AUTOMATED ENZYME IMMUNOASSAY SYSTEM

Operators Manual

Revision.9

Thank you for purchasing the AUTOMATED ENZYME IMMUNOASSAY SYSTEM

AIA-360.
You are recommended to read carefully and familiarize yourselves with the
information provided in this manual to ensure safe and correct operation of the
system.

TOSOH CORPORATION
BIOSCIENCE DIVISION
 Safety Precautions

Preface

It is recommended that you read carefully and familiarize yourselves with the following
safety precautions in order to ensure safe and correct operation of the AIA-360 analyzer.
The information displayed with the "Warning" and "Caution" signs in this manual is
provided for the purposes defined below.

Warning Indicates a hazard with a medium level of risk which, if

not avoided, could result in death or serious injury.

Caution Indicates a hazard with a low level of risk which, if not

avoided, could result in minor or moderate injury.

Precautions for Installation

Warning
z Connect System to Suitable Power Source
z Make sure to connect the AIA-360 analyzer to a power source that has
ample capacity and is free of significant voltage fluctuations.
z Power sources with insufficient capacity or significant fluctuations in
voltage pose a potential fire hazard.

z Carefully Check Ground Connections

z Failure to properly ground the system is a potential source of electrical
shock.
z Make sure to connect the system to a three-pronged power socket.
z Grounding the system helps to prevent system malfunctions due to noise
as well as prevent electrical shock.
z 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 rods and telephone lines are a potential source of danger
when lightning strikes

I
Safety Precautions

Caution
z Select Installation Site with Care
z Refer to section System Installation in this manual and select a suitable
site for installation of the AIA-360 system. Always notify a Tosoh service
counter whenever installing or moving the AIA-360 system.

z Avoid Altering Power Cables, Using Under-Capacity Extensions and Branch

Connecting from Power Outlets
z These are potential sources of electrical shock or even fire.
z Always select extension cables that have sufficient capacity and a ground
line.

z Confirm Plug is Free of Dust or Dirt and Insert Firmly Into Socket
z Make sure to remove and inspect the power plug several times a year.
Contamination from dust or foreign matter, failure to fully insert into
socket or a loose socket may result in electrical shock or even fire.

Precautions for Use

Warning
z Handling Biohazards With Care
z Only personnel with sufficient knowledge of immunological assay
techniques and the procedures for handling infectious waste materials
should be allowed to operate the AIA-360 system.
z There is always the possibility that human sera have been contaminated
with infectious agents. Mistakes in system operation and handling of such
materials can transmit infectious agents to personnel in the general vicinity,
as well as to the system operator. It is recommended that all specimens be
handled with the utmost care and that the proper protective gear (goggles,
gloves, masks etc.) be used at all times during maintenance procedures.
z All specimen containers, including used reagent cups, sample tips, reagent
bottles, sample cups and waste fluids, have been exposed to human sera.
It is recommended that proper protective gear (goggles, gloves, masks
etc.) be worn at all times and that waste materials be disposed of in
accordance with your areas directive and the relevant laws and
regulations in order to protect all personnel in the general operating
vicinity and the surrounding environment.

Opening covers or panels during operation may result in personal injury,

such as lacerations or even the severing of fingers or hands if they are
caught in such moving parts such as the dispense arm.

z Avoid Opening Covers or Panels During Assay Operations

z Opening covers or panels during operation may result in personal injury,
such as lacerations or even the severing of fingers or hands if they are
caught in such moving parts such as the dispense arm.

II
 Safety Precautions

Caution
z Operate Only in Accordance with Procedures Described in the Manual
z Attempts to operate the AIA-360 using procedures not specified in this
manual may affect the integrity of assay results and cause system
malfunction.

z Preventing Leakage of Fluids

z Leakages of assay solutions and wash solutions are potential sources of
corrosion, electrical shock or even fire.
z When fluid leakage is discovered, immediately shut down system operation
and remove the power plug. It is recommended that proper protective wear
(goggles, gloves, masks etc.) be worn at all times when cleaning up the
leakage and inspecting and repairing the tubing connections that may be
the source of the leak.
z Should the system continue to leak, contact the nearest Tosoh Service
counter.

z Immediately Shut Down System and Remove Power Plug When Signs of
Malfunction (Burnt Odors, Etc.) Appear. Contact the Nearest Tosoh Service Counter.
z Continuing to operate the system while it is malfunctioning may result in
electrical shock and even fire.

z Avoid Opening Covers or Panels and Inserting Fingers or Rods into Operating
Mechanisms.
z The interior of the system is comprised of motor driven components
operating at high speeds. Foreign objects or fingers and hands can easily
be caught in the mechanisms, resulting in personal injury.

z Keep Covers and Doors Closed During Operation

z Keep all covers and doors firmly closed during operation. The interior of the
AIA-360 contains various moving parts, high-temperature components and
high-voltage circuitry. Fingers and hands can easily get pinched or tangled
in the mechanisms, resulting in lacerations, burns and electrical shock.
z Special precautions must be taken when opening doors to replenish
supplies of reagents and sample tips during system operation.

z Avoid Stopping and Starting System by Simply Inserting and Removing the Power
Plug
z This may cause electrical shocks or even fires.
z Whenever shutting down the system, press the power supply switch
located at the rear left of the system.

z Avoid Damaging the Power Supply Cable

z Excessive pulling and bending or anchoring the cable into place may
damage it, resulting in electrical shock or even fire.
z Always take firm hold up the plug when removing the power cable.

z Do Not Replace Fuses Yourself

z Always contact the nearest Tosoh service counter when replacing the
fuses installed on the various system circuit boards. Do not attempt to
replace fuses yourself.
z Burnt out fuses can indicate failures in electrical circuits caused by fluid
leakage. Thus it is important to contact the Tosoh service counter.

III
Safety Precautions

Caution
z Avoid Touching System Parts with Wet Hands
z Touching certain system components may result in electrical shock.

z Used Only Trained Maintenance Personnel

z Maintenance work must be performed by personnel with proper knowledge
of system maintenance procedures and equipped with the proper
protective gear (goggles, gloves, masks etc.). Physical injury incurred
during maintenance can result in infection from specimens. Therefore, it is
important that maintenance personnel perform their work in accordance
with procedures outlined in this manual and only after they have received
sufficient training in maintenance procedures.
z Feel free to contact the Tosoh service counter for information on
maintenance procedures.

z Properly Disposing of Waste Materials

z Take appropriate steps to separate all used materials from assay
operations, including reagent cups, sample tips, reagent bottles, sample
cups, specimen containers and waste fluids, according to the type, of
waste, and dispose of them in accordance with designated procedure.
Always wear protective gloves to avoid direct contact with such materials.
Waste materials must be disposed of in accordance with the following
directive and the relevant laws and regulations in order to protect all
personnel in the general system vicinity and the surrounding environment.

z Always Wear Protective Gear

z Make sure to wear the required protective gear (goggles, gloves, Masks
etc.) to prevent infection when working with specimens, waste fluids and
the accessories used for system calibration

z Place Fluid Containers in Their Designated Locations

z Placing solution containers randomly in the main unit may result in spillage
causeing short-circuits that will damage electrical insulation and result in
electrical shock.

z Inspect all specimens for air bubbles and foaming. Remove any air bubbles prior
to analysis
z The liquid surface detection automatically performed on every specimen by
the instrument is susceptible to bubbles or foaming. The instrument may
detect the bubble as the liquid surface.
Do not run samples which contain bubble or foam. Make sure to remove
any air bubbles prior to analysis regardless of their size.

z Use Only Tosoh Designated Components

z Use only those accessories and expendables (supplies) listed in the
Maintenance Accessories and Expendables section.

IV
 Safety Precautions

Warning
z At system shutdown, replace the substrate solution remaining in the substrate line
with substrate replacement solution (70% ethanol)
z If the substrate solution remains in the substrate line for a long time, it may
precipitate. Precipitation in the substrate line may clog the substrate line.
Replacement of the substrate solution with distilled water may cause
contamination of the substrate line and raise the substrate background.
Make sure to use the substrate replacement solution (70% ethanol) at
system shutdown

z Avoid Placing any Source of Flame Near the Substrate Compartment

z 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.

z Avoid Opening the Specimen Door During STAT (Priority) Sampling

z When the STAT door lamp is red it indicates a sampling operation is in
progress. Forcing the door open will damage the sampling nozzle and
affect the integrity of assay results.

Removal of equipment from use for repair or disposal

- Contact the authorized 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
authorized representative.

V
 Safety Precautions
Additional Precautions
z Locations of "Warning" and "Caution" Labels
z Warning labels are provided at various locations on the AIA-360 system.
Read these carefully to ensure safe system operation.

Specimen Loading Location Warning Label

A red lamp comes on 10 seconds prior to start of

rotation. Avoid adding or removing specimens or
reagents when lamp is flashing, as hands or
fingers may get caught in the mechanisms.

VI
Safety Precautions
Uncap Primary Tubes Warning Label

Please be sure to remove the cap of primary tubes and to

set it on the carousel.
Operation will damage the parts in the AIA-360, with a cap
attached.

Substrate Bottle Compartment Warning Label

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

substrate compartment, as the substrate line is composed of
70% ethanol at the end of an assay operation and there is
danger it may catch fire.

Waste Bottle and Contaminated Sera Caution Label

Note that the waste bottles are contaminated from sampled specimen.
It is recommended that proper protective gear (gloves, etc.)
be worn at all times when handling waste materials in an effort
prevent contamination.

z Contact a Tosoh service counter if the Warning or Caution labels become difficult to
read due to peeling or becoming dirty. Replacement labels will be sent.

z Always store this manual in a safe and convenient place and make sure that it is
passed on to any new person in charge.

Always Have Servicing Done by Tosoh Personnel

Attempts to disassemble, repair or modify the AIA-360 yourself may result in
electrical shocks and even fires.
The location of the Tosoh service center is listed at the back of the manual.

TOSOH CORPORATION
BIOSCIENCE DIVISION

VII
How to Use This Manual

This system Operator's Manual is designed to ensure you will have the information
you need to use and operate the AIA-360 system safely and correctly.
The AIA-360 manual is organized according to the layout shown below. Use this as a reference
when reading this manual.

Section Headings
Sections are
divided into to 3
subsections.

Illustrations and
Menu Screens
Combine with text to
provide precise
explanations.

Page
numbering is organized
by chapter

Key Points provide helpful hints for mastering system operation.

Stop signs warn the potential operational mistakes.

VIII
Contents

Chapter 1: Introduction

1. System Outline ....................................................................................................11

2. Specifications.......................................................................................................13
3. Checking Packing Box Content ...........................................................................14

Chapter 2: Installation

1. Environment of transportation and storage ..........................................................21

2. Operating Environment ........................................................................................21
3. Installation Environment.......................................................................................22
4. Space Required for Installation ............................................................................24
5. Installation Procedures ........................................................................................25
Connecting Tubing .......................................................................................25
Connecting Level Sensor Lead Wires ..........................................................27
Installing Printer Paper.................................................................................28
Installing Enzyme Substrate Fluid ..............................................................210
6. Power Supply.....................................................................................................212

Chapter 3: Name of Parts and Functions on Main Unit

1Display and Operation Panel..............................................................................32

2Carousel.............................................................................................................33
3Substrate Compartment .....................................................................................34
4Printer Unit .........................................................................................................34
5Bottle Tray ..........................................................................................................34
6Smart Media Card Slot .......................................................................................34

Chapter 4: Preparing System for Assay Operations

Introduction ..............................................................................................................41
1. Prior to Commencing Operation ..........................................................................42
2. System Startup ....................................................................................................44
2.1 Confirming/Selecting Operator Name ....................................................45
2.2 Confirming Enzyme Substrate Solution Level ........................................47
2.3 DAILY CHECK .......................................................................................48

IX
 Contents

Chapter 5: Calibration

Introduction ............................................................................................................. 51
1. Generating Calibration Curves ............................................................................ 52
1.1 Calibration Requests ............................................................................. 52
1.2 Performing Calibration ........................................................................... 55
2. Reviewing/Updating New Calibration Curves (CALIBRATION REVIEW) ............ 58
2.1 Calibration Review................................................................................. 58
2.2 Verifying Calibration Curves ................................................................ 510

Chapter 6: Assay Procedures

Introduction ............................................................................................................. 61
1. Registring Assay Requests.................................................................................. 62
2. Registering Sample ID ........................................................................................ 62
2.1 Entering Sample ID ............................................................................... 63
3. Commencing Assay Operations .......................................................................... 65
3.1 Commencing Assay Operations ............................................................ 65
4. Assay Results...................................................................................................... 69
4.1 External Output of Assay Results .......................................................... 69
4.2 Printing Assay Results ......................................................................... 610
4.3 Recalculating Assay Results................................................................ 611

Chapter 7: Error Messages and Flags

1. List of Error Messages ........................................................................................ 71

1.1 Error Message Lists............................................................................... 71
2. List of Flags....................................................................................................... 712
2.1 Flag Lists ............................................................................................. 712
2.2 Detailed Descriptions of Flags and Actions.......................................... 713
2.3 Meaning of Daily Check Flags and Action ........................................... 717

Chapter 8: Shut Down Operation (Shut Down Menu)

Introduction ............................................................................................................. 81
1. Shut Down Operation (Shut Down Menu) ........................................................... 82

X
Chapter 9: Other Functions in SPECIAL MENU
1. MAINTE (Maintenance Tool)................................................................................92
2. COMM. (RS232C Transmission Parameter Settings)..........................................96
3. DATE/TIME (Time and Date Settings) .................................................................97
4. OPERATOR (Registering and Changing) ............................................................97
5. TEST FILE (of analyte parameters) .....................................................................98
6. BCR PARAM (Detailed Barcode Settings) .........................................................910
7. SYSTEM SPEC. (System Operation Settings) ..................................................914

Chapter 10: Daily Maintenance Procedures

1. Daily Maintenance Procedures ..........................................................................101

1.1 System Startup.....................................................................................101
1.2 System Shutdown ................................................................................101
2. Weekly Maintenance Procedures ......................................................................101
2.1 Wash Substrate Line ............................................................................101
3. Monthly Maintenance Procedures .....................................................................102
3.1 Updating Calibration Curves ................................................................102
4. Three-Month Cycle Maintenance Procedures....................................................102
4.1 Wash Diluent and Wash Solution Bottles .............................................102
5. Six-Month Cycle Maintenance Procedures ........................................................102
5.1 Wash Diluent and Wash Lines .............................................................102
5.2 Replacing Filters for Diluent and Wash Solution Bottles ......................103
6. If AIA-360 Becomes Dirty...................................................................................103

Chapter 11: Supplies/Optional Parts

1. Supplies Parts....................................................................................................111
2. Optional Parts ....................................................................................................112

Chapter 12: Appendix

Appendix A: Bar-Code Label Specifications and Precautions for Use ...................121

1. Bar-Code Label Specifications ...............................................................121
2. Barcode Effective Read Range ..............................................................121
3. Maximum Number of Readable Barcode Digits .....................................122
4. Loading Test Tubes With Bar-Code Labels Applied ...............................123
Appendix B: RS232C Transmission.......................................................................124
1. Transmission Specifications ...................................................................124
2. Pin Assignment ......................................................................................125

XI

Chapter

Introduction
Chapter 1: Introduction

Thank you for purchasing the AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-360.
This operators manual provides a detailed description of the system configuration and
operating procedures for the AIA-360. You are recommended to read carefully and familiarize
yourselves with the information provided in this manual before commencing operation of the
system.

Fig. 1-1 Overview of Main Unit

AUTOMATED ENZYME IMMUNOASSAY SYSTEM

AIA-360For in vitro diagnostic use

1. System Outline
The AIA-360 is designed with a very compact footprint, enabling it to serve as a desktop
unit.
While the specimens and reagents used with the AIA-360 must be manually prepared,
after sample loading, all processes prior to the assay results and system output are fully
automated. The system is capable of performing up to 36 tests per hour. The first test
results appear approximately 20 minutes after the assay operation commences. New
assay operations can be added, even after assaying has begun. Up to four assay
operations can be performed for each specimen.

1 1
Chapter 11System Outline

Fig. 12 Exterior View of AIA-360

Front View Rear View

Left Side Right Side

1 2
Chapter 12Specifications

2. Specifications
Main Specifications
Assay principal Fluorometric enzyme immunoassay (FEIA)
Processing method Automated continuance random access
Processing capacity Max. 36 tests / hr.ST reagents
In vitro diagnostic reagent
ST AIA-PACK Series
medical
Sample volumes 10 to 100l
Sample clog detection Pressure detection
Measuring conditions Reaction temperature: 37C
Antigen-antibody reaction time10 min.
Detection method Florescent detectiontop-to-top system
Carousel
Reagent set count Max. 25
Specimen set count Max. 25
Sample containers Test tubes1375, 13100, 1675, 16100
Combinable 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 (narrow)
: 0.191 (0.254 or over recommended)

External output RS-232C

Power supply/consumption 100 to 240 V AC, 50/60 Hz, 250 VA

External Dimensions/Weight Main unit: 400 (W) 400 (D) 520 (H) mm, 29 kg
Operating Environment
Temperature 15C to 30C
Humidity 40 % to 80 %no condensation
Best Average office level
Conformance Status
EMC standard IEC60601-1-2: 1993
CISPR class and group categories Class A, Group 1
FCC Part15 Sub, Part B Class A
EMC standard Class 1: IEC60825-1: 1994

1 3
Chapter 13Checking Packing Box Content

3. Checking Packing Box Content

As a rule, Tosoh service personnel always set-up the system. You are requested to refrain
from opening the packing box and attempting to install the system yourselves.
You are requested to confirm, in the presence of the Tosoh serviceperson, that all
accessories in the following list are included with the system when it is unpacked.

Packing List

Main UnitAIA-360

Accessories

Power cable: 1
Product no. 0008272

Substrate bottle rubber stopper: 1

Product no. 0021207

Bottle cap: 10
Product no. 0021002

Printer paper core: 1

Product no. 0019510

Substrate holder: 1
screw and spacer: 2 pcs (each)
Product no. 0021066

Bottle tray: 1
Product no. 0021076

1 4
Chapter 13Checking Packing Box Content

Bottle 30 mL :2
Product no. 0018619

Bottle 100 mL with a cap : 1

Diluent bottle 500 mLDILUENT: 1

Product no. 0021067

Wash solution bottle 1000 mLWASH: 1

Product no. 0021068

Waste fluid bottle 1000 mLWASTE: 1

Product no. 0021069

Tank filter: 2
Product no. 0018585

Diluent bottle cap: 1

Product no. 0021103

Wash solution bottle cap: 1

Product no. 0021140

1 5
Chapter 13Checking Packing Box Content

Waste fluid bottle cap: 1

Product no. 0021141

Level sensor lead: 1 set

Product no. 0021138

Smart media card: 1

(In the initial parameters)

Waste Box: 1
Product no. 0019398

Printer paper (thermal paper roll): 1

Product no. 0019563

Sample cups: 100

Detector adjusting cup (STD cups): 1

1 6
Chapter 13Checking Packing Box Content

Others
Operation manual (this manual): 1

Inspection Certificate: 1

Warranty: 1

The items listed above should be included in this package.

If any items are missing, immediately contact the supplier or the nearest
Tosoh service counter.

1 7

Chapter

Installation
Chapter 2: Installation

As a rule, installation and set-up of a newly delivered AIA-360 analyzer is performed by

a qualified Tosoh service personnel. You are asked to refrain from unpacking and
installing the system yourselves.

1. Environment of transportation and storage

Temperature 5 to 50C
Humidity 80% or less
Dust: level Keep dry Store indoors

2. Operating Environment
Make sure to install the system on a level table in an environment free from toxic fumes,
dust, vibrations and exposure to direct sunlight.
Operate the AIA-360 within the range of conditions specified below.

Table 2-1 Operating Environment Conditions

Temperature 15 to 30C
Humidity 40 to 80%
Power supply/consumption
100 to 240 V AC, 50/60 Hz, 250 VA
Overvoltage Category II
Contamination level 2
Dust: level equivalent to average office environment
Max. altitude 2000 m

Make sure to operate the AIA-360 within the range of conditions

specified in the table above in an environment free of moisture from
condensation.

2-1
Chapter 2 - 2Installation Environment

3. Installation Environment

Avoid installing the AIA-360 in locations subject to the following types of conditions

Sharp fluctuations in power supply voltage Sharp fluctuations in temperature

Powerful air currents Excessive dust

Excessive vibration s Unstable foundations

2-2
Chapter 2 - 2Installation Environment

High humidity Open flames

Narrow spaces with poor ventilation Strong electromagnetic fields and high
frequencies

2-3
Chapter 2 - 3Space Required for Installation

4. Space Required for Installation

The dimensions of the AIA-360 are 400 mm (W) x 400 mm (D) x 520 mm (H).In addition
to these dimensions, the AIA-360 requires extra space on the right side for the external
attachment of the bottle tray for the diluent, wash solution and waste fluid bottles.
For ventilation purposes an electric fan is installed on the rear of the unit. Provide a extra
margin of at least 150 mm at the back to allow the fan to function properly.
Also allow a margin of at least 250 mm on the left side to open the carousel door when
loading samples and reagent cups.
The standard system weight of 29 kg increases to about 35 kg when the reagents are
loaded. Make sure that the base on which the AIA-360 is installed is sufficiently strong to
withstand this weight without vibrating.

Fig. 2-1 Space Required for Installation

150 mm or more

250 mm or more

2-4
Chapter 2 - 4Installation Procedures

5. Installation Procedure

Connecting Tubing
Fig. 2-2 Port Branching Assembly

Tubing
DILdiluent
WASHwasher

Tubing
Port WASTEwaste
DILdiluent
WASHwasher
WASTEwaste

Connect the tubes extending from the rear of the AIA-360 to the port branching
assembly as shown below.
DiluentDIL tube Port branch DIL
Wash solutionWASH tube Port branch WASH
Waste fluidWASTE tube Port branch WASTE

Identification seals are attached to each tube. Use these to ensure tubes
are connected to the correct port. Errors will result in incorrect assay results.

Connect the tubes linked to the port branching assembly to the caps on each of
the bottles.

2-5
Chapter 2 - 4Installation Procedures

Fig. 2-3 Bottle Installation Order

Waste bottleWASTE

Washer bottleWASHER

Disinfecting ethanol
Diluent bottleDILUENT

Tighten the bottle caps and arrange them in the order shown in Fig. 2-3, starting
from the front with the diluent bottle, wash solution bottle, and waste fluid bottle.

The wash solution and waste fluid bottles are identical in shape, so be sure
to check the identification seals to prevent any mixups.
Mistakes will result in incorrect assay results.

2-6
 Chapter 2 - 4Installation Procedures

Connecting Level Sensor Lead Wires

Fig. 2-4 Level Sensor Lead Wires

Green

Yellow

Red

Diluent bottleDILUENT

Washer bottleWASHER

Waste bottleWASTE

Connect the connectors on the ends of the level sensor lead wires in the
direction of the arrows shown in the figure above.
Use the color coding for the level sensor lead wires to ensure that they are
correctly connected to the electrodes for each bottle.
Waste fluid bottleWASTE red
Wash solution bottleWASHER yellow
Diluent bottleDILUENT green

Make sure that level sensor lead wire connectors are correctly matched.
Incorrectly connecting the lead wires will result in failure to issue warnings
when the diluent and washer levels are low or when the waste tank is full.

2-7
Chapter 2 - 4Installation Procedures

Installing the Printer Paper

Open the printer cover (top) by lifting upward.

Fig. 2-5 Printer

Pull the paper clamp lever to the full forward position and remove the paper core
shaft by pulling upward.
Insert the core shaft into the paper roll and install it in the printer so it faces the
correct direction.

Fig. 2-6 Installing Printer Paper

Core shaft

Paper clamp lever

2-8
Chapter 2 - 4Installation Procedures

Return the paper clamp lever to its full back position and insert the tip of
the paper into the printer mechanism

Fig. 2-7 Installing Printer Paper

Note that the lever has two settings, so make sure to set to the full back
position.

Close the printer cover (top) again, while remembering to pass the end of
the printer paper through the covers paper opening.

If paper is not positioned correctly, pull the paper clamp lever to the forward
position and adjust, then return lever to full back position.

2-9
Chapter 2 - 4Installation Procedures

Installing Enzyme Substrate Fluid

Fig. 2-8 Attachment of the Substrate Solution Holder (1)

(1) Remove the screw shown in Fig. 2-8 (The removed screw will be of no use).

Fig. 2-9 Attachment of the Substrate Solution Holder (2)

(2) Using the screws and spacers included in the accessory fix the substrate holder
as shown in Fig. 2-9.

The substrate solution tube passes through beneath the holder

2 - 10
Chapter 2 - 4Installation Procedures

Fig. 2-10 Substrate Solution Holder and Enzyme Substrate Bottle

Level
Indicates level of Substrate
remaining.

(3) Set the substrate bottle on the holder (See Fig. 2-10).

(4) Put the substrate solution tube deeply into the substrate bottle and plug the bottle
with the rubber cap.

Put the tube into the bottle until the tube end touches to the bottom of the bottle.

2 - 11
Chapter 2-5Power Supply

6. Power Supply

Confirm the following system power supply specifications.

Power specifications100/120V AC and 220/230V AC 10 V
250 VA
50/60 Hz

Connect the AIA-360 using the accessory power cable grounded to

the power supply socket (10 A).
Avoid connecting the AIA-360 to the same power socket as other
equipment, such as refrigerators and compressors, that consume large
volumes of power.
Use only a power supply line equipped with circuit protector.

After confirming that the power supply switch located on the left rear of
the system is set to the OFF position, insert the power supply cable into the
socket.

Fig. 2-9 Power Supply Socket

Note that the position marked is OFF and the position marked is
Point
ON.

2 - 12
 Chapter

Name of Parts and Functions

on Main Unit
Chapter 3: Name of Parts and Functions on Main Unit

The AIA-360 is comprised of the modules illustrated below.

Fig. 3-1 Overview of Main Unit

1 4

6
5

1Display and operation panel

2Carousel (located inside door)
3Substrate compartment
4Printer unit
5Bottle tray
6Smart media card slot

3 1
Chapter 3: Name of Parts and Functions on Main Unit

1Display and Operation Panel

A LCD touch-panel equipped with sheet keys serves as both the display and key
entry device for the AIA-360.
The LCD display is located on the front right side (when facing front) of the main unit.
The display shows the operating status of the current system and the assay results.

Fig. 3-2 Display and Sheet Keys (Sample)

PAPER SAMPLE
MENU START
FEED FEED

Paper Feed Key

Used to feed printer paper.
Sample Feed Key
Feeds sample line forward by 1 cup.
Menu Key
Displays the menu screen.
Start Key
Starts the assay operation.

Do not depress the START key for a long time.

Depressing the START key for a long time (about two seconds or longer) sends an
abort request for an emergency stop.

3 2
Chapter 3: Name of Parts and Functions on Main Unit

2Carousel
The main carousel is the unit that serves as both the reagent cup holder and the
sample holder. The carousel is designed to rotate the specimen and reagent cups.
Seven reagent cup holder slots and seven sample holder slots are visible when the
carousel door is opened.

Fig. 3-3 View With Carousel Door Open

Reagent cup holder

Sample holder

LED lamps

Flashingpre-transport

Onassaying
Offstopped

When the SAMPLE FEED key is depressed for two seconds or longer, the
carousel rotates automatically and returns to its home position.
To stop the carousel from automatically rotating, press the SAMPLE FEED key
once again.

Be careful not to get your fingers caught when the carousel moves.

3 3
Chapter 3: Name of Parts and Functions on Main Unit

3Substrate Compartment
This compartment is used for the enzyme substrate bottle and the disinfect ethanol
solution bottle.

4. Printer Unit
The printer is designed to the print assay results, error information and system
parameters onto a roll of thermal printer paper. Depending on the font selected, the
printer can print the assay results for up to 2000 test cups on one roll of paper.

5. Bottle Tray
Note that the diluent, wash solution, waist fluid and disinfecting ethanol bottles are
stored outside rather than inside the main unit.

6. Smart Media Card Slot

The system program is updated using smart cards.

3 4
 Chapter

Preparing System
for Assay Operations
 Chapter 4: Preparing System for Assay Operations

Introduction

Preparation of System

- Overview of Chapter -
1. Prior to Commencing Operation 4-2
2. Starting the AIA-360analyzer 4-3 Calibration curves
Chapter 5

Assay Procedures
- Commencing Assay Operations -
Chapter 6

Completing Assay Operation Chapter 8

4-1
Chapter 4 -1Prior to Commencing Operation

1. Prior to Commencing Operation

The following items are required for performing assay operations.

z Reagent cup
z Enzyme substrate solution
z Detector standardization cupSTD cup
z Diluent and wash solution
z Ethanol Disinfectant
z Samplespatient specimens and calibrators

Make sure to properly mix the substrate, diluent and wash solutions in
accordance with the instructions provided in the manual.

The following two types of samples are used for assay operations in the AIA-360.
1Patient specimens
2Calibratorsstandards

1Assaying Patient Specimens

Prepare the specimens and reagent cups. Dispense the required volume of
specimen into the sample cup or primary tube. The required specimen volume is
defined as the sum of all dispensed analyte volumes, plus the dead volume.
Dead volume: defined as 100L for sample cups. Is approximately
500 L for the straight type OD 11 mm primary tube
but varies depending on tube bore and shape.

Point
Up to four analytes can be assayed from a single specimen. However,
the specimen must be divided into two portions whenever assaying five or more
analytes from a single specimen.

Applicable specimen type for the AIA-360 is indicated on the insert sheet
provided with reagents for each analyte. Users are asked to avoid assaying the
following types of specimens, as they can affect system operation.
z Specimens that have a tendency to clot during the assay process.
z Specimens containing solid particles that tend to form occlusions during
dispense operations.

4-2
Chapter 4-2System Startup

2Generating Calibration Curves

Prepare calibrator and reagent cups. Measuring calibrators is necessary when
generating calibration curves. Begin by compiling an appropriate calibration
program, then prepare calibrators and reagent cups and perform measuring
operations accordingly.

4-3
Chapter 4 - 2System Startup

2. System Startup

Before Turning on Power

Open the operation cover on the main unit and confirm there is nothing blocking
the movement of the carousel.

Next, go to the system power switch located on bottom left rear of the main unit
and switch it to On.

Fig. 4-1Power switch

Power switch

Point
Note that the position markedis OFF and the position markedis ON.

When system power is turned on, the following

Program Loading screen is displayed, followed
by the Opening Screen (Fig. 4-1 OPENING),
as shown below.
The Program Loading screen indicates the
system initialization routine is in progress.

Pressing displays the factory default

system installation procedures.
As a rule, installation of a newly delivered
AIA-360 is performed by qualified Tosoh
service personnel. Customers are asked to
refrain from unpacking and installing the system
themselves. OPENING Screen

4-4
Chapter 4-2System Startup

2.1 Confirming/Selecting Operator Name

Confirm the current operator name displayed in the OPENING screen.

Point
The operator name is also printed on the printouts.

If the correct operator name is displayed, simply press the icon.

Proceed to section 2.2 Confirming Enzyme Substrate Solution Level.
To change the operator name, simply press

the icon. Use to move the

cursor to the desired operator name then press

the icon to select.

OPERATOR Screen

Registering New Operator Name

The AIA-360 analyzer allows registration of up to 5 operators, retained retained

even when the power is turned off.

1) Press the icon.

This displays the OPERATOR Screen.

OPERATOR Screen

2) Use to move the cursor to the new

operator number to be registered.

Then press the icon.

This displays the KEYBOARD INPUT screen.

KEYBOARD INPUT Screen
Point Pressing the icon displays the following content.
Alphabet (uppercase) Alphabet (lower case)
Numerals

4-5
Chapter 4 - 2System Startup

3) Register operator name (using up to eight characters).

4) Press the icon after entering the name and return to the Operator
Screen.

Changing/Deleting Operator Names

1 Press the icon to display Operator

Screen.
2 Use to move cursor to operator

number to be deleted and press the OPERATOR Screen

icon.
This displays the KEYBOARD INPUT Screen.

1) Press the to delete when changing

or deleting the operator name.

2) When name change is successful, press KEYBOARD INPUT Screen

the icon.

4-6
Chapter 4 - 2System Startup

2.2 Confirming Enzyme Substrate Solution Level

The SUBSTRATE Screen is displayed.

Enter the enzyme substrate solution level

indicated on the solution level scale.

Next, press the icon.

SUBSTRATE INPUT Screen

Note that the correct enzyme substrate solution level must always be entered.
Failure to do so will result in DAILY CHECK errors.
Also be sure to enter the new substrate level in the SUBSTRATE screen
whenever installing a new enzyme substrate solution.

Point The current level of enzyme substrate solution can be checked by going to

the START UP screen and pressing or by going to the ASSAY

MONITOR screen and pressing the icon.

This displays the SUBSTRATE screen, which indicates the current level of
solution and number of assay tests possible with this solution.

4-7
Chapter 4-System Startup

2.3 DAILY CHECK

The MENU screen is displayed.

MENU Screen

Press the icon in the MENU screen to

display the DAILY START CHECK screen.
Then check the following items.

DAILY START CHECK Screen

Check Reagents
Make sure there is sufficient WASHERWash Solutionand DILUENTdiluent.
Empty Waste
Discard waste fluid and empty the waste tank (WASTE).
Check Paper
Check to see that there is sufficient printer paper.

In accordance with the SetSTDCup to POSITION 1 instructions, place one

detector standardization cup (STD cup) in position No. 1 of in Reagent Cup
table.

Then press the icon.

4-8
Chapter 4 2System Startup

When DAILY CHECK screen appears, press

the START key.
Fill up the fluid supply lines and perform a
substrate background measurement (enzyme
substrate florescent intensity check).
DAILY CHECK Screen

The DAILY CHECK requires approximately seven minutes.

Screens that appear during the DAILY CHECK

Confirmation of initialization sequence

Priming of diluent

Priming of wash solution

When errors occur during priming of diluent

or wash solution, check bottle level and
confirm tube reaches down to the fluid.

4-9
Chapter 4 - 2System Startup

Priming of substrate

Measuring substrate background

When errors occur during substrate

background measurement, check
substrate level and whether substrate
has been replaced with ethanol disinfectant.

In the Event of Errors

An error message is displayed at the top right of the DAILY CHECK screen whenever
an item deviates from the normal operating range.

Press the icon to return to the START UP

screen.
Redo the DAILY CHECK once corrective measures
have been taken.
ERROR Screen (Example)

4 - 10
Chapter 4 - 2System Startup

Sample lines are initialized and the results output to the printer when the
substrate background measurement operation is complete.

Fig. 4-2 Sample Printout

1
2
Measurement value
3

1.Indicates whether the enzyme substrates solution priming operation was

successful by OK or ERR.
OK: When successful
ERR: When unsuccessful
Check substrate level and perform DAILY CHECK again.

2.Performs fluorescent intensity (background intensity) measurement of

enzyme substrate solution to check for possible problems. This
measurement result is reported by OK or HB with measurement value in
nmol/L.
OK: When lower than 1500 nmol/L (No problem)
HB: When equal to or higher than 1500 nmol/L (Background was too
high)
Replace the enzyme substrate and perform DAILY CHECK again.

3.Indicates intensity of Detector lamp by OK or LL.

OK: If sufficient
LL: If insufficient
Contact a Tosoh service counter.

Press the icon.

4 - 11
 Chapter

Calibration
 Chapter 5: Calibration

Introduction

Preparing System for Assay Operations Chapter 4

Calibration Curves
-Overview of Chapter-

1Generating Calibration Curves

(CALIBRATION REQUEST) 5 -2

2Reviewing/Verifying New Calibration

Curves(CALIBRATION REVIEW)
5-9

Calibration curves are generated:

Assay Procedures
Anew after the expiration of
- Commencing Assay Operations -
calibration curve.
Chapter 6
When changing reagent lots.

After detector or other hardware

adjustments.

Completing Assay Operation Chapter 8

5-1
Chapter 5 -1Generating Calibration Curves

1. Generating Calibration Curves

1.1 Calibration Requests

Procedures for generating calibration requests are described in the following sections.
Note that calibration curves cannot be generated during assay operations.
Sample measurement cannot be performed during calibration.

Procedures

Press the MENU key to display the MENU

Screen.

MENU Screen

Press to display the CALIB REQUEST

screen.

CALIB REQUEST Screen

Press to move the cursor to

desired item and press to select.

Point Pressing moves the display to

the next page.

Note that the number of analytes that can be calibrated is four for a
two-point calibration, one for a 6-point calibration and one for a combined
two-point and six-point calibration

5-2
Chapter 5- 1Generating Calibration Curves

Pressing displays the CALIB

REQUEST (Conc. Set) screen.

Confirm that the concentration matches

the concentration listed on the calibrator label.

CALIB REQUESTConc. Set Screen

Press if the correct concentration is displayed.

Otherwise, change the concentration.

Changing Concentration

1) Use to move the cursor to CAL

and click .

This displays the Conc Input screen.

2) Press to clear the concentration and

enter the new concentration (shown on

calibrator bottle).

Conc. INPUT Screen

3) Press to redisplay the CALIB
REQUEST (Conc. Set) screen.

4) Confirm that the concentration has changed in the CALIB REQUEST

(Conc. Set) screen then press .

5-3
Chapter 5- 1Generating Calibration Curves

This displays the CALIB REQUEST (Analyte

set) screen. Install the calibrator and reagent
cup while confirming progress on the screen.

Point
Press to display the next screen

and move the carousel to the next

position.

Calibration measures each

concentration three times.
Calibrators must be positioned in order,
starting from lowest concentration.
Failure to do so will yield inaccurate
results.
Reagent cups are positioned in
sequence without empty slots in
between.

CALIB REQUEST(Analyte set) Screen

5-4
Chapter 5- 1Generating Calibration Curves

1.2 Performing Calibration

Load the calibrator and reagent cup and press .

If Diluent, Wash, or Substrate ran short at a calibration, the calibration should
be redone to obtain an accurate result.
Please be sure the residual quantity of Diluent, Wash, or Substrate.

This displays the CALIB REQUEST (Check

Start) screen.

CALIB REQUEST(Check Start) Screen

Press to rotate the carousel and

check the positioning of calibrators and
reagent cups. This displays the Calibrator &
Analyte Check 1 screen.

CALIB REQUEST(Analyte Check 1) Screen

Point
Move the cursor to the CAL being checked.
This highlights the selected CAL.
Checking takes approximately 2 minutes for a two-point calibration,
five minutes for a six-point calibration and seven minutes for a combined
two-point and six-point calibration.

Press to skip the calibrator and reagent cup check and go on to

the CALIB REQUEST (Analyte Check 2) screen.

5-5
Chapter 5- 1Generating Calibration Curves

Errors

Errors occur when the calibrator position is wrong, the calibrator is missing or when
the reagent cup analyte or lot numbers are wrong.

1) Errors are displayed on the CALIB REQUEST

(Analyte Check 1) screen.

Point The cursor stops at the location of the error.

ERROR ScreenSample

2) Pressing redisplays the CALIB

REQUEST (Conc. Set) screen.

CALIB REQUEST(Conc. Set) Screen

3) Reload the calibrator and reagent cups correctly and check again.

Misplacing the calibrator concentrations will not result in errors.

Always position the calibration solution in order of concentration,
from the lowest to the highest.

When loaded correctly, the CALIB REQUEST

(Analyte Check 2) screen appears.

Press the START key to start the calibration.

CALIB REQUEST (Analyte Check 2) Screen

5-6
Chapter 5-1Generating Calibration Curves

Screens Displayed During Calibration

Sample measurement cannot be performed

during calibration.

When the calibration is complete, the CALB

displayed at the top right of the screen changes
to STOP.

5-7
Chapter 5 - 2Reviewing/Updating New Calibration Curves

2. Reviewing/Updating New Calibration CurvesCALIBRATION REVIEW

2.1 Calibration Review

The first assay result is output approximately 20 minutes after the assay operation begins,
result reports appear every 100 sec thereafter.
Review and calculations using the calibration data should be conducted when calibration
is complete.
Calibration data can be reviewed using the CALIB REVIEW screen.

Procedures

Press the MENU key to display the MENU

screen.

MENU Screen

Press to display the CALIB REVIEW screen.

CALIB REVIEW Screen Item and Lot

Calculates Calibration Curve

Deletes calibration data

Displays unreviewed calibration data

in sequence.

Displays list of
reviewed calibrations.

Assigns accept and do not

accept flags to each value.

5-8
Chapter 5 - 2Reviewing/Updating New Calibration Curves

The system is designed so that all unflagged assay results that appear when the
screen is displayed are accepted. In order to delete data inappropriate for the
calibration calculations, use to move the cursor to the inappropriate

value and press to reject.

Point
To accept the rejected data item, simply press to toggle.

Once assay results have been reviewed, click .

This displays the CALIB ACCEPT screen.

CALIB ACCEPT Screen

Displays formula

Accepts the calibration curve

Prints out the CALIBRATION

REPORT.

Redisplays the CALIB

Horizontal axis flags indicate concentrations REVIEW screen.
and vertical flags the rates.

Point
Calibrations displayed in the CALIBRATION ACCEPT screen can be

recalculated repeatedly until calibration verifyis pressed.

5-9
Chapter 5 - 2Reviewing/Updating New Calibration Curves

2.2 Verifying Calibration Curves

The calibration curves are verified once calibration results have been reviewed.

Note that assay data cannot be changed or recalculated once verification has
been performed.

Point
The maximum number of lots verifiable per analyte is two.
The same lot cannot be verified.

Procedures

Go to the CALIB ACCEPT screen

Press to review the calibration curves.

A CALIBRATION REPORT will be printed out.

Fig. 5 - 1 Sample Printout Formula

Calibration flag

Concentrations

Rates

Coefficients

5 - 10
Chapter 5 - 2Reviewing/Updating New Calibration Curves

Any unverified calibration results can be

displayed by calling up the CALIB REVIEW
screen.

Point
To delete unverified calibration results,

press . CALIB REVIEW Screen

The CALIBRATION REVIEW LIST screen is displayed when all calibration

curves have been verified.

CALIB REVIEW LIST Screen

Displays the CALB.

REVIEW screen.

Deletes calibration curve.

5 - 11

Chapter

Assay Procedures
Chaper 6: Assay Procedures

Introduction

Preparing System for Assay

Operations Chapter 4

Calibration curves Chapter 5

Assay Procedures
- Commencing Operations -
- Overview of Chapter -
1. Registering Assay Requests 6-2
2. Registering Sample ID 6-2
3. Commencing Assay Operations 6-5
4. Assay Results 6-9

Completing Assay Operation

Chapter 8

6-1
Chapter 6 - 1.Registering Assay Requests

1. Registering Assay Requests

Assay requests are registered automatically using the combination of an internal barcode
reader and a cup reader.
The AIA-360 is equipped with a camera capable of reading analyte names and lot numbers,
enabling it to automatically distinguish between specimen types and select the appropriate
assay operations, as soon as specimens and reagent cups are loaded in the carousel.

Point Note that up to four tests can be performed per specimen. This means that the fifth
and all subsequent reagent cups per specimen will be skipped.
In cases where tests are performed using designated sample cups, sample IDs will
be assigned in the order SMPL1, SMPL2, SMPL3, etc.

2. Registering Sample ID

AIA-360 automatically registers a samples ID using the built-in barcode reader.

The ID of an arbitrary sample can be registered by entering a sample ID before starting an
assay.
The sample ID registration conditions are as follows:

Arbitrary Sample ID
Sample Container
Input No Input
Auto registration
Sample cup Entered ID is registered.
(SMPL1, SMPL2, SMPL3, )
Blood tube with no Auto registration
barcode label
Entered ID is registered.
(SMPL1, SMPL2, SMPL3, )
Entered ID is registered if it
matches the sample ID read by the
built-in barcode reader. If they do Auto registration
Blood tube with
barcode label (Sample ID on barcode label)
not match, an IM flag is attached
with no assay.

For the settings of the built-in barcode reader, see Chapter 9 OTHER FUNCTIONS -
SPECIAL, MENU - 6.BCR PARAM (DETAILED SETTINGS OF BARCODE).

6-2
Chapter 6 - 2.Registering Sample ID

2.1 Entering a sample ID

Enter a sample ID before the sample passes the built-in barcode reader.
Once a sample has passed the barcode reader, its ID cannot be entered.

Press on the ASSAY MONITOR screen.

The SAMPLE ID LIST screen is displayed.

ASSAY MONITOR Screen

Move the cursor to the sample ID to be inputted

by using and then press .

The SAMPLE ID screen is then displayed.

SAMPLE ID LIST Screen

Enter a sample ID (16 digits max.).

Pressing changes the mode as follows:

Alphabetic characters (uppercase)
Alphabetic characters (lowercase)
Numerals and/or symbols
SAMPLE ID Screen

After inputting, press to return to the

SAMPLE ID LIST screen.

SAMPLE ID LIST Screen

6-3
Section 6-2: Registering a Sample ID

Point
Pressing prints a sample ID list.

To prevent mistakes occurring, check the

sample ID list when loading samples.

After checking that a sample ID has been entered, press .

When the ASSAY MONITOR screen is displayed, start inspection according to

Section 3. Commencing Assay Operations.

<ASSAY MONITOR screen>

The built-in barcode reader reads a

sample and the entered sample ID is
registered.

Point
After a sample has been read by the built-in barcode reader, the entered
sample ID disappears from the SAMPLE ID LIST screen.
An arbitrary sample ID can also be entered for additional assay.

6-4
 Chapter 6 - 2.Commencing Assay Operations

3. Commencing Assay Operations

3.1 Commencing Assay Operations

Assay operations begin with the loading of specimens and reagent cups into
the carousel.

Test Tube (sample cup) and Reagent Cup Loading Procedure

Begin by loading test tubes (or designated sample cups) into the sample holder and
reagent cups (numbers correspond to analytes) into the reagent cup holder.

FIg. 6-1 Test Tube and Reagent Cup Loading Procedure

Reagent cup

Reagent cup holder

Sample cup holder

Note the barcode reader slits in the sample

holder.

Point The maximum limit for reagent cups per specimen is four.
When analyzing multiple analytes per specimen, leave one position open between
each set of reagent cups.
The carousel can be moved one position at a time by pressing the SAMPLE FEED
key.

6-5
Chapter 6 - 2.Commencing Assay Operations

Make sure to firmly insert the test tubes (sample cups) and reagent cups into
their holders. Loosely inserted cups can get caught when the carousel rotates
and stops the assay operation.
Be sure to position the bar codes at the sample holder slits when using test
tubes with barcodes attached, so that they can be easily read.

Slit

6-6
Chapter 6 - 2. Commencing Assay Operations

Once the samples and reagent cups have been

loaded, press on the MENU screen to

display the ASSAY MONITOR screen.

Press START to start the assay operation.

ASSAY MONITOR Screen>
The carousel moves in clockwise direction
When the assay begins.

Do not depress the START key for a long time.

Depressing the START key for a long time
(about two seconds or longer) sends an abort
request for an emergency stop.

Note that pressing SAMPLE FEED during

the assay operation will not move the carousel
forward.

SAMPLE ID
Sample ID (up to 16 characters) can be displayed

on the screen when the specimen is read.

ANALYTE
Analytes in the reagent cups read from

the camera are displayed for each sample.

(Maximum 4 tests)

Pressing the START key for a long time (about two

seconds or longer) sends an abort request for an
emergency stop.

6-7
Chapter 6 - 2.Commencing Assay Operations

The carousel makes one more rotation after the

reagent cup in the final position has been
assayed.

Once it has confirmed that all reagent cups

have been assayed, 'CLOSING' will be
displayed on the upper right of a screen and it
will go into end process.
After end process, 'STOP' is displayed and
measurement is suspended.

Additional

Additional assays can be added while assay operations are in progress by inserting
them in the visible section of the carousel.

Point
Additional assays may be added only while either ASSAY or SEARCH
are displayed at the top right of the ASSAY MONITOR screen.

1) Make sure to remove any samples and reagent cups that have already been
assayed at this time.

2) Then insert the additional samples and reagent cups in the visible section of
the carousel.

The LED lamp begins flashing 10 seconds before the carousel begins
to rotate.
Take can not to get fingers caught in the carousel when inserting additional
samples and reagent cups.

3) The new assays will be added automatically.

6-8
Chapter 6 - 3.Assay Results

4. Assay Results
4.1 External Output of Assay Results

Press on the MENU screen to display

the RESULT REVIEW screen.

RESULT REVIEW Screen>

Press and use to select

the range of detailed Assay Results to output
externally.
Selected range is flagged by the + sign

Point
Press to proceed to

the next screen.

Press to confirm the selected range.

This changes the + signs to the > sign

To delete the specified range, press

Point

Next, press .

This displays the RESULT EXECUTE screen.

Pressing the displays the RESULT

REVIEW screen and the selected range of

Assay Results is output externally. RESULT EXECUTE Screen>

6-9
Chapter 6 - 3.Assay Results

4.2 Printing Assay Results

Press on the MENU screen to display

the RESULT REVIEW screen.

RESULT REVIEW Screen>

Press and use to select

the range of detailed Assay Results to output

externally.
Selected range is flagged by the + sign

Point

Press to proceed to

the next screen.

Press to confirm the selected range.

This changes the + signs to the > sign

Point
To delete the specified range, press .

Next, press .

This displays the RESULT EXECUTE screen.

Press to print out the selected range

of Assay Results.

6 - 10
 RESULT EXECUTE Screen>
Chapter 6 - 3.Assay Results

Fig. 6-2 Sample Assay Result Printout

Assay Time/Date
Reagent
Operation name cup and lot
Sample ID

Analyte name Position no.

Meas. value

Flag
See section 3. List of Flags in Appendix Rate value
A, Chapter 12.

4.3 Recalculating Assay Results

Press on the MENU screen to display

the RESULT REVIEW screen.

RESULT REVIEW Screen>

Press and use to select

the range of detailed Assay Results to output
externally.
Selected range is flagged by the + sign

Point
Press to proceed to

the next screen.

6 - 11
Chapter 6 - 3.Assay Results

Press to confirm the selected range.

This changes the + signs to the > sign

To delete the specified range, press

Point

Next, press .

This displays the RESULT EXECUTE screen.

Pressing recalculates the selected

range of Assay Results.
RESULT EXECUTE Screen>

6 - 12
 Chapter

Error Messages and Flags

Chaper 7: Error Messages and Flags

1. List of Error Messages

If a problem occurs during assay or it is difficult to continue an assay, an error message is
displayed.
Together with the error message, a buzzer sounds to alert the operator to the error.
At the same time, the printer also prints the error message.

If an assay is not completed normally due to an error, an error flag may be

attached to the assay value.
1.1 Error Message Lists
When an assay is started soon after turning the power switch on, if the incubator has not
reached the appropriate temperature, Error Message No. 3003 is displayed and the assay
may not be started.

No. Error Message Meaning Troubleshooting

3003 WAITING FOR Waiting for the temperature Wait until the temperature rises to
TEMPERATURE to rise. correct temperature.

If one of Error Messages No. 3017 to 3020 is displayed, the assay is suspended. If a
reaction is in progress, however, the assay continues. Take the appropriate action in
accordance with the displayed message and restart the assay. After all the ongoing assays
end, perform the corresponding troubleshooting and press the START key to restart assays.

No. Error Message Meaning Troubleshooting

3017 SUBSTRATE LOW Insufficient substrate. After confirming that ASSAY displayed on
the upper right of the ASSAY MONITOR
screen changes to STOP, replace the
enzyme substrate with new one and press
the START key to restart assay operation.
3018 WASTE TANK FULL The waste tank is full. After confirming that ASSAY displayed on
the upper right of the ASSAY MONITOR
screen changes to STOP, empty the
waste tank and press the START key to
restart assay operation.
3019 WASHER LOW Insufficient wash solution. After confirming that ASSAY displayed on
the upper right of the ASSAY MONITOR
screen changes to STOP, replace the
wash solution with new one and press the
START key to restart assay operation.
3020 DILUENT LOW Insufficient diluent. After confirming that ASSAY displayed on
the upper right of the ASSAY MONITOR
screen changes to STOP, replace the
diluent with new one and press the START
key to restart assay operation

7-1
Section 7-1: List of Error Messages

If an error occurs, the device stops and the message shown below is displayed.
If an error message is displayed during an assay, you may not be able to continue
the assay.

Operating Errors
No. Error message Description Troubleshooting
0001 FILE SYSTEM ERROR The smart media could not be Use other media or contact
initialized. the service department.
0002 MAIN PROGRAM OPEN The main program cannot be Use other media or contact
ERROR read. the service department.
0003 MAIN PROGRAM FORMAT The file format of the main Use other media or contact
ERROR program is incorrect. the service department.
0004 SLAVE PROGRAM OPEN The slave program cannot be Use other media or contact
ERROR read. the service department.
0005 SLAVE PROGRAM FORMAT The file format of the slave Use other media or contact
ERROR program is incorrect. the service department.
0006 TOUCH PANEL PROGRAM The touch panel program cannot Use other media or contact
OPEN ERROR be read. the service department.
0007 INSTALLATION OPEN The image data cannot be read. Use other media or contact
ERROR the service department.
0008 INSTALLATION FORMAT The format of the image data file Use other media or contact
ERROR is incorrect. the service department.
0009 INSUFFICIENT STANDARD No standard cup is loaded for the Load a standard cup on reagent
CUP daily check. cup holder No.1 and repeat.
0010 TWO CALIBRATION Calibration curves of two lots Delete a calibration curve before
CURVES CONFIRMED have already been confirmed. accept a new one.
0011 SAME LOT CALIBRATION Calibration curves have already Delete the old calibration curve
CURVE been confirmed for the same lot. before accept a new one.
0012 CALIBRATION NOT There is insufficient data to Repeat the calibration.
ENOUGH calculate calibration curves.
0013 CALCULATION ERROR Calculation error of the Repeat the calibration.
calibration curve.
0014 CALIBRATION DATA ZIGZAG The calibration curve rates are Repeat the calibration.
not in ascending order.
0015 TOO MANY CALIBRATION The calibration curve data is Repeat the calibration.
DATA abnormal.
0016 CALIBRATION DATA MINUS Logarithm calculation of Repeat the calibration.
RATE calibration curve failed.
0017 TOMAS DATA WRITE ERROR Unable to write smart media. Use other media or contact
the service department.
0018 TOMAS DATA READ ERROR Unable to read smart media. Reset the smart media or
contact the service department.
0019 TESTFILE WRITE ERROR Unable to write test file. Use other media or contact the
service department.
0020 TESTFILE READ ERROR Unable to read smart media. Reload the smart media or
contact the service department.

7-2
 Section 7-1: List of Error Messages

Communication-related errors
No. Error message Description Troubleshooting
1001 UNABLE TO SEND TO FIFO has become full during Turn the power off and on again.
SLAVE transmission to the slave. If this problem reoccurs, contact
the service department.
1002 UNABLE TO RECEIVE FROM A communication error Turn the power off and on again.
SLAVE occurred during transmission to If this problem reoccurs, contact
the slave. the service department.
1003 RECEIVE DATA ERROR A communication error Turn the power off and on again.
FROM T.PANEL occurred during reception from If this problem reoccurs, contact
the touch panel. the service department.
1004 TRANSMISSION TO T.PANEL A timeout error occurred Turn the power off and on again.
TIMED OUT during reception from the If this problem reoccurs, contact
touch panel. the service department.
1005 BARCODE ERROR A barcode communication Turn the power off and on again.
error occurred. If this problem reoccurs, contact
the service department.

Control related errors

No. Error message Description Troubleshooting
1006 ASTM PARITY ERROR A parity error occurred in ASTM Check the communication
communication. settings and cable.
1007 ASTM FRAME ERROR An ASTM communication Check the communication
frame error occurred. settings and cable.
1008 ASTM OVERRUN ERROR ASTM communication Check the communication
overrun error settings and cable.
1009 ASTM BUFFER FULL The ASTM communication Check the communication
buffer has become full. settings and cable.
1011 ASTM RETRY ERROR An ASTM communication retry Check the communication
error occurred. settings and cable.
1012 ASTM SEND TIMEOUT A send timeout event occurred in Check the communication
ASTM communication. settings and cable.
1013 ASTM RECEIVE TIMEOUT A receive timeout error occurred Check the communication
in ASTM communication. settings and cable.
1014 ASTM NO RESPONSE No response was received in Check the communication
ASTM communication. settings and cable.
2001 RTC POWER ON CLEAR An internal clock backup error Reset the date and time.
occurred. If this problem reoccurs, contact
the service department.
2002 TESTCUP READ ERROR The test cup read error occurred. If this problem reoccurs
frequently, contact the service
department.
2003 TESTCUP READ ERROR The test cup position error Set the test cup to a right
occurred at the detector position.
calibration.
2004 DET CALIB. TESTCUP READ The test cup read error at the Set the STD cup to a right
ERROR detector calibration. position.
2005 DET CALIB. DIVIDE BY ZERO Data error at the detector Check the conditions,
calibration. Repeat the detector calibration.

7-3
Section 7-1: List of Error Messages

Control related errors

No. Error message Description Troubleshooting
2006 DET CALIB. DATA VARIANCE Data variance error at the Check the conditions,
ERROR detector calibration. Repeat the detector calibration.
2007 DET CALIB. ABNORMAL Data abnormal error at the Check the conditions,
DATA detector calibration. Repeat the detector calibration.
2008 DET CALIB. SUBSTRATE HB The background intensity of Replace the new substrate
substrate is high
2009 BF PROBE LIQUID SENSOR Liquid detection error in BF Contact the service department.
ERROR probe
2010 SAMPLE LEVEL FAILURE A liquid detection open-circuit Contact the service department.
error occurred at the sample
nozzle.
2011 AIR DETECTED [SAMPLE] There is no contact with the Contact the service department.
liquid surface after sample
suction.
2012 AIR DETECTED [DILUENT] There is no contact with the Contact the service department.
liquid after diluent suction.
2013 SAMPLE LEVEL DETECTION The liquid surface cannot be Contact the service department.
ERROR detected even at the bottom of
the sample cup or the blood
sample tube.
2014 SAMPLE SHORTAGE Insufficient sample. Prepare enough volume of
DETECTED specimen.
2015 BF PROBE PURGE FAILURE Purging by the BF probe is Clean up the wash probe tip or
abnormal. replace it. Contact the service
department.
2016 BFPROBE SUCTION FAILURE Suction by the BF probe is Contact the service department.
abnormal.

Monitor-related errors
No. Error message Description Troubleshooting
3001 PRINTER PAPER END No paper is loaded in the printer. Load paper in the printer.
3002 PRINTER HEADUP The printer head has gone up. Lower the printer head.
3003 WAITINGFOR Waiting for the temperature to Wait until the temperature rises
TEMPERATURE rise. to correct temperature.
3004 TEMPERATURE TIMEOUTED A timeout error occurred while Turn the power off and on again.
waiting for the temperature to If this problem reoccurs, contact
rise. the service department.
3005 TURN TABLE TEMPERATURE The turntable temperature is Turn the power off and on again.
LOW below the lower limit. If this problem reoccurs, contact
the service department.
3006 WASHER TEMPERATURE The wash solution Turn the power off and on again.
LOW temperature is below If this problem reoccurs, contact
the lower limit. the service department.
3007 SUBSTRATE TEMPERATURE The substrate temperature is Turn the power off and on again.
LOW below the lower limit. If this problem reoccurs, contact
the service department.

7-4
 Section 7-1: List of Error Messages

Monitor-related errors
No. Error message Description Troubleshooting
3008 TURN TABLE TEMPERATURE The turntable temperature is Turn the power off and on again.
HIGH above the upper limit. If this problem reoccurs, contact
the service department.
3009 WASHER TEMPERATURE The wash solution Turn the power off and on again.
HIGH temperature is above the If this problem reoccurs, contact
target temp. the service department.
3010 SUBSTRATE TEMPERATURE The substrate temperature is Turn the power off and on again.
HIGH above the upper limit. If this problem reoccurs, contact
the service department.
3011 TURN TABLE TEMP. The turntable temperature Turn the power off and on again.
MALFUNCTION sensor disconnection If this problem reoccurs, contact
occurred. the service department.
3012 WASHER TEMP. The wash solution Turn the power off and on again.
MALFUNCTION temperature sensor If this problem reoccurs, contact
disconnection occurred. the service department.
3013 SUBSTRATE TEMP. The substrate temperature Turn the power off and on again.
MALFUNCTION disconnection error If this problem reoccurs, contact
occurred. the service department.
3014 TURN TABLE TEMP. LIMIT The turntable temperature is Turn the power off and on again.
above the upper limit. If this problem reoccurs, contact
the service department.
3015 WASHER TEMP. LIMIT The wash solution temperature Turn the power off and on again.
reach the upper limit. If this problem reoccurs, contact
the service department.
3016 SUBSTRATE TEMP. LIMIT The substrate temperature is Turn the power off and on again.
above the upper limit. If this problem reoccurs, contact
the service department.
3017 SUBSTRATE LOW Insufficient substrate. Replace the enzyme substrate.
3018 WASTE TANK FULL The waste tank is full. Empty the waste tank.
3019 WASHER LOW Insufficient wash solution. Replenish the wash solution.
3020 DILUENT LOW Insufficient diluent. Replenish the diluent.
3021 LEAK SENSOR S701 Leakage sensor S701 activated. Contact the service department.
DETECTED
3022 LEAK SENSOR S702 Leakage sensor S702 activated. Contact the service department.
DETECTED

Actuator-related errors
No. Error message Description Troubleshooting
4001 TURN TABLE HOME SENSOR The turntable motor home Turn the power off and on again.
sensor remains activated. If this problem reoccurs, contact
the service department.
4002 TURN TABLE HOME NOT The home position of the Turn the power off and on again.
FOUND turntable motor cannot be If this problem reoccurs, contact
detected. the service department.
4003 TURN TABLE HOME The turntable motor overran on Turn the power off and on again.
OVERRUN the home side. If this problem reoccurs, contact
the service department.

7-5
Section 7-1: List of Error Messages

Actuator-related errors
No. Error message Description Troubleshooting
4004 TURN TABLE SLIP The turntable motor slipped. Turn the power off and on again.
If this problem reoccurs, contact
the service department.
4005 TURN TABLE ACCELL The acceleration/deceleration Turn the power off and on again.
table of the turntable motor was If this problem reoccurs, contact
incorrectly set. the service department.
4006 TURN TABLE S106 The turntable anti-rotation sensor Check that the blood sample
is activated. tube is in contact with the
sensor.
4007 MIXER HOME SENSOR The mixer motor home sensor Turn the power off and on again.
remains activated. If this problem reoccurs, contact
the service department.
4008 MIXER HOME NOT FOUND The home position of the mixer Turn the power off and on again.
motor cannot be detected. If this problem reoccurs, contact
the service department.
4009 MIXER HOME OVERRUN The mixer motor overran on the Turn the power off and on again.
home side. If this problem reoccurs, contact
the service department.
4010 MIXER SLIP The mixer motor slipped. Turn the power off and on again.
If this problem reoccurs, contact
the service department.
4011 MIXER ACCELL The acceleration/deceleration Turn the power off and on again.
table of the mixer motor was If this problem reoccurs, contact
incorrectly set. the service department.
4012 SPEC.SY HOME SENSOR The specimen syringe motor Turn the power off and on again.
home sensor remains If this problem reoccurs, contact
activated. the service department.
4013 SPEC.SY HOME NOT FOUND The home position of the Turn the power off and on again.
specimen syringe motor If this problem reoccurs, contact
cannot be detected. the service department.
4014 SPEC.SY HOME OVERRUN The specimen syringe motor Turn the power off and on again.
overran on the home side. If this problem reoccurs, contact
the service department.
4016 SPEC.SY ACCELL The acceleration/deceleration Turn the power off and on again.
table of specimen syringe motor If this problem reoccurs, contact
was incorrectly set. the service department.
4017 SPEC.SY CLOG DETECTED Specimen clog was detected. The item is not assayed. Repeat
assay.
4018 SPEC.Z-AXIS HOME SENSOR The specimen Z-axis motor Turn the power off and on again.
home sensor remains activated. If this problem reoccurs, contact
the service department.
4019 SPEC.Z-AXIS HOME NOT The home position of the Turn the power off and on again.
FOUND specimen Z-axis motor cannot If this problem reoccurs, contact
be detected. the service department.
4020 SPEC.Z-AXIS HOME The specimen Z-axis motor Turn the power off and on again.
OVERRUN overran on the home side. If this problem reoccurs, contact
the service department.

7-6
 Section 7-1: List of Error Messages

Actuator-related errors
No. Error message Description Troubleshooting
4022 SPEC.Z-AXIS ACCELL The acceleration/deceleration Turn the power off and on again.
table of the specimen Z-axis If this problem reoccurs, contact
motor was incorrectly set. the service department.
4023 SPEC.R-AXIS HOME SENSOR The specimen R-axis motor Turn the power off and on again.
home sensor remains If this problem reoccurs, contact
activated. the service department.
4024 SPEC.R-AXIS HOME NOT The home position of the Turn the power off and on again.
FOUND specimen R-axis motor If this problem reoccurs, contact
cannot be detected. the service department.
4025 SPEC.R-AXIS HOME The specimen R-axis motor Turn the power off and on again.
OVERRUN overran on the home side. If this problem reoccurs, contact
the service department.
4027 SPEC.R-AXIS ACCELL The acceleration/deceleration Turn the power off and on again.
table of the specimen R-axis If this problem reoccurs, contact
motor was incorrectly set. the service department.
4028 SPEC.T-AXIS HOME SENSOR The specimen -axis motor Turn the power off and on again.
home sensor remains If this problem reoccurs, contact
activated. the service department.
4029 SPEC.T-AXIS HOME NOT FOUND The home position of the Turn the power off and on again.
specimen -axis motor If this problem reoccurs, contact
cannot be detected. the service department.
4030 SPEC.T-AXIS HOME OVERRUN The specimen -axis motor Turn the power off and on again.
overran on the home side. If this problem reoccurs, contact
the service department.
4032 SPEC.T-AXIS ACCELL The acceleration/deceleration Turn the power off and on again.
table of the specimen -axis If this problem reoccurs, contact
motor was incorrectly set. the service department.
4033 SEAL BREAK HOME SENSOR The seal breaker motor home Turn the power off and on again.
sensor remains activated. If this problem reoccurs, contact
the service department.
4034 SEAL BREAK HOME NOT FOUND The home position of the seal Turn the power off and on again.
breaker motor cannot be If this problem reoccurs, contact
detected. the service department.
4035 SEAL BREAK HOME OVERRUN The seal breaker motor Turn the power off and on again.
overran on the home side. If this problem reoccurs, contact
the service department.
4037 SEAL BREAK ACCELL The acceleration/deceleration Turn the power off and on again.
table of the seal breaker motor If this problem reoccurs, contact
was incorrectly set. the service department.
4038 WASH.PROBE HOME SENSOR The BF probe motor home Turn the power off and on again.
sensor remains activated. If this problem reoccurs, contact
the service department.
4039 WASH.PROBE HOME NOT The home position of the BF Turn the power off and on again.
FOUND probe motor cannot be detected. If this problem reoccurs, contact
the service department.
4040 WASH.PROBE HOME The BF probe motor overran on Turn the power off and on again.
OVERRUN the home side. If this problem reoccurs, contact
the service department.

7-7
Section 7-1: List of Error Messages

Actuator-related errors
No. Error message Description Troubleshooting
4042 WASH.PROBE ACCELL
The acceleration/deceleration Turn the power off and on again.
table of the BF probe motor was If this problem reoccurs, contact
incorrectly set. the service department.
4043 WASH.SY HOME SENSOR
The BF syringe motor home Turn the power off and on again.
sensor remains activated. If this problem reoccurs, contact
the service department.
4044 WASH.SY HOME NOT FOUND
The BF syringe motor home Turn the power off and on again.
position cannot be detected. If this problem reoccurs, contact
the service department.
4045 WASH.SY HOME OVERRUN
The BF syringe motor overran on Turn the power off and on again.
the home side. If this problem reoccurs, contact
the service department.
4047 WASH.SY ACCELL
The acceleration/deceleration Turn the power off and on again.
table of the BF syringe motor If this problem reoccurs, contact
was incorrectly set. the service department.
4048 SUBST.SY HOME SENSOR
The substrate syringe motor Turn the power off and on again.
home sensor remains activated. If this problem reoccurs, contact
the service department.
4049 SUBST.SY HOME NOT
The substrate syringe motor Turn the power off and on again.
FOUND
home position cannot be If this problem reoccurs, contact
detected. the service department.
4050 SUBST.SY HOME OVERRUN
The substrate syringe motor Turn the power off and on again.
overran on the home side. If this problem reoccurs, contact
the service department.
4052 SUBST.SY ACCELL
The acceleration/deceleration Turn the power off and on again.
table of the substrate syringe If this problem reoccurs, contact
motor was incorrectly set. the service department.
4053 SEAL BREAK POS. SENSOR
The seal breaking position Turn the power off and on again.
sensor is faulty. If this problem reoccurs, contact
the service department.

7-8
 Section 7-1: List of Error Messages

System-related errors
No. Error message Description Troubleshooting
5001 INTERNAL ERROR Internal program error. Turn the power off and on again.
If this problem reoccurs, contact
the service department.
5002 NO RESPONSE FROM SLAVE Slave response not detected Turn the power off and on again.
error If this problem reoccurs, contact
the service department.
5003 SLAVE COMMAND ERROR Slave command error. Turn the power off and on again.
If this problem reoccurs, contact
the service department.
5004 SLAVE FIFO ERROR Slave FIFO error Turn the power off and on again.
If this problem reoccurs, contact
the service department.
5005 MAIN PROGRAM ERASE Main program erase timeout. Turn the power off and on again.
TIMED OUT If this problem reoccurs, contact
the service department.
5006 MAIN PROGRAM WRITE ERROR Main program write error. Turn the power off and on again.
If this problem reoccurs, contact
the service department.
5007 MAIN PROGRAM COMPARE Main program compare error. Turn the power off and on again.
ERROR If this problem reoccurs, contact
the service department.
5008 MAIN PROGRAM NOT Main program not found. Contact the service department.
INSTALLED
5009 SLAVE PROGRAM ERASE Slave program erase timeout. Turn the power off and on again.
TIMED OUT If this problem reoccurs, contact
the service department.
5010 SLAVE PROGRAM WRITE Slave program write error. Turn the power off and on again.
ERROR If this problem reoccurs, contact
the service department.
5011 SLAVE PROGRAM COMPARE Slave program compare error. Turn the power off and on again.
ERROR If this problem reoccurs, contact
the service department.
5012 SLAVE PROGRAM NOT Slave program not found. Contact the service department.
INSTALLED
5013 INSTALLATION ERASE TIMED Image data erase timeout. Turn the power off and on again.
OUT If this problem reoccurs, contact
the service department.
5014 INSTALLATION WRITE Image data write error. Turn the power off and on again.
ERROR If this problem reoccurs, contact
the service department.
5015 INSTALLATION COMPARE Image data compare error. Turn the power off and on again.
ERROR If this problem reoccurs, contact
the service department.
5016 INSTALLATION NOT Image data not found. Contact the service department.
INSTALLED
5017 PRINTER HARD ERROR Printer hardware error. Turn the power off and on again.
If this problem reoccurs, contact
the service department.

7-9
Section 7-1: List of Error Messages

System-related errors
No. Error message Description Troubleshooting
5018 ASSAY ABORTED Measurement terminated. Repeat assay.
5019 DETECTOR CALIB. ABORTED Detector calibration aborted Check the conditions,
Repeat the detector calibration.
5020 DETECTOR TASK ERROR Detector calibration task Turn the power off and on again.
execution error. If this problem reoccurs, contact
the service department.
5021 TURNTABLE TASK ERROR Turntable task execution error. Turn the power off and on again.
If this problem reoccurs, contact
the service department.
5022 SPECIMEN TASK ERROR Specimen arm task execution Turn the power off and on again.
error. Send the printed error report to
the service department.
5023 SEALBREAK TASK ERROR Seal break task execution Turn the power off and on again.
error. If this problem reoccurs, contact
the service department.
5024 CCD TASK ERROR Cup read task execution Turn the power off and on again.
error. If this problem reoccurs, contact
the service department.
5025 SUBTRATE TASK ERROR Substrate task execution Turn the power off and on again.
error. If this problem reoccurs, contact
the service department.
5026 WASHER TASK ERROR BF washing task execution Turn the power off and on again.
error. If this problem reoccurs, contact
the service department.
5027 DRAIN TASK ERROR Drain task execution error. Turn the power off and on again.
If this problem reoccurs, contact
the service department.
5029 CSUM ERROR (PARAM) Control parameter checksum Turn the power off and on again
error. and check the parameters.
If this problem reoccurs, contact
the service department.
5030 CSUM ERROR (REAGENT) Test file checksum error. Turn the power off and on again
and check the test file and
calibration curve.
If this problem reoccurs, contact
the service department.
5031 CSUM ERROR (RESULT) Assay result checksum error. Turn the power off and on again.
If this problem reoccurs, contact
the service department.
5032 CSUM ERROR (ERRLOG) Error log checksum error. Turn the power off and on again.
If this problem reoccurs, contact
the service department.
5033 CSUM ERROR Operation log checksum Turn the power off and on again.
(OPERATION LIST) error. If this problem reoccurs, contact
the service department.

7 - 10
 Section 7-1: List of Error Messages

System-related errors
No. Error message Description Troubleshooting
5034 TESTFILE FLASH COMPARE Test file data write compare error. Turn the power off and on again.
ERROR If this problem reoccurs, contact the
service department.
5035 MUTEX LOCK UNLOCK Control variable acquisition error for Send the printed error report to the
ERROR sample dispensing task. service department.

7 - 11
Section 7-2: List of Flags

2. List of Flags
A flag is attached to an assay result as appropriate: an error flag if an assay does not
complete normally because of a problem or a user flag (normal or abnormal value) to
enable the user to discriminate an assay result.
When an error flag is attached, the assay result may or may not be available depending on
the error. When an error flag is not attached, the result of a normally finished assay is
available. If no assay result is available due to an error, take the appropriate action
according to Section 2.1 Flag Lists and Section 2.2 Detailed Meanings of Flags and
Action.

2.1 Flag Lists

Error flags
FLAG Meaning Action CAL. Result
SE System error Terminate assay REJECT INCOMPLETE
ME Item error (unable to assay) Do not assay REJECT INCOMPLETE
AE Test cup read error Do not assay REJECT INCOMPLETE
NB Seal breaking failure Do not assay REJECT INCOMPLETE
IM Sample ID mismatch Do not assay REJECT INCOMPLETE
WU B/F washing failure Do not assay REJECT INCOMPLETE
DS Insufficient diluent Do not assay REJECT INCOMPLETE
WS Insufficient wash solution Do not assay REJECT INCOMPLETE
SS Insufficient sample Do not assay REJECT INCOMPLETE
SP Waste liquid full Do not assay REJECT INCOMPLETE
SC Nozzle clogged Do not assay REJECT INCOMPLETE
LE Lot read error Do not assay REJECT INCOMPLETE
DO Over detector range Perform assay REJECT INCOMPLETE
NC No calibration curve Perform assay - RATE
CE Operation error Perform assay REJECT INCOMPLETE
<L Lower than the calibration area Perform assay - RATE
>H Higher than the calibration area Perform assay - RATE
IO Imperfect temperature control Perform assay REJECT CONC
MF Mechanical error in dispensing sample Do not assay REJECT INCOMPLETE
BS Insufficient enzyme substrate Perform assay REJECT INCOMPLETE
HB High substrate blank Perform assay REJECT RATE
CV Calibration curve expired Perform assay - CONC
If it passes 60 days or more since the
expiration date, assay results will be
reported in rate values with NC flags.
DL Insufficient substrate dispensing volume Perform assay REJECT RATE
or low detector light intensity
Mismatch between reading and order
MA (CALIBRATION) Use reader Info REJECT -

7 - 12
Section 7-2: List of Flags

User flags
L Lower than (user) reference range Perform assay - CONC
H Higher than (user) reference range Perform assay - CONC
No flag indicates normal result Perform assay ACCEPT CONC

Abbreviations

CAL. : ACCEPT Calibrator data automatically accepted

REJECT Calibrator data automatically rejected
Result : INCOMPLETE Assay result incomplete
RATE Only rate value obtained
CONC Rate and concentration value obtained

2.2 Detailed Descriptions of Flags and Actions

SE: The assay could not be completed due to a problem (error) that does
not disable the device.

ME: The assay item could not be read at calibration or it was an item which
cannot be used in AIA-360. Check labeling on the test cup and repeat
assay.
If this flag appears continuously, the cup reader may have been
displaced. Contact the service department.

Point This flag may be attached if the test cup is not checked by pressing
[SKIP] in the CALB REQUEST (Check START) screen.

AE: The assay item could not be read by the cup reader.
In this case, no assay request is assumed and the assay is cancelled.
Check labeling on the test cup and repeat assay.
If this flag appears continuously, the cup reader may have been
displaced. Contact the service department.

NB: The seal of the test cup could not be broken. The assay is cancelled.
The seal breaker may have a dirty blade or be displaced.
Contact the service department.

7 - 13
Section 7-2: List of Flags

IM: The sample was skipped because the input sample ID did not match
the one read by the built-in barcode reader. Repeat assay after
checking the barcode label position and quality and also the sample
order.

WU: During B/F washing, the wash solution could not be drained.
If this flag appears continuously, the tip of the B/F washing probe may
be dirty or clogged. Contact the service department.

DS: Insufficient diluent has been detected. Replenish the diluent and repeat
assay.

WS: Insufficient wash solution has been detected. Replenish the wash
solution and repeat assay.

SS: The assay was cancelled because of insufficient sample. If this flag
appears when there is an enough sample, either the sample nozzle or
the sample detection sensor may be faulty. If this problem occurs
frequently, contact the service department.

SP: The waste bottle has become full. Discard the waste liquid and repeat
assay.

SC: Dispensing was cancelled because clogging was detected during

sample suction. Check that the sample is free of fibrin or other
substances. If the sample is not clouded, the sample nozzle may be
faulty or the piping may be blocked. If this problem occurs frequently,
contact the service department.

LE: The lot number of the assay item could not be read by the cup reader.
In this case, no assay request is assumed and the assay is cancelled.
Check labeling on the test cup and repeat assay.
If this flag appears continuously, the cup reader may have been
displaced. Contact the service department.

7 - 14
Section 7-2: List of Flags

DO: No result could be obtained because the measuring range of the

detector was exceeded. Dilute the sample as required and repeat
assay.

NC: No result was obtained because there was no calibration curve for the
item or lot.
Alternatively, the concentration could not be calculated because the
calibration curve has expired 60 days ago or earlier.
In these cases, create a calibration curve and recalculate to obtain a
result.

CE: No result was obtained because an operation error occurred during the
rate calculation or the conversion of concentration. An item using a
multi-point calibration curve may result in an error for some relationship
between the shape of the calibration curve and the conversion range of
concentration. Check that the calibration curve does not have the
minimum value or the maximum value in the calibration area (see the
figure) and that the calibration area is in the range specified by the
manufacturer.
For the range of calibration area, the minimum value is set to ASSAY L
and the maximum value to ASSAY R in the TEST FILE screen.

The maximum value The maximum value

The minimum value The minimum value

<L: The assay result was not accepted because it lies below the calibration
area.

>H: The assay result was not accepted because it lies above the calibration
area. Dilute the sample as required and assay it again.

7 - 15
Section 7-2: List of Flags

IO: The temperature exceeded the controllable range.

If this flag appears frequently, contact the service department.

MF: A flag is attached due to an abnormality occurring during sample

dispensing.
Operation continues but a return failure disables the assay.

BS: There is insufficient enzyme substrate.

Replace the enzyme substrate.

HB: The substrate has decomposed and the blank is high.

If the substrate blank is high, dispersion in a low enzyme activity area
will be large. Replace the substrate and repeat assay.
If the HB flag appears even after the substrate is replaced, the
substrate line may be contaminated. In this case, contact the service
department.

CV: The calibration curve has expired.

Set up the calibration curve for the same lot and recalculate in the
RESULT REVIEW screen.
If it passes 60 days or more since the expiration date, assay results will
be reported in rate values with NC flags.

DL: The substrate dispensing amount is less than the specified amount or
the lamp intensity of the fluorescence detector is low. If the DL flag is
attached, replace the substrate (MAINTE screen 6. REPLACE
SUBSTRATE ) and repeat assay. If the DL flag appears again,
contact the service department.

MA: The assay item read by the camera is different from the requested
assay item. Check the read and requested items.

Point This flag may be attached if the test cup is not checked by pressing
[Check] in the CALB REQUEST (Check START) screen.

7 - 16
Section 7-2: List of Flags

2.3 Meanings of Daily Check Flags and Action

After performing a daily check on the substrate background, the result is printed. The
printed flags have the following meanings:

1. Substrate Replacement
OK: Liquid substitution with the enzyme substrate is sufficient.
ERR: Liquid substitution with the enzyme substrate is insufficient.
Check the remaining amount of enzyme substrate and perform the
daily check again.

2. 4MU Background
OK: The fluorescence intensity (background intensity) of the enzyme
substrate is below 1500 nmol/L.
HB: The fluorescence intensity (background intensity) of the enzyme
substrate is 1500 nmol/L or more.
Replace the enzyme substrate and perform daily check again.

3. Lamp Intensity Level

OK: The lamp intensity of the detector is sufficient.
LL: The lamp intensity of the detector is not sufficient.
Contact the service department.

7 - 17

Chapter

Shutting Down Operation

(Shut Down Menu)
Chapter 8Shut Down Operation (Shut Down Menu)

Introduction

Preparing System for Assay Operations

Chapter 4

Calibration Curves Chapter 5

Assay Procedures
Commencing Assay Operations
Chapter 6

Shut Down Operation

8 1
Chapter 8 - 1.Shut Down Operation (Shut Down Menu)

1. Shut Down Operation (Shut Down Menu)

Make sure to prime the substrate lines at the end of each day of operation. Leaving the
substrate in the lines will result in fluid evaporation and precipitation of the reagent, which may
clog the lines. Residual substrate in the lines may also cause a higher background
measurement.

Replace the substrate in the lines by priming them with ethanol disinfectant
solution.
Also note that priming the lines with distilled water will contaminate the lines and
cause higher background measurement results for the enzyme substrate.

Procedures

Remove all sample cups, test tubes and reagent cups for which assays have
been completed.
Remove the enzyme substrate bottle and replace it with the disinfecting ethanol
bottle.

Seal the enzyme substrate bottle with a clean rubber stopper or parafilm
and place in refrigerator.
Diluent and wash solution do not require refrigeration, so need not be
removed.

Press MENU to display the MENU screen.

Press .

<MENU Screen>
Message on the SHUT DOWN screen. This
displays Set substrate replacement solution
and press START.

Point
Note that the SHUT DOWN screen is not
displayed during the assay operations

<SHUT DOWN Screen>

8 2
Chapter 8 - 1.Shut Down Operation (Shut Down Menu)

Press START to commence the substrate

replacement operation.
The Please Wait message is displayed
while the priming operation is in progress.

A shut down operation in progress can be terminated by pressing .

Please Turn off the Power will appear on the

screen, indicating that the priming operation is
complete.
Turn off the system power supply.

Point Note that assay results are retained in the system memory after the power is
turned off. System memory is capable of storing up to 800 assay results.
Assay results are deleted in order starting from the oldest as new results are
entered in the memory.

8 3


Chapter

Other Functions
in SPECIAL MENU
Chapter 9: Other Functions in SPECIAL MENU

The SPECIAL MENU provides the menus required for entering various system operation
settings and maintenance utility functions.

Press in the MENU screen to display the SPECIAL MENU screen.

Used to monitor the status of various system

MAINTE
components.

COMM. RS232C transmission parameter settings

DATE/TIME Use to set date and time.

OPERATOR Use to register and change operator names.

Use to enter parameters for individual test items

TEST FILE
(analytes).

BCR PARAM Use to enter barcode parameters.

SYSTEM SPEC. Used to enter system operating specifications.

9 1
Chapter 9 1.MAINTE (Maintenance Tool)

1. MAINTEMaintenance Tool

This utility is used to check the operating status of the AIA-360 systems various operating
components.

Basic Operating Procedures

Go to MAINTE SCREEN, move cursor to the item to

be checked and press .

MAINTE Screen
The WAIT screen (Please Wait) appears while the
selected item is being checked.

WAIT Screen

The status check is completed by pressing

when Complete! appears on the screen.

Please observe the operation checking procedures Complete! Screen (Sample)

whenever they are provided for specific items.

9 2
Chapter 9 - 1.MAINTE (Maintenance Tool)

1ALL SET HOME Moves the various system components back to their
correct start positions.

2SUBSTRATE BG MEAS Performs substrate background measurement.

Perform after installing a new substrate solution bottle, but first use
6REPLACE SUBSTRATE to prime the enzyme substrate lines.

Place 1 detector standardization cupSTD cupin the No. 1 position (slot) in

the reagent cup holder.
Move cursor to 2SUBSTRATE BG MEAS.

Press the button to activate the carousel and perform substrate

background measurement.
The Complete! Screen is displayed and measured results are printed out
when the measuring operation completes.

Fig 9-1 Sample Printout of Substrate Background Measurement Results

1 1Indicates whether substrate

2
value replacement using the new
3 substrate solution was successful.
OK When successful
ERR When unsuccessful

2Indicates whether the operation to measure fluorescent intensity

(background intensity) of the enzyme substrate detected any problems.
This is reported with value in nmol/L.
OK When lower than 1500 nmol/L (No problem)
HB When equal to or higher than 1500 nmol/L (Background was too
high)
3Indicates the status of detector lamp intensity.
OK When sufficient
LL When insufficient Contact a Tosoh Service counter.

9 3
Chapter 9 - 1.MAINTE (Maintenance Tool)

3PRIME SAMPLE DILUENTUsed when filling up diluent

This is used when priming system with diluent.
Prime the system with diluent.

Move cursor to 3PRIME SAMPLER DILUENT and press .

This launches the diluent filling operation.

4WASH SAMPLER NOZZLEUsed for washing sampling nozzle

5PRIME BF WASH Used when filling buffer with wash solution

This is used when priming system with wash
solution.
Prime the system with wash.

Move cursor to 5PRIME BF WASH and press to start the filling

operation.

6REPLACE SUBSTRATE Used when priming enzyme substrate lines

This is used when priming system with new
substrate.
Replace current substrate with a new bottle of substrate.

Move cursor to 6REPLACE SUBSTRATE and press to start the

substrate priming operation.

When substrate priming is finished, use 2SUBSTRATE BG MEAS to

perform substrate background measurement.

7TESTCUP READ Used when performing reagent cup read test

Use the SAMPLE FEED key to move the cup reader into position when
performing a read test on a reagent cup.

Move cursor to 7TESTCUP READ and press .

This reads the reagent cup analyte code and lot number located below the
cup reader and displays them on the screen.

9 4
Chapter 9 - 1.MAINTE (Maintenance Tool)

8DETECTORLIGHT Used for Testing Florescent Detector

Use the SAMPLE FEED key to move the reagent cup to a position below
the fluorescent detector unit.

Move cursor to 8DETECTORLIGHTand press .

This displays detector data. (While lamp is on.)

9DETECTORDARK Used to Test Fluorescent Detector Unit

Dark measurement
Use the SAMPLE FEED key to move the reagent cup to be tested to
a position below the florescent detector unit.

Move cursor to 9DETECTORDARKand press .

This displays detector data. (While lamp is off.)

10BARCODE READ Used to Test Barcode Read Performance

Used the SAMPLE FEED key to move the primary tube to be read beside
the barcode reader.

Move cursor to 10BARCODE READ and press .

This performs the barcode read operation and displays the data.

9 5
Chapter 9 - 2.CommunicationsRS232C Transmission Parameter Settings

2. COMM.RS232C Transmission Parameter Settings

The AIA-360 uses the RS232C serial interface for transmitting data with external devices.
Enter the parameter settings required for transmitting with the selected external device.
The settings in parentheses to the right are the ones currently selected for that parameter.
Move cursor to the desired parameter and press

to select.

COMM. Screen

These settings must be entered or updated the first time the AIA-360 is started or when
changes to the settings are required. Note that the new settings are stored in the system
memory and retained, even when the power is turned off.
For detailed descriptions of transmission protocols and hardware settings, refer to
Appendix B: RS232C Transmission in Chapter 12.

Note that transmission settings cannot be modified while assay operations are in
progress.

Point Pressing will print out the current screen.

Fig. 9-2 Sample printout of transmission parameters

9 6
Chapter 9 3.DATETIMETime and Date Settings

3. DATE/TIMETime and Date Settings

Press to display the DATE/TIME

screen.

DATE/TIME Screen

Press to display the DATE/TIME

INPUT screen.

Enter the current time and date then press

to redisplay the DATE/TIME screen.

DATE/TIME INPUT Screen

4. OPERATOR (Registering and Changing)

The OPERATOR screen is used to register new operators, or change or delete currently
registered operators.
For a detailed description, refer to section 2.1 Confirming/Selecting Operator Name) in
Chapter 4.

Point The operator name is included on system printouts.

9 7
Chapter 9 - 5.TEST FILEof Analyte parameters

5. TEST FILEof analyte parameters

The AIA-360 enables users to check and modify certain parameter settings for the
individual analytes used in the assaying of reagents. Users are able to select the median
range and decimal place settings for parameters as necessary.

The TEST FILE consists of

multiple pages, which can be
scrolled through using the
arrow keys.

TEST FILE settings cannot be modified while assay operations are in progress.
Note that the new settings are stored in the system memory and retained even
when the power is turned off.
Changes made to parameter settings will be saved when the operator leaves
the TEST FILE screen to go to another screen. It is important to note that
parameter changes will be lost if system power is lost while still in the TEST
FILE screen.

Point
Parameter information can be printed by pressing .

Fig. 9-3 Sample TEST FILE Printout

9 8
Chapter 9 5.TEST FILEof Analyte parameters

Column Name Description

NO. Analyte code Number from 0 to 127 unique to each analyte.
CODE Analyte name Abbreviated name consisting of five alphanumerics.
CALIB.REQ* Specifies whether this Analyte code is displayed or not on the screen.
CALIB.1 to 6 Calibration concentrations
CAL LOT L Number of the lot for which calibration curves were selected.
CAL LOT R The AIA-360 allows for the creation of 2 lots of calibration curves per
analyte.
Lot numbers for current calibration curves are displayed under LOTL
and LOTR.
Units of
UNIT Unit of measurement for concentration.
concentration
SMPL. VOL Sample volume Sample volume (L).
DIL. VOL Diluent volume Volume of diluent dispensed together with sample (L).
Assay range Designates minimum effective assay concentration.
ASSAY L
lower limit Concentrations below this limit are not assayable.
Designates maximum effective assay concentration.
Assay range
ASSAY H Concentrations higher, even if mathematically viable,
upper limit
cannot be used as concentration values.
Median range
REF. L* Users can specify as required.
lower limit
Median range
REF. H* Users can specify as required.
upper limit
Designates the effective number of decimal places for
DECIMAL* Decimal places
expressing concentrations. Users can specify as required.

Procedures for Setting CALIB.REQ* Places

Move cursor to CALIB REQ* column and press .

Select SHOW and HIDE.

SHOW : Display
HIDE : Do not display

Procedures for Setting REF. L*, REF. H* and DECIMAL* Places

Move cursor to desired column and press .

Enter desired values when the INPUT screen is displayed.

Press to confirm setting.

Note that users cannot change settings other than those for CALIB REQ*,
REF. L*, REF. H* and DECIMAL* Places.

9 9
 Chapter 9. 6.BCR PARAMDetailed Barcode Settings

6. BCR PARAMDetailed Barcode Settings

These settings are used to specify various barcode parameters.
The settings in parentheses to the right are the ones currently selected for that parameter.
To change the setting, move the cursor to the design

parameter and press to change a value or a

enter setting.

1BCR START DIGIT

Designates start digits (1 to 15) for reading the barcode
IDs attached to specimens.
Default1

2BCR LENGTH
Designates the maximum double-digit length (1 to 16)
for reading the barcode IDs attached to specimens.
Default16

3CODE39 BCR PARAMETER Screen

Specifies whether or not to read the CODE39 barcode label.
Default valueYESread
ST/SP CHAR OUTPUT
Designates the start or stop character for reading CODE39 barcode labels.
Default valueOFFunused
CHECK DIGIT CHECK
Specifies the check setting for the CODE39 check digit.
Default valueOFFdo not check
CHECK DIGIT OUTPUT
Specifies whether or not to send check digit for CODE39 barcode label.
Default value ONused

When CHECK DIGIT CHECK is set to OFF, CHECK DIGIT OUTPUT

automatically becomes ON and cannot be switched to OFF.
When CHECK DIGIT CHECK is set to OFF, not all digits can be used as an
ID without setting CHECK DIGIT OUTPUT to ON.

9 10
Chapter 9 - 6.BCR PARAMDetailed Barcode Settings

4CODE128
Specifies whether or not to read the CODE128 barcode label.
Default valueYESread
DOUBLE PATTERN CHECK
Specifies whether or not to use double character start pattern for CODE39 barcode
label.
Default valueOFFunused
5ITF
Specifies whether or not to read the ITF barcode label.
Default valueYESread
CHECK DIGIT CHECK
Specifies the checks setting for the ITF check digit.
Default valueOFFdo not check
CHECK DIGIT OUTPUT
Specifies whether or not to send check digit for ITF barcode label.
Default valueONused

When CHECK DIGIT CHECK is set to OFF, CHECK DIGIT OUTPUT

automatically becomes ON and cannot be switched to OFF.
When CHECK DIGIT CHECK is set to OFF, not all digits can be used as an
ID without setting CHECK DIGIT OUTPUT to ON.

6NW7
Specifies whether or not to read the NW7 barcode label.
Default valueYESread
ST/SP CHAR OUTPUT
Designates the start or stop character for reading NW7 barcode labels.
Default valueOFFunused
ST/SP CHAR
Designates the type of start or stop character for the NW7 barcode label.
Default valueLOWERlowercase
CHECK DIGIT CHECK
Specifies the checks setting for the NW7 check digit.
Default valueOFFdo not check

9 11
Chapter 9 - 6.BCR PARAMDetailed Barcode Settings

CHECK DIGIT OUTPUT

Specifies whether or not to send check digit for NW7 barcode label.
Default valueONused

When CHECK DIGIT CHECK is set to OFF, CHECK DIGIT OUTPUT

automatically becomes ON and cannot be switched to OFF.
When CHECK DIGIT CHECK is set to OFF, not all digits can be used as an
ID without setting CHECK DIGIT OUTPUT to ON.

CHECK DIGIT
Designates the type of check digit for the NW7 barcode label.
7 CHK-DR 7 check DR
M16 modulus 16Default value
M11 modulus 11
M10/2W modulus 10/2 wait
M10/3W modulus 10/3 wait
M11-A weighted modulus 11
M10/2W-A runs

BCR PARAM settings cannot be changed while assay operations are in progress
Changes made to parameter settings will be saved when the operator leaves
the BCR PARAM screen to go to another screen. Parameter changes are saved
in system memory, and thus do not have to be reentered each time the system
is restarted.

9 12
Chapter 9 - 6.BCR PARAMDetailed Barcode Settings

Point Parameter information can be printed by pressing .

Fig. 9-4 Sample Barcode Parameter Printout

9 13
Chapter 9 - 7.SYSTEM SPEC.System Operation Settings

7. SYSTEM SPEC.System Operation Settings

The various operating conditions for the AIA-360 are entered from this screen.
The settings in parentheses to the right are the ones currently selected for that parameter.

To change setting, move cursor to design parameter and press to change value

or enter setting.

1REALTIME PRINT OUT

Specifies whether or not to print assay reports
for each assay operation.
The factory default is Yes.

SYSTEM SPEC Screen

2RATE PRINT OUT
Specifies whether or not to output rate when printing assay reports.
The factory default is No.

3REALTIME RS232C OUT

Specifies whether or not to output assay reports via the RS232C port for each assay
operation.
The factory default is No.

4RATE RS232C OUT

Specifies whether or not to output rate when outputting assay reports via the RS232C port.
The factory default is No.

5DATE DISPLAY
Specifies the format for displaying the date.
YY/MM/DD The factory default is .
MM/DD/YY
DD/MM/YY

9 14


Chapter

Daily Maintenance Procedures

Chapter 10: Daily Maintenance Procedures

This chapter describes the daily inspection and maintenance procedures that users must
perform in order to maintain the peak performance capability of AIA-360

1. Daily Maintenance Procedures

1.1 System Startup

For the description of system startup maintenance procedures, refer to section
2. System Startup in Chapter 4: Preparing System for Assay Operation.

1.2 System Shutdown

For description of system shutdown maintenance procedures, refer to section
1. System Shutdown (Shutdown menu) in Chapter 8: Terminating Assay
Operations.

When shutting down the system the enzyme substrate solution in

the mobile phase lines must be replaced with a disinfectant ethanol
solution. If mobile phase is not washed out with ethanol, the water
content in the mobile phase will evaporate and the reagent/additive
will precipitate and clog the lines.

Seal the substrate bottle with a clean rubber stopper or parafilm and
refrigerate.

2. Weekly Maintenance Procedures

2.1 Substrate Line

If the substrate line is dirty, the substrate blank becomes higher. After assays, wash
the substrate line following the procedures below every week.
1) Replace the substrate bottle with a bottle of 70% ethanol.
2) Prime the substrate line by performing 6: REPLACE SUBSTRATE on the
MAINTE screen.
3) Perform the procedure 2) three times.

10 1
Chapter 103. Monthly Maintenance Procedures

3. Monthly Maintenance Procedures

3.1 Updating Calibration Curves

The length of validity of the calibration curve varies according to the item; however,
most remain valid for 90 days. Assay results will be flagged with the CV flag when a
calibration curve has expired. Update calibration curves as necessary.

4. Trimonthly Maintenance Procedures

4.1 Diluent and Wash Solution Bottles

Make sure to clean the diluent and wash solution bottles with aqueous hypochlorite
on a regular basis by following the procedures below.
1) Discard the solution out of the bottles and rinse them with tap water.
2) Pour about 300 mL of tap water and about 3 mL of aqueous hypochlorite into
each bottle.
3) Tightly cap the bottles and wash them by rigorously shaking them. If the bottle is
very dirty, leave it for an hour.
4) Rinse them thoroughly under running water not to leave hypochlorous acid.
5) Rinse them in purified water.
If you use extra tanks to reserve diluent or wash solution, wash the extra tanks in the
same procedure.

5. Six-Month Cycle Maintenance Procedures

5.1 Diluent and Wash Lines

It is effective to clean the diluent and wash lines at the same time to clean the diluent
and wash solution bottles. Note that it takes an hour.
1) Pour about a liter of purified water and 10 mL of aqueous hypochlorite into a
clean reservoir.
2) Remove the tubes from the diluent and wash solution bottles and detach the
filters from the tube ends. Put the tube ends into the reservoir prepared at the
procedure 1). The procedures 3) 6) should be performed as quickly as possible
not to expose the metallic sensor portion to aqueous hypochlorite for a long time.
3) Perform 3: PRIME SAMPLER DILUENT on the MAINTE screen five times to fill
the diluent line with aqueous hypochlorite. Next perform 5: PRIME BF WASHER
on the same screen five times to fill the wash line with aqueous hypochlorite.

10 2
Chapter 103. Six-Month Cycle Maintenance Procedures

4) Pour about a liter of purified water into another clean reservoir and put the tube
ends into this reservoir. Make sure the metallic sensor portion exposed to
aqueous hypochlorite is to be washed well in purified water not to leave
hypochlorous acid.
5) Leave them for about five minutes.
6) Perform 3: PRIME SAMPLER DILUENT and 5: PRIME BF WASHER on the
MAINTE screen five times each to remove hypochlorous acid from the diluent
and wash line completely.
7) Prepare the diluent and wash solution in the cleaned diluent and wash solution
bottles respectively. Attach new filters to the diluent and wash line tube ends and
put them into each bottle. Be sure not to put the tube ends into the wrong bottles.

5.2 Replacing Filters for Diluent and Wash Solution Bottles

Make a point of replacing the in-line diluent and wash solution bottle filters on a
regular basis. Do this by removing the tubes from the diluent and wash solution
bottles, detaching the filters from the tube ends and replacing them with new ones.
Product no. 0018585

6. If AIA-360 Becomes Dirty

Wet a cloth with a neutral detergent; wring well, and wipe down the dirty area of the
instrument. If the instrument is very dirty, use a cloth wetted with the disinfectant ethanol
solution. Avoid water or moisture build-up on the surface of the AIA-360 system, as it may
cause the metal to rust.

10 3

Chapter

Maintenance Parts
Chapter 11: Supplies/Optional Parts

1. Supplies Parts
Part no. Part Name and Specifications Schematic Diagram No.
Included
0019510 PRINTER PAPER CORE 1
SHAFT For AIA-360

0020107 PROBE TIP 6/pack

0015970 DETECTOR 200/box

STANDARDIZATION CUP
STD CUP

0018581 SAMPLE CUPS 1000/pouch

0019563 PRINTER PAPER 10 rolls/box

60 mm42 m

0019398 WASTE BOX 1

0018585 TANK FILTERS 10/pouch

11 1
Chapter 11 - 1. Supplies/Optional Parts

Part no. Part Name and Specifications Schematic Diagram No.

Included
0018619 BOTTLE 30mL 1

2. Optional Parts
Part no. Part Name and Specification Schematic Diagram No.
Included
0021067 DILUENT BOTTLE: with label 1
500 mL

0021068 WASH SOLUTION BOTTLE: 1

with label
1000 mL

0021069 WASTE BOTTLE: with label 1

1000 mL

0021138 LEVEL SENSOR LEADS 1

0021207 RUBBER STOPPER 1

11 2

Chapter 12

Appendix
Chapter 12: Appendix

Appendix A: Bar-Code Label Specifications and Precautions for Use

The following sections outline the specifications for barcode labels used when performing
assay operations that utilize the internal barcode reader to read barcode labels applied to
primary tubes. Precautions for use are also described.

1. Bar-Code Label Specifications

Applicable barcodes CODE128NW-7CODE39ITF

Minimum element width 0.1910.254 or higher recommended
Narrow width
PCS 0.5 or higherwhite reflectance 75%

2. Barcode Read Range

The barcode effective read range is designated as shown below in corresponding to the
sample holder slit position.

Point
The barcode reader is unable to read the bottom 20 mm portion. It is important to
apply barcode labels near the top of 75 mm primary tubes to ensure effective
label reading in cases where sample IDs use a large numbers of digits.

Non-readable
range of 20 mm

75 mm:
100 mm:
Max. primary tube
Max. primary
readable range of 55
tube readable
mm
range of 60 mm

Non-readable Non-readable
range of 20 mm range of 20 mm

Note: Read range includes barcode margin (quiet zone).

121
Chapter 12 - Appendix A: Barcode Label Specifications and Precautions for Use

3. Maximum Number of Readable Barcode Digits

The table below lists examples of the maximum readable number of barcode digits
calculated according to the barcode effective read range.

Code Element width Max. no. readable digits

narrow 75 mm 100 mm
1 0.191min.
CODE128 16
2 0.254norm.
3 C/D: no 0.191min. 16
4 NW-7 (check digit) 0.254norm. 14
5 C/D: yes 0.191min. 16
6 0.254norm. 13
7 C/D: no 0.191min. 16
16
8 0.254norm. 10
CODE39
9 C/D: yes 0.191min. 16
10 0.254norm. 9
11 C/D: no 0.191min.
12 0.254norm.
ITF 16
13 C/D: yes 0.191min.
14 0.254norm.
Note: Calculated with wide : narrow ratio of 2.5 and margin (quiet zone) of 2.54 mm per digit

Note that the number of readable digits may be limited for CODE39 and NW7,
depending on the conditions when using 75 mm test tubes.
Effective barcode read range may decrease, depending on the quality of the
bar-code label used.

122
Chapter 12 - Appendix A: Barcode Label Specifications and Precautions for Use

4. Loading Test Tubes with Barcode Labels

The sample holders used in the carousel are equipped with slits in order to read the
barcodes.
Make sure to position the test tubes with the bar code label facing out of the slit.

Slit

123
Chapter 12 - Appendix B: RS232C Transmission

Appendix B: RS232C Transmission

The RS232C port provided in the AIA-360 is used for transmitting data to external
systems using the following specifications.

1. Transmission Specifications

(1) Signal format RS232C

(2) Transmission format asynchronous, half duplex

(3) Transmission speed 9600

(4) Data length 8-bit ASCII

(5) Stop bits 1

(6) Parity NONE

(7) Protocol mode independent

(8) Check characters none

(9) Connector D-SUBmale 9-pin

124
Chapter 12 - Appendix B: RS232C Transmission

2. Pin Assignment

Standard Configuration

AIA-3609-pin Connector Host unit25-pin connector

F G
RXD TXD
TXD RXD
DTR RTS
SG CTS
DSR DSR
RTS S G
CTS DTR

Signal Names
Signal name Abbreviation Direction Description
Frame ground FG - Used to ground frame.
Data send TXD output Sends data from AIA-360.
Off when data not present.
Data receive RXD input Receives data coming to AIA-360.
Off when data not present.
Request to send RTS output On during request to send.
Clear to send CTS input Transfers data when on.
Data set ready DSR input Not used.
Signal ground SG - Used to ground signal
Data terminal ready DTR output Always on.

Signal Specifications
Signal status Signal voltage
SPACE (ON) + 3 V or higher
MARK (OFF) - 3 V or lower

125
 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

TOSOH BIOSCIENCE N.V.

EC REP Transportstraat 4,
B-3980, Tessenderlo, Belgium
Phone: +32-13-66 88 30
Fax: +32-13-66 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 Printed in Japan.

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