AIA1800 Operator Manual

AUTOMATED ENZYME IMMUNOASSAY SYSTEM
Operators’ Manual
Revision 5
TOSOH CORPORATION
BIOSCIENCE DIVISION
AIA-1800
Version Overview Operator’s Manual
AIA-1800
Version Date Amendments

1 Original manual
2-4 Only applied in Japan
5 08/2008 See overview 08/2008
08/2008
Chapter Paragraphs
2 2.3
3 3.4
6.2
6.2.1
6
6.5.7
6.10.2
8 8.3.1
9.4.1.1
9
9.4.1.2
12.5.1
12
12.7.3
13 3003
1
About This Manual
This Operators’ Manual is designed to ensure that users can operate the AUTOMATED ENZYME
IMMUNOASSAY SYSTEM AIA-1800 safely and correctly.
This manual is geared to you who have acquired all the technical qualifications required for working with the
AIA-1800 system
It is recommended for you to carefully read and familiarize yourselves with the information in this manual
and operate the AIA-1800 system in strict accordance with the instructions provided.
Keep this manual in a safe, easily accessible location for reference purposes.
All safety precautions outlined in this manual must be strictly adhered to.
This material presented is subject to change without prior notification due to ongoing enhancements to
system performance and functionality.
Be sure to include this manual whenever selling or relocating the AIA-1800.
Should you notice any discrepancies, errors or omissions in the information provided, you are requested to
immediately notify the nearest Tosoh service center or local representative.
Transfer or copy, in whole or in part, of the information contained in this manual is strictly forbidden.
TRADEMARKS
Microsoft, Windows and Windows XP are globally registered trademarks of Microsoft Corporation. (USA). Other
product and company names mentioned in this document are the registered trademarks of the respective
companies.
Safety Precautions
SAFETY PRECAUTIONS
Preface
It is recommended that you read carefully and familiarise yourselves with the following safety
precautions to ensure safe and correct operation of the AIA-1800 analyzer.
The information displayed using “Warning” and “Caution” signs in this manual is provided for
the purposes defined below.
Caution Indicates a hazard with a low level of risk which, if not avoided,
could result in minor or moderate injury.
Warning Indicates a hazard with a medium level of risk which, if not

avoided, could result in death or serious injury.
Installation Precautions
Warning
● Connect System to Suitable Power Source
● Be sure to connect the AIA-1800 to a power source with a sufficiently high power rating
that is free of voltage fluctuations.
● Power sources that have an insufficient power rating or significant fluctuations in voltage
pose a potential fire hazard.
● Carefully Check Ground Connections

● Failure to properly ground the system is a potential source of electrical shock.
● Be sure to connect the analyzer to a locally validated power socket.
● Grounding the system helps to both prevent system malfunctions due to noise and to
reduce the chance of electrical shock.
● Do not connect the system ground line to gas pipes, water pipes, lightning rod lines or the
telephone system ground line.
Gas pipes can ignite fires and cause explosions
Water pipes are not an effective ground
Lightning rod and telephone lines are a potential source of danger when lightning
strikes
I
Safety Precautions
Caution
● Select Installation Site with Care
● Refer to Chapter 3: System Installation in this manual to select a suitable site for
installation of the AIA-1800 system. Always notify a Tosoh service center or local
representative when installing or moving the AIA-1800 system.
● Avoid Modifying Power Cables, Using Insufficiently Rated Extension Cables or

Power Distribution Adapters
● These are potential sources of electrical shock or even fire.
● Always select extension cables that have a sufficiently high power rating and that have a
ground line.
● Confirm Plug Is Free of Dust or Dirt and Insert Firmly Into Socket
● Be sure to remove and inspect the power plug several times a year.
● Contamination by dust and/or foreign matter, failure to fully insert the plug into the socket
or a loose connection may result in electrical shock or fire.
Precautions for Use
Warning
● Handling Biohazards With Care
● Only personnel with sufficient knowledge of immunological assay techniques and the
procedures for handling infectious waste materials should be allowed to operate the AIA-
1800 system.
● There is always the possibility that blood and body fluid may have been contaminated by
infectious agents. Mistakes in system operation and handling of such materials can result
in the transmission of infectious agents to the system operator and/or to nearby
personnel. It is recommended that all specimens be handled with the utmost of care and
that the proper protective clothing (goggles, gloves, masks etc.) be used at all times
during maintenance procedures.
● All specimen containers, including used reagent cups, sample tips, reagent bottles,
sample cups and waste fluids may have been contaminated by blood and body fluid. It is
recommended that proper protective clothing (goggles, gloves, masks etc.) be worn at all
times and that waste materials be disposed of in accordance with the following directives
and all other relevant laws and regulations to protect all personnel in the general operating
vicinity and the surrounding environment.
II
Safety Precautions
● Avoid Opening Covers or Panels During Assay Operations

● Opening covers or panels during operation exposes moving parts, such as the dispenser
arm, which can cause severe personal injuries, including lacerations and/or the severing
of fingers or hands.
Caution
● Operate Only in Accordance with the Procedures Described in this Manual
● Attempts to operate the AIA-1800 using procedures not prescribed in this manual may
adversely affect the integrity of assay results and cause system malfunctions.
● Preventing Fluid Leaks

● Leakage of assay solutions and wash solutions are potential sources of corrosion,
electrical shock and fire.
● When fluid leakage is discovered, immediately shutdown the system and remove the
power plug. It is recommended that proper protective clothing (goggles, gloves, masks
etc.) be worn at all times when cleaning up leakages, and inspecting and repairing tube
connections that are possible leak sources.
● Should the system continue to leak, contact the nearest Tosoh Service center or local
distributor.
● Immediately Shutdown the System and Remove the Power Plug when Signs of
Malfunction (Burning Smell, Etc.) Appear. Contact the Nearest Tosoh Service Center or
local representative.
● Continuing to operate a system that is malfunctioning may result in electrical shock and/or
fire.
● Avoid Opening Covers or Panels and Inserting Fingers or Any Foreign Material into
Operating Mechanisms.
● The interior of the system is comprised of motor driven components that operate at high
speeds. Foreign objects or fingers and hands can easily get caught in the mechanisms,
resulting in personal injury.
Caution
● Keep Covers and Doors Closed During Operation
● Keep all covers and doors firmly closed during operation. The interior of the AIA-1800
contains various moving parts, high-temperature components and high-voltage circuitry.
Fingers and hands can easily get snared or tangled in the mechanisms, resulting in
lacerations, burns and electrical shock.
● Special precautions must be taken when opening doors to replenish reagent and sample
tip supplies during system operation.
III
Safety Precautions
● Avoid Stopping and Starting System by Simply Inserting and Removing the Power
Plug
● Operating the AIA-1800 system in this way may damage and corrupt data on the hard disk
in the controller PC and is a potential source of electrical shock and fire.
● Whenever closing down the system, be sure to exit the system program using the
Shutdown button, then exit Windows and turn off using the power supply switch located
on the left front of the system.
● Avoid Damaging the Power Supply Cable

● The power cable may be damaged by excessive stretching and bending or anchoring the
cable into place, resulting in electrical shock and/or fire.
● Always remove the power cable from an outlet using the plug.
● Do Not Replace Fuses Yourself

● Always contact the nearest Tosoh service center or local representative when replacing
fuses on various system circuit boards. Do not attempt to replace fuses yourself.
● Blown fuses may indicate electrical circuit failures due to fluid leakage. Thus it is
extremely important to contact the Tosoh service center.
● Avoid Touching System Parts with Wet Hands

● Touching certain system components may result in electrical shock.
● Use Only Trained Maintenance Personnel

● Maintenance work must be performed by personnel with proper knowledge of system
maintenance procedures and who are equipped with proper protective clothing (goggles,
gloves, masks etc.). Physical injuries sustained during maintenance work can result in
infections from specimens. Therefore, it is important that maintenance personnel conduct
work in accordance with the procedures outlined in this manual and only after they have
received sufficient training in maintenance procedures.
● Please feel free to contact the Tosoh service center for information on maintenance
procedures.
● Proper Disposal of Waste Materials

● Take appropriate steps to separate according to type all used materials from assay
operations, including reagent cups, sample tips, reagent bottles, sample cups, specimen
containers and waste fluids, and dispose of them in accordance with designated
procedures. Always wear protective gloves to avoid direct contact with such materials.
● Waste materials must be disposed of in accordance with the following directive and with
relevant laws and regulations to protect all personnel in the general vicinity of the system
and the surrounding environment.
IV
Safety Precautions
Caution
● Always Wear Protective Clothing
● Always wear suitable protective clothing (goggles, gloves, masks etc.) to prevent infection
when working with specimens, waste fluids and system calibration accessories.
● Place Fluid Containers Only in Designated Locations

● Placing solution containers randomly within the main unit may result in spillage, causing
short circuits that can damage electrical insulation and result in electrical shock.
● Use Only Tosoh Designated Components

● Use only accessories and consumables (supplies) listed in the Maintenance Accessories
and Consumables section
● - Avoid Opening the STAT Specimen Door During STAT (Priority) Sampling
● The red STAT door lamp lights up to indicate that a sampling operation is in progress.
Forcing the door open will damage the sampling nozzle and affect the integrity of assay
results.
● Avoid Placing any Source of Flame Near the Substrate Compartment

● It is important not to place any sources of flame near the substrate compartment, as the
substrate line contains 70% ethanol at the end of an assay operation.
Removal of equipment from use for repair or disposal
Warning
● Contact the authorised representative
● Blood to be tested might have been infected by pathogen. Misconduct on repair or
disposal may bring infection to the operator or others working together. In the case of
repairing and disposing, please contact the authorised representative.
V
Safety Precautions
Additional Precautions
● Locations of “Warning” and “Caution” Labels

● Warning labels are located at various positions on the AIA-1800 system. Read these
carefully to ensure safe system operation.
<7>
<2> <3> <1> <6>
<4>
<5>
<8>
<9>
<10>
<1> STAT Compartment Warning Label
A red lamp on the door indicates that a STAT dispense operation is in

progress. Forcing the door open may damage the sampling nozzle and/or
smash the test tubes.
VI
Safety Precautions
<2> B/F Drawer Caution Label
Make sure that system operation has stopped and the power is off before
performing wash probe maintenance. Failure to do so may result in
personal injuries caused by contact with moving parts.
Maintenance procedures should always be performed by trained
maintenance personnel.
<3> Wash Probe Caution Label
Never touch the wash probe while the system is in operation, as this may
affect the integrity of assay results. Doing so may also result in personal
injury caused by contact with moving parts.
The wash probe tip is contaminated by the specimen, so must be handled
with the utmost of care.
<4> Sample Rack Loader Caution Label
Make sure to pause any current assay operations and stop

the sample loader before attempting to add new sample
racks. Note that Sample racks must be positioned in front
of the line or the rack may not load properly.
<5> Substrate Bottle Compartment Caution Label
It is important not to place any sources of flame near the substrate

compartment, as the substrate line is filled with 70% ethanol at the end of
an assay operation and thus there is a danger of fire.
<6> Sorter Drawer Caution Label
Always use the handle when opening and closing the sorter drawer.
Attempting to grasp other parts may result in injuries from your hand getting
caught during opening or closing.
<7> Sample Suction Caution Label
Avoided inserting hands in the sample suction unit, as the descending

sampling nozzle can cause personal injuries.
VII
Safety Precautions
<8> Diluent and Wash solution Tubing Caution Label
Note that the diluent and wash solution tanks are of the same shape and
size.
Be sure to select the one of the correct colour.
Selecting the wrong tank will directly affect assay results.
Max. Pressure: Atmospheric pressure
<9> Waste Box Biohazard Label
Be sure to wear appropriate protective clothing, such as gloves, when

handling the waste box, as discarded cups and tips have been
contaminated by potentially infectious specimens.
<10> Waste Tank Biohazard Label
Be sure to wear appropriate protective clothing, such as gloves, when

handling the waste tank, as waste liquid has been contaminated by
potentially infectious specimens.
● Contact Tosoh Service Center or local representative if the Warning or Caution

labels become difficult to read due to dirt or peeling. Replacement labels will be
sent out.
● Always store this manual in a safe, readily accessible place. Ensure that all new
operators and administrators have access to this manual.
Contact a Tosoh Service Center or Local Representative When Requesting

Repairs
● Improperly performed in-house disassembly, repair and modification work may result
in electrical shock and/or fire.
TOSOH CORPORATION
BIOSCIENCE DIVISION
VIII
Introduction
Introduction
Thank you for purchasing the AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-1800.
This Operator’s Manual is designed to ensure that you can operate the AIA-1800 system safely and
correctly. It is recommended that you read carefully and familiarise yourselves with the information provided
in this manual before operating the AIA-1800 system.
Overview of the Manual
Chapter 1: General Precautions for Use

This chapter provides general precautions for system use designed to ensure the system will operate at
its maximum performance capability. Chapter 1 should be read prior to commencing any system
operations.
Chapter 2: System Configuration and Functionality

This chapter describes AIA-1800 system configuration, features and functionality. Included is an
introduction to the assay principles of the AIA-1800, and an overview of system performance capacities
and limitations.
Chapter 3: System Installation, Transportation, and Storage

Chapter 3 offers a detailed description of various installation requirements, including operating
environment and power supply.
Chapter 4: Overview of System Operation

This chapter describes procedures and precautions that must be observed when loading specimens
and reagents. Be sure to follow the procedures given in Chapter 4 when operating the system.
Chapter 5: Operational Flow

Chapter 5 provides a general overview of system operation, starting with system start-up and finishing
with a description of a typical analysis operation.
Chapter 6: System Operation

Chapter 6 provides detailed descriptions of all aspects of system operation.
Chapter 7: Quality Control Functionality
Chapter 8: Other Aspects of Operation
Chapter 9: Maintenance
Chapter 9 describes the inspection and maintenance procedures required to keep the AIA-1800
operating at peak performance.
Symbol Representation
A peculiarity of the AIA-1800 controller is that it both displays and prints the µ (micro) symbol as well as a
small “u”.
VIII
Introduction
How to Use This Manual
The AIA-1800 manual is organised according to the layout shown below. Use this as reference when
reading this manual.
Section Headings
Sections are divided into Chapter
up to three subsections Number
and Title
Illustrations and Menu

Screens
Used in combination with
the text to provide
precise explanations.
Page numbering by chapter
Point
Key Points provide helpful hints for mastering system operation.
Point
Stop signs warn the potential operational mistakes.
IX
Contents
1: GENERAL PRECAUTIONS FOR USE ......................................................................................... 1-1

1.1. General precautions for use of the AIA-1800 are provided in the following sections.1-1
2: SYSTEM CONFIGURATION AND FUNCTIONALITY...................................................................... 2-1
2.1. System Configuration............................................................................................... 2-1
2.2. Controller PC Configuration ..................................................................................... 2-1
2.2.1. File Configuration ........................................................................................ 2-1
2.2.2. System Files ............................................................................................... 2-2
2.2.3. System Backup ........................................................................................... 2-2
2.3. Specifications ........................................................................................................... 2-3
2.4. Names of Parts ........................................................................................................ 2-5
2.5. Functions of System Units ....................................................................................... 2-6
2.5.1. Analyzer Module ......................................................................................... 2-6
2.5.2. Sorter Module ............................................................................................. 2-7
2.5.3. Operation Control Screens ......................................................................... 2-8
2.6. Solution Flow Plan ................................................................................................... 2-9
2.7. System Functionality .............................................................................................. 2-10
2.7.1. Authorization Level Control ....................................................................... 2-10
2.7.2. Automatic Dilution Function ...................................................................... 2-10
2.7.3. Automatic Pretreatment Function ............................................................. 2-10
2.7.4. STAT Assay Function ................................................................................ 2-10
2.7.5. Automatic Rescheduling Function ............................................................ 2-10
2.8. Operating Modes ................................................................................................... 2-10
2.8.1. Non-Barcode Mode ................................................................................... 2-10
2.8.2. Barcode Mode........................................................................................... 2-10
2.8.3. Host Query Mode ...................................................................................... 2-10
3: SYSTEM INSTALLATION, TRANSPORTATION, AND STORAGE .................................................... 3-1
3.1. Environment of transportation and storage.............................................................. 3-1
3.2. Environment of use .................................................................................................. 3-1
3.3. Power Supply ........................................................................................................... 3-1
3.4. Installation Space..................................................................................................... 3-2
3.5. Standard Accessories .............................................................................................. 3-3
3.6. Registering a System Administrator ........................................................................ 3-3
3.7. Operating Mode ....................................................................................................... 3-3
4: OVERVIEW OF SYSTEM OPERATION ....................................................................................... 4-1
4.1. Installing Wash Solution........................................................................................... 4-1
4.2. Installing Diluent....................................................................................................... 4-2
4.3. Disposing of Waste Solution .................................................................................... 4-3
4.4. Disposing of Discarded Cups and Tips.................................................................... 4-4
4.5. Changing Substrate and Substrate Replacement Solution Bottles ......................... 4-6
4.6. Installing Sample Tips .............................................................................................. 4-7
4.7. Loading Conjugate and SDS ................................................................................... 4-9
4.8. Loading Specimens, Calibrators and Controls into Sample Loader ...................... 4-11
4.9. Loading STAT specimens ...................................................................................... 4-15
4.10. Loading Test cups.................................................................................................. 4-16
5: OPERATIONAL FLOW ............................................................................................................ 5-1
6: SYSTEM OPERATION ............................................................................................................ 6-1
6.1. System Startup ........................................................................................................ 6-1
6.2. Daily Maintenance ................................................................................................... 6-2
6.2.1. Daily Maintenance Checklist....................................................................... 6-2
6.2.2. Maintenance Routine .................................................................................. 6-3
6.2.3. Checklists .................................................................................................... 6-5
X
6.3. Inventory Check ....................................................................................................... 6-7
6.4. Entering Parameter Settings .................................................................................. 6-10
6.4.1. Test File Parameters ................................................................................. 6-10
6.5. Generating Calibration Curves .............................................................................. 6-11
6.5.1. Loading Immunoassay Reagents ............................................................. 6-11
6.5.2. Checking Reagent Lot No. ........................................................................ 6-11
6.5.3. Calibration Request .................................................................................. 6-12
6.5.4. Worklists.................................................................................................... 6-13
6.5.5. Loading Calibrator Solution ...................................................................... 6-13
6.5.6. Scheduling Calibration .............................................................................. 6-14
6.5.7. Reviewing Calibration Results .................................................................. 6-15
6.6. Specimen and Control Assay ................................................................................ 6-18
6.6.1. Loading Immunoassay Reagents ............................................................. 6-18
6.6.2. Checking Reagent Lot No. ........................................................................ 6-18
6.6.3. Entering Assay Request ........................................................................... 6-19
6.6.4. Specimen Sets .......................................................................................... 6-25
6.6.5. Assay Start ................................................................................................ 6-26
6.6.6. Additional Assay Operations ..................................................................... 6-27
6.7. STAT Assay Requests ........................................................................................... 6-28
6.7.1. Entering STAT Specimen Assay Request ................................................. 6-28
6.7.2. Loading STAT Specimens ......................................................................... 6-29
6.7.3. Starting STAT Assay Operation................................................................. 6-30
6.8. Assay Pause/Continue........................................................................................... 6-31
6.9. Assay Monitoring ................................................................................................... 6-32
6.9.1. Assay Monitor ........................................................................................... 6-32
6.9.2. Rack Monitor ............................................................................................. 6-34
6.9.3. Error Messages......................................................................................... 6-35
6.10. Result Review ........................................................................................................ 6-36
6.10.1. STAT Specimens ..................................................................................... 6-36
6.10.2. Specimens .............................................................................................. 6-37
6.10.3. Controls................................................................................................... 6-42
6.11. Retest ..................................................................................................................... 6-43
6.12. Emergency Stop .................................................................................................... 6-44
6.13. Shut Down ............................................................................................................. 6-45
7: MAINTAINING SYSTEM PRECISION ......................................................................................... 7-1
7.1. Levey Jennings Chart .............................................................................................. 7-1
7.2. Registering QC Materials ......................................................................................... 7-3
7.3. Selectable Rules ...................................................................................................... 7-4
8: OTHER ASPECTS OF OPERATION .......................................................................................... 8-1
8.1. Utilities - Test File .................................................................................................... 8-1
8.1.1. Test File ....................................................................................................... 8-1
8.1.2. Changing Reference Range ....................................................................... 8-2
8.1.3. Panel ........................................................................................................... 8-3
8.2. Utilities – Flags and Rules ....................................................................................... 8-4
8.2.1. Flags ........................................................................................................... 8-4
8.2.2. Rules ........................................................................................................... 8-6
8.2.3. Reschedule Panel ..................................................................................... 8-10
8.3. Utilities - Host ......................................................................................................... 8-11
8.3.1. ASTM standard ......................................................................................... 8-11
8.3.2. OpenLA21 Standard (HL7 Ver2.4) ............................................................ 8-13
8.4. Utilities - Specifications .......................................................................................... 8-14
8.4.1. Assay Result Report Settings ................................................................... 8-14
8.4.2. RS-232C Port Setting Parameter ............................................................. 8-15
8.4.3. Calibration Auto Acceptance ..................................................................... 8-16
8.4.4. Priority for 10 Minute Assay ...................................................................... 8-17
8.4.5. Barcode Settings....................................................................................... 8-18
8.5. Other Settings ........................................................................................................ 8-19
8.6. Utilities - Statistics .................................................................................................. 8-20
XI
8.7. Utilities – Change Logon ........................................................................................ 8-21
8.7.1. Administrator/Operator Registration ......................................................... 8-21
8.8. Beltline Menu Screens ........................................................................................... 8-22
9: MAINTENANCE ..................................................................................................................... 9-1
9.1. Daily Maintenance ................................................................................................... 9-1
9.1.1. Cleaning the Substrate Lines...................................................................... 9-1
9.2. Weekly Maintenance................................................................................................ 9-2
9.2.1. Cleaning Wash Probes ............................................................................... 9-2
9.3. Monthly Maintenance ............................................................................................... 9-5
9.3.1. Replacing Filters for Wash Solution and Diluent ........................................ 9-5
9.3.2. Replacing Probe Tips of Wash Probes ....................................................... 9-6
9.4. Three-month Maintenance ....................................................................................... 9-8
9.4.1. Cleaning Wash Solution and Diluent Tanks ................................................ 9-8
9.5. Six - to- 12 Month Maintenance Tasks .................................................................... 9-8
9.6. When Idle for Long Periods ..................................................................................... 9-8
9.7. Startup after Extended Idle Period........................................................................... 9-9
9.8. Controller PC ........................................................................................................... 9-9
9.8.1. Maintaining Optimum Performance ............................................................ 9-9
9.8.2. System Backup ........................................................................................... 9-9
9.9. Consumables (Supplies) ........................................................................................ 9-10
9.10. Maintenance Parts ................................................................................................. 9-10
10: APPENDIX 1 TEST FILES ..................................................................................................... 10-1
11: APPENDIX 2: BARCODE SETTINGS ...................................................................................... 11-1
11.1. CODE 39 ................................................................................................................ 11-1
11.2. CODABAR (NW-7)................................................................................................. 11-1
11.3. ITF .......................................................................................................................... 11-2
11.4. CODE 128 .............................................................................................................. 11-2
12: APPENDIX 3: FLAGS ........................................................................................................... 12-1
12.1. Flags with Concentrations ..................................................................................... 12-1
12.1.1. Blank ....................................................................................................... 12-1
12.1.2. L .............................................................................................................. 12-1
12.1.3. H.............................................................................................................. 12-1
12.1.4. RL ........................................................................................................... 12-1
12.1.5. RH ........................................................................................................... 12-1
12.2. Calculation Failures for High Concentration Specimens ....................................... 12-2
12.2.1. DO ........................................................................................................... 12-2
12.2.2. >H ........................................................................................................... 12-2
12.3. Calculation Failures for Low Concentration Specimens ........................................ 12-2
12.3.1. <L ............................................................................................................ 12-2
12.4. Sampling Failures .................................................................................................. 12-2
12.4.1. SS ........................................................................................................... 12-2
12.4.2. NS ........................................................................................................... 12-2
12.4.3. SC ........................................................................................................... 12-3
12.4.4. UC ........................................................................................................... 12-3
12.5. Calibration Failures ................................................................................................ 12-3
12.5.1. NC ........................................................................................................... 12-3
12.5.2. CL ........................................................................................................... 12-3
12.5.3. CV ........................................................................................................... 12-3
12.5.4. CE ........................................................................................................... 12-4
12.6. Reagent Errors....................................................................................................... 12-4
12.6.1. BH ........................................................................................................... 12-4
12.6.2. PS ........................................................................................................... 12-4
12.6.3. RS ........................................................................................................... 12-4
12.6.4. ES ........................................................................................................... 12-4
12.6.5. TS ........................................................................................................... 12-4
12.6.6. LS ............................................................................................................ 12-5
XII
12.6.7. WS .......................................................................................................... 12-5
12.6.8. BS ........................................................................................................... 12-5
12.6.9. DS ........................................................................................................... 12-5
12.7. Analyzer Errors ...................................................................................................... 12-6
12.7.1. IO ............................................................................................................ 12-6
12.7.2. WU .......................................................................................................... 12-6
12.7.3. DL ........................................................................................................... 12-6
12.7.4. SE ........................................................................................................... 12-6
12.7.5. MF ........................................................................................................... 12-7
12.7.6. NB ........................................................................................................... 12-7
12.7.7. RF ........................................................................................................... 12-7
12.7.8. SP ........................................................................................................... 12-7
13: APPENDIX 4: ERROR MESSAGE ........................................................................................... 13-1
14: APPENDIX 5:PRINTING FORMAT .......................................................................................... 14-1
14.1. Daily Maintenance ................................................................................................. 14-1
14.2. Worklist .................................................................................................................. 14-1
14.3. Assay Results ........................................................................................................ 14-2
14.4. Specimen Information and Assay Results ............................................................. 14-2
14.5. Calibration Reports ................................................................................................ 14-3
14.6. Levey Jennings Charts .......................................................................................... 14-4
14.7. QC Materials Lists.................................................................................................. 14-5
14.8. Test Files ............................................................................................................... 14-5
14.9. Checklists ............................................................................................................... 14-6
XIII
1: General Precautions for Use
1: General precautions for use
1.1. General precautions for use of the AIA-1800 are provided in the following sections.
Registering Operators and Administrators
While the actual assay tasks are performed automatically by the AIA-1800 system, the user is required
to manage reagents, enter specimen request information, assess results and perform daily maintenance
tasks. Mistakes made at any stage can compromise the integrity of assay results.
Users of the AIA-1800 system are required to log on as either ordinary operators or administrators. Both
the operator and administrator level users are able to perform routine assay operations, however, only
administrator-level users are authorized to change critical system parameters and assay settings of
individual system components.
System parameters that are not accessible to ordinary operators can only be modified by logging on as
an administrator.
Be sure to register all system users as operators or administrators as soon as the

system is installed, and limit users to those who have received the proper training.
Untrained personnel are likely to make mistakes that can cause system
malfunctions.
Operational Training
Trained service personnel always oversee and provide detailed orientation during the installation of the
AIA-1800 system. A Tosoh or local representative in each country also operates a training class for
system operators. Feel free to contact a Tosoh Service Center or local representative for detailed
information on training programs.
Effective System Management
Producing consistently accurate assay results requires managing both the AIA-1800 system and the
various reagent supplies according to a set of designated management standards. The performance of
the system and reagents can be verified to meet these performance standards by conducting control
measurement operations at regular intervals.
The AIA-1800 system is equipped with self-diagnosis routines that display error messages whenever
faults are detected. Corrective steps can be taken in the event of errors by referring to the appropriate
section in this manual.
Managing Reagents
The AIA-1800 is designed to manage reagents by lot number. Mixing reagents with different lot numbers
will create confusion in assay results due to the inability to distinguish between lots. Carefully read the
insert sheets provided with the reagents for information on how to manage reagent lots.
1-1
1: General Precautions for Use
Specimens
Applicable specimen type for the AIA-1800 is indicated on the insert sheet provided with reagents for
each analyte. Any questions regarding specimen assay operations should be addressed to a Tosoh
Service Center or local representative.
You are asked to avoid assaying the following types of specimens, as you can affect system operation.
(1) Specimens that have a tendency to clot during the assay process.
(2) Specimens containing solid particles that tend to form occlusions during dispense operations.
(3) Specimens containing alkaline phosphatase inhibitor.
1-2
2: System Configuration and Functionality

2.1. System Configuration
The AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-1800 is comprised of the AIA-1800
analyzer unit (the main unit) and a personal computer (the controller PC) that are linked by an RS-232C
cable. The system is designed for the main unit to perform assay operations in response to instructions
sent from the controller PC unit.
The controller PC, in turn, can be linked by an RS-232C cable to a host computer from which it receives
assay requests and returns assay results.
AIA-1800
RS-232C
AIA-1800
Control
unit
Controller PC Remote host computer
2.2. Controller PC Configuration

The controller PC is an IBM PC/AT compatible system equipped with an Intel Pentium 4 class CPU and
512 MB or more memory running the Microsoft Windows XP Professional operating system.
It is recommended that the controller PC be shut down when main unit operations are completed and that
hard disk defragmentation be performed once every three months.
Be sure to observe the following precautions, which are designed to prevent

system instabilities.
- Avoid using screensavers or limited power-saving functions.

- Do not use the controller PC for any applications other than controlling AIA-1800
operations.
- Do not start any other applications while the AIA-1800 system control program is in
operation.
2.2.1. File Configuration

The AIA-800 system program is stored in the C:\Nexus folder on the C: drive of the controller PC.
The C:\Nexus folder consists of the following directory structure.
(1) C:\Nexus \Documents

Location of electronic documentation (in HTML format).
(2) C:\ Nexus \log
Contains log files to which system operation information is automatically saved.
These log files will be compressed at the system closing and saved in the folder
C:\Nexus\log\Backup\ as the file "date.lzh", which represents the date when the system was
closed.
(3) C:\ Nexus \Mainte
Contains system maintenance program files.
(4) C:\Nexus\Resource\
Contains system character and image resources.
(5) C:\Nexus\System
Contains the database required for system operation and various related database files. Also
contains system start-up parameter files.
Do not edit or move any of the files located in the C:\Nexus folder of the controller
PC, as this may make the system unstable.
2-1
2.2.2. System Files

AIA-1800 system parameter files are described in the following sections.
Avoid editing system parameter files, as this may make the system unstable.
(1) C:\ Nexus \System\NexusConst.ini

Contains various parameters for main unit operation.
(2) C:\ Nexus \System\Nexus.ini
Contains system operation parameters (operating modes, RS-232C settings etc.).
(3) C:\ Nexus \System\Detector.ini
Contains detector unit parameters.
(4) C:\ Nexus \ System \Master.mdb
Contains information on calibration data, test files and panels.
(5) C:\ Nexus \ System \Spec.mdb
Contains information on assay requests and assay results.
(6) C:\ Nexus \ System \QC.mdb
Contains assay results of control samples.
2.2.3. System Backup

It is recommended that system files be backed up on a regular basis as a precaution against
system failure. This can be done easily using the CD-RW drive on the controller PC. Make sure
that all main unit operations have stopped, and then simply save the entire C:\Nexus folder to the
backup disk.
Refer to the CD burning software help for information on operating the CD-RW
drive.
- Wait until system operation has terminated before backing up Nexus system files.
- Attempting to perform backup operations while the system is in operation may
damage the files.
2-2
2.3. Specifications
Main Specifications
Assay principal Fluorometric enzyme immunoassay (FEIA)
Processing method Automated continuance random access
Processing capacity Max. 180 tests/h (ST reagents)
In vitro diagnostic reagent AIA-PACK Series
Sample volumes 10 to 125 µl
Sample clot detection Pressure detection (Note 1)
Measuring conditions Reaction temperature: 37 degree Celsius
Antigen-antibody reaction time: 10 min. or 40 min.
(depending on assay specification)
Specimen dilution factors 2 per assay specification selectable in the 2 to 625 range
Specimen pretreatment Automatic pretreatment (10 min. at 37 degree Celsius)
Detection method Fluorescent measurement (top-to-top system)
Precision control Levey-Jennings charts
Reagent Sorter
Reagent set count Max. 31 trays (equivalent to 31 analytes and 620 tests)
Can be added or changed at any time by key request
Sample Loader
Specimen set count ST model: 170 specimens, (add/ change as required)
LA model: 90 specimens, (add/ change as required)
STAT: 1 specimen
Sample containers Test tubes :13x75, 13x100, 16x75, 16x100(Diameter x Long)
Can be used in combination with dedicated sample cups
Specimen barcodes CODE39, CODE128, ITF, NW-7 compatible (compliant with
ASTM14466-92 and CLA guideline compliant bar codes)
Min. element width: 0.191 (0.254 or over recommended)
Tip/Reagent Loader
Tip Dedicated tips
Tip set count 288 (96/rack, in 3 racks)
Reagent set count Holds a max. of 8 reagent types
Can be added or changed at any time by key request
External Input/Output
RS-232C (for connecting controller PC and Beltline)
Power Supply/Power Consumption
100 - 240 VAC, 50/60 Hz, 500 VA (excluding controller PC and printer)
External Dimensions/Weight (excluding controller PC and monitor)
1800 ST 1650 (W) x 930 (D) x 1250 (H) mm Approx.300 kg
1800 LA 1650 (W) x 1100 (D) x 1250 (H) mm Approx.300 kg
Operating Environment
Temperature 15 to 30 degree Celsius
Humidity 40% to 80% (with no condensation)
Dust Average office level
Conformity Standard
EMC standard IEC60601-1-2: 2001
CISPR class and group categories Class A, Group 1
FCC Part 15, Sub Part B, Class A
BARCODE READER Class 1 :IEC60825-1: 1994
Note 1: Sample clot at nozzle tip will be checked after specimen suction and reported by flag “SC” if vacuum
pressure exceeded approximately 10% or more of that when it is completely clogged.
Another flag UC, which does not work at the default setting, will be reported if the system detected
abnormal vacuum pressure variance during specimen suction.
2-3
External Dimensions of AIA-1800 ST
External Dimensions of AIA-1800 LA
2-4
2.4. Names of Parts

Analyzer Module Sorter Module
1 STAT specimen unit

9 Control panel
2 Reagent tip cover

(Reagent bottle/sample tip loader)
10 Controller PC operating
unit
(Monitor, keyboard and mouse)
3 Sample loader
(Specimen set position)
4 Main power switch 11 Sorter drawer

(Test cup compartment)
5 Substrate bottle compartment
12 Drawer handle
6 (From left)
Wash solution tank, Diluent tank
7 Waste box 13 Controller main unit

(Waste cups and tips)
8 Waste tank
2-5
2.5. Functions of System Units

2.5.1. Analyzer Module
(1) STAT Specimen Port
Port where STAT specimens can be loaded, the door can be opened and specimens loaded
when the lamp to the left is green. Red indicates dispensing operations in progress, during
which specimens cannot be loaded.
(2) Reagent/Tips Cover

This cover is opened when replenishing reagent bottles (specimen diluting solution, conjugate
and pretreatment reagent) and sample tips. The compartment where the reagent bottles and
sample tips are installed is referred to as the Reagent/Tips sample loader.
(3) Sample Loader

The sample racks contains sample cups and test tubes, which get loaded into sample loader.
(4) Power Switch

Used to turn system power on and off.
(5) Substrate Bottle Compartment

Compartment where substrate bottles are installed; equipped with level sensors indicating the
amount of substrate remaining.
(6) Wash Solution and Diluent Tank Compartment

The wash solution tank is positioned on the left and the diluent tank on the right. Each tank has
a capacity of 5 L and is equipped with electrode sensors indicating the amount remaining.
(7) Waste Box

Holds used sample tips and test cups, with sample tips placed at the front and the sample
cups at the back.
(8) Waste Tank

Designed to hold waste fluids, the waste tank has a capacity of 10 L and is equipped with an
electrode sensor to indicate when it is full.
2-6
2.5.2. Sorter Module
(1) Control Panel
Cup Sorter Key

Press to load test cup.
For lamp status definitions see Note 2
POWER Alarm Clear Key Reagent/Tips Key

Lights when system power is on. Lights when errors occur. Press to load reagents and tips.
READY Press to turn off alarm. For lamp status definitions see Note 1
Lights when system is ready for operation.
Note 1: Reagent/Tips lamp status definitions:

Off: Standby
Flashing red: Preparing to open reagent/tips cover after the Reagent/Tips key was
pressed or a scan operation is in progress.
On, green: Reagent/Tips cover may now be opened
On, red: Either a 2-step reagent (conjugate) dispense operation or pretreatment
is in progress. The Reagent/Tips key must not be pressed, as this will
cause the assay process to be skipped.
Note 2: Cup Sorter lamp status definitions

Off: Standby
Flashing red: Preparing to open Sorter drawer after the Cup Sorter key was pressed
or a scan operation is in progress.
On, green: Sorter drawer may now be opened
On, red: Pretreatment in progress. The Cup Sorter key must not be pressed, as
this will cause the assay process to be skipped.
(2) PC Controller Console

Comprised of a monitor, keyboard, mouse and barcode scanner, the console is designed for
the operation of the controller.
(3) Sorter Drawer

Test cup trays are loaded by opening this drawer.
(4) Drawer Handle

This is used to open and close the sorter drawer. Always use the drawer handle, as attempting
to grasp other parts may result in hand and/or finger injuries.
(5) Controller PC Unit

The controller PC is turned on by turning on the power switch at the front of the controller PC
case.
2-7
2.5.3. Operation Control Screens

The various menu screens and menu buttons that appear on controller display are described below.
Menus
Request: Includes Clear, Open, Save and Print Page Setup settings
Log: Displays the error log
Database: Closes the system database and opens past data
Version: Displays program version details
Toolbar
Displays current reagent information.
Click on each tool button to display submenus.
Check box
Text box
Tree view
Simply click on any item in the list to display the desired form. Button Form
Operation of the software is based around using the tree view
to switch between forms.
2-8
2.6. Solution Flow Plan
2-9
2.7. System Functionality

2.7.1. Authorization Level Control
The AIA-1800 system separates users into the two categories, operator and administrator, with
access to all system functions based on these categories. Users without the proper authorization
are not permitted to enter parameter settings.
2.7.2. Automatic Dilution Function

The measurable concentration range for each analyte is determined by the assay range. Highly
concentrated specimens exceeding the assay range are first diluted with specimen diluting
solution (SDS) before being assayed. Users select the analyte dilution factor from the Assay
Request menu screen. Specimens are automatically diluted according to the selected factor and
assay results are multiplied by the same factor. (Some exceptional analytes are not multiplied by
the factor)
2.7.3. Automatic Pretreatment Function

The automatic pretreatment process performs a pretreatment reaction for 10 minutes at 37°C.
Pretreatment 1 (reaction solution) and Pretreatment 2 (stop solution) are provided for use as
pretreatment solutions. The pretreatment parameters are entered beforehand in the test file.
2.7.4. STAT Assay Function

The AIA-1800 provides a STAT port where high-priority specimens can be loaded for priority
processing.
2.7.5. Automatic Rescheduling Function

Assay request can be automatically rescheduled if the initial results have been flagged according
to the user-defined condition.
2.8. Operating Modes

The AIA-1800 system provides three basic operating modes. These are the non-barcode, barcode and
host query modes. System operation format differs according to whether specimens are supplied using
the built-in sample loader unit or an external beltline unit.
- - Beltline operation is only available with the LA model.

- - Note that the non-barcode mode is not available for beltline operation.
2.8.1. Non-Barcode Mode

As the name indicates, specimens are processed without the use of individual specimen
barcodes. Specimen request information is entered manually from the controller PC or
downloaded from Host computer prior to assay operations. Once a specimen container is
detected, assay operation commences, starting in order with the first container in accordance with
the assay request information. (Note that the non-barcode mode cannot be used with beltline
operation.)
2.8.2. Barcode Mode

In barcode mode, assay request information is either downloaded directly from the host computer
or entered manually from the controller PC. When a specimen container barcode is read, the
system extracts information for that code from the assay request information received from the
controller PC and performs the specified assay operation.
2.8.3. Host Query Mode

In host query mode, the system reads the specimen container barcode and searches the
controller PC for assay request information corresponding to that code. If not found, the system
issues a query to the host computer and downloads the necessary information. The assay
operation is performed as specified and the results are sent to the host computer.
2-10
3: System Installation, Transportation, and Storage
This chapter provides specific guidelines to be followed both before and after installation of the AIA-1800
system.
The AIA-1800 is a high-precision analyser that requires careful adjustment according to specific standards to
ensure stable and reliable operation. Tosoh or local representatives dispatch service personnel trained in
installation and maintenance procedures to oversee system delivery and installation. It is recommended that the
AIA-1800 system be installed in accordance with instructions provided by the service personnel.
3.1. Environment of transportation and storage
Temperature: 5 to 50 degree Celsius

Humidity: 80 % or less (non-condensing)
Others: Keep dry Store indoors
3.2. Environment of use

Install the AIA-1800 main unit on a level floor in an environment where it is not exposed to dust, toxic
fumes, vibration and direct sunlight.
Temperature: 15 to 30 degree Celsius

Humidity: 40 to 80 % (non-condensing)
Dust: Levels equivalent to the average office
Altitude Up to 2000 m
Do not operate the AIA-1800 system in an environment characterised by sharp

temperature fluctuations. The resulting condensation can cause current leakage
that can adversely affect normal system operation.
3.3. Power Supply

Connect the AIA-1800 system to a grounded power supply socket. Use an independent power socket
and never share power outlets with equipment that consumes large amounts of power.
The AIA-1800 system power supply requirements are listed below.
Voltage: 100-240 VAC

Frequency: 50/60 Hz
Max. Power: 1 KVA for main unit and controller PC (excluding printer)
Do not operate the AIA-1800 in an environment characterised by sharp voltage

fluctuations, as these are a potential source of system errors.
3-1
3.4. Installation Space

Install the AIA-1800 system in a location with plenty of peripheral space and a solid floor foundation
capable of supporting the 300 kg weight. Space is an important consideration for this system, which
combines a main unit and controller PC.
System Dimensions
ST model: 1650mm (W) x 930mm (D) x 1250mm (H)
LA model: 1650mm (W) x 1100mm (D) x 1250mm (H)
For both the ST and LA models, height of 1900 mm is needed when the cover is open.
It is important to ensure sufficient peripheral space exists to accommodate flow of ventilation from
internal cooling fans. Also avoid directly exposing the system to exhaust discharged by nearby
equipment.
Installation Space for the AIA-1800 ST
Installation Space for the AIA-1800 LA
3-2
3.5. Standard Accessories

When unpacking the system in the presence of service personnel, check the list of accessories provided
in the accessories box to make sure that all standard accessories are included in the package.
Immediately notify service personnel or the sales agent if components are found to be missing.
3.6. Registering a System Administrator

It is necessary to register a system administrator during the installation process. Be sure to have a
suitable operator name and password ready when requested to perform registration by service personnel.
The system will not operate until the system administrator has been registered.
3.7. Operating Mode

There are several operating modes as illustrated below. Refer to “Chapter 6: System Operation” for a
detailed description of system operating modes.
Mode Selection Procedure
Start
Beltline
Choose specimen
location
Sample Loader
Not used
Use of barcodes
Used Remote Host

Remote Host Computer
Computer
Assay Requests Assay Requests
Controller PC Controller PC
Sample Sample Sample Loader Beltline Beltline
Loader Loader Barcode-Query Barcode Barcode-Query
Non-Barcode Barcode
Note that Beltline mode is not available with the ST model. (All operating modes are
available for the LA model).
3-3
MEMO
4: Overview of System Operation
The procedures for loading specimens are described in the following sections. Be sure to follow these
procedures when operating the AIA-1800 main unit.
4.1. Installing Wash Solution

(1) Open the wash solution compartmented by gently pressing on the lower front doors of the
AIA-1800 main unit.
Wash Solution Tank
(2) Take out the wash solution tank and remove the lid.
Note that the wash solution and diluent tanks are of the same shape and size. Be
sure to select the one of the correct colour (orange). Selecting the wrong tank
will directly affect assay results.
Take care not to spill wash solution in the compartment by immediately

transferring the feed tube to another container when disconnecting it from the
tank. Fluid leakage is a potential source of current leakage and electrical shock.
(3) Refer to the insert sheet of Wash when mixing wash solution.
It is important to mix Wash and pure water in the correct proportions. Failure to
do so will result in an uneven concentration gradient in the tank that will
adversely affect assay results.
(4) Replace the lid on tank.

(5) Return the tank to compartment.
(6) Close the lower front doors of the AIA-1800 main unit.
4-1
4.2. Installing Diluent Solution
(1) Open the diluent compartment by gently pressing on the lower front doors of the AIA-1800
main unit.
Diluent Tank
(2) Take out the diluent tank and remove the lid.
Note that the diluent and wash solution tanks are of the same shape and size. Be
sure to select the one of the correct colour (green). Selecting the wrong tank will
directly affect assay results.
Take care not to spill diluent in the compartment by immediately transferring the
feed tube to another container when disconnecting it from the tank. Fluid
leakage is a potential source of current leakage and electrical shock.
(3) Refer to the insert sheet of Diluent when mixing the diluent.
It is important to mix Diluent and pure water in the correct proportions. Failure
to do so will result in an uneven concentration gradient in the tank that will
affect assay results.
(4) Replace the lid on the tank.

(5) Return the tank to the compartment.
(6) Close the lower front doors on the AIA-1800 main unit.
4-2
4.3. Disposing of Waste Solution
(1) Open the waste solution compartment by gently pressing on the lower front doors of the
AIA-1800 main unit.
Handle
Waste Tank
(2) Grasp handle and pull forward gently to remove the waste tank.
(3) Place the waste tank on the floor and confirm that any fluid remaining in the tube flows into
the tank.
(4) Remove the lid from the waste tank.
- Avoid removing the lid before placing the tank on the floor, as this can result in
fluid spillages.
- Be sure to wear appropriate protective clothing, such as gloves, when handling
the waste tank, as waste solution has been contaminated by potentially infectious
specimens.
- Take care not to spill waste solution in the compartment by immediately
transferring the outlet tube to another container when disconnecting it from the
tank. Fluid leakage is a potential source of current leakage and electrical shock.
(5) Dispose of the waste solution at the designated location.

(6) Replace the lid on the empty waste tank.
(7) Place the waste tank back onto its stand.
4-3
4.4. Disposing of Discarded Cups and Tips
(1) Open the waste compartment by gently pressing on the lower front doors of the AIA-1800
main unit
Waste Box
Be sure to wear appropriate protective clothing, such as gloves, when handling

the waste box, as discarded cups and tips have been contaminated by
potentially infectious specimens.
(2) Grasp the waste box and pull it forward.
(3) Remove the waste bags containing discarded cups and tips and dispose of them at the
designated location.
(4) Place new waste bags in the waste box and return the box to its normal position.
Waste Bag (cups)

Part No. 020104
Waste bag (tips)

Part No. 020105
Point
Note that the discarded tips drop into the bag at the front, while cups drop into
the bag at the back, and that the sizes of the bags differ.
4-4
(5) Close the lower front doors of the AIA-1800 main unit.
(6) After disposing of the waste cups, go to the Waste Cup menu on the Toolbar and reset
Waste Cup status.
(7) After disposing of the waste tips go to the Waste Tip menu on the Toolbar and reset Waste
Tip status.
Note that waste cups and tips are counted as they are discarded. Waste Cup
Point
status changes from “OK” to “Full” when the count reaches 2000. Tip status
changes when the count reaches 1600. Resetting changes status back to “OK”
and clears the count to zero.
Waste box content is not sensor-monitored, so always check the waste level
prior to commencing system operation.
4-5
4.5. Changing Substrate and Substrate Replacement Solution Bottles

(1) Open the substrate fluid compartment by pressing on the lower front doors on the
AIA-1800 main unit.
Substrate Bottle
Compartment
(2) Remove the substrate bottle tube.
(3) Remove the bottle.

- When changing from substrate cleaning solution to substrate:
Place the lid back on the substrate cleaning solution bottle, and store until the assay
operation has completed. After this, reinstall the substrate cleaning solution.
- When changing from substrate to substrate cleaning solution:
Place the lid back on the substrate bottle and put it in the refrigerator.
(4) Install the bottle in its designated location.
Always install the substrate bottle with the label facing the front. The substrate
level optical sensor is located at the rear, so having the label face the rear will
cause sensing errors.
(5) Insert the tube into the bottle.
Avoid placing the potential sources of sparks or flame near substrate lines, as
the substrate cleaning solution consists of 70% ethanol.
4-6
4.6. Installing Sample Tips
(1) Press the Reagent/Tips key on the AIA-1800 main unit control panel.
If the LED on the Reagent/Tips key is continuously red, either a 2-step reagent
(conjugate) dispense operation or pretreatment is in progress. The
Reagent/Tips key must not be pressed, as this may cause the assay process to
abort with loss of the results.
(2) The LED flashes for a few seconds.
(3) The LED changes to green to indicate that the lock has been released.
(4) Open the Reagent/Tips cover.

Lift the cover up to the hold-open catch. When closing the cover, lift up first to release the
catch.
(5) Pull out the tip rack and replenish the sample tips. A single rack holds 96 sample tips.
4-7
(6) Replace the tip rack by aligning it with the positioning pins. The Reagent/Tips loader holds
a maximum of three tip racks (a total of 288 tips).
(7) The AIA-1800 automatically detects the current number of sample tips when the cover is
closed. (Reagent/Tips scan)
Avoid opening sample tip cover for long periods of time when working with
2-step reagents and pretreatment solutions. Skipping and the loss of assay
results may occur when timing coincides with conjugate dispense or
pretreatment operations.
Point The system detects the presence of a tip in the far back line of the rack as a row
of 12 tips. Therefore, it is important to fill each row without leaving any
vacancies.
Note that inventory is not updated if tip positions in the back row remained
unchanged between opening and closing the Reagent/Tips cover. Therefore, it
is important not to remove tips from the first partially full row, as this is included
in the inventory count.
Back row monitored

by sensor.
The system detects
the presence of 11
rows by 12 tips = 131
tips.
In the example below where the count has fallen to 124, the system assumes that no tips were
replenished and maintains the same count. This is because there was no change in the back row
of tips after the cover was opened and closed (using Reagent/Tips key). (Count not updated to
131.)
4-8
4.7. Loading Conjugate and SDS
(1) Press the Reagent/Tips key on the AIA-1800 main unit control panel.
A continuously red LED on the Reagent/Tips key indicates that either a 2-step
reagent (conjugate) dispense operation or pretreatment is in progress. The
Reagent/Tips key must not be pressed, as this may cause the assay process to
abort with loss of the results.
(2) The red LED flashes for a few seconds.
(3) The LED changes to green to indicate that the cover lock has been released.
(4) Open the Reagent/Tips cover.

Lift the cover up to the hold-open catch. When closing the cover, lift upwards first to
release the catch.
(5) Load the conjugate and Sample Diluent Solution into the rack with barcode labels facing
the front
Positioning pin
(6) Replace the rack by aligning it with the positioning pin.
4-9
(7) Close the cover. The Reagent type and lot number are automatically read when the cover
is closed. (Reagent/Tips scan)
(8) The Reagent/Tips key LED flashes red during the Reagent/Tips scan.
Avoid leaving the sample tip cover open for long periods when working with
2-step reagents and pretreatment solutions, as this can cause skipping and the
loss of assay results when it coincides with conjugate or pretreatment
operations.
Point - The different types of solutions are managed using serial numbers included in
the barcode label. The system uses the previous remaining level value when a
barcode read record exists. Level detect values from the next fluid feed operation
are used to update the level value.
- Pretreatment solution 2 must be set on the right side position of pretreatment
solution 1.
- The solution 2 which has no barcode label is automatically registered the right
side position of the solution 1 registered with barcode.
4-10
4.8. Loading Specimens, Calibrators and Controls into Sample Loader
(1) Specimens can be loaded in their test tubes or only dispensed in required amounts into
Tosoh sample cups and loaded into sample racks.
Note that sample cup adapters must be installed in the sample rack when using the Tosoh
sample cups.
Sample Cup
Sample Cup Adapter
Point The dead-volume specification is 100 µl for Tosoh sample cups and 500 µl for
straight round-bottomed test tubes.
Note that sampling results cannot be guaranteed for tapered test tubes. Feel
free to contact a Tosoh service center or local representative for information on
the type of test tubes that can be used.
In barcode mode, install test tubes with the barcode label facing towards the
opening in the sample rack.
Make sure barcode labels are within the valid barcode read range, as illustrated
in the figure below. Dirty, wrinkled labels or crooked labels will affect barcode
reading.
Max. read range for

100 mm test tube: 75
mm Max. read range for 75 mm
test tube: 55 mm
Non-readable length: Non-readable length: 20 mm

20 mm
Note: Read Range includes barcode margin (quiet zone).
4-11
(2) When loading the sample rack into the sample loader, position with the rack opening
facing the back.
The sample loader feeds sample racks in the circulating format illustrated below. The
loading order is from right back to right front and left front going to left back.
Upright retainer guide
An upright retainer guide is positioned on the right side of the sample rack.
Make sure to load sample racks aligned to the groove on the right. Failure to do
so disables the upright retainer function and affects sample rack motion.
Align sample rack with groove.
(3) Load the sample racks to be assayed and insert an end marker or an empty sample rack at
the end.
Example using end Example using empty

marker rack
With specimen
No specimen
End Marker Empty Rack
4-12
(4) If planning additional assay tasks after an operation has started, load new sample racks
only after dispensing of the previous rack has completed and the sample loader has
stopped.
(5) Use the Pause function in cases where the sample loading requires significant amount of
time. Go to Assay on the Toolbar and select Pause from the drop-down menu.
(6) Load additional sample racks after the sample loader has stopped.
(7) Either an end marker or an empty rack must also be inserted at the end of the new sample
racks.
Assay operation has started

but stopped by Pause function
Additional Racks
Insert end marker or empty

rack
Point When adding specimens frequently, End pointer can be used for pointing the
very end so that adding point is easily shown.
End pointer
END
4-13
- Confirm that the sample loader has stopped before loading the new racks. Doing
so while the loader is operating may result in stoppages caused by rack feed
errors.
- An end marker or an empty rack must be inserted at the end; otherwise the loader
will continue its circulating motion. Locations where sample racks cannot be
loaded are shown below.
Will not feed properly if inserted into

path at front.
Inserting at very back during

loader operation (even when
paused) may cause error and
stop operation.
4-14
4.9. Loading STAT specimens
(1) Check to see if the lamp on the left of the STAT port has turned green.
Lamp
Do not open port when lamp is red, as this may damage the sampling nozzle.
(2) STAT port door can be opened by turning the knob to the right.
13 diameter adapter
(3) Loading Specimen Container

If using Tosoh sampling cups, insert the sample cup adapters. If using size Φ13 test tubes,
insert size 13 diameter adapters.
- The test tube length limit is 75 mm.

Point - The STAT port is not equipped with a sensor to distinguish between sample cups
and test tubes, so the specimen container type must be specified using the
Request menu.
- For a detailed description, refer to Chapter 6: Section 6.7.1 Entering Specimen
Assay Requests.
4-15
4.10. Loading Test cups

(1) Press the Cup Sorter key on the AIA-1800 control panel.
The red LED on the Cup Sorter key indicates that a pretreatment operation is in
progress. The Sorter key must not be pressed during this operation, as this will
cause the assay process to be skipped and results to be lost.
(2) The Cup Sorter key LED flashes for a few seconds.
(3) When the led changes to green, the lock has been released and the Sorter Drawer can be
opened.
(4) Open the Sorter Drawer.
Handle
(5) Load the test cup tray in the Sorter Drawer.
Point Load test cup trays into the drawer with the barcode labels facing the front,
otherwise they cannot be read by the unit.
Avoid leaving the sorter drawer open for long periods when working with
pretreatment reagents, as skipping and the loss of assay results may result
when coinciding with pretreatment operations.
(6) After the loading, push the drawer fully to the back to close the Sorter Drawer.
(7) The test cup specifications, lots and numbers are automatically read while the Cup Sorter
LED flashes red. (Sorter scan)
Always use drawer handle when opening and closing the Sorter Drawer, as
attempting to grasp other parts may result in injury to hands or fingers.
4-16
5: Operational Flow
5: Operational Flow
The following flow chart illustrates the workflow during a standard operation performed using the AIA-1800
system. Referred to “Chapter 6: System Operation” for a detailed description of system operation. System
operations can roughly be divided according to whether specimens are supplied by the use of the built-in
sample loader or the beltline unit.
The AIA-1800 system provides three basic operating modes. These are the Non-Barcode, Barcode and Host
Query modes.
Point - Beltline operation is only available with the LA model.

- Note that the non-barcode mode is not available for beltline operation.
Start
Main unit startup “Chapter 6: 6.1 System Startup”
“Chapter 6: 6.2 Daily Maintenance”

Daily Maintenance “Chapter 6: 6.3 Inventory Check”
Yes
Parameters entered?
Entering Parameters “Chapter 6: 6.4 Entering Parameter

Settings”
Calibration curves Yes

generated?
“Chapter 6: 6.5 Generating

Calibration Curves”
Generating calibration Curves
“Chapter 6: 6.6 Specimen and Control Assay”

“Chapter 6: 6.7 STAT Assay Request”
Specimen Assay “Chapter 6: 6.8 Assay Pause/Continue”
“Chapter 6: 6.9 Assay Monitoring”
“Chapter 6: 6.10 Result Review”
“Chapter 6: 6.11 Retest”
End “Chapter 6: 6.12 Emergency Stop”
Yes
Operation Terminated “Chapter 6: 6.13 Shut Down “
Finish
5-1
5: Operational Flow
5-2
6. System Operation
6: System Operation
6.1. System Startup
(1) Turn on the power to the main unit.
(2) Turn on the power to the controller PC.
(3) Log on to Windows XP as “AIA-1800.” (No password necessary)
(4) Double-click the AIA-1800 icon on the desktop to launch the AIA-1800 program. This
displays the following dialog box.
(5) Enter your username and password.
Since preset username “root” has authority of administrator without password,

Point password setting for “root” is recommended for safety reason.
For a description of username and password registration procedures, refer to
Chapter 8: Section 8.7.1 Registering Administrators and Operators.
(6) Click the OK button
(7) This starts the system initialisation sequence and displays the following splash screen until
initialisation is completed.
6-1
6. System Operation
6.2. Daily Maintenance

The daily maintenance procedure should be performed prior to the first assay once a day. It is a
combination of some operations; inspecting the system, replenishing reagents, emptying waste and
checking the substrate background.
Clicking Daily Maintenance in the tree view menu displays the following screen.
Check each box

after inspection.
Inspection procedures,
progress and results are
displayed here.
If just a substrate background measurement is needed, click “substrate background measurement" in

the submenu of the substrate button.
6.2.1. Daily Maintenance Checklist

(1) Wash Solution
Check and replenish as necessary, then click the check box.
(2) Diluent
Check and replenish as necessary, then click the check box.
(3) Waist Fluid Level
Check the waste tank and empty if necessary, then click the check box.
(4) Waste Cups and Tips
Check waste cup and tip levels in the waste box and discard as necessary, then click the
check box.
(5) Substrate Install
Replace the 70% ethanol substrate cleaning solution bottle with the substrate bottle, then
click the check box. Check the residual quantity of the substrate before an assay starts in
order not to run short during the assay.
6-2
6. System Operation
Remove the substrate bottle from refrigerator and acclimatize at room

temperature for 15 to 30 minutes. Wipe away any condensation from the bottle
before installing in the substrate compartment. Air tends to enter the supply
lines when the substrate is cold, causing inconsistent assay results.
Condensation on the bottle can also cause level sensor malfunctions. In
addition, make sure that the bottle label faces forward to prevent interfering with
sensor operation.
(6) Test cups

Install the detector standardization cup (STD cup) and test cups required for analytes used
in assay operations in the sorter unit.
Point - The detector standardization cup (normally 1 cup) is mandatory, as it is used to

check the substrate background during daily maintenance.
- For a description of inventory checking procedures, refer to Chapter 6: Section
6.3 System Inventory.
(7) Reagent
Install SDS, conjugate and other required reagents in the Reagent/Tips loader, then click
the check box.
(8) Tips
Replenish tips in the Reagent/Tips loader as necessary, then click the check box.
(9) Wash Nozzle Inspection
Perform maintenance of the wash nozzle as necessary, then click the check box. Clean
the wash nozzle once a week and replace the No. 3 wash probe tip once a month. For a
description of cleaning procedures, refer to Chapter 9: Section 9.2.1 Cleaning the Wash
Probe. For a description of replacement procedures, refer to Chapter 9: Section 9.3.2
Replacing Probe Tips on No. 3 Wash Probe.
(10) Lot Number Entry for Common Reagents
Entering lot numbers for wash solution, diluent, and substrate in the upper right text boxes
in the Daily Maintenance screen. This enables these lot numbers to be recorded in the
online maintenance checklist.
(11) Click the Start button after all items on the maintenance checklist have been verified.
Point - Maintenance routine progress reports are displayed in text form in the lower half
of the screen.
- Once the Start button is clicked and processing begins, this changes to the red
Abort button. Note that other menu screens cannot be loaded while the daily
maintenance routine is in progress.
6.2.2. Maintenance Routine

(1) Priming the Substrate Line
Prime the substrate line with substrate.
(2) Flush the Wash Solution
Flush out any wash solution remaining in the wash lines. The following error messages
appear if the wash solutions are not properly flushed.
“2296: Wash probe 1 flush failure” appears when wash probe 1 flush fails.
These messages indicate that air was not completely flushed from the wash solution lines.
If errors occur, press the Reagents/Tips key, open the cover and check inside for possible
causes of the malfunction. After this, go to the toolbar, click Prime Wash, Solution then
Prime Diluent to repeat the flush procedure until the lines are full and the errors stop.
Contact Tosoh service centre or local representative if error messages still appear after
five flushes.
The wash probes are designed to draw wash solution that was dispensed into the detector
standardization cup. The following error messages appear when a problem occurs.
“2293: Probe 1 suction failure” appears when probe 1 suction operation fails.
6-3
6. System Operation
If these appear, check the wash probe tip for foreign matter. If clogged, refer to the probe
tip cleaning procedures described in Chapter 9: Section 9.2.1 Cleaning Wash Probe.
Contact Tosoh service centre or local representative if messages still appear after the
probe tip has been cleaned.
(3) Flush the Diluent

Flush out any diluent remaining in the diluent lines.
(4) Substrate Background Measurement

<1> Dispense substrate into the detector standardization cup (STD cup), measure the
fluorescence intensity in the detector and check for the following results.
- Substrate properly primed.

- Substrate background level is within specifications.
- Light source is within specifications.
The “Substrate background measurement in progress” message is displayed when the

measuring operation begins. Note that if the temperature at the incubator, detector,
wash solution heater or substrate heater has not stabilized, the level background
measurement will not begin and the “3100: Waiting for temperature to stabilize” error
message will appear. The system will then enter the standby state.
If background measurement does not commence within 30 minutes, the “Daily
maintenance routine did not complete” message appears, indicating possible
temperature control failure. It is recommended that you contact Tosoh service centre or
local representative.
<2> Measurement results are displayed as soon as the measuring operation completes.
The following results are displayed.
- Substrate Priming
In the event of a prime failure, make sure there is substrate in the substrate bottle
loaded in the AIA-1800 unit. If the “Error has occurred” message appears even
when substrate is present, the substrate prime detect parameter probably needs
adjusting. It is recommended you contact a Tosoh service centre or local
representative.
- 4MU Level Measurement

OK: 4MU level in the substrate is below 1500 nM
BH: 4MU level in the substrate is above 1500 nM
Indicates deterioration of substrate or dirt in substrate supply lines. For detailed
information, refer to Chapter 9: Section 9.9.2 Cleaning Substrate Lines.
Lamp: light source intensity
OK: light source intensity sufficient
LL: light source intensity insufficient or incorrect substrate dispense volume
Contact Tosoh service centre or local representative.
6-4
6. System Operation
6.2.3. Checklists
Daily maintenance results are recorded in the online maintenance checklist, displayed by
clicking Checklist in the Tree view Menu. The list records up to 1,100 entries.
Use the Up and Down arrow keys to "All List" displays all results. Print
select entries in the order of date. displays a preview of print image.
Entries can be made in calendar format by displaying the calendar.
6-5
6. System Operation
Checklist Items and Their Descriptions:

Date: Date and time of daily inspection
Operator Name: Name of operator conducting daily inspection
Wash Sol: Item entered by selecting check box in Daily Maintenance screen
Dil: Item entered by selecting check box in Daily Maintenance screen
Subst: Item entered by selecting check box in Daily Maintenance screen
Test Cup: Item entered by selecting check box in Daily Maintenance screen
Reag: Item entered by selecting check box in Daily Maintenance screen
Tips: Item entered by selecting check box in Daily Maintenance screen
Waste Cup: Item entered by selecting check box in Daily Maintenance screen
Waste Sol: Item entered by selecting check box in Daily Maintenance screen
B/F Probe: Item entered by selecting check box in Daily Maintenance screen
Substrate Repl: Item entered by selecting check box in Daily Maintenance screen
Wash Prime: Item entered by selecting check box in Daily Maintenance screen
Dil. Prime: Item entered by selecting check box in Daily Maintenance screen
Subst BGR: Item entered by selecting check box in Daily Maintenance screen
Ref BG: Detector reference section fluorescence intensity without substrate.
Smp BG: Detector sample section fluorescence intensity without substrate.
Ref Sub: Detector reference section fluorescence intensity with substrate.
Smp sub: Detector sample section fluorescence intensity with substrate.
Wash Lot: Lot no. entered during inspection
Dil Lot : Lot no. entered during inspection
Subst Lot: Lot no. entered during inspection
Comment: Comment input
Verify: Check box for verification.
Point - The number of characters that can be input in the comment cell is up to 48, but
just its first 26 characters can be printed out.
- The following messages will not be printed out: “Ref BG”, “Smp BG”, “Ref Sub”,
and “Smp Sub”.
6-6
6. System Operation
6.3. Inventory Check

To check the inventory of test cups, reagent solutions, SDS and tips, go to the tree view, click Setup
and select Inventory Check
There are no entries to be made in this menu screen.
Inventory List Tab
Top List:
Tip: Displays current, requested and required tip counts and estimated
time of shortage
Specimen Treatment Cup: Displays current, requested and required specimen treatment
cup (STC) count and estimated time of shortage
Standard cup: Displays current, requested and required standardization cup (STD)
count and estimated time of shortage
Middle List:
Displays the current, requested and required test cup count and estimated time to shortage.
The current inventory (test count) of conjugate is displayed on the reagent worksheet bottom
list in the case of 2-step reagents.
Point
If the conjugate inventory is not checked, current inventory count (test count) is
designated as “unknown.”
Bottom List:
Displays current, requested and required SDS and pretreatment solution inventory and
estimated time to shortage.
Point - If current SDS and pretreatment solution inventory is not checked, the current
inventory is designated as “unknown.”
- Inventory levels are updated by the level check performed during dispense
operations.
6-7
6. System Operation
Sorter Map Tab

This displays the current test cup inventory (by analyte, lot no. and count), as detected by the
sorter. Colour-coding is used to indicate whether calibration curve is available and whether the
calibration curve is valid.
Key of color- coding
Analyte, lot no.,

count
Reagent Table Tab

This displays reagent rack inventory.
Bottle presence and level
6-8
6. System Operation
Clicking the Reagent/Tips key displays the following pop-up dialog box when the No. 3 Tip Rack
has been designated as a reagent load area.
The barcode labels on reagent bottles in this area cannot be read automatically, so must be
registered in the screen using the bar code scanner.
Operation resumes when cover and

dialog box closed.
Be sure to register reagents correctly to ensure reliable assay results.
6-9
6. System Operation
6.4. Entering Parameter Settings

Procedures for entering required parameter settings are described below. Once registered,
parameter settings rarely need modification. Refer to the sections listed below if parameter setting is
required. If not, continue to the next section.
- Chapter 7: 7.2 Registering QC Materials
- Chapter 8: 8.1.1 Registering Analytes
- Chapter 8: 8.1.3 Registering Analytes Panels
- Chapter 8: 8.2 Assay Rescheduling Utility (Assay Result Verify Settings)
- Chapter 8: 8.3 Host Communications Utility (Host Communication (ASTM protocol) Settings)
- Chapter 8: 8.4.1 Assay Result Output Settings
- Chapter 8: 8.4.3 Calibration Auto Acceptance
- Chapter 8: 8.4.4 Priority for 10 Minutes Assays
- Chapter 8: 8.7.1 Administrator/Operator Registration
6.4.1. Test File Parameters

Test files contain the parameters required to set assay conditions for each analyte. If
parameter settings have been completed, continue to the next section.
(1) Go to the tree view and select Test File.
(2) Selecting an analyte checkbox displays the parameter settings.

(3) The Parameter Settings list shown in the centre of the screen shows settings for the
following items.
- Decimal Places
- Reference Range Low (L)
- Reference Range High (H)
- Reschedule Low (L)
- Reschedule High (H)
The reschedule (L) and (H) settings must be entered when performing RL or RH flag
verification.
Use the assay range low and high limits when dispensing with RL or RH flag verification.
Some parameters may not be edited depending on the authority allocated to a user.
For detailed description of Test File parameters, refer to Chapter 10: Appendix 1 Test Files.
6-10
6. System Operation
6.5. Generating Calibration Curves

Users who have completed the calibration curve generation step may continue to the next section.
6.5.1. Loading Immunoassay Reagents

Load the test cups for analytes for which calibration curves are being generated into the sorter.
For 2-step reagents, load conjugate into the Reagent/Tips loader.
Calibration curves are generated and managed using the reagent lot numbers
Point
read by either the sorter or the Reagent/Tips loader units. This means that the
immunoassay reagents (test cups and conjugate) must be loaded prior to the
curve generation step.
6.5.2. Checking Reagent Lot No.

The lot number and count for the loaded reagent is displayed in the Inventory screen. Check to
confirm lot numbers for the test cups to be used in generating calibration curves.
(1) Go to the tree view and select Inventory screen.
(2) Confirm the reagents required to generate calibration curves are in the inventory list.
(3) When using 2-step reagents, confirm that the analyte names and lot numbers listed in the
Test Cup section and Reagent section match.
6-11
6. System Operation
6.5.3. Calibration Request

(1) Normally barcodes are not put on calibrators dispensed in sample cups, so select the
NonBarcode mode and click the OK button.
(2) Click the Calibration button to display the following dialog box.
(3) Select the check box next to the desired analyte in the Valid Analyte list on the left and click
the Add button. Then confirm selection and click the OK button to generate the calibration
request.
- The test cup analyte and lot numbers in the sorter are displayed next to the check
Point boxes in the list. Blue in the “Analyte” box shows the analytes with valid
calibration, Red with no calibration and Orange shows an expired calibration.
- Note that requests for calibration checks are automatically generated when
calibration checks have been validated in the QC Materials Registration screen.
For a detailed description, refer to Chapter 7: Section 7.2 Registering QC
Materials.
(4) Registering Lot Numbers and Assigned Values.

Lot numbers and assigned values for calibrators can be entered by simply clicking the
desired cell to enable editing and using the scanner provided to read the barcode of the
calibrator.
6-12
6. System Operation
Examples of Calibrator Barcodes
Calibrator Lot No.
Assigned values
Use the Test File screen for entering the calibrator lot numbers and assigned values for
analytes not included in the sorter unit inventory.
<1> Go to the tree view and click Test File.
<2> Select the analyte to be calibrated.
<3> Click on the calibrator Lot No. cell.
<4> Use the handheld barcode scanner to scan the calibrator barcode from the
barcode sheet included with the calibrator set.
<5> Click the Conc. cell for the CAL(1).
<6> Use the handheld scanner to scan the CAL (1) barcode from the barcode sheet of
the calibrator set
<7> Use the same procedures to read with the assigned values for calibrators from
CAL (2) on.
Always register calibrator assigned values in incremental order starting with the
calibrator with the lowest value (CAL 1, CAL 2, …) to ensure correct assay
results.
6.5.4. Worklists
Worklists can be previewed as soon as the calibration request is complete by clicking the Print
button on the Request (non-barcode) screen. The worklist can also be printed out.
6.5.5. Loading Calibrator Solution

Calibrators and controls are dispensed into sample cups using pipette tips in volumes
consisting of the worklist volume plus dead-volume and placed in the sample rack positions
specified in the worklist.
Point Sample cup dead-volume is 100 µl.
6-13
6. System Operation
6.5.6. Scheduling Calibration
(1) Go to the toolbar, click Assay and select the Start Assay menu item.
(2) Select the desired mode. In the case of non-barcode calibration, enter the last record
number for each request. Normally barcodes are not put on calibrators dispensed in
sample cups, so select the NonBarcode mode and click the OK button.
(3) Clicking the OK button starts the calibration process.
The following screen is displayed if a reagent shortage is detected. Replenish reagents

and click OK. Note that affected tests will be skipped if the OK button is clicked without
replenishing reagents.
6-14
6. System Operation
6.5.7. Reviewing Calibration Results

When calibration completes, go to the tree view and click Calibration to confirm calibration
results and verify calibration curves.
Selecting a line in the Calibration tab at the top of the screen displays the corresponding
calibration data and calibration curve graph.
Lot no. of calibrator
Date & time: Date and time calibration curve was generated
Analyte: Analyte name
Lot: Lot no. of test cups
Sts: Void (expired)
Void+ (The numbers after “+” denotes the number of the days passing from the
expiration.)
Accepted (fixed)
Pending (not fixed)
Assay in progress
Rate 1 to 6: Mean value (rate value) of results for each calibrator
Conc: Calibrator assigned values
Rate: Calibrator rate value
Dil: Calibrator dilution factor
Flag: Calculation flag
Pos.: Calibrator calibration position, used as key for position changes
Rept.: Measurement order for calibrators of identical concentration
Point For a “void” calibration curve, the assay result with the CV flag is displayed. But
for a “void+” curve, because the concentration is not calculated, the assay
result cannot be displayed.
6-15
6. System Operation
Editing Data
Unnecessary data can be eliminated by simply unchecking the checkboxes in the Deci column
under the Pending status.
Concentration priority can be changed in the Edit tab at the upper right of the screen. Redundant
calibration curve data can also be deleted by clicking the Delete button on the Edit tab.
The more calibrations, the longer the access and processing times required for
Point
curve data. Maximum calibrations should be limited to 300 and unnecessary
data regularly deleted.
The delete button on the Edit tab deletes the currently displayed calibration curve
Note that deleted calibration curves cannot be restored.
To ensure accuracy of the calibration curve calculation, data needs to be entered in order. The
Reposition button on the Edit tab enables calibration results to be sorted in ascending or
descending order.
Going to the Graph Info tab and selecting the Graph Memory checkbox stores the graph to be
overlaid, enabling overlaying of subsequent calibration result graphs. Unchecking the box cancels
the graph overlay function.
The graph can be overlaid on only when the data are of the same analyte and the same lot.
6-16
6. System Operation
Calibration Check Tab

This tab displays assay results of the control calculated with the calibration curve. The control
result is calculated using the calibration curve from the calibrator. Control results accepted as
Final are used as QC data and are displayed in the QC screen. Controls used for calibration
checks are entered in the QC Materials Registration screen (refer to Chapter 7: Section 7.2
Registering QC Materials).
QC material: Name of control material

Mean Mean value (rate value) of results for single control
Conc: Calculated concentration
Unit: Measuring unit
Flag: Calculation flag
Sts: Assay result status (Pending/Final/Reject)
Low: Lower limit entered in QC Materials Registration screen
High: Upper limit entered in QC Materials Registration screen
6-17
6. System Operation
6.6. Specimen and Control Assay

6.6.1. Loading Immunoassay Reagents
Load the test cup into the sorter. For 2-step reagents, load the conjugate into the Reagent/Tips
loader.
6.6.2. Checking Reagent Lot No.

(1) Go to the tree view and click Inventory.
(2) Confirm that all necessary reagents are listed in the Inventory screen.
(3) Clicking the Sorter Map tab displays load position, lot no. and test cup count.
(4) Confirm test cup lot numbers, as they are required for confirming the presence of
calibration curves.
(5) When using 2-step reagents, go to the Inventory tab and confirm that the analyte names
and lot numbers listed in the inventory cells in the analyte cup section and reagent section
match.
(6) Confirm that the SDS for each analyte is listed in the Reagent section of the Inventory tab
when dilution is required.
(7) Then check the Reagent Table to confirm availability of reagents.
6-18
6. System Operation
6.6.3. Entering Assay Request

Three kinds of input sheets are available for assay request: for Barcode mode, Non-barcode
mode and STAT specimen.
The following function keys can be used to view in each request screen as below,
F1: Jump to the headline. F2: Jump to the last line
F5: Scroll to the left side F6: Scroll to the right side
6.6.3.1. Using Barcodes

Go to the tree view and selected Request (barcode) when generating requests for
barcoded specimens.
<1> Go to the Material cell and select specimen type from the dropdown box.
<2> Select Specimen ID, then enter the barcode IDs either manually or using the handheld
barcode scanner.
<3> Double clicking Analyte 1 displays a dialog box of valid analytes. Select the desired
analyte and click OK. Multiple analytes can be selected at one time.
Multiple Lines can be selected
The box displays the dilution factors in the test file for
Sp. 1 and Sp. 2. These settings can also be entered
manually.
Items with dilution factors exceeding 1 are displayed
together with dilution factor in worksheet form.
Right clicking is the same as clicking the OK button
6-19
6. System Operation
Making Multiple Copies of Requests

Drag and drop the cells (press and hold mouse button while moving) from the desired sections.
Right clicking the mouse displays pop-up menus then select IntelliPaste.
Point Automatic Request Generation

- The automatic request generation function simplifies the copying procedure. The
first (top) cell of selectable range can be copied into the second and lower cells.
Note that copying is only possible when the first cell is not blank.
- Information in the leftmost cell is copied when a single row is selected. This
feature is used to generate multiple copies of the same request in one sample.
- If specimen type has already been entered, the automatic generation process
copies the dilution factors for the individual items as well. Copying of individual
specimen type information can be avoided by holding down the Ctrl key during
the generation process.
- Specimen IDs are copied incrementally. The number of digits is not automatically
increased.
(Example)
“9” followed by “0.”
“09” followed by “10.”
Specimen Information
Patient information is entered in the top half of the screen.
Clicking an assay request line enables patient information for that specimen ID to be either
entered or confirmed.
Patient ID: 14 or less alphanumeric characters

Surname: Patient last name entered using 16 or less alphanumeric characters
Name Patient first name entered using 16 or less alphanumeric characters
Comment: Individual remarks entered using 32 or less alphanumeric characters
Birthdate: Patient date of birth entered using “YYYY/MM/DD” format
Sex: Patient gender, selected from Male/Female/Unknown
Smoker: Indicates whether or not the patient smokes tobacco
Error Check Button

Clicking the ERROR CHECK button displays any lines containing errors, enabling the
operator to check error of the assay request. While automatic checks are run when assay
operation starts, checking in advance is convenient when there are many assay requests to
be performed.
Clicking the ERROR CHECK button also automatically shifts information to the left to fill in
voids if analytes were deleted at any point.
The check process also checks reagent inventory and issues warning messages if a shortage
is detected.
6-20
6. System Operation
Saving and Opening Requests

Generated assay requests can be saved by choosing Request from the menu and selecting
SAVE AS. Saved requests can also be read by clicking Open and selecting the desired
request.
Point Note that all remaining requests are stored at program shutdown, even if not
previously saved.
Control Assay Requests

Clicking the CONTROL button displays the following dialog box
This shows a list of registered QC materials and their lot numbers. Choose the desired QC
material by selecting the check box. For a detailed description of the QC material registration
procedure, refer to Chapter 7: Section 7.2 Registering QC Materials.
Next, select analytes for each QC material and click the OK button.
Dilution factors can only be changed by editing the control dilution factor information in the test
file.
Requests can be done from the Barcode request screen when operating with a
beltline unit
Point Only the assay results obtained by putting QC material name to the specimen ID
are used for quality control.
Control data will be checked with the assay range(<L,>H) but will not be
checked with the reference range(L,H) nor the reschedule range(RL,RH).
Calibration Check Requests

Control assay requests for calibration checks will be automatically generated whenever
calibration requests are entered if Calibration Check has been enabled in the QC Materials
Registration screen. For a detailed description of the QC material registration procedure, refer
to Chapter 7: Section 7.2 Registering QC Materials.
6-21
6. System Operation
6.6.3.2. Operating Without Barcodes

Go to the tree view and select Request (non-barcode).
This is basically the same as the barcode request procedure with the only difference being
that the information for specimen positions in assay requests must be entered beforehand in
the position cells.
The number used to indicate specimen position is a combination of the two-digit sample rack
position (rack number) number indicating assay starting order and a two-digit specimen
position (in rack) number.
The rack numbers for each assay batch start from 01, with position numbers ranging from 01
to 10.
(Sample Entry) Rack Number－Position Number
01－01 (position 1 in sample rack 1)
-
-
-
-
Point - Requests can be automatically generated by simply entering the first position
and dragging and dropping the required lines of the request.
- Note that non-barcode assay requests are not valid for Beltline operation.
- Specimens without barcodes cannot be automatically rescheduled.
6-22
6. System Operation
6.6.3.3. Downloading Assay Requests from a Host Computer

Assay requests can be obtained from a host computer by performing a download operation.
Clicking the Download button in the Assay Request screen displays the following dialog box.
Select either “Receive All Requests” or “Receive Requests for Existing Specimen IDs.”
The downloaded request is displayed in the following dialog box. Select the data to be
assayed, then select the mode and copy to Assay Request screen. Any unnecessary lines
can be deleted from this form.
Any requests issued unilaterally by the host computer will appear as “Reservations” beneath
“Host” on the toolbar.
This dialog box can also be displayed by clicking on Host on the toolbar and selecting from the
Download List.
Although requests for controls can be issued from the host computer, control
results cannot be used as quality control data unless the QC material name is
used as the specimen ID.
6-23
6. System Operation
6.6.3.4. Assay Requests in Host Query Mode

Requests issued to the host computer are referred to as “host queries” in the AIA-1800 system.
Assay requests do not have to be generated when host query mode is used.
The host query mode setting must be entered to enable the system to query the host computer
for assay requests based on scanned barcode information.
This is done by going to the tree view, clicking Host and selecting the Yes in Query status.
When the AIA-1800 reads the specimen ID barcode, it searches the database for an existing
assay request. If not found, it queries the host computer. If an assay request for the specimen
ID is still not found, the specimen is skipped.
6-24
6. System Operation
6.6.4. Specimen Sets

The description given in this section is limited to the built-in sample loader. Refer to the beltline
unit documentation for a description of beltline system operation.
If barcodes are used, specimen order can be random, as they will be processed in assay
request order. If not used, however, they must be loaded in order of position number.
Control and specimen loading positions can be checked in the Assay Request
Point screen. Specimen volumes, on the other hand, are checked by clicking the Print
button in the Assay Request screen and displaying the worklist.
Load a sample rack containing specimens with an end marker (or empty sample rack) inserted
at the final position. Note that the sample loader will simply continue operating unless if
detects the end marker.
Example Using Example Using

End Marker Empty Rack
With specimen
No specimen
End Marker
Empty Rack
Confirm that the sample loader has stopped before attempting to load new
sample racks. Doing so while the loader is still operating may result in
stoppages caused by rack feed errors.
Locations where sample racks cannot be loaded are shown below.
Will not feed properly if inserted along

this path.
The sampling operation ends normally when the sample loader detects the end marker and
stops. If planning additional assay tasks, be sure to load a sample rack containing specimens
and insert a rack containing an end marker before starting.
- An empty rack can be substituted for the end marker.

Point
- A single assay unit is referred to as a “batch” operation in the sample loader. The
sample loader detects the end marker at the end of the sample racks or empty
rack as the end of the batch operation and terminates operation
6-25
6. System Operation
6.6.5. Assay Start

(1) Go to the toolbar, click Assay and Start Assay.
(2) Select the desired assay mode. Be sure to enter the number of the last line (last sequence)
of the assay request when operating in non-barcode mode.
Point System operating modes can be switched between batch processing units.
(3) The Beltline option is included in the mode list on the LA model. Select Beltline mode when
operating from the Beltline.
(4) Clicking the OK button now starts the assay operation. If Clear Assay Monitor is checked,
all data from previous assay operations will be cleared from the Assay Monitor.
The following warning dialog box indicates a reagent shortage. Replenish the
reagent and click OK. Note that affected tests will be skipped if the OK button is
clicked without replenishing reagent.
6-26
6. System Operation
6.6.6. Additional Assay Operations

Wait until the previous batch dispensing operation has completed and the sample loader is
stopped. Then load the next batch of specimens behind the end marker (or empty rack)
inserted at the end of the previous batch. Be sure to include an end marker (or empty rack) at
the end of the new batch. The end marker (or empty rack) must be inserted at the end of every
batch.
After the specimens have been loaded, generate a new assay request and start the assay
operation.
When adding specimens frequently, End pointer can be used for pointing the very end so that
adding point is easily shown.
Previous batch
Additional
batch
END
Insert end marker or

empty rack at the end.
End pointer
Point In cases where the sample loader requires significant time to stop, stop
operation by first selecting Pause from the Assay menu on the toolbar, then
load a new rack.
- Note that additional assay requests cannot be added to the batch once assay
operation has started.
- When entering additional assay operations before the sampling operation for the
current batch has completed, first select Pause to stop the sample loader, then
load the new sample racks. Not pausing the sample loader before loading may
result in stoppages caused by rack feed errors.
- Note that additional assays cannot be entered during automatic retest assay
operations.
When adding new racks while the sample loader is paused, be sure to position
the sample racks in front of the designated line to ensure racks load properly
(see the appropriate warning labels).
Placing racks at the very

back during operation (even
if paused) triggers errors and
stops the sample loader.
6-27
6. System Operation
6.7. STAT Assay Requests

STAT assay requests are entered from the STAT Assay screen. New STAT assay requests will not be
accepted until sampling of the current STAT assay sampling completes.
6.7.1. Entering STAT Specimen Assay Request

The STAT assay request is entered using the STAT Request screen.
(1) Go to the tree view and click STAT Request.
(2) Enter specimen Material type, Specimen ID and specimen container Type.
The STAT port is not equipped with specimen container sensors, so the correct
container type (sample cup or primary tube) must be entered in the Container
Type cell. Incorrect settings can cause abnormal assay results and / or even
damage the sampling nozzle.
(3) Double clicking analytes 1 (to 24) displays the following analyte entry dialog box.
(4) The dialog box shows a list of valid analytes, which are selected by highlighting and
clicking the OK button. The dilution factors displayed for each specimen type can be
modified by clicking the Dil cell.
(5) Right clicking on Analyte cell displays a pop-up menu of registered panels, enabling batch
entry of analytes.
(6) Enter specimen information as necessary once the STAT assay request has been entered
(entry of all information not required).
ERROR CHECK Button

Clicking the ERROR CHECK button checks error of the assay request.
The check process also checks reagent inventory and issues warning messages if a shortage
is detected.
6-28
6. System Operation
6.7.2. Loading STAT Specimens

(1) Check to see if the lamp on the left of the STAT port has turned green.
Lamp
Do not open STAT port when lamp is red, as this may damage the sampling
nozzle.
(2) STAT door is opened by turning the knob to the right.
13 diameter
adapters
(3) Loading the Specimen Container

If using Tosoh sampling cups, insert the sampling cup adapter. If using size 13 diameter
test tubes, insert the 13 diameter adapter.
Point - The test tube length limit is 75 mm.

- The STAT port is not equipped with sample cup and test tube detector sensors,
so specimen container type must be specified in the Request menu screen.
6-29
6. System Operation
6.7.3. Starting STAT Assay Operation
(1) Go to the toolbar, click Assay and select Start Assay.
(2) Select STAT specimen mode.
(3) Clicking OK starts the assay operation.
6-30
6. System Operation
6.8. Assay Pause/Continue

The assay Pause/Continue feature can be used to temporarily pause current specimen dispensing so
that new specimens can be loaded in time for processing during an ongoing operation or when
specimen skip occurs due to a reagent shortage. Assay of already dispensed specimens will
continue.
(1) Go to the toolbar, click on Assay and select Pause.
(2) When the following dialog box appears, click Yes.
(3) Sampling pauses when the next scheduled sampling to begin.

(4) To resume operation, complete the task at hand, then go to Assay and select Pause again
to display the Continue dialog box.
(5) Click Yes when the above dialog box appears.

(6) The paused sampling will now resume.
6-31
6. System Operation
6.9. Assay Monitoring

6.9.1. Assay Monitor
Once assay has started, the assay requests in the Assay Request screen move to the Assay
Monitor screen and the system operator can then monitor assay operation progress using the
Assay Monitor. The background colours of the various status cells are colour-coded to indicate
current status of each cell.
Simply placing the mouse pointer over analytes with assays completed displays the results.
Any unassayed analyte is returned to the Assay Request screen at the end of the assay
operation.
All lines display estimated completion times until the final result of the line is obtained.
The order of the list will be resorted as assay progress. Finished samples will be placed upper,
arranged samples in the middle and scheduled samples lower.
By scrolling the screen to the right can show patient information.

Point The following function keys can be used to change the view of the screen,
F1: Jump to the head line F2: Jump to the last line
F5: Scroll to the left F6: Scroll to the right
F7: Jump to patient information
The incomplete sample or the rescheduled sample can be displayed clicking the List button.
6-32
6. System Operation
The dialog box for the incomplete sample list cannot be edited. The list will not be updated
automatically but by clicking the Update button.
The rescheduled sample list can be found in the dialog box for the rescheduled samples.
An assay request can be created using this list. After selecting the request mode, either
Barcode or NonBarcode, choose the records to be re-assayed, and then click the Create
Request button. The chosen records will be deleted from the list and a new request will be
created accordingly on the Assay Request screen. Some requests in the request screen can
be deleted if they are not necessary.
The dialog box of the reschedule list automatically appears when a result was
Point
judged as reschedule.
The records judged as retest will not be displayed on the reschedule list.
6-33
6. System Operation
6.9.2. Rack Monitor

The Rack Monitor displays the current status of sample racks that have completed sampling
operations. Status information includes sample rack ID, sample rack position and specimen
status.
Patient information can be displayed at the upper right of the screen by clicking on individual
cells.
Specimens whose assay results could not be obtained are displayed on the left side of the
screen, enabling easy sorting and confirmation of specimen positions when rescheduling an
assay operation.
Point This function is available for assay operations performed using the built-in
sample loader.
6-34
6. System Operation
6.9.3. Error Messages

Error messages output during system operation are recorded in the error log file. The following
error dialogue box appears whenever an error occurs. The operator can continue other
operations while the box is displayed.
Each error message has a check box that can be selected to indicate the error was confirmed.
Previous errors can be redisplayed by selecting Log from the Menus.
When the entire error message text cannot be seen, double click the cell to
Point expand the size of the cell. Double-click a second time to restore the cell to its
original dimensions.
Error logs can be deleted by selecting the area, right clicking and then selecting
“delete”. Note that they will not be recovered if once deleted.
6-35
6. System Operation
6.10. Result Review

6.10.1. STAT Specimens
To view only the STAT specimen results, go to the tree view, click Assay Results and Select
STAT specimen. Click on an individual line highlights it and displays patient information at the
top of the screen.
Recalc: Calculates concentration using latest calibration curve

Verify: Selects whether to accept as Final or Reject assay result
Upload: Transmits Final assay results to the host computer
Find: Finds and displays results matching search conditions entered in the
search dialog box
All: Cancel the search and displays all data
Print: Displays preview of print image on-screen
Sort: Sorts results
Register Conditions List:
Registers search conditions set on Find dialog
6-36
6. System Operation
6.10.2. Specimens
To view routine specimen assay results, go to the tree view, click Assay Results and select
Specimens, which displays the following screen. STAT specimen results are also included.
Point - The latest data is shown in the first line of the table.
- To view only STAT specimen results, click Assay Results and select STAT
specimen.
Cell Definitions
Specimen ID: ID of specimen being assayed
Analyte: Assay analyte
Dil: Assay dilution factor
Result: Assay result
Unit: Unit of the assay result
Flag 1: System flags. For a detailed description of flags, refer to Chapter 12:
Appendix 3: Types of Flags.
Flag 2: Calculation flags
Flag 3: Verification flags
Date time: Most recent date and time of assay result calculation
Status: Assay result status
Pending
Reject
Final
Host: Status of result transmission to host computer
I unsent
X send
Operator: Name of operator performing assay operation
Rate value: Rate value
Lot No.: Lot no. of test cup used in assay operation
Position: Specimen position number
Confirmed by: Name of the operator verifying assay results
Assay date and time: Date and time assay operation was performed
6-37
6. System Operation
Button Functions
Recalc
Used to perform recalculation of assay results using valid calibration curves. Select the target
data, then click the Recalc button.
Point Only assay results showing the “Pending” status can be recalculated.
Data Selection Procedure Identical to that of Windows operation.

(Example 1)
When selecting lines 1 to 10 for recalculation:
Use mouse to select line 1.
Hold down the Shift key on the keyboard and select item 10 with the mouse.
With lines 1 to 10 highlighted, click the Recalculate button.
(Example 2)
When selecting lines 1 and 5 for recalculation:
Use mouse to select line 1.
Hold down the Ctrl key on the keyboard and select item 5 with the mouse.
With lines 1 and 5 highlighted, click the Recalculate button.
Verify
Used to check the integrity of results, “Pending” assay results will be either accepted as Final
or Rejected. Data selection procedure is identical to that for Windows. Refer to the Examples
illustrated in the foregoing Recalculate button description.
About Delete UC flag (UC flag function is set as no working at the default setting)
When abnormal pressure is detected during specimen suction, the UC flag will be
attached to the result. The possible causes are the suction of clot or air or high viscosity of
the sample. If the same flag were attached to the retested result even after the removal of
clots or bubbles from the specimen, then high viscosity of the sample would be most
probable. If the result was reproduced and thus the result would be no concern, then the
UC flag could be deleted from the result selecting “Delete UC flag” on the Verification
dialog.
Upload
Used to transmit assay results to the host computer. Select the target data, then click the
Upload button.
The data selection procedure is identical to that of Windows operation. Refer to the examples
above.
6-38
6. System Operation
Reschedule
To reschedule an assay request. Select the results to be re-assayed, then click the
Reschedule button and the reschedule list dialog will appear. After selecting request mode,
whether Barcode or NonBarcode, choose records to request then click the “Create Request”
button.
Find and Register Conditions List

Clicking the Find button displays the Find dialog box that allows users to enter multiple search
conditions. Pressing the Find button in the dialog box retrieves information matching the
search conditions and displays it on a worksheet.
The first search condition can be entered by clicking the Add (AND) button and additional
search conditions can be added by clicking the Add (AND) or the Add (OR) buttons.
For example, to search results whose flag 3 are <L or >H.

Choose “Flag 3” in the Properties box, input “<L” in the Value box and choose “Match
case” in the Condition box, and then click the Add (AND) button. The search condition will
appear in the blank box accordingly. To add a search condition, input “>H” in the Value box
and click the Add (OR) button.
6-39
6. System Operation
Clicking the upper Find button shows the results that meet the search condition set.
Frequent used search condition sets can be registered into the Register Condition List box
using the Register button. Clicking the lower Find button shows the results that meet the
registered condition set. Use the Delete list button to delete research conditions from the
registered list.
"?" in the value box works as a variable in searching.

For example, select “Specimen ID” in the Properties box, input “?” in the Vale box and
choose “A word is included” in the Condition box.
When clicking the upper Find button, the input value dialog will appear as below. After
inputting Specimen ID, click OK. Then the results with the same Specimen ID will be searched
and be displayed on the screen.
All
Clicking All discards search conditions and displays all assay results.
Print
The Print feature allows a printout of the current screen with or without patient information
added (by selecting the check box).
Select the target data then click the Print button. Refer to the examples illustrated above for
the data selection procedure.
Real time reports are printed in the order that data arrives, which means that the most recent
data is printed last.
6-40
6. System Operation
Sort
The order of results displayed on the screen can be specified by the settings in the Sort dialog
box. Three sort keys are available.
These sort conditions are stored automatically. Choose "<None >" at the top of the list to clear
the sort condition.
When no condition is specified for these three keys, the lower most condition is applied.
Point Assay results can be used in other applications by first copying them to the
Clipboard.
(1) Double clicking the mouse switches from line selection to cell selection.
(2) Drag the mouse to select the section of data to copy.
(3) Press Ctrl-C (hold down Ctrl while pressing C) to transfer the data to the Clipboard.
(4) Double clicking the mouse once more to return to line selection mode.
Some function keys can be used to change view as below,

Point F1 (or Ctrl + PageUp key): Jump to the top of the list
F2 (or Ctrl + PageDown key): Jump to the end of the list
These functions are available only when the worksheet is active.
Browsing Previous Data

Previous assay results are stored in the database. Selecting the Past results database
from the Menus switches operation to that database. Note that new assay operations
cannot be started while the past results database is selected.
The system automatically switches back to the current database when an assay operation
is started.
Upload of the past data

It is possible to upload the past data. Note that, however, since the current test file
parameters such as assay range will be used at the time of upload, the test file parameters
used at the time of assays in the past need to be the same as the current parameters.
Note that previous data cannot be recalculated, so it is important to confirm the

data before shutting down the system.
6-41
6. System Operation
6.10.3. Controls
To view control specimen assay results, go to the tree view, click Assay Results and select
Control. The menu items and button functions are identical to those provided in the Assay
Results/Specimens screen.
Point When accepted as Final, control results will be used as QC data.
Recalc: Calculates concentration using latest calibration curve

Verify: Selects whether to accept as Final or Reject assay result
Upload: Transmits Final assay results to the host computer
Reschedule: Reschedule a request on the request screen
Find: Finds and displays results matching the search conditions entered in
the search dialog box
All: Cancel search conditions and displays all data
Print: Displays preview of print image on-screen
Register Conditions List:
Applies registered search conditions.
Sort Changes result order as specified in the Sort dialog
6-42
6. System Operation
6.11. Retest
Retest condition is defined on Flag and Rules screen as follows, (See 8.2 Utilities- Flag and Rules for
further information)
(1) Retest
Retest the sample on the same analytes with the same condition
(2) Retest (TestFileDil.)
Dilute the sample with the dilution factor defined in Test File and retest it on the same
analytes.
(3) Retest (Panel)
Retest the sample on analytes defined in Panel
(It is possible to apply other dilution factor that is not defined in Test File.)
When assay results meet the retest condition, Retest Mode starts. The cell colour turns to be
light blue.
After sampling process on all of requested samples is finished, sample racks are rotated
quickly seeking for the samples to be tested again. Sample rack loading stops as the
corresponded barcode label is found. The sample position must be identical to the original
position. The sought samples are tested with the retest condition defined above.
Point - Samples requested on Barcode Request screen can be retested.

- Retest is available one-time on one sample.
- Request will be rescheduled if the assay has been requested from the Non
Barcode request screen and the flag of the result has been set as “retest”.
- Additional request is NOT available during Retest Mode. It is recommended that

reschedule function is used when additional requests are frequently needed.
- Do not remove any sample racks during Retest Mode, or the samples cannot be
sought.
6-43
6. System Operation
6.12. Emergency Stop
It is recommended that operators perform an emergency stop of the system during assay operations
when the possibility of the system causing personal injury, and/or fire arises.
(1) Turn the power switch on the left side of the main unit off.
(2) Take first-aid measures as necessary to limit any injury or damage.
(3) Report all details of the incident to the nearest Tosoh service centre or local
representative and follow the instructions provided by the service personnel.
Note that the normal shutdown routines will not be performed when the power
supply switch is used to terminate operation.
Main power switch
6-44
6. System Operation
6.13. Shut Down
When assay operations have completed, store specimens, immunoassay reagents and other materials
that deteriorate at room temperature to a refrigerator. Prime the substrate lines with Substrate
Replacement Solution (70% ethanol).
(1) Remove specimens from the sample loader and the entire rack that contains conjugate
and SDS from the Reagent/Tips loader and transfer them to refrigerator.
Cover the tops of the reagent bottles using parafilm etc.
(2) Remove all test cups from the sorter and transfer to refrigerator.
(3) Transfer substrate bottles to refrigerator and replace with Substrate Replacement Solution
bottle.
(4) Closing down the system

Click Database in the Menus and select System Close. Save the Specimen Database
and/or QC Database (according to QC configuration). Saving the databases enables a
new database to be opened.
- The specimen database contains assay data from STAT specimens, routine
Point specimens and control specimens. The QC Database contains QC data.
- It is recommended that the QC Database be closed according to the terms of
Quality Control.
- It is recommended that the specimen database be closed on a daily basis. Log
files will be automatically compressed and stored at the system closing showing
the following message.
- Note that new assay operations cannot be performed until the system is closed in
cases where the current number of assay results exceeds 10,000.
- All specimen results have to be confirmed before the specimen database is
closed, or recalculation cannot be performed.
- Please note that when QC database is closed the database switches to new one
and data in the previous database is not retrievable.
(5) Click the x button located at the top right of the screen, followed by the Yes button shown
below.
6-45
6. System Operation
(6) When the following dialog box prompts you to replace the substrate, confirm that
Substrate Replacement Solution has been set in the substrate compartment and click
“Yes” to commence the substrate flush operation.
(7) The program closes when this procedure has completed. Turn the main power switch off.
(8) Shut down Windows XP.
6-46
7. Maintaining System Precision
7: Maintaining System Precision
7.1. Levey Jennings Chart

Shown in the screen below is the Levey-Jennings chart, which displays control assay results as
determined by the combination of “Analyte-QC Material-Lot No.” as well as related statistical
information.
Point The data displayed in the Levey-Jennings chart is comprised of the assay results
for controls requested as QC materials, which results must have been finalized. It
also includes finalized data filed as calibration checks.
The above screen is the Levey-Jennings chart that can be displayed by selecting “QC Material Name,
Lot and Analyte”. The daily average Levey-Jennings Chart data are displayed on the right of the screen.
Double-clicking a cell displays a dialog box containing detailed data, which can be used to delete
unnecessary data. The authority of Administrator is required to delete unnecessary data.
The R1 to R6 flag assessment results, which are entered using the QC-Selectable Rules screen are
displayed in graph and worksheet form. Also shown in the graph is the calibration log.
The Period is used to set the date range for the Levey-Jennings chart displayed.
7-1
The Update Button (QC update) is used to update the Mean, SD and CV values (expected values), as
well as the Levey-Jennings chart.
Point Pressing F1 key enables “expected” values (mean, SD and CV) to appear on the
input form. Pressing F2 key enables SelectCumulative values (mean, SD and CV)
to appear on the input form.
Statistical Information
Control range（Expected）
Date: The updated date
Mean: Expected average value (corresponds to the mean value of the graph). If the value is
not updated, it is determined from the following formula using the Range Low and
Range High values that were entered when registering the QC material.
Mean = (Range High + Range Low) / 2
SD: Expected standard deviation value (corresponds to the SD value of the graph). If the
value is not updated, it is determined from the following formula using the Range Low
and Range High values that were entered when registering the QC material.
SD = (Range High - Mean) / 2
CV Expected CV%. If the value is not updated, it is determined from the following formula
using the Range Low and Range High values that were entered when registering the
QC material.
CV = (SD / Mean) × 100
Display Period (Selected Cumulative)

This is a statistical value for the graph display period (date range). The mean data for a single day
is calculated as a single item.
Mean: Average value
SD: Standard deviation
CV: CV%
Point
Environment settings can be used to specify the display of three items. Not all
information can be shown in a single screen. Undisplayed results can be viewed
by double-clicking on the graph, which will change the results view. For
information on entering settings, refer to Chapter 8: Section 8.5 Other Settings.
When an analyte is selected in an analyte box while pressing the Ctrl key, control data with the
same analyte but with different lots of the QC material can be displayed in the other control
charts.
7-2
7.2. Registering QC Materials

QC material registration must be performed before any assay control material requests.
(1) Click on QC material in the tree view.
(2) Clicking the Add button displays the following dialog box. To add materials, enter the material
name, Lot No. and expiration date and select analytes by checking the boxes, then click the
OK button.
The Add from File button is used to enter QC material data from previously saved files.
Point Note that hyphens (-) cannot be used for QC material names or lot numbers.
(3) Enter upper and lower acceptable limits for each analyte in the Range Low and Range High
cell.
(4) When simultaneously measuring control materials during calibration, check off the Cal. Chk.
cell and enter the repeat count in the Cal. Chk. Reps. cell
(5) Clicking the Del button deletes the currently displayed material name and lot no.
Point
- While users may register QC materials with the same name but differing lot numbers,
only one can be assayed at a time. In this case, the lot number with the Active
checkbox checked specifies the QC material that will be assayed.
- The control material to be used for quality control operations must first be
registered as a QC material. Note that results of unregistered control materials will
not be used as QC data.
7-3
7.3. Selectable Rules

These are used to set the control range and control rules for the QC materials.
Rules
R1: Result is R1-flagged when one control observation exceeds the specified SD value.
R2: Result is R2-flagged when one control observation exceeds the specified SD value.
R3: Result is R3-flagged when two consecutive control observations exceed the specified
SD value.
R4: Result is R4-flagged when the difference between two consecutive control
observations exceeds the specified SD value.
R5: Result is R5-flagged when four consecutive control observations exceed (in same
direction) the specified SD value.
R6: Result is R6-flagged when ten consecutive control observations fall on the same side
of the mean.
7-4
8. Other Aspects of Operation
8: Other Aspects of Operation
8.1. Utilities - Test File

The Test File menus are used to enter assay parameter settings for individual analytes. For a detailed
description of test file parameters, refer to Chapter 10: Appendix 1 Test Files.
Because test file settings directly affect assay results, only users with Administrator level authority are
permitted to display and edit all test file parameters.
8.1.1. Test File

Analytes used in the AIA-1800 must first be selected and entered as valid system analytes.
The analytes with boxes checked in the list on the left are valid analytes that are available for
selection from the Assay Request screen.
(1) Go to Tree view, and click Test File.

(2) Go to the list on the left of the Test File tab and select the check boxes next to the desired
analytes.
Point Note that test files can be saved with respect to each individual analyte.
Press the Print button to display a print preview.
8-1
8.1.2. Changing Reference Range

The AIA-1800 provides a function that enables users to define specific reference range
according to age group and gender. Flag verification is normally performed using reference
range entered in test files. What is important to note however, is that the reference range
entered in the following screen will override that specified in test files. Therefore, users are
recommended to limit settings to only analyte that are required.
Use this function in strict accordance with the instructions provided by Tosoh
to ensure accurate verification of results.
8-2
8.1.3. Panel
Registering analytes as a panel simplifies complex assay request operations, such as those
used for tumour markers and thyroid hormones, which involve the use of multiple analytes.
(1) Go to Tree view and click Test File.
(2) Click the Panel tab.
(3) Enter panel name and various analytes. Analytes can be selected by clicking on the
Analyte cells and selecting from the dropdown lists.
(4) Note that the panel names entered here can be viewed in the pop-up menus displayed by
right clicking on the Analyte cells in the Assay Request screen. Selecting the panel name
will enable batch entry of all analytes selected.
(5) To delete any unused panels, select the panel name and click the Del button.
8-3
8.2. Utilities – Flags and Rules

8.2.1. Flags
This is used to enter the criteria for determining whether completed assay results are to be
automatically processed with specified operations.
(1) Go to the tree view and click Flags and Rules.

(2) Status (Judge) and specified operations (Action) are defined for each flag, as shown
below.
Selecting the “All Pending” radio button assigns the “Pending” status to all assay results.
Selecting the “User Defined” radio button activates the operation settings specified for each
flag. Completed assay results are either assigned a status or automatically issued an assay
request to reschedule processing, depending on the flag setting.
Flag: (for a detailed description of flags, refer to Chapter 12: Appendix 3: Flags)
Judge: (Assay Result Status)
Final
Indicates that assay results are accepted and fixed as final.
Pending
Indicates that assay results are pending further decision.
Reject
Indicates that assay results (excluding those for calibrators) were rejected. Same status as
when assay results are rejected in the Result screen.
8-4
Action: (Flag-definable Operations)
Reschedule
Automatically generates re-assay requests for the assays put flags in previous assay
cycle.
Reschedule (TestFile Dil.)
Automatically generates a re-assay request based on the dilution factor in the Test file.
When “Reschedule (TestFile Dil.)” is set for the flag “>H”, a re-assay request will be
automatically created with the dilution factor used in the previous assay cycle multiplied by
the number which is set in “Default multiplier for >H” in the Test file.
When being set for the flag “DO”, a re-assay request will be automatically created with the
dilution factor used in the previous assay cycle multiplied by the number which is set in
“Default multiplier for DO” in the Test file.
When being set for another flag other than above, a re-assay request will be automatically
created with the dilution factor used in the previous assay cycle multiplied by the number
which is set in “Dilution factor for each specimen (SP1 or SP2 or Control)” in the Test file.
The maximum dilution factor is 625 times.
Reschedule (Panel)
Automatically generates a re-assay request based on a reschedule panel registered on
the Reschedule Panel tab. The panel can be selected on the Panel cell on the right side.
Refer to “8.2.3 Reschedule Panel tab” in this chapter for reschedule panel setting.
Retest
Automatically generates re-assay requests and starts the assay operation.
Retest (TestFile Dil.)
Automatically generates re-assay requests based on the dilution factor in the Test file and
starts the assay operation.
When “Retest (TestFile Dil.)” is set for the flag “>H”, a re-assay request will be
automatically created with the dilution factor used in the previous assay cycle multiplied by
the number which is set in “Default multiplier for >H” in the Test file.
When being set for the flag “DO”, a re-assay request will be automatically created with the
dilution factor used in the previous assay cycle multiplied by the number which is set in
“Default multiplier for DO” in the Test file.
When being set for another flag other than above, a re-assay request will be automatically
created with the dilution factor used in the previous assay cycle multiplied by the number
which is set in “Dilution factor for each specimen (SP1 or SP2 or Control)” in the Test file.
The maximum dilution factor is 625 times.
Retest (Panel)
Automatically generates re-assay requests based on a reschedule panel and starts the
assay operation. The reschedule panel is registered on the Reschedule Panel tab. The
panel can be selected on the Panel cell on the right side. Refer to “8.2.3 Reschedule Panel
tab” in this chapter for reschedule panel setting
Point Flags are displayed in order of priority with the highest priority flag at the top of
the list.
Flags 01 to 99 are all user-definable flags. The various flag verification criteria
are entered using the Rules Tab.
8-5
8.2.2. Rules
8.2.2.1. Verification Rules for User-Defined Flags

The verification rules for user-defined flags are entered in the Rules Tab.
Flags can be assigned to assay results that satisfy specific verification criteria. Multiple
individual criteria can be defined for flagging.
Use this function in strict accordance with instructions provided by Tosoh to

ensure accurate verification of results.
Flags 01 to 99 are user-definable and can be assigned a two-character (alphanumeric) name.

Flags can be assigned different names according to whether their verification criteria were met
or the verification criteria were not applicable.
Verification results for flags 01 to 99 are displayed at the Flag 3 position in the Result screen.
Flag verification criteria can be defined according to analytes that have been applied, analytes
assigned the flag, conditions, age and gender.
As the verification screen guide illustrates, whether the target falls within the Low (L), Normal
(M) or High (H) range is determined by the use of criteria. The low and high limits here are
reference range (L, H) of the analyte and the values can be modified.
Low Limit High Limit
Low (L) Normal (M) High (H)
[Types of Criteria]
L : Result (Conc.) is in a Low-range
M : Result (Conc.) is in a Normal-range
H : Result (Conc.) is in a High-range
!L : Result (Conc.) is out of Low range
!M : Result (Conc.) is out of Normal range
!H : Result (Conc.) is out of High range
8-6
8.2.2.2. Entering Verification Data Settings
(1) Position the analyte to be assigned the flag on the first line and click the Flag Target
checkbox.
(2) The Reference Range for the Test File is normally entered using the “Low limit” and “High
limit” values (the values entered when the analyte was first entered are used by default.)
(3) With verification criteria, the verifiers (L, M, H, !L, !M, !H) shown in the lower section of the
screen are used to select the type of result values to be flagged.
(4) Two coupling conditions “Or” and “And” are provided and are used according to the
following procedures.
<1> When there is one or zero analyte to be verified, apart from those assigned the flag
(combination conditions are not applied):
Analyte assigned the flags will be flagged when all the verification results are “True”
(items are ignored if the Flag Target checkbox has not been selected.)
<2> When there are multiple analytes to be verified, apart from the one assigned the flag
(and combination condition is “Or”):
When the analyte assigned the flag is “True,” other analytes are checked in sequence
to determine whether their status is True/False/No Result/Not Tested. (See Case A.)
- When “True,” is found, the analyte is flagged and verification terminates.
- When “False,” is found, the analyte is not flagged and verification terminates.
- If all analytes are “No Result,” the analyte is flagged with the “Unverifiable” flag.
- If all analytes are “Not Tested,” verification ends without the analyte being flagged.
<3> When there are multiple analytes to be verified, apart from the one assigned the flag
(and combination condition is “And”):
When the analyte assigned the flag is “True,” other analytes are checked in sequence
to determine whether their status is True/False/No Result /Not Tested. (See Case B.)
In this case all analytes are verified.
- If all analytes are “True,” the analyte is flagged.
- If any analyte is “False,” the analyte is not flagged.
- If any analyte is “No Result,” the analyte is flagged with the “Unverifiable” flag.
- If any analyte is “Not Tested,” and there are no “No Result”, the analyte is not flagged
Verifications are performed at the point when all assay results required for the specimen in
question have been completed.
Assay results include the following indicators
Result normal: Assay result of the detected concentration. Results “DO,” “>H” or
“<L” are verified. In the case of DO, concentrations are verified as
either very high or very low, depending on calibration factor.
No result: Indicates inability to determine the concentration.
This is for cases when all system flags and arithmetic flags (NC, CL,
CE, DL, BH) are assigned.
Not tested: Indicates that analyte was skipped instead of being tested due to
SS or PS status.
8-7
Case A
When the values for analytes A and B are high, or when the values for analytes A and C are
high, the analytes are flagged.
When no concentration is detected for analytes B and C, the analytes are not verified and the
“Unverifiable” flag is applied. In this case, analyte B takes precedence over analyte C and thus
analyte C is not referenced when concentration is detected in analyte B.
If the “Unverifiable” flag is not required it can be disabled by not entering a setting for that
name.
8-8
Case B
When the values for analytes A, B and C are high, analyte A is flagged.
When no concentration is detected for analytes B or C, analyte A is not verified and the
“Unverifiable” flag is applied.
If the “Unverifiable” flag is not required it can be disabled by not entering a setting for that
name.
8-9
8.2.3. Reschedule Panel

The Reschedule Panel is used when rescheduling assayed specimens for new tests based on
different dilution factors. The re-assay operations to be performed are defined in the Flag Tab.
Operations that use panels should specify the rescheduling panel name.
8-10
8.3. Utilities - Host

Communication with the host computer is conducted using a RS232C cable and ASTM E1381-91
and E1394-91 compatible transmission interface or using Ethernet and OpenLA21 standard (HL7
Ver2.4) compatible transmission interface.
Contact the TOSOH Service Center or local representatives if more detailed specifications of the
communication between AIA-1800 and host computer are needed.
8.3.1. ASTM standard
Host Query Status

The AIA-1800 system begins by reading a specimen ID and issuing a query to the
controller PC, which checks its inventory of generated assay requests and returns the
relevant information to the AIA-1800. If matching information is not found, the controller
PC issues a query to the host computer.
Real-time Upload
Specifies the types of specimens for which reports are issued to the host computer when
assay is complete.
Upload Option
Send Instrument Flag With C Record
This specifies whether (or not) to send instrument flags.
Send R Record For Rate

This specifies whether (or not) to send rate values.
Send O Record For Lot

This specifies whether (or not) to send Lot No. of TEST CUP.
8-11
Result Flag 1
This determines the way in which data is reported instead of concentration when no
concentration is obtained.
Result Flag 2 (In cases with results of “>H” or “<L”)

This determines the way in which data is reported instead of concentration when the assay
result is “>H” or “<L.”.
- The test file Assay Range (upper limit and lower limit) is included in reports when
Assay Range is selected.
- The <”, “> symbols are added to the report when Assay Range (< >) is selected.
RS232C and Protocol Settings

Settings are entered here to configure the transmission interface with the host computer.
The settings entered here should not be changed once the connection is established.
Enter parameters in accordance with host computer specifications.
Point Close the system program and restart the system in order to validate the new
parameter settings.
When sending the lot number of TEST CUP to the host, since the data structure
Point
and the length of strings to be sent change, the host should be checked to verify
if it properly works with the change.
8-12
8.3.2. OpenLA21 Standard (HL7 Ver2.4)
Connection Setting
Setting of the IP Address of the host computer and the Port Number between the AIA-1800
and the host computer.
Query
First the AIA-1800 system reads a specimen ID and issues a query to the controller PC.
Then the PC checks the assay requests already generated and stored in it and returns the
relevant information to the AIA-1800. If no matched information was found, the controller
PC issues a query to the host computer when the “Yes” button has been selected.
Real-time Upload
Specifies the types of specimens for which reports is issued to the host computer when
their assays were completed.
AIA Status Auto Sending

Defines if the analyzer status is sent to the LIS periodically.
Result Flag 1
This determines what data is reported instead of concentration if no concentration is
obtained.
Result Flag 2 (In the cases of results of “>H” or “<L”)

This determines what data will be reported instead of concentration if the assay result is
“>H” or “<L”.
- The Assay Range (upper limit and lower limit) in the Test file is included in the reports
when Assay Range is selected.
- The” <” or “>” symbols are added to the report when the Assay Range (< >) is
selected.
Point
Close the system program and restart the system in order to enable the new
parameter settings.
8-13
8.4. Utilities - Specifications

The Specifications screen is used to enter the parameter settings for printing, system operation and
assay and assay results.
8.4.1. Assay Result Report Settings

This parameter selects printout settings to output assay results to the printer when the assay
is completed.
Real-time Report
With the Page Report setting, assay results are printed in the order they are received, a
page at a time as soon as each page is filled. In cases where assay results do not fill an
entire page, they are printed at the end of the assay operation.
With the Specimen Report session, assay results are printed in units of specimens as soon
as all operations for individual specimen IDs have been completed. This enables reports to
be issued for individual patients. Note that any previous results for the same specimen ID
will be included in the report in cases where the system has not been shut down since that
operation.
Real-time Report type

The printing of real-time reports can be specified according to individual specimen type.
Paper Size
A4 is the standard page size for report printouts.
(1) Go to the tree view and click Specifications.

(2) Select appropriate settings for real-time report output and the report type.
8-14
8.4.2. RS-232C Port Setting Parameter

This parameter is used to enter the port assignment settings for RS232C ports used for linking
the AIA-1800, controller PC and host computer. The communications port for the main unit is
assigned using the Analyzer COM Port.
- Be sure to restart the system after changing communication ports in order to

validate the new settings.
- The main unit (AIA-1800) is normally assigned the COM1 port and the host
computer the COM2 port.
8-15
8.4.3. Calibration Auto Acceptance

This parameter selects whether calibration curves are to be accepted automatically or
manually.
- Selecting “Automatic” means that calibration curves generated will be used to

calculate concentrations for all controls processed in the same operation. The new
calibration curve is automatically accepted if it falls within the upper and lower limits
specified in the QC Material screen.
- Selecting “Manual” enables the operator to view the calibration results in the
Calibration screen and decide whether to accept the calibration curves.
8-16
8.4.4. Priority for 10 Minute Assay

This parameter is used to select the priority for 10-minute assays for operations in which
40-minute assays and 10-minute assays are processed together. This setting is ignored if
assays are not mixed.
This parameter is configured to assign assay positions to 10-minute assays after “n” (1 to 9)
number of 40-minute assays. If “0” is entered for “n”, processing of the 10-minute assays must
wait until the immune reactions for the last 40-minute assay has completed.
8-17
8.4.5. Barcode Settings

The AIA-1800 system is designed to operate with a maximum of four different types of
barcodes at one time. Enter parameter settings in accordance with barcode type and
specifications. Note that ITF conventions must be observed for all Tosoh calibrators, which
use the ITF barcode format.
(1) Go to the Barcode Reader Setup section in the Specifications screen and click the Options
button.
This displays the following screen.
(2) Select parameters for each barcode type.

(3) Click the OK button.
Start Digit
Indicates the first digit position used for specimen IDs in barcodes on specimen
containers.
Length
Indicates the valid digit length used for specimen IDs in barcodes on specimen containers.
Example: When the Start Digit is 3 and effective length 10, the specimen ID for barcode
“123456789ABCDE“ will be” 34567890AB”.
For a detailed description of barcode parameters, refer to Chapter 11: Appendix 2: Barcode
Settings.
8-18
8.5. Other Settings
3rd Rack Type

The Reagent/Tips loader accepts up to 3 tip racks. Reagents can be loaded in 3rd Rack
position. Note that the reagent barcode labels cannot be read, in this position, so reagent
information must be entered manually.
Press the Reagent/Tips key on the main unit and load the reagents. Closing the cover
starts the scan process, which displays reagent information and pop-up windows on the
screen. Use these to enter the correct reagent information.
For detailed information on the use of this feature, contact Tosoh service center
or local representative.
Selecting the number of the Levey-Jennings chart windows

The number of Levey-Jennings charts displayed for comparison purposes on a single
screen can be switched between 2 and 3.
8-19
8.6. Utilities - Statistics

The Statistics screen is used to collate the monthly totals for specimens and test cups used.
The number of “Patient Sample” does not mean the number of patients assayed but the number of all
assayed samples including patient samples, controls, calibrators and calibration check materials.
Statistical data can be cleared by going to the Database menu and selecting System Close, followed
by Clear Statistics. Note that you cannot select specific information to clear, but must clear all
information at once.
8-20
8.7. Utilities – Change Logon

This Change Logon screen is used for re-logging on to the system. It is important to log on as
administrator level in order to be able to access all the required menu screens and perform the
necessary actions. In addition to system startup, the log on utility can be used when changing
operators while the system is in operation.
8.7.1. Administrator/Operator Registration

Shut down the AIA-1800 system program and load the User Manager program from the
Windows start menu. In the event that the system administrator password is lost, contact
Tosoh service center or local representative.
(1) Enter the necessary information by clicking the corresponding cells shown in the menu
screen.
User names can be entered using up to 32 alphanumeric characters. Passwords are
entered using up to 32 alphanumeric characters.
Administrators register as “Super User” and assay operators as “Operator.”
Register the required number of users (administrators and operators) for the AIA-1800
system. The factory default administrator username is “root” with no password.
Point
Certain test file parameters are only accessible to administrator level users.
(2) Exit the User Manager program.

(3) Start the AIA-1800 system program, select newly added user from the log on screen and
log on to the system.
8-21
8.8. Beltline Menu Screens

The following menu screen is only provided for the LA model AIA-1800 systems. The beltline unit is
operated using the following menu screen provided on the Toolbar.
Menu
Online: Enables the AIA-1800 to process specimens from the beltline unit
Offline: Disables AIA-1800 processing of specimens from the beltline unit
Restart: Restarts sending specimens from the beltline unit
Error Reset: Clears any errors that occurred during operation with the beltline unit
Signal Control: Displays the following dialog box used for defining the signal configuration of the
beltline unit
Beltline Dialog Box

This displays signal status, as either ON, OFF or “-“ in the case of unknown.
The Signal Control screen is used for maintenance of the beltline unit. It should
not be used during normal operation. For detailed description, refer to the
“Beltline System Manual”.
8-22
9. Maintenance
9: Maintenance
Implementing a program of regular maintenance will ensure maximum safety and optimal performance
for AIA-1800 system operation. Orientation on the correct maintenance procedures is provided during
the installation process. Make sure to allow only qualified, properly trained personnel to perform
maintenance work.

Always perform daily maintenance prior to starting the AIA-1800 system. At system shutdown, replace
the substrate with substrate replacement solution (70% ethanol) and use it to prime the substrate lines.
Do not replace the substrate with distilled water. If left too long, this may cause
contamination of the substrate line and raise the substrate background.
9.1.1. Cleaning the Substrate Lines

If the blank high (BH) flag appears with 4MU Background during daily maintenance, use the
following procedures to clean the substrate lines.
(1) Replace the substrate bottle with the 70% ethanol substrate replacement solution.
(2) Go to the Toolbar, click Substrate and select Replace Substrate from the menu. This starts
the substrate replacement sequence.
(3) Repeat the foregoing procedures three times.
(4) Prepare nitric acid of concentration 0.14 mol/L. (Concentrated nitric acid mixed with
distilled water at 1:100 creates an equivalent concentration.)
(5) Replace the 70% ethanol solution bottle with the one containing the nitric acid solution.
(6) Go to the Toolbar, click Substrate and select Replace Substrate from the menu. This starts
the substrate replacement sequence.
(8) Reinstall the 70% ethanol solution bottle.
(9) Go to the Active Bar, click Substrate and select Replace Substrate from the menu. This
starts the substrate replacement sequence.
(11) Replace the 70% ethanol solution bottle with the substrate bottle. Go to Tree view, and
perform the daily inspection once more.
9-1
9. Maintenance
9.2. Weekly Maintenance

9.2.1. Cleaning Wash Probes
9.2.1.1. Removing B/F Unit
(1) Confirm that the AIA-1800 has stopped operation, then go to the toolbar, click Wash menu and
select B/F Unit Unlock.
(2) After the lock releases, open the Reagent/Tips cover.
(3) Remove the B/F unit by pulling on the knob shown below. (The B/F unit can be removed while
the lamp on the left is on (green).)
Lock Released While Lamp

ON (green) Knob
(4) Close the AIA-1800 system program. (A dialogue box prompting you to replace substrate will
appear. Simply ignore this (Push No) if planning to continue assay operations.)
(5) Turn off the main power.
9-2
9. Maintenance
- Probe tips are constantly in contact with specimens which may contain infectious
substances, so always wear gloves when replacing probes.
- Be sure to turn the system power off before performing maintenance tasks. Personal
injury may result from getting caught in moving mechanical parts of the system.
9.2.1.2. Removing B/F Wash Probes

(1) Loosen the securing screws for the three wash probes and remove them by lifting upward.
Securing Screws
9.2.1.3. Cleaning Wash Probes

(1) Pull off the probe tips from the each of the end of the probes.
Stainless-steel pipe
Probe Tip
(2) Clean the removed probe tips for approximately 5 minutes in an ultrasonic neutral wash
solution bath then wash with deionised water. If still not clean, replace with new probe tips.
(Part No.: 020107)
(3) After cleaning, reattach the probe tips to their probes.
9-3
9. Maintenance
(4) Reinstall by firmly inserting the probe tips with the stainless steel pipe passing through the
center. The stainless steel pipe at the center should protrude slightly past the tip when
correctly installed.
Press on firmly until

stainless-steel pipe
protrudes slightly.
Incorrect Correct
(5) Reinstall wash probes to their position and tighten the securing screws.
Improper installation of the probe tips may cause inaccurate assay results.
9.2.1.4. Installing B/F Unit

(1) After the wash probes have been reinstalled, reinstall B/F unit by pushing it right to the back.
(Unit locks into place when pushed right to the back.)
(2) Close the Reagent/Tips cover.
9-4
9. Maintenance
9.3. Monthly Maintenance

9.3.1. Replacing Filters for Wash Solution and Diluent
(1) Open the lower front doors of the main unit.
(2) Take out the 5 L tank of wash solution or diluent and remove the lid from the side where the
tube is inserted.
(3) As shown in the figure below, remove the wash solution or diluent filter attached to the end of
the suction nozzle and replace with a new one. (Part no.: 018585)
Wash solution or diluent filter
(4) Screw the lid back onto the tank and return it to the main unit.
9-5
9. Maintenance
9.3.2. Replacing Probe Tips of Wash Probes
(1) Confirm that the AIA-1800 has stopped, then go to the Toolbar, click Wash and select B/F
Unit Unlock from the menu.
(2) After the lock is released, open the Reagent/Tips cover.
(3) Remove the B/F unit by pulling on the knob shown below. (The B/F unit can be pulled out
while the lamp on the left is on (green).)
Lock Released While Lamp

ON (green) Knob
Wash Probes
(4) Close the AIA-1800 system program. (A dialogue box prompting you to replace the substrate
will appear. Simply ignore this (Push No) when planning to continue assay operations.)
(5) Turn off the main power.
- Because probe tips are constantly in contact with specimens, which may contain
infectious substances, always wear gloves when replacing probes.
- Be sure to turn the system power off before performing maintenance tasks. Personal
injury may result from getting caught in moving mechanical parts of the system.
9-6
9. Maintenance
(6) Loosen the securing screws on wash probes and remove by lifting upward.
Securing Screws
(7) Pull the tip off the end of the probe.
Probe Tip
(8) Replace with new probe tips. (Part No.: 020107)

(9) Reinstall by firmly inserting the probe tips with the stainless steel pipe passing through the
center. The stainless steel pipe at the center should protrude slightly past the tip when
correctly installed.
Press on firmly until

stainless-steel pipe
protrudes slightly.
Incorrect Correct
(10) Return wash probes to their position and tighten the securing screws.
Improper installation of the probe tip may cause inaccurate assay results.
(11) After the wash probes have been reinstalled, reinstall B/F unit by pushing it right to the back.
(Unit locks into place when pushed right to the back.)
(12) Close the Reagent/Tips cover.
9-7
9. Maintenance
9.4. Three-month Maintenance

9.4.1. Cleaning Wash Solution and Diluent Tanks
Make sure to regularly clean the plastic tanks that hold wash solution and diluent. After mixing, the
two solutions will remain stable for thirty days at room temperature. Simply topping up solution
already in the tank after this period may result in the build-up of mold and bacteria that can change
the pH balance. Changes in pH balance are a potential cause of between-run fluctuations for
some analytes.
Clean tanks thoroughly with tap water, then rinse lightly with distilled water. If mold or bacteria is
discovered, disinfect the tank and the AIA-1800’s wash solution and diluent lines using
hypochlorous acid (or commercially available chlorine bleaches).
Disinfecting procedures are described below.
9.4.1.1. Disinfecting Tanks

(1) Thoroughly wash tank using tap water.
(2) Add approximately two liters of water to the plastic tank, then mix in approximately 20 mL of
hypochlorous acid.
(3) Screw the cap firmly onto the tank and shake thoroughly to clean. Leave cleaning mixture in
tank for about one hour when especially dirty.
(4) Rinse tank well with tap water to remove any residual hypochlorous acid.
9.4.1.2. Disinfecting Solution Lines

(1) Prepare a tank containing about one liter of distilled water. Add to this approximately 10 mL
hypochlorous acid.
(2) Insert the wash solution and diluent suction pipes into the two openings in the tank.
(3) Go to the Toolbar, click Diluent and select Diluent Prime from the menu. Repeat this
procedure five or more times..
(4) Go to the Toolbar, click Wash and select Wash Solution Prime from the menu. Repeat this
procedure five or more times.
(5) Remove the wash solution and diluent pipes from the tank.
(6) Rinse tank well with tap water to remove any residual hypochlorous acid.
(7) Add 1 liter of distilled water to the tank.
(8) Insert the wash solution and diluent suction pipes into the two openings in the tank.
(11) Insert the wash solution and diluent suction pipes into their respective newly mixed tanks of
wash solution and diluent.
9.5. Six - to- 12 Month Maintenance Tasks

To ensure stable operation of the AIA-1800 system, it is important to regularly lubricate the moving parts
with grease, perform position accuracy adjustments and clean the various system parts at regular
intervals. These maintenance tasks are performed at regular intervals by service personnel.
9.6. When Idle for Long Periods

It is recommended that wash solutions and diluents be discarded and their supply lines primed with
distilled water when the system is left idle for extended periods. Also make sure to empty the waste tank
and the waste box of cups and tips. Prime the substrate lines with the 70% ethanol substrate
replacement solution and confirm that the main power switch has been turned off.
9-8
9. Maintenance
9.7. Startup after Extended Idle Period

It is important to clean the wash probes, as wash solution tends to crystallize on probe tips, preventing
normal solution dispense and suction performance when the system has been idle for extended periods.
Any errors involving abnormal dispense of wash solution and diluent over the course of daily
maintenance inspections is possibly caused by air not having been completely purged from the solution
supply lines. Make a point of going to the Diluent and Wash button menus on the Toolbar and performing
Diluent Dispense and Wash Solution Dispense operations several times before the daily maintenance.
Clean the substrate lines first with nitric acid, then with the 70% ethanol solution before switching to
substrate. For description of procedures, refer to “Chapter 9: 9.1.1 Cleaning the Substrate Lines.”
9.8. Controller PC
9.8.1. Maintaining Optimum Performance
Operating the AIA-1800 for extended periods results in a large build-up of information in the
database that can slow down processing speeds and destabilize system operation. If this occurs,
follow the procedures listed below.
(1) Shut down system. (Save current database and change to new database).
For detailed description, refer to “Chapter 6: 6.12 Shutting Down Operation.”
(2) Close Windows XP.
(3) Run Defrag and ScanDisk (refer to the Help and support features provided for Windows XP).
System Shutdown
Running Defrag and
Item Specimen QC database Program close
ScanDisk
Database
Recommended When shutting QC segments When shutting Once every 3 months (as
times down system down system a rule)
(daily basis) (daily basis)
Point Defrag may take up to several hours so should be performed overnight.
9.8.2. System Backup

It is recommended that system files be backed up on a regular basis as a precaution against
system failure. This can be done easily using the CD-RW drive on the controller PC. Make sure
that all main unit operation has stopped, then simply save the entire C:\Nexus folder to the backup
disk.
Point Refer to the CD burning software help files for information on operating the CD-RW drive.
- Wait until system operation has terminated before backing up the Nexus system
files.
- Attempting to perform the backup operation while the system is still operating may
damage the files.
9-9
9. Maintenance
9.9. Consumables (Supplies)
No. Part No. Description Specifications Quantity

1 019215 Sample tip 1000/box 1 box
2 019216 Tip rack(without tips) － 1
3 018581 Sample cup 1000/ bag 1 bag
4 020100 Sample rack with spring, 18/box 1 box
5 020101 Sample cup adapter 10/ bag 1 bag
6 020104 Waste bag (for cups) 10/ bag 1 bag
7 020105 Waste bag (for tips) 10/ bag 1 bag
Filters Wash solution and
8 018585 10/ bag 1 bag
Diluent
10 020107 Probe tip for AIA-1800, 5/bag 1 bag
11 020102 Reagent rack (6 holder) with spring 1
12 020106 End marker for AIA-1800 1
13 013647 Wash solution/Diluent tank 5L 1
14 016320 Waste fluid tank 10L 1
15 015970 Standardization cup (STD) 200/box 1 box
16 015971 Sample treatment cup (STC) 200/box 1 box
9.10. Maintenance Parts

Service personnel will replace maintenance parts whenever necessary.
No. Part No. Description Specifications

1 020167 Fluorescent detector unit for AIA-1800
2-way solenoid valve (waste
2 020178 MCV-2R-NM6F
fluid)
3-way solenoid valve (wash
3 020171 MCV-3R-NM6F
solution)
4 020174 3-way solenoid valve (substrate) MTV-3-NM6NATS
5 020160 Wash probes 1 and 2 for AIA-1800
6 020161 Wash probe 3 for AIA-1800
7 017121 Seal breaker head common with AIA-600II
8 020155 Substrate syringe for AIA-1800
9 020156 Bushing (wash syringe) for AIA-1800
10 020169 Diluent pump NF10
11 018606 Check valve (for diluent line) MFP-3-E
12 020177 Waste pump NF30
13 020146 Vacuum pump SPP-15EBS-160
14 020147 Vacuum filter VFU3-66
15 020148 Rubber heater ass’y for Dispense Lane
16 020157 Sheet heater ass’y for incubator
17 020165 Sheet heater ass’y for upper turntable
18 020166 Sheet heater ass’y for lower turntable
19 020168 Diluent heater ass’y diluent
20 020170 Wash solution heater ass’y wash solution
21 020172 Substrate heater ass’y substrate
Barcode reader (specimen,
22 020153 BL185
Reagent)
23 020142 Barcode reader (sorter) BL180
9-10
10. Appendix 1 Test Files
10: Appendix 1 Test Files
The assay conditions (sampling volume, calibration curves figure, and dilution factor) for individual analytes
are entered in test files. This chapter provides detailed description of the various items that go into the test
files.
Symbols R, W or H under an item show edit permission to a systems engineer, a super user, and an operator,
respectively in that order. If no symbol is shown, all users can edit the item.
R means Readable only, W means Writable and H means Hidden (not displayed).
Item Meaning
Unit Unit of measurement for concentrations.
Used when displaying, printing and sending to the host computer assay
results.
Decimal places Specify the degree of concentration in decimal terms.
Used when displaying, printing and sending to the host computer assay
results expressed in decimals.
Reference Range low (L) Specifies lower limit of reference range.
Under range assay results are assigned the L flag. Set L value after
reference range is established.
Reference Range high (H) Specifies upper limit of reference range.
Over range assay results are assigned the H flag. Set H value after
reference range is established.
Reschedule low Specifies lower limit for rescheduling range.
Under range assay results are assigned the RL flag. Defaults to Assay
range low value when this limit is not used.
Reschedule high Specifies upper limit for rescheduling range.
Over range assay results are assigned the RH flag. Defaults to Assay
range high value when this limit is not used.
Assay range low Specifies lower limit for assay range.
Under range assay results are assigned the <L flag.
Assay range high Specifies upper limit (linearity) for assay range.
Over range assay results are assigned the >H flag.
Reference
<L RL L Range H RH >H
Reference Range
Reschedule Range
Assay Range
Item Meaning
Specimen diluent code Specifies code used for specimen diluting solution (SDS).
Specimen diluent name Specifies name used for specimen diluting solution (SDS).
Dilution factor for Sp.1 Specifies default dilution factor for specimen material 1 (Sp.1).
Dilution factor for Sp.2 Specifies default dilution factor for specimen material 2 (Sp.2).
Dilution factor for Control Specifies default dilution factor for control sample.
Default multiplier for DO Default multiplier for generating reschedule request when assay result
flagged with Detector-over-range (DO) flag. Current dilution factor will be
multiplied by this value.
Default multiplier for >H Default multiplier for generating reschedule request when assay result
flagged with >H flag. Current dilution factor will be multiplied by this
value.
Factor A, B Compensation factors (concentrations).
Cal. formula: Y = AX + B, where A is the slope and B is the y-intercept
(X: conc. before factored, Y: conc. after factored)
10-1
10. Appendix 1 Test Files
Item Meaning
Calibration code Specifies code defining calibration curve model constants (fixed value).
RW R R
Calibrator replicates (n) Specifies number of times same-concentration calibrator measurements
are replicated when generating curves.
Calibrator lot 16-digit number used to specify calibrator lot.
RW RW H
Calibrator name (1-12) Specifies names of calibrators of various concentrations. Calibrator
RW RW H names are automatically generated when their lot numbers are entered.
Names cannot be entered directly.
Calibrator conc. 1-12 Specifies concentrations for calibrators.
RW RW H Between 2 and 6 different concentrations may be used, depending on
analyte type.
Dilution factor for Calibrator Specifies calibrator dilution factor.
(Cal)
RW RW H
Calibration Period Specifies valid period of calibration curve.
RW R H
Incubation Time (10/40)
RW R H
Assay Protocol (1-4)
RW R H
Specimen Volume
RW R H
Diluent Volume
RW R H
Conjugate Volume
RW R H
Diluted Conjugate Volume
RW R H
Pretreatment
RW R H Represent parameters specific to individual measurements.
Pretreatment Specimen Volume Do not modify.
RW R H
Pretreatment Reagent Code
RW RW H
Pretreatment Reagent Name
RW RW H
Pretreatment Reagent 1
Volume
RW R H
Pretreatment Reagent 2
Volume
RW R H
System Factor
RW R H
Calibration Check Code Used to check calibration lot entered manually.
RW R H
Virtual Concentration Parameters in log-logit cubic format specifying virtual concentration.
RW R H
Graph Origin Parameters in log-logit cubic format specifying graph origin.
RW R H
Calculation with Dilution Factor This factor is for result review.
RW RW R
10-2
11. Appendix 2: Barcode Settings
11: Appendix 2: Barcode Settings
The definitions for the parameter settings in the Barcode Settings screen are provided below.
11.1. CODE 39
(1) Start Stop Character Output
Specifies whether to read the asterisk“*”, used as a start stop character, as part of the ID.
ON read as part of ID
OFF do not read
(2) Check Digit Check
Specifies whether to perform check digit verification.
ON check digit verification enabled
OFF check digit verification disabled
(3) Check Digit Output
Specifies whether to use check digit as part of the ID.
ON use
OFF do not use
11.2. CODABAR (NW-7)

(1) Start Stop Character Output
Specifies whether to read the “A,B,C,D,a,b,c,d”, used as start/ stop characters, as part of
the ID.
ON read as part of ID
OFF do not read
(2) Start Stop Character
Specifies the type of start/ stop character to use.
Uppercase A, B, C, D
Lowercase a, b, c, d
Specifies whether to perform the check digit verification.
Specifies whether to use check digit as part of the ID.
ON use
OFF do not use
(5) Check Digit
“Specifies the checking mode to use when “check digit verification enabled” is selected.
- Modulus16
- Modulus11
- Modulus10 2W
- Modulus10 3W
- 7 Check DR
- Modulus11-A (weighted modulus 11)
- Modulus10 2W-A (runes)
11-1
11. Appendix 2: Barcode Settings
11.3. ITF
Note that ITF cannot be disabled as ITF is used in the calibrators and controls supplied by
Tosoh.

Specifies whether to perform check digit verification.
Specifies whether to use check digits as part of the ID.
ON use
OFF do not use
11.4. CODE 128

(1) Double Character Start Pattern Check
Specifies whether to perform “double character start pattern check.”
ON check enabled
OFF check disabled
11-2
12. Appendix 3: Flags
12: Appendix 3: Flags
The various assay results are flagged to indicate status. Descriptions of the flags are provided in the
following sections.
The concentration values displayed together with system flags are for use as
reference values. It is important that users not ignore the flags with assay
results of the AIA-1800.
12.1. Flags with Concentrations

12.1.1. Blank
Indicates that assay results are within the normal range.
Print, display (rate value) : outputs obtained value
Print, display (concentration value) : outputs calculated value
RS-232C output (concentration value) : outputs calculated value
RS-232C output (flag) :N
12.1.2. L
Indicates that assay result is below the lower limit value of reference range (Reference range
(L) value). This flag will not be attached to control results.
RS-232C output (flag) :L
12.1.3. H
Indicates that assay result is above the upper limit value of reference range (Reference range
(H) value). This flag will not be attached to control results.
RS-232C output (flag) :H
12.1.4. RL
Indicates that assay result is below the lower limit of reschedule range (Reschedule (L) value
in test file). This flag will not be attached to control results.
RS-232C output (flag) :L
The RL check is only performed for the first assay result with concentration
value for a single analyte of a single specimen.
12.1.5. RH
Indicates that assay result is above the upper limit of reschedule range (Reschedule (H) value
in test file). This flag will not be attached to control results.
Print, display (concentration value) : outputs calculation value
RS232C output (concentration value) : outputs calculation value
RS232C output (flag) :H
The RH check is only performed for the first assay result with concentration
value for a single analyte of a single specimen.
12-1
12.2. Calculation Failures for High Concentration Specimens

12.2.1. DO
Calculation failed due to specimen concentration exceeding Detector Unit detection range.
->Dilute specimen and reschedule assay operation.
Print, display (rate value) : blank
Print, display (concentration value) : blank
RS232C output (concentration value) : Follow the “Flag 1” setting of the Upload Option in
Utility-Host screen
RS232C output (flag) :A
12.2.2. >H
Calculation failed due to assay result being over assay range (represented by assay range
upper limit value in test file).
->Dilute specimen and reschedule assay operation.

RS232C output (concentration value) : Follow the “Flag 2”setting of the Utility-Host screen
RS232C output (flag) :>
12.3. Calculation Failures for Low Concentration Specimens

12.3.1. <L
Calculation failed due to assay result being under assay range (represented by assay range
lower limit value in test file).

RS232C output (concentration value) : Follow the “Flag 2” setting from the Utility-Host
screen
RS232C output (flag) :<
12.4. Sampling Failures

12.4.1. SS
Indicates that sampling failed due to shortage of sample.
->Increase sample and reschedule assay operation.
RS232C output (concentration value) : Follow the “Flag 1” setting of the Utility-Host screen
12.4.2. NS
Indicates that sampling failed due to no sample (container) present.
->Check sample (container) and reschedule assay operation.
12-2
12.4.3. SC
Indicates that vacuum pressure exceeded abnormal level after the suction of a specimen. The
measurement will be skipped due to clogging.
->Check for lumps or clots. If found, use centrifuge to remove and reschedule assay
operation.
12.4.4. UC
Indicates that abnormal vacuum pressure pattern was observed during the suction of a
specimen. The cause could be semi-coagulated specimen or air suction or high viscosity of a
sample.
->Check if there is no lump, clots or bubbles in the specimen. If found, make a centrifugation to
remove them and reschedule assay operation. If the same flag was attached to the retested
result again, the possible cause is high viscosity of the sample.
12-3
12.5. Calibration Failures

12.5.1. NC
Indicates that the calculation of concentration failed because no calibration curve was found
or the calibration curve was “void+”.
->Measure calibrator and register calibration curve. Then reschedule assay operation.
12.5.2. CL
Indicates concentration calculation failed due to calibration curve not registered (accepted).
->Register (have accepted) calibration curve and reschedule assay operation.
12.5.3. CV
Indicates validity of calibration curve has expired. The expired calibration curve was used to
calculate concentration.
->Calibrate reference solution, register calibration curve and reschedule assay operation.

Print, display (concentration value): outputs calculation value or blank when assigned >H
or <L
Follow the “Flag 2” setting of the Utility-Host screen
when >H or <L is assigned
12.5.4. CE
Indicates calculation error due to use of approximate expression for calibration curve.
->Check calibration curve and reschedule assay operation.
12-4
12.6. Reagent Errors

12.6.1. BH
Indicates substrate background high (BH).
->Change to new substrate and reschedule assay operation.
Print, display (concentration value) : outputs calculation value or blank when >H or <L is
assigned
RS232C output (concentration value) : outputs calculation value or follow the “Flag 2”
setting of the Utility-Host screen when >H or <L is
assigned.
12.6.2. PS
Indicates inability to perform assay operation due to test cup shortage.
->Replenish test cups and reschedule assay operation.
12.6.3. RS
Indicates inability to conduct assay operation due to conjugate shortage.
->Replenish conjugate and reschedule assay operation.
12.6.4. ES
Indicates inability to conduct assay operation due to pretreatment solution shortage.
->Replenish pretreatment solution and reschedule assay operation.
12.6.5. TS
Indicates inability to conduct assay operation due to sample tip shortage.
->Replenish sample tips and reschedule assay operation.
12-5
12.6.6. LS
Indicates inability to conduct assay operation due to SDS shortage.
->Replenish SDS and reschedule assay operation.
12.6.7. WS
Indicates inability to conduct assay operation due to wash solution shortage.
->Replenish wash solution and reschedule assay operation.
Print, display (rate value) : outputs calculation value
Print, display (concentration value) : outputs obtained value blank when NC, CL, CE, >H
or <L is assigned
RS232C output (concentration value) : outputs calculation value or Follow the “Flag 1”
setting of the Utility-Host screen when NC, CL or CE is
assigned. Follow the “Flag 2” setting of the Utility-Host
screen when >H, or <L is assigned.
12.6.8. BS
Indicates inability to conduct assay operation due to substrate shortage.

->Replenish substrate and reschedule assay operation.
Print, display (rate value) : outputs calculation value
Print, display (concentration value) : outputs obtained value blank when NC, CL, CE, >H
or <L is assigned
RS232C output (concentration value) : outputs calculation value or Follow the “Flag 1”
setting of the Utility-Host screen when NC, CL or CE is
assigned. Follow the “Flag 2” setting of the Utility-Host
screen when >H, or <L is assigned.
12.6.9. DS
Indicates inability to conduct assay operation due to diluent shortage.
->Replenish diluent and reschedule assay operation.
Print, display (concentration value) : outputs calculation value or blank when NC, CL, CE,
>H or <L is assigned
when NC, CL or, CE is assigned. Follow the “Flag 2”
setting of the Utility-Host screen when >H, or <L is
assigned.
12-6
12.7. Analyzer Errors

12.7.1. IO
Indicates temperature malfunction occurred in incubator used for antibody-antigen reactions
and enzyme reactions.
->Contact Tosoh service center or local representative.
Print, display (concentration value) : outputs calculation value or blank when NC, CL, CE,
setting of the Utility-Host screen when >H, or <L is
assigned.
12.7.2. WU
Indicates B/F separation failure.
->Perform maintenance of wash probes by referring to “Chapter 9: Maintenance.”
If this fails to resolve the problem, contact Tosoh service center or local representative.
Print, display (concentration value) : outputs calculation value blank when NC, CL, CE,
setting of the Utility-Host screen when >H or, <L is
assigned.
12.7.3. DL
Indicates malfunction in detector unit or substrate dispense failure.
->Contact Tosoh service center or local representative.
Print, display (concentration value) : blank.
12.7.4. SE
Indicates that either operator terminated (aborted) operation or system error occurred.
12-7
12.7.5. MF
Indicates inability to perform assay operation due to mechanical failure.
12.7.6. NB
Indicates inability to perform assay operation due to no breaking (NB) of test cup seal.
12.7.7. RF
Indicates inability to perform assay operation due to error when dispensing conjugate.
12.7.8. SP
Indicates in ability to perform assay operation due to one of the following causes.
- Either sorter or Reagent/Tips cover was open at the operation.
- Reagent/Tips cover was open at conjugate dispense operation.
- Mismatch error detected when comparing specimen ID received from host and ID of
specimen arriving at beltline when operating in beltline query mode.
- Other causes.
12-8
13. Appendix 4: Error message
13: Appendix 4: Error message
[0001] Instrument power off

Cause: Unable to execute task due to instrument power off.
Solution: Turn on instrument power and retry operation.
[0002] Instrument not initialized

Cause: Instrument not ready due to initialization sequence in progress.
Solution: Wait for initialization sequence to finish, then retry operation.
[0003] Instrument busy

Cause: Instrument unable to accept new task while task currently in progress.
Solution: Wait until instrument finishes current task, then retry operation.
[0010] Sorter drawer open

Cause: Task suspended due to sorter drawer-open status detected.
Solution: Close sorter drawer, then retry operation.
[0012] Reagent/Tip cover open

Cause: Task suspended due to Reagent/Tip cover-open status detected.
Solution: Close Reagent/Tip cover, and then retry operation.
[0020] Beltline BCR not installed

Cause: Beltline BCR option setting not entered in system mode settings (NexusConst.ini file).
Solution: Use the P00 command to enter 'HITACHI' for the 'Beltline' setting or the P03 command to enter
'Beltline BCR option' for the 'Mode' setting in the NexusConst.ini file.
[0100] Sorter scan error

Cause: Error occurred in mechanism during sorter scan. Measuring operation paused.
Solution: Open sorter drawer and inspect interior. Then close drawer and resume measuring operation.
[0102] Reagent/Tip scan error

Cause: Error occurred in mechanism during Reagent/Tip scan. Measuring operation paused.
Solution: Open Reagent/Tip cover and inspect interior. Then close cover and resume measuring
operation.
[0200] Sorter drawer lock open

Cause: Sorter drawer lock-open state detected while executing task. Measuring operation paused.
Solution: Press Cup Sorter key to lock drawer. Then resume measuring operation.
[0201] Reagent/Tip loader cover lock open

Cause: Reagent/Tip loader cover lock-open state detected while executing task. Pause any measuring
operation in progress.
Solution: Press 'Reagent/Tips' key to lock cover. The system then automatically resumes any measuring
operation in progress.
[0300] Waiting for sorter scan operation to complete

Cause: Either a sorter scan error has occurred or a normal scan operation is still in progress. Measuring
operation paused.
Solution: If not due to scan operation, open sorter drawer and inspect interior. Then close drawer and
system resumes measuring operation.
[0302] Waiting for Reagent/Tip scan operation

Cause: Either a Reagent/Tip scan error has occurred or normal scan operation is in progress.
Measuring operation paused.
Solution: If not due to scan operation, open Reagent/Tip cover, inspect interior and close the cover.
13-1
[0400] Sorter scheduled to start soon

Cause: Sorter operation for Pretreatment task is scheduled in 2 minutes. However, the system has
detected a Sorter Pause command. If this is not changed, the operation will not be performed
and Sample Pause (SP) flag will be attached to the assay items.
Solution: Complete reagent filling operation and close sorter drawer within 30 seconds.
[0401] Reagent/Tip loader scheduled to start soon

Cause: System operation for pretreatment (or tip-attaching and reagent-loading for
Conjugate-dispensing) is scheduled in 1.5 minutes. However, the system has detected
Reagent/Tip Pause command. If this is not changed, the operation will not be performed and
Sample Pause (SP) flag will be attached to the assay items.
Solution: Complete reagent/tip filling operation and close drawer within 30 seconds.
[0410] Reagent bottle not installed

Cause: Reagent bottle is not installed in specified location. Terminating current task.
Solution: Install the reagent bottle and run scan. Then retry operation.
[0500] Pretreatment reagent layout error

Cause: Pretreatment reagent in Reagent/Tip loader not arranged in the designated order (bottle 2
positioned to the right of bottle 1 in rack-position). Specified reagent will not be registered in
inventory.
Solution: Reposition Pretreatment reagent bottles 1 and 2 in their designated (contiguous) order.
[1010] Timed out waiting for data from PC

Cause: Data being received via RS-232C CH0 is not received within the designated 30 sec period.
Solution: Inspect cables and connections.
[1011] Timed out waiting for data from Beltline

Cause: Entire receive data is not received within 2sec of header when data received via RS-232C CH1.
Solution: Inspect cables and cable connections.
[1020] Too much data received from PC

Cause: RS-232C CH0 received data exceeding 256 characters.
[1021] Too much data received from Beltline

Cause: RS-232C CH1 received data exceeding 256 characters.
[1030] Overrun error while receiving data from PC

Cause: Hardware overrun detected at RS-232C CH0.
Solution: Inspect cables and cable connections
[1031] Overrun error while receiving data from Beltline

Cause: Hardware overrun detected at RS-232C CH1.
[1040] Frame error while receiving data from PC

Cause: Hardware frame error detected at RS-232C CH0.
[1041] Frame error while receiving data from Beltline

Cause: Hardware frame error detected at RS-232C CH1.
[1050] Parity error while receiving data from PC

Cause: Hardware parity error detected at RS-232C CH0.
[1051] Parity error while receiving data from Beltline

Cause: Hardware parity error detected at RS-232C CH1.
13-2
[1060] Buffer overflow receiving data from PC

Cause: Over 512 characters received in single transfer at RS-232C CH0.
[1061] Buffer overflow receiving data from Beltline

Cause: Over 512 characters received in single transfer at RS-232C CH1.
[1070] Transmission to PC timed out

Cause: RS-232C CH0 transmission failed to complete within the designated 10sec period.
Solution: Contact local service center. Inspect the MAIN board.
[1071] Transmission to Beltline timed out

Cause: RS-232C CH1 transmission failed to complete within designated period.
[1101] Unable to send to Slave1

Cause: Consecutive FIFO FULL states detected when writing to FIFO CH1.
Solution: Contact local service center. Inspect the SLV#1 and MAIN boards.



[1111] Unable to receive from Slave1

Cause: Consecutive FIFO EMPTY states detected when receiving from FIFO CH1.


Solution: Contact local service center. Inspect SLV#3 and MAIN boards.

[1121] Receive data overrun from Slave1

Cause: Illegal (long) data length detected when receiving from FIFO CH1.



13-3
[1131] Receive frame error from Slave1

Cause: Frame error detected when receiving from FIFO CH1.



[1200] Illegal command length received from PC

Cause: Abnormal length command detected when checking received command.
Solution: Contact local service center. Inspect cables and cable connections.
[1210] Invalid command received from PC

Cause: Invalid command content detected when checking received command.
Solution: Contact local service center. Inspect cables and cable connections.
[1220] Invalid message received from SLV board

Cause: Illegal data was detected in message received via FIFO from SLV board.
Solution: Contact local service center. Inspect the SLV board and MAIN board.
[1300] Error when resending to PC

Cause: Retry error occurred when resending to RS-232C CH0.
Solution: Contact local service center. Inspect the PC and the various cables and connections.
[1301] Error when resending to Beltline

Cause: Retry error occurred when resending to RS-232C CH1.
Solution: Contact local service center. Inspect the PC and the various cables and connections.
[1310] No response from PC

Cause: No response to ENQ was received from RS-232C CH0.
Solution: Contact local service center. Inspect the PC, its various cables and connections and the MAIN
board.
[1311] No response from Beltline

Cause: No response to ENQ was received from RS-232C CH1.
Solution: Inspect the Beltline and its cables and connections. If the problem persists, inspect the MAIN
board.
13-4
[2000] Diluent low! Operation stopped

Cause: Measuring stopped due to low Diluent tank level detected at start of measurement.
Solution: Replenish Diluent and restart operation
[2001] Washer low! Operation stopped

Cause: Measuring stopped due to low washer tank level detected at start of measurement.
Solution: Replenish washer and restart operation
[2002] Substrate low! Operation stopped

Cause: Measuring stopped due to low substrate bottle level detected at start of measurement.
Solution: Replenish substrate (replace bottle) and restart operation
[2003] Waste tank full! Operation stopped

Cause: Measuring stopped due to waste tank full detected at start of measurement.
Solution: Empty out waste tank and restart operation.
[2004] STD cup short! Operation stopped

Cause: Measuring stopped due to STD cup shortage detected at start of measurement.
Solution: Replenish STD cups and restart operation.
[2005] Sample tip short! Operation stopped

Cause: Measuring stopped due to sample tip shortage detected at start of measurement.
Solution: Replenish sample tips and restart operation.
[2007] Substrate and washer priming error! Operation stopped

Cause: Wash Solution priming operation failed to complete within 5 minutes.
Solution: Contact local service center. Inspect mechanism and restart measuring operation.
[2010] Dispense lane temperature control error! Operation stopped

Cause: Dispense lane temperature too low at start of measurement.
Solution: Contact local service center. If temperature is still low after waiting 30 minutes, inspect Dispense
lane heater and temperature sensor (T030).
[2011] Incubator temperature control error! Operation stopped

Cause: Incubator temperature too low at start of measurement.
Solution: Contact local service center. If temperature is still low after waiting 30 minutes, inspect Incubator
heater and temperature sensor (T120).
[2012] Detector table lower heater temperature control error! Operation stopped
Cause: Detector table lower heater temperature too low at start of measurement.
Solution: Contact local service center. If temperature is still low after waiting 30 minutes, inspect Detector
table lower heater and temperature sensor (T140).
[2013] Detector table upper heater temperature control error! Operation stopped
Cause: Detector table upper heater temperature too low at start of measurement.
Solution: Contact local service center. If temperature is still low after waiting 30 minutes, inspect Detector
table upper heater and temperature sensor (T141).
[2014] Washer temperature control error! Operation stopped

Cause: Washer temperature too low at start of measurement.
Solution: Contact local service center. If temperature is still low after waiting 30 minutes, inspect Washer
[2015] Diluent temperature control error! Operation stopped

Cause: Diluent temperature too low at start of measurement.
Solution: Contact local service center. If temperature is still low after waiting 30 minutes, inspect Diluent
[2016] Substrate temperature control error! Operation stopped

Cause: Substrate temperature too low at start of measurement.
Solution: Contact local service center. If temperature is still low after waiting 30 minutes, inspect
Substrate heater and temperature sensor (T170).
13-5
[2017] Dispense lane temperature malfunction! Operation stopped

Cause: Dispense lane temperature abnormal at start of measurement.
Solution: Contact local service center. Inspect Dispense lane heater and temperature sensor (T030).
[2018] Incubator temperature malfunction! Operation stopped

Cause: Incubator temperature error occurred again at start of measurement.
Solution: Contact local service center. Inspect incubator heater and temperature sensor (T120).
[2019] Detector table lower heater temperature malfunction! Operation stopped

Cause: Detector table lower heater temperature error occurred again at start of measurement.
Solution: Contact local service center. Inspect detector table lower heater and temperature sensor (T140).
[2020] Detector table upper heater temperature malfunction! Operation stopped

Cause: Detector table upper heater temperature error occurred again at start of measurement.
Solution: Contact local service center. Inspect detector table upper heater and temperature sensor
(T141).
[2021] Washer temperature malfunction! Operation stopped

Cause: Washer temperature error occurred again at measuring start.
Solution: Contact local service center. Inspect washer heater and temperature sensor (T160).
[2022] Diluent temperature malfunction! Operation stopped

Cause: Diluent temperature error occurred again at start of measurement.
Solution: Contact local service center. Inspect Diluent heater and temperature sensor (T150).
[2023] Substrate temperature malfunction! Operation stopped

Cause: Substrate temperature error occurred again at start of measurement.
Solution: Contact local service center. Inspect substrate heater and temperature sensor (T170).
[2030] Sample loader specimen ID mismatch error

Cause: Mismatch error detected when comparing pre-programmed specimen ID and ID of specimen
arriving at sample loader. Assay result will be flagged (SP flag).
Solution: Terminate current task, then retry assay operation. If the problem recurs, Contact local service
center.
[2031] Beltline specimen ID mismatch error

Cause: Mismatch error detected when comparing pre-programmed specimen ID and ID of specimen
arriving at sample loader. Assay result will be flagged (SP flag).
Solution: Terminate current task, then retry assay operation. If the problem recurs, Contact local service
center.
[2032] No response to QUERY sent to PC

Cause: PC failed to respond within 2 min to QUERY from Instrument.
Solution: Contact local service center. Inspect integrity of PC system operation.
[2040] BF wash unit not fixed into position

Cause: S1311 sensor detected position not fixed state in BF wash unit.
Solution: Fix the BF wash unit correctly in position
[2050] Sorter control delay

Cause: Sorter control operation failed to complete within the designated 20 sec cycle.
Solution: Contact local service center. Inspect Sorter actuator position adjustment mechanism.
[2051] Dispense lane control delay

Cause: Dispense lane control operation failed to complete within the designated 20 sec cycle.
Solution: Contact local service center. Inspect Dispense lane actuator position adjustment mechanism.
[2052] Reagent/Tip control delay

Cause: Reagent/Tip control operation failed to complete within the designated 20 sec cycle.
Solution: Contact local service center. Inspect Reagent/Tip actuator position adjustment mechanism.
[2053] Sample loader control delay

Cause: Sample loader control operation failed to complete within the designated 20 sec cycle.
Solution: Contact local service center. Inspect Sample loader actuator position adjustment mechanism.
13-6
[2054] Specimen arm dispense control delay

Cause: Specimen arm dispense control operation failed to complete within the designated 20 sec cycle.
Solution: Contact local service center. Inspect Specimen dispense actuator position adjustment
mechanism.
[2055] Cup transfer control delay

Cause: Cup transfer control operation failed to complete within the designated 20 sec cycle.
Solution: Contact local service center. Inspect Cup transfer actuator position adjustment mechanism.
[2056] Incubator control delay

Cause: Incubator operation failed to complete within the designated 20 sec cycle.
Solution: Contact local service center. Inspect Incubator actuator position adjustment mechanism.
[2057] BF wash operation control delay

Cause: BF wash operation failed to complete within the designated 20 sec cycle.
Solution: Contact local service center. Inspect BF wash unit actuator position adjustment mechanism.
[2058] Substrate control delay

Cause: Substrate operation failed to complete within the designated 20 sec cycle.
Solution: Contact local service center. Inspect Substrate actuator position adjustment mechanism.
[2059] Detector control delay

Cause: Detector operation failed to complete within the designated 20 sec cycle.
[2060] Detector table control delay

Cause: Detector table operation failed to complete within the designated 20 sec cycle.
Solution: Contact local service center. Inspect Detector table actuator position adjustment mechanism.
[2100] Tip shortage detected

Cause: Tip shortage detected during operation to attach tips. Will retry operation. If problem persists,
assay result will be flagged (MF (mechanical failure) flag).
Solution: Replenish tips. Make sure not to remove tips during assay operation.
[2101] Tip attach error

Cause: Tip attach operation failed to detect tip. If problem persists when operation retried, assay result
will be flagged (MF (mechanical failure) flag).
Solution: Contact local service center. Inspect tip attach positioning parameter (P05,070-072/087-089), tip
rack upper limit position parameter (P05,098), level sensor (S063), tip detect sensitivity
parameter (P10), tip attach operation, tip control sensor (S092) and tip scan operation.
[2102] Tip removal error

Cause: Operation to detect tip removal failed. If problem persists when operation retried, assay result
will be flagged (MF (mechanical failure) flag).
Solution: Contact local service center. Inspect tip removal positioning parameter (P05,084/085/096/097),
level sensor (S063), tip detect sensitivity parameter (P10) and tip removal operation.
[2103] Tip dropped from moving specimen arm

Cause: Tip not detected at fluid surface and during test cup dispense operation. If problem persists
when operation retried, assay result will be flagged (MF (mechanical failure) flag).
Solution: Contact local service center. Inspect tip attach positioning parameter (P05,070-072/087-089), tip
rack upper limit position parameter (P05,098), fluid level sensor (S063) and tip attach operation.
[2110] Sample level detect failure

Cause: Tip unable to detect sample level, even when lowered to cup bottom. Assay result will be
flagged (SS (short sample) flag.
Solution: Check to see whether sample position and volume are correct. Adjust suction position and
inspect sample container detect sensors (S081, S082), fluid level detect operation and sensor
(S063) and fluid level detect sensitivity parameter (P10).
13-7
[2111] Unable to detect sample diluent level

Cause: Tip unable to detect sample diluent level, even when lowered to bottle bottom. Will retry
operation with different bottle. If problem persists, assay result will be flagged (LS flagged).
Solution: Replenish sample diluent. Adjust suction position and inspect fluid level detect operation and
sensor (S063) and fluid level detect sensitivity parameter (P10).
[2112] Unable to detect Pretreatment level

Cause: Tip unable to detect Pretreatment level, even when lowered to bottle bottom. Assay result will be
flagged (ES flag).
Solution: Replenish Pretreatment. Adjust suction position and inspect fluid level detect operation and
[2113] Unable to detect Conjugate level

Cause: Tip unable to detect Conjugate level, even when lowered to bottle bottom. Assay result will be
flagged (RF flag).
Solution: Replenish Conjugate. Adjust suction position and inspect fluid level detect operation and sensor
(S063) and fluid level detect sensitivity parameter (P10).
[2114] Unable to detect Detector calibrator level

Cause: Tip unable to detect Detector calibrator level even when lowered to bottle bottom. Terminating
detector calibration.
Solution: Replenish Detector calibrator and retry measuring operation. Adjust suction position and inspect
fluid level detect operation and sensor (S063) and fluid level detect sensitivity parameter (P10).
[2120] Sample level detection error

Cause: Level detect occurred prior to reaching actual sample level. If problem persists when operation
retried, assay result will be flagged (MF (mechanical failure) flag).
Solution: Contact local service center. Adjust suction position and inspect fluid level detect operation and
[2121] Sample diluent level detection error

Cause: Level detect occurred prior to reaching actual sample diluent level. If problem persists when
operation retried, assay result will be flagged (LS flag).
Solution: Contact local service center. Inspect fluid level detect operation and sensor (S063) and fluid
level detect sensitivity parameter (P10).
[2122] Pretreatment level detection error

Cause: Level detect occurred prior to reaching actual Pretreatment level. Assay result will be flagged
(ES flag).
[2123] Conjugate level detection error

Cause: Level detect occurred prior to reaching actual conjugate level. Assay result will be flagged (RF
flag).
[2124] Detector calibrator level detection error

Cause: Level detect occurred prior to reaching actual Detector calibrator level. Terminating detector
calibration.
[2130] Clogging detected during sample suction

Cause: Clogged state detected after sample suction operation. If problem persists when operation
retried, assay result will be flagged (SC flag).
Solution: Check sample for clotting and remove it or confirm there is sufficient quantity when suction from
primary tubes. Adjust suction position and inspect sample container bottom position, pressure
sensor (S102), clog detect operation and pressure threshold value parameter (P09).
13-8
[2131] Clogging detected during sample diluent suction

Cause: Clogged state detected after sample diluent suction operation. If problem persists when
Solution: Contact local service center. Adjust suction position and inspect sample diluent bottle bottom
position, pressure sensor (S102), clog detect operation and pressure threshold value parameter
(P09).
[2132] Clogging detected during Pretreatment suction

Cause: Clogged state detected after Pretreatment suction operation. If problem persists when operation
retried, assay result will be flagged (ES flag).
Solution: Contact local service center. Adjust suction position and inspect Pretreatment bottle bottom
(P09).
[2133] Clogging detected during conjugate suction

Cause: Clogged state detected after conjugate suction operation. Assay result will be flagged (RF flag).
Solution: Contact local service center. Adjust suction position and inspect conjugate bottle bottom position,
pressure sensor (S102), clog detect operation and pressure threshold value parameter (P09).
[2134] Clogging detected during Detector calibrator suction

Cause: Clogged state detected after Detector calibrator suction operation. Terminating detector
calibration.
Solution: Contact local service center. Adjust suction position and inspect Detector calibrator bottom
(P09).
[2135] Bubble was detected at sample suction.

Cause: Bubble was detected at sample suction. Flag SC will be attached to a measurement result.
Solution: Remove bubbles on the sample.
[2140] Air detected during sample suction

Cause: Failed to detect tip contact with sample after suction of sample from container confirmed to have
level over 2 mm (from bottom). If problem persists when operation retried, assay result will be
flagged (MF (mechanical failure) flag).
Solution: Check for correct sample position and the presence of air bubbles. Inspect container shape
select parameter (P07, if primary tubing), fluid level detect operation and sensor (S063) and
fluid level detect sensitivity parameter (P10). board - SAMP board - SENS board - SLV#2 board.
[2141] Air detected during sample diluent suction

Cause: Failed to detect tip contact with Solution when suction ended. If problem persists when
Solution: Check for correct sample diluent bottle position and the presence of air bubbles. Inspect fluid
level detect operation and sensor (S063) and fluid level detect sensitivity parameter (P10).
[2142] Air detected during Pretreatment suction

Cause: Failed to detect tip contact with Pretreatment when suction ended.
Solution: Check for correct r Pretreatment bottle position and the presence of air bubbles. Inspect fluid
level detect operation and sensor (S063) and fluid level detect sensitivity parameter (P10).
[2143] Air detected during conjugate suction

Cause: Failed to detect tip contact with conjugate when suction ended.
Solution: Check for correct conjugate bottle position and the presence of air bubbles. Inspect fluid level
detect operation and sensor (S063) and fluid level detect sensitivity parameter (P10).
[2144] Air detected during Detector calibrator suction

Cause: Failed to detect tip contact with Detector calibrator when suction ended.
Solution: Check for correct Detector calibrator bottle position and the presence of air bubbles. Inspect
fluid level detect operation and sensor (S063) and fluid level detect sensitivity parameter (P10).
13-9
[2151] Sample diluent shortage detected

Cause: Sample diluent not found or bottle empty despite availability confirmed when scheduling
dispense operation. Moving to other bottle. If problem persists when operation retried, assay
result will be flagged (LS flag).
Solution: Sample diluent may have been used for assay operation. Install new bottle or remove empty
one.
[2152] Pretreatment shortage detected

Cause: Pretreatment not found or bottle empty despite availability confirmed when scheduling dispense
operation. Moving to other bottle. If problem persists when operation retried, assay result will be
flagged (ES flag).
Solution: Pretreatment may have been used for assay operation. Install new bottle or remove empty one.
[2153] Conjugate shortage detected

Cause: Conjugate not found or bottle empty despite availability confirmed when scheduling dispense
operation. Moving to other bottle. Assay result will be flagged (RF flag).
Solution: Conjugate may have been used for assay operation. Install new bottle or remove empty one.
[2160] Sample shortage detected

Cause: Detected volume insufficient for sampling operation. Assay result will be flagged (SS flag).
Solution: Replenish specimen and retry assay operation. In cases where sample volume is found to be
sufficient, inspect the sample container bottom position setting parameter
(P05,102-105/110/111), container shape select parameter (P07, if primary tubing) and fluid level
detect sensitivity parameter (P10).
[2161] Sample diluent shortage detected

Cause: Detected volume insufficient for sampling operation. Assay result will be flagged (LS flag).
Solution: Replenish Solution and retry assay operation. In cases where Solution volume is found to be
sufficient, inspect the Solution bottle bottom position setting parameter (P05,106-109) and fluid
[2162] Pretreatment shortage detected

Cause: Detected volume insufficient for sampling operation. Assay result will be flagged (ES flag).
[2163] Conjugate shortage detected

Cause: Detected volume insufficient for sampling operation. Assay result will be flagged (RF flag).
[2170] Sample dispense timed out

Cause: Sample dispense operations start timed out. If problem persists when operation retried, assay
result will be flagged (SE flag). Position adjustment parameter calibration values may be set too
high.
Solution: Contact local service center. Readjust mechanisms if position calibration values are too high,
then retry assay operation.
[2171] Unable to complete 2nd phase of pretreatment

Cause: Unable to complete 2nd phase of pretreatment due to other process errors. Assay result will be
flagged (SE flag). Position adjustment parameter calibration values may be set too high.
[2172] Unable to dispense conjugate

Cause: Unable to dispense conjugate due to other process errors. Assay result will be flagged (SE flag).
Position adjustment parameter calibration values may be set too high.
13-10
[2180] STAT door open

Cause: STAT door open sensor (S0705) detected door-open status. If problem persists after retrying
sampling operation, assay result will be flagged (MF (mechanical failure) flag).
Solution: Close STAT door and inspect door-open sensor (S0705).
[2181] Air detected during Diluent suction

Cause: Unable to detect tip contact with Diluent during suction operation. If problem persists when
operation retried, assay result will be flagged (DS flag).
Solution: Contact local service center. Adjust suction position (P05,094) and inspect fluid level detect
operation and sensor (S063) and fluid level detect sensitivity parameter (P10).
[2182] Abnormal pressure detected during sample suction

Cause: (1) Viscosity of the sample was high. (2) Clots in the sample were sucked. (3) Air was sucked.
Solution: Check the sample if there is no clot or if there is sufficient serum volume when sucked from a
primary tube. If there were clots or bubbles, remove them. If the same error occurs again even
after these treatments, possible cause could be high viscosity of the sample.
[2220] Seal break failure

Cause: Unable to detect broken seal after seal break operation. If problem persists when operation
Solution: Contact local service center. Inspect Dispense lane seal break position (P05,067), seal break
detect sensor (S041) and seal break operation.
[2221] Unable to detect cup from Sorter in Dispense lane

Cause: Cup sensor (S031) failed to detect cup from Sorter unit. If problem persists when operation
Solution: Contact local service center. Inspect sensor (S031), Sorter-Dispense lane cup pickup position
(P05,053/060/064/068), cup sensor position (P05,069) and cup release operation.
[2230] Sorter drawer open

Cause: Sorter drawer open sensor (S011) detected drawer-open state. Sorter scan operation
terminated.
Solution: Contact local service center. Inspect drawer-open sensor (S011) and sorter drawer lock
mechanism.
[2231] Sorter drawer lock open

Cause: Sorter drawer-lock sensor (S010) detected lock-open state. Sorter scan operation terminated.
Solution: Contact local service center. Inspect DS010 and S010 of lock mechanism and Sorter Drawer
mechanism.
[2232] Sorter cup release failure

Cause: Sorter cup hold sensor (S027) detected cup present state after cup was released. If problem
persists when operation retried, assay result will be flagged (MF (mechanical failure) flag).
Solution: Contact local service center. Inspect cup hold sensor (S027) and release operation.
[2233] Unable to read cup tray barcode

Cause: Tray barcode reader detected invalid code.
Solution: Inspect tray read position (P05,054/055/062) and tray barcode for dirt and foreign matter. Then
retry read operation.
[2234] Cup not found

Cause: Cup not found despite availability confirmed when scheduling dispense operation. Assay result
will be flagged (PS flag).
Solution: Cup may have been taken from Sorter during assay operation. Retry assay operation.
[2235] Unable to pick up cup from sorter

Cause: Cup hold sensor (S027) failed to detect cup during cup pickup operation. If problem persists
Solution: Inspect top area of Test cup for foreign matter (dart or turned up of seal). In cases of frequent
failure, Contact local service center. Inspect Cup hold sensor (S027), cup pickup position
(P05,050-052/057-059/063) and cup pickup operation. Also inspect cup detect sensor (S026)
and cup scan operation.
13-11
[2236] Sorter dropped cup

Cause: Cup hold sensor (S027) failed to detect cup prior to cup release on Dispense lane. Sorter
operation paused.
Solution: Remove cup dropped by Sorter. Assay operation will resume when Sorter door is closed. If the
problem recurs, Contact local service center.
[2240] Unable to read Reagent bottle barcode

Cause: Reagent bottle barcode reader detected invalid barcode.
Solution: Confirm Reagent bottle barcode label installation angle and check for foreign matter, then retry
operation. If problem persists, inspect Reagent bottle barcode read position (05,077-080) and
integrity of read operation.
[2241] Reagent/Tip rack cover open

Cause: Reagent/Tip rack cover-open state detected by cover-open sensor (S091). Reagent/Tip loader
operation terminated.
Solution: Contact local service center. Inspect cover-open sensor (S091) and Reagent/Tip cover
mechanism.
[2242] Reagent bottle not found

Cause: Unable to find specified Reagent bottle. If problem persists when operation retried, assay result
will be flagged (LS, ES and RS flags).
Solution: Reagent bottle may have been removed during assay operation. Replace reagent bottle and
retry operation.
[2250] Substrate dispense timed out

Cause: System error
Solution: Contact local service center. Retry assay operation
[2263] Cup transfer failed to detect cup

Cause: Transfer cup hold sensor (S054) failed to detect cup prior to pick up operation. Assay result will
be flagged (MF and SE flags).
Solution: Contact local service center. Inspect cup hold sensor (S054), cup pickup position
(P05,119/121/124) and cup pickup operation.
[2265] Cup transfer cup pickup failure

Cause: Transfer cup hold sensor (S054) failed to detect presence of cup after cup pickup operation.
Solution: Contact local service center. Inspect cup hold sensor (S054), cup pickup position
(P05,119/121/124) and cup pickup operation.
[2266] Cup transfer drops cup

Cause: Transfer cup hold sensor (S054) failed to detect cup before cup release operation.
Solution: Contact local service center. Inspect cup hold sensor (S054), the cup pickup positions for
various mechanisms(S050, S051, S052, S120, S140, P05,068/112-114/117/118/127/133) and
the cup hold mechanism.
[2267] Cup transfer cup release failure

Cause: Transfer cup hold sensor (S054) detected cup after release operation.
Solution: Contact local service center. Inspect cup hold sensor (S054) and cup release operation.
[2270] Detector table rotation start timed out

Cause: System error occurred.
Solution: Contact local service center. Retry assay operation.
[2290] Overflow sensor 1 failure

Cause: Overflow sensor 1 (S1308) continuously detects fluid.
Solution: Contact local service center. Inspect Overflow sensor 1 (S1308).

Cause: Overflow sensor 2 (S1309) continuously detects fluid.

Cause: Overflow sensor 3 (S1310) continuously detects fluid-present state.
13-12
[2293] Probe 1 suction failure

Cause: Overflow sensor 1 (S1308) detected fluid-present state after a Solution suction operation. Assay
result will be flagged (WU flag).
Solution: Clean Wash Probe 1 (referred to Maintenance, Chapter 9) and inspect Overflow sensor 1
(S1308), wash (waste) solenoid valve (SV180), waste tubing and fluid pump (LP180).

Cause: Overflow sensor 2 (S1309) detected fluid-present state after a Solution suction operation. Assay
Solution: Clean Wash Probe 2 (refer to Maintenance, Chapter 9) and inspect Overflow sensor 2 (S1309),
wash (waste) solenoid valve (SV181), waste tubing and fluid pump (LP180).

Cause: Overflow sensor 3 (S1310) detecting fluid-present state after a Solution suction operation.
Assay result will be flagged (WU flag).
Solution: Clean Wash Probe 3 (referred to Maintenance, Chapter 9) and inspect Overflow sensor 3
(S1310), wash (waste) solenoid valve (SV182), waste tubing and fluid pump (LP180).
[2296] Probe 1 purge failure

Cause: Overflow sensor 1 (S1308) failed to detect fluid-present state when washer was purged.
Solution: Air may have entered wash tubing. Prime to remove air. Inspect washer level, presence of air in
wash tubing, Overflow sensor 1 (S1308), wash 1st valve (SV160) and wash tubing.

wash tubing, Overflow sensor 2 (S1309), wash 2nd valve (SV161) and wash tubing.

wash tubing, Overflow sensor 3 (S1310), wash 3rd valve (SV162) and wash tubing.
[2300] Sample loader step feed failure

Cause: X1-pitch sensor (S0701) failed to activate during step feed operation.
Solution: Check sample rack path for obstacles. If problem recurs, Contact local service center. Inspect
pitch sensor (S0701) and step feed mechanism.
[2301] Sample loader rack step feed failure

Cause: Rack sensor (S0702) failed to detect rack movement during step (X1) feed operation.
rack sensor (S0702) and step feed mechanism.
[2302] Sample loader rack step feed detect failure

Cause: Rack sensor (S0702) failed to deactivate after rack step (X1) feed operation.
rack sensor (S0702), step feed position (P05,134) and step feed mechanism.
[2303] Sample loader rack feed to BCR position failure

Cause: X1-pitch sensor (S0701) fails to deactivate during step (X1) feed operation.
Solution: Check sample rack path for obstacles. If problem recurs, Contact local service center. X1-pitch
sensor (S0701), step feed position (P05,134) and step feed mechanism.

Cause: Rack feed sensor (S0702) failed to deactivate when step (X1) feed of single rack to barcode
read position completed.
rack feed sensor (S0702) and step feed mechanism.
13-13

Cause: Rack feed sensor (S0702) failed to activate during step (X1) feed of two racks to barcode read
position.
rack feed sensor (S0702) and step feed mechanism.
[2310] Rack not at sample loader transfer in position

Cause: Rack start position (X1) sensor (S0707) failed to detect rack when transfer in (Y1) belt was
operated.
Solution: Set sample rack into position or inspect rack start position (X1) sensor (S0707) and transfer in
(Y1) belt mechanism.
[2320] Unscheduled rack detected at step feed start position

Cause: Rack step (X1) feed back to home position failed due to rack detection by rack start position
(X1) sensor (S0707).
Solution: Move rack away from start position and, if necessary, inspect rack start position (X1) sensor
(S0707).
[2321] Rack not fed to sample loader out position

Cause: Rack end position (X1) sensor (S0708) failed to detect rack during step feed (X1) to rack end
position.
rack end position (X1) sensor (S0708) and step feed mechanism.
[2322] Rack not fed out from sample loader step feed position
Cause: Rack end position (X1) sensor (S0708) detected rack present, even after rack out (Y2) belt was
operated.
rack end position (X1) sensor (S0708) and step feed mechanism.
[2323] Unscheduled rack detected at step feed and position

Cause: The rack step (X2) feed back to home position operation failed due to presence of rack detected
by rack start position (X2) sensor (S0709).
Solution: Move rack away from end position or inspect rack start position (X2) sensor (S0709).
13-14
[3001] Diluent shortage detected

Cause: Diluent tank level sensor (S150) failed to detect fluid - present state. Pausing assay operation.
Solution: Replenish Diluent in tank and assay operation will resume automatically. If Diluent level is
sufficient, inspect Diluent level sensor (S150).
[3002] Washer shortage detected

Cause: Washer tank level sensor (S160) failed to detect fluid. Pausing assay operation.
Solution: Replenish Washer in tank and assay operation will resume automatically. If Solution level is
sufficient, inspect Washer level sensor (S160).
[3003] Substrate shortage detected

Cause: Substrate bottle level sensor (S170) failed to detect fluid. The assay stops and go into “Pause
state”.
Solution: The sampling operation stops from this error, but already sampled specimens are continued to
assay. After all assay are over, place a new substrate bottle (after being room temperature), and
exit from the pause state. Then measurement of the remaining samples will start. Exchanging
substrate bottles during measurement may Cause the air suction and influence the result.
[3004] Waste tank full

Cause: Waste tank level sensor (S180) detected tank-full state. Pausing assay operation.
Solution: Empty waste tank. If tank not full, inspect the waste tank level sensor (S180).
[3006] Sample tip shortage

Cause: Sample tip shortage detected. Pausing assay operation.
Solution: Replenish sample tips and assay operation will resume automatically.
[3020] Test cup shortage

Cause: Test cup shortage detected. Assay result will be flagged (PS flagged).
Solution: Replenish Test cups and retry assay operation.
[3021] STC cup shortage

Cause: STC cup shortage detected. Assay result will be flagged (PS flagged).
Solution: Replenish STC cups and retry assay operation.
[3022] Sample diluent shortage

Cause: Sample diluent shortage detected. Assay result will be flagged (LS flag).
Solution: Replenish sample diluent Solution and retry operation.
[3023] Pretreatment shortage

Cause: Pretreatment Solution shortage detected. Assay result will be flagged (ES flag).
Solution: Replenish Pretreatment and retry operation.
[3024] Conjugate shortage

Cause: Conjugate shortage detected. Assay result will be flagged (RF flag).
Solution: Replenish Conjugate and retry operation.
[3031] Sample diluent bottle empty

Cause: Sample diluent bottle empty state detected.
Solution: Make sure to remove empty bottle the next time the Reagent/Tip cover is opened.
[3032] Pretreatment bottle empty

Cause: Pretreatment bottle empty state detected.
[3033] Conjugate bottle empty

Cause: Conjugate bottle empty state detected.
[3100] Waiting for temperature to stabilize

Cause: System is waiting for temperature level to stabilize.
Solution: Wait a little longer for temperature to stabilize. Then measuring operation will commence.
13-15
[3201] Dispense lane temperature abnormal

Cause: Dispense lane temperature abnormal (50C) signal detected. Unable to execute new assay
operation. Assay result will be flagged (IO flag).
Solution: Contact local service center. Inspect heater and temperature sensor (T030). It will be necessary
to cold reset main power.
[3202] Diluent temperature abnormal

Cause: Diluent temperature abnormal (50C) signal detected. Unable to execute new assay operation.
Assay result will be flagged (IO flag).
[3203] Washer temperature abnormal

Cause: Washer temperature abnormal (50C) signal detected. Unable to execute new assay operation.
[3204] Incubator temperature abnormal

Cause: Incubator temperature abnormal (50C) signal detected. Unable to execute new assay operation.
[3205] Detector table lower heater temperature abnormal

Cause: Detector table lower heater temperature abnormal (50C) signal detected. Unable to execute
new assay operation. Assay result will be flagged (IO flag).
Solution: Contact local service center. Inspect lower heater and temperature sensor (T140). It will be
necessary to cold reset main power.
[3206] Detector table upper heater temperature abnormal

Cause: Detector table upper heater temperature abnormal (50C) signal detected. Unable to execute
new assay operation. Assay result will be flagged (IO flag).
Solution: Contact local service center. Inspect upper heater and temperature sensor (T141). It will be
necessary to cold reset main power.
[3207] Substrate temperature abnormal

Cause: Substrate temperature abnormal (50C) signal detected. Unable to execute new assay operation.
[3211] Dispense lane temperature lower limit error

Cause: Dispense lane temperature below lower limit (of 34C). Unable to execute new assay operation.
Solution: Contact local service center. Inspect heater and temperature sensor (T030).
[3212] Diluent temperature lower limit error

Cause: Diluent temperature below lower limit (of 32C). Unable to execute new assay operation. Assay
result will be flagged (IO flag).
[3213] Washer temperature lower limit error

Cause: Washer temperature below lower limit (of 32C). Unable to execute new assay operation. Assay
Solution: Inspect heater and temperature sensor (T160). It will be necessary to cold reset main power.
[3214] Incubator temperature lower limit error

Cause: Incubator temperature below lower limit (of 34C). Unable to execute new assay operation.
13-16
[3215] Detector table lower heater temperature lower limit error

Cause: Detector table lower heater temperature below lower limit (of 34C). Unable to execute new
assay operation. Assay result will be flagged (IO flag).
[3216] Detector table upper heater temperature lower limit error

Cause: Detector table upper heater temperature below lower limit (of 34C). Unable to execute new
[3217] Substrate temperature lower limit error

Cause: Substrate temperature below lower limit (of 36C). Unable to execute new assay operation.
[3221] Dispense lane temperature upper limit error

Cause: Dispense lane temperature below upper limit (of 40C). Unable to execute new assay operation.
Solution: Inspect heater and temperature sensor (T030).
[3222] Diluent temperature upper limit error

Cause: Diluent temperature below upper limit (of 46C). Unable to execute new assay operation. Assay
[3223] Washer temperature upper limit error

Cause: Washer temperature below upper limit (of 46C). Unable to execute new assay operation. Assay
[3224] Incubator temperature upper limit error

Cause: Incubator temperature below upper limit (of 40C). Unable to execute new assay operation.
[3225] Detector table lower heater temperature upper limit error

Cause: Detector table lower heater temperature below upper limit (of 40C). Unable to execute new
[3226] Detector table upper heater temperature upper limit error

Cause: Detector table upper heater temperature below upper limit (of 40C). Unable to execute new
[3227] Substrate temperature upper limit error

Cause: Substrate temperature below upper limit (of 42C). Unable to execute new assay operation.
[3231] Dispense lane temperature malfunction

Cause: Line connecting Dispense lane temperature sensor has been severed. Unable to execute new
Solution: Contact local service center. Inspect temperature sensor (T030).
[3232] Diluent temperature malfunction

Cause: Line connecting Diluent temperature sensor has been severed. Unable to execute new assay
[3233] Washer temperature malfunction

Cause: Line connecting washer temperature sensor has been severed. Unable to execute new assay
13-17
[3234] Incubator temperature malfunction

Cause: Line connecting incubator temperature sensor has been severed. Unable to execute new assay
[3235] Detector table lower heater temperature malfunction

Cause: Line connecting Detector table lower heater temperature sensor has been severed. Unable to
execute new assay operation. Assay result will be flagged (IO flag).
[3236] Detector table upper heater temperature malfunction

Cause: Line connecting Detector table upper heater temperature sensor has been severed. Unable to
execute new assay operation. Assay result will be flagged (IO flag).
[3237] Substrate temperature malfunction

Cause: Line connecting substrate temperature sensor has been severed. Unable to execute new assay
[3300] Incubator mixing failure

Cause: Rotation detect sensor (S121) on incubator mixer motor (PM121) failed to detect mixing. Unable
to execute new assay operation. Assay result will be flagged (IO flag).
Solution: Contact local service center. Inspect mixer motor (PM121) and mixing detect sensor (S121).
[3301] Detector table mixing failure

Cause: Mixing detect sensor (S141) on detector table mixer motor (PM141) failed to detect mixing.
Unable to execute new assay operation. Assay result will be flagged (IO flag).
Solution: Contact local service center. Inspect mixer motor (PM141) and mixing detect sensor (S141).
[3400] Power supply fan failure

Cause: Power supply fan-stopped signal detected. Measuring operation will continue.
Solution: Contact local service center. Inspect power supply system after assay operation completes.
[3500] Fluid level sensor failure

Cause: Signal output by level sensor (S063) indicates fluid below hand-touch level, pointing to possible
sensor failure. Unable to execute new assay operation. Assay result will be flagged (MF flag).
Solution: Contact local service center. Inspect level sensor for severed lines and circuit board operation.
[3600] Detector (sample signal) malfunction

Cause: Line connecting Detector (sample signal) has been severed. Measuring operation stopped.
Solution: Contact local service center. Inspect Detector and Detector's cable.
[3601] Detector (reference signal) malfunction

Cause: Line connecting Detector (reference signal) has been severed. Measuring operation stopped.
Solution: Contact local service center. Inspect Detector and Detector's cable.
[4021] Sorter X-axis (PM020) home detect error

Cause: Home sensor (S020) failed to activate after Sorter X-axis move to home. If problem persists
Solution: Contact local service center. Inspect home sensor (S020) and X-axis pulse motor (PM020)
operation.
[4023] Sorter X-axis (PM020) home overrun

Cause: Home sensor (S020), which should not activate after Sorter X-axis movement, activated. If
problem persists when operation retried, assay result will be flagged (MF (mechanical failure)
flag).
Solution: Contact local service center. Check home sensor (S020) operation and inspect pulse motor
(PM020) for possible Causes of slipping during movement in limit direction.
13-18
[4024] Sorter X-axis (PM020) limit overrun

Cause: Entered command or setting (P05,051/052/054-056) Caused Sorter X-axis to move beyond
range. If problem persists when operation retried, assay result will be flagged (MF (mechanical
failure) flag).
Solution: Contact local service center. Take care not to enter commands or settings that Cause Sorter to
move out of designated operating range.
[4031] Sorter Y-axis (PM021) home detect error

Cause: Home sensor (S021) failed to activate after Sorter Y-axis move to home. If problem persists
Solution: Contact local service center. Inspect home sensor (S021) and Y-axis pulse motor (PM021)
operation.
[4033] Sorter Y-axis (PM021) home overrun

Cause: Home sensor (S021), which should not activate after Sorter Y-axis movement, activated. If
flag).
Solution: Contact local service center. Check home sensor (S021) operation and inspect Y-axis pulse
motor (PM021) for possible Causes of slipping during movement in limit direction.
[4034] Sorter Y-axis (PM021) limit overrun

Cause: Entered command or setting (P05,057/058/061/062) Caused Sorter Y-axis to move beyond
range. If problem persists when operation retried, assay result will be flagged (MF (mechanical
failure) flag).
[4041] Sorter Z-axis (PM022) home detect error

Cause: Home sensor (S022) failed to activate after Sorter Z-axis move to home. If problem persists
when operation retried, assay result will be flagged.
Solution: Contact local service center. Inspect home sensor (S022) and Z-axis pulse motor (PM022)
operation.
[4043] Sorter Z-axis (PM022) home overrun

Cause: Home sensor (S022), which should not activate after Sorter Z-axis movement, activated. If
problem persists when operation retried, assay result will be flagged.
Solution: Contact local service center. Check home sensor (S022) operation and inspect Z-axis pulse
[4044] Sorter Z-axis (PM022) limit overrun

Cause: Entered command or setting (P05,063/064) Caused Sorter Z-axis to move beyond range. If
flag).
[4071] Dispense lane (PM030) home detect error

Cause: Home sensor (S030) failed to activate after Dispense lane move to home. If problem persists
Solution: Contact local service center. Inspect home sensor (S030) and Dispense lane pulse motor
(PM030) operation.
[4073] Dispense lane (PM030) home overrun

Cause: Home sensor (S030), which should not activate after Dispense lane movement, activated. If
flag).
Solution: Contact local service center. Check home sensor (S030) operation and inspect Dispense lane
pulse motor (PM030) for possible Causes of slipping during movement in limit direction.
[4074] Dispense lane (PM030) limit overrun

Cause: Entered command or setting (P05,069) Caused Dispense lane to move beyond range. If
problem persists when operation retried, assay result will be flagged.
Solution: Contact local service center. Take care not to enter commands or settings that Cause Dispense
lane to move out of designated operating range.
13-19
[4091] Seal breaker (DM040) home detect error

Cause: Home sensor (S040) failed to activate after seal breaker move to home. If problem persists
Solution: Contact local service center. Inspect home sensor (S040) and seal breaker pulse motor
(DM040) operation.
[4092] Seal breaker (DM040) limit detect error

Cause: Home sensor (S040) failed to activate after seal breaker move to limit.
Solution: Contact local service center. Inspect home sensor (S040) and seal breaker pulse motor
(DM040) operation.
[4101] Cup transfer Y-axis (PM050) home detect error

Cause: Home sensor (S050) failed to activate after cup transfer Y-axis move to home. Unable to
execute new assay operation. Assay result will be flagged (MF (mechanical failure) flag).
operation.
[4103] Cup transfer Y-axis (PM050) home overrun

Cause: Home sensor (S050), which should not activate after cup transfer Y-axis movement, activated.
Unable to execute new assay operation. Assay result will be flagged (MF (mechanical failure)
flag).
[4104] Cup transfer Y-axis (PM050) limit overrun

Cause: Entered command or setting (P05,117/118) Caused cup transfer Y-axis to move beyond range.
flag).
Solution: Contact local service center. Take care not to enter commands or settings that Cause cup
transfer to move out of designated operating range.
[4106] Cup transfer Y-axis (PM050) positioning sensor error

Cause: Positioning sensor (S051 or S052) failed to activate during cup transfer Y-axis movement.
flag).
Solution: Contact local service center. Inspect positioning sensors (S051 and S052) and Y-axis pulse
motor (PM050) operation.
[4107] Cup transfer Y-axis (PM050) positioning sensor overrun

Cause: Positioning sensors (S051 or S052), which should not activate after cup transfer Y-axis
movement, activated. Unable to execute new assay operation. Assay result will be flagged (MF
(mechanical failure) flag).
Solution: Contact local service center. Inspect positioning sensor (S051 and S052) and Y-axis pulse
motor (PM050) operation.
[4111] Cup transfer Z-axis (PM051) home detect error

Cause: Home sensor (S053) failed to activate after cup transfer Z-axis move to home. Unable to
operation.
[4113] Cup transfer Z-axis (PM051) home overrun

Cause: Home sensor (S053), which should not activate after cup transfer Z-axis movement, activated.
flag).
13-20
[4114] Cup transfer Z-axis (PM051) limit overrun

Cause: Entered command or setting (P05,063/064) Caused cup transfer Z-axis to move beyond range.
flag).
[4121] Cup transfer chuck (PM052) home detect error

Cause: Home sensor (S055) failed to activate after cup transfer chuck move to home. Unable to
Solution: Contact local service center. Inspect home sensor (S055) and chuck pulse motor (PM052)
operation.
[4123] Cup transfer chuck (PM052) home overrun

Cause: Home sensor (S055), which should not activate after cup transfer chuck movement, activated.
flag).
Solution: Contact local service center. Check home sensor (S055) operation and inspect Chuck pulse
[4124] Cup transfer Chuck (PM052) limit overrun

Cause: Entered command or setting (P05,126) Caused cup transfer Chuck to move beyond range.
[4131] Specimen arm Y-axis (PM060) home detect error

Cause: Home sensor (S060) failed to activate after Specimen arm Y-axis move to home. If problem
operation.
[4133] Specimen arm Y-axis (PM060) home overrun

Cause: Home sensor (S060), which should not activate after Specimen arm Y-axis movement, activated.
If problem persists when operation retried, assay result will be flagged (MF (mechanical failure)
flag).
[4134] Specimen arm Y-axis (PM060) limit overrun

Cause: Entered command or setting (P05,093) Caused Specimen arm Y-axis to move beyond range. If
flag).
Solution: Contact local service center. Take care not to enter commands or settings that Cause Specimen
arm to move out of designated operating range.
[4141] Specimen arm Z-axis (PM061) home detect error

Cause: Home sensor (S062) failed to activate after Specimen arm Z-axis move to home. If problem
operation.
[4143] Specimen arm Z-axis (PM061) home overrun

Cause: Home sensor (S062), which should not activate after Specimen arm Z-axis movement, activated.
flag).
[4144] Specimen arm Z-axis (PM061) limit overrun

Cause: Entered command or setting (P05,094-112) Caused Specimen arm Z-axis to move beyond
range. Assay result will be flagged (MF (mechanical failure) flag).
arm to move out of designated operating range.
13-21
[4161] Sample loader X1-axis (PM070) home detect error

Cause: Home sensor (S0700) failed to activate after Sample loader X1-axis move to home. Unable to
execute new assay operation.
Solution: Contact local service center. Inspect home sensor (S0700) and X1-axis pulse motor (PM070)
operation.
[4163] Sample loader X1-axis (PM070) home overrun

Cause: Home sensor (S0700), which should not activate after Sample loader X1-axis movement,
activated. Unable to execute new assay operation.
Solution: Contact local service center. Check home sensor (S0700) operation and inspect X1-axis pulse
[4164] Sample loader X1-axis (PM070) limit overrun

Cause: Entered command or setting (P05,134) Caused Sample loader X1-axis to move beyond range.
Solution: Contact local service center. Take care not to enter commands or settings that Cause Sample
loader to move out of designated operating range.
[4171] Sample loader X2-axis (PM071) home detect error

Cause: Home sensor (S0703) failed to activate after Sample loader X2-axis move to home. Unable to
execute new assay operation.
Solution: Contact local service center. Inspect home sensor (S0703) and X2-axis pulse motor (PM071)
operation.
[4173] Sample loader X2-axis (PM071) home overrun

Cause: Home sensor (S0703), which should not activate after Sample loader X2-axis movement,
activated. Unable to execute new assay operation.
Solution: Contact local service center. Check home sensor (S0703) operation and inspect X2-axis pulse
[4174] Sample loader X2-axis (PM071) limit overrun

Cause: Entered command or setting (P05,135) Caused Sample loader X2-axis to move beyond range.
Unable to execute new assay operation.
Solution: Contact local service center. Take care not to enter commands or settings that Cause Sample
loader to move out of designated operating range.
[4221] Reagent/Tip loader (PM090) home detect error

Cause: Home sensor (S090) failed to activate after Reagent/Tip loader move to home. If problem
Solution: Contact local service center. Inspect home sensor (S090) and Reagent/Tip loader pulse motor
(PM090) operation.
[4223] Reagent/Tip loader (PM090) home overrun

Cause: Home sensor (S090), which should not activate after Reagent/Tip loader movement, activated.
flag).
[4224] Reagent/Tip loader (PM090) limit overrun

Cause: Entered command or setting (P05,071-080) Caused Reagent/Tip loader to move beyond range.
Unable to execute new assay operation.
Solution: Contact local service center. Take care not to enter commands or settings that Cause
Reagent/Tip loader to move out of designated operating range.
[4241] Specimen syringe (PM100) home detect error

Cause: Home sensor (S100) failed to activate after Specimen syringe move to home. If problem persists
Solution: Contact local service center. Inspect home sensor (S100) and specimen syringe pulse motor
(PM100) operation.
13-22
[4243] Specimen syringe (PM100) home overrun

Cause: Home sensor (S100), which should not activate after Specimen syringe movement, activated. If
flag).
[4244] Specimen syringe (PM100) limit overrun

Cause: Entered command or setting (P05,003/004) Caused Specimen syringe to move beyond range.
Assay result will be flagged (MF (mechanical failure) flag).
syringe to move out of designated operating range.
[4251] Substrate syringe (PM110) home detect error

Cause: Home sensor (S110) failed to activate after Substrate syringe move to home. Assay result will
be flagged (BS flag).
Solution: Contact local service center. Inspect home sensor (S110) and Substrate syringe pulse motor
(PM110) operation.
[4253] Substrate syringe (PM110) home overrun

Cause: Home sensor (S110), which should not activate after Substrate syringe movement, activated.
Assay result will be flagged (BS flag).
[4254] Substrate syringe (PM110) limit overrun

Cause: Entered command or setting (P05,009/010) Caused Substrate syringe to move beyond range.
Assay result will be flagged (BS flag).
Solution: Contact local service center. Take care not to enter commands or settings that Cause Substrate
[4261] Wash syringe (PM111) home detect error

Cause: Home sensor (S112) failed to activate after Wash syringe move to home. Assay result will be
flagged (WU flag).
Solution: Contact local service center. Inspect home sensor (S112) and Wash syringe pulse motor
(PM111) operation.
[4263] Wash syringe (PM111) home overrun

Cause: Home sensor (S112), which should not activate after Wash syringe movement, activated. Assay
[4264] Wash syringe (PM111) limit overrun

Cause: Entered command or setting (P05,007/008/011) Caused Wash syringe to move beyond range.
Solution: Contact local service center. Take care not to enter commands or settings that Cause Wash
[4271] Chain transfer (PM120) home detect error

Cause: Home sensor (S120) failed to activate after Chain transfer move to home. Terminating assay
operation.
Solution: Contact local service center. Inspect home sensor (S120) and Chain transfer pulse motor
(PM120) operation.
[4273] Chain transfer (PM120) home overrun

Cause: Home sensor (S120), which should not activate after Chain transfer movement, activated.
Terminating assay operation.
13-23
[4275] Chain transfer (PM120) slipping detected

Cause: Home sensor (S120) detected chain slippage after chain transfer operation. Terminating assay
operation.
(PM120) operation.
[4276] Chain transfer (PM120) positioning error

Cause: Home sensor (S120) failed to activate when the chain moved to censor position. Terminating
assay operation.
(PM120) operation.
[4277] Chain transfer (PM120) positioning overrun

Cause: Home sensor (S120), which should not activate after Chain transfer, activated. Terminating
assay operation.
Solution: Contact local service center. Inspect home sensor (S120) and pulse motor (PM120) operation.
[4301] BF probe 1 (PM130) home detect error

Cause: Home sensor (S1300) failed to activate after BF probe 1 move to home. Terminating assay
operation.
Solution: Contact local service center. Inspect home sensor (S1300) and BF probe 1 pulse motor
(PM130) operation.
[4303] BF probe 1 (PM120) home overrun

Cause: Home sensor (S1300), which should not activate after a BF probe 1 movement, activated.

operation.
(PM131) operation.


operation.
(PM132) operation.

[4351] Detector table (PM140) home detect error

Cause: Home sensor (S140) failed to activate after Detector table move to home. Terminating assay
operation.
Solution: Contact local service center. Inspect home sensor (S140) and Detector table pulse motor
(PM140) operation.
[4353] Detector table (PM140) home overrun

Cause: Home sensor (S140), which should not activate after a Detector table movement, activated.
13-24
[4355] Detector table (PM140) slipping detected

Cause: Home sensor (S140) detected table slippage after Detector table rotation. Terminating assay
operation.
(PM140) operation.
[4356] Detector table (PM140) positioning error

Cause: Home sensor (S140) failed to activate after Detector table move to home. Terminating assay
operation.
(PM140) operation.
[4357] Detector table (PM140) positioning overrun

Cause: Home sensor (S140), which should not activate after Detector table rotation, activated.
[4501] Substrate dispense unit table (DM170) positioning error

Cause: Home sensor (S171) failed to activate after substrate dispense unit move to home (drain), while
limit sensor (S172) activated.
Solution: Contact local service center. Inspect home and limit sensors (S171 and S172) and Dispense
Unit motor (DM170) operation.
[4502] Substrate dispense unit table (DM170) limit detect error

Cause: Limit sensor (S172) failed to activate after substrate dispense unit move to limit (Detector table),
while home sensor (S171) activated.
Solution: Contact local service center. Inspect home and limit sensors (S171 and S172) and Dispense
Unit motor (DM170) operation.
[4703] Sorter x-axis (PM020) home overrun

Cause: Home sensor (S020), which should not activate after Sorter assay movement, activated.
[4704] Sorter X-axis (PM020) limit overrun

Cause: Entered command or setting (P05,051/052/054-056) Caused Sorter X-axis to move beyond
range during assay operation. Unable to execute new assay operation.
[4713] Reagent/Tip loader (PM090) home overrun

Cause: Home sensor (S090), which should not activate after Reagent/Tip assay operation, activated.
[4714] Reagent/Tip loader (PM090) limit overrun

Cause: Entered command or setting (P05,071-080) Caused Reagent/Tip loader to move beyond range
during assay operation.
Solution: Contact local service center. Take care not to enter commands or settings that Cause
Reagent/Tip loader to move out of designated operating range.
[4721] Sorter BCR error

Cause: Error occurred when sending read command to Sorter BCR.
Solution: Contact local service center. Inspect BCR (B020) and SLV#1 board.
[4722] Sample loader BCR error

Cause: Error occurred when sending read command to Sample loader BCR.
[4723] Beltline BCR error

Cause: Error occurred when sending read command to Beltline BCR.
13-25
[4724] Reagent BCR error

Cause: Error occurred when sending read command to Reagent BCR.
[4731] Sorter BCR mode error

Cause: Error occurred when transferring mode to Sorter BCR.
[4732] Sample loader BCR mode error

Cause: Error occurred when transferring mode to Sample loader BCR.
[4733] Beltline BCR mode error

Cause: Error occurred when transferring mode to Beltline BCR.
[4734] Reagent BCR mode error

Cause: Error occurred when transferring mode to Reagent BCR.
[4911] Slave1 FIFO error

Cause: Error occurred during Slave1 read of FIFO.
Solution: Contact local service center. Inspect MAIN board and SLV#1 board.
[4912] Slave1 RS-232C error

Cause: Error occurred during Slave1 write to BCR.
Solution: Contact local service center. Inspect SLV#1 board.
[4913] Slave1 CPU error

Cause: Error occurred in Slave1 memory.








13-26

[5001] PC error
Cause: Error warning received from PC.
Solution: Contact local service center. Inspect PC unit.
[5100] Assay operation aborted!

Cause: Assay aborted due to occurrence of event inhibiting assay operation.
Solution: Conduct inspection of possible Causes.
[5101] Detector calibration operation aborted!

Cause: Detector calibration aborted due to event inhibiting further operation.
[5102] Substrate background measurement abort!

Cause: Substrate background measurement aborted due to event inhibiting further operation.
[5103] Detector dark measurement aborted!

Cause: Detector dark measurement aborted due to event inhibiting further operation.
[5200] Test cup reservation table shortage

Cause: The number of types of Test cup items that can be managed for Dispense scheduling has
exceeded the limit of 50.
Solution: Reduce the number of types of reagents requested for measuring.
[5201] Reagent reservation table shortage

Cause: The number of types of diluting, pretreatment and Conjugate that can be managed for dispense
scheduling has exceeded the limit of 24.
Solution: Reduce the number of types of reagents requested for measuring.
[5702] Command overlap to PM020

Cause: Command(s) for new operation received by PM020 while executing current operation.
Solution: Retry assay or other operation.



[5709] Command overlap to DM040

Cause: Command(s) for new operation received by DM040 while executing current operation.


13-27








[5723] Command overlap to DS090

Cause: Command(s) for new operation received by DS090 while executing current operation.







13-28




[5800] Activated control process timed out

Cause: Operation failed to complete within the allotted time.
Solution: Retry operation.
[5801] No response from Slave1

Cause: Slave1 failed to respond within the designated time period.
Solution: If problem persists after a cold restart, Contact local service center. Inspect the SLV#1 board.



[5900] Time-load for all tasks = 50 ms

Cause: It took 50 ms to complete all current tasks.
Solution: No special measures required.






13-29
[5910] Less than 100 stacks remaining

Cause: The stacks remaining are now under 100 words.
Solution: Contact local service center.
[5920] Timer shortage

Cause: A system timer shortage has occurred.
[5930] Function not supported

Cause: User selected function not currently supported by the system.
Solution: Select from those functions supported by the system.
[5931] Control branch destination not found

Cause: Unable to locate branch destination for current control operation.
Solution: Perform a cold restart at the system.
[5932] Illegal interrupt

Cause: Illegal interrupt occurred during system operation.
[6000] Mismatch error between pre-programmed ID and Beltline specimen barcode ID

Cause: Mismatch error occurred between barcode information read at Beltline suction position and
pre-programmed specimen ID information.
Solution: Inspect integrity of specimen barcode and Beltline unit operation.
[6001] Unable to read Beltline specimen barcode

Cause: Unable to read the barcode at the Beltline suction position.
Solution: Inspect barcode on specimen and barcode reader (BCR).
[6101] Error message received from Beltline

Cause: Error (Malfunction) occurred in Beltline system.
Solution: Inspect the Beltline system.
[6102] Unexpected specimen ID received from Beltline

Cause: Specimen ID was received from Beltline when system not in ready state.
Solution: Inspect the Beltline.
[6103] Beltline delivered specimen with unprogrammed ID

Cause: Sampling request delivered without accompanying pre-programmed specimen ID. Specimen
was skipped.
[6104] Beltline power off

Cause: Connect signal from Beltline was turned off.
13-30
14. Appendix 5:Printing Format
14: Appendix 5: Printing Format
Clicking the Print button on any of the operation screens displays a preview of the print results for
that screen. Users can print from the Preview screen by clicking the Print button on the toolbar. The
Preview screen can also be used to enlarge or reduce images and change the page order.
Displaying multiple Preview screens is useful for comparing different combinations of print settings.

The substrate background measurement report can be scheduled to print automatically when the
background measuring operation, conducted as part of daily maintenance, completes.
14.2. Worklist
14-1
14.3. Assay Results

This screen features printout of assay results in units of single specimens. Specimen information,
however, is not available with this form.
14.4. Specimen Information and Assay Results

This screen is designed to enable information to be printed in units of individual specimen items.
14-2
14.5. Calibration Reports
14-3
14.6. Levey Jennings Charts
14-4
14.7. QC Materials Lists
14.8. Test Files
14-5
14.9. Checklists
Date Date of inspection.

Operator Name Name of operator in conducting inspection
Wash Sol Item selected by clicking checkbox in Daily Maintenance screen
Dil Item selected by clicking checkbox in Daily Maintenance screen
Substrate Item selected by clicking checkbox in Daily Maintenance screen
Test Cup Item selected by clicking checkbox in Daily Maintenance screen
Reagent Item selected by clicking checkbox in Daily Maintenance screen
Tips Item selected by clicking checkbox in Daily Maintenance screen
Waste Cup Item selected by clicking checkbox in Daily Maintenance screen
Waste Sol Item selected by clicking checkbox in Daily Maintenance screen
B/F Probe Item selected by clicking checkbox in Daily Maintenance screen
Subst. Rept: Result performing replacement substrate in Daily Maintenance
Wash Prime: Result performing fill up wash in Daily Maintenance
Dil. Prime: Result performing fill up diluent in Daily Maintenance
Subst BGR: Result check substrate background in Daily Maintenance
Wash Lot: Lot no. entered during in Daily Maintenance screen
Dil Lot: Lot no. entered during in Daily Maintenance screen
Subst Lot: Lot no. entered during in Daily Maintenance screen
Comment: Comment input
Verify: Check box for verification.
14-6
Warranty
The AIA-1800 has passed the stringent product testing standards of Tosoh. In the event of malfunction, the
system will be repaired in accordance with the provisions of this Warranty. Please contact the nearest Tosoh
service center or local representative.
Warranty Provisions
Warranty Period: One year from the date of system installation
Warranty Coverage: The AIA-1800 system will be repaired at no cost in accordance with the provisions of
this Warranty in cases where the malfunction is due to a manufacturing defect or
premature component failure.
Warranty Limitations: System malfunctions that occur under the following conditions are chargeable
repairs that shall be performed in accordance with standard servicing fees, whether
before or after the warranty period expires.
1. Malfunctions or damage caused by inappropriate installation or system

operation.
2. Malfunctions or damage caused by user modifications to AIA-1800 system
components, circuitry or software.
3. Malfunctions or damage caused by the user moving or transporting the
AIA-1800 system to another location.
4. Malfunctions or damage caused by the user dropping the AIA-1800 system or
its components or otherwise exposing it to strong shock or impact.
5. Malfunctions or damage caused by fire, earthquakes, or other natural disasters.
6. Malfunctions or damage caused by the use of a power source (voltage and
frequency) other than that specified in the operator’s manual or exposure to
abnormally strong power surges.
7. Malfunctions or damage caused by equipment or supplies (consumables) not
provided by Tosoh.
8. Malfunctions or damage caused by repairs, adjustments, or modifications made
by personnel not provided by Tosoh or a Tosoh designated service station.
* This warranty does not cover supplies listed consumables, list in this manual tubing
components and connectors.
* Repairs made and parts replaced during the warranty period are warranted until the
AIA-1800 system warranty is expired.
* Replacement parts shall be supplied for a period of seven years from the date the AIA-1800
system is discontinued. Tosoh will provide notification of the dates when replacement parts
are scheduled for discontinuation.
* Customers will be charged standard servicing fees for repairs conducted after the warranty
period.
* This Warranty is valid only in Japan. Customers should check with the local Tosoh sales
representative for details of warranty provisions that apply to their area.
TOSOH CORPORATION
BIOSCIENCE DIVISION
IVD
TOSOH CORPORATION
BIOSCIENCE DIVISION
Shiba-Koen First Bldg.
3-8-2, Shiba, Minato-ku, Tokyo 105-8623, Japan
Phone: +81-3-5427-5181
Fax: +81-3-5427-5220
EC REP TOSOH EUROPE N.V.

Transportstraat 4
B-3980, Tessenderlo, Belgium
Phone: +32 (0)13 66 88 30
Fax: +32 (0)13 66 47 49
Supplied by TOSOH BIOSCIENCE, INC.

6000 Shoreline Ct., Suite101
South San Francisco, CA 94080, USA
Phone: +1-650-615-4970
Fax: +1-650-615-0415
Phone: (800) 248-6764
Fax: (800) 685-7595
This manual may not be reprinted or copied in whole, or in part without written consent of TOSOH
CORPORATION. The contents of the manual is subject to change without notice.
Copyright© by TOSOH CORPORATION

996231(0808)

AIA1800 Operator Manual

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

AIA1800 Operator Manual

Uploaded by

Copyright:

Available Formats

AUTOMATED ENZYME IMMUNOASSAY SYSTEM

Version Date Amendments

Be sure to include this manual whenever selling or relocating the AIA-1800.

Warning Indicates a hazard with a medium level of risk which, if not

● Carefully Check Ground Connections

● Avoid Modifying Power Cables, Using Insufficiently Rated Extension Cables or

Precautions for Use

● Avoid Opening Covers or Panels During Assay Operations

● Preventing Fluid Leaks

● Avoid Damaging the Power Supply Cable

● Do Not Replace Fuses Yourself

● Avoid Touching System Parts with Wet Hands

● Use Only Trained Maintenance Personnel

● Proper Disposal of Waste Materials

● Place Fluid Containers Only in Designated Locations

● Use Only Tosoh Designated Components

● Avoid Placing any Source of Flame Near the Substrate Compartment

Removal of equipment from use for repair or disposal

● Locations of “Warning” and “Caution” Labels

<1> STAT Compartment Warning Label

A red lamp on the door indicates that a STAT dispense operation is in

<2> B/F Drawer Caution Label

<3> Wash Probe Caution Label

<4> Sample Rack Loader Caution Label

Make sure to pause any current assay operations and stop

<5> Substrate Bottle Compartment Caution Label

It is important not to place any sources of flame near the substrate

<6> Sorter Drawer Caution Label

<7> Sample Suction Caution Label

Avoided inserting hands in the sample suction unit, as the descending

<8> Diluent and Wash solution Tubing Caution Label

Max. Pressure: Atmospheric pressure

<9> Waste Box Biohazard Label

Be sure to wear appropriate protective clothing, such as gloves, when

<10> Waste Tank Biohazard Label

Be sure to wear appropriate protective clothing, such as gloves, when

● Contact Tosoh Service Center or local representative if the Warning or Caution

Contact a Tosoh Service Center or Local Representative When Requesting

Overview of the Manual

Chapter 1: General Precautions for Use

Chapter 2: System Configuration and Functionality

Chapter 3: System Installation, Transportation, and Storage

Chapter 4: Overview of System Operation

Chapter 5: Operational Flow

Chapter 6: System Operation

Chapter 7: Quality Control Functionality

Chapter 8: Other Aspects of Operation

How to Use This Manual

Illustrations and Menu

Page numbering by chapter

Stop signs warn the potential operational mistakes.

1: GENERAL PRECAUTIONS FOR USE ......................................................................................... 1-1

1: General precautions for use

Registering Operators and Administrators

Be sure to register all system users as operators or administrators as soon as the

Effective System Management

2: System Configuration and Functionality

Controller PC Remote host computer

2.2. Controller PC Configuration

Be sure to observe the following precautions, which are designed to prevent

- Avoid using screensavers or limited power-saving functions.

2.2.1. File Configuration

(1) C:\Nexus \Documents