze pad.
Roche Diagnostics
Operators Manual Version 1.0 C-37
8 Maintenance cobas e 411 analyzer
As needed maintenance
7 Wipe the inside of the compartments with damp (not wet) gauze pads. Do not
allow water to pool in the bottom of the compartments. Avoid the photosensors in
the two inside compartments, that check for the presence of ProCell/CleanCell
bottle sets. Each sensor is in a rectangular window at the back of its compartment,
just below the top edge. If you wet the sensors, dry them with a cotton swab.
B C
A Photosensor locations (visible when bottle B Bottle set 2, CleanCell position
removed)
C Bottle set 1, ProCell position
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C-38 Operators Manual Version 1.0
cobas e 411 analyzer 8 Maintenance
As needed maintenance
To maintain the efficiency of the analyzer, the reagent rotor and compartment must
be cleaned as soon as any signs of dirt or contamination appear. Any reagent spills
must be cleaned up as they occur.
This maintenance task is divided into the following procedures:
o Procedure 1: To clean the reagent rotor
o Procedure 2: To clean the reagent rotor compartment
Perform these procedures in the correct order.
Materials Item
Gauze pads
Distilled or deionized water
70% isopropyl alcohol
Cloth or lint-free towels
Table C-32 Required materials
For essential safety information, see Avoid damage to motorized components on page A-13.
Roche Diagnostics
Operators Manual Version 1.0 C-39
8 Maintenance cobas e 411 analyzer
As needed maintenance
B
A Thumbscrews B Alignment pin
Roche Diagnostics
C-40 Operators Manual Version 1.0
cobas e 411 analyzer 8 Maintenance
As needed maintenance
7 Inspect the reagent rotor, and use gauze pads soaked with 70% isopropyl alcohol
to clean any visible dirt from the rotor. Wipe the cleaned rotor with gauze pads
soaked with distilled or deionized water.
8 Dry the reagent rotor with a cloth or lint-free towels.
9 Set the reagent rotor to one side while cleaning the reagent rotor compartment.
For essential safety information, see Barcode reader window on page 13.
4 Inspect the reagent rotor compartment and the barcode reader window. Remove
any visible dirt or contamination using gauze pads soaked with 70% isopropyl
alcohol. Then wipe the cleaned reagent rotor compartment and barcode reader
window with gauze pads soaked with distilled or deionized water.
5 Dry the reagent rotor compartment and the barcode reader window with a cloth
or lint-free towels.
6 Return the reagent rotor to the compartment.
7 Note that the rotor is keyed; make sure that the alignment pin on the center plate
is aligned with the hole on the rotor.
8 Replace and secure the thumbscrews.
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Operators Manual Version 1.0 C-41
8 Maintenance cobas e 411 analyzer
As needed maintenance
During operation, the solid waste tray is filled with disposed tips and cups. Check the
solid waste tray regularly, and empty as needed.
Materials Item
Clean-Liner
Table C-34 Required materials
For essential safety information, see Changing the Clean-Liner on page A-6.
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cobas e 411 analyzer 8 Maintenance
As needed maintenance
4 Remove the Clean-Liner from the tray and dispose of it according to the waste
handling and disposal procedures that apply in your laboratory.
5 Place a fresh Clean-Liner into the tray.
6 Verify that the sliding door is open and that the opening is located at the back of
the tray.
7 Insert the tray into the analyzer and close the door.
On the System Overview screen, the solid waste counter automatically resets to 0
(zero) when the solid waste tray is removed.
8 Dispose of the Clean-Liner appropriately, as it contains potentially biohazardous
material.
If you remove the solid waste tray for any reason you should also discard the solid waste or replace
the Clean-Liner at the same time. The software counts the AssayTips and AssayCups used during
the course of operation. When the analyzer senses that the solid waste tray was removed, the
counter resets to 0 (zero).
Roche Diagnostics
Operators Manual Version 1.0 C-43
8 Maintenance cobas e 411 analyzer
As needed maintenance
If the analyzer is not going to be used for more than seven days, it is important to
prepare the system properly and perform the correct shutdown maintenance. Failure
to observe these recommendations may result in damage to the measuring cell.
Different shutdown procedures are recommended, depending upon the duration of
inactivity. Certain procedures may require the assistance of a Roche Diagnostics
service representative.
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C-44 Operators Manual Version 1.0
Troubleshooting D
9 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-3
10 Data alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-31
cobas e 411 analyzer 9 Troubleshooting
Table of contents
Troubleshooting
Roche Diagnostics
Operators Manual Version 1.0 D-3
cobas e 411 analyzer 9 Troubleshooting
Table of contents
Roche Diagnostics
Operators Manual Version 1.0 D-4
cobas e 411 analyzer 9 Troubleshooting
Introduction
Introduction
To identify and isolate problems effectively, you must understand the theory of
operation, operating procedures, emergency procedures and test reaction
descriptions covered in this manual.
The information in this chapter will help you to recognize the causes of various
operational problems, find information to resolve operational problems, and
minimize the potential for operator-induced problems.
e If you are unable to resolve the problem, and you need support, see Contacting Technical
Support on page D-8 for a list of information that Roche might request if you call for
assistance.
Alarms
If any abnormality occurs while the system is switched on, the system notifies the
operator of the potential problem by issuing an alarm.
There are two types of alarm:
o Instrument alarms
These are displayed alarms that indicate abnormal instrument conditions, such as
reagent rotor temperature, and mechanical malfunctions.
o Data alarms
These are printed or displayed alarms or flags that indicate unusual reaction
conditions, such as insufficient sample or reagent, or measures values outside the
limits.
e For further information, see Data alarms on page D-31.
Problem categories
The problems that may be encountered can be separated into the following categories:
o Sample/reagent problems
o Instrument/hardware problems
o Computer/software problems
o Facility problems
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Operators Manual Version 1.0 D-5
9 Troubleshooting cobas e 411 analyzer
Problem categories
Sample/reagent problems
Instrument/hardware problems
o Electrical/electronic
o Mechanical:
O Pinch valve tubing leaking
O AssayCup/AssayTip jammed
O Problem with solid waste tray removal
o Operator error:
O Incorrect size of sample tubes or cups used
O Incorrect replacement of AssayCup/AssayTip
O Incorrect or insufficient maintenance
O Caps not removed from liquid waste containers
O Caps not opened on ProCell/CleanCell bottles
Computer/software problems
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cobas e 411 analyzer 9 Troubleshooting
Problem categories
o Orders/result database capacity exceeded (up to 2000 results can be stored, for
routine samples, STAT (Short Turn Around Time) samples, and controls)
o Alarms
o Operator error
Facility problems
o Temperature
o Humidity
o Power supply
o Water supply
o Drain
e See System specifications on page A-37.
For essential safety information, see Electrical safety precautions on page A-7.
When troubleshooting, review the alarms and isolate the problem to the area denoted
by the alarms. In many cases, you may be able to find the problem, correct it, and
resume test processing. The remainder of this section provides you with instructions
and guidelines to assist you in isolating problems.
If there is a problem with barcode reading, first check the position of the barcode label.
Roche Diagnostics
Operators Manual Version 1.0 D-7
9 Troubleshooting cobas e 411 analyzer
Contacting Technical Support
General information
The following general information is required for all problems:
o Account number or customer ID number
o Contact name and telephone number
o Instrument serial number
o Description of the problem, including relevant alarm(s) and alarm code numbers
o When the problem first occurred (for example, after reagent pack lot change)
o Whether the problem was observed with just one system or with all systems
o Copies of the original instrument printouts (send by fax or e-mail)
Immunoassay problems
The following general information is required for immunoassay problems:
o Whether the problem was observed with just one assay or with all assays
o Whether the problem was observed with just one sample type or with all sample
types
o Control results from the last few controls performed
o Sample type used (serum, plasma, urine, or saliva)
o Sample tube used (manufacturer, diameter, primary or secondary tube)
o Elapsed time between specimen collection and measurement
o Patient results (with correlation results, if relevant)
o Test(s) affected and other tests on board
o Whether SysWash was added to the system water container
o Catalog number, lot numbers, and expiration dates of reagents
o Catalog number, lot numbers, and expiration dates of calibrators and controls
o Calibration signals (HetIA) from the last few calibrations performed
o Control results from the last few controls performed
o Details of reagent/calibrator/control handling (such as calibration frequency,
stability, ambient temperature, foam, and evaporation)
o When the reagent was loaded onto the system
Software problems
The following general information is required for software problems:
o The version of software installed
o The sequence number of the reagent packs
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D-8 Operators Manual Version 1.0
cobas e 411 analyzer 9 Troubleshooting
Contacting Technical Support
Instrument problems
The following general information is required for instrument problems:
o Rack or disk system
o Instrument maintenance and service history
o Whether a host or Pre-Analytic Systems Manager (PSM)(1) was connected
o Number of tests performed
o Other instrument or maintenance related information
o Error code and error description
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Operators Manual Version 1.0 D-9
9 Troubleshooting cobas e 411 analyzer
Basic troubleshooting flow chart
The following flow chart details the basic decisions to be made when performing
troubleshooting on the cobas e 411.
Problem detected
Was an
instrument alarm Follow the remedy
Yes
generated? displayed on screen
No
Does
Was a No the alarm
Yes Follow appropriate remedy data alarm recur?
Yes
in Data alarms chapter generated?
Continue normal
operation
Does Yes
the alarm No
recur?
No
Continue normal
operation
Yes Check the Troubleshooting
chapter for a description of
this problem
Was a
description of this Yes Follow the remedy
problem
found?
Does the
Yes problem
No recur?
Continue normal
Identify the type of problem: operation
Immunoassay problem?
Software problem?
Instrument problem?
Call
Technical Support
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D-10 Operators Manual Version 1.0
cobas e 411 analyzer 9 Troubleshooting
Immunoassay troubleshooting
Immunoassay troubleshooting
Mechanical problems are evident when the analyzer displays an alarm message. A
chemistry problem may display a data alarm, or may only become evident with an
unexpected result.
Deciding that a problem exists is the first step in the process. The following situations
may require troubleshooting:
o Error codes on calibration documentation.
o Data alarms on control or patient samples.
o Quality control sample results outside established range.
o Patient tests with unexpected results.
When troubleshooting a problem, open the Print screen (using the Print global
button), choose Utility tab, and print an alarm list. Use this list to assist you with
troubleshooting.
To troubleshoot effectively, eliminate extraneous information and pinpoint the
problem. Use the calibration documentation, quality control results, or patient results
to decide which of the following conditions apply, and perform the associated checks
outlined in the following sections:
e See also:
For problems with a single sample on page D-13
For problems with a single assay on page D-13
Sometimes conditions arise that cannot be detected by the analyzer. These conditions
do not generate alarms and therefore must be detected by the operator. When one or
more of these conditions are present, test results can be extremely high, low or erratic.
To identify the cause of high, low or erratic test results, first verify the handling of
reagents, calibrators and controls by considering the following lists of checks.
For essential safety information, see Contact with solutions on page A-6.
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Operators Manual Version 1.0 D-11
9 Troubleshooting cobas e 411 analyzer
Immunoassay troubleshooting
o Was the reagent allowed to reach the correct temperature on board (15 minutes
from room temperature or one hour from 4C) before starting the instrument?
o Were the reagent packs within the allowed stability after opening and the
expiration dates not exceeded?
o Were the system reagent bottles closed overnight?
o Were the partly used ProCell/CleanCell bottles replaced from the left to right side?
o Was any foam observed on the surface of the reagents?
o Were any bubbles observed in the pipetters or syringes?
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cobas e 411 analyzer 9 Troubleshooting
Immunoassay troubleshooting
o Were the lyophilized controls carefully reconstituted with, for example, 3 mL for
PreciControl Universal and PreciControl Tumor Marker (stand closed for 30
minutes), and 2 mL for PreciControl Cardiac (stand closed for 15 minutes)?
o Were the controls transferred to the correct barcoded vials?
o Were the controls checked and found to be within the allowed stability after
opening, and the expiration date not exceeded?
o Was any foam observed on the surface of the controls?
o Were drops observed hanging on the control vial cap? (You need to clean the
control caps carefully with a paper tissue.)
o Was crystallized material observed on the control vial cap? (If so, discard the
control vial.)
o Were the controls aliquoted and frozen? (This is recommended for controls such
as PreciControl Universal, Cardiac, and Tumor Marker.)
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Operators Manual Version 1.0 D-13
9 Troubleshooting cobas e 411 analyzer
Instrument troubleshooting
Instrument troubleshooting
When troubleshooting a problem, open the Print screen (using the Print global
button), choose Utility tab, and print an alarm list. Use this list to assist you with
troubleshooting.
Troubleshooting at power up
If the instrument does not power up, this could be caused by one of the conditions
listed in the following table.
To troubleshoot a problem, determine the category below that best describes the
problem, and follow the recommended remedy. If all remedies are unsuccessful, call
Technical Support.
The control unit controls and monitors all mechanical functions of the instrument.
When a mechanical problem arises within the instrument, it is immediately
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D-14 Operators Manual Version 1.0
cobas e 411 analyzer 9 Troubleshooting
Instrument troubleshooting
recognized by the system. An audible alarm sounds, if enabled on the Alarm Sound
Setting window (Alarm > Sound), and the alarm indicator on the global Alarm
button lights, alerting you to the problem. Choose Alarm (global button) to display
the Alarm screen with the specific alarm code, date and time the alarm occurred and a
description of the alarm. Choose a specific alarm to display the alarm details and
appropriate remedy.
For certain problems affecting the instrument's performance, the system terminates
the operation mode and enters the sampling stop or stop mode. In the sampling stop
mode, the system allows completion of the samples in process unaffected by the
failure. If the problem affects all samples in process, the computer immediately
terminates the operation mode with a stop or emergency stop.
For essential safety information, see Instrument problems without alarms on page A-9.
If you are having problems switching the analyzer on, follow the steps below:
1 Are the operation on/off switch and analyzer circuit breaker turned off?
o If yes, go to step 2.
o If no, go to step 3.
2 Switch on both the analyzer circuit breaker and power switches.
3 Is the power cable plug disconnected at either the instrument or the outlet?
o If yes, go to step 4.
o If no, go to step 5.
4 Firmly connect the power cable.
5 Is the outlet working?
o If yes, go to step 7.
o If no, go to step 6.
6 Check the circuit breaker in the laboratory distribution box.
7 If the instrument still does not power up, call Technical Support.
If you are unable to access another software screen, follow the steps below:
1 Switch the analyzer off at the circuit breaker.
2 Switch the analyzer on at the circuit breaker. If you are still unable to access
another screen, then call Technical Support.
Roche Diagnostics
Operators Manual Version 1.0 D-15
9 Troubleshooting cobas e 411 analyzer
Instrument troubleshooting
If you are having problems with the touchscreen, follow the steps below:
1 Is the operation on/off switch on the right side of the analyzer switched off?
o If yes, go to step 2.
o If no, go to step 3.
2 Switch the operation switch on. Does the touchscreen switch on?
o If no, go to step 3.
3 Firmly connect the cable.
4 Call Technical Support.
The solid waste tray does not come out or produces unusual sounds
If you are having problems removing the solid waste tray or unusual sounds are
coming from the solid waste tray area, follow the steps below:
1 Are the tray and Clean-Liner seated correctly?
o If yes, go to step 3.
o If no, go to step 2.
2 Reseat the tray and Clean-Liner.
3 Are there stray cups or tips behind the tray?
o If yes, go to step 4.
o If no, go to step 5.
4 Remove the stray cups and tips and replace the tray and Clean-Liner.
5 Call Technical Support.
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D-16 Operators Manual Version 1.0
cobas e 411 analyzer 9 Troubleshooting
Instrument troubleshooting
If you are having problems opening or closing the reagent rotor cover, follow the steps
below:
1 The reagent rotor cover is keyed. Is the reagent rotor cover correctly oriented for
placement?
o If yes, go to step 3.
o If no, go to step 2.
2 Make sure that the reagent rotor cover fits into the key, which is there to prevent
the cover being placed in the wrong orientation.
3 Is there an obstacle around the cover?
o If yes, go to step 4.
o If no, go to step 5.
4 Remove the obstacle.
5 Call Technical Support.
If the sample disk does not move properly, follow the steps below:
1 Is the sample disk seated correctly?
o If yes, go to step 3.
o If no, go to step 2.
2 Remove and reseat the sample disk.
3 Is there an obstacle around the sample disk?
o If yes, go to step 4.
o If no, go to step 5.
4 Remove the obstacle.
5 Call Technical Support.
If you are having problems placing a reagent pack on the reagent rotor, follow the
steps below:
1 Reagent packs are keyed for correct placement. Is the reagent pack correctly
oriented?
o If yes, go to step 3.
o If no, go to step 2.
2 Reorient the reagent pack (the transparent cap and the barcode should face the
outside of the reagent rotor).
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Operators Manual Version 1.0 D-17
9 Troubleshooting cobas e 411 analyzer
Instrument troubleshooting
If you are having problems replacing an AssayTip or AssayCup tray, follow the steps
below:
1 AssayTip and AssayCup trays are keyed for correct placement. Is the AssayTip or
AssayCup tray correctly oriented?
o If yes, go to step 3.
o If no, go to step 2.
2 Remove and reseat the AssayTip or AssayCup tray.
3 Is there an obstacle around the tray?
o If yes, go to step 4.
o If no, go to step 5.
4 Remove the obstacle.
5 Is the tray damaged or deformed?
o If yes, go to step 6.
o If no, go to step 7.
6 Replace the tray.
7 Call Technical Support.
If you are having problems replacing a ProCell or CleanCell reagent bottle, follow the
steps below:
1 The system reagent bottles are keyed for correct placement. Is the bottle in its
correct position?
o If yes, go to step 3.
o If no, go to step 2.
2 Remove the bottle and check the position before placing the reagent into its
correct position. ProCell must only be placed in positions 1 and 3, and CleanCell
in positions 2 and 4.
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cobas e 411 analyzer 9 Troubleshooting
Instrument troubleshooting
The analyzer can operate with just one bottle set of ProCell and CleanCell reagent, but they must be
placed either in positions 1 (ProCell) and 2 (CleanCell), or in positions 3 (ProCell) and 4
(CleanCell).
Sometimes the system reagent bottle appears to bulge until the cap is opened. You may be able to fit
the bottle in the compartment after opening the cap.
o If yes, go to step 6.
o If no, go to step 7.
6 Replace the system reagent bottle.
7 Call Technical Support.
If you are having problems replacing the system water container, follow the steps
below:
1 The system water container must be correctly oriented for placement. Verify that
the cap is closest to the rear of the analyzer. Is the container facing the right way?
o If yes, go to step 3.
o If no, go to step 2.
2 Reseat the container and gently push down until you feel a snap indicating that
the bottle is connected.
3 Is there an obstacle around the system water container?
o If yes, go to step 4.
o If no, go to step 5.
4 Remove the obstacle.
5 Is the system water container damaged or deformed?
o If yes, go to step 6.
o If no, go to step 7.
6 Replace the system water container.
7 Call Technical Support.
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Operators Manual Version 1.0 D-19
9 Troubleshooting cobas e 411 analyzer
Instrument troubleshooting
If you are having problems replacing the solid waste tray, follow the steps below:
1 Does the Clean-Liner fit properly (the opening in the sliding door must point to
the rear of the analyzer) and is not damaged or bent?
o If yes, go to step 3.
o If no, go to step 2.
2 Try a different Clean-Liner.
3 Is there an obstacle around the solid waste tray?
o If yes, go to step 4.
o If no, go to step 5.
4 Remove the obstacle.
5 Is the solid waste tray damaged or deformed?
o If yes, go to step 6.
o If no, go to step 7.
6 Replace the solid waste tray.
7 Call Technical Support.
If your empty liquid waste container gives an alarm stating that the container is full,
follow the steps below:
1 Is there an obstacle causing the tray on which the container rests, to remain in the
down position (that is, is it still activating the sensor)?
o If yes, go to step 2.
o If no, go to step 3.
2 Remove the obstacle.
3 Call Technical Support.
If the direct drain reserve tank is full and operation has stopped, follow the steps
below:
1 Is the drain tube placement correct? For correct placement of the tube, see Direct
liquid drain (optional) on page A-93.
o If yes, go to step 3.
o If no, go to step 2.
2 Place the tube correctly.
3 Call Technical Support.
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D-20 Operators Manual Version 1.0
cobas e 411 analyzer 9 Troubleshooting
Instrument troubleshooting
If the S/R probe or sipper probe tip does not descend to the liquid surface, follow the
steps below:
1 Are there bubbles on the liquid surface?
o If yes, go to step 2.
o If no, go to step 3.
2 Eliminate the bubbles in the sample container with an applicator stick.
3 Did the probe tip touch something during descent?
o If yes, go to step 4.
o If no, go to step 5.
4 Remove the obstacle.
5 If the S/R probe or sipper probe tip still does not descend to the liquid surface, call
Technical Support.
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Operators Manual Version 1.0 D-21
9 Troubleshooting cobas e 411 analyzer
Instrument troubleshooting
Possible causes There is a problem writing to or reading from the USB storage device (flash memory
card or DVD-RAM) used to store the data backup.
Actions/Prevention Use the following flow chart to troubleshoot data backup write errors.
Is there a
removable storage device
Yes connected to the No
USB port?
No
Does No
the alarm Continue normal operation
recur?
Yes
Call
Technical Support
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D-22 Operators Manual Version 1.0
cobas e 411 analyzer 9 Troubleshooting
Instrument troubleshooting
Bubbles in syringes
If you see bubbles in either the S/R syringe or sipper syringe, follow the steps below:
1 Perform S/R pipetter prime (item 7 on the Maintenance Items list) or sipper
pipetter prime (item 6 on the Maintenance Items list), or both primes if bubbles
are seen in both syringes, from Utility > Maintenance. Choose Parameter and type
10 in the Prime Cycles text box.
2 If there are still bubbles in the syringe, repeat this process for the appropriate
syringe.
3 If bubbles remain in the syringe after the second pipetter prime, call Technical
Support.
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Operators Manual Version 1.0 D-23
9 Troubleshooting cobas e 411 analyzer
Chemistry troubleshooting
Chemistry troubleshooting
False measurements
Problem Values out of measuring range (values below the lower detection limit or values above
the measuring range).
Actions/Prevention o Have you handled the reagents, calibrators, and controls according to the package
inserts?
o Empty the system water container and refill with fresh distilled or deionized water
and 35 ml of SysWash, pouring carefully to avoid creating air bubbles.
o Have you performed recommended maintenance?
o If you are still experiencing problems, contact Technical Support.
Drift
Possible causes o Evaporation or incorrect storage conditions of reagent packs, ProCell, and
CleanCell.
o Reagent packs are not at the correct temperature.
o Recommended calibration frequency not followed.
o Recommended handling of controls or samples not followed (for example,
stability and evaporation).
Actions/Prevention o Have you handled the reagents, calibrators, and controls according to the package
inserts?
o Have you performed recommended maintenance?
o If you are still experiencing problems, contact Technical Support.
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cobas e 411 analyzer 9 Troubleshooting
Chemistry troubleshooting
Actions/Prevention o Have you handled the reagents, samples and controls according to package
inserts?
o Have you performed the recommended maintenance?
o If you are still experiencing problems, contact Technical Support.
Assay calibration
Actions/Prevention o Check the barcodes of calibrator vial, calibrator barcode card, and reagent pack. Is
the barcode damaged, or not in the correct position?
o Wipe off the dust on the surface of the barcode reader.
o Dry the calibrator vial if it is wet.
o Check calibrator position.
o If you are still experiencing problems, contact Technical Support.
Problem The calibration is not released because duplicates are out of limits.
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Operators Manual Version 1.0 D-25
9 Troubleshooting cobas e 411 analyzer
Chemistry troubleshooting
Actions/Prevention o Have you handled the reagents, calibrators, and controls according to the package
inserts?
o Empty the system water container and refill with fresh distilled or deionized water
and 35 ml of SysWash, pouring carefully to avoid creating air bubbles.
o Perform a new assay calibration (new CalSet).
o Have you performed recommended maintenance?
o If you are still experiencing problems, contact Technical Support.
Problem The calibration is not released because the monotony has not been fulfilled.
Possible causes o Calibrator not transferred to the correct barcoded calibrator vials (for example,
content of bottle Cal1 transferred to vials Cal1 and Cal2).
Actions/Prevention o Have you handled the reagents, calibrators, and controls according to the package
inserts?
o Perform a new assay calibration (new CalSet).
Missing values
Actions/Prevention o Have you handled the reagents, calibrators, and controls according to the package
inserts?
o Perform a new assay calibration (new CalSet).
o If you are still experiencing problems, contact Technical Support.
Problem The calibration is not released because of values below the minimum signal (valid for
quantitative and qualitative assays), or the signal difference between vials Cal1 and
Cal2 or the maximum signal is out of limits (valid for qualitative assays only).
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cobas e 411 analyzer 9 Troubleshooting
Chemistry troubleshooting
Actions/Prevention o Have you handled the reagents, calibrators, and controls according to the package
inserts?
o Perform a new assay calibration (new reagent pack or new CalSet).
o Have you performed recommended maintenance?
o If you are still experiencing problems, contact Technical Support.
Problem The calibration is not released because the calibration factor is out of limits.
This problem is only valid for quantitative assays, and applies to reagent pack
calibration only.
Actions/Prevention o Have you handled the reagents, calibrators, and controls according to the package
inserts?
o Perform a new assay calibration (new reagent pack or new CalSet).
o Have you performed recommended maintenance?
If you are still experiencing problems, contact Technical Support.
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Operators Manual Version 1.0 D-27
9 Troubleshooting cobas e 411 analyzer
Chemistry troubleshooting
Recovery of controls
Actions/Prevention o Have you handled the reagents, calibrators, and controls according to the package
inserts?
o Use another control vial.
o Perform a new reagent pack calibration (new reagent pack and CalSet).
o Have you performed recommended maintenance?
o If you are still experiencing problems, contact Technical Support.
Actions/Prevention o Have you handled the reagents, calibrators, and controls according to the package
inserts?
o Empty the system water container and refill with fresh distilled or deionized water
and 35 ml of SysWash, pouring carefully to avoid creating air bubbles.
o Have you performed recommended maintenance?
o If you are still experiencing problems, contact Technical Support.
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cobas e 411 analyzer 9 Troubleshooting
Chemistry troubleshooting
Actions/Prevention o Have you handled the reagents, calibrators, and controls according to the package
inserts?
o Empty the system water container and refill with fresh distilled or deionized water
and 35 ml of SysWash, pouring carefully to avoid creating air bubbles.
o Have you performed recommended maintenance?
o If you are still experiencing problems, contact Technical Support.
Problem There is a deviation of control and samples when measured with different systems.
Possible causes o Recommended handling of assay, system reagents, calibrators, or controls not
followed (for example, stability and evaporation).
o Calibration not carefully performed.
Actions/Prevention o Have you handled the reagents, system reagents, calibrators, and controls
according to the package inserts?
o Have you performed recommended maintenance?
o If you are still experiencing problems, contact Technical Support.
Method comparison
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Operators Manual Version 1.0 D-29
9 Troubleshooting cobas e 411 analyzer
Chemistry troubleshooting
Actions/Prevention o Have you handled the reagents, calibrators, and samples according to the package
inserts?
o Have you performed recommended maintenance?
o If you are still experiencing problems, contact Technical Support.
Problem An auto dilution is no longer possible, even though a bottle of Elecsys Universal
Diluent or Elecsys Diluent MultiAssay is on board.
Possible causes The Elecsys Universal Diluent bottle may have been incorrectly placed on the reagent
rotor. If this happens, the MODULAR ANALYTICS barcode is read instead of the
cobas e 411 (Elecsys) barcode. This is because the barcode reader is outside the
reagent rotor on the cobas e 411, whereas it is inside the reagent rotor on the
MODULAR ANALYTICS.
If the wrong barcode is read, it will not be possible to use this diluent for auto dilution
on the cobas e 411 analyzer. The reason for this is that if the same lot number is
scanned again by the barcode reader, it will not be accepted by the system because the
information will already be in the database.
Actions/Prevention Take care to position the Elecsys Universal Diluent or Elecsys Diluent MultiAssay
Reagent Pack carefully, so that the cobas e 411 (Elecsys) barcode is read, and not the
one for the MODULAR ANALYTICS.
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D-30 Operators Manual Version 1.0
cobas e 411 analyzer 10 Data alarms
Table of contents
Data alarms
This chapter describes the data alarms generated by the cobas e 411 analyzer system,
together with the cause of each alarm and suggested remedies.
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Table of contents
Reag.F ...................................................................................................................... 44
Reag.H ..................................................................................................................... 44
Reag.S ...................................................................................................................... 44
Reag.T ..................................................................................................................... 45
Samp.C .................................................................................................................... 45
Samp.S ..................................................................................................................... 45
SLLD.E .................................................................................................................... 46
SLLD.N .................................................................................................................... 46
SysR.S ...................................................................................................................... 46
SysR.T ...................................................................................................................... 47
SysR.U ..................................................................................................................... 47
Data problems without an alarm ................................................................................ 48
Drift of result data ................................................................................................... 48
Erroneous operation ............................................................................................... 48
Poor reproducibility ................................................................................................ 48
Result data at high level ........................................................................................... 48
Result data at low level ............................................................................................ 49
Trouble for each test ............................................................................................... 49
Trouble for all tests ................................................................................................. 49
Instrument problems without an alarm ...................................................................... 49
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cobas e 411 analyzer 10 Data alarms
Introduction
Introduction
If any abnormality occurs while the system is switched on, the system notifies the
operator of the potential problem by issuing an alarm. These alarms comprise data
alarms (referring to irregular measuring results or conditions) and instrument alarms
(referring to irregular system conditions).
Alarm indication Data alarms are indicated on the Workplace > Data Review screen, on the Test Review
window (Workplace > Data Review > Test Review), and on printed reports. If a data
alarm occurs, a symbol (also referred to as flag) is attached to the measurement result.
These flags are strings of three to six characters, which are all explained in this
chapter.
Instrument alarms are indicated by the Alarm button (global button) on the System
Overview screen as well as by an audible alarm. If an alarm occurs, the Alarm button
lights up. Its color indicates the alarm level: yellow indicates warning level; red
indicates emergency stop.
In case of an alarm, choose the Alarm button to open the Alarm window. This
window provides an alarm list and descriptions and remedies for each listed alarm.
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10 Data alarms cobas e 411 analyzer
List of data alarms
The following table displays the data alarms and their presentation (flag) on screens
and reports.
Flag Alarm
>AB AB level range over
>Curr Measuring cell current range over
<SigL Low level signal
>Test Measurement range (upper)
<Test Measurement range (lower)
AB.E AB level check error
ADC.E ADC abnormal
Cal.E Calibration result abnormal
Calc.? Calculation not possible
Cancel Power Fail/Power Off Cancel
Cancel E.STOP Cancel
Cancel STOP Cancel
Cancel P.STOP/A.STOP Cancel
Cancel S.STOP Cancel
Cancel Recovery Cancel
Cancel Sample ID Error Cancel
CarOvr Potential microparticle carry over
Cell.T Cell temperature
ClcT.E Calc Test Error
Curr.E Measuring cell current check
FacA Instrument factor A reset
H Outside of expected value (upper)
Inc.T Incubator temperature
L Outside of expected value (lower)
Over.E Overflow
Reag.F Assay reagent film detected; Diluent film detected; Pretreatment film
detected
Reag.H Assay reagent hovering; Diluent hovering; Pretreatment hovering
Reag.S Assay reagent short; Diluent short; Pretreatment reagent short
Reag.T Abnormal reagent disk temperature
ReagEx Reagent expired
Samp.C Sample clot
Samp.S Sample short
SLLD.E Sample LLD abnormal
SLLD.N Sample LLD noise
Table D-2 List of data alarms
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cobas e 411 analyzer 10 Data alarms
List of data alarms
Flag Alarm
SysR.S System reagent short
SysR.T System reagent temperature
SysR.U System reagent temperature unstable
Table D-2 List of data alarms
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10 Data alarms cobas e 411 analyzer
Data alarms
Data alarms
For each data alarm, this section gives the nature of the alarm, a fuller description of
the problem, the cause or causes, and appropriate remedies.
>AB
Description During run preparation, the ProCell count level was out of range (the ProCell signal
was <200 or >400 counts).
>Curr
Description The measuring cell current was out of range when checked during run preparation.
Remedy 1 Choose Utility > Maintenance > Maintenance and perform the Liquid Flow
Cleaning maintenance item (10 cycles).
2 Rerun all flagged samples.
3 If the alarm recurs, call Technical Support.
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cobas e 411 analyzer 10 Data alarms
Data alarms
<SigL
Description The signal is lower than the specified lower limit value coded in the reagent pack
barcode. For qualitative and quantitative assays.
>Test
Description The measured value is above the upper limit of the measuring range encoded on the
reagent pack barcode.
Cause The sample concentration is above the upper limit of the measuring (reportable)
range.
Remedy Rerun using the recommended dilution and check the measured value.
<Test
Description The measured value is below the lower limit of the measuring range encoded on the
reagent rack barcode.
Cause The sample concentration is below the lower limit of the measuring (reportable)
range.
Remedy Report the result as less than the lower detection limit of the assay. Rerun is not
requested.
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10 Data alarms cobas e 411 analyzer
Data alarms
AB.E
Cause ProCell liquid level check failed. The ProCell Volume is inadequate for run
preparation.
Remedy 1 Replace the low volume ProCell bottle with a new bottle.
2 Rerun all flagged samples.
3 If the alarm recurs, call Technical Support.
ADC.E
Remedy 1 If other instrument alarms exist, correct those alarms and resume operation.
2 Choose Utility > Maintenance > Maintenance and perform the System Reset
maintenance item.
3 If the alarm recurs call Technical Support.
Cal.E
Description There is no valid calibration data in the system for this reagent pack (that is, a new
assay on the analyzer).
Cal.E appears on each control and patient sample for the affected test until the problem is resolved.
Remedy 1 Check the calibrators and reagents and repeat the calibration.
2 Set new calibrators and a reagent pack if necessary, and repeat the calibration.
3 Rerun the samples after a successful calibration is obtained.
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cobas e 411 analyzer 10 Data alarms
Data alarms
Calc.?
Description The test concerned was cancelled by power fail or power off.
Cause Test cancelled due to power failure or power off. Sample(s) may be excluded; refer to
printout.
Cause Test cancelled due to E.Stop. Sample(s) may be excluded; refer to printout.
Description Operation stopped by operator or the test concerned was cancelled by Stop.
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10 Data alarms cobas e 411 analyzer
Data alarms
Cause Test cancelled due to P.Stop or A.Stop. Sample(s) may be excluded; refer to printout.
Description Operation stopped by operator or the test concerned was cancelled by S.Stop.
Cause Test cancelled due to instrument handling error. Sample(s) may be excluded; refer to
printout.
Cause The sample ID that was scanned just before pipetting is different from the ID scanned
during the sample scan. All tests for the sample were cancelled.
Remedy Verify that sample tubes are not removed until the Status screen reads Proc or
Complete.
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cobas e 411 analyzer 10 Data alarms
Data alarms
CarOvr
ClcT.E
Description Data flag is attached. If one or both of two tests are flagged, no result.
Cause A data alarm has occurred for a test needed in the calculation. It is not valid for the
alarm Calculation not possible (Calc.?).
Cell.T
Description Measuring cell temperature is out of range. The system performs an initial check 30
minutes after start-up and checks the temperature continuously thereafter.
Remedy 1 Check the fans at the rear are operating normally and are free of obstructions.
2 Check that room temperature is between 18C and 32C.
3 If the alarm recurs, call Technical Support.
Curr.E
Cause ProCell liquid level check failed. The ProCell volume is inadequate for run
preparation.
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Operators Manual Version 1.0 D-41
10 Data alarms cobas e 411 analyzer
Data alarms
FacA
Description For patient samples, the calculated concentration is greater than the upper limit of the
expected value range.
For control samples, a concentration exceeded the 3 SD values specified on QC >
Install.
Inc.T
Description Incubator temperature is out of range. The system performs an initial check 30
minutes after start-up and checks the temperature continuously thereafter.
Remedy 1 Check the fans at the rear are operating normally and are free of obstructions.
2 Check that room temperature is between 18C and 32C.
3 If the error recurs, call Technical Support.
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cobas e 411 analyzer 10 Data alarms
Data alarms
Description For patient samples, the calculated concentration is less than the lower limit of the
expected value range.
For control samples, a concentration was less than the 3 SD values entered on QC >
Install.
Over.E
Alarm Overflow
Cause Wrong calibrator. The data contains more than six digits (including a negative sign
and decimal point).
Remedy Minimize the difference in concentration between the sample and the calibrator.
ReagEx
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10 Data alarms cobas e 411 analyzer
Data alarms
Reag.F
Alarm Assay reagent film detected; Diluent film detected; Pretreatment film detected
Remedy Remove foam or air bubbles with an applicator stick and rerun the affected sample.
Reag.H
Cause A premature LLD signal was detected during reagent pipetting, causing the S/R probe
to hover over the reagent pack.
Reag.S
Cause o There is no reagent in the reagent pack, the assay reagent volume is insufficient.
o The diluent volume is insufficient.
o The pretreatment volume is insufficient.
Remedy 1 Verify that reagent, diluent, and pretreatment volumes are adequate. Replace the
low reagent, if necessary, and perform a reagent scan after the replacement.
2 If adequate reagent volumes are present, verify volumes on the Reagent screen.
3 Resume operation and rerun the sample.
4 If the alarm recurs, call Technical Support.
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cobas e 411 analyzer 10 Data alarms
Data alarms
Reag.T
Description Reagent rotor temperature is out of range. The system performs an initial check 30
minutes after start-up and checks the temperature continuously thereafter.
Samp.C
Remedy 1 Check sample volume, and fill the required volume in the sample container as
necessary.
2 Check the sample for fibrin. Remove any clots.
3 Rerun the sample.
Samp.S
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Operators Manual Version 1.0 D-45
10 Data alarms cobas e 411 analyzer
Data alarms
SLLD.E
Description The S/R probe does not start liquid level detection (LLD) or LLD is not completed.
Remedy 1 Clean and dry the S/R probe, and resume measurement.
2 If the alarm recurs, call Technical Support.
SLLD.N
SysR.S
Description Liquid short signal is detected, or the liquid level cannot be detected in the ProCell
reservoir.
Cause The volumes in the system reagent bottles (ProCell and CleanCell) are insufficient.
Remedy 1 Check levels in ProCell and CleanCell bottles, and replace as necessary.
2 Resume operation and rerun the sample.
3 If the alarm recurs, call Technical Support.
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D-46 Operators Manual Version 1.0
cobas e 411 analyzer 10 Data alarms
Data alarms
SysR.T
Description ProCell/CleanCell temperature is out of range. The system performs an initial check
30 minutes after start-up and checks the temperature continuously thereafter.
Remedy 1 Check the fans at the rear are operating normally and are free of obstructions.
2 Check that room temperature is between 18C and 32C.
3 If the alarm recurs, call Technical Support.
SysR.U
Remedy ProCell and CleanCell must be at 28C before operation. Either bring the reagent to
temperature, or place it on the analyzer approximately 15 minutes before operation.
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10 Data alarms cobas e 411 analyzer
Data problems without an alarm
Remedy Avoid leaving the sample in the sample cup for a long time.
Erroneous operation
Remedy 1 Carry out preliminary or periodical check according to the specified procedure.
2 Eliminate fibrin or dust. Be sure to check the sample and reagent before setting
them.
3 Use the recommended sample container.
Poor reproducibility
Remedy 1 Carry out daily checks and periodic maintenance according to the specified
maintenance procedure.
2 Set a new reagent pack.
3 Set new ProCell or CleanCell bottles.
4 The water quality must be 10 S/cm (microsiemens per cm) or less.
5 Use the recommended reagent handling.
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cobas e 411 analyzer 10 Data alarms
Instrument problems without an alarm
Remedy 1 If the sample has been loaded for more than two hours, repeat the analysis with a
fresh sample.
2 Set a new ProCell/CleanCell bottle.
3 Use the recommended reagent, control and standard handling.
Cause o Intrusion of air bubbles into S/R or sipper syringe (poor reproducibility).
o Liquid leakage from the sample or reagent syringe coupling (poor
reproducibility).
o Deterioration of ProCell or CleanCell.
o The electrode of the measuring cell is contaminated or has deteriorated (high
value or low value).
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Instrument problems without an alarm
Roche Diagnostics
D-50 Operators Manual Version 1.0
Appendix E
11 Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3
cobas e 411 analyzer 11 Appendix
Table of contents
Appendix
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Operators Manual Version 1.0 E-3
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Table of contents
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Operators Manual Version 1.0 E-4
cobas e 411 analyzer 11 Appendix
Table of contents
Day______________Month______________Year__________
Customer information
Account number or customer ID number
Contact name and telephone number
General information
Instrument serial number
Description of the problem, including relevant
alarm(s) and alarm code numbers
When the problem first occurred (for example, after
reagent pack lot change)
Whether the problem was observed with just one
system or with all systems
Copies of the original instrument printouts (send by
fax or e-mail)
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Operators Manual Version 1.0 E-5
cobas e 411 analyzer 11 Appendix
Table of contents
Roche Diagnostics
Operators Manual Version 1.0 E-6
Glossary F
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cobas e 411 analyzer Glossary
2-dimensional barcode -AssayCup disposal opening
Glossary
This glossary is a compendium in which to look up the aliquot Portion of sample material pipetted into any
meaning of technical terms used in conjunction with the secondary cup.
cobas e 411 automatic analyzer.
alphanumeric sorting The listing of information, in a
printout or on a screen, in a pre-defined order by letters
Numbers
or numbers.
2-dimensional barcode A type of barcode on reagent analyte The constituent in the sample that is to be
packs, calibrators, and control barcode cards or sheets. determined.
These matrix barcodes, which use PDF417 symbology,
contain more information than traditional linear analytical instrument A device or a combination of
barcodes. devices used to carry out an analytical process.
air purge The removal of air from the hydraulic tubing arbitrary units A result classification using 1+, 2+, and
between the probes (reagent or sample) and their 3+ classes instead of numerical concentration results.
respective pipetters.
ASCII Abbreviation for American Standard Code for
alarm A visual or audible operator notification of any Information Interchange. A character code used by most
system irregularity. computers.
alarm code The classification number for an alarm. aspiration station A position located next to the
Each alarm has a major classification code and a minor incubator where an AssayCup containing the reaction
classification code. mixture is placed for aspiration into the measuring cell
by the sipper probe.
ALARM global button A button used to display the
Alarms global menu. Detailed information is displayed in assay 1. A specific test.
the Detail window. 2. The process of measuring a substance.
alarm level A level that identifies the source and AssayCup A plastic vessel that is used to hold the assay
severity of a problem. There are five levels: data alarm, reaction mixture. An alternative term is reaction vessel.
warning, sampling stop, stop, and emergency stop. A
system uses the alarm levels to determine how to respond AssayCup disposal opening 1. One of two openings
to any problem that generates alarms. to the right of the incubator where used AssayCups are
disposed into the solid waste tray.
A-Line A section of the input buffer where samples or 2. The opening to the left of the incubator where used
racks are placed for processing. AssayCups are disposed into the solid waste tray.
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Operators Manual Version 1.0 F-3
Glossary cobas e 411 analyzer
AssayTip -BC
AssayTip A disposable pipette tip made of black, backup operation A function that performs
conductive plastic. AssayTips are used by the sample/ measurement by using only analysis unit when a trouble
reagent (S/R) probe. occurs in the rack sampler and a rack cannot be
conveyed.
assigned value (Roche-defined) Roche-defined
concentration for calibrator material that is encoded on bandwidth 1. A network's capacity to carry data.
the calibrator barcode card or transfer sheet. 2. Also used in optics to characterize a photometer.
See also target value.
barcode A numeric or alphanumeric code used on
ASTM Abbreviation for American Society for Testing sample tubes, racks, and reagent packs to identify the
and Materials, a US organization that develops and samples, racks, and reagents. Different barcode standards
proposes industry standards. are available. See also barcode type.
ASTM protocol A host interface protocol according to barcode card A card bearing a barcode that encodes
the American Society for Testing Materials standard. either assigned values (calibrator card) or target values
and ranges (control card) for assays.
automatic calibration 1. Automatic time-out
calibration. A calibration of a parameter performed if a barcode labeler A pre-analytical instrument or
specified time interval expires. The calibration can be module for the automatic labeling of sample tubes.
defined for each method separately.
2. Automatic calibration after bottle or lot exchange. A barcode mode The operational mode when a system is
calibration performed if a new bottle or lot is registered. configured to operate using barcoded samples.
The calibration can be defined for each method
separately. barcode reader The device that reads the code from
3. Automatic calibration on QC failure. A calibration sample or reagent barcode labels or reagent pack
request is generated by the system if a QC value is outside barcodes. This term also applies to handheld barcode
a pre-defined range. The calibration can be defined for readers.
each method separately.
barcode scan The process of reading barcode
Automated Download (ADL) A service that provides information into the memory of an instrument.
the information necessary for analysis, for example
analytical parameters or concentration information from barcode type Typical sample barcode types used in the
the data center. ADL is a cobas TeleService application. IVD industry are Code39, NW7 (Codabar), ITF, and
See also TeleService. Code 128.
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F-4 Operators Manual Version 1.0
cobas e 411 analyzer Glossary
BC card scan -calibration trace
BC card scan A scan to read the information from the button A button is found on a screen or pop-up
two-dimensional calibrator barcode card or control window. It can be touched either to initiate an action or
barcode card. to move to a different screen.
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Operators Manual Version 1.0 F-5
Glossary cobas e 411 analyzer
calibration type -cobas Link data station
calibration type 1. The kind of standard solution used check digit A verification number used in barcodes
in calibration including 1-point, 2-point, span, and full. and software.
The factors updated differ depending on which type of
calibration is performed. check sum The result of a mathematical procedure to
2. In electrochemiluminescence: lot calibration (L-Cal) validate the integrity of a set of data.
or reagent pack calibration (R-Cal).
3. In clinical chemistry: bottle or cassette calibration. circuit breaker 1. The main power switch on the
instrument. It controls the power to the Peltier elements
calibration validation Analysis, performed by and, consequently, controls the temperature in the
software, to check a calibration data set against specific reagent rotor, incubator, and measuring detection unit.
criteria encoded in a reagent barcode. Calibration 2. A switch that controls power to the Peltier elements,
validation results are: successful or failed. thereby controlling the temperature in the reagent rotor,
incubator, system reagent compartment, and measuring
calibration verification A procedure required by cell
HCFA and CLIA. Calibration verification is the assaying
of calibration materials in the same manner as patient CLAS 2 Clinical Laboratory Automation System,
samples to confirm that the calibration of the instrument second generation.
kit or test system has remained stable throughout the
laboratory's reportable range for patient test results (for CleanCell An auxiliary reagent used to rinse the tubing
example, Elecsys CalChecks). system and measuring cell after each measurement and
condition the electrodes in the measuring cell.
calibrator 1. A material of known composition or
properties that can be presented to the analytical cleaning solution See wash solution.
instrument for calibration purposes.
2. The test portion or test solution used for calibration of Clean-Liner A disposable liner used in the solid waste
an analytical procedure. tray of Elecsys 2010/cobas e411.
calibrator code The identification number of the client/server A network in which computer processing
standard solution in calibration measurement. is distributed among many individual PCs (clients) and a
more powerful, central computer (server).
capacitance The property of an electrical non-
conductor that provides the basis for liquid level C-line The transport line that receives racks from the B-
detection in the S/R (sample/reagent) probe and sipper Line via the output buffer.
probes. The probes carry a high-frequency, low-voltage
electrical charge. Frequency and electrical charge clot detection 1. A device built into the pipetting
characteristics are altered and sensed when the probe system to detect clots and to avoid false pipetting.
touches liquid. 2. The procedure of detecting a clot.
CapTwist An opener to aid the manual removal of cobas A modular range of in vitro diagnostics systems
ProCell and CleanCell bottle caps. from Roche Diagnostics/Hitachi High-Technologies.
carryover A process by which materials are carried into cobas e pack The name given to a reagent cassette
a reaction mixture where they do not belong. used on cobas e systems and Elecsys systems.
CC Abbreviation for clinical chemistry and for cobas Link The infrastructure of network connections
CleanCell that enables cobas TeleService to exchange information
between the Roche service network and a customer's
cell holder A container holding the electrode in the laboratory.
electrode measurement unit.
cobas Link data station A specific desktop computer,
channel 1. The number of reagent positions on an located in the laboratory, that has been configured to act
analytical instrument. as a gateway between Roche systems and the Internet. As
2. A specific reagent position. well as providing a communication link, the data station
also stores data and documentation for assay processing
and can provide a data archive.
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cobas e 411 analyzer Glossary
cobas TeleService -data disk
cobas TeleService The set of software applications control material A material used to assess the
that use cobas Link to exchange service information performance of an analytical procedure or part of an
between Roche service network and a customer's analytical procedure. Also called the control sample.
laboratory. cobas TeleService provides remote
monitoring and diagnosis, hotline support, and software control name The name of a control material, for
and documentation updates. example PreciControl Universal.
Code39 A barcode type for sample tubes that can be control SD value The acceptable variation SD value of
read by the barcode reader. a quality control sample.
coefficient of variation A statistical measure used to control unit An external PC or printer by which an
describe imprecision. Often abbreviated to CV. analytical system is controlled. The control unit also
serves as the user interface.
communication The exchange of data between
different computers. correction item A function that corrects the
measurement result of one item by using figures or the
compensated test A test that has the result modified measurement result of other tests.
by a formula that takes account of known or defined
interference factors. CPU The Central Processing Unit of the system or
computer.
competitive principle One of three test principles that
can be applied to ECL immunoassays. It is used to detect cross-reactivity The reaction of an antibody with an
analytes of low molecular weight (for example, FT3). antigen other than the one that elicited its formation as a
See also bridging principle, sandwich principle. result of shared, similar, or identical antigenic
determinants.
Complete A sample status found on several screens
indicating that all requested determinations have been CSF Abbreviation for cerebral spinal fluid. A sample
completed. type for clinical analysis.
conditioning The process of letting serum-type liquid cumulative QC The accumulated data and associated
flow through the flow path before electrolyte statistics of individual QC data.
measurement.
cup-on-tube The placement of a smaller secondary
consumables A generic term for items that are used sample container (for example a Hitachi Cup) on top of a
during test processing and must be replaced on a regular primary sample tube.
basis by the operator. Examples of consumables include
AssayCups, printer paper, and reaction cells. CV See coefficient of variance.
consumables area The area of an analyzer where the cycle The instrument time interval during which
consumables, such as AssayCups and AssayTips, are pipetting or measurement can be carried out.
stored.
cyclic QC Controls run at fixed intervals.
container See sample container.
D
continuous access The instrument function that
enables an operator to permanently access the sample
loading area of an analyzer. DAT Abbreviation for Drugs of Abuse Testing. The
abbreviation DAU is also used.
continuous loading/access The ability to load (or
unload) sample or reagents at any time. data alarm An alarm that occurs if a measurement
result or calibration result is abnormal.
control ID The abbreviated name for a control
material, for example PC U1 or PC TSH. Control IDs are data disk 1. The floppy disk or Zip Disk used to store
used on software screens and windows where limited patient data.
space prevents the use of longer names. 2. The floppy disk contains files that enable
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Operators Manual Version 1.0 F-7
Glossary cobas e 411 analyzer
data entry field -dual value method
communication between the analyzer and the user deviation of duplicate measurements See
software. The files might include analyzer-specific duplicate limit.
adjustment files, assay reference tables, or calibration
data. Diagnostics The status that is required to perform
system diagnostics and hardware error tracking actions.
data entry field A field on the software screen where a The field service engineer may request a system to go to
user can enter or edit data. Diagnostics mode to perform such procedures. The
system may require initialization afterwards to resume
data field A field on the software screen that contains normal operation.
information. There is no user access to this type of field.
diluent (DIL) A liquid agent used to reduce the
data flags Printed or displayed alarms or flags that concentration of a sample in electrolyte measurement.
indicate unusual reaction or instrument conditions, for
example insufficient sample or reagent or substrate dilute waste solution A waste solution resulting after
depletion rinsing with water.
database A defined section of the computer memory dilution factor A software preset or manually assigned
where all instrument, assay, and patient-relevant data are dilution ratio that is used by the analyzer to perform a
processed and stored. requested dilution.
database management system A software system disk position A dedicated position on the reagent or
that provides the necessary procedures and programs to sample disk.
collect, create, organize, store, retrieve, and maintain
databases or data files with security and integrity. dispense The process of adding sample material or
reagents by the pipetter probe into a reaction vessel or
DAU Drug of Abuse in Urine. The old term for DAT or cell
Drugs of Abuse Testing.
dispenser technology A technique in which a rinsed
DB Abbreviation for database. probe transfers reagents into a reaction vessel and the
reagent container is directly connected with the pipetter
DBMS Abbreviation for database management system. probe.
default profile A pre-defined set of tests that the disposable Typically a plastic tip, vessel, or cuvette that
analyzer automatically applies to a sample unless the is discarded after a single use.
operator specifies a different set of tests.
DMS Abbreviation for data management system.
default value A set value registered in advance (initial
setting). document (to ...) The process of printing or uploading
a result report to a LIS.
deionized water supply A device that produces
purified water. down time The period of non-operation between an
instrument failure and the resumption of operation.
demographics Patient-related data such as name, date
of birth, and gender. download The process of receiving data from Roche by
a network link.
detection unit A hardware unit comprising a
photomultiplier tube, Peltier elements, flow-through dual value method A mode of expression of the
measuring cell, magnet drive assembly, and an amplifier control chart in real-time quality control. For X-axis and
circuit board. Y-axis, measure simultaneously the average and the
standard deviation of control of a low value and a high
determination The process of quantifying analytes. value, and display them by X and Y coordinates,
respectively.
deviation A value minus its reference value.
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F-8 Operators Manual Version 1.0
cobas e 411 analyzer Glossary
duplicate limit -functional sensitivity
emergency stop An instrument alarm level that first registration The date and time when a reagent
immediately stops all instrument functions. pack or sample was successfully recognized by the
barcode reader for the very first time
electromotive force (EMF) The physical principle
that provides the basis for electrolyte measurement. fixing knob A screw lid that fixes the reaction disk.
endpoint assay An analytical technique taking flag An identifier used to call an operator's attention to
measurements after a reaction is completed or has been a result.
halted.
float sensor A sensor that detects the surface of
error handling A process during which the analyzer solutions. The sensor position moves up and down
attempts to recover from an error condition (for depending on the surface level.
example, an AssayTip is not picked up from the
magazine). If the analyzer cannot successfully recover front access panel A door behind which the floppy
from error, an alarm is issued and the instrument is disk drive and solid waste tray are located.
halted.
function key 1. An analyzer button that an operator
ESC key The Escape key on a computer keyboard can use to control various analyzer actions (for example,
typically used to close a window in the software. moving specific items), depending on the current
operational mode.
E-stopped A status indicating that the system has 2. Any one of a set of keys (F1 to F12), located along the
performed an emergency stop (E. Stop). This could be top of the keyboard, used to enter a specific command.
due to hardware failure or because any of the safety
devices have requested an emergency stop. The system functional sensitivity The concentration of an analyte
requires either complete power off, or at least at which a pre-defined level of imprecision is obtained.
initialization, to resume normal operation.
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Glossary cobas e 411 analyzer
global action key -Internet
hardware (HW) The mechanical and electrical in vitro qualitative assay A determination outside
components of a computer and its peripheral devices. the living body of constituents of a substance without
regard to quantity.
Het IA Abbreviation for heterogeneous immunoassay.
in vitro quantitative assay A determination outside
HIA Abbreviation for homogeneous immunoassay. the living body of constituents of a substance with regard
to a specified number or amount.
HIS Abbreviation for Hospital Information System. A
computer system that manages the hospital's overall incubator A temperature-controlled aluminum block
information processing. Sometimes also (incorrectly) for AssayCups on cobas and Elecsys instruments.
referred to as LIS (Laboratory Information System).
initial BlankCell procedure The calibration
Hitergent 1. A detergent, with antibacterial properties, procedure for ECL instruments performed by Roche
that can be added to the reaction bath where it acts as a Diagnostics service staff when setting up an ECL-based
surfactant, reducing the formation of foam. analyzer for the first time.
2. A surfactant diluted for use in some cleaning
procedures. Initialization Also known as Initializing. The
operational mode of an analyzer that occurs immediately
home position The position to which a certain part of after switching on and during which the instrument
the instrument returns on reset. The start position of a prepares itself for operation.
mechanism.
input buffer A section of an analyzer where samples are
homogeneous immuno assay (HIA) An analytical loaded by using a rack or rack tray. See also rack loader.
technique employing antigens and antibodies. An HIA
uses assay protocols similar to clinical chemistry without instrument alarm A displayed alarm that indicates an
a bound-free separation (for example, latex assays). unusual instrument condition such as an abnormal
reaction bath temperature or a mechanical malfunction.
host computer 1. A computer used for overall
management and control of the computer network. Instrument Manager Typically, PC-based software
2. A clinical laboratory computer that stores and that controls or supervises one or more analytical
processes patient requests and results. A host is able to instruments.
communicate with analytical instruments.
interface See parallel interface, user interface.
host communication Data exchange with a clinical
laboratory information system (LIS). Internet A publicly available, internationally
interconnected system of computers.
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F-10 Operators Manual Version 1.0
cobas e 411 analyzer Glossary
intranet -master calibration
intranet An access-restricted network used internally in loading capacity The maximum number of samples
an organization. that can be loaded onto the input buffer.
inventory control The real-time monitoring of the local area network (LAN) A computer network
quantities of all consumable items (liquid and solid) on covering a limited area, such as an office or a home.
an analyzer.
log file A set of data, typically stored in the control unit,
IVD Abbreviation for in vitro diagnostics. A diagnostic that traces instrument-related or operator-related
procedure performed outside the living body with activities such as maintenance.
specimen body fluid.
log off The procedure of terminating access to a system.
IVDD Abbreviation for In Vitro Diagnostics Directive. A Also known as log out or logoff. The reverse procedure is
set of rules and regulations laid out by the EU known as log on or log in.
commission to ensure the safety of IVD products.
Log off button A button used to terminate access to a
system. See also log off.
L
log on The procedure of gaining access to a system by
lab automation The process of managing the entire entering a user name and, if required, a password. Also
analytical process with minimal operator intervention. known as log in or logon. The reverse procedure is
known as log out or log off.
LDL Abbreviation for lower detection limit.
See analytical sensitivity. Log on button A button used to gain access to a
system. See also log on.
level detection A check for the availability of sufficient
liquid in a container. lot calibration (L-cal) A mandatory calibration when
a new lot of reagents is introduced to an analytical
LIMS Abbreviation for Laboratory Information instrument.
Management System. See LIS.
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Glossary cobas e 411 analyzer
master curve -onboard
master curve A lot-specific master calibration curve missing value In ECL assays, a calibration quality
(n=5 or 6) measured at Roche Diagnostics using lot- criterion. All calibrator values must be available for a
specific test-kit reagents and master calibrators. The successful calibration.
shape of the lot-specific master curve is characterized by
a four-parameter Rodbard function. The data mode Defined states of operation of an analyzer.
characterizing this curve is stored in the lot-specific
reagent barcode. Lot-specific, calibrator-assigned values monochromatic Absorbance measurement at one
(CalSet-assigned values) are read from the lot-specific (primary) wavelength.
master calibration curve and encoded in the CalSet
calibrator barcode transfer sheet. monotony of curve A calibration quality criterion. All
measured calibrator values must fall in either ascending
Material Safety Data Sheets (MSDS) Documents (sandwich or bridging principle) or descending
that list components of chemical solutions and (competition principle) order for a successful calibration.
precautions for the handling and disposal of the
solutions. multi-wavelength spectrophotometer A
spectrophotometer in which detectors are placed at
mean The sum of values divided by the number of multi-wavelength positions to enable simultaneous light
values. reception.
measuring cell A flow-through device that is used to NaOH-D A detergent used in cell wash and probe wash.
generate light during the ECL detection process.
nipple A part for connecting a syringe and the flow
measuring range See reportable range. path.
message In computing, a defined set of alphanumeric non-barcode mode A mode of instrument operation
data that transfers information from computer to during which the instrument identifies samples by using
computer or from an analytical instrument to the the rack and position numbers.
operator.
normal range See expected values.
microbeads Paramagnetic streptavidin-coated
microparticles used as the solid phase for heterogeneous nozzle A pipe or tube of varying diameter that is used
immunoassays in the Elecsys format. to direct or modify the flow of a liquid or gas.
Microcup A secondary sample cup made by Hitachi nozzle head The cover of the device holding multiple
with a small dead (residual) volume rinse nozzles.
microparticle See microbead. nozzle seal A seal placed between the tube and the
probe to connect them.
microbead mixer A paddle or propeller that
thoroughly mixes the microbead reagent to ensure nozzle tip A tip attached to the end of the nozzle that
resuspension before use. sucks up rinse water remaining after a reaction cuvette
has been washed.
minimum sample volume The smallest volume of
sample required to ensure faultless sample aspiration. In O
practice this is the sum of the residual volume plus the
volume required to assay all requested tests.
onboard 1. A technical device or function that is part of
minimum signal In ECL assays, a calibration quality the analytical instrument and can be used by the
criterion. A pre-defined, assay-specific signal level that instrument at any time.
must be achieved to establish a valid calibration. 2. The availability of reagents and consumables on an
analytical instrument for use at any time.
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cobas e 411 analyzer Glossary
one-way serial processing -plunger
one-way serial processing The sample flow and paramagnetic A property of microbeads that do not
processing along a single, serial process lane that allows exhibit magnetic forces themselves but are capable of
no bypass function and no rerun. becoming magnetic in the presence of a magnet or
magnetic field used with ECL technology.
online help On-screen documentation that a user can
request in a context-sensitive manner and search for any parameters A set of criteria or definitions used to
given term. establish how an assay is performed. Examples of
parameters include sample and reagent volumes and
online support A service that supports the preparation incubation times and temperatures. Such information is
for analysis and maintenance management by typically encoded on reagent barcode labels and cannot
exchanging information over networks. be changed by the operator.
See also TeleService.
password A form of authentication that uses secret
open request See pending requests. data to control access to a resource.
Operate The operational mode during which the patient ID A set of alphanumeric data that
instrument processes samples. unmistakably identifies a particular patient. For example,
a social security number and a sample number.
operating system A software program that controls all
basic functions of a computer (for example, Windows, PC Abbreviation for personal computer.
Linux, and Palm OS).
pending requests Also known as open requests. The
operator The person who uses and controls the results for a sample are partially available; other tests have
analytical instrument or a computer system. not yet been performed or completed.
See also user.
photomultiplier A light-sensitive tube that collects and
operator ID An alphanumeric ID that a system uses to amplifies emitted photons from the ECL reaction and
identify a particular operator. Access levels differ for converts them into an electric signal.
operators, administrators, and service personnel.
photon A quantum of electromagnetic energy, having
order Also called a request. A test selected for a specific both particle and wave behavior, that carries the light
sample or control. emitted from the ECL reaction.
order date/time A field used to maintain the arrival pinch valve A valve that pinches the suction tube and
date and time of an order in the laboratory. The date/ switches the flow path.
time data may be entered manually or transmitted by LIS
protocols. pipette (to ) The process of aspirating and
dispensing sample and reagents performed by an
order ID The sample order identification refers to a appropriate probe.
number of sample tubes (one or more specimen types) of
a given patient collected for a panel of different tests. pipetting station The part of the analytical unit that
Typically, the sample order identification is printed on performs all pipetting-related functions. See also pipetter.
order sheets.
pipetter A device used for pipetting a fixed amount of
output buffer A section of an analyzer to which sample or reagent.
samples are moved on completion of the analytical
process and from which they can be unloaded. pipetter technology A technique used to transfer
See also rack unloader. reagents into a reaction vessel by using a rinsed probe or
a disposable tip. Reagents are aspirated from cassettes,
bottles, or reagent packs.
P
plunger A rod that connects with the drive arm and
parallel interface The interface (Centronics type) moves up or down, depending on the pipetting amount.
through which the analyzer can be connected to an
external printer.
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Glossary cobas e 411 analyzer
pop-up window -quantitative measurement
pop-up window A small screen window that contains prozone The lack of agglutination in an antibody-
additional information or additional options required for antigen mixture where the concentration of antibody is
making entries or decisions. high. The antibody excess leads to the formation of small
complexes that do not clump to form visible
positive displacement Water in the pipetter that is agglutination. Agglutination occurs if the sample is
displaced by the plunger during an aspirate/dispense subsequently diluted. The cobas product range can
cycle. The positive displacement is equal to the amount of identify the presence of prozone phenomena by
sample or reagent that is aspirated or dispensed by the determining the change in test sample absorbance when
probe. additional antigen is added in a separate pipetting step.
post-analytical The sample management process, PSD Abbreviation for Primary Sample Distribution.
typically storage and archiving, after results have been
reported. PSID Abbreviation for Positive Sample Identification.
potentiometric assay An assay in which analytes (for PSM Abbreviation for Pre-Analytic Systems Manager,
example Na, K, or Cl) are measured in millivolts by ion- which is PC-based software in a laboratory environment
selective electrodes. connected to one or more pre-analytic or analytical
devices. A PSM controls the sample flow and offers
Power Up The system status while it is loading extended data management. PSM is not available in the
programs, performing self-checks, and so on. United States of America.
PPID Abbreviation for Positive Patient Identification. pushing spring A part that presses down a seal piece.
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F-14 Operators Manual Version 1.0
cobas e 411 analyzer Glossary
query download -recalibration
query download A communication process between reagent A composition of chemicals used to determine
instrument PC and LIS by which a pre-defined data set is the concentration of substances in body fluid.
transmitted upon request of the analytical instrument.
reagent cap open/close mechanism A mechanism
that prevents evaporation by automatically opening and
R
closing the reagent pack caps before and after reagent
pipetting or operation.
RA Abbreviation for random access.
reagent compartment A temperature-controlled
rack A sample carrier device that holds sample cups or section on an analyzer that holds reagents and diluents.
primary sample tubes (including those for routine
samples, standard and washing solutions, quality control, reagent rotor The device in the reagent compartment
STAT, and rerun samples). The rack enables easy into which the reagent bottles are placed.
transportation on analytical systems and modules.
Different rack types can be distinguished by their reagent rotor cover The cover that closes the reagent
differing colors. compartment.
rack circuit breaker A technical device controlling the reagent rotor position One of the multiple positions
power to the rack sampler unit. on the reagent rotor.
rack ID A barcode (one-dimensional or binary) at the reagent interrupt A function that allows a user to
end of the rack that unmistakably identifies the rack. place reagents on the system while in the Operation
mode.
rack loader Area where the racks to be measured are
set. Fifteen racks can be placed on the rack tray and 15 reagent pack A complete set of physically combined
racks on the input buffer. and ready-to-use reagent bottles for Elecsys assays. The
components of a reagent pack cannot be interchanged
rack pusher arm An arm, located on the A-line, for with another reagent pack.
pushing racks. See also cobas e pack.
rack sampler A sample-handling device that presents reagent pack calibration (R-cal) The calibration
sample tubes in racks to the analytical unit. performed when a reagent has been onboard the analyzer
more than 24 hours or when generated by an operator-
rack tray A device for carrying many racks and setting released calibration. A reagent pack calibration is valid
them in a rack sampler. for one specific assay.
RAM Abbreviation for random access memory. reagent pack number A unique number on the
Semiconductor memory devices used in computers. reagent bottle label that identifies each reagent pack.
RAM content gets lost when a computer is switched off.
reagent probe The probe used to transfer or pipette
random access The ability of an analytical instrument reagents from the reagent bottles to the reaction cells.
to process requests from a patient sample in any order.
reagent probe rinse station The area located
rate assay A determination in which measurements between the reagent rotors and reaction disk where
are taken as the reaction proceeds. The rate of the reagent probes are rinsed both internally and externally
reaction is proportional to the sample component being with water.
analyzed. Also known as a kinetic assay.
reagent scan A scan of the reagent rotor to read
raw data The unprocessed values obtained during the information from the reagent barcode into the analyzer
analytical process on an instrument (for example mVolt and to update the inventory.
or absorbance).
real time The display of information on the monitor at
reaction mixture The mixture of reagents and sample the very moment a change to such information occurs.
material.
recalibration The repetition of a calibration.
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Glossary cobas e 411 analyzer
reflex testing -sample ID
reflex testing A request for additional testing based on RSP module The restopper module of MODULAR
customer-defined algorithms or rules and previous test PRE-ANALYTICS.
results.
ruthenium A rare metallic chemical element of the
repeat The performance of the same test on a sample platinum group that is employed in
again under unchanged conditions. electrochemiluminescent (ECL) reactions.
repeat limit A user-definable limit at which a test is run ruthenium complex [Ru(byp)32+] N-
again under unchanged conditions. hydroxysuccinimide (NHS) ester. This chemical complex
is employed in the ECL detection technology.
reportable range The range of results that can be
reported for the assay. It stretches from the lower
S
detection limit to the high end of the calibration curve.
rinse station A technical device that cleans disposable sample cup A small container that is used for samples
tips or probes with deionized water or cleaning solutions and also for calibrator and control material. A sample
to avoid contamination and carryover. cup can be placed either on specific racks, other inserts,
or on sample tubes. Compared to a sample tube, a sample
Rodbard function A mathematical algorithm used to cup allows the use of smaller liquid volumes and so
convert measured signals into concentrations. It uses reduces the residual volume.
four parameters to define the shape and the position of
the calibration curve. sample disk A rotor into which sample containers are
placed.
ROM Abbreviation for read-only memory.
Semiconductor memory devices used in computers. sample ID A set of alphanumeric data that
ROM content remains when a computer is switched off. unmistakably identifies a particular sample.
See also patient ID.
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sample probe -solid waste tray
sample probe The rinsed probe used to transfer secondary tube A sample container of variable size
sample material from the sample disks to the reaction into which aliquots are transferred
cells.
sequence number A number automatically assigned
sample scan A scan of the sample disk to read the to each sample by the analyzer and used to track samples
information from the primary sample tubes into the and orders.
analyzer.
serum index A function by which the absorbance
sample splitting The act of making one or more characteristics of the samples are described to assess the
aliquots from a primary or secondary specimen. presence of lipemia, hemolysis, and icterus.
sample tray See sample disk. serum work area (SWA) The section of a clinical
laboratory where all CC, HIA, and HetIA tests (including
sample tube A glass or plastic container for liquid pre-analytical and post-analytical work) are processed.
samples to be used with the system. It may or may not
have a barcode label, which may be used for positive Service The status that is required to perform a
sample identification. A sample tube contains sample of maintenance action. See maintenance item, maintenance
one specific specimen (sample) type. procedure.
sample type One of four types of sample that can be shutdown The process of powering off an instrument.
analyzed: serum, plasma, cerebrospinal fluid, or urine.
The sample volume and normal value are settable for shutter A door, located on the lid of the reagent rotor,
each type. that is used to load and unload cobas c packs (reagent
cassettes).
sampling stop An instrument alarm level that
indicates a problem with the sampling system. signal The emission of light converted into an electrical
See also S.Stop. signal that is subsequently converted into an analyte
concentration.
sandwich principle One of three test principles that
can be applied to ECL immunoassays. It is used to detect sipper arm A horizontally moving arm that holds the
higher molecular weight analytes, such as TSH. sipper probe.
See also bridging principle, competitive principle.
sipper pipetter A device, filled with deionized water,
scan See barcode scan. that uses positive displacement to aspirate and dispense
from the sipper probe.
scroll The action of moving through text or graphics
(up, down, left, or right) to see parts of the file or list that sipper probe The probe that aspirates reaction mixture
cannot fit on the screen. out of the AssayCup into the measuring cell. This probe
also aspirates ProCell and CleanCell.
scroll arrow An arrow on either end of a scroll bar that
you use to scroll through the contents of the window or Sleep mode Also called sleeping. A mechanical and
list box. electrical status of an analytical instrument during which
no immediate processing can be initiated by the operator.
scroll bar A bar that appears at the bottom or right
edge of a window whose contents are not entirely visible. software A computer-operated program that processes
Each scroll bar contains a scroll box and two scroll data in a defined manner. Software is usually intellectual
arrows. property of the software supplier or its licensee.
scroll box In a scroll bar, the small box that shows the solid waste compartment A metal waste container
position of information currently in the window or list holding a liner that collects discarded solid waste.
box relative to the contents of the entire window.
solid waste tray A metal waste container holding a
SD Abbreviation for standard deviation. liner that collects discarded solid waste.
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standard -tip
standard Traceable reference material used to create the SysClean An auxiliary reagent used for the periodic
master calibration curve. cleaning of the measuring cell.
standard deviation A statistic used as a measure of the system cleaning solution See wash solution.
dispersion or variation in a distribution of data.
system error 1. A calibration quality criterion that
standard rack A standardized transportation device originates from a hardware failure while a calibration
for a maximum of five sample containers on Roche measurement is performed.
Diagnostics/Hitachi High-Technologies instruments. 2. The general term for a case of instrument-related
problems.
standard tray A metal device that holds and carries
multiple standard racks and that can be placed directly in system reagent A non-test specific reagent that is
the sample reception area of an analyzer. needed to perform testing on an analyzer.
Standby An operational mode of the analyzer during systematic error An error that is generated by a cause
which power is on but no sample analysis or maintenance giving deviation to measured values. An alarm generated
procedures are being performed. when control of a low value or a high value is changed in
the same direction in real-time quality control.
Start button A button used to start system operation
(Operating status) and begin the pipetting of samples, SysWash A system-specific agent used to avoid reagent
measurement, and the result calculation process. carryover. It also prevents bacterial growth.
STAT port Special entry area for STAT samples, which test code The abbreviated name for a test. This code is
will be processed with priority. displayed on test buttons shown on software screens or
windows.
STAT sample Emergency sample. Results should be
available within shortest possible time. See also STAT. test principle A technique that serves as the basis for
designing an assay to detect or quantify analytes.
status A general term used to refer to the current status
of the system. Explicit terminology may be used to test protocol The sequence of test steps used to
address sub-parts of the system status (such as analyzer perform an assay (for example, volumes and timings).
status and printer status).
text box A box, on a screen, where a user can type
stop barcode A special barcode used on disk systems information or a command.
to halt sample scanning.
time-out calibration An instrument mode that
STOP button A button used to immediately stop all automatically generates a calibration request after a pre-
system operations, including test processing functions. defined interval.
The system may need special attention to resume its
normal operation state. tip See AssayTip.
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tip eject station -web tunnel
tip eject station An opening in the instrument user The person who operates and controls the
housing through which AssayCups and AssayTips are analytical instrument or a computer system.
discarded. See also operator.
touch screen An input device that allows the user to user interface The part of a system exposed to a user.
interact with the computer by touching the display In a computer system, the user typically interacts with an
screen. operating system or with application software. With
these the user interacts by using menus, icons, keystrokes,
transaction The smallest unit of interaction between mouse clicks, and similar means.
the two computers. One computer (a host computer or
Instrument Manager) sends a message and a receiving
V
computer returns a reply.
tray A container used to collect a number of racks for validation The process of checking results or data
easier handling (such as Hitachi trays 75 or 150). against defined rules or ranges in clinical laboratories.
Validation can be against technical or clinical criteria.
tray indication light A light, at the left side of both the
A-Line and C-Lines, that indicates the mode of vessel See AssayCup.
operation.
vial A small sample container with flip-top lid, mainly
trend An upward or downward tendency in data values used for calibrator and control material.
after the exclusion of the random error and cyclic effects.
virtual private network (VPN) A way of using a
tripropylamine (TPA) One of two electrochemically public telecommunication infrastructure, such as the
active substances used in the ECL reaction. Internet, to provide remote offices or individual users
with secure access to their organization's network.
turn-around-time 1. The time between the decision to
perform a test and the time when the doctor receives the W
result and can act on it.
2. Inside the laboratory (Lab-TAT): Time between
receiving a sample and sending out the validated result. WAM Workarea management: PC-based software that
controls and monitors sample tracking and offers
two-way processing A type of sample flow allowing extended data management for a defined workarea in a
two directions, typically a main lane to feed analytical clinical laboratory environment.
modules with samples and a return line to handle rerun
and reflex testing. waste Anything discarded by the analyzer; waste can be
liquid or solid.
U waste solution reservoir Container that collects
reaction waste.
ultrasonic unit A mechanical unit, in a waterproof
pack, that generates ultrasound used to stir samples. water level sensor A sensor that monitors the water
level of temperature-controlled water.
unit A chosen reference quantity of an analyte used to
compare quantities of the same dimension (for example, water supply tank A tank used to store ion-exchanged
mol/L, g/L, or U/L). water.
unloader The output buffer. An unloader holds racks water supply tube A tube for connecting a water
after the completion of the analytical process. supply tank and an analyzer.
upload The process of sending data to Roche by a web tunnel A web service that transports encrypted
network link. data from a company network to a dedicated server
application outside of the network.
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window -workarea consolidation
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Index
Symbols
<SigL (data alarm), D-37 replacing, B-30
<Test (data alarm), D-37 tray positions, A-90
>AB (data alarm), D-36 Assigning
>Curr (data alarm), D-36 calibrator positions, B-104
>Test (data alarm), D-37 control positions, B-104
Automatic Printout area options, B-85
A
B
AB level check error (data alarm), D-38
AB level range over (data alarm), D-36 Barcode card reading station, A-84
AB.E (data alarm), D-38 Barcode cards, calibrator, A-49
Abbreviations, 10 Barcode labels
Abnormal reagent disk temperature (data alarm), D-45 applying correctly, B-94
Access levels, software screens, A-66 calibrator, A-49
Accumulating QC results, B-41 control, A-50
ADC abnormal (data alarm), D-38 reagent, A-46
ADC.E (data alarm), D-38 Barcode readers
Administrator logon, A-66 rack, A-83
Alarm screen sample, A-80
reviewing, B-17 Barcodes
Alarm types, D-5 supported symbologies, A-41
Alarms, issued by the system, B-17 use of check digits, A-13
A-Line (of rack sampler), A-74 B-Line (of rack sampler), A-75
Analyzer Boxes
components, A-71 list, A-63
dimensions, A-37 text, A-64
safety labels, A-18 Bubbles, in syringes, D-23
troubleshooting, D-14 Buttons
unit, A-30 global, A-65
Analyzer compartments options, A-64
cleaning, C-36, C-39 standard, A-64
removing condensation, C-14 types, A-64
Approvals, instrument, 2
Approved parts, A-13, A-23 C
Archiving sample data, B-99
Assay calibration, troubleshooting, D-25 Cal.E (data alarm), D-38
Assay reagent film detected (data alarm), D-44 Calc.? (data alarm), D-39
Assay reagent hovering (data alarm), D-44 Calc.Test Error (data alarm), D-41
Assay reagent short (data alarm), D-44 Calculated tests, programming, B-115
AssayCup trays Calculation not possible (data alarm), D-39
replacing, B-30 Calibration
troubleshooting, D-18 assay troubleshooting, D-25
AssayCups measuring, B-36
disposal opening, A-91 performing, B-32
inventory, B-20, B-21 validating, B-38
tray positions, A-90 Calibration result abnormal (data alarm), D-38
AssayTip trays Calibration settings, changing, B-118
replacing, B-30 Calibration/QC Load List
troubleshooting, D-18 in daily operation, B-23
AssayTips loading calibrators, B-32
inventory, B-20, B-21 loading controls, B-32
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License, 3
G
Liner
Global buttons, A-65 See, Clean-Liner
Gripper unit, A-90 Liquid flow path cleaning, C-22
Guidance prompt, A-61 Liquid waste
container, A-92
H direct drain, A-93
specifications, A-40
H (data alarm), D-42 Liquid waste container
Help checking, B-27
See, Online Help cleaning, C-33
Host interface, A-59 List boxes, A-63
Load list, reagents, B-23
I Loading
calibrators, B-32
IEC 61010 (noise levels), A-39 consumables during operation, B-79
Inc.T (data alarm), D-42 continuous, using multiple disk mode, B-62
Incubation, specifications, A-43 continuous, using rack systems, B-62
Incubator temperature (data alarm), D-42 continuous, using single disk mode, B-60
Incubator, description, A-97 controls, B-32
Input buffer (of rack sampler), A-74 Logging on, B-16
Inserts, package, A-47 Low signal level (data alarm), D-37
Installation, safety precautions, A-8
Installing
non-Roche controls, B-107
M
Roche controls, B-106 Main circuit breaker, A-35
Instrument Maintenance, C-3
approvals, 2 as needed, C-30
dimensions, A-37 cleaning liquid waste container, C-33
troubleshooting, D-11, D-14 cleaning reagent rotor/compartment, C-39
Instrument factor A reset (data alarm), D-42 cleaning the CleanCell compartments, C-36
Intended use, 2 cleaning the microbead mixer, C-35
Interface cleaning the ProCell compartments, C-36
host, A-59 cleaning the rinse stations, C-19
USB, A-58 cleaning the sample/reagent probe, C-12
Inventory cleaning the sipper probe, C-15
AssayCups, B-20, B-21 daily, B-87, C-12
AssayTips, B-20, B-21 emptying the solid waste tray, C-42
CleanCell, B-20 every two months, C-24
ProCell, B-20 every two weeks, C-19
solid waste, B-20 finalization maintenance, C-30
Inventory area, B-20 items, C-6
liquid flow path cleaning, C-22
K performing, C-6
procedures, C-5
Keyboard protecting the measuring cell, C-44
See, Software keyboard replacing the pinch valve tubing, C-24
Kits weekly, C-15
calibrator, A-48 Maintenance log, C-9
controls, A-50 Maintenance schedule, C-8
reagent, A-46 Measurement range
lower (data alarm), D-37
L upper (data alarm), D-37
Measurements, troubleshooting false values, D-24
L (data alarm), D-43
Labels, reagent barcode, A-46
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Waste, solid
emptying, B-29
inventory, B-20
Water container, system, A-92
Water supply, requirements, A-40
Weekly maintenance, C-15
Windows
confirmation type, A-66
description, A-66
Work Flow Guide, preventive action, B-22
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Notes H