Operator's Manual Ca 400

OPERATOR’S MANUAL
Clinical Chemistry Analyzer
CA-400
Original issue : Mar / 2008

4th edition : Aug / 2009

Publication No. OM-E 7219-1D

W A R R A N T Y
The term of warranty of this analyzer is one year from the date of purchase.
Our company shall not be responsible for the following failures and damages for
the warranty period.
(1) Failure/damage caused by the result of misuse.

(2) Failure/damage caused by repair or a lteration performed by any company
other than our company.
(3) Failure/damage caused by the phenomenon which is due to other than our
pr
p r o d u c t .
(4) Failure/damage caused by the condition beyond the normal operat ing
condition of this analyzer such as the power supply, the installation
environment.
(5) Failure/damage caused by fire, earthquake, flood damage or other natural
disaster.
(6) Failure/damage caused by shift or transportation performed by other than our
company after our installation.
Technical
TRADEMARKS
TRADEMARKS
W i n d o w s X P i s a re g i st e re d t ra d e m a rk o f Mi c ro so ft C o rp o ra t i o n .
F F F TP i s fre e w a re , a n d i t s c o p y ri g h t b e l o n g s t o M r. S o t a .
COPYRIGHT OF THIS MANUAL
C o p y ri g h t o f t h i s d o c u m e n t b e l o n g s t o F U R U N O ELEC TR IC C O . , LTD . N o p a rt o f t h i s
d o c u m e n t sh a l l b e re p ro d u c e d , t ra n sm i t t e d , t ra n sc ri b e d , st o re d i n a n y re t ri e v a l sy st e m , o r
t ra n sl a t e d i n t o a n y l a n g u a g e b y a n y m e a n s, e l e c t ro n i c o r m e c h a n i c a l , i n c l u d i n g p h o t o c o p y i n g
a n d re c o rd i n g , fo r a n y p u rp o se o t h e r t h a n t h e p u rc h a se r' s p e rso n a l u se w i t h o u t t h e e x p re ss
w ri t t e n p e rm i ssi o n o f F U R U N O ELEC TR IC C O . , LTD .
Warranty / Trademark / Copyright of This Manual

REVISION RECORD
Th e l a t e st e d i t i o n su p e rse d e s a n y p re c e d i n g o n e s. If y o u h a ve
ve o l d e d i t i o n s, d i sc a rd t h e m t o
a v o i d p o ssi b l e c o n fu si o n .
REV DATE REVISION HIGHLIGHT

1A March 2008 Published as first version.
1B July 2008 [0.7 Component List] :

Modified Component List and Standard Accessories List.
[0.2 Precautions for Use] and [0.8 Software Operating Environm
Environment]
ent] :
Added notifications for external devices.
[Overall] :
Corrected minor errors.
1C Dec. 2008 [Forward] :
Modified [5. Technical
T echnical Specifications].
[1.1 General] and [1.2 Built-in Unit]:
Added comments that “RCU Barcode is optional”.
[1.4 Operation Basics] :
Modified [1.4.5 Menu Structure].
[2.2 Reagent Registration] :
Modified overall.
[2.4 Placement for Reagent Bottles] :
Modified bottles types.
[2.7 Test Selection Setting] :
Modified [2.7.1.5 Multi Standard Sample].
Modified [2.7.1.8 Control Sample].
Modified [2.7.2.2 Multi Standard Sample].
Modified [2.7.2.3 Control Sample].
[3.1 Run Menu] :
Modified [3.1.5 Reagent Remainin
Remainingg Volume].
[3.5 System Menu] :
Modified [3.5.1 System Settings].
Modified [3.5.2 Reagent Registration].
Modified [3.5.5 Technical
T echnical Range and the Registration for Patient Generation].
[Chapter 4 Alarm] :
Added Alarm Messages for SPT
1D Aug. 2009 Modified [Foreword].
REVISION RECORD

TH IS P A G E IS
IN TEN TIO N A LLY
LEF T B LA N K .
REVISION RECORD

Table of Contents
Table of Contents
Forwards
1. Safety Precautions .........
...................
...................
...................
....................
...................
...................
.................
.......0-2
2. Precautions for Use .........
...................
...................
...................
....................
...................
...................
...............
.....0-4
3. Installation Environment.........
..................
...................
....................
...................
...................
.................
.......0-9
4. Warning
arni ng Labels ................
................................
................................
................................
..............................
.............. 0-12
5. Techni
echnical
cal Specif
Specification
ication ...............................
............... ................................
................................
...................
...0-14
6. System Configuration ...................
.............................
...................
...................
....................
...................
...........0-20
7. Component
Compon ent List...............
...............................
................................
...............................
...............................
..................0-21
8. Software Operating Environment ........
..................
....................
...................
...................
..............
....0-23
9. Handling of barcode reader .........
...................
....................
...................
...................
....................
............
..0-24
Chapter 1 Overview
1.1 Gener
General
al ..............
..............................
................................
................................
................................
..............................
.............. 1-1
1.2 Built-in Unit ..............
..............................
................................
................................
................................
......................
......1-4
1.3 Measurement Flow ..........
....................
...................
...................
....................
...................
...................
...............
.....1-9
1.3.1 Normal Measurement.................................................
Measurement.......................................................................
...........................
..... 1-9
1.3.2 Sample Dilution ...........................................
.................................................................
.........................................
................... 1-11
1.3.3 Reagent Blank Measurement ............................................
................................................................
.................... 1-11
1.3.4 Water Blank Measurement .........................................
...............................................................
...........................
..... 1-11
1.3.5 ISE Measurement ............................................
..................................................................
......................................
................ 1-11
1.4 Operat
Operation
ion Basics ...............
...............................
................................
................................
..............................
.............. 1-12
1.4.1 Analysis Specifications ..........................................
................................................................
...............................
......... 1-12
1.4.2 Sample Identification Code...........................................
Code.................................................................
........................
.. 1-13
1.4.3 Barcode Label Specifications for both Sample and Reagent ................ 1-14
1.4.4 Keyboard ...........................................
.................................................................
............................................
..............................
........ 1-15
1.4.5 Menu Structure.........................................
...............................................................
............................................
........................ 1-16
1.4.6 Control Screen Layout ...........................................
.................................................................
...............................
......... 1-19
Table of Contents
1

Table of Contents
Chapter 2 Measurement Procedures

2.1 Prior Checking and Power O
On
n .........
...................
...................
...................
....................
.................
....... 2-1
2.1.1 Checking Prior to Work ............................................
..................................................................
............................
...... 2-1
2.1.2 External Tank Rack (Optional) ...........................................
.............................................................
..................2-3
2.1.3 Power ON...............................................
.....................................................................
............................................
.........................
...2-4
2.1.4 Power OFF .........................................
...............................................................
............................................
.............................
....... 2-5
2.2 Reagent Registration ..........

...................
...................
....................
...................
...................
...................
......... 2-9
2.2.1 Addition ..........................................
................................................................
............................................
................................
..........2-10
2.2.2 Editing ............................................
..................................................................
............................................
.................................
...........2-11
2.2.3 Delete ..........................................
................................................................
............................................
....................................
..............2-12
2.3 Settings for Chemistry Parameters ..........

...................
...................
....................
.................
....... 2-13
2.3.1 Setting for Chemistry Parameters (1) ............................................
....................................................
........ 2-14
2.3.2 Setting for Chemistry Parameters (2) ............................................
....................................................
........ 2-21
2.3.3 Setting for ISE Parameters .......................................
.............................................................
.............................
....... 2-25
2.3.4 Setting for Serum Information (SI) Parameters
Paramet ers ....................................
.................................... 2-29
2.3.5 Definition of Method to Method Calculation ........................................
........................................2-32
2.3.6 Definition of Profile ...........................................
.................................................................
...................................
.............2-32
2.3.7 Setting for Measurement Orders ...........................................................
...........................................................2-32
2.3.8 Definition of Nozzle Wash Program .....................................................
.....................................................2-32
2.4 Placement for Reagent Bottles (RCU) ...................

............................
...................
.............
... 2-33
2.4.1 Sequence Procedures for Bottles .............................
...................................................
..............................
........ 2-33

2.5 Calibration Setting ....................................................................... 2-34
2.5.1 Calibration Curve Type
Type ............................................
..................................................................
.............................
....... 2-34
2.5.2 Calibration Registration/Setting ......................................
............................................................
......................2-35
2.5.3 Serial Dilution Setting ...........................................
.................................................................
................................
..........2-40
2.5.4 Multi Standard Setting ........................
..............................................
............................................
.............................
....... 2-40
2.5.5 Confirmation of ISE Calibration ............................................
...........................................................
...............2-40
2.6 Confirmation of System Parameters ............

......................
...................
...................
.............
... 2-41
Table of Contents
2

Table of Contents
2.7 Test Selection Setting ....................................................................2-42

2.7.1 Normal Test
Test Selection: [Run (F5)] – [Selection] ......................................
...................................... 2-43
2.7.1.1 ........................................................................ 2-44
Normal Sample (Normal)........................................................................
2.7.1.2 Emergency
Emergency Sample (STA
(STAT) ..................................................................... 2-49
.....................................................................
2.7.1.3 .................................................................. 2-50

Replicate Sample (Replicate)..................................................................
2.7.1.4 Standard Sample (Standard)

(Standard) .................................................................... 2-52
....................................................................
2.7.1.5 Standard) ................................................ 2-53
Multi Standard Sample (Multi Standard)
2.7.1.6 Dilution Standard Sample (Serial Dilution) ............................................ 2-54

Standard
2.7.1.7 Blank Sample (Blank) ............................................................................. 2-55

.............................................................................
2.7.1.8 ........................................................................ 2-56

Control Sample (Control)........................................................................
2.7.1.9 ............................................................................... 2-57

Mask Setting (Mask) ...............................................................................
2.7.1.10 Orderless Sample (Orderless) ................................................................. 2-58

(Orderless) .................................................................
2.7.1.11 .......................................................................... 2-59

Online Sample (Online) ..........................................................................
2.7.1.12 ........................................................................................ 2-63

ISE Calibration........................................................................................
2.7.1.13 ISE Cleaning ........................................................ ................................. 2-64

.........................................................................................
2.7.1.14 SPT Wash .................................................................. .............................. 2-65
................................................................................................
2.7.2 Special Test Selection: [Run (F5)] – [Std QC] .........................................

......................................... 2-66
(Standard) .................................................................... 2-66
....................................................................
2.7.2.2 Standard) ................................................ 2-68

Multi Standard Sample (Multi Standard)
2.7.2.3 Dilution Standard Sample (Serial Dilution) ............................................ 2-69

Standard
2.7.2.4 ........................................................................ 2-70

Control Sample (Control)........................................................................
2.7.2.5 Blank Sample (Blank) ............................................................................. 2-71

.............................................................................
2.7.2.6 ........................................................................................... 2-72

ISE Cleaning ...........................................................................................
2.7.2.7 SPT Wash ................................................................................................ 2-73

................................................................................................
2.8 Sample placement (ASP) .........
..................
...................
....................
...................
...................
...............
.....2-74
2.8.1 Placement to Tube Tray ............................................
..................................................................
.................................
........... 2-75
2.8.2 Placement to Sample Cup Tray (Innermost slot of ASP) .................
..........................
......... 2-76
2.9 Confirmation of Reagent Remaining Volume...............................2-77

2.10 Measurement Start and Monitor ..................
............................
...................
...................
..............
....2-78
2.10.1 Measurement Start ..........................................
................................................................
......................................
................ 2-78
2.10.2 Measurement Status Monitor (Run Monitor)........................................
........................................ 2-79
2-79
2.10.3 Measurement Process Monitor (Round Monitor) .................................
................................. 2-80
Table of Contents
3

Table of Contents
2.11 Sample Addition ........................................................................... 2-81

2.11.1
2.11.1 Emergency Sample Addition ............................................
.................................................................
.....................2-81
2.11.2
2.11.2 Normal Sample Addition ...........................................
.................................................................
............................
...... 2-83
Chapter 3 Explanation of Menus

3.1 Run (F5) ................
................................
................................
................................
................................
........................
........ 3-1
3.1.1 Monitor..........................................
................................................................
............................................
.....................................
...............3-1
3.1.2 Round (Error Flags) ..........................................
................................................................
.......................................
.................3-5
3.1.3 Selection ............................................
..................................................................
............................................
.................................
...........3-10
3.1.4 Result ............................................
..................................................................
............................................
.....................................
...............3-15
3.1.4.1 Measurement Result ..........................................
................................................................
..............................
........ 3-15
3.1.4.2 Testing Count
Count ...........................................
.................................................................
........................................
..................3-19
3.1.5 Inventory ...........................................
.................................................................
............................................
.................................
...........3-20
3.1.6 Sleep Scheme ...........................................
.................................................................
............................................
..........................
.... 3-23
3.1.7 Std QC ............................................
..................................................................
............................................
....................................
..............3-25
3.1.8 Patient.........................................
...............................................................
............................................
........................................
..................3-27
3.2 Paramet
Parameter
er (F6) ...............
...............................
................................
................................
................................
................ 3-29
3.2.1 Normal ...........................................
.................................................................
............................................
....................................
..............3-29
3.2.2 Normal 2 ...........................................
.................................................................
............................................
.................................
...........3-34
3.2.3 ISE ..........................................
................................................................
............................................
............................................
......................3-38
3.2.4 SI ............................................
..................................................................
............................................
............................................
......................3-40
3.2.5 Calc ............................................
..................................................................
............................................
........................................
..................3-42
3.2.6 Profile .........................................
...............................................................
............................................
........................................
..................3-44
3.2.7 Order ..........................................
................................................................
............................................
........................................
..................3-45
3.2.8 Wash ...........................................
.................................................................
............................................
........................................
..................3-46
3.3 Calibr
Calibration
ation (F7) ................
................................
................................
................................
.............................
............. 3-49
3.3.1 Reg Calib...........................................
.................................................................
............................................
.................................
...........3-49
3.3.2 Serial Dilut ............................................
..................................................................
............................................
.............................
....... 3-53
3.3.3 Multi-Std ...........................................
.................................................................
............................................
.................................
...........3-55
3.3.4 ISE ..........................................
................................................................
............................................
............................................
......................3-56
Table of Contents
4

Table of Contents
3.4 QC (F8) ...............

..............................
...............................
................................
................................
............................
............ 3-57
3.4.1 Graph ...........................................
.................................................................
............................................
......................................
................ 3-57
3.4.2 Details ..........................................
................................................................
............................................
......................................
................ 3-60
3.4.3 Daily ............................................
..................................................................
............................................
......................................
................ 3-63
3.4.4 Cumulative..........................................
................................................................
............................................
...............................
......... 3-66
3.4.5 Settings ............................................

..................................................................
............................................
..................................
............ 3-68
3.4.6 Registration .........................................
...............................................................
............................................
...............................
......... 3-72
3.5 System (F9) ..............................

.............. ................................
................................
................................
......................
......3-74
3.5.1 Setup ............................................
..................................................................
............................................
......................................
................ 3-74
3.5.2 Reagent ...........................................
.................................................................
............................................
...................................
............. 3-80
3.5.3 Login............................................
..................................................................
............................................
......................................
................ 3-82
3.5.4 Backup .........................................
...............................................................
............................................
......................................
................ 3-84
3.5.5 Setup2 ..........................................
................................................................
............................................
......................................
................ 3-87
3.5.6 Define ..........................................
................................................................
............................................
......................................
................ 3-88
3.5.7 Range ...........................................

.................................................................
............................................
......................................
................ 3-90
3.6 Mainte (F10) ...............
..............................
...............................
................................
................................
....................
....3-91
3.6.1 W Blank ...........................................
.................................................................
............................................
..................................
............ 3-91
3.6.2 Work Hour ...........................................
.................................................................
............................................
..............................
........ 3-92
3.6.3 Sequence .........................................
...............................................................
............................................
...................................
............. 3-94
3.6.4 Sensor ..........................................
................................................................
............................................
...................................... 3-98
................ 3-98
3.6.5 Perform ............................................
..................................................................
............................................
..................................
............ 3-104
3-104
3.6.6 Adjust...........................................
.................................................................
............................................
......................................
................ 3-106
3.6.7 DTR Pos .........................................
...............................................................
............................................
...................................
............. 3-107
3.6.8 Password ..........................................
................................................................
............................................
..................................
............ 3-108
3.6.9 Operational Logs ...........................................
.................................................................
..........................................
.................... 3-111
3-111
3.7 Printo
Printout
ut ...............
...............................
................................
................................
................................
............................
............ 3-113
3.7.1 Live Print Out .........................................
...............................................................
............................................
...........................
..... 3-113
3-113
3.7.2 Print of the Setting Items ..........................................
................................................................
...............................
......... 3-116
3-116
Table of Contents
5

Table of Contents
Chapter 4 Alarm
4.1 Alarm Overv
Overview
iew ...............
...............................
................................
................................
.............................
............. 4-1
4.1.1 Alarm Type
Type .........................................
...............................................................
............................................
................................
..........4-2
4.1.2 Alarm Output Destination ...........................................
.................................................................
.............................
....... 4-2
4.1.3 Alarm Code Numbering System ............................................
..............................................................
..................4-2
4.2 User Interface Alarm .........

...................
...................
...................
....................
...................
...................
............
.. 4-3
4.3 Unit Alarm ................................
................ ...............................
...............................
................................
......................
...... 4-6
4.3.1 Reagent Pipette 1 (RPT1) .................................................................................. 4-6
4.3.2 Reagent Pipette 2 (RPT2) .................................................................................. 4-10
4.3.3 Pipette（SPT
Sample Pipette（） ..................................................................................... 4-14
SPT）
4.3.4 Mixer Unit 1 (MIX-1) .........................................

...............................................................
.....................................
...............4-20
4.3.5 Mixer Unit 2 (MIX-2) .........................................
...............................................................
.....................................
...............4-22
4.3.6 Wash Unit (WU) .................................................................................................. 4-24
4.3.7 Incubation Reaction Unit (IRU) ....................................................................... 4-28
4.3.8 Reagent Container Unit (RCU) ......................................................................... 4-30
4.3.9 Detector Unit (DTR) ........................................................................................... 4-30
4.3.10 Auto Sampler Unit (ASP) .................................................................................. 4-31
4.3.11
4.3.11 Ion Selectable Electrode Unit (ISE) ................................................................. 4-32
4.3.12 Tank ............................................
..................................................................
............................................
........................................
..................4-33
4.3.13 Sensor Status ......................................................................................................... 4-34
4.3.14 Temperature .......................................................................................................... 4-37
4.3.15 Others ..................................................................................................................... 4-37
Table of Contents
6

Table of Contents
Chapter 5 Troubleshooting
5.1 Actions to be Taken at Trouble ................
................................
................................
......................
......5-1
5.1.1 Details When
When You Contact Our
Our Servicing
Servicing ..........................................
...............................................
..... 5-1
5.2 Abnormality of Power On..........

....................
...................
...................
....................
...................
.............
....5-2
5.3 Abnormality of Measurement Results ..................
............................
....................
...............
.....5-3
5.3.1 Preparation check of Reagent, Standard Sample and QC sample ........... 5-3
5.3.2 When Measurement Results of a Certain Method are Higher for All Samples
............................................
..................................................................
............................................
............................................
........................ 5-4
5.3.3 When Measurement Results of a Certain Method are Lower for All Samples
............................................
..................................................................
............................................
............................................
........................ 5-4
5.3.4 Wrong Measurement Results Come Out at Random
Random ...............................
............................... 5-4
5.3.5 Measurement results
results of One Sample Show Abnormal Value for All Methods
............................................
..................................................................
............................................
............................................
........................ 5-5
5.3.6 Multiple Abnormal Measurement Results ............................................
.............................................. 5-5
5.4 Ma lf u n c ti o n of A
Analyz
nalyzer
er....
........
........
........
........
........
........
........
........
........
........
........
........
........
........
....5-6
5.4.1 Detection of Mechanical Problem ..........................................
...........................................................
................. 5-6
5.4.2 Error Message of Each Unit .............................................
...................................................................
........................ 5-6
Table of Contents
7

Table of Contents
Chapter 6 Maintenance
6.1 Cleaning and Decontamination ....................
.............................
...................
....................
..............
.... 6-1
6.1.1 External Tank ............................................
..................................................................
...........................................
.....................6-1
6.1.2 and Internal Tank ..........................................
Piping and Internal ................................................................
.............................
....... 6-1
6.1.3 Pipettes (for RPT1/RPT2/SPT) ............................................
.............................................................
.................6-9
6.1.4 WU Nozzles ...........................................
.................................................................
............................................
.........................
... 6-10
6.1.5 Stirrers (for MIX1/MIX2) .........................................
...............................................................
............................
...... 6-10
6.1.6 Auto Sampler Unit (ASP)..........................................
(ASP)................................................................
............................
...... 6-11
6.1.7 Reagent Container Unit (RCU) ...........................................
.............................................................
..................6-12
6.1.8 Worktable ............................................
..................................................................
............................................
............................
...... 6-13
6.2 Part Replac

Replacement
ement ................
................................
................................
...............................
..........................
........... 6-14
6.2.1 Syringe Tips (for SPP/RPP/WPP) ................................................................. 6-15
6.2.2 Wipe Tip (in WU) ...........................................
.................................................................
.......................................
.................6-18
6.2.3 Pipette (for SPT/RPT) ..................................................................................... 6-20
6.2.4 Halogen Lamp ................................................................................................. 6-23
6.2.5 Cuvettes (in IRU) ............................................
..................................................................
......................................
................6-25
6.2.6 Mesh Filter (or Inline Filter) ...........................................
.................................................................
......................6-26
6.2.7 Dust Filter ...........................................
.................................................................
............................................
.............................
....... 6-27
6.2.8 Electrode (in ISE) ............................................................................................. 6-28
Electrode
6.2.9 Pump Cassette (for ISE) .................................................................................. 6-30
6.2.10 CAL-A bag (in ISE) ......................................................................................... 6-32
Table of Contents
8

FOREWORDS
FOREWORDS
This operation manual is the one to use the Fully Automated Clinical Chemistry Analyzer safely and correctly. Before
you operate this Analyzer, please read this manual carefully and understand
u nderstand the contents enough.
This analyzer is designed to measure the human specimen (Serum, Plasma, Urine and so on) and is used with
Windows PC, and the measurement result can be printed out.
[Precaution]
1 The contents of this manual are described for the clinical laboratory technologists who operate this analyzer.
2.The contents of this manual may be changed without a previous notice in the future.
This analyzer belongs to “In vitro diagnostic (IVD) medical device”, and complies with IVD Directive (98/79/EC)
and EMC Directive (89/336/EEC) or EU Directive.
FURUNO ELECTRIC CO., LTD.
9-52, Ashihara-cho, Nishinomiya-City, 662-8580 Japan
EMERGO EUROPE
Molenstraat 15 2513 BH, The Hague The Netherlands
Tel: +31-70-345-8570
Fax: +31-70-346-7299
0-1

FOREWORDS
<Precaution for Use and Installation Environment>

This section explains points to note when using the analyzer, the installation environment required for normal
operation, standard accessory and warning labels. Before using the analyzer, please read this manual. If the
equipment is used in a manner not specified by the manufacturer, the protection
pr otection may be impaired.
1. Safety Precautions
Prevention
Prevention of damage and ignition
Please observe the following precautions to prevent damage and ignition of the analyzer.
· Install the analyzer according to the installation environment and the installation requirements specified
in this manual.
· Contact our servicing or sa
sales
les division when you need to move the analyzer to other locati
location.
on.
Prevention of electric shock
Please observe the following precautions to prevent electric shock caused by the use of the analyzer.
analyzer.
operating, do not remove the covers (front cover, rear cover, side cover, etc.)
· Whenever the analyzer is operating,
that are installed by using screws.
· If liquid falls into the analyzer
analyzer or liquid spills inside the analyzer, contact our
our servicing division. In this
case, careless action may cause electric shock.
Prevention of injury
Please observe the following precautions to prevent injury due to the use of
o f the analyzer.
· Whenever the an
analyzer
alyzer is operating, ne
never
ver touch the m
moving
oving parts including sample probes, reagent
probes, stirrer, etc. Also do not put your fingers or hand into the openings.
· As for replacing lam lamps,
ps, turn the power off and wait for the lam
lampp to get cold (over 30 minutes), then
replace the lamp. Direct conta
contact
ct with the heated lamp may cause burn
burn injury.
· For safety reasons, follow the instructions written on the labels attache
attached
d to the analyzer and the
instructions of this manual.
· As for personal computers and printers, refer to each operating
operating manual.
Protection of eyes
Please observe the following precautions to protect eyes.
· Do
theynot
maylook directly
cause at the lighted lamps of the analyzer or laser beam used in the bar code reader,
eye injury. reader, as
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FOREWORDS
To ensure the accuracy of measurement data
· Whenever the analy

analyzer
zer is operating, do n
not
ot open the cov
covers
ers including top cover, rea
rearr cover, side cove
covers
rs
(left cover and right cover).
· Whenever the analyzer is operatin
operating,
g, do not open the Reagent
Reagent Container Unit (RCU) cover (lid) and
Auto Sampler Unit (ASP) cover (lid).
If the lid for ASP or RCU is removed, then the measurement is aborted.
· For use of the analyzer, conduct accuracy control so that the analyzer functions correctly.
· As for maintenance or components needing periodic repla
replacement
cement for the analyzer, follow the
instructions in this manual.
· As for reagents, ac
accuracy
curacy control substances aand
nd standard substances, follow the instructions of their
manufacturers and suppliers.
Disposal of wastewater
Special attention is required for disposal of some wastewater or residual samples. This analyzer
discharges high concentrated wastewater and low concentrated wastewater separately. Please observe the
following precautions.
Substances regulated by the pollution control laws and wastewater discharge standards are contained in
.
some samples, reagents, accuracy control substances, standard substances, wash solutions (detergents), etc.
used for the analyzer
analyzer.. Please refer th
thee disposal of such substances to the instructions of relevant
manufacturers and suppliers to comply with the facility wastewater standards.
Prevention
Prevention of infection
It is necessary to correctly handle samples used in the analyzer
analyzer.. Unless the samples are correctly handled,
handled, it
may result in infection. Please observe the following precautions to prevent infection.
Do not directly touch samples, reagents, wastewaters, etc. that may cause infection. If there is possibility to
touch them, make sure to wear protective gloves, masks an

and
d goggles to prevent infection. In case you
touch them accidentally,
accidentally, follow your company's operating procedure and consult a physician as required. If
they contact the analyzer, immediately wipe away.
Handling of test reagents

Please observe the following precautions to prevent injury.
Some reagents are strong acid or strong alkali. Be careful not to touch them directly with hands or spill
over your clothes. In case where they mistakenly spill over your skin or clothes, immediately wash enough
with water and soap. If they contact eyes, flush thoroughly with plenty of
o f water and consult a physician.
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FOREWORDS
Prevention of affect on other facility/equipment
As for the installment of the analyzer, make appropriate power supply wiring so that failure of the analyzer
should not affect other important facility or equipment (example: power supply unit of surgical equipment,
etc.).
2. Precautions for Use

strictly the
Please observe strictly the following precautions to ensure safe
s afe and efficient use of the analyzer.
General precautions for use of the analyzer
1. Use of samples
(1) This analyzer is designed to analyze
analyze human serums, urine, etc. There might
might be some sample that
cannot be analyzed depending on the ananalysis
alysis item and the reagents. In this case, refer to the
relevant manufacturers and suppliers.
(2) Use samples that contain no suspended pa
particles.
rticles. As for serum samples, use serum
serum samples that
contain no blood clots. Use of serum samples containing blood clots or use use of urine samples
samples
containing suspended particles may cause the analyzer's
a nalyzer's probes to get clogged and adversely affect
the analysis processing.
(3) Note that there are some cases where a significant clinical affect is achieved depending on
chemical substances which coexist with samples (medication, anticoagulant, preservative, etc.)
2. Storage of samples
Store samples in an appropriate manner. If stored in an inappropriate eenvironment,
nvironment, samples may
change in quality. For example, if blood is kept in ccold
old storage, potassium in the blood w
will
ill be
increased.
3. Sample pretreatment and handling of samples
(1) Fibrins contained
contained in serum may clog the probes. When separating
separating serum, make sure that blood is
clotted enough. Samples to be used in the analyzer shall be free of fibrin.
(2) As for using urine as a sample, if there
there is suspension of particles in a urine sample, centrifugalize
centrifugalize
the urine sample so that the suspended particles get precipitated.
pr ecipitated.
(3) If sample pretreatment unique to the analysis item is required, consult the relevant reagent
manufacturers and suppliers. Regarding the advisability of serum separation agents,
agents, refer to their
manufacturers.
(4) To prevent samples from evaporating, do not leave the sample
sample containers unsealed for a long time.
The evaporation may lead to incorrect analysis results.
4. Handling of reagents, standard substances, and accuracy control substances
(1) Regarding the ways to store, handle and use reagents, standard substances and accuracy control
substances, follow the instructions of the relevant reagent manufacturers and suppliers.
s uppliers.
(2) If a reagent, standard substance or accuracy control substance is not stored appropriately,
regardless of the specified expiry date, correct analy
analysis
sis results m
may
ay not be gained. With regard to
the ways to store reagents, follow the instructions specified on their packaging, container or
attached documents.
(3) Regarding safety after opening the package of rea
reagents,
gents, etc., refer to the relevant manufacturers
and suppliers.
(4) Make sure to calibrate the analyz

analyzer
er whenever reagents are replaced. To gain correct analy
analysis
sis
results, correct calibration is important.
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FOREWORDS
5. Reagent interference of assay method-to-method

In the analysis process sometimes a reagent may be contaminated by other reagents and that may
adversely affect the analysis results. Refer to the relevant
relevant manufacturers and suppliers for details
because the influence is different by individual reagents.
reagents.
6. Analysis performance
If hemolysis, turbidity or bilirubin is contained in serum at high concentrate rate, the medical agent or
its metabolic products may adversely affect analysis results. Refer to the relevant manufacturers
and suppliers for details.

7. Connection of water supply/exhaust hoses
(1) Leave connection work
work of wwater
ater supply/exhaust hoses to qualified
qualified personnel only. Incorrect
connection may cause troubles including hose disconnection during the operation, leakage. etc.
(2) Make sure to prevent air bubbles from entering the ion-exchange water to be supplied to the
analyzer.
8. Electromagnetic waves, noise, etc.
(1) Do not install the analyzer near the eequipment
quipment that generates aan
n abnormal noise.
(2) Turn off a portable radio or cellular phone ne
near
ar the analyzer. Abnormal noise
noise or electromagnetic
electromagnetic
waves generated from the portable radio or cellular phone may cause malfunction of the analyzer.
(3) Do not use medical equipment that may be affected by electromagnetic waves ne
near
ar the analyzer.
9. Operational environment of the analyzer
temperature:: 15 to 30°C humidity: 45 to 85% and temperature variation:

Operate the analyzer with temperature
less than 2°C per hour.
Use ion-exchange water (pure water) at water temperature 5 to 25 °C. If used outside the specified
range, analysis performance by the analyzer may not be guaranteed.
10. CRT monitor, keyboard and mouse
Do not handle a CRT monitor, keyboard and mouse by hand wet with water or reagents to prevent
failure.
11. Points to check when analyzing
As for the points to check when analyzing, follow your company's
co mpany's operating standards.
Check the following points at least:
· quality of pure water
· remaining amount of reagents and wash solutions
· calibration results
· accuracy control data
· analysis results
· that there is no leakage in pipettes (SPT and RPT) or piping system
· that there is no dust, fibrin or foam within samples.
· that there is enough amount of samples required for analysis
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FOREWORDS
12. Maintenance checks and periodical parts replacement

(1) As for maintenance checks and
and periodical parts replacemen
replacement,
t, follow the instructions stated in this
manual.
(2) After replacing main parts of the analyzer
analyzer including a halogen lamp, probes, syringes, cuvettes,
cuvettes,
etc., make sure to calibrate them.
(3) Use consumables
consumables and replacement parts w wee recommend. Use of non-recommended
non-recommended consumables
or parts may adversely affect the performance and safety of the analyzer.
Parts such as nozzle, cuvette, syringe tip, wipe tip, mesh filter, electrode of ISE, diaphragm pump,
micro syringe, electromagnetic valve, waste line tube and etc. that have been replaced may be
infected. When they are discarded after exchanging, refer to the relevant manufacturers and
suppliers and follow your company’s or national regulation for disposal substances and dispose
them appropriately.
13. Backup of data
Please back up parameters and analysis result data, etc. stored in hard disc periodically, so that data
recovery can be provided in unexpected events including failure of the equipment or power
interruption.
When you use external devices, please confirm that those devices are Virus Free.
14. Prohibition of use for purposes
purpos es other than those intended
Do not use the analyzer for purposes other than those intended.
i ntended.
15. Cleaning of covers, etc.
When covers, worktable, CRT monitor, etc. get dirty, wipe and clean them with a dry cloth, etc.
16. Other cautions
If accidentally any reagent or sample contacts mucous, or if any reagent or sample is swallowed,
immediately consult a physician for the instructions.
17. In the event of trouble, do not play with the analyzer and leave repair work to authorized experts.
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FOREWORDS
General Precautions for Use of Medical Electrical Equipment

(for Safety and Prevention of Danger)
The followings are general precautions for use of medical electrical equipments.
As for precautions unique to each equipment, please read its operation manual for full understanding and do not
do wrong handling.
1. Only qualified personnel shall use the analyzer.

2. The following precautions shall be taken when the analyzer is installed.
(1) Keep the analyzer
analyzer away from rain or aany
ny other water.
(2) Avoid areas that are adversely affected by atmospheric pressure, temperature, humidity,
ventilation, sunlight, dust, air containing salt or sulfur,
s ulfur, etc.
(3) Do not expose the analyzer
analyzer to inclination, vibration, shock (including shock during transportation),
etc. and pay attention to the state of safety.
(4) Do not install the analyzer in a place adjacent to a storage room of chemicals or a place w
where
here any
gas is likely to be generated.
(5) Pay attention to frequency,
frequency, voltage and perm
permissible
issible current (or power consumption).
consumption).
(6) Confirm the conditions of battery power source (state of discharge, polarity, etc.).
(7) Make sure that the analyzer is correctly and well grounded.
(8) Secure the space (minimum 300mm) at the left side of analyzer in order to be easily taken
power-off the analyzer at emergency situation.
3. The following precautions shall be taken before using the analyzer.
(1) Confirm that the analyzer operates correctly by checking contact status of switches, polarity, dial
setting, meters, etc.
(2) Make sure that the analyzer is correctly and completely grounded.
(3) Make sure that all
all necessary electrical cables are correctly and completely
completely connected.
(4) Special care shall be taken
taken not to result in misdiagnosis or any da
danger
nger to analyzer or human body
when the analyzer is used in conjunction with other equipment.
(5) Check battery powe
powerr source.
4. The following precautions shall be taken during operation.
(1) Pay attention not to exceed time an

and
d volume required for diagn
diagnosis
osis and treatment.
(2) Keep monitoring the behavior of whole system in order to detect any malfunction.
(3) Take immediate corrective measures
measures including shutdown of operation when any malfunction
malfunction is
detected in the analyzer.
(4) Avoid any possibilities of direct acc
access
ess from patients.
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FOREWORDS
5. The following precautions shall be taken after use of the analyzer.

(1) Turn off the power after every operational switch and control is restored to its pre-use state as
directed.
(2) Do not remove the line cord plugs from receptacles by cords not to give undue stress to cords.
(3) Storage areas:
· Keep awaway
ay from rain or any other water splash.
· Avoid areas that are adv
adversely
ersely affected by atm
atmospheric
ospheric pressure, temperature, humidity
humidity,,
ventilation, sunlight, dust, air containing salt or sulfur,
s ulfur, etc.
· Do not expose the analyzer to inclination, vibration and shock (including shock during
transportation), etc. and pay attention to the state of safety.
· Do not store the analyzer at a place adjacent to the storage room of chemicals or a place
place
where any gas is likely to be generated.
(4) Organize and store the

the accessory parts and ccords
ords after they have been cleaned.
(5) Keep the analyzer clean not to cause
cause any inconvenience to the next use.
use.
6. In the event of trouble, do not play
p lay with the analyzer and leave repair work to authorized experts.
7. Do not refurbish the analyzer.
8. Conduct maintenance checks correctly.

(1) Make sure to conduct periodic checks on th
thee analyzer and its aassociated
ssociated parts.
(2) Make sure to check that the analyzer
analyzer operates normally and safely when it is reused after
after being
kept unused for some time.
9. The following precautions shall be taken when the cleaning procedure will be performed.
(1) Appropriate decontaminations is carried out if hazardous meterial is split onto or into the analyzer.
(2) No decontamination or cleaning agents
a gents are used which could cause a HAZARD as a result of a
reaction with parts of the analyzer or with material contained in it.
(3) Our agent is consulted if there is any doubt about the compatibility of
o f decontamination or cleaning
agents with parts of the analyzer or with material contained in it.
10. When you discard the analyzer from the field, you should consult our agents in advance.
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FOREWORDS
3. Installation Environment
The analyzer is required to be installed under the environmental conditions that will not adversely affect its
operation or analysis. Qualified service engineer of our servicing division shall carry installation work out
(unpacking, installation, operation check).
Installation environmental conditions

The analyzer shall be installed:
(1) in a place that
that is not subject to direct sunlight.
(2) in a place
place that is not exposed to direct w
wind,
ind, rain or any other w
water.
ater. (The analyzer shall be installed
installed
indoors.)
(3) in a dustless
dustless place.
(4) in a place that
that is not subject to vibration or sound.
(5) in not inclined but horizontal place (slope: 1/200 or less).
(6) on a floor that is strong enough to support the weight of the whole an
analyzer
alyzer system (about 150 kg).
(7) in a place that
that is not subject to volta
voltage
ge variation (less than ±10%).
(8) not near noise sources (facility or equ
equipment).
ipment). Avoid placing the analyze
analyzerr right under
under the fluorescent
light.
(9) at the height of 2,000 meters above sea-level
sea-level or lower. (Use the analyzer only indoors.)
Temperature/humidity conditions
(1) Indoor temperature:
temperature: 15 to 30°C, Temperature variation: less than 2°C per hour
(2) Indoor humidity: 45 to 85% (No condensation shall be formed.)
(3) Install the analyzer
analyzer in a place w
with
ith good ventilation or with v
ventilation
entilation system.
(4) Do not install the analyzer in a place subject to direct wind
wind from the air conditioning.
Space
Refer to the figure below for space required for installation including space for maintenance and for exhaust
ventilation.
Secure the space (minimum 300mm) at the left side of analyzer in order to easily power off the analyzer at
emergency situation.
<space for exhaust 150 and up
300 PC 300 300

Main 690
and up Control and up and up
Unit
1340
600 970
500 and up
Front
(Unit: mm)
2470
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FOREWORDS
Power supply and grounding

Install a 3-pronged power outlet with a ground terminal (A-Type, S-Type or O-Type) within the reach of the
analyzer's accessory power cable (2 m). Ground resistance shall be less than 100W.

Refer power outlet installation to qualified personnel only.
3-Pronged Power
Outlet
Cable Plug
Ground Ground Terminal
Water supply and drainage

As for connection part for water supply and drainage, there are 8 types of tube connections on the right side of
the analyzer
analyzer.. Refer to the table below for deta
details.
ils.
Type of Water supply and drainage Type of connection tube Remarks
Pressure-resistant hose
Pure water supply
Inside diameter: 12mm Main analyzer - Purified water generator
Outside diameter: 18mm
P.V.C tube (R-3603)
Main analyzer - Wash Solution Tank 1
Wash solution 1 supply Inside diameter: 1.59mm
(with tube (1m), inline filter and pipe)
Outside diameter: 4.76mm
P.V.C tube (R-3603)
Main analyzer - Wash Solution Tank 2
Wash solution 2 supply Inside diameter: 1.59mm
(with tube (1m), inline filter and pipe)
Outside diameter: 4.76mm
Silicon tube
ISE - High-concentrated wastewater tank
ISE high-concentrated wastewater Inside diameter: 3mm
(length:1m)
Outside diameter: 7mm
WU high-concentrated wastewater Main analyzer - High-concentrated

Pressure-resistant hose wastewater tank (length:1m)
WU low-concentrated wastewater Inside diameter: 15mm
Main analyzer - Low-concentrated
Trough low-concentrated wastewater Outside diameter: 22mm
wastewater drainage system
Overflow
Before installation of the analyzer, it is required to install a pure water supply system and a low-concentrated
wastewater drainage
drainage system. As for high-concentrated wastewater,
wastewater, place
place a high-concentrated wastewater
wastewater tank
close to the
the main analyzer.
analyzer. Before this tank becomes full, dispose of high-
high-concentrated
concentrated wastewate
wastewaterr being stored
in this tank in accordance with the specified wastewater standards.
Please wash Wash Solution Tank 1 and Wash Solution Tank 2 enough with pure water before use.
* Disposal limit of this high-concentrated wastewater tank is approx.

appr ox. 7 hours at the use of 5L tank.
0-10

FOREWORDS
(1) Water supply system (purified water generator)

· Water
Water pressure: 0.15 to 0.34 MPa
· Capacity: the Equipment that has ability of 18 L per hour or more
· Connection tube: Pressure-resistant hose (Inside diameter: 12mm, Outside diameter: 18mm)
Caution
Water pressure for the water supply system iiss required 0.15 to 0.34 MPa.
(2) Drainage system

(2)
· Capacity: 18 L per hour
· Position: Drainage system shall
shall be at a position that is 500mm or more lower than the wastewater
outlet of the main analyzer
a nalyzer..
Main Analyzer
500 and up
Installation Table
Wastewater outlet
outlet
· Lay the exhaust hose in the wastewater outlet so that the wastewater is drained by a natural drop.
· Open the end of th
thee exhaust hose to the aatmosphere.
tmosphere. (Do not soak it in the liquid.)
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FOREWORDS
4. Warning Labels
Main meaning of warning labels

The following labels that show warning and attention are affixed on the places that are potentially hazardous.
Biohazard
Electric shock
High temperature
Injury
Action to be taken as directed by the “OPERATOR’S

MANUAL”
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FOREWORDS
Warning labels
The following warning labels are affixed on the main places that are hazardous within the
t he analyzer.
WARNING LABEL WARNING ABOUT PLACE
Risk of electric shock Power supply inlet
Covers of SPT,
SP T,
Do not touch moving
RPT1, RPT2, MIX1,
parts
MIX2 and WU
Mosaic plate (Mosaic

CONTAINS 1),
HAZARDOUS SWU cover and
MATERIALS Panel in lower
(SERUM, PLASMA right-hand of the
OR URINE) main analyzer (Side
Panel RD)
Lid for replacing

halogen lamps, lid of
RISK OF INJUR
INJ URY
Y
ISE tank, lid for
replacing ISE
TURN THE POWER
electrodes, lid for
OFF BEFORE THE
replacing cuvettes and
PANEL OPEN
Mentenance cover
1/R1/R2
HOT SURFACE DTR
IRU heat insulation

Work according to the
place, lid for ASP
ASP,, lid
instruction of the for RCU and
and input
operation manual.
line for purified water
CLASS 1 LEASER
PRODUCT
CLASS 1 LASER PRODUCT
CAUTION –
CAUTION – CLASS 2 LASER LIGHT WHEN OPEN
DO NOT STARE INTO THE BEAM CAUTION-CLASS 2 Barcord reader of
650nm, 1mW LEASER LIGHT ASP and RCU
(IEC60825-1:1993+A1:1997+A2:2001)
WHEN OPEN
DO NOT STARE
INTO THE BEAM
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FOREWORDS
5. Technical
Technical Spe
Specification
cification
1. Kind of device CA-400
2. Usage General chemistry as photometric assay

Immunology as photometric assay (Latex reagent available)
3. Assay type 1 point end, 2 point end, 1 point rate, 2 point rate
4. Type of calibration Factor, Linear, Loglogit, Exponential, Spline

5. Throughput 400 tests per hour
6. Incubation time One reagent assay: 10 minutes (R1)
Two
Two reagent assay: 5 minutes for R1 + 5 minutes for R2
(The samples for which the methods of the
t he One reagent assay are used
and the samples for which the methods of the Two reagent assay are used
can be set at the same time.)
7. Sample type Serum, Plasma and Urine
8. Number of simultaneous 60 methods (Max.) + Electrolyte: 3 methods
measurement *Electrolyte (ISE Unit) is optional
9. Components
(1) Main Analyzer CHS (Chassis Unit)
IRU (Incubation Reaction Unit)
ASP (Auto Sampler Unit)
RCU (Reagent Container Unit)
RPT (Reagent Pipette Unit)
SPT (Sample Pipette Unit)
RPP (Reagent Pump Unit)
SPP (Sample Pump Unit)
WPP (Wash Pump Unit)
DTR (Detector Unit)
MIX (Mixing Stirrer Unit)
SWU (Supply Water Unit)
WU (Wash Unit)
PSU (Power Supply Unit)
CNT (Control Unit)
ISE (Ion Selective Electrode Measurement Unit)
TR (Trough)
STK (Subtank)
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FOREWORDS
9-1 IRU (Incubation Reaction Unit)

Heating method: Direct heat with silicon-rubber heater (The heat block made of aluminum
in IRU is heated.)
Heating range: 37 ± 0.3°C
9-2 Cuvette
Material: PYREX
Size: 8mm(W) × 6.23mm(D) × 30mm(H)
Light length: 6mm (Calibrated to 10mm by the calculation.)
Quantity: 90
Minimum volume: 150ml
Maximum volume: 450ml
9-3 ASP (Auto Sampler Unit)

Tube: Diameter:13 to 16mm, Length: 75 to 100mm
Turn table: Detachable type

Number of tubes: Maximum 92
(Normal / Emergency samples : 36 tubes on the outer circumference + 36
tubes on the middle circumference
Standard samples / ISE cleaning: + 20 sample cups on the
t he inner
circumference)
Cooling method: Cooling with peltier modules (*Optional, cooling only the tubes on the
inner circumference.)
9-4 SPT(Sample Pipette Unit) / SPP(Sampling Pump Unit)

Number of pipettes: 1
Pump type: Syringe pump

Liquid level detection: Micropipette with a liquid level sensor by sensing a change of
capacitance
Sampling volume: 2 to 35ml (0.1ml / step), ISE: 100ml
9-5 RCU (Reagent Container Unit)

Turn table: Detachable type
Number of bottles: Maximum 60 (30 bottles for 100 / 70 / 50 / 40 mL types in total and 30
bottles for 20ml types)
Cooling method: Cooling with peltier modules
Cooling range 8 to 15°C
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FOREWORDS
9-6 RPT1/2 (Reagent Pipette Unit) / RPP1/2(Reagent Pump Unit)

Number of pipettes: 1 per each unit
Pump type: Syringe pump
Liquid level detection: Micropipette with a liquid level sensor by sensing a change of
capacitance
Sampling volume: RPT1 / RPP1: 20 to 350 ml (1 ml / step)
RPT2 / RPP2: 20 to 250 ml (1 ml / step)
9-7 DTR (Detector Unit)

Method: Measurement of absorbance (1 or 2 wavelength measurement)
Selectable wavelength: 12 wavelengths
(340, 380, 415, 450, 510, 546, 570, 600, 660, 700, 750, 800nm)
Wavelength
Wavelength selection: Grating method
Light source: Tungsten halogen lamp
Cooling for light source Air-cooled by fan
9-8 MIX1/2 (Mixing Stirrer Unit)

Stirring mechanism: Stirrer (stirring bar) driven by a stepping motor (5 speed)
9-9 SWU (Supply Water Unit)

WU wastewater: 8 diaphragm pumps
Trough wastewater: Free fall
Trough pure water
water supply : 5 diaphragm pumps (one per trou
trough
gh / R
RPT1,
PT1, RPT2,
RPT2, SPT,
SPT, MIX1 and
MIX2)
9-10 PT Trough 3 PT Troughs (SRT Trough, RPT1 Trough, PRT2 Trough)

Mix Trough 2 Mix Troughs (Mix-1 Trough, Mix-2 Trough)
Trough chamber 1 Trough chamber
9-11 Subtank
(with Water level detector)
detector)
Subtank R 1 Subtank
Subtank L 1 Subtank
9-12 WPP (Water

(Water Pump Unit)
Wash
Wash solution supply for 6 syringe pumps
cuvette cleaning:
0-16

FOREWORDS
9-13 WU (Wash Unit)

Cleaning mechanism: 8 step cleaning
st
1 step: Drainage + Wash solution supply
nd
2 step: Drainage + pure water supply
rd
3 step: Drainage + Wash solution supply
th
th
th
th
7 step: Drainage
th
8 step: Drainage (Remove remaining liquid by using a wipe tip)
9-14 Power Supply Unit

Power requirements: 100 to 120V
120VAC,
AC, 9A(Max) / 200 to 240V
240VAC,
AC, 4.5A(Max), 50/60Hz
Power consump
consumption:
tion: 900VA (Max.)
Permissible voltage ±10% (Max.)
variation:
10. Other Functions - Auto start / shutoff,

- Emergency sample insertion
- Automatic sample dilution
- Water blank measurement
- Reagent blank measurement
- Test selection by profile
- Host communication by RS232C with Operational PC.
11. Environment (under operation)

Temperature: 15 to 30°C, 2°C / hou
hour,
r, (Storage / Transport: -10 to +50°C)
Humidity: 45 to 85% (No dew condensation allowed.), (Storage / Transport: 45 to

85%)
Pressure: 800 to 1060 hPa, (Storage / Transport: 500 to 1060 hPa)
12. Dimension
Outside diminution 970mm(W) × 690mm(D) × 582mm(H) (The
(T he height of the rubber pad is
(Main analyzer): not included.)
Weight 150 kg (Max.)
(Main analyzer):
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FOREWORDS
13. Connectors to main analyzer

1) Electrical connectors
- Power connector
- RJ-45 modular jack (for connection between main analyzer and
operational PC)
- D-sub receptacle (for connection between main analyzer and optional
external tank rack)
2) Piping Connectors for supply / drainage
dr ainage
- Pure water
- WU high conc. wastewater (output)
- ISE high conc. wastewater (output)
- WU low conc. wastewater (output)
- Trough low conc. wastewater (output)
(output)
- Overflow line
- Wash solution 1
- Wash solution 2
14. Maximum sound level 75dB (at the location 1m or longer distant from
fro m the main analyzer with
its hatch closed.)
15. Transient overvoltage Overvoltage category II
16. Rated pollution degree Pollution degree 2
0-18

FOREWORDS
17. The rating and characteristics of fuses
TYPE SIZE RATING CHARACTERI

CHARACTERISTICS
STICS LOCATION AND PART
PART NO.
Glass tube fuse 5 × 20 2A / 250V Slo-Blo PCB:25P3503

mm (ASP_DRV) F1

mm (RCU_DRV) F1

mm (ASP_DRV) F2
PCB:25P3506
(SWU_DRV) F1
Glass tube fuse 3AG 10A / 250V Fast-Acting PCB:25P3502

(RCU_DRV)
(RCU_DRV) F2,F3,F4,F5
PCB:25P3505
(SWU_DRV2) F1
PCB:25P3509
(IRU_DRV) F1
Glass tube fuse 3AG 4A / 250V Slo-Blo PCB:25P3507

(SWU_DRV3) F1
Ceramic tube fuse 3AB 10A / 250V Slo-Blo Fuse Holder

(AC input) F1 & F2
0-19

FOREWORDS
6. System Configuration
High Con.
Wastewater
Tank
Printer
Low Con.
Main Overflow Wastewater Outlet
Analyzer
XP PC
Purified water
generator
Wash Wash
AC Power Outlet Sol.1 Sol.2
Note: Standard supplies are illustrated in full line.
1 10
2
9
3
4
5 6 7 8
Right side of Main Analyzer
No. Use Note

1 Output line for high conc. wastewater for WU (Pressure-
(Pressure-resistant
resistant hose. See Page 0-10.) standard
preparation
2 Output line for low conc. wastewater for WU (Pressure-
(Pressure-resistant
resistant hose. See Page 0-10.)
by customer
customer
preparation
3 Output line for low conc. wastewater for troughs (Pressure-
(Pressure-resistant
resistant hose. See Page 0-10.)
by customer
customer
4 Output line for high conc. wastewater for ISE (Silicon tube. See Page 0-10.) standard
5 Input line for wash solution 2 (P

(P.V
.V.C
.C tube. See Page 0-10.) standard
6 Input line for wash solution 1 (P

(P.V
.V.C
.C tube. See Page 0-10.) standard
preparation
7 Input line for pure water (Pressure-res
(Pressure-resistant
istant hose. See Page 0-10.)
by customer
customer
preparation
8 Output line for overflowing (Pressure-r
(Pressure-resistant
esistant hose. See Page 0-10.)
by customer
customer
9 Connecter for external tank rack cable Option
Option
10 Hose clamp standard
0-20

FOREWORDS
No. Use
1 Power cable
2 Fuses
3
3 Power switch
4 LAN connecter and cable for PC
2
Left side of Main Analyzer
7. Component List
Please check a component list.
NO. EQUIPMENT MODEL/STANDARD QTY REMARKS
1 Clinical Chemistry CA-400 1 -

Analyzer
2 Power Cable 25AZ-X-6001(25S1031) 1 For Clinical Chemistry Analyzer

Between PC and Chlinical
3 LAN Cable Assy. 25AP-X-6001 1
Chemistry Analyzer
4 Operator’s Manual OM-E7219 1 -

Refer to the Standard Accessories
5 Accessories - 1 set
List.
-
6 Spare parts Ceramic Tube Fuse 326 010 : 2 1 set
Glass Tube Fuse 218 002 :1
0-21

FOREWORDS
STANDARD ACCESSORIES LIST
Please check an accessories list.
Pa r t
NAME TYPE Q TY REMAR
REMARKS
KS
code #
- Syringe
Tool Tip Insertion 25-012-4101 1 For exchange of syringe tip
- Screw Driver No. 123-S75 1 -

1.5 mm
- Hexagonal Wrench 1 -
3.0 mm
- Hose Clamp 2269-08 1 -
For Tank 1
Plastic Tube P.V.C tube 1.59 mm (Inside) × 4.76
- 25-023-4011
25-023-4011 1 mm (Outside): 1m
Wash Solution -1 Inline filter: 1
Pipe: 1
For Tank 2
Plastic Tube P.V.C tube 1.59 mm (Inside) × 4.76
- 25-023-4012
25-023-4012 1 mm (Outside): 1m
Wash Solution -2 Inline filter
Pipe: 1
Plastic Tube High
- 15 x 22 1m Line for high conc. waste water
Conc. Waste
Furuno Clean No. 3
- Wash Solution No. 3 1 x 200
(500g)
Furuno Clean No. 9
- Wash Solution No. 9 1 x 200
(500g)
- Wash Solution C-1 Furuno Clean C-1 (500g) 1 x 100
5L Wash Solution
- 25AZ-X-4951 1 For Wash
Wash Solution No. 3
Tank 1
5L Wash Solution
- 25AZ-X-4952 1 For Wash
Wash Solution No. 9
Tank 2
- Mix Arm Cover 25-023-1911 2 -
- Pipette Arm Cover 25-023-2012 3 -

- Sample Tray Assy 25AZ-X-4307 1 -
- Inner Sample Tray 25-023-2353 1 -
- ASP Lid Assy

Assy.. 25AZ-X-4314 1 -
- Reagent Bottle Tray 25-034-2451 1 -
- RCU Lid 25AZ-X-4416 1 -
0-22

FOREWORDS
8. Software Operating Environment

ITEM SPECIFICATIONS
OS Window XP Professional version + Multi-language (option)
CPU Ty
Type:
pe: Intel CPU
Operating frequency: 1GHz or more
Memory Mbytes（Other 512Mbytes) or more
English 256 Mbytes（
VGA 1024*768 or more
Hard Disc 2GB or more ,Capacity before analyzer installation
Serial Port RS232C (used only when using ASTM)

Ethernet 10/100 Base-T
Sound Function Sound function + speaker (when using alarm sounds)
CDROM Used at the time of analyzer installation

Operating mode can be designated by software.
(1) Page Printer
Printer A page printer with the driver corresponding to XP
(2) Line Printer
Fujitsu M33051, only English and Japanese modes are available.
Modem (Optional) Windows Dial-up connection
Backup System etc.* １

CD-R, MO, ZIP, Flash Memory, etc.*１
Others Keyboard, mouse, and PS2 compatible BCR

*1 : The device w
which
hich OS file recognizes as file system. This can be connected to USB, IEEE1394.
*2 : When you use external devices, please confirm that
t hat those devices are Virus Free.
*3 : This operating PC shall not be used with applications of other companies, since it is not guaranteed.
List of installed software in PC

Program
Program No. Use
Name
UI Main 25504631XX This program is for handling of user interface.

UI UC 25503291XX This program is for handling of communication between PC and main unit.
UI PRT 25504741XX This software is for live printing.
UI LIS 25503311XX This software is for handling of communication between host.
XX shows the software
so ftware version number.
List of installed software in Main unit

Program
Program No. Use
Name
Unit Main 25504221XX This program is for handling of machinery unit (main unit).
Uinit LIQ 25503041XX This program is for handling of liquid level detection.
Unit DTR 25503031XX This software controls the DTR.
Unit SPT 25504431XX This software controls the SPT.
XX shows the software
soft ware version number.
Note: Version number of each program can be verified by opening the tab menu [Version]
[Version] under the job menu
[System (F9)].
0-23

FOREWORDS
9. Handling of barcode reader

(1) Specifications
- Class2 laser product
- Emitted wavelength: 650nm
- Maximum output: 1.0mW
(2) Safety Precautions

- Do not stare beam light.
- Do not ray the laser beam to human body for a long time.
- Do not disassemble the unit.
- Do not remove the cover. A
Adjustment
djustment of BCR is carried out by a service engineer.
Caution
Use of controls or adjustments, or the performance of procedures other then those specified
herein, may result in hazardous radiation exposure.
Laser beam is rayed out from each BCR unit to the arrow
arr ow direction while analyzer is operating. (See below.)
RCU ASP
0-24

Chapter 1 Overview
Chapter 1 Overview
1.1 General
This Fully Automated Clinical Chemistry Analyzer is a middle-sized automated biochemical analyzer,
which is capable of performing 400 tests per hour. This analyzer is operated by an external operational PC
and measurement results can be printed out from a printer.
This analyzer may be connected to a host computer, when needed (ASTM Protocol capable).
Ninety cuvettes, where the samples are reacted with reagents, are located on the Incubation Reaction Unit
(IRU), the inside of which is kept at 37 C constantly.
° constantly. Cuvettes are cleaned by the cleaning mechanism of the
analyzer after each use for the next use.
The absorbance of the content of each cuvette on the Incubation Reaction Unit (IRU) is measured every 9
seconds by the Detector Unit (DTR) after the sample fully mixed with a reagent. Wavelength(s) (to a
maximum of 2 wavelengths) used for a measurement can be chosen from 12 pre-specified wavelengths.
Samples [including standard samples and quality control samples (QC samples)] are placed on the
removable ASP tray.
tray. The ASP tray can accommodate maximum of 72 tube-holders and 20 cup-holders.
Cup holders are located in the center of the ASP and can keep samples cold, which are exclusively used
for standard samples and QC samples (control samples). They cannot be used for normal samples. Barcode
labels can be affixed to the sample tubes so that the analyzer can identify the contents by using the barcode
reader.
Reagents are mounted on the removable RCU tray. Maximum of 60 reagent bottles can be mounted.
Barcode labels can be affixed to the reagent bottles so that the analyzer can identify the contents by
b y using the
barcode reader (optional). The RCU
RCU has a cooling function to keep a constant
constant temperature.
LAN Cable
RS232C
Main Analyzer
PC
Host Computer
Operational PC
Clinical Chemistry Analyzer

Equipment Layout
Figure 1.1-1
Refer to Figure 1.1-2 for the appearance of the main analyzer (control section).
Chapter 1 Overview
1.1 General
1-1

Chapter 1 Overview
Appearance of Main Analyzer (Control Section)

Figure 1.1-2
Chapter 1 Overview
1.1 General
1-2

Chapter 1 Overview
Viewed
Viewed from the front
fron t
Viewed
Viewed from the
t he Rear
Perspective View of Main Analyzer (Control Section)
Figure 1.1-
Chapter 1 Overview
1.1 General
1-3

Chapter 1 Overview
1.2 Built-In Unit
The main analyzer consists of various built-in units

u nits as shown below.
RPT2 MIX2 IRU WU
RCU RPT1 MIX1 ASP SPT
DTR MIX2 RPT2 RPT1

Trough Trough Trough
SPT MIX1 ISE

Trough Trough
Built-In Units 1/2

Figure 1.2-1
1.2 Built-in Unit
1-4

Chapter 1 Overview
Sub-Tank L RPP2 RPP1 SWU3
WPP
SPP (Washing)
SPP (Sample)
SWU2
Sub-Tank R
SWU1 (Inside)
Built-In Units
Figure 1.2-2
1.2 Built-in Unit
1-5
15
Chapter 1 Overview
Major functions of each unit are summarized in the table below.
Major Functions of Each Unit
Unit
Major Functions
(Abbreviation)
IRU Incubation Reaction Unit:
The cuvette table (turntable) of the IRU holds 90 cuvettes. It rotates and brings the
designated cuvettes to where samples/reagents
s amples/reagents are dispensed by the SPT/RPT.
DTR DeTectoR unit:

The DTR measures the absorbance of reaction liquids during reaction (mixing and
incubation) process in cuvettes. This disperses the light from the halogen lamp as a source of
light with a grading method and measures 12 wavelengths at one time.
ti me.
SPT Sample PipeTte unit:

The SPT aspirates the sample from the Auto SamPler unit (ASP) by using the SPP and
dispenses it into a cuvette (in IRU) and/or into the ISE. Each nozzle is cleaned in the SPT
TRough after use.
RPT Reagent PipeTte unit:

The RPT aspirates a reagent from a reagent bottle (in RCU) by using the RPP, then
dispenses it into a cuvette (in IRU). The RPT consists of the RPT1 for the reagent #1 and the
RPT2 for the regent #2. Each nozzle is cleaned in the RPT Trough after use.
MIX MIXing stirrer unit:

After a sample and a reagent are dispensed into a cuvette, the MIX brings down the
paddle-type stirrer and stirs the mixture in the cuvette by rotating the stirrer to react the
sample with the reagent evenly. This unit consists of the MIX 1 for the reagent #1 and MIX2
for the reagent #2. The stirrer is cleaned with pure water after every use.
WU Wash Unit:
The WU consists of six supply/drain nozzle pairs, one drain nozzle and one wipe tip. This
unit drains the reaction liquid out of each cuvette after the completion of measurement and
cleans the inner surface of each cuvette by pouring wash solution or pure water into the
cuvette.
ASP Auto SamPler unit: *Barcode Reader and Cooling Function are optional.
The ASP
sample cups holds 72 tubes
(standard of and
samples samples (normal
the ISE samples and
wash solution) and emergency samples),
brings the required and 20
sample to
the SPT pipetting position by rotating its turntable.
RCU Reagent Container Unit: *Barcode Reader is optional.

The RCU holds maximum of 60 reagent bottles in the reagent tray and brings the required
reagent to the RPT pipetting position.
SPP Sampling PumP unit:

The SPP aspirates/dispenses both samples and pure water by moving its plungers up and
down. Since the sample syringe and the cleaning syringe have separate motors, they can
operate independently
independently..
1.2 Built-in Unit

16
Chapter 1 Overview
Unit
Major Functions
(Abbreviation)
RPP Reagent PumP unit:
The RPP aspirates/dispenses both reagents and pure water by moving its plungers up and
down. This unit consists of the RPP1 for the reagent #1 and the RPP2 for the regent #2. Since
the reagent syringe and the cleaning syringe have separate motors, they can operate
independently.
WPP Wash PumP unit:

The WPP (consists of six pumps which) aspirate/dispense wash solution or pure water by
moving its plungers up and down, which are connected to the nozzles of the WU (Cuvette
Wash Unit). This unit supplies wash solution or pure water to WU1 and WU3, and supplies
pure water to WU2, WU4, WU5
WU5 and WU6.
SWU Supply Water Unit:

The SWU consists of SWU1, SWU2 and SWU3.
This unit
- controls pure water supply from the purified water generator to the subtanks R/L
(SWU1-1),
- supplies pure water from the sub-tank R to the SPT Trough and the MIX1 and 2 Troughs
(SWU2),
- supplies pure water from the sub-tank L to the RPT1 and 2 Troughs (SWU3),
- drains wastewater from the WU (SWU1-2).
TR TRough unit:
The TR (Wash Station) consists of 5 troughs and one trough chamber
chamber..
This unit collects wastewater in the nozzles of the SPT and the RPT-1 and 2, and cleans the
external surfaces of these nozzles of the SPT and the RPT-1 and 2 and also cleans the stirrers
of the MIX-1 and 2 with pure water, then collects the wastewater after cleaning.
ST SubTank:
The ST consists of the sub-tanks R and L. These tanks store pure water, which will be
supplied to the SPP, the WPP and the RPP-1 and 2, and each trough for the SPT, the MIX-1
and 2, and the RPT-1 and 2.
ISE Ion Selectable Electrode unit:*Optional

The ISE determines the concentration of the electrolytes (sodium, potassium and chloride)
contained in serum, plasma and urine by using ion electrodes.
- Chassis Unit (Enclosure):

This Chassis Unit houses the above-mentioned units, and the PC boards and the power
supply unit that are not installed in these units, and protects them from damage using covers.
This unit also has functions such
s uch as cooling, dust-proof etc. using fans and filters.
fil ters.
- External tanks and external tank sensors:*Optional

External tanks supply wash solutions that are used by the analyzer and store the
wastewater discharged from the analyzer. The external tank sensor(s) monitor the amount of
liquid in each tank. (Optional)
1.2 Built-in Unit

17
Chapter 1 Overview
THIS PAGE IS
INTENTIONALLY
LEFT BLANK.
1.2 Built-in Unit

18
Chapter 1 Overview
1.3 Measurement Flow
1.3.1 Normal Measurement

Test selection(s) and calibration curve(s), which are required for the measurement, must already exist, or
required amount of calibrators necessary to find calibration curves must be set at the
t he starting position of the
ASP in advance.
A) Reagent Control (RCU Scan)
When you execute the “RCU Scan”, the tray in the RCU unit goes into a 360-degree roll. During this
movement, the barcode reader reads the barcodes on the reagent bottles in the tray. Based on these barcode
records, the reagent information is controlled. This “RCU Scan” needs to be performed prior to pressing
the [F1] key for Measurement Start.
B) Preparatory Operation
When you press the [F1] key for Measurement Start, the following preparatory operations will be
performed.
(1) Each unit is initialized.
(1)
(2) The SPP, RPP-1 and 2 are primed. The ISE is also primed.
(2) primed .
(3) Water blank measurement is performed for the cuvette (Cuvette #6), which will be used at first.
(3)
(4) The ASP turns around and barcode of the sample to be measured is read. Then, an inquiry to the PC
(4)
regarding the measurement schedule (Test Selection) is performed.
perfo rmed.
C) Reagent No. 1 Measurement
As long as there is no lack of the reagents (R1 and R2), pure water, wash solution and diluent, the
following processes are performed.
(1) Reagent No. 1 (R1) Dispensing
(1)
Reagent No.1 Pipette (RPT-1) aspirates the Reagent No.1 on the RCU and dispenses it into
cuvette on the IRU. The IRU and the RCU rotate individually and move to the positions where
the reagent is aspirated/dispensed.
(2) Sample Dispensing
(2)
The Sample Pipette (SPT) aspirates the sample in the ASP and dispenses it into the cuvette in
the IRU in which the R1 reagent is already dispensed. The ASP and the IRU rotate individually
and move to the position where the sample is aspirated/dispensed.
(3) Stirring
(3)
The R1 reagent and the sample dispensed in the cuvette in the IRU are stirred thoroughly by the
stirrer (MIX-1). The IRU rotates and brings the cuvette to the stirring position of the MIX-1.
(4) Photometry (1-34)
(4)
The absorbance of the thoroughly stirred mixture of Reagent No.1 and the sample in the
cuvette is measured by the DTR every 9 seconds and up to 34 times. The results of measurement
are collected as R1 Time
T ime Course Data.

1-9
Chapter 1 Overview
D) Reagent No. 2 Measurement

(1) Reagent No. 2 (R2) Dispensing
(1)
The Reagent No.2 Pipette (RPT-2) aspirates the Reagent No.2 in the RCU and dispenses it into
the cuvette (where the Reagent No.1 and the sample have already been dispensed). The IRU and
the RCU rotate individually and move to the position where each reagent is aspirated/dispensed.
(2) Stirring
(2)
The R2 reagent and the sample dispensed in the cuvette on the IRU are stirred thoroughly by
the stirrer (MIX-2). The IRU rotates and brings the cuvette to the stirring position of the MIX-2.
(3) Phometry (35 – 68)
(3)
The absorbance of the thoroughly stirred mixture of Reagent No.1, Reagent No.2 and the
sample in the cuvette is measured by the DTR every 9 seconds and up to 34 times. The results of
measurement are collected as R2 Time Course Data.
E) Cleaning
After the measurement of the R2 Time Course is complete, the mixture in the cuvette is discharged at the
WU unit. The used cuvette is cleaned with wash solution and pure water, then used for the next
measurement.

Measurement
1-10
Chapter 1 Overview
1.3.2 Sample Dilution
High concentrated sample that is beyond the measurement range is diluted prior to the measurement. The
quantity of the sample that will be diluted, the quantity of diluent and the sample to be diluted shall comply
with the contents specified by the Chemistry Parameters. The measurement results are output using the
concentration corrected by dilution proportion.
1.3.3 Reagent Blank Measurement

This is to measure the absorbance of the cuvette with a dispensed reagent. There are four types of
Reagent Blank Measurements as follows,
(1) R1
(1)
(2) R1+ R2
(2)
(3) R1+ Water
(3)
(4) R1+ R2 + Water
(4)
Measurement conditions such as dispensing quantity, number of the measurements (one chosen from
Single, Duplicate and Triplicate) and measurements with or without water (equivalent to sample), are
determined by the Chemistry Parameters. Adjustment by the reagent blank value allows you to obtain
higher accurate results of the absorbance
a bsorbance measurement.
1.3.4 Water Blank Measurement

“Water blank Measurement” is defined as an absorbance measurement for the cuvette with dispensed
water. This measurement is inevitably performed for each cuvette that is used for sample measurement.
The purpose of this measurement is to adjust the differences among cuvettes. The measurement results are
also used to evaluate the condition of the cuvettes’ contamination. The measurement results of the water
blank can be referred in the tab menu [Mainte
[Mainte (F10)] – [W Blank].
1.3.5 ISE Measurement
The ISE unit measures the concentration of sodium (Na), potassium (K) and chloride (CI) contained in
serum, plasma, urine etc. by using ion electrodes. Urine must be diluted ten times before measurement.
The code number and name of the diluent need to be registered on the tab menu [System (F9)] –
[Reagent] prior to measurement.
The ISE measurement of the sample is executed by conducting test selection setting on the tab menu
[RUN (F5)] – [Selection].
The ISE prime, the ISE cleaning and the ISE calibration can be executed on the tab menu [Mainte (F10)]
– [Sequence].

1.3.2 Sample Dilution /1.3.3 Reagent Blank Measurement /
1.3.4 Water Blank Measurement / 1.3.5 ISE Measurement
1-11
Chapter 1 Overview
1.4 Operation Basics
1.4.1 Analysis Specifications
Items Specifications
Up to 240 methods (Common: 60, Serum: 60, Plasma: 60, Urine:
Number of analysis methods
60)
Normal range 50 steps

6 types = gender (2 kinds) x age (3 generations), others: 44 types
Multi standard Capable of 10 set definition
Control sample Capable of registration of 40 types (samples)
Profile Capable of 20 type definition
Method to method calculation Capable of 40 type definition
Normal sample: Up to 1,000 samples

Test selection
Emergency sample: Up to 100 samples
Reagent registration Up to 200 types
Number of controllable reagent bottles Up to 800 bottles (10 trays)

Sample measurement results: 1,000,000 tests
Sample time course: 60,000 tests
Measurement results
Calibration results: 25,000 tests
Calibration time course: 6,000 tests
Calibration curve Number of methods x 2 (Old and New): 480 curves
QC measurement results Up to 50,000 tests (approximately for one year)
Number of identifiable patients 30,000 patients
Number of maximum rounds per day.

day. 99 rounds per day

1.4.1 Analysis Specifications
1-12
Chapter 1 Overview
1.4.2 Sample Identification Code

All samples placed in the ASP have been assigned identification codes as shown in the table below.
These identification codes (SID) are printed on the barcode labels attached to the samples.
*General Identification Code: Identification code (SID) with additional information of measurement
numbers, which will be displayed in the SID section of the Run Monitor screen and the Result Search
screen.
Identification Digit General

Type of sample code identification code Details
number
(SID) (Refer to above *)
xxxxxxxxxxxx: Sample
Normal sample xxxxxxxxxxxx 3 - 12 Nxxxxxxxxxxxxnn1 identification code
nn: Number of measurement
xxxxxxxxxxxx: Sample
On line sample xxxxxxxxxxxx 3 - 12 Oxxxxxxxxxxxxnn1 identification code
xxxx: Sample identification code
Pediatric sample 8999xxxx 8 n8999xxxxnn1
xxx: Sample identification code
Emergency sample 99000xxx 8 E99000xxxnn1
Pediatric emergency xx : Sample identification code
990009xx 8 e990009xxnn1
sample nn : Number of measurement
xx : Sample identification code
Control sample 970000xx 8 C970000xxnn1 nn : Number of measurement
xxxxx : Reagent code

y : Classification (from 1 to 7)
Standard sample 98xxxxxy 8 S98xxxxxynnm
nn : Number of measurement
m : Number of repetition
x : Set number
y : Classification (from 1 to 7)
Multi-standard sample 950000xy 8 M950000xynnm
nn : Number of measurement
xxxxx: Reagent code
Serial dilution y : Classification (from 1 to 7)
93xxxxx0 8 D93xxxxxynnm
standard sample nn : Number of measurement
Replicate sample 9400xx01 8 R9400xxnn111
R9400xxnn111 xx: Sample identification code
Orderless sample 920000xx 8 A920000xx11

A920000xx111
1 xx : ASP position code
x: Sample identification code
Blank sample 9510000x 8 B9510000xnnm nn: Number of measurement
m: Number of repetition
xxxxx : Reagent code
Reagent blank 91xxxxx1 8 RB91xxxxx1nnm nn : Number of measurement

1.4.2 Sample Identification Code
1-13
Chapter 1 Overview
1.4.3 Barcode Label Specifications for both Sample and Reagent

A) Barcode Type
* Only numbers can be used for Reagent barcode label.
Ty
Type
pe Data digit number Check digit Effective characters
UPC(JAN) From 3 to 12 digits 1 digit, Modulus 10 Numbers (from 0 to 9)
Numbers (from 0 to 9)
NW7 From 3 to 12 digits 1 digit, Modulus 16
Symbols (-, $,/,.,+)
From 3 to 8 digits Numbers (from 0 to 9), Alphabet
Alphabet
CODE39 1 digit, Modulus 43
Symbols (-, $,/,.,+)
ITF From 3 to 12 digits 1 digit, Modulus 10 Numbers (from 0 to 9)
Numbers (from 0 to 9), Alphabets
Alphabets (capital
CODE128 letters and small letters)
2 digits, Modulus
(Set A, B From 3 to 12 digits Symbols (!,”,#,$,(,),*,+,.,/,:,;,<,>,=,?,@,[,])
103
and C) Note: Small Roman letters cannot be used used for
the Set B.
From 13 mm to 16 mm
B) Barcode Specifications for Sample
Bar module width From 0.25mm to1.00mm

Barcode height 15 mm or higher
Barcode length 60 mm or shorter, including quiet zone.
Quiet zone Blank areas before/after the barcodes.
4 mm or 10 times length of the minimum
module width, whichever the greater.
Maximum 77mm
Printing Black on the white background. Quality
standard shall comply with the ANSI MH10.8M
standard.
Barcode label location Refer to the drawing on the right.
Note: Usable sample tube:

tube: Diameter in the range of 13 mm to 16 mm
10 mm or shorter
Barcode Label
C) Barcode Specifications for Reagent Bottle
Bar module width From 0.25 mm to1.00 mm

Barcode height 15 mm and higher
Barcode length 80 mm or shorter, including quiet zone
Quiet zone Blank areas before/after the barcodes.
4 mm or 10 times length of minimum module 70 mm
width, whichever the greater.
Printing Black on the white background. Quality
standard shall comply (compatible) with the
t he
ANSI MH10.8M standard.
Barcode label location Refer to the drawing on the right. 10±1 mm
Barcode label

1.4.3 Barcode Label Specifications for both Sample and Reagent
1-14
Chapter 1 Overview
1.4.4 Keyboard
This analyzer is controlled using the PC keyboard and/or the mouse.
The function and description of each key are shown below.
Key Function Description

Press this key when you start measurement and/or restart
[F1] Measurement start measurement.
Stop dispensing of the sample into the subsequent cuvettes.
[F2] Sampling stop However, the measurement for the dispensed sample(s) will
be continued.
[F3] Emergency sample addition Press this key when you add an emergency sample.
When an alarm occurs, this key starts blinking in red.
[F4] Alarm
When you press this key, the alarm screen will be displayed.
[F5] Daily performance Job menu [Run (F5)] selection key.
key.
[F6] Analysis condition setting Job menu [Parameter (F6)] selection key.
key.
[F7] Calibration setting Job menu [Calibration (F7)] selection key.

key.
[F8] QC setting Job menu [QC (F8)] selection key.

key.
[F9] System parameter setting Job menu [System (F9)] selection key.
key.
[F10] Maintenance Job menu [Maintenance (F10)] selection key
[F11] Tab menu selection (upward) Tab menu selection key.
[F12] Tab menu selection (downward) Tab menu selection key.

[Shift] When you wish to start the simple measurement without
+ Orderless measurement start settings of test selection, press [Shift] and [F1] keys
[F1] simultaneously.. (Refer to the Note below)
simultaneously
[Shift]
When you press [Shift] and [ESC] keys simultaneously, the
+ Alarm sound stop
alarm sound will stop.
[ESC]
[Control] When you wish to abort the measurement process in progress,
+ Emergency stop press [Control] and [F2] keys simultaneously.
simultaneously. This brings the
[F2] analyzer operation to a complete halt.
[Control] When you wish to print the screen image that is currently
displayed using the printer, press [Control] and [F5] keys
+ Screen-print
simultaneously.. This function
simultaneously f unction is not available during
[F5]
measurement process.
Note: The “Orderless measurement start” function is available either with or without the ASP barcodes.
This function allows the analyzer to measure all available samples positioned in the ASP for all
methods that are set by the chemistry parameter regardless of the presence of the test selection. The
measurement methods for the Orderless measurement can also be selected in advance. The necessary
reagents that have been registered must be positioned in the RCU for this operation. (Refer to Chapter
2, “2.7.1.10 Orderless Sample”)

1.4.4 Keyboard
1-15
Chapter 1 Overview
1.4.5 Menu Structure
Power on
Monitor
Round
Selection
Result
Run (F5) Inventory
Sleep Scheme Normal
Std QC Normal2
Patient ISE
SI
Parameter (F6)
Calc
Reg Calib Profile
Serial Dilution Order
Calibration [F7] Multi-Std Wash
ISE
Graph
Job Menu Details
QC [F8] Daily
Cumulative
Setup Settings
Reagent Registration
Login
System (F9) Backup
Setup2 Water B1
Define Work Hour
Range Sequence
Sensor
Perform
Mainte (F10) Passwd
* Adjust
Depending on login mode, these
* DTR Pos
menus become invisible.
* Operation Logs
Combination
Emergency stop
Start (F1) (Cntrl) + (F2)
SStop (F2)
Print-screen
Global (Cntrl) + (F5)
STAT (F3)
Menu
Orderless measurement start
Alarm (F4) (Shift) + (F1)
TabUP (F11)
Alarm sound stop
TabDOWN (F12) (Shift) + (ESC)

1-16
Chapter 1 Overview
A) Job Menu List
Job Menu Tab Menu Description

Run (F5) Monitor Measurement status monitor
Round Measurement details status monitor

Test order (patient sample, standard sample, control sample and blank
Test
Selection sample), patient information and mask settings.
Result Measurement results control
Inventory Reagent remaining amount control
Sleep Scheme Settings of sleep schedule and wake-up conditions

Test order settings for standard samples and control samples positioned
Test
Std QC
in the innermost circle of the ASP
ASP.. (Barcode label is not applicable)
Patient Patient information registration
Parameter (F6) Setting for the analysis condition per method.

Normal (Settings for analysis method, measurement point, dispensing amount,
normal range, technical range, stirring speed etc.)
Setting for the analysis condition 2 per method.
Normal2 (Settings for limit check, blank measurement condition, inter-equipment
coefficient etc.)
ISE Analysis condition setting for the ISE.
SI Condition setting for serum information.
Calc Definition of method to method calculation
Profile Profile setting
Order Settings for measurement order and printout order.
Wash Method to method wash setting

settin g
Calibration (F7) Reg Calib Registration and setting for calibration curve
Serial Dilution (Serial) Dilution standard setting
Multi-Std Multi-standard setting
ISE ISE calibration results display
QC (F8) Graph QC graph display
Details QC measurement results details display
Daily Daily statistical processing for QC results
Cumulative Statistical processing of QC results for specified days
Settings Setting for the evaluation criteria of QC results
Registration Registration of control samples for quality control (QC).

1-17
Chapter 1 Overview
Job Menu Tab Menu Description

System (F9) Setup for system parameter 1
(Host communication parameters, higher-order digits in the sample
Setup numbers, settings for sample barcode type etc., settings for various
selection condition flags and the RPT special wash solution code,
header settings for real-time printing.)
Reagent Registration
etc. and settings for reagent codes, reagent names, bottle sizes
Versions Display of various program numbers
Backup Backup for system parameter and measurement data

Setup for system parameter 2
Setup2 (Settings for default settings of reagent bottles, technical range value
and age and generation of patients etc.)
Define Definition and editing for patient information
Range Definition and editing for normal range name(s).

Mainte (F10)
Water Bl Display for water blank value of cuvettes
Work Hour Display for operating time of the equipment and consumable parts
Sequence Single operation and specific sequence operation of units
Sensor Test and display for sensor status

Temperature status monitor for IRU, RCU and ASP.
Perform
Sensitivity status monitor for various wavelengths of DTR.
Passwd Setup necessary password for each user level.
Adjust For factory adjustment (volume adjustment)

Execution of DTR light path adjustment for cuvettes and adjustment
DTR Pos
amount display
Operation Logs Operational record by any operator’s

1-18
Chapter 1 Overview
1.4.6 Control Screen Layout

The screen layout of the control
co ntrol section (Operational PC) is shown below.
To select the menu, click each function key (for example [Run (F5)]) displayed on the screen or press
[F5] key on the keyboard.
(5) Equipment status (1) Current date and time (2) Wakeup time (3) Mode display
Status Date Time Wakeup Time Mode
Run (F5) Parameter (F6) Calibration (F7) QC (F8) System (F9) Mainte (F10) SHUT DOWN
(11) Login level
(6) Job Menu

(4) Shut down or Sleep cancel
(7) Tab Menu
(10) Indication message
Indication
Start (F1) SStop (F2) STAT (F3) Alarm (F4) TabUP (F11) (F1 2)
TabDOWN (F12)
(8) Global Menu (9) Tab Menu Selection
No. Details
(1) Date Time

Current date and time is displayed.
(2) Wakeup Time
Wakeup time from the sleep mode is displayed.
(3) Mode
One of the following messages is displayed.
・Receiving order ：Indicates that the test order is being received from the host computer.
・ RCU Scan in process：The RCU is currently rotating in order to obtain reagent control information
・ No displays: None of the above.
(4) SHUT DOWN / SLEEP CANCEL

During measurement process, this button is used to shut down the analyzer or shift to the sleep mode.
When pressed during the sleep status, the sleep is cancelled.

1-19
Chapter 1 Overview
No. Details
(5) Status
“Main status” and “Sub-status” messages that indicate the status of the analyzer are displayed.
<Main status display message (left display box) >
Not ready： Communication with each CPU in the analyzer has not been
established yet.
Pre-ready
： The boot process has been completed, however, cuvette water
dispensing and prime have not yet been performed.
Ready： Ready to perform measurement any time.
Measurement： Measurement for normal sample(s) is now in process.
STAT-measurement ： Emergency samples are being measured as a priority.
priority. Standard
sample and QC samples are not measured.
MSStopping： Sample dispensing is completed or being stopped, or samples
are being added to the ASP.
ESStopping： Sample dispensing cannot be continued due to an error
Sleeping： The analyzer is in a sleeping status.
Maintenance： Units of the analyzer are operated from the [Maintenance]
screen.
Emergency Stop： The analyzer has stopped emergently due to equipment
abnormality or user command.
Sampling stop in progress： An error that disables sample dispensing occurred.
Sampling stop complete： The measurement(s) have been completed after an error that
disables sample dispensing occurred.
Maintenance complete： Operation from the [Maintenance] screen has been completed.
Em Stop in progress： The process enabling Emergency Stop is in progress.
Em Stop complete in progress： Restoring from Emergency Stop status.
<Sub status display message (right display box) >
PowerOn： The power-on process is in progress.

Preparation： Either initialization of units or the SPP/RPP prime is in
progress.
Startup： Process to start measurement is in progress.
AddSTAT ： The process to add emergency sample is in progress.
STAT measurement complete： Emergency sample measurement has been completed.
Sampling Complete： Sample dispensing to cuvettes has been completed.
Measurement complete： All measurement processes have been completed.
Sleep Progress： Shift to the sleep mode is being prepared.
Wakeup： The analyzer is booting from the sleep mode.
STATStop： Emergency sample dispensing to cuvettes is stopped.
STATReStart ： Emergency sample dispensing to cuvettes is restarted.
ReStart： Normal sample dispensing to cuvettes is restarted.
CancelSleep： Preparation for the shift to sleeping status is cancelled.
Maintenance in process： [Performance] Tab in the Maintenance Menu is in progress.
Maintenance Complete： [Performance] Tab in the Maintenance Menu has been
completed.
Passing： The analyzer is ready after the completion of priming,
Shutdown： The analyzer has been shut down.
Sampling stop in process： Sample dispensing to cuvettes is stopped due to an error.

1-20
Chapter 1 Overview
No. Details
(6) Job Menu
By clicking the displayed Job Menu buttons, the following menus can be selected.
(Refer to “1.4.5 Menu Structure, (A) Job Menu List”.)
・ Run (F5) Refer to “3.1 Run Menu: [Run (F5)]”.
・ Parameter (F6) Refer to “3.2 Set-up Menu 1: [Parameter (F6)]”.
・ Calibration (F7) Refer to “3.3 Set-up Menu 2: [Calibration (F7)]”.
・ QC (F8) Refer to “3.4 QC Menu: [QC (F8)]“.
・ System (F9) Refer to “3.5 System Menu: [System (F9)]”.
・ Mainte (F10) Refer to “3.6 Maintenance Menu: [Mainte (F10)]”.
(7) Tab Menu
By clicking the displayed Tab Menu Button, the Tab Menu attached to each Job Menu can be
selected.
(Refer to “1.4.5 Menu Structure: A) Job Menu List”.)
(8) Global Menu
These Global Menu buttons are always shown on the bottom of the screen, they are available in any
Menu.
・ Start (F1) By clicking this button, measurement can be started.
・ Sstop (F2) By clicking this button during measurement, sample dispensing can be
stopped. To
To restart the measurement, click the [[Start
Start (F1)] button.
・ STAT (F3) When you add an emergency sample to the ASP tray tray,, click this button.
・ Alarm (F4) By clicking this button, the alarm message screen can be selected. All
alarm messages can be referred in this screen. When an alarm happens,
this button starts blinking in red.
(9) Tab Menu Selection
The following buttons allow you to select Tab Menu that is attached to each selected Job Menu.
・ TabUP (F11) Press this button to move up to select Ta
Tab
b Menu.
・ TabDOWN (F12) Press this button to move down to select Tab Menu.
(10) Indication message
Indication messages that will help your operations such as selection, input settings, are displayed.
(11) Login Level
Login level (L1 or L2 or L3 or EL) is displayed in this box.

1-21
Chapter 1 Overview
THIS PAGE IS
INTENTIONALLY LEFT
BLANK.

1-22
Chapter 2 Measurement Procedure
Chapter 2 Measurement Procedures

2.1 Prior Checking and Power On
2.1.1 Checking Prior to Work

Make sure that you check out the followings before measurement work.
1. Confirm that each discharge line (high or low level concentration of waste fluid used for WU, and
low level concentration of waste fluid used for the trough) and the overflow line or the pure water
supply line connect to the analyzer accurately (it means the right side of the
t he unit).
Each drain line should be placed in a sloping path and led to the waste equipment located in the
premises so as not to remain waste fluid inside the tube.
2. Confirm that the pure water supply line is in a condition that some pure water from the water
supply unit can be transferred
tr ansferred to the analyzer.
- The quantity of water supply: 18 liters or more per an hour
- The supply water pressure: 0.15 - 0.34 Mpa
3. Confirm that wash solutions (Wash-1 and Wash-2) are in full in each tank then each tube is
sufficiently inserted so as not to come out from the
t he fluid level in measurement operation.
High concentration of waste The right side of the unit

fluid used for WU
Low concentration of waste
fluid used for WU
External tank rack cable
connector
Low-concentrated waste
fluid line for Trough
High –concentrated waste fluid
line for ISE
Overflow Line
Pure Water Supply Line

Wash
Wash Solution Line
Wash-1
Wash
Wash Solution Line
Wash-2
2.1 Prior checking and Power On

2-1

4. The following checking is required to confirm as well if an ISE unit is added.
(a) Make empty
empty the waste
waste fluid tank for ISE (High concentrated w
waste
aste fluid). Then set the
the edge
of the ISE waste fluid line tube not to touch the surface of the waste fluid line for high
concentrated waste fluid tank.
(b) Make sure that each electrode w
within
ithin expiration date (Na, K, Cl) has been applied to the unit.
(c) Make sure that
that the Cal-A (Calibrant-A solution) in a pack has enough solution for the
number of the tests to be implemented.
i mplemented.
(d) Confirm that the Cal-A solution can be discharge
discharged
d from a small hall next
next to the
the sample port
when you try to do ISE prime
pr ime from 3 to 5 times.
(e) Note that the ISE calibrations must be implemented after the analyzer is power on. The setup
to calibrate about 2-points calibrator is available on the tab menu [Mainte (F10)] – [Sequence].
(See “3.6.3 [Sequence]” in “Chapter 3 Menu Details”)

2-2

2.1.2 External Tank Rack (optional)

(optional )
You can purchase a tank rack to set a tank for wash solution. This is an option.
The external tank rack is available to place both of the Wash solution-1 and Wash solution-2 (Wash-1/2)tanks
and the remaining wash solution of each tank is being monitored by a sensor attached to the rack. The sensor
will send out a warning signal to the analyzer when the solution of the tank goes under the regular amount.
Connect a sensor cable, detecting the liquid level of the high-concentrated waste fluid tank used for ISE, to
the external tank rack. Connect the edge of the sensor to the high-concentrated waste fluid tank used for ISE
as well.
External tank rack

Cable for connection between (Optional)
external tank rack and the analyzer
A detecting
detecting sensor for the liquid
level（high-conce
high-concentrated
ntrated waste
fluid tank ）
Wash-1 and Wash-2 tanks
Cable for connection between

external tank lack and the analyzer
A detecting sensor for the liquid level

(high-concentrated waste fluid tank)

2.1.2External
2.1.2External Tank Rack
2-3

2.1.3 Power ON
A) Power on the main unit
First you have to check that all electrodes and the Cal-A (Calibrant solution)
solu tion) has been set before turning
the power on.
The power on switch is attached to the right side of the analyzer.
LAN connector
PC ）
(connector for the operating PC）
Power supply switch
Power supply cable
The left side of the analyzer
B) Power on for printer

Turn on the power supply of the printer connected to the operating PC so that the printer will change a
ready status. Make sure that enough print papers are set in the printer as well.
C) Power on for operating PC

Turn on the power supply for the operating PC connected via a LAN connector of the analyzer.
Basically all the software has been installed in the analyzer designed as becoming a run mode
automatically after the PC turns on.
After the PC’s power on, the following pop-up message will be shown in the center of the screen as an
inquiry that whether you need to implement a preparatory mode that it fills pure water (or system water)
enough in an internal tank of the analyzer or the supply lines. (See the figure below.). This inquiry will not
happen in an automatic run by sleep mode, however. We strongly recommend you implement this
preparatory mode such as the completion of an analyzer
analyzer setting or before resumption of the analyzer out of
operation for a long time.

2.1.3 Power ON / 2.1.4 Power OFF
2-4
OK ： By clicking the button, a preparatory m mode

ode wwhich
hich ffills
ills pure water line or the wash solution lin
linee
inside of the analyzer will start. (About 8 minutes)
Cancel：
Cancel ：By clicking the button, a preparatory mode will be passed.
2.1.4 Power OFF

A) Shut down for the operating PC
To shut down your analyzer, click the Shut Down displayed in the upper-right corner of the screen so
you will see the following pop-up message. Next, choose one of the following modes for shutdown.
The Shut Down button is available on all screen modes.
(1)
(2)
(3)
Sleep： Selecting a Sleep mode

(1) Sleep：
By choosing this mode the analyzer will execute a pre-sleep process then turn into a sleep mode.
Therefore, you MUST NOT turn off the power of the analyzer when selecting this mode.
A sleep state is that all functions will stop except that cooling function for a reagent container unit
(RCU) and an Auto Sampler unit (ASP) for the analyzer will continue. The analyzer will resume in a
run mode, available for measurement, at the time specified sleep release in advance. (See the tab
menu [RUN (F5)] – [Sleep Scheme])
For choosing sleep modes, you have to register these “After Sleep” and “Sleep Scheme” on the
tab menu [RUN (F5)] – [Sleep Scheme] in advance then set up “Before Sleep” on a pop-up menu to
shift Sleep Mode from Shut Down.

2-5
ISE cleaning:
Specify the number of ISE cleaning times (0-5 times).
ti mes).
SPT Wash:
Specify the number of SPT cleaning times. Selecting “(W)” will execute SPT wash with system
water and “(S)” will be for wash solution. Wash solution should be registered on [Run (F5)] – [Std
QC] in advance.
The number can be chosen form 0 to 5 times and SPT wash will not be executed when the number
is “0”.
Note that you cannot select both “(W)” and “(S)”
“(S)” at the same time.
RPT1, 2 Wash:
Specify the number of RPT cleaning times. Selecting “(W)” will execute RPT wash with system
water and “(S)” will be for wash solution. Wash solution should be registered on [System (F9)] –
[Setup] in advance.
The number can be chosen form 0 to 5 times and RPT wash will not be executed when the
number is “0”.
Cuvette Fill:
Choose whether you fill cuvettes with system water, wash solution or none (not fill cuvettes).
Wash solution should be registered on [System (F9)] – [Setup] in advance.
Nozzle Wash:
Nozzle wash operation will be implemented
implemented in IRU cuvettes for 10 minutes.
Mix Wash:
Mix 1 / 2 wash operation will be implemented in IRU cuvettes for 10 minutes.

2-6
Even in sleep mode you can go to see any screens as you like because the mode will not affect the
operating PC. But note that the [Start (F1)] key for starting measurement and the [Mainte (F10)] key
for the job menu for each unit operation will not work as each unit of the analyzer is inoperative.
It is possible to return in a normal condition regardless of sleeping. By clicking on the Shut Down
button again for release. The pop-up massage confirming the release will be shown as below.
below. To click
the OK button inside of the message, the sleep mode will release.
Sleep：
- Before Sleep：
This is some preparatory event for the analyzer such as nozzle's cleaning before
transferring to a sleep mode. You need to set up those events at pop-up screen to shift
Sleep Mode from Shut Down.
Sleep：
- After Sleep：
This is prime and nozzle cleaning actions to be done for the analyzer when it returns
from a sleep mode (Wake up). You need to set up those actions at [Sleep Scheme] screen
on the job menu.
Scheme：
- Sleep Scheme：
This is a setting such as a wakeup time to be returned from a sleep mode and a
necessity to be done events after a sleep mode everyday (from Monday to Sunday). You
need to set up those actions at [Sleep Scheme] screen on the job menu.
(2) Power Off ：Selecting of A power-off mode.

By choosing this mode, the operating PC will start a process that makes all the analyzer equipments
turn off the power and after that it will shut down itself automatically.
Cancel：
(3) Cancel： Your selecting the Shut Down will be canceled.

2-7
B) Power OFF for the measurement equipment

(1) When selecting Sleep
After having completed some Before Sleep processes, set by the [Sleep Scheme] on the job menu,
the analyzer itself will be in a sleep mode. The current status will be shown in the upper left portion
of the screen so that you can watch the transitional condition of each process.
The following shows change of a Status on the left side of the top line of the screen as an example.
<A status shown in processing a “Before Sleep” (Shut Down click >
<A status shown in sleeping mode>
<A status shown in releasing a sleep mode (Shut Down click again >
(2) When selecting Power Off
Make the analyzer turn off after the completion of the end processes of software at the PC side.
Note that cooling function
f unction for the Reagent Container Unit ((RCU)
RCU) and Auto Sampler Unit (ASP) will
not be applied to this condition.
C) Power Off for the printer

Turn off the printer as appropriate.

2-8
2.2 Reagent Registration

It is required to register each reagent for measurements including wash solutions and dilute solutions iin
n
advance with measurements. Go to register its information in the tab menu [System (F9)] – [Reagent].
The list of the registered reag

reagents
ents Bottle information
Reagent Register Panel：[System (F9)]-[Reagent]
First, the bottle information of registered reagents and the list of registered reagents will be shown in
the screen. On the registered reagent list, a reagent list that is currently being registered will be seen on
the left side of the screen. It is available to delete its registration and change some information of the
reagent, by clicking any reagent codes or reagent names on the list. In this regard, you don’t need to click
inside of the list in the case of
o f additional registration.
Generally,, some white parts in the sscreen
Generally creen are a selecting or settings for input items available.
A reagent code consists of 5 digits (numerals only) and you cannot use following
follo wing codes.
Codes start from “000” and codes end at “00”.
You can select “Reagent bottle types” up to 3 types. Default types depends on “Default setting for
reagent bottle types” on [System]-[Setip2].

R egistration
29
2.2.1 Addition
<Additional registry procedures>
1 Enter a reagent
reagent code in 5 digits, which you want to add as new
new,, in the ““Reagent
Reagent Code” area.
2 Enter a new nam

namee within 6 digit aalphanumeric
lphanumeric characte
characters
rs in the
the “Reagent Name” area.
3 For the information for for the setting of th

thee first reagent bottle (R1), y
you
ou have to click the
“Enable” box of R1 and wait until it turns on. Register the amount of the bottle to be used from
“Reagent bottle types”. If you want to check the term of stability for this reagent bottle, click the
“Enable” box of the “Stability Check” then enter 2 numeric digits (from 0 to 99) as an effective
stability term in the
t he “Term” area.
4 For the information

information for the setting of the second reagent bottle (R2), y you
ou have to click the
“Enable” box of R2 and wait until it turns on. Register the quantity of the bottle to be used from
“Reagent bottle types”. If you want to check the term of stability for this reagent bottle, click the
“Enable” box of the “Stability Check” then enter 2 numeric digits (from 0 to 99) as an effective
stability term in the
t he “Term” area.
The start point for the stability check is the date registered reagent codes. This function will be
implemented in the tab menu [Run (F5)] – [Inventory], and as a result, part of the inventory of
the reagent that is no longer within the stability term
ter m will be displayed with yellow background.
5 For the information for the setting of the w wash

ash solution (or WWash),
ash), you have to click the
“Enable” box of Wash.
Wash. Then register the initial amount of the bottles to be used by 70 / 20 mL.
6 For the information

information for the sesetting
tting of the dilute solution (or Dil), you you have to click the
“Enable” box of Dil. Then register the initial amount of the bottles
b ottles to be used by 70 / 20 mL.
7 Save all the settings by clicking the Save button.
2.2 Additional registry procedures

procedures
2.2.1 Addition
2 10
2.2.2 Editing
<Editing procedures for the registered information>

1 By clicking
clicking a reag
reagent
ent code or a reagen
reagentt name in the registered list, the information of current its
bottle will be shown.
2 Enter the information of the bottle that y

you
ou want to change.
3 Save all the settings by clicking the Save bu

button.
tton.

R egistration
2.2.2 Editing
2-11
2.2.3 Delete
<Deletion of the registered information>

1 By clicking a reagent code or a reagent nam
namee in the registered list, the information of its current
bottle will be shown.
2 Click the Delete button.
3 The following pop-up message w will

ill be shown to reconfirm y your
our elimination command, so that
press OK if you can commit it. However
However,, it will become invalid to click the Cancel button.
2.2 Measurement Procedures

2.2.3 Delete
2-12
2.3 Settings for Chemistry Parameters

Parameters related to the assay conditions for measurements should be defined in advance to
measurement. You
You need to register those necessary parameters for measurements using some tab menu on
the job menu [Parameter (F6)]. The following table describes the outline of each tab menu.
[Parameter (F6)]
Setting Description
Tab menu
Method Number / Name, Sample
Samp le types, Output unit for concentrated value, Assay
Ty
Type,
pe, Measurement point, Measurement Wave Length, Amount of Sample dispensing,
[Normal] Amount of Dilute Solution, Amount of reagent dispensing,
dispe nsing, Normal Range, Technical
Technical
Range, and Stirring Speed
(See “3.2.1 [Normal]”in the “Chapter 3 Explanation of Menus”.)
Method Number / Name, Sample ttypes,
ypes, Limit Values
Values (Duality, Sensitivity, linearity,
linearity,
Prozone, Absorbance limit), Conditions for Blank Measurements (Application
( Application available
[Normal2] / unavailable, Application conditions, Reagent types, the number of measurement times,
Duality limit Values),
Values), Instrument Factor
(See “3.2.2 [Normal 2]”in the “Chapter 3 Explanation of Menus”.)
Sample Types,
Types, Dilute Solution name, Instrument Factor, Normal Range (Maximum
[ISE] and Minimum values per Na, K and Cl)
(See “3.2.3 [ISE)” in the “Chapter 3 Explanation of Menus”.)
Factors for blood serum information (from A to F), Amount of sample dispensing,
Instrument Factor, Reagent names, Amount of reagent dispensing, SI criteria
[SI]
(Hemolysis / Turbidity / Icterus)
(See “3.2.4 [SI]” in the “Chapter 3 Explanation of Menus”.)
Definition of Method to Method calculation
This value is a combination of several results produced from the measurement results.
The value is calculated based on some results that have been taken by some
so me type of
[Calc]
methods in real measurements and its calculation uses four arithmetic operations. The
produced value is used as another value of the real
real value.
(See “3.2.5 [Calc]” in the “Chapter 3 Explanation of Menus”.)
Definition of a profile
A profile is that is combined several measurement methods in a file. It is possible
poss ible to set
[Profile]
up to 20.
(See “3.2.6 [Profile]” in the “Chapter 3 Explanation of Menus”.)
Definition of Orders in Measurement Procedure
[Order] The definition of measurement order and print order
(See “3.2.7 [Order]” in the “Chapter 3 Explanation of Menus”.)
Definition of nozzle wash Program
This is to define cleaning for reagent nozzle in every measurement methods to prevent
[Wash] from being infected with the nozzles (RPT1 / RPT2), of which dispensing different
reagents used by a measurement method may cause contamination problem.
(See “3.2.8 [Wash]” in the “Chapter 3 Explanation of o f Menus”.)
2.3 Setting for Chemistry Parameters

2-13
2.3.1 Setting for Chemistry Parameters (1)

Before starting measurement, specify necessary parameters for measurement to select the tab menu
[Parameter (F6)] – [Normal].
[Parameter (F6)]－[Normal]
[Normal]
<Setting descriptions>
1 Specify the Method number and the Method Name.
Click the drop-down arrow on the list
box to display.
display.
Your choice for a method number and name is 3 types. One is that you move your cursor to
the center of the box then type a value directly; the other
ot her one is that you keep pressing tthe
he press
key to display the list and select one of the values, or the other is that you select one from the
drop-down menu. Choose one as appropriate.
The space key function list will be shown as a pop up at the center of the screen. (Refer the
figure on the next page.)

2-14
Space Key List
2 Specify a measurement n name

ame used for printing. If this print name is not inputted, the name
will be used in printing with the measurement name that was set in the Name section. The
name can use alphanumeric and signs within 15 digits.
3 Specify a sample category

category..

box to display.
display.
Select any one of types on the drop-down menu as a sample type: Common, Serum, Urine
or Plasma.
4 Type a measurement unit for concentration
concentration..
Specify a unit that will be added with the measurement results. Type a unit what you need
inside the box.
5 Specify an assay type.

box to display.
display.
Select “ Rate” or “End” from the drop-down menu for the assay
as say type.

2-15
6 Specify measuring points

Specify the measuring points from the measured time course data to evaluate a
concentrated value
The points can be selected from 1 to 68 on the drop- down menu.
Click the drop-down arrow

on the list box
bo x to display.
Specify a range for Measuring point-1.

Specify a range for Measuring point-2 to click the “Enable” check box.
Make sure that the range of measuring point is from 1 to 68, Start<=End, [Measuring
point-1]<[Measuring point-2].
7 Select a wa
wavelength
velength for Primary and Sec
Secondary.
ondary.
Click the drop-down arrow on the list box to

display available wavelengths.
Specify a Primary Wavelength and a Secondary Wavelength for measuring. The available
wavelengths are 12 wavelengths: 340 / 380 / 415 / 450 / 510 / 546 / 570 / 600 / 660 / 700 / 750 /
800. Click the “Disable” check box of the Sec. not to use a Secondary Wavelength.
8 Specify an amount of the sample. (See 10)

Three cases can be specified for the amount as a normal measurement, rerun for high value
measurement, rerun for low value measurement.
The setting for “Sample (µL)” and “Diluent (µL)” are unavailable when the Dilution check
box is OFF.
OFF.
Click those check boxes

to dilute.
Amount of the sample used for measurement An amount of the dilution

(An amount after mixing with dilution)
An amount of the sample for mixing with the dilution

2-16
9 Specify an amount of the primary (R1) and the secondary reagent (R2) for dispensing.
You can select Reagent Name from the pop-up list displayed by pressing the Space key where you
type in the box, or form
for m the drop-down menu. Available reagents, which are registered in the tab menu
[System (F9)] – [Reagent], will be displayed in any of those lists.
Click the “Enable” box of R2 to apply the secondary reagent (R2).

The range for R1 reagent consumption is from 20 to 350 μL (1 μL step) and that of R2 is from 20 to
250 μL(1 μL step).
μL step).
The range of dilution water is from 100 to 350 μL (1 μL
Note: You can specify aan n amount of pure water (or

( or system water) for diluting reagents for
both R1 and R2. However
However,, the total amount of the reagent and pure water, which will be
injected in cuvettes, comes to the dispensing amount for IRU’s cuvettes when you specify
the amount of pure water for reagent dilution.
The total volume (sample, R1 / R2 reagents, R1 / R2 dilution) used for measuring
should be between 150 and 450 μL.
Click the check box to apply R2 Specify reagent amount for measurement
Specify a reagent name Specify an amount pure water for

dilution when the reagent dilution.
10 Specify a Dilution
Specify the name used for a sample dilution to dilute it. Click the “Enable” box to be able to
specify a dilution name. The ways to specify like the previous section, you can choose from the
list by using the Space key or from
fro m the drop-down menu.
You can specify some amount of pure water to dilute an identified dilution with pure water.
Note: Be aware of the sample dilution (Item-8) if you register an amount of pure water of
reagent dilution. Therefore, the total amount comes to the sum of the dilution and pure
water.
Click the drop-down arrow on the The box is available to type an amount
list box to display
display.. of pure water to dilute the Dilution.

2-17
11 Specify a significant decimal point for measurement.

box to display.
display.
The range of number 0 to 5 can be chosen from the drop-down menu. For example, when you
select “2” as a decimal point, the concentration of your measurement result will be displayed to
two places of decimals.
12 Specify a Normal Range value.

By double clicking a box of Min and Max on the list,
l ist, you can change the value.
Those boxes can be able to change or modify

their value of Min and Max.
The Range Names from No.1 to No.6 are the fixed values. Refer the below.
1. Male-G1 ： Male Generation1

Go to register the range of each age to the tab menu
[System (F9)] – [Setup2]
4. Female-G1 ：Female Generation1
Numbers up to No.50 after No.7 can be defined
defined on the T
Tab
ab Menu [System (F9)] – [Range].
13 Specify a Tech
Technical
nical Range.
Here, you can specify the lower

lo wer and upper limit of the concentration as a Techn
Technical
ical Range.
The lower limit The upper limit
Concentration
Absorbance
The setting for absorbance is not here. Its setting is defined on the tab menu [System (F9)]
– [Setup2].

2-18
14 Specify a special wash for SPT nozzles.

Select one of wash solutions from the drop-down menu by clicking the “Enable” check box
to execute SPT nozzle wash.
box to display.
display.
Those solutions displayed on the drop-down menu have been registered on the tab men
[System (F9)] – [Reagent], and you can choose among them.
15 Specify a stirring speed.

Specify the stirring speed for the Mix-1, which R1 reagent and a sample is dispensed in
cuvettes.
Specify the stirring speed for the Mix-2, which R1 & R2 reagent and a sample is dispensed
in cuvettes.
Any of the stirring speeds can be selected

s elected from the drop-down menu.
Select one from

the drop-down
16 Click the Save button to save the editing parameter un

unless
less it has any problems.
Use the Cancel button to cancel the editing parameters.

Click the Delete button for deleting the method number of chemistry parameters that you are
selecting from the database.

2-19
17 This is a param
parameter
eter registration by using a copy function.
Parameters that are the same as the copy parameter except the Method, the Name and the
sample type can be registered to another method of the chemistry parameters.
Click the “Copy” check box (on the lower left corner of the screen)
When you click the Copy check box, the “Method”, “Name” and “Sample” parameters and the
Save and Cancel button will be available, and the others cannot be changed. All you have to do
is type your necessary information such as a measurement method number and its name, a
sample type then press the Save button so that the chemistry parameter will be registered as a
new one.
Change available

2-20
2.3.2 Setting for Chemistry Parameters (2)

A measurement condition like each limit value and a reagent blank is defined on the tab menu
[Parameter (F6)] – [Normal2].
[Parameter (F6)] - [Normal2]
1 Specify the method number, the method name and a sample category on the screen.
The method name that is registered on the tab menu [Normal] will be shown automatically
when you set the Method number. Select one of the categories from the drop-down menu:
Common, Serum, Urine and Plasma
The drop down menu

2.3.2 Setting for Chemistry Parameter (2)
2-21
2 Click the enable ch

check
eck box for the Duplicate Limit and define the valu
valuee to get the Duplicate
Limit check effective. This check will be effective only when a calibration measurement.
Enable check box
3 Click the enable

enable ch
check
eck box for the Sensitivity Limit and define
define the value to get the
Sensitivity Limit check effective. This check will be effective only when a calibration
measurement.
Enable check box
4 Click the enable check box ffor

or th
thee Linearity Limit an
and
d define its perce
percent
nt threshold value
value (%)
and absorbance limit (mAbs/10) to get the Linearity Limit check effective. This check will be
effective only for a rate method measurement.
Enable check box
5 Click the enable check box for the Prozone Limit and define its percent threshold value (%),
a choice of a judge direction (Upper/Lower), the first and last measurement point numbers of
the Slope-1, the first and last measurement point numbers of the Slope-2 and a sensibility limit
value in order to get the Prozone Limit check effective. Make sure that
t hat this check is not applied
to a calibration measurement.
Enable check box Prozone threshold value Judge direction (Upper/Lower)

(Upper/Lower)
The measurement rang of Slop-1

(SL1-S < SL1-F)
The measurement rang of Slop-2

(SL2-S < SL2-F)
Sensibility Limit
6 Click the enable check box for the Absorbance Limit and define its reaction trend (increase/
decrease) and its limit value (mAbs/10) to get the Absorbance Limit check effective. This
check will be effective only for a rate assay measurement.
box
Enable check box
Select a reaction trend
(Increase / Decrease)
Limit value setting

2-22
Select the type of blank measurement

7 Specify the Blank measurement.
from the drop-down menu.
Drop-down menu
- Disable
Disable rea
reagent
gent blank an
and
d S1 blank : It does not
not measure
measure a reagent blank and S1 blank.
By choosing this, item-8 ， 9 and 10 are unnecessary to
define.
- Enable S1 Blank (Factor or Linear) : It measures S1 blank.
- Enable reagent blank : It measures reagent blank.
- Enable reagent
reagent blank for S1 (Linear) : It takes the reagent bla
blank
nk result substitute for a S1 result.
8 Specify the measurement timing for reagent blank.
Select the measurement

timing from the drop-down
menu.
menu
Drop-down menu
- Daily : It executes any of the Methods that has not been measured for reagent blank in
a same day. The timing of measurement is anytime an unprocessed reagent blank
occurs.
method occurs.
- Next Run : It executes the reagent blank in every round.
- None : It does not measure any reagent blank. (Because a reagent blank in the past is
applied.)
9 Specify blank measurement method.
Select a measurement method

- Reagent blank (no sample) :It measures blank only with a reagent.
- Reagent blank (system water) :It measures blank with pure water instead of a sample.
10 Specify the number of reagent blank measurements.
Select the number of measurement

menu
Drop-down menu
- Single : It determines the value of the reagent blank by just 1time measurement.
- Duplicate : It determines the value of the reagent blank from 2 times of the measurement results.
- Triplicate : It determines the value of the reagent blank from 3 times of the measurement results.

2-23
11 Specify whether or not to need a Duplicate Limit check for the reagent blank measurement
and its limit.
Click the enable check box for the Duplicate Limit and define its response to get the
Duplicate Limit checks effective. This determines whether the result is duplication. After
ticking off the check box, enter its limit value in the box.
box
Enable check box
Input the limit in the box.
- In the case of a Duplicate, if both of the 2 measurement results are within its limit, it will
adopt its average.
- In the case of a Triplicate, if all of the 3 measurement results are within its limit, it will adopt
the center value of the results. It will adopt the average of the 2 results, which are within its
limit in the 3.
12 Specify an Instrument Factor.
In ut a slo e In ut an intercee t
interc
The measurement result of methods defined in this menu can be corrected with linear
equation to be consistent with other analyzers. You can specify its parameters (a slope and an
intercept) here.
13 Click the Save button to fix the setting on the menu.
・ Save : By clicking the button, the setting will be saved.

・ Cancel : By clicking the button, the setting will be canceled.

2-24
2.3.3 Setting for ISE Parameters
You can specify ISE measurement methods on the tab menu [ISE] in the job menu [Parameter (F6)].
[Parameter (F6)] - [ISE]
1 Specify a sam
sample
ple type and an ISE type.
- Note that you have to choose whether ISE or ISE(D) for ISE type when you select Common
for a sample type.
- When you select Serum or Plasma for a sample type, ISE will be automatically selected for
the ISE type.
- When you select Urine for a sample category, ISE (D) will be automatically selected for the
ISE type. The meaning of ISE (D) is that it executes ISE measurement using a sample
dilution.
Drop-down menu for

sample category
Drop-down menu for
ISE t es
2.3Ssetting for Chemistry Parameters

2-25
2 When you select ISE (D) for ISE type, you need to specify its dilution name.
The dilution name should have been registered on the tab menu [Reagent] in the job menu
[System (F9)]
Ty
Type
pe dilution name
Note: If any dilution names have been typed in

i n the box, you can choose a previous name from
the drop-down menu.
3 Specify a value for Normal Range.

Double-click any part of the Na-Min, K-Min and Cl-Min cells for the lower Limit and the
Na-Max, K-Max and Cl-Max cells in the box to change
change its value.
You can correct or change the Min and Max value on the list.
The Range Names from No.1up to No.6 are the fixed values. Refer the below
belo w.
1. Male-G1: Male Generation1
2. Male-G2: Male Generation2
3. Male-G3: Male Generation3 Go to define the range of each age to the tab
4. Female-G1: Female Generation1 menu [Setup2] in the job menu [System (F9)]
(F9) ]
5. Female-G2: Female Generation2
6. Female-G3: Female Generation3
4 Define an Instrument Factor

Here you can calibrate your results, each Na, K and Cl, with a linear equation
equation in order to be
consistent with the results of other analyzers. You can define parameters for the calibration (a:
Sloop, b: Intercept).

2-26
5 Click the Save button to fix the setting parameters in the menu.
menu.
・ Save : By clicking this button, the setting parameters will be saved.

・ Cancel : By clicking this button, the setting parameters will be canceled.
・ Print : By clicking this button, the setting parameters will be printed out.
However, this button should be available to click.

2-27
This page is intentionally left blank.

2-28
2.3.4 Setting for Serum Information (SI) Parameters

You can specify serum information parameters for a measurement and judgment condition, on the
tab menu [SI] in the job menu [Parameter
[P arameter (F6)] (See Chap 3 “3.2.4 [SI]”).
All necessary parameters for SI measurement are defined correctly and then selecting SI
measurement on the tab menu [Selection] in the job menu [Run (F5)] will be available.
[Parameter (F6)]－[SI]
1 Specify a reagent type. Click the arrow to display the
drop-down menu.
Specify whether “R1” or “Dil” for a reagent type, from the drop-down menu
2 Specify a reag
reagent
ent name
name aand
nd its dispensing amount.
Enter a reagent name Enter an amount of reagent dispensing
You can select a reagent name from the list displayed by pressing the Space key where you
type in the cell box, or from the drop-down menu. Note that the reagent names you will choose
should have been defined on the tab menu [Reagent] in the job menu [System (F9)]
(F9) ] beforehand.

2.3.4 Serum Information SI Parameters
2-29
3 Define a Factor value.

Specify Factor A to F each (The range: 0 -999999).
4 Specify an amount of dispensing for the sample
Set sample’s dispensing amount
5 Specify the range for judgment.
H0 < 100
100 ≤H1 < 110
The judge range 110 ≤ H2 < 120

(Hemolysis)
120 ≤ H2 < 130
H4 > 130
L++ < 150
150 ≤L+ < 160

The judge range 160 ≤L+- < 170
(Turbidity)
170 ≤L- < 180
L-- > 180
I+++ < 200
200 ≤I++ <210

The judge range
(Icterus) 210 ≤I+ <220
220 ≤I+- <230
I- > 230
Max 5 letters available for judgment signs
Judgment value (0 –999999 available)

2-30
6 You can specify an Instrument Fac

Factor
tor
The measurement result in each Hemolysis (or H), Turbidity (or L) and Icterus (or I) can be
consistent with that of other analyzer so that the result can be calibrated with a linear equation.
You can specify those parameters (a: gradient / bb:: intercept).
5 Click the Save button to fix the setting parameters on this menu.
menu.
All necessary parameters for SI measurement are defined correctly and then selecting SI
measurement on the tab menu [Selection] in the job menu [Run (F5)] will be available.
・ Save :By clicking this button, the setting parameters will be saved.
・ Cancel : By clicking this button, the setting parame
parameters
ters will be canceled.
canceled.
・ Print : By clicking this button, the saved parameters can be printed out.
Note, this button should be available to click.

2-31
2.3.5 Definition of Method-to-Metho

Method-to-Method
d Calculation
Method to Method calculation is a combination of several measurement produced from the measurement
results. The value is calculated based on some results that have been measured and you can use it as if another
one. You can define the method on the tab menu [Calc] in the job menu [Parameter(F6)]. (See Chap 3 “3.2.5
[Calc]”).
2.3.6 Definition of Profile
You can define several mesurement items in a file. This is called a “Profile”, and it is possible to define 20
files per a sample. The registration way for this, go to the tab menu [Profile] in the job menu [Parameter(F6)].
(See Chap 3 “3.2.6 [Profile]”).
2.3.7 Setting for Measurement Orders
You can define a measurement order and a result printing order on the tab menu [Order] in the job menu
[Parameter (F6)]. (See Chap 3 “3.2.7 [Order]”)
2.3.8 Definition
Definiti on of Nozzle Wash Program
Reagent nozzles (RPT1 or RPT2) mutually used over different methods may cause infection trouble. To
avoid this, you can define nozzle wash program on the tab menu [Wash] in the job menu [Parameter (F6)]. This
program will be processed in measuring so that the throughput of this measurement may be affected,
affected, indeed.
(See Chap 3 “3.2.8 [Wa
[Wash)”)
sh)”)
Method A Reagent Nozzle Wash Method B
Dispensing Reagent Dispensing Reagent

(RPT1 or RPT2) (RPT1 or RPT2)

2.3.5 Definition of Method to Method Calculation / 2.3.6 Profile Defenition /
2.3.7 Define Measurement Order/ 2.3.8 Define Nozzle Wash Program
2-32
2.4 Placement for Reagent Bottles (RCU)

Before starting measurement, place all necessary items such as reagents, dilutions, and wash solutions
on the tray in Reagent Container Unit (RCU).
The bottle types are 100 / 70 50 / 40 / 20mL. You can put 30 bottles of 100 / 70 50 / 40 / 20mL types in
total on inner side and 30 bottles of 20mL types on outer side.
This reagent tray can be removed from the RCU.
Bottles can be placed in any slots on the RCU’s tray but they need to be registered beforehand. (See
Chapter 2 “2.2 Reagent Registration”)
An analyzer distinguishes bottles on the RCU’s tray by reading barcodes attached on the bottles. In
addition, it needs to know all the information of reagents placed on the RCU’s tray (reagent types, reagent
remaining, bottle type etc) before the measurement; therefore Reagent Scan process should be performed.
(See Chapter 2 “2.9 Confirmation of Reagent Remaining V
Volume”)
olume”)
2.4.1 Sequence Procedures for Bottles

1 Place some bottles horizontally on an empty slot ooff the RCU’s tray.
2 Set the reagent try you placed some bottles inside of RCU in the analyzer
analyzer..
3 Turn the reagent tray slowly and make the guide pin fit.
Reagent Tray
Guide pin
4 Detach the lid of the bottle you placed.

5 Set the lid of RCU.
2.4 Placement for Reagent Bottles

2.4.1 Sequence Procedures for Bottles
2-33
2.5 Calibration Setting
For converting the absorbance of the measurement result into a concentrated value, the analyzer needs an
approximation formula. Therefore, it will get the approximation formula to calculate from Standard sample (or
Calibrator) that has a previous concentrated value. Standard sample usually consists of a concentrated value below
7 types. This result, an approximation formula,
for mula, is needed to all measurement methods and the value should have
been prepared in the analyzer

analyzer in advance with measurement.
A regulatory calibration for each method is fundamentally required to implement a stable measurement. This
analyzer has a function that can set an expiry for a calibration in order to guarantee the regulatory calibration
updates. Moreover, the analyzer has another function that
t hat can check its expire date of the calibrator.
The calibration types are;
- Full-calibration
This is to get a calibration curve, using all necessary calibrators.
- Re-calibration (Partial calibration)
This is to calibrate the current calibration curve, measuring only a necessary calibrator.
There are 2 types as you see on the above.

As a result of a calibration measurement, the result can get 2 types of calibration curves as followings.
- Master
This curve is resulted in a full calibration measurement and it will also go to the Work result.
- Work
This curve is a curve that resulted in a re-calibration and it is corrected with a Master.
This Work curve is used for converting a sample (including control measurement) into a concentration
value.
The calibration result that was measured by reagent sets (R1/R2)

( R1/R2) of different lot number can be saved as “New”
and “Old” areas. You
You can use both by switching as approp
appropriate.
riate. (Lot numbers are available up to 2 types)
2.5.1 Calibration
Calibrati on Curve Type
As a calibration type, 5 curves can be selected among the following.

(1) Factor: equation in the system. An intercept
An operator should set a gradient value of a linear equation
value can be calibrated to measure a standard sample (SI).
(2) Linear: This is to get a linear equation
equation from the measurement results of various standard
samples.
(3) Point To Point: This is to get a linear equation for each measurement point from the measurement
results of various standard samples.
(4) Log-Logit: This is to get a log formula from the measurement results of various standard samples.
(5) Spline: This is to get a spline curve approximation formula from the measurement results of
various standard samples.
(6) Exponential: This is to get an approximation formula of an exponential function from the
measurement results of various standard samples.
2.5 Caribration Setting

2.5.1 Calibration Curve Type
2-34
2.5.2 Calibration Registration / Setting
You can define calibration parameters that you need for measurements on the tab menu [Reg Calib] in the job
menu [Calibration (F7)].
[Calibration (F7)] - [Reg Calib]
<Setting Descriptions>
1. Specify both of a Method number and a Method
Method Name
Name..
There are 3 types of specifying a Method number. One is to input it directly in the cell by making the key
cursor move where you input, the other one is to choose one of the values from the list displayed by
pressing the space key and the other is to select one fro
fromm the dr
drop-down
op-down list. All three are possible so you
can select one as applicable. (Note: This is the same as “2.3.1 Chemistry Parameter Setting (1)”) The
method name added with related to its method number will be shown automatically.
2. Specify a sample category to apply
apply..
Choose one from Common / Serum / Urine / Plasma,
P lasma, shown by the drop-down list.
3. Specify the number of measurements
measurements for
for a calibrator.
Choose the number from the drop-down list.
- Duplicate: This function executes duplicate measurement, and it takes its average for a measurement
result.
- Triplicate:
Triplicate: This function executes triplicate measurement, an
and
d it takes its median
median value for a
measurement result.

2.5.2 Cariblation Registration /Setting
2-35
4. Specify a stability term for a calibration.

To get a stable and precision measurement, a calibration curve modifying with some regular intervals is
preferable. Input an expiry term (days: 0- 99) for the reason.
The expiry term check will not be executed when you set 0 days
d ays for the term.
This check detects any method names which have past their expiry date from the latest calibration
measurement, and it makes them turn red on the Test Selection screen ([Run (F5)] – [Selection]). In
addition, a “CTO” flag will be added for the result of the sample measurement.
1 Method Number
3 The number of calibration measurement
2 Sam le T e
4 The calibration’s expiry terms
5 Automatic measurement condition
6 Type of automatic measurement
10 Reagent lot (New/ Old)
9 Material name 7 Time interval for automatic measurement
8 Calibration type
5. Specify an automatic measurement condition. (See note.)

Choose either “Change Lot” or “Timeout” by the drop-down list.
- Chang Lot: When the lot number of reagent for the calibration is changed, the calibration
measurement can be automatically executed.
- Timeout: When the times are passed over the specified interval time in the “Auto Interval”,
the calibration measurement can be automatically executed.
6. Specify the type of au
automatic
tomatic mmeasurement.
easurement. (See note.)
Choose one type from Blank/ One/ Two/ Full Calibration by the pull-down list.
-- Blank:
One: Blank measurement
One-point calibration
- Tw
Two:
o: Tw
Two-point
o-point calibration
- Full Calibration: Full ccalibration
alibration
7. Input the time interval for automatic measurement of calibrator.
calibrator. (See note.)
This setting becomes available when the “Timeout” is selected as the automatic measurement condition.
8. Specify a calibration type. (See note.)
Choose one type from Factor / Linear / Point To Point / Log-Logit / Spline / Exponential, shown by the
drop-down list. (See item-12 later discussed, when you select Factor.)
Note: The function of automatic execution for calibration measurement

measurement is applied only when the
calibrator(s) is/are placed in the innermost slot (#I01 to I20) of ASP. (Refer to “2.7.2 Special Test
Selection”.)

2-36
9. You ca
can
n input a calibrator material name. (W
(Within
ithin 8 alphanumeric)
10. Select either “New” or “Old” for th thee reag
reagent
ent lot.
This is used for a partial resetting for a calibration that has been measured, or for a calibration switching
to apply another one.
The meaning of “New” and ”Old” is that the calibration results of which reagent lot numbers are
different can be administrative as 2 types.
(a) The first ccalibration

alibration result using reagent lot number N1 will be stored in “New”.
(b) The second calibration
calibration result u
using
sing reagent lot number N2 w
will
ill be stored in “New” and the first
first result
will be transferred to “Old”.
(c) After the third result, a result using a calibration result whic
which
h is diffe
different
rent from “New” or “Old” one
will be executed as same as a (b) process. However, a result using the same lot number as “New” (or
“Old”) one will be overwritten it to its area which is stored, and also its time-stamp is renewed.
Depending on time-stamp, the name of “Old” (or “New”) is changed to “New” (or “Old”).
11. Input a concentration of each standa

standard
rd sample (Calibrator). Max 7 samples are possible to set.
This setting must be defined before calibration measurements.
But, when selecting “Factor” as a case of calibration curve type, you don’t have to deal with this setti
setting.
ng.
12. The absorbance
absorbance result of calibration m
measurement
easurement w
will
ill be displayed.
Work: At Full-calibration, the value will be shown same as Master’s
At Re-calibration, the only Work will be updated.
Master: The result of Full-calibration w
will
ill be display
displayed.
ed. In aaddition,
ddition, those absorbance
absorbance values can be
edited except “Factor”.
13. You cacan
n input
input the lot number of a normal samsample
ple (Calibrator).
It is effective that a calibration type is Linear / Point
Po int To Point / Log-Logit / Spline / Exponential.
But, when selecting “Factor” as a case of calibration curve type, you don’t have to deal with this setti
setting.
ng.
By clicking this check box, the same lot number S1 you

entered is applied to from S2 to S7.
12 Absorbance value for calibration 13 Lot number for standard samples

11 Concentration for standard
sample result.

2-37
14. In case of only selecting ““Factor”

Factor” for a calibration curve type, the cells for K-Factor will be displayed.
displayed.
For Point To Point, Log-Logit, Spline, Exponential, those cells will not be displayed.
Also, next to K-Factor, blank measurement check box “ON” or “OFF” on the tab menu [Normal2] of the
job menu [Parameter (F6)] will be indicated. (See chapter
chapter 2 “2.3.2 The setting chemistry Paramete
Parametersrs (2)”)
14 Type the K-Factor, only when you select” Factor” as a

calibration type. (-99999.999 to 99999.999)
Applicable to “Factor” and “Linear”; Applicable to only “Linear”;
: will execute S1 blank measurement : The reagent blank is defined as S1.

(You don’t have to set s1 to ASP at calibration
: will NOT execute S1 blank measurement. measurement.)
15. After the

the completion of selecting or inputting the necessary parameters for calibration, click the Save
button. This action makes all the settings effective.
effective.
The Print button for printing calibration parameters will be available after the save action.
16. The reagent lot number (R1 or RR2)

2) used for calibration measurement w
will
ill be displayed.
If there is any information of a lot number on the barcode label attached on a reagent bottle, its number
will be displayed. As you switch “New” and “Old”, this lot number will change consistently. (See item-
10.)
17. The date and time exe
executed
cuted a full calibration will be shown (yyyy / mm / dd hh:mm)
As you switch “New” and “Old”, this date and time of measurement will change consistently. (See item-
10.)
18. A graph of s calibration result will be sh
shown.
own.
On the graph chart, the red line shows the Full-calibration result and the blue line shows Re-calibration.
The horizontal axis is concentration and vertical is absorbance.
absorbance.
19. The latest reagent blank measurement
measurement (mAbs/10) its m
measurement
easurement date (yyyy / mm / dd hh:mm) will be
shown.
20. The latest S1 blank measurement (mAbs/10) its measurement
measurement date and and time (yyyy / mm / dd hh:mm) will
be shown. When the calibration type is “Factor” and “Linear”, it is available.
21. This will

will be able to simulate a concentration
concentration conversion.
This simulator enables to convert an absorbance into a concentration, using the current calibration curve.

2-38
Ty
Type:
pe: Select either “Master” or “W
“Work”
ork” as an applicable calibration curve.
Absorbance: calibrated.
Type an absorbance value that will be calibrated.
Conc: A concentration value after converting will be displayed.
Recalculation : By clicking this button, a converting calculation starts.
16 Reagent Lot Number 17 Calibration measurement date and time
08/10/2008 11:24
18 Calibration graph
19 Reagent blank and its

measurement date and time
20 S1 blank and its measurement date and time

21 Concentration converting simulator

2-39
2.5.3 Serial Dilution Setting

By auto diluting of a standard sample that is the maximum concentration, the analyzer produces some
standard samples and executes calibration measurement, called this serial dilution.
This fuction can automatically caluculate an appropriate amount of dilution relevant to necessary each
standard sample on tab menu [Serial Dilu] of the
t he job menu [Calibration(F7)].
By specifying the Method number on the screen, it will get a right dilute concetration, which is relevant to
other standard samples, from maximum standard samples defined on the tab menu [Reg Calib]. (See Chapter 3
“3.3.2 [Serial Dilut]”)
2.5.4 Multi Standard Setting

This can be alocated some method to a standard sample. We call this “Multi Standard”. In advance to
calibration measurement, define “Multi Standard” samples on the tab menu [Multi-Std] of the job menu
[Calibration (F7)] (See Chap 3 “3.3.3 [Multi-Std]”)
2.5.5 Confirmation of ISE

ISE Calibration
Calibration
For confirmation of ISE calibration result, go to see the Tab Menu [ISE] of the [Calibration (F7)]. (See
Chapter 3 “3.3.4 [ISE)”)
2.5 Calibration Setting

2.5.3 Serial Dilution Setting / 2.5.4 Multi Standard Setting /
2.5.5Configuration
2.5.5Configuration of ISE Calibration
2-40
Chapter 2 Measurement procedure
2.6 Confirmation of System Parameters

A variety of condition settings for the whole system can be set as the system parameter by job menu
[System (F9)]. When you execute the daily measurement work, the various settings and the definitions as
the system parameters must be executed in advance.
There are the following tab menus for setting of the system parameters.
(1) Setup: System settings

(2) Reagent: Registration of Reagent information (Refer to Chapter 2 “2.2 Reagent
Registration”)
(3) Login: Login with password and Confirmation of software versions
(4) Backup: Backup of data
(5) Setup2: Definition of range of Techn
Technical
ical Range
(6) Define: Definition of Patient Information basic data
(7) Range: Definition of Normal Range name
It is recommended that the backup of the system parameter and the measurement data be executed
regularly to prepare for unexpected problems.
Refer to Chapter 3 “3.5 System Menu” for the specific content and the setting
settin g method of tab menu.
2.6 Confirmation of System Parameters

2-41
2.7 Test Selection Setting

The measurement schedule about which Method is executed to each sample is necessary before the
measurement of samples is executed. This measurement schedule is called “Test Selection” or “Test Order”.
Unique sample ID numbers are added to the all samples (Patient sample, Standard sample, Control sample,
Blank sample) placed in ASP and the ID number identifies them. Therefore, Test Selection is to define about
which Method is executed to each sample.
<Sample Barcode Management>

The Auto Sampler Unit (ASP) has a barcode reader as standard equipment. Therefore, if the barcode
labels that have the barcode information of the sample ID number are stuck and are read with the ASP
barcode reader, it can
can be automatically recognized which
which slot position in the ASP the sample is at. Therefo
Therefore,
re,
you only have to define the relation between the sample ID number and the Method about the test selection
in this case.
<Sample Barcode non-management>

When there sample ID barcode management is not applied, the relation between the sample ID number
and the Method should be defined as Test Selection Setting after deciding about which ASP slot the sample
which has certain sample ID number is in.
This system responds to both of Sample Barcode Management and Sample Barcode non-management.
Test Selection Setting is done basically by the Menu [Run (F5)] - [Selection]. However, Standard sample,
Multiple standard sample, Dilution standard sample, Control sample, Blank sample, ISE wash solution and SPT
wash solution except Patient sample can be placed at installation slot only
onl y for sample cup (the slot number I0
I011 to
I20) in the innermost circumference block in ASP. This innermost circumference block has the cold insulation
function to prevent the liquid in cups from evaporating and its inside is kept 10°C or less for cold insulation. The
samples placed in that area is the Sample Barcode non-management. Test Selection Setting for the innermost
circumference block is done by tab menu [Run (F5)] – [Std QC]. (Refer to “2.7.2. Special Test Selection: [Run
(F5)]-[Std QC]”)
When you place a sample cup in the ASP slot# I01 to I20 for a long time without applying, it is recommended
to wrap proper waxed paper around the cup to protect evaporation and condensation for the liquid.
<The execution sequence of test selection>

The execution sequence of test selection is as follows.
First the content of tab menu [Std QC] is executed and then the content of tab menu [Selection] is executed.

2-42
2.7.1 Normal Test Selection:[Run

Selection :[Run (F5)]-[ Selection]
Selection ]
SID List
List
Display area of Ordinary Method
Display area of ISE Method
Display area of Profile
The background color of warning for Method display (Ordinary Method and ISE Method) is shown in
the table below.
Method
Priority background Meaning of warning notice
color
High Red The calibration

the time limit ofmeasurement has
calibration has not been executed or
passed.
The control measurement has not been executed or
Middle Yellow
the time limit of control has passed.
The method is not executable because its method is set
--------- Dark Gray on the mask. Refer to “2.7.1.9 Mask Setting” to release
the mask condition.

2.7.1 Normal Test Selection: [Run (f5)]-[Selection]
2-43
2.7.1.1 Normal Sample (Normal)
Measurement will be proceeded in ASP position order.
<Order setting procedure>

1 Specify the ASP slot number to place the sample.
In the case of Barcode Management : Select “Blank” without the slot number.
In the case of Barcode Non-management : Select the slot number from drop-down
dro p-down menu.
outer circumference 36 (1 to 36),
middle circumference 36 (37 to 72)
2 Select “Normal” as the sample type from drop-down m menu.
enu.
3 When using the barcode reader for the keyboard, clic
click
k this “BCR” box ON.
4 Select the type of the sample cup.
Select either “Normal”or “Pediatric” from drop-down menu.
However, The selection of “Pediatric” becomes effective only for Normal samples or Emergency samples.
5 Set the sample ID number (SID)
When making high-order digit the fixed number, defining can be done by tab menu [System (F9)] –
[Setup] in advance. After defining, you have only to input low-order digit. However, that becomes
effective only when “Normal” of sample cup has been selected.
When “Pediatric” has been selected, inputting the SID number of four digits becomes possible and
“8999” of upper 4 figures is automatically added. (Refer to “1.4.2. Sample Identification Code”)
As the default, SID number is automatically produced, that SID number is same as the designated ASP
slot number in “Pos”. (In the case of barcode non-management.)
6 Set the Patient ID num
number.
ber. Selecting ones have been set by tab menu [Patient] from the drop-down menu
is possible. When PID number is inputted into the “PID” box, if its PID is not registered in advance, the
pop-up screen for definition of patient information is automatically popped up to determine the patient
information, and its pup-up screen is disappeared after completing the definition. (Note: The pop-up screen
is very close to “3.5.6 [Define]”.)
7 When being still Normal sample and treat as the Emergency sample(STAT), click this “E” box
(Emergency sample specification) ON.
8 Set a drawing blood date from the calender by pulling down the drop-down menu.
1 ASP Slot number 2 Sample type 3 Keyboard BCR 5 Sample ID number 6 Patient ID number
4 Sample cup type 7 Emergency sample specification 8 Drawing blood date

Normal Sample (Normal)
2.7.1.1 Normal Sample
2-44
9 Select th
thee sample category. Selec
Selectt Common or Serum or Urine or Plasma from drop-down menu.
10 Select th
thee type of normal range taht is the evaluation standard of measurement
measurement result.
Default is “Human Auto”.
Human Auto means that the type of the normal range is automatically selected from the sex and the age
of the patient which was set by tab menu [Patient] and the judgment is performed by that reference value.
However, when the age of the patient is uncertain, it is treated as the middle generation (G2).
11 Select Doctor name anandd Place and Sample Comment from each drop-down menu. It is necessary to set
these information beforehand. When they have not been set, the drop-down menu is blank. These setting
information is added to the printer output of the measurement result.
9 Sample Categories 10 Normal range type 11 Doctor name, Place, Sample comment
SID List
Note:
When both type of Samples, with and
without barcode, are mingled
mingled in the SID list,
the sample with barcode is displayed at the
end of SID list without number of “Pos”.
12 Method (Ordinary item) 13 Measurement number of times
12 Specify the Method. When clicking the box on the left side of Method Method name ON, taht Method is orderd.
ISE and the profile are in the lower
lo wer part than the display area of the Ordinary Method.
13 Specify th
thee measurement number of times to the Method from drop-down menu of the “Number” box.
Default value is once. Allowable range is 1 ~ 99. When this repetition measurement number of times is two
or more, the rerun is not executed (when being outside the technical range and outside the prozone check
range, the rerun becomes the object).
14 Then fixing the

the setting contents, click the Save button in the lower part of screen. After
After fixing them, the
ASP sample position number and its Sample ID number (SID) are displayed in Order list on the left side of
screen. In the case of the Barcode management sample, the ASP sample position number is blank. Execute
from the procedure-1 when continuously executing the Test Selection of another sample.
After saving the setting contents, SID number is automatically counted up byb y one.
14 Setting save button

2-45
<Order Copy Procedure (in the case of the barcode management)>

After proceeding the procedures-13;
15 When wanting to apply the present content of the test order to two
two or more sample IDs, click the “C/D”
box ON.
16 Input the copy final sample ID number.
17 Click the Save button. The presen

presentt test order is continuously set to the final sample ID.
15 Copy Function ON 16 Copy Destination Final sample ID number

20 Group Delete Function ON 21 Delete Final sample ID number
18 SID List

2-46
<Order Copy Procedure (in the case of the barcode non-management)>

After proceeding the procedures-13;
15 When wanting to apply the present content of the test order to two
two or more sample IDs, click the “C/D”
box ON.
16 Set ASP slot number of the copy end sample or input the copy destination final sample ID number.
When the copy end slot number is set, the present test order will be automatically copied between the
copy source slot number and the copy end slot number. The setting box for the end sample ID number of
copy destination becomes unavailable.
When the sample ID number of the copy end is inputted to its box, the present test order will be
continuously copied until the end sample ID number of copy destination.
17 When click the Save button, the copy of the order is executed.
4. Copy source Sample position 16. Copy end sample position 15. Copy function ON
21. Delete beginning sample position 21. Deletion end sample position 20. Group Delete function ON
18 SID List
16. Copy Destination Final

sample ID number

2-47
<Deletion Procedure of Order>

18 The SID numbers of all samples set in A ASP
SP such as current Normal sample, Standard sample,
sample, Control
sample, etc. are displayed in “SID List” on the left of
o f the screen.
19 When deleting the orders of all samples, click the Delete All button.
When delete the order of a specified sample, click the sample ID number (SID) or the patient ID number
(PID) in the order list and then the order state of its sample (Method) is displayed, and so click the Delete
button after confirmation.
20 When deleting the orders of a group of sample IDs within the range, click the “C/D” box ON.
21 In the case of the barcode management sample, input the Delete final sample ID number. (See page 2-46.)
In the case of barcode non-management sample, set the Delete beginning slot number and the Deletion
end slot number in the lower “Pos” part. (See
( See page 2-47.)
22 Click the Delete button. 19/22 Delete button
23 When click
clicking
ing the Delete or De
Delete
lete All button, the sample IDs to delete are deleted from the order list on
the screen, and the screen becomes in the status to wait clicking the Save button or the Cancel button.
When clicking the Cancel button, deletion becomes invalid and the former state returns.
When clicking the Save button, the following alert messages is displayed at the center of the screen by
the pop-up to confirm the deletion execution. When actually executing deletion, click the OK button.
When invalidating deleting, click the Cancel button.
message for Delete
message for Delete All

2-48
2.7.1.2 Emergency Sample (STAT)

(STAT)
Measurement will be proceeded in ASP position order same as normal sample.
<Order setting procedure>
1 Specify the ASP slot number to place the sample from drop-down menu. (1 ~ 72)
2 Select ““STAT”
STAT” as the sample ty
type
pe from drop-down m
menu.
enu. These are same as
“2.7.1.1 Normal
Sample (Normal)”.
3 When using
using the
the bar-code reader for the keyboard, click this “BCR” box ON.
4 Select the typ of sample cup. (This is similar to Procedure of Normal sample-4)
5 Set sample ID number. Input the numeric code of 3 digits.

When Normal has been selected as the Sample cup, “99000” of upper 5 figures is automatically added.
When Pediatric has been selected as the Sample cup, the numerical value of 2 digits can be input as
Sample ID number and “990009” of last 6 digits is automatically added. (Refer to “1.4.2 Sample
Identification Code”.)
As the default, SID number tht is same as the designated ASP slot number in “Pos” is produced
automatically to save the operator’s labor.
6 Set the Patient ID number (PID). (This is similar to Procedu

Procedure
re of Normal sample-6)
Procedure of Normal sample-7 doesn't exist in the case of Emergency
E mergency sample.
The same procedures as from procedure-8 to procedure-13
p rocedure-13 of Normal sample are applied in the case of
Emergency sample.
5. Sample ID number
This is similar from

<Order copy procedure > ( In the case of Barcode Management) > Setting Procedure-14 to
Setting Procedure-22 of
<Order copy procedure > ( In the case of Barcode Non-management) > “2.7.1.1 Normal Sample
<Delete procedure of order> (Normal)”.

2.7.1.2 Emergency Sample (STAT)
2-49
2.7.1.3 Replicate Sample (Replicate)

< Order Setting / Delete Procedure >
1 Specify the ASP slot number to place the sample.
In the case of Barcode Management: Select “Blank” without the slot number.
In the case of Barcode Non-management:
Non-management: Select the slot number from drop-down menu.
outer circumference 36 (1 ~ 36),
middle circumference 36 (37 ~ 72)
2 Select “Replicate” as the sample type from drop-down me
menu.
nu.
3 When using the barcode reader for the key
keyboard,
board, click this “BCR
“BCR”” box ON.
4 Specify the sample ID number. Inputting the numeric value of 2 digits is possible and “9400” of upper 4
figures and “01” of last 2 digits are automatically added. (Refer to “1.4.2. Sample Identification Code”).
As the default, SID number is automatically produced, that SID number is same as the designated ASP
slot number in “Pos”.
5 Select sample
sample category. Select Common / Serum / Urine / Plasma from drop-down menu.
6 Select the type of the normal range taht is the evaluation standard of the measurement
measurement result. Default
Default is
“Human Auto”.
Human Auto means that the type of the normal range is automatically selected from the sex and the age
of the patient set by tab menu [Patient] and the judgment is performed by that reference value. However,
when the age of the patient is uncertain, it is treated as the middle generation (G2).
7 Specify the Method. When clicking the box on the left side of MethMethodod name ON, that Method is ordered.
ISE and the profile are in the lower part than the display area of the ordinary Method.
8 Specify the measurement numbe
numberr of times to the specif
specified
ied Method from drop-down menu of the
“Number” box. Allowable range is 1 ~ 99. In case of Replicate sample, auto-rerun is not available.
1.ASP Slot Number 2 Sample Type 3 Keyboards BCR 4 Sample ID Number
5 Sample category
6 Normal Range type
SID List
Note:
When both type of Samples, with and
without barcode, are mingled
mingled in the SID list,
the sample with barcode is displayed at the
end of SID list without number of “Pos”. 7 Method list（ Normal Method） 8 Measurement number of times
9 Click the Save button in the lower

lower part of screen to fix setting contents. When
When fixed, in the case of the
sample of Barcode Non-management, the ASP Sample position number and its Sample ID number (SID)
are displayed in “SID List” in the left side of the screen. In the case of the sample of Barcode
management, the ASP Sample position number is the blank. Execute from the procedure-1 when
continuously doing Test Selection of another sample.
After saving the setting contents, SID number is automatically counted up by one.

2-50
10 When Delete,
Delete, Click the SID number that shows Replicate sample in “SID List” and click the Delete
button. Specified sample will be delete from the list on the screen, and click the Save button next. Alert
message of deletion confirmation
“Warning ! Is it all right if the specified order is deleted ?”
is displayed at the center of the screen by the Pop-up. Executing delete, click the
the OK button.in the Pop-up
message.
10 Delete button 9 Setting save button

10 Delete determination button
<Order Copy Procedure>

11 When applying the order of the present sample ID number (SID) to the other sample ID, after setting
sample ID number of “SID” part by Procedure-4, click the “C/D” box ON.
12 In the case of Barcode Management : Input the Copy end sample ID number (2digits) in the Input
part right under the “SID” box.
In the case of Barcode Non-management : Set the Copy end sample position number in the lower “pos”
part. Select the position number from drop-down menu.
13 Click the Save button and the test order w
will
ill be ccopyed
opyed within the range of the samples which is set by
any one of above-mentioned method.
UPPER: 1 Copy source Sample position UPPER: 4 Copy source Sample ID number
LOWER: 12 Copy end Sample position 11 Copy Function ON LOWER: 12 Copy end Sample ID number
12. Copy execution button

2-51
The Standard sample to which the barcode management is applied can be judged about all necessary
information in the inside of the system from the content of the barcode label. Therefore, place the Standard
samples of necessary number in ASP and no necessary to set the order. When samples are not managed by the
barcode, it is necessary to set those Test Order according to the following procedures.
<Order Setting / Delete Procedure>
1 Specify the slot nummber of ASP to place the standerd sample from drop-down menu. (1 - 72)
2 Select “Standard” as the sample type from drop-down menu.
3 Select sample category. Select Common / Serum / Urine / Plasma from drop-down menu.
menu.
4 Set Method. (Only one type can be selected.)
5 Specify the num
number
ber of sample in “No” part. For Full-calibration, select
select “Full” and for Re-calibration,
select the number of Sandard sample to place (which standard sample). (Refer to “2.5.2. Registration and
setting for calibration.”)
6 Click Save button and the oder is fixed an
and
d the SID number of calibrator is displayed in the “SID List”.
(Refer to “1.4.2. Sample Identification Code”.).
7 In case for tw
two
o or m
more
ore ccalibrators
alibrators by Re-calibration, repeat from Procedure-1 to Proce
Procedure-6.
dure-6.
8 As for delete, click the SID number that shows the Sandard sample
sample in “SID List” and click the Delete
button. The specified sample is deleted from the list on the screen, and so click the Save button next.
Alert message of deletion confirmation
is displayed at the center of the screen by the Pop-up. To delete, click the OK button.in the Pop-up
message.
1. ASP slot number 2. Sample type 5. Number of Standard Sample 3. Sample category 4. Method List
SID List
6. Setting save button
8. Delete button
8. Delete determination
determination button

2-52
2.7.1.5 Multi Standard Sample (Multi Standard)
When the barcode management is applied, all necessary information can be judged in the inside of the
system from the content of the barcode label. Therefore, place the Multi Standard samples of necessary
number in ASP and no necessary to set the order. When samples are not managed by the barcode, it is
necessary to set those Test Order according to the following
follo wing procedures.
1 Specify the slot nummber of ASP to place the
the Multi-standerd sample from drop-down menu. (1 - 72)
2 Select “Multi Standard” as the sample type from drop-down menu.
3 Select the Sample category. Select Common / Serum / Urine / Plasma from drop-down menu. (Follow the
content registered by Tab Menu [Calibration (F7)] – [Multi-Std]).
[M ulti-Std]).
4 Select the Multi Standard name from drop-down men.
5 The m
method
ethod is orderd acc
according
ording to the content registered by tab m
menu
enu [Calibration
[Calibration (F7)] – [Multi-Std].
6 Specify the number
number of sample in “No” part. For Full-calibration, sele
select
ct “Full” and for Re-calibration, slect
the number of Standard sample to place (which standard sample). (Refer to “2.5.2. Registration ×and setting
for calibration”.)
7 Click the Save button and the oder is ffixed
ixed and the SID number of Multi-standard Sample is displayed in
the “SID List”. (Refer to “1.4.2. Sample Identification Code”.)

8 As for Delete, Click the SID numnumber
ber that shows the Multi standa
standard
rd sample in “SID List” and click the
Delete button. The specified sample is delete from the list on the screen, and so click the Save button next.
message.
6 Number of
1 ASP slot number 2 Sample type 4 Multi-standard name 3 Sample category
Standard Sample
5 Method List
SID List


2-53
2.7.1.6 Dilution St
Standard
andard Sample (Serial Dilution)
Before executing the test selection setting, the necessary dilution rate and the dilution stage need to be
decided in tab menu [Calibration (F7)] – [Serial
[ Serial Dilut].
system from the content of the barcode label. Therefore, place the required dilution standard sample in the
ASP and the order setting is not required. When samples are not managed by the barcode, it is necessary to set
the Test Order according to the following procedures.
1 Specify the A
ASP
SP slot nummber to place the dilution standard sam
sample
ple from
menu.
2 Select “Serial Dilution” as the sample type from drop-down menu.
3 Select the sample ccategory.
ategory. Selec
Selectt C
Common
ommon / Serum / U
Urine
rine / Plasma from
from drop-down menu.
4 Specify the Method. Click the box on the left side of a Method name
name and this Method will be orderd.
Follow the Setting contents of tab menu [Serial Dilut]on job menu [Calibration (F7)] about Procedure-3 and
Procedure-4.
5 Click the Save button and the oder is ffixed
ixed then the SID number of the dsilution standard sample is
displayed in the “SID List”. (Refer to “1.4.2. Sample Identification Code.”).
6 As for Delete, click the SID number that shows the dsilution standard samsample
ple in “SID List” aand
nd click the
Delete button. The specified sample is deleted from the list on the screen and so click the Save button next.
message.
1 ASP slot number 2 Sample type 3 Sample category
SID List 4 Method list

6 Delete button

2.7.1 Normal Test Selection: [Run (f5)] [Selection]
2.7.1.6 Dilution Standard Sample (Serial Dilution)
2-54
2.7.1.7 Blank Sample (Blank)
Before executing the Test selection setting of the blank sample, “Enable S1 Blank (Factor or Linear)” needs
to be set by tab menu [Parameter (F6)] – [Normal2].
system from the content of the barcode label. Therefore, place the required blank sample in ASP and the order
setting is not required. When samples are not managed by the barcode, it is necessary to set the Test Order
according to the following procedures.
1 Specify the ASP slot n
nummber
ummber to plac
placee the blank sample from drop-down menu.
2 Select “Blank” as the sample type from drop-down menu.
3 Select the sample category. Select Common / Serum / U
Urine
rine / Plasma from drop-down menu.
menu.
4 Only the Methods whose “Blank
“Blank measurement enable” was set by tab menu [Parameter (F6)] – [Normal2]
has been orderd. (You cannot change the order here.)
5 Click Save button and the oder is fixed then the SID number of the blank sample is displayed in the “Sid
List”. (Refer to “1.4.2. Sample Identification Code.”).
6 As for Delete, click the SID num

number
ber that shows the blank sample in ““SID
SID List” and click the Delete button.
The specified sample is deleted from the list on the screen and so click the Save button next. Alert message
of deletion confirmation
is displayed at the center of the screen by the Pop-up. Todelete, click the OK button.in the Pop-up
message.
1 ASP slot number 2 Sample type 3 Sample category
4 Method list
SID List

6 Delete button

2-55
2.7.1.8 Control Sample (Control)
Before executing the Test selection setting of the control sample, it is ecessary to register the name of the
control sample by tab menu [QC (F8)] – [Registration] and set the Method which is applied on tab menu
[Settings] and the accuracy management data..
When the barcode management are applied, all necessary information can be judged in the inside of the
system from the content of the barcode label. Therefore, place the required control samples in the ASP and the
order setting is not required. When samples are not managed by the barcode, it is necessary to set the Test
Order according to the following procedures.
1 Specify the ASP slot n
nummber
ummber to place the control
control sample from drop-down me
menu.
nu.
2 Select “control” as the sample type from drop-down menu.
3 Select the name of the control sample ffrom
rom drop-down menu.
4 The Methods which wa
wass set by tab menu [QC (F8)] – [Settings] has been order.
5 Clicking the Save button and the oder is fixed then the SID number of the control
control sample is displayed on
the Order List. (Refer to “1.4.2. Sample Identification Code”.)
6 As for Delete, click the SID number that shows the control sample in “SID List” and click the Delete
button. The specified sample is deleted from the list on the screen and so click the Save button next. Alert
is displayed at the center of the screen by the Pop-up. To deletion, click the OK button in the Pop-up
message.
1 ASP slot number 2 Sample type 3 Control name
SID List 4 Method list


2-56
2.7.1.9 Mask Setting (Mask)

The Method that can be measured on this analyzer, that is to say, about the Method which meets the
condition that the chemistry parameter is set and the calibration curve exists and the necessary reagent for the
measurement exists in RCU, too, even if the test order exists, forbidding the actual measurement is enabled.
This is called “Mask settings”.
When the mask is ON (no check mark), its method is not applied to the measurement for specimen (include
profile), control and calibration (include multi-standard).
<Mask settings / Procedure of release>

1 Select “Mask” as the sam
sample
ple type from drop-down m
menu.
enu.
2 Select Normal / Control / Standard as the Ma
Mask
sk Type.
3 The mask state of the Method is displayed.
The Methods with check mark in the check box of the Method name show the mask off, and they
become measurable Methods. When cclicking
licking the
t he ccheck
heck mark again, the
t he mark disappears and tthe
he M
Method
ethod
becomes the mask on, and becomes the measurement
measurement forbiddance Method.
4 When ma
making
king all Methods the mask on, click the Mask A
All
ll button.
5 After that, the button ch

changes
anges to the Clea
Clearr All button. When click
clicking
ing this button, the masks of all Methods
are reset, and all Methods become measurable Methods.
6 When cclicking
licking Save button, the mask state of the Method list is fixed.
NOTE: “SID Llist” in the left of the screen only displays the current order state of measurable Method and
there is no influence on the state of the mask.
No check mark: Mask ON (Disable measurement)

measurement)
1 Sample type Check mark: Mask OFF (Enable measurement) 2 Mask Type
SID List
3 Method list
4 All item mask setting

button
6 Setting save button 5 All method’s mask release

2.7.1.9 Mask Settings (Mask)
2-57
2.7.1.10. Orderless Sample (Orderless)

(Orderless)
Before executing the orderless measurement, the Method that permits measuring can be selected beforehand.
NOTE：The Orderless measurement means that when “Shift” key and the “F1” key are pushed at the same
time, all measurable Methods of all samples that exist in ASP will be measured.
<Selection procedure of Method>

1 Select “Orderless” as the sample ty
type
pe from drop-down men
menu.
u.
2 Select sample
sample type. Select Common / Serum / Urine / Plasma from drop-down menu.
3 Select the type of N
Normal
ormal range tah
tahtt is the evaluation standard of measurement results. Default is “Human
Auto”.
Human Auto means that the type of the normal range is automatically selected from patient's sex and
age set by Taab Menu [Patient] and the judgment is performed by that reference value. However, when the
patient's age is uncertain, it is treated as the middle generation
generation (G2).
4 Set No Permission / Permission of measurement by the Meth
Method
od list.
The Methods that have the check mark in the check box in the left side of the Method name are
measurement permission Methods. Methods that don’t have the check mark on that erea are no permission
Methods. Every time the check box is clicked, the check mark alternately changes between ON and OFF.
5 Specify the measurement number of times to the the Method from drop-down menu of “Number” box.
Default is one time. Allowable range is 1 ~ 99. When this replicate number is two or more, the auto-rerun
is not executed. (when the result is over the Technical Range and Prozone Check Range, the auto-rerun
becomes available.)
6 Clicking the Save button and the Method is fixed.
1 Sample type 2 Sample category 3 Normal Range type
5 Measurement number of times
4 Method list

(Orderless)
2.7.1.10 Orderless Sample (Orderless)
2-58
2.7.1.11. Online Sample (Online)

(Onlin e)
“On Line Batch” or “On Line Real time” should be selected beforehand as Host Communication Mode by
tab menu [System
menu [System (F9)] – [Setup] to execute the online measurement. In case of Online real time and sample
barcode management, the order is automatically established by the communication
co mmunication between the host computer
and the analyzer. The order setting explained here is to confirm the order. However, in case of sample barcode
non-management, it is necessary to relate the ASP slot number to the sample ID number beforehand to specify
the slot number of ASP where the sample is mounted. Therefore, execute processing according to the
following order setting procedure.
<Order setting procedure >

1 Specify the ASP slot number
number to place the sample.
In the case of Barcode Management : Select “Blank” without the slot number.
In the case of Barcode Non-management : Select the slot number from drop-down
dro p-down menu.
outer positions 36 (1 ~ 36),
middle positions 36 (37 ~ 72)
2 Select “Online” as the sample ty

type
pe from drop-down me
menu.
nu.
3 Click this “BCR” box ON when using the barcode reader for the keyboard.
keyboard.
4 Set the sample ID number (SID)

When the high-order digit is made the fixed number, it is possible to define it beforehand by tab menu
[System (F9)] – [Setup]. After defining it, you only have to input only the low order digit of the sample ID
number.
5 Click the Sav

Savee button. Then, the sample ID number to be placed is fixed.
When fixed, in case of the barcode non-management, the ASP Sample Position Number (Pos) and the
Sample ID Number (SID) are displayed in “SID List” in the left side of screen. In case of the barcode
management, the ASP Sample Position Number (Pos) is the blank. Execute from the procedure-1 when
continuously setting another sample ID number. Moreover, if the sample ID numbers are consecutive, the
use of the copy function is very effective to set those samples. Refer to after-mentioned “<Sample group
setting · delete procedure>”.
6 Click the Acquire orders button an

and
d the order inf
information
ormation of the Method etc. will be sent from the host
computer.
7 The sample order state is displayed in the order Me

Method
thod list.(Editing is impossible)

(f5)]-[Selection]
2.7.1 Normal Test Selection: Run (f5)]-[Selection]
2.7.1.11 Online Sample (Online)
2-59
1 ASP slot number 2 Sample type 3 Keyboard BCR 4 Sample ID
7 Order item list
SID List
6 Host order demand 5 Sample ID save

(f5)]-[Selection]
2-60
<Group setting and Delete procedure of samples (In the case of Barcode Management)>
8 Click the “C/D” box ON.
9 Input the C
Copy
opy (or Delete) beginning sample ID num
number.
ber.
10 Input the C
Copy
opy (or Delete) end sam
sample
ple ID number.
11 Click the Save button (Delete button

button).
).
Clicking the Save button and a series of sample ID number (SID) will be added and displayed in the
order list.
Clicking the Delete button and a series of sample ID number (SID) will be deleted from the order list on
the screen then click the Save button next. Alert message of deletion confirmation
message.
12 Click the Acquire orders button for the order confirmation after copying (or deleting) completed.
8 Copy (Delete) function ON 10 Copy (Delete) End sample 9 Copy (Delete) Beginning sample
number number
12 Host order demand 11 Group SID deletion 11 Group SID copy execution

(f5)]-[Selection]
2-61
<Group setting and Delete procedure of samples (In the case of Barcode Non-management)>
Non-management)>
8 Click the “C/D” box ON.
9 Input the Copy (or Delete) ASP slot number of Beginning sample placing.
10 Input the Copy (or Delete) ASP slot number of End sample placing.
11 Click the Save button (Delete button).

Clicking the Save button and a series of sample ID number (SID) will be added and displayed in the
order list.
Click the Delete button and a series of sample ID number (SID) will be deleted from the order list on the
screen then click the Save button next. Alert message of deletion confirmation
message.
12. Click the Acquire orders button for the order confirmation after copying (or deleting) completed.
9. Copy (Delete) Beginning sample 10. Copy (Delete) End sample

number number
8. Copy (Delete) function

(f5)]-[Selection]
2-62
2.7.1.12 ISE Calibration

It is necessary to specify the ASP installation site of necessary ISE standard (Calibrant-B) for the ISE
calibration measurement. . When the sample barcode management is applied, the installation site becomes
clear by reading the barcode label. However, in the case of the sample barcode non-management, specify /
delete the ASP slot number to place the ISE standard
s tandard according to the following procedures.
1. Select the ASP slot number to place the ISE standard from drop-down menu. (1 ~ 72)
2. Select “ISE Calibration” as the sample type from
fro m drop-down menu.
1 ASP Slot Number Designation 2. “ISE Calibration” Designation
3. Click the Save button 3 Set save button

5 Delete button 5 Delete determination button
4. The ASP slot number and the SID number “96000001” of the ISE standard sample are displayed in “SID
List”.
4 SID List
5. As for delete,
delete, click the SID n
number
umber that shows the ISE standard in ““SID
SID List” and click the Delete button.
The specified ISE standard is deleted from the list on the screen and then click the Save button next. Alert
is displayed at the center of the screen by the Pop-up. When actually executing deletion, click the OK
button.in the Pop-up message.

2.7.1.12 ISE Calibration
2-63
2.7.1.13 ISE Cleaning

It is necessary to specify the ASP installation site of necessary ISE
ISE wash solution (
solution (ISE
ISE Cleaner) for Cleaning
treatment of the ISE module. When the sample barcode management is applied, the installation site becomes
clear by reading the barcode label. However, in the case of the sample barcode non-management, specify /
delete the ASP slot number to place the ISE wash solution according to the following procedures.
1 Select th
thee ASP slot number to place the ISE wash ffluid
luid from drop-down menu. (1 ~ 72)
2 Select ““ISE
ISE Cleaning
Cleaning”” as the sam
sample
ple type from drop-down menu.
1 ASP Slot Number Designation 2 “ISE Cleaning” Designation
3 Click the Save button. 3 Setting save button

4 The ASP slot number and the SID number ““96000101”

96000101” of the ISE Cleaner are displayed in “SID List”.
4 SID List
5 As for Delete, click the SID num

number
ber that shows the ISE C Cleaner
leaner in “SID List” and click the Delete button.
The specified ISE Cleaner is deleted from the list on the screen and then click the Save button next. Alert
“Warning ! Is it all right if the
t he specified order is deleted ?”
message.

2-64
2.7.1.14 SPT Wash

It is necessary to specify the ASP installation site of necessary wash solution (SPT wash solution) for
Cleaning treatment of the SPT nozzle. When the sample barcode management is applied, the installation site
becomes clear by reading the barcode label. However, in the case of the sample barcode non-management,
specify / delete the ASP slot number to place the nozzle wash solution
s olution according to the following procedures.
1 Select the ASP slot n
number
umber to place the SPT nozzle wash solution from drop-down menu. (1 ~ 72)
2 Select “SPT Wash” as the sample type from drop-down menu.
2 “SPT Wash” Designation
1 ASP Slot Number Designation
3 Click the Save bu

button.
tton. 3 Setting save button
4 The ASP slot number and the SID number “9600201” of th

thee SPT w
wash
ash solution are display
displayed
ed in “SID List”.
4 SID List
5 As for Delete,
Delete, click the SID number tha
thatt shows the SPT wash solution in “SID List” and click the Delete
button. The specified SPT wash solution is deleted from tthe he list on the screen and so click the Save button
b utton
next. Alert message of deletion confirmation
“Warning ! Is it all right if the
t he specified order is deleted ?”
message.

2.7.1.14 SPT Wash
2-65
2.7.2 Special Test Selection:

Selection : [Run (F5)] – [Std QC]
The innermost 20 slots (Slot #I01 to #I20) of the ASP are used for special samples such as standard samples,
control samples or washing solutions, and only accommodate cups can be used. Therefore, barcode control is not
available. It is required to perform settings for slot numbers and sample types in advance.
2.7.2.1. Standard Sample (Standard)

<Slot Number Setting/Delete Procedure>
1. Select the number of the slot where
where the cup is placed from the drop-down menu.
2. Select the
the ““Standard”
Standard” as a sam
sample
ple type from the drop-down menu
menu..
3. Select the sample category. Select one sample category ffrom
rom Common / Serum / Urine / Plasma from the
drop-down menu.
4. Select the “Auto” function for execution mode

mode.. Select Inv
Invalid
alid / Start / Auto / Start+Auto from the
drop-down menu. (Refer to “3.1.7 [Std QC]”.)
- Invalid: The measurement of this test order is suppressed.
- Start: The measurement is automatically performed when the first round of this test order is
started. After the measurement is completed, this selection is changed to “Invalid”.
- Auto: At theover,
goes timethe
when the lot number
measurement of reagent
of this is is
test order changed or the time-out
automatically period
performed. for conditions
These calibration
should be set in the tab menu [Calibration] – [Reg Calib] in advance.
- Start+Auto: The measurement of this test order is automatically performed when the first round of this
test order is started or the lot number of reagent is changed or the time-out period for
calibration goes over. These conditions should be set in the tab menu [Calibration] – [Reg
Calib] in advance. After the measurement is completed, this selection is changed to “Auto”.
5. Select the measurement method. Click the box left of the method n
name
ame and a check mark appears then the
method becomes effective. Click the checkmark again and the checkmark disappears then the method
becomes non-effective.
6. Designate the number of samples at the “No.” section from the pull-down menu. To perform full
calibration, select “Full”. To perform partial calibration (recalibration), select the number of standard
samples you will place. (Refer to “2.5.2 Registration and Setting for Calibration”)
7. Click the Save button to decide th thee order. C

Calibrator
alibrator SID num
number
ber will be displayed on the “SID List”.
(Refer to “1.4.2 Sample Identification Code”)
8. For the partial calibration (set more than one calibrator), repeat the procedures from 1 to 7.
9. To delete the standard sample, click the SID number indicating the standa
standard
rd sample in the “SID List”, and
click Delete button. After the designated standard sample is shown as deleted, click Save button. The
warning message
“Warning! Is it all right if the specified order is deleted?”
to confirm the delete action, will be pop-upped in the middle of the screen. If you are sure to execute the
delete action, click on the OK button in the pop-up message.
2.7 Test Selection

2.7.2 Special Test Selection: Run (f5) - Std QC
2.7.2.1 Standard Sample
2-66
1. ASP Slot Number Designation 2 ”Standard” selections 3. Sample category selection 4. “Auto” selection
6. Number of Standard Sample selection
5. Measurement Method Selection
9. Delete button 7. Setting save button

9. Delete determination button
2.7 Test Selection

2.7.2.1 Standard Sample
2-67

2. Select the
the ““Multi
Multi Standard” as a sample ty
type
pe from the drop-down menu.
3. Select the sample category. Select one sample category ffrom
rom Common / Serum / Urine / Plasma from the
drop-down menu.
4. Select the “Auto”
“Auto” function for eexecution
xecution mode. Se
Select
lect Invalid / Sta
Start
rt / Auto / Start+Auto from the
drop-down menu.
menu. (Same
(Same as the 4. of “2.7.2.1 Standard Sample”.)
5. Select the Multi Standard name
name ffrom
rom the drop-down menu.
menu.
6. Defined measurement
measurement methods can be referred on th thee tab menu [Calibration (F7)] – [Multi Std]. The
measurement methods with checkmarks in the left boxes will be measured.
7. Designate the number of samples at the “No.” section from the pull-down menu. To perform full
calibration, select “Full”. To perform partial calibration (recalibration), select the number of standard
samples you will place. (Refer to “2.5.2 Registration and Setting for Calibration”)
8. Clicking the
the Save button top decide tthe
he order. C
Calibrator
alibrator SID num
number
ber will be displayed on the
the “SID List”.
9. For the partial
partial calibration (to set more th
than
an one ca
calibrators),
librators), repeat the procedures from 1 to 8.
10. To delete the multi standard sample, cclick

lick the SID number inindicating
dicating the multi
multi standard sample in the
“SID List”, and click Delete button. After the designated multi standard sample is shown as deleted, click
Save button. The warning message
to confirm the delete action, will be pop-upped in the middle of the screen. When you are sure to execute the
delete action, click the OK button in the pop-up message.
1. ASP Slot Number Designation 2 ”Multi Standard” selection 3 Sample category selection
7 Number of Standard 5. Multi-standard name selection

Sample selection
4. “Auto” selection
SID List 6. Measurement Method Confirmation

10. Delete determination button
2.7 Test Selection

2.7.2.2 Multi Standard Sample
2-68

2. Select the
the ““Serial
Serial Dilution” as a sample type from the drop-down menu.
3. Select the sample categ
category.
ory. Select Common / Serum / Urine / Plasma from the drop-down menu.

“Auto” function for execution mode. Select Invalid / Sta
Start
rt / Auto / Start+Auto
Start+Auto from the
drop-down menu. (Same as the 4. of “2.7.2.1 Standard Sample”.)
5. Select the measurement

measurement method. Clic
Click
k the box left of the m
method
ethod name and
and check mark appears then the
method becomes effective. When you click the checkmark (again), the checkmark disappears and the
method becomes non-effective.
6. Clicking the Save button finalizes the order. Dilution calibrator SID number will be displayed on the “SID
List”. (Refer to “1.4.2 Sample Identification Code”)
7. To delete the
the dilution calibrator, click the SID number indicating the dilution calibrator in the “SID List”,
and click Delete button. After the designated dilution calibrator is shown as deleted, click Save button. The
warning message
to confirm the delete action, will be pop-upped in the middle of the screen. When you are sure to execute the
delete action, click the OK button in the pop-up message.
1 ASP Slot Number Designation 2 “Serial Dilution” selection 3 Sample category selection
SID List 5 Measurement Method selections
6 Setting Save Button

7 Delete Button 7 Delete Save Button
2.7 Test Selection

2-69

2. Select the
the “Control”
“Control” as a sample type from the drop-down menu.
3. Select the Control Sample n
name
ame from the drop-down m
menu.
enu.
4. Select the “Auto” fun
function
ction for execution mode. Select one of Invalid / Start / Auto / Start+Auto from the
drop-down menu.
- Invalid: The measurement of this test order is suppressed.
- Start: The measurement is automatically performed when the first round of this test order is
started. After the measurement is completed, this selection is changed to “Invalid”.
- Auto: At the time when the test count is reached the specified numbers (“Auto test interval”) or
the times are passed over the specified interval time (“Minutes”), the measurement of this
test order is automatically performed. These conditions should be set in the tab menu
[QC (F8)] – [Settings] in advance.
- Start+Auto: When the first round of this test order is started, the measurement is automatically
performed. And at the time when the test count is reached the specified numbers or the
times are passed over the specified interval time, the measurement of this test order is
automatically performed. These conditions should be set in the tab menu [QC (F8)] –
[Settings] in advance. After the measurement is completed, this selection is changed to
“Auto”.
5. The measurement method(s),
method(s), which have bee
been
n set on the tab menu [QC (F8)] – [Settings], are being
ordered.
6. Click the Save button to decide the
the order. CControl
ontrol Sample’s SID number w
will
ill be displayed
displayed on the Order
List. (Refer to “1.4.2 Sample Identification Code”.)
7. To delete the control sample, clic
click
k the SID n
number
umber indicating the control sample in the “SID List” and
click Delete button. After the designated control sample is shown as deleted, click Save button. The
warning message
to confirm the delete action, will be pop-upped in the middle of the screen. When you are sure to execute
the delete action, click the OK button in the pop-up message.
1.ASP Slot Number Designation 2. “Control” Designation 3. Control Name Designation
5.Measurement Method Confirmation
SID List

determination button
7. Delete determination
2.7 Test Selection

2-70

< Slot Number Setting/Delete Procedure>
2. Select the
the ““Blank”
Blank” aass a sample type from the drop-down menu
menu..
3. Select the sample ca
category.
tegory. Select Common / Serum / Urine / Plasma from the drop-down menu.

“Auto” function for eexecution
xecution mode. Se
Select
lect Invalid / Sta
Start
rt / Auto / Start+Auto from the
drop-down menu.
menu. (Same
(Same as the 4. of “2.7.2.1 Standard Sample”.)
5. Only the measurement methods, which have been set as the “S1 Bla
Blank
nk Measurement Enable”
Enable” on the Tab
Menu [Normal2] of the Job Menu [Parameter (F6)], are being ordered. (Order change is not available here.)
6. Click the Save button to decide the order. Blank Sample SID number w
will
ill be displayed on the “SID List”.
7. To delete the
the blank sample, click the SID num
number
ber indicating the blank sample in the “SID List” and click
click
Delete button. After the designated blank sample is shown as deleted, click Save button. The warning
message
1 ASP Slot Number Designation 2 “Blank” selection 3 Sample category selection
SID List
5. Measurement Method Confirmation

2.7 Test Selection

2-71

1. Select the number of the slot where the cup is placed from the drop-down menu.
2. Select the “ISE Cleaning” as a sample type from the drop-down

dr op-down menu.
3. Clicking the Save button to decide the order. ISE Cleaner SID number (96000101) will be displayed on the
“SID List”. (Refer to “1.4.2 Sample Identification Code”.)
4. To delete the ISE Cleaner, click the SID number indicating the ISE Cleaner in the “SID List” and click
Delete button. After the designated ISE Cleaner is shown as deleted, click Save button. The warning
message
1 ASP Slot Number Designation 2 “ISE Cleaning” Designation
SID List

2.7 Test Selection

2-72
2.7.2.7 SPT Wash

1. Select the number of the slot where the cup is placed from the drop-down menu.
2. Select the “SPT Wash” as a sample type fro m the drop-down menu.
3. Clicking the Save button to decide the order. SPT washing solution SID number (96000201) will be
displayed on the “SID List”. (Refer to “1.4.2 Sample Identification Code”)
4. To delete the SPT washing solution, click the SID number indicating the SPT washing solution in the “SID
List” and click Delete button. After the designated SPT washing solution is shown as deleted, click the
Save button. The warning message
1. ASP Slot Number Designation 2 “SPT Wash” Designation
SID List

2.7 Test Selection

2.7.2.7 SPT Wash
2-73
2.8 Sample Placement (ASP)

Blood collection tubes (Tube) and sample cups for normal samples, emergency samples, control samples and
standard samples can be placed into the two types of trays in the Auto Sampler Unit (ASP) of the analyzer.
The tray mechanism inside the ASP is equipped with a holder of double structure, which can hold samples as
described below.
1) Tube tray (capable of placing 72 samples in the inner
i nner and outer circles):
Barcode labels on the tubes enable barcode control. Sample cups placed on the lip of tubes with
barcode labels also can be controlled.
2) Sample cup tray (capable of placing 20 samples):
Sample cup tray is located in the innermost layer of the ASP and used to place special samples such as
standard samples or control samples. Barcode control of the sample cups placed here is not available.
Measurement begins with the test order for the sample cup tray in the innermost circle, and then the test order
for the tube tray is performed.
Note:
Sample volume of the cup installed in ASP should be satisfied the following requirements;
- Sample cup: More than 150μL
- Pediatric cup: Within 50 to 100μ L

100
Sample cup tray (from #I01 to #I20)
Tube tray (Outer circle: from #1 to #36, Inner circle: from #37 to #72)
2.8 Sample Placement
2-74
2.8.1 Placement to Tube Tray
When you place standard samples on the tray, make sure to start placing from the position #1. Samples
placed after a patient sample cannot
cannot be calibrated adequately.
<Sample Placement>
1 Take out the tube tray from the Auto Sampler Unit (ASP).
( ASP).
2 Place the sample into a slot of the tray. The tube with a barcode label should be positioned in such a
way that its label faces the slit of the slot.
3 Set the tray into the ASP unit so that the inner guide pins can be fit into the two pin-holes (located
between Slot #40 and #41, and between
between Slot #57 and #58) of the tray.
Guide pin Barcode label

2.8.1 Placement to Tube Tray
2-75
2.8.2 Placement to Sample Cup Tray (Innermost slots of ASP)

<Sample Placement>
1 Take out the sample cup tray from the Auto Sampler Unit.
2 Place the cups containing samples (standard samples, control samples etc.) into the
t he cup placement holes.
3 Set the sample cup tray into the un
unit
it inside so th
that
at the inner guide pin can be fit
fit into the pin
pin-hole
-hole (at Slot
#10) of the sample cup tray.
Note: When you place a cup for a long time without applying, it is recommended to wrap proper waxed
paper around the cup to protect evaporation / condensation for the liquid.

2.8.2 Placement to Sample Cup Tray
2-76
2.9 Confirmation of Reagent Remaining Volume

Prior to the measurement, you need to check if the necessary reagents are placed adequately in the
Reagent Container Unit (RCU) and to confirm the reagent remaining amount.
Information such as types and remaining volume of the reagents, which are placed inside the Reagent
Container Unit (RCU), can be confirmed on the tab menu [Inventory] of the job menu [Run (F5)]. If
necessary, add new reagent bottles after confirmation.
Every time you add a new reagent, make sure to perform “Reagent Scan” in order to update the reagent
information.
For barcode controlled reagent bottles, it is very easy to carry out the “Reagent Scan”. When you click
the RCU Scan button of the tab menu [Inventory], the Reagent Container Unit (RCU) starts rotating and
the barcode reader reads the barcodes on the bottles. Necessary information such as reagent types,
t ypes, reagent
quantity, bottle capacity is automatically
auto matically recognized.
However, for the bottles which are not controlled by reagent barcodes, the necessary information is
required to be input on the tab menu [Inventory] from the keyboard.
(Refer to the “3.1.5 Reagent Information Control: [Inventory]”)
[Run (F5)]-[Inventory]
Red line: Number of test is less than 1.

Pink line: Valid term is expiry.
Yellow line: Stability
Stability term is expiry.
2.9 Confirmation of Reagent Remaining Volume
2-77
2.10 Measurement Start and Monitor
2.10.1 Measurement Start

By pressing the [F1] key on the keyboard or clicking on the [Start (F1)] button of the Global Menu located at
the bottom of the screen, you can start the measurement operation. Measurement Start operation can be carried
out from any screens, however, in principle, we recommend that you perform the Measurement Start after
selecting [Monitor] or [Round] of the tab menu in the job menu [Run (F5)].
The measurement cannot be performed unless following conditions are satisfied prior to the measurement.
1) Each lid for ASP, RCU and ISE is closed.
2) The temperatures inside the RCU are 15 °C or lower.
3) The temperature range inside the IRU is within 37 ± 0.5°C.

4) Halogen lamp is stable. (20 minutes or more has passed
pas sed after the light turned on)
5) 30 or more usable cuvettes are present in the IRU.
6) Purified water of regulated amount or more is reserved in the sub tanks (R and L) inside the analyzer.
7) No water leakage inside the analyzer.
analyzer.
8) No insufficient reagents for measurement methods.
If you press [Control] and [F1] keys, you can skip remaining reagent volume check at Measurement Start.
Press [Ctrl] and [F2] keys for emergency stop. When Alarm (F4) blinks at measurement start, press [Ctrl] and
[F2] keys for emergency stop and then verify alarm messages.
The measurement status can be monitored either on the tab menu [Monitor] or [Round] of the job menu [Run
(F5)]. On the tab menu [Round], further details of the measurement process status can be monitored.
· Click on the Start (F1) button:

Start (F1)
· First check message is popped up:
Start check in process

Inventory check in process
· Secondary check message is popped up:

Click OK ; Measurement start is proceed.
Click Cancel; Measurement start is canceled.
Check remaining volume of wash solution.
OK Cancel
· Preparation message is popped up:
Measurement preparation in process.

2.10.1 Measurement Start
2-78
2.10.2 Measurement Status Monitor (Run Monitor)

By selecting the tab menu [Monitor] of the job menu [Run (F5)], the Run Monitor screen can be opened. This
screen allows you to easily perform the ISE calibration, the ISE cleaning, the SPT cleaning etc. immediately
before the Measurement Start. Addition of emergency samples and/or normal samples during the measurement is
also performed on this screen.
For the details and functions of this screen,
s creen, refer to “3.1 [Run (F5)]” of Chapter 3.
When the mouse cursor is put on ASP

ASP Monitor
slot mark, a sample number is displayed.
d isplayed.
Run Monitor ：[Run (F5)] - [Monitor]
ASP monitor Meaning ASP monitor Meaning

Green Sampling process started White Sampling process not started yet
Blue Range over occurred in the result Yellow Any test order not recognized
Purple Auto-rerun required for the result Gray Measurement process not started yet
Barcode not recognized and any test
Red Error occurred in the result Pale Gray
order not found
Light Blue Measurement normally completed
2.10.2 Measurement Status Monitor (Run Monitor)
2-79
2.10.3 Measurement Process Monitor (Round Monitor)

By selecting the tab menu [Round] of the job menu [Run (F5)], the Round Monitor screen can be opened. On
this screen, detailed progress status of measurement process can be monitored.
For the details and functions of this screen,
s creen, refer to “3.1 Run Menu: [Run (F5)]” of Chapter 3.
Reagent Blank
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10) (11) (12) (13) (14)
No. Process Detail

0: Water of the interior of SPT is dispensed to the cuvette. This case
is only the Reagent Blank Measurement.
(1) ASP Position Number
1 to 92: ASP position number of the cu cup
p or tube contained the sample to be
dispensed to the cuvette is displayed.
Specified PID in the tab menu [Selection] of the job menu [Run (F5)] is
(2) Patient ID Number
displayed.
Specified SID in the tab menu [Selection] of the job menu [Run (F5)] or the
(3) Sample ID Number
automatically defined SID, for example “Reagent Blank”, is displayed.
(4) Method Name Method name for the measurement is displayed.
(5) R1 dispensing completion When R1 dispensing to the cuvette is completed, star mark is displayed.
(6) Sample dispensing completion When sample dispensing to the cuvette is completed, star mark is displayed.
(7) R1 Mixing completion When the stirring of the Mixer-1 is completed, star mark is displayed.
When the photometry for the first half (1 to 34 points) is completed, star
(8) Photometry (1) completion
mark is displayed.
(9) R2 dispensing completion When R2 dispensing to the cuvette is completed, star mark is displayed.
(10) R2 Mixing completion When the stirring of the Mixer-2 is completed, star mark is displayed.
When the photometry for the last half (35 to 68 points) is completed, star
(11) Photometry (2) completion
mark is displayed.
(12) Result After the concentration value is calculated, its result is displayed.
(13) Cuvette Number The cuvette number that has been used for the measurement is displayed.
When any error is occurred during measurement, error flag is i s displayed.

(14) Error Status
In the case of no error, the blank code is filled in this cell.
2.10.3 Measurement Details Monitor (Round Monitor)
2-80
2.11 Sample Addition
2.11.1 Emergency Sample Addition

Added Emergency Samples will be measured prior to other samples.
To add an emergency sample while the measurement is in process, perform

perfor m the following procedures.
1. Click the [STAT (F3)] button of the Global
Global Menu. Sampling process for new sample comes to a pause,
however, the measurement process for already dispensed cuvettes in the IRU is carried on.
2. After sampling process is stopped, ASP rotates to the position where aany
ny test order is not still registered.
However, if there is more than one slot, ASP rotates to the youngest number of slot.
And the present screen is automatically jumped to the tab menu [Selection] and the following pop-up
message is appeared.
“Place the sample at following position: gray, yellow, light blue or blue.
Do not use following colored position: white, green purple and red”
When the operator selects the ASP slot position to place the additional sample, it should be considered
the sort of color in the SID List at the left of screen as referring to the pop-up message.
When click the OK button in the pop-up message, the pop-up message is disappeared from the screen.
Available ASP slot for

additional sample
SID List
3. Then, you can perform to designate the test order of the addition
additional
al sample. Refer
Refer to “2.7.1.2 Emergency
Emergency
Sample (STAT)” of Chapter 2.
2-81
4. Remove the “Sample addition lid” and place the additional sample to the ASP slot.
After completion of sample placement, return the “Sample addition lid” to its original position.
When you want to add more than one sample, repeat the procedures from 3 to 4.
Sample Addition Lid
Sample Addition Opening
5. Click the Global Menu button [Start (F1)] flickering yellow to restart the measurement process. The
following message is popped up while the analyzer performs the start up check and inventory check, then
the message is disappeared after completion of check process.
The ASP starts rotating and the measurement is resumed. But the measurement of emergency sample is
prioritized. Of course, the measurement for the suspended sampling process is restarted.
3. [Rotation ASP] Button
5. [Start (F1)] Button 1. [Stat (F3)] Button

2-82
2.11.2 Normal Sample Addition

Added Normal Samples will NOT be measured prior to other samples.
To add a normal sample while the measurement is in process,

pro cess, perform the following procedures
1. Click the [STAT (F3)] button of the Global
Global Menu. Sampling process for new sample comes to a pause,
however, the measurement process for already dispensed cuvettes in the IRU is carried on.
2. After sampling process is stopped, ASP rotates to the position where aany
ny test order is not still registered.
However, if there is more than one slot, ASP rotates to the youngest number of slot.
And the present screen is automatically jumped to the tab menu [Selection], and the following pop-up
message is appeared. (Refer to previous page “2.11.1 Emergency Sample Addition”.)
“Place the sample at following position: gray, yellow, light blue or blue.
Do not use following colored position: white, green purple and red”
When the operator selects the ASP slot position to place the additional sample, it should be considered
the sort of color in the SID List at the left of screen as referring to the pop-up message.
When click the OK button in the pop-up message, the pop-up message is disappeared from the screen.
Available ASP slot for

additional sample
SID List
3. Then, you can perform to set the te

test
st order for the additional sample. Refer to “2.7.1.1 Normal
Normal Sample
(Normal)” of Chapter 2.
When click the Rotation ASP button, the ASP slot that has been newly selected rotates to CW.
2-83
4. Remove the “Sample addition lid” and place the additional sample to the ASP slot.
After completion of sample placement, return the “Sample addition lid” to its original position.
When you want to add more than one sample, repeat the procedures from 3 to 4.
Sample Addition Lid
Sample Addition Opening
5. Click the Global Menu button [Start (F1)] flickering yellow

yellow to restart the measurement
measurement process. The
following message is popped up while the analyzer performs the start up check and inventory check, then
the message is disappeared after completion of check process.
ASP starts rotating and the suspended sampling process is restarted, then the measurement of samples
including additional sample is performed.
3. [Rotation ASP] Button
1. [Stat (F3)] Button

5. [Start (F1)] Button
2-84

3.1 [Run (F5)]:Run Menu
3.1.1 [Monitor]:Run Monitor
This menu is available to monitor the measurement progress and to execute some functions such as ISE Calibration,
ISE Cleaning, SPT Wash, Initialization or Prime.
(1)
(4)
(2)
(3)
No. Descriptions
(1) Time at run started
It will display the measurement start time.
Estimated time at sampling complete

It will display an estimated time for the completion of
o f a sampling.
Some necessary time will be added for BCR samples
s amples when the order inquiry about samples.
Estimated time at run end

It will display the measurement end time.
IRU
It will display the IRU temperature. The temperature of the IRU is monitored with several sensors, and the
screen will show their representing temperature. If any of them exceed ±0.5 from 37˚C, the temperature value of
its sensor will be displayed in red.
3.1 Run
3.1.1 Monitor
3-1
No. Descriptions
(1) Halogen
It will display the remained time that Halogen lamp is available to use. (by minute)
After Power ON, it will be counted down from 20 minutes.
Auto Rerun
Specify whether or not to need an auto-rerun operation.
Rerun will be performed automatically with setting parameters in advance by this Auto-Rerun function when
results are over the technical range or error flags occurred.
Refer to “3.2.1 Chemistry Parameter 1” for details on rerun
r erun operations.
(2) ISE Calibration

This button is to implement ISE Calibration. The setting for the ISE calibrating solution is available on the
“Selection” or “Std QC” screen.
ISE Cleaning
This button is to implement ISE cleaning. The setting for ISE cleaning solution is available on the
“Selection” or “Std QC” screen.
SPT Wash
This is to perform the SPT cleaning with wash solution.
This SPT wash solution is defined on the “Selection” or “Std QC” screen.
MIX Ascend / MIX Descend

This is for easy stirrer cleaning of MIX1 / MIX2. Click this button and MIX1 / MIX2 unit move to upper
direction and the button title will be changed to MIX Descend. After cleaning work, click on the button MIX
Descend to return MIX1 / MIX2 units to initial position.
WU Ascend / WU Descend
This is for easy nozzle cleaning of WU. Click on this button and WU unit move to upper direction and the
button title will be changed to WU Descend
Descend.. After cleaning work, click on the button WU Descend to return
WU unit to initial position.
Inner ASP
ASP will rotate CW.
Initialization
Click on this button and it will make each unit return to its home position.
Prime
Click this button and as well as filling the purified water and wash solution inside of the tubing, the air in
the path is discharged. It will execute the number of times specified in the .
ISE Prime
Click this button and it will execute a discharging air in the path by the solution Calibrant A. It will execute
the number of times specified in the .
3.1 Run
3.1.1 Monitor
3-2
No. Descriptions
(3) Start (F1)

Click this button and the measurement process is started. During the measurement, this button is flickered
with yellow color.
Sstop (F2)
Clicked this button, the sampling movement is suspended until the Start (F1) button is clicked again.
STAT (F3)
This is an operational button for additional sample. It will be switched over the tab menu [Selection] by
pressing [F3] key from any screen.
3.1 Run
3.1.1 Monitor
3-3
No. Descriptions
(4) <ASP Monitor>

The monitor shows the status of each sample placed in the ASP with colors.
And when the key cursor is placed on the sample mark, its sample number (SID) is displayed.
Display Addition
High Color Status of samples
Grey It means that the status is unprocessed and the (Gray) shows before
Allowed
(Unknown) the round starts.
It means that at least one error method is included. (Except for STB
error)
Red When conversion concentration has been failed due to such as a Not
(Error) calibration curve error or no calibration curve, the color will be red. allowed
Note: Abnormal temperature error may not be shown immediately
on the screen.
P
r
i It means that at least one method for rerun is included.
o
r
i When samples
samples are technical range over an and
d the samples are rerun, the
t
y Purple
i color will be changed from (Green) to (Purple). Not
n (Rerun
t Rerun samples will be measured when their barcodes are read at the allowed
h Required)
e
c re-circulation of ASP and
and its color is changed from (Purple)
(P urple) to (White).
a
s
e It means that at least one range-over method is included.
i ncluded.
e
a
c The measurement has been completed and the conversion of
h Blue Not
m concentration of the measurement has been normally done but the
e (Range Over) result is over Technic
Technical
al Range. allowed
t
h
o The color will be changed from (Green) to (Blue).
d
‘
s
s It means that all methods have been completed (STB error is deemed
t
a
t
u Light Blue as normal completion.).
s The measurement has completed and its concentration conversion Allowed
i
s (Process
d Complete) has been normally done, all methods are within the technical range.
i
f
f
e The color will be changed from (Green) to (Light blue).
r
e
n It means that the process from sampling for the first method to the
t
.
Green sampling for all methods has done (Except for occurrences of rerun,
Not
(Sampling errors and range over.).
allowed
Started) The color will be changed from (White) to (Green) at the time that
the sample has been dispensed in cuvettes.
It means that all methods are unprocessed sampling.
If the sample barcode can be read and its order is registered, the
White color will be changed from (Grey) to (White) and the status means that Not
(Not it is waiting for a sampling process. allowed
Processed) Meanwhile, it remains (Grey) in the case that the barcode could not
be read.
Yellow It means that any test order is not registered.

(No test Although the sample barcode can be read, its order is not registered and Allowed
Ordered) the color will be changed from (Gray) to (Yellow).
(Yellow).
Low
It means barcode is not recognized and any test order is not Allowed
Dark Gray
registered for its ASP slot.
3.1 Run
3.1.1 Monitor
3-4
3.1.2 [Round]:Round
[Round]:Rou nd Monitor (Error Flags)
You can check both of the statuses, the unit control before start and an each sample’s condition in process.
(1)
<Reaction Process>
(2)
No. Descriptions
(1) IRU C
The temperature of the IRU is monitored with several sensors and represented temperature of them is
displayed on the screen.
◦
If any of which exceeds ±0.5 from 37 C, its temperature will be displayed in red.
Halogen Min
It will show a remaining time that the Halogen lamp will be
b e available (stable) by minutes.
Time at run started

It will display the measurement start time.
Estimated time at sampling complete

It will display the sampling estimated completion time.
Estimated time at run end

It will display the measurement completion time.
(2) <Operational Monitor List>

The measurement status of each sample will be shown.
Pos
This will display the sample position number at the IRU.
I RU.
PID
This is patient ID. It will be blank if it is not registered.
3.1 Run
3.1.2 Round
3-5
No. Descriptions
(2) SID
A sample ID will be shown.
On the list, the sample number will be displayed together with its number added measurement times and
repeat times.
Normal sample Nxxxxxxxxxxxxnn1 (3 to 12 digit display)

nxxxxxxxxxxxxnn1 (Pediatric)
Exxxxxxxxxxxxnn1 (STAT)
e8999xxxxnn1 (STAT & Pediatric)
On line sample Oxxxxxxxxxxxxnn1
oxxxxxxxxxxxxnn1 (Pediatric)
Normal Pediatric sample n8999xxxxnn1
STAT
STAT sample E99000xxxnn1
E99000 xxxnn1
e99000xxxnn1 (Pediatric)
STAT Pediat
STAT Pediatric
ric sample e990009
e990009xxnn1
xxnn1
Control sample C970000xxnn1
Standard sample S98xxxxxynnm
Multi-Standard sample M950000xynnm
Serial Dilution sample D93xxxxxynnm
Replicate sample R9400xx0111
r9400xx0111
r9400xx011 1 (Pediatric)
Orderless sample A920000xx11
Blank sample B9510000xnnm
Reagent Blank sample RB91xxxxx1nnm
“nn” indicates the measurement times, “m”
does repeat times, and “y” does the solution
number(1 to 7).
Method
The measurement method name will be shown.
<Reaction Process>
The reactive process in measurement will be shown by “*”.
R1: R1 Reagent dispensing completion
S: Sample dispensing completion
M1: R1 Stirring completion
O1: Photometry for the first half completion

R2: R2 Reagent dispensing completion
M2: R2 Stirring completion
O2: Photometry for the last half completion
Result
The measurement result (the concentration value) will be shown.
CN
The number of a cuvette used in measurement will be shown.
Error
When an error occurs, its error flag will be displayed with alphabets then the flag will be shown. If some
errors are duplicated, one of the higher priorities will be chosen to display.
3.1 Run
3.1.2 Round
3-6
Error Flags
Error Error
Descriptions Matter of error
ranks flags
<None> Normal
IE1 Requirement of ISE No correspondence for the measurement requirement is from
(1)
measurement is abnormal ISE.
IE2 Not received ISE
The measurement result from ISE could not be
b e received.
measurement result data
(2) SPS SPT nozzle clogging SPT becomes step-out on the IRU.
The liquid level of SPT is not detected or a hit of the bottom
SS Sample shortage
is detected in ASP.
SS Out of the range of the liquid The result of SPT liquid level detection is out of the range in
level of sample ASP.
Non detection of the liquid The liquid level of SPT is out of the range or a hit of the
SI1
level of sample discharge bottom has been detected in IRU.
Out of the range of the liquid The result of SPT liquid level detection is out of the range in
SI1
level of sample discharge IRU.
The liquid level of SPT is out of the range or a hit of the
SI2 Dilution sample shortage
bottom has been detected in IRU.
Out of the range of the liquid The result of SPT liquid level detection is out of the range in
SI2
level of Dilution sample IRU.
When R1 reagent aspirating, the RPT liquid level is not
R1S R1 Reagent shortage
detected or a hit of the bottom is detected.
Out of the range of the liquid When R1 reagent aspirating, the result of the RPT liquid level
R1S
level of R1 Reagent detention is out of the range.
When R2 reagent aspirating, the RPT liquid level is not
R2S R2 Reagent shortage
Out of the range of the liquid When R2 reagent aspirating, the result of the RPT liquid level
R2S
level of R2 Reagent detention is out of the range.
When dilution aspirating, the RPT liquid level is not detected
DS Dilution shortage
or a hit of the bottom is detected.
Out of the range of the liquid When dilution aspirating, the result of the RPT liquid level
DS
level of dilution detention is out of the range.
When wash solution aspirating, the RPT liquid level is not
WS Wash
Wash solution shortage
Out of the range of the liquid When wash solution aspirating, the result of the
t he RPT liquid
WS
level of the wash solution level detention is out of the range.
R1B No R1 reagent bottle R1 reagent bottle has not been registered.
R1S Volume Zero in R1 reagent The remaining volume of R1 reagent has reached zero.
R2B No R2 reagent bottle R2 reagent bottle has not been registered.
R2S Volume Zero in R2 reagent The remaining volume of R2 reagent has reached zero.
DB No dilution bottle The dilution bottle has not been registered
DS Volume Zero in dilution

The remaining volume of the dilution bottle has reached zero.
bottle
WB No wash solution bottle Wa
Wash
sh solution bottle has not been registered
WS Volume Zero in wash solution The remaining volume of the wash solution bottle has
bottle reached zero.
LOT Lot inconsistency The reagent lot number has not been inconsistency.
inconsistency.
SPW Failure of SPT wash SPT wash has been failed. Check the alarm to determine the
reason for its fail.
3.1 Run
3.1.2 Round
3-7
Error Error
Descriptions Matter of error
ranks flags
Method to Method washing, an operation in advance to R1,
R1W Failure of RPT 1 wash
has failed. Check the alarm to determine the reason for its fail.
Method to Method washing, an operation in advance to R2,
R2W Failure of RPT 2 wash
has failed. Check the alarm to determine the reason for its fail.
IRU temperature extremely ◦
(3) TE1 low IRU temperature < 37-2( C)

IRU temperature extremely ◦
TE2 IRU temperature > 37+2( C)
high
RCU temperature extremely ◦
TE3 RCU temperature > 15 C
high
ASP temperature extremely ◦
TE4 ASP temperature > 10 C
high
EST Anomalous measurement Error sampling stop. Check the alarm for the reason.
The reagent is no longer An expired reagent was used in the measurement
(4) EXP
valid.
STB Reagent stability expired Invalid reagent stability was used with the measurement.
The reason is that the measurement was taken by a method of
CTO Calibration expired which calibration has not been implemented within a setting
term.
The reason is that the measurement was taken by a method of
CXP Control expired which QC measurement has not been implemented within a
setting term.
(5) An error of concentrations of No calibration curve, or ISE calibration ever has been
CA?
conversions. executed after the startup.
(6) An error out of the range of The value is not between Calibrator’s minimum and
OVR
calibrator. maximum.
LIN Linearity Limit Error Linearity Limit Error
PRO Prozone Limit Error Prozone Limit Error

AB1 Absorbance Limit1 Error Only one of the measured values is in Absorbance Limit.
After the first 3 points of the measured value that are out of
(7)
Absorbance Limit, and also more than 2 points of the measured
AB2 Absorbance Limit2 Error value are out of Absorbance Limit. But when more than 8 points
of the measured value are within Absorbance Limit, “AB2” flag
is not applied to the result.
Using the different lot Used reagent lot number in the specimen or control
CLT measurement has been different from the reagent in the
number of R1 or R2
calibration measurement.
The measurement was taken by sample type of each method
(8)
that does not match the sample type.
STM Sample type Inconsistent
The concentration value was converted with a calibration
curve that does not match the sample type.
(9) DUP Duplicate Limit Error Duplicate Limit Error
SEN Sensitivity Limit Error Sensitivity Limit Error

An operation of calibration has filed in shortage of points etc.
CAL Failure of calibration
(*) In an error, a Concentration value (or the measurement value) will be shown by “*****”.
The priority of each error rank should be (1)> (2)> (5)> (6)> (3)> (4)
(4)>> (7)> (8)> (9).
The errors from (1) to (4) are that has been occurred in the main analyzer, and the errors from (5) to (9) are that has
been detected in the UI side.
3.1 Run
3.1.2 Round
3-8
The descriptions for ISE error codes are provided with the following list.
The code consists of 4 bytes. When the numeric value of each byte is converted into binary numbers, each method of
the following case may be error.
In the case the Bit 0 (0x01) is ON, the measurement value for Na will be shown by “*****” if Na error.
In the case the Bit 1 (0x02) is ON, the measurement value for K will be shown by “*****” if K error.
In the case the Bit 2 (0x04) is ON, the measurement value for CI will be sshown
hown by “*****” if CI error.
All the three methods are considered error unless the value has set with from “0 to 7”. This will be applied except that
the value from “K” to “R” for the byte
b yte 4 is effective.
Byte1 Byte2 Byte3 Byte4

Out of Range
Noise or Air
Noise or Air for Sample / Out of Range and/or Na Error for
for Sample / Drift in Cal A
for Cal A Cal B and Urine Only (Note１)
Cal B
Urine
ISE No error 0 0 0 0
Noise, Na 1 1 1 1
Drift or
K 2 2 2 2
Out of
Range Na, K 3 3 3 3
Cl 4 4 4 4
Na, Cl 5 5 5 5
K, Cl 6 6 6 6
Na, K, Cl 7 7 7 7
ISE(D) Na Urine error
No error 0 0 0 0 K only, no out of
range error
Noise, Na 1 1 1 1 L
Drift or
K 2 2 2 2 M
Out of
Range Na, K 3 3 3 3 N Na Urine error
Cl 4 4 4 4 O and out of range
error
Na, Cl 5 5 5 5 P
K, Cl 6 6 6 6 Q
Na, K, Cl 7 7 7 7 R
Air S (Note2) A －－－
B (Note2) －－－－
ISD (D) is basically uses error codes from “0 to 7”. However, “K” is used for a case as Na error and no range
(Note 1):
over, from “L to R” are used for another case as both Na errors and range
r ange over
over..
(Note 2) :”S” indicates aeration when sample dispensing, “B” does when Cal B dispensing either
eit her..
3.1 Run
3.1.2 Round
3-9
3.1.3 [Selection]:Test Selection

Selectio n
The orders of the outer and inner circumferences are registered.
(2)
(4)
(1)
(3)
(5)
No. Descriptions
(1) <Order List>

The order list will be shown. To edit the order, click to chose some orders on the list.
list.
“Pos” column:
The sample position number of the outer and middle positions in ASP will be shown. The Pos will be
shown from 1 to 72, and after that the registered orders in “Sample Barcode Exist” will be displayed.
“SID” column:
A sample ID will be shown.
<Untitled> column:
Unique name attached to the sample will be shown.
Such as PID, Control name, Reagent name, Multi-standard name, “REP”, “ISE STD”, “ISE CLEAN”,
“ORDERLESS”, “BLANK” and “SPT WASH”.WASH”.
(You
(You can register a set
setup
up for the ASP center circumference on the [Run (F5)] – [Std QC] menu.)
3.1 Run
3.1.3 Selection
3-10
No.
No. Descriptions
(2) Pos (Upper)

Choose an ASP position.
The outer circumference 36 (1－36)
The middle circumference 36 (37－72)
Specify an ASP position for order input.
When you order by specifying the Pos, it will be considered as “Sample Barcode Reader not exist Order”.
When you order by Pos with blank, it will be considered as Sample Barcode Reader exist Order”.
In that case, it is only available to register Normal, STA
STAT,
T, Replicate and Online sample order.
Pos (Lower)
Enter the end position of the copy and the repeat deletion (1 to 72).
Type
Choose a type of setting object by means of drop-down menu.
The following types can be selectable by means of the drop-down
drop-do wn menu.
Normal
STAT
Replicate
Standard
Multi Standard
Serial Dilution
Blank
Control
Mask
Orderless
Online
ISE Calibration
ISE Cleaning
SPT Wash
Cup
Specify attribute sample by means of drop-down menu.
Select either one of “Normal” or “Pediatric”.
Choosing “Pediatric” means that the Pediatric process will be taken by the sample number of Normal
sample and STAT sample.
BCR
Choose a mode for keyboard BCR use.
As the barcode reader accommodated to connect a keyboard, you can input SID with full digits to tur
turnn this
check mark ON. At this time, the upper digits of SID will turn blank in a Normal sample case, and some
information such as “Type” will automatically change depending on the reading SID number.
C/D
Package registration (by Save button) and delete (by Delete button) orders will be available in a specified
range with this check mark ON.
You can specify “Pos (End Number)” and the “SID (End Number)” then.
Meanwhile, it will be able to use the Save button and Delete button to register or delete an each sample
with this check mark OFF.
OFF.
In addition, the both of ”Pos (End Number)” and “SID (End Number)” will be prohibited the designation.
E
Specify an emergency sample.
Specify a STAT
STAT sample remaining its ”SID” as a Normal
Nor mal sample.
This is only effective for Normal sample.
SID: Upper
Input a sample ID (Should be within alphanumeric 12 digits).
digits ).
SID: Lower
Input the last sample ID to be copied or deleted when the “C/D check box” is ON.
3.1 Run
3.1.3 Selection
3-11
No.
No. Descriptions
(2) PID
You can input a patient ID
I D (Should be within alphanumeric 20 digits).
Choose a registered patient ID from the drop-down
drop-do wn menu.
If your input PID is not registered, the patient information settings is automatically popped up so that you
can newly create the patient information for the inputted PID.
Collection date
Choose a drawing blood date from the drop-down calendar.
Physician
Choose an attending physician (or an archiater) from the drop-down
drop -down menu.
Physician can be created in the tab menu [Define] of the job menu [System (F9)] in advance.
Department
Choose a department from the drop-down menu.
Department can be created in the tab menu [Define] of the job menu [System (F9)]
(F9) ] in advance.
Sample Comment
Choose a sample’s comment from the drop-down menu.
Sample’s comment can be created in the tab menu [Define] of the job menu [System (F9)] in advance.
Sample
Choose aa sample
Choose sampletype.
category from “Common”, “Serum”, Urine”,” Plasma” displayed on the drop-down
menu. It will display the measurement methods for each selecting sample type and then switch over the
screen.
Range
Specify the Normal Range to use for judgment of the
t he result.
Need to be chosen from Human Auto (Auto), six types of Human (each 3 Generations in both Sexes) and
other 44 types. The default setting is Human Auto.
No.01 to 06 are fixed as follows.
01: Male-G1
02: Male-G2
(This standard value should be applied if no age and no sex have been specified in Human Auto.)
03: Male-G3
04: Female-G1
05: Female-G2
06: Female-G3
The No.07 to 50 are available to select only for ranges
r anges of which name has been registered on the tab menu
[Range] of the job menu [System (F9)].
MS: This item is only output when you select “Multi-Standard” in “Type” selection.
By choosing a set name shown on the drop-list, the check box of measurement methods registered in each
set will be shown as “ON”.
Control: This item is only outputted when you select “Control” in “Type” selection.

“Type”
It will be shown when you select the Control in “Type
“Type”.
”.
Choose a control sample from the drop-down menu.
3.1 Run
3.1.3 Selection
3-12
No. Descriptions
(3) <Measurement methods specification>

(1) In the case of setting of Normal, STAT
STAT and Replicate sample’s measurement order
Specify measurement methods (Standard, ISE, SI and Profile).
It is available to select methods registered on each menu of Normal, ISE, SI, and Profile. Methods
which reagents have not been registered or which reagents have been shortage will not be displayed.
Methods which calibrations have not been executed or which calibrations have been expired will be
displayed in red. However, methods which calibration types are “Factor”
“Factor” will not
not be checked.
Methods which Control have not been executed or expired will be shown in yellow.
Methods which Calibrators have been expired will be shown in orange.
Note: The priority levels are;
“Calibration expired” > “ Control expired” > “Calibrator expired”
ISE methods will be displayed differently by types specified in “Sample”.

Common :It is possible to choose from ISE or ISE (D).
Serum and Plasma :It is only available to choose ISE.
Urine :It is only available to choose ISE (D).
All the measurement methods in Profile will be displayed with underline when you choose “Profile”.
Move a mouse pointer to any of Profile
P rofile methods and the registered measurement methods in Profile
Pro file will
be shown in a hint box..
(2) In the case of setting of Control sample’s measurement
measurement order
By choosing a control name from the drop-down menu, check boxes of registered methods will be
changed ON. These measurement methods cannot be modified here.
(3) In the case of setting of Standard sample’s
sample’s measurement order
Choose a sample type from the drop-down menu and the registered method will be displayed. Then
you can specify a measurement method here.
(4) In the case of setting of Multi-Standard sample’s measurement
measurement order
Choose a Multi-standard name and sample type and measurable methods will be checked and
displayed set on the “Multi-Std” screen.
Measurement methods cannot be modified here.
(5) In the case of setting of Blank sample’s measurement
measurement order
Choose this order and the measurement methods used for Blank sample will be shown.
Measurement methods cannot be modified here.
(6) In the case of setting of Masking
By check-OFF on this setting, it will mask the measurement methods.
The mask information is not eliminated even when the measurement has been completed.
From the next measurement, the previous setting will be displayed.
The Mask order you set will be applied to all the samples.
(7) In the case of setting of Orderless sample’s measurement
measurement order
Specify methods that you will measure in all methods measurement (Shift+F1).
Click the check box ON to implement measurements.
(8) In the case of setting of Online measurement order
In “Online Batch” mode, click the Acquire orders button and sample order information will be
transferred from the host computer. The order list will be updated by receiving data.
When you measure any samples without a sample barcode in “Online Real Time” mode, you have to
register a “SID” for each “Pos” in advance.
In case that the received Online Orders and the registered orders on the screen match, the orders will
be determined. However, if they don't match, the orders will be an error and then it will not be
determined (result in fail).
An “SID” received from the host computer becomes an “SID” added to the error err or message
(9) In the case of setting of ISE Calibration, ISE Cleaning and SPT Wash
Specify an ISE Calibrator, ISE wash solution and a position for
f or SPT special wash solution.
You can execute each performance on the [Monitor] screen or the [Sequence] screen of the job menu
[Maint (F10)].
3.1 Run
3.1.3 Selection
3-13
No.
No. Descriptions
(4) Number
Specify Normal samples / Replicate samples when you repeatedly measure.
Choose a number from 1 to 99 on
o n the drop-down menu.
Note that Auto Rerun will not be performed when this number is two or bigger.
bigger.
(5) Rotation ASP

When the STAT (F3) button is clicked for the sample addition (Emergency or Normal), this button
becomes available to move the ASP slot.
Acquire orders
Receive host orders.
Click this button and the analyzer will start to receive the order information from the Host computer.
Normal and emergency samples are available. QC samples are also available in Online Real m mode.
ode.
During receiving orders from the host, the message of “Receiving Orders.” will be displayed in the
“Mode” box at the upper right of screen.
Delete
Delete the order of the selected sample ID.
All samples from Start Sample ID (start position) to End Sample ID (end position) will be deleted at once
with the C/D function.
A confirmation massage will notify you to complete delete process.
To press the OK button will continue the delete and to press the Cancel button will be dissolved the
deletion.
Save
Order settings will be saved.
Order information of Start Sample ID (start position) will be copied from the Start Sample ID to End
Sample ID (end position) with the C/D function.
Cancel
It will cancel editing data and original data is available.
Print
It will print out the registered orders
ord ers when you specify the range of sample numbers you need.
Mask All
All / Clear All
Both buttons will be only available on the mask order
or der screen.
By clicking the Mask All, all the measurement methods will be masked (Their check boxes will become
“OFF”). At the same time, the button name will switch over the Clear All.
By clicking the Clear All, all the measurement methods that have been masked will be released (Their
check boxes will become “ON”). Associated
Associated with this, the button name will switch
s witch over the Mask All.
3.1 Run
3.1.3 Selection
3-14
3.1.4 [Result]:Measurement
[Result]:Measu rement Results
On this screen, you can retrieve the measurement results
res ults and testing count for each sample
sa mple type then display it, print it
out and send it to the Host computer.
3.1.4.1 Measurement Result

(A) In the case of selection “All” in the “Sample Type”
(1)
(2)
(3)
(B) In the case of selection “Control” in the “Sample Type”
(1)
(2)
3.1 Run
3.1.4 Result
3-15
No. Descriptions
(1) Sample Type

Specify a sample type.
Choose a type from the following: All, Normal, STAT, Online, Standard, ISE Standard, Control, Replicate,
and Test Number.
Normal, STAT, Online, Replicate and Control sample’s results will be outputted when you select “All”.
“Standard” includes “Serial Dilution” and “Multi-Standard” and Blank sample.
Sample
Select a sample type.
Choose a type from the following: All, Common, Serum, Urine and Plasma.
”Common”, “Serum”, “Urine” and “Plasma” will be subject to retrieve when you select “All”.
<ID select>
Select an ID (SID, PID, Name or Medical Chart) for a search.
“Name” & “Medical Chart”
C hart” can be selected when Sample Type is “Normal”, “STAT” or “Online”.
▪ 12 digits will be available in both “From” and “To” boxes on the screen when you select a SID.
▪ 20 digits will be available in both “From” and “To” boxes
boxes on the screen when you select a PID.
PI D.
The content of “From” and “To” boxes will be cleared when its ID is changed.
From / To
Specify the range of a search SID or PID,
PI D, depending on the selection of ID select.
Input it within 20 alphanumeric digits. (Should be the Start number (From)
(Fro m) ≤ the End number (To))
“*” (Asterisk) can be used for the wildcard character and all SID / PID will be target with “*”.
Date From / To
By pulling down the drop-down menu, set a date from
fro m the calendar.
[From]: Input a search start date.
If the “Disable” check box is ON, you don’t have to input the date. In that case, all data you have
will be target.
[To]: Input an end date.
If the “Disable” check box is ON, you don’t have to input the date. In that case, the latest date
will be the end date.
Round#
Specify a round number for search.
Round number1 - 99 can be entered.
The first measurement in a day will be Round 1, the second measurement will be Round 2 and the third
measurement will be Round 3. Round number is a serial measurement number in a day.
“*” (Asterisk) can be used for the wildcard character and all rounds will be target with “*”.
Method (for Control result extraction)
Choose a method name for the result of the
t he control measurement.
This selection method is only appeared on the screen when “Control” is specified in the “Sample Ty
Type”.
pe”.
Refer to previous page “(B) In the case of selection “Control “ in the “Sample Type”.
Name (for Control result extraction)

The name of the selected “Method” will be shown.
Refer to previous page “(B) In the case of
o f selection “Control “ in the “Sample Type”.
Send
Specify a result data type transferred to host computer from
fro m 3 types bellow.
This will be available when “Normal” is specified as “Sample Ty Type”.
pe”.
▪ ALL: all results
▪ OK : results which have been transferred successfully
▪ NG : results which have been failed to be transferred
tr ansferred
3.1 Run
3.1.4 Result
3-16
No.
No. Descriptions
(1) Select Test

Specify methods that you want to output for the search result.
res ult.
Clicking this button and the method select list will be displayed.
displayed.
Specify the measurement methods (light blue for effective / the background color for ineffective).
Result Output
Specify where to be output.
▪ Monitor: The result will be displayed on the Monitor.
▪ Normal Print: The result will be printed out with normal print format.
▪ Report Print: The results will be printed out with report print format. This format can be chosen
when “Normal”, “STAT”
“STAT” or “Online” sample is specified
sp ecified in “Sample Type”.
▪ File: The result will be printed out to a file. The … button will be available and you can
choose where to be output (saved).
▪ Patient history Print: The results w
will
ill be printe
printed
d out w
with
ith a history
history print format. This format can be chosen
when “Normal”, “STAT” or “Online” is specified in “Sample Type”.
▪ Host: This can be chosen when “Normal”, “STA “STAT”, “Control” or “Online” is specified in
“Sample Type”. However, when the “Off Line” is selected in the “Host Communication
Mode”, this “HOST” cannot be specified.
Search
This will execute result search.
The mouse pointer will be busy during search.
The search will be suspended if the search targets exceed more than 2,000. Change search condition and
search again.
Delete
condition.
Delete measurement results with specified condition.
Click this button and a confirmation message will be shown. Click OK button for implementing the delete, or
Cancel for cancel.
Select Output
Methods selected will be output.
Select measurement result in a Search Result List and thist his button will be available.
▪ Methods selected in a Se Search
arch Result List will be output.
output.
▪ Click a m measurement
easurement result an and
d press Space key,
key, then the mmeasurement
easurement result will
will be “Select” or
“Not Selected”.
▪ Press Ctrl key and click a m mouse
ouse at the same time, then a measurement result you select will be
“Select” or “Not Selected”.
▪ Press Ctrl key and click a mou mousese at the sam
samee time, it is possible to select all the range
range between the
line selected in the last and the line selected now
▪ Keep pressing Shift key and click ↑ or ↓ key at the same time, it is possible to change change focus line
line to
the upper / lower line.
(2) Result
It will show the concentration of the measurement results.
Judgment
Normal range judgment selected in Search Result List will be displayed with
with “H” or “L”.
Range
Technical
Technical range judgment selected in Search Result List will be displayed with “<” or “>”.
Flag
The error status of the measurement result selected from
fro m Search Result List will be sshown.
hown.
The error status will be described in four digits consisted of three digits for error flag and one digit for rerun
flag.
E.g.) Error flag of a rerun
r erun for AB1 error will be displayed as AB1r .
3.1 Run
3.1.4 Result
3-17
No.
No. Descriptions
(2) QC Judgment
This will be available in selecting Control samples and show the QC judgment for the measurement result.
Judgment result will be shown by by three items and seven digits.
When there are two or more errors / warnings in QC Judgment, higher priority errors / warnings, up to
three, will be displayed in order from the left side of results.
ABS
The absorbance value of measurement result is shown selected from Search Result
Res ult List.
This ABS will not be displayed in “Standard” or “ISE Standard” as sample type.
Conc (S)
The concentration value of measurement result is shown selected from
fro m Search Result List.
This value will be shown in “Standard” as sample type..
Delete
This will delete the measurement result selected in Search Result List.
Press this button and a confirmation message will be shown. Press OK button for implementing the delete and
Cancel button for cancel.
Output Time Course Graph

This will display time course GRAPH of the measurement result selected in Search Result List.
Output Time Course Print

This will print put time course DA
DATA
TA of the measurement result selected in Search Result List.
Output Time Course File

This will output time course DATA of the measurement result selected in Search Result List to a specified
file with CSV Format.
(3) <Search Result List>

Searched measurement results will be shown here.
Date: Measured Date
Round: Round Number
PID: Patient ID (Control Name for Control sample)
SID: Sample ID
Method: Method Names
Result: Measurement results
You can confirm data in

i n process here.
3.1 Run
3.1.4 Result
3-18
3.1.4.2 Testing Count

L1 and L2 user cannot open this menu.
In the tab menu [Result] of [Run (F5)], when the “Test Number” is selected in the “Sample Type”, the test
counts for all sample types (Normal, Online, STA
STAT,
T, Replicate, Standard, Control, Blank, ISE Calibration, ISE
Cleaning and Reagent Blank) which measuring result have been obtained are listed on the screen.
The testing count data is saved in the system for one year, therefore, past data over one year is
automatically deleted from the system storage when the system becomes “Sleep Mode” or the Shutdown
process starts. And the file name of saved data is created automatically as
“TESTCNT20060309104321.DES”.
TESTCNTyyyymmddhhmmss[n].DES
TESTCNT: Specific characters

yyyy: Year (4 digits numeric number)
mm: Month (2 digits numeric number)
dd: Day (2 digits numeric number)
hh: Hour (2 digits numeric number)
mm: Minute (2 digits numeric number)
ss: Second (2 digits numeric number)
[n]: Division number, if necessary
Refer to (1) of the A) Measurement Result.
Testing count list of each measurement method
Total testing count of measurement method.
Sample count of the sample type
Sample type of measurement

3.1 Run
3.1.4 Result
3-19
3.1.5 [Inventory]:Reagent
[Inventory]:Reag ent Remaining
Remaini ng Volume
This manages reagents set in Reagent Container Unit (or
(o r RCU).
(1)
(2)
No. Descriptions
(1) <Reagent List>

Pos: Click this column and
and “Pos” column is rearranged by numerical
numerical order
order..
This shows the number of RCU position.
The outer position: 1 – 30 / The middle position: 31 –60
Name: Click this column and “Name” column is rrearranged

earranged by alphabetical/numerical order.
This shows registered reagent names.
names .
Reagent names will be displayed by RCU scan or a manual input of a barcode.
Type: Click this column and “Ty

“Type”
pe” column is rearranged by alpha
alphabetical order.
betical / numerical order.
This shows a reagent type.
Lot: Click this column and “Lot” column is rea

rearranged
rranged by alphabetical / numerical order.
numerical
This shows Lot Numbers.
Reagent barcodes which do not include Lot Numbers will be displayed with * (asterisk
( asterisk mark).
3.1 Run
3.1.5 Inventory
3-20
No. Descriptions
(1) Size: Click this column and “Size” column is rearranged by alphabetical / numerical order.
This shows reagent bottle sizes.
The “Pos”
“Pos” number 31 – 60 can be used for 20ml bottle only.
Vol (mL)
( mL): Click this column and “V
“Vol i s rearranged by alphabetical / numerical order.
ol (mL)” column is
This displays the remaining volume of the reagent (unit: 0.1mL).
Those lines which reagents have been run short will be display
d isplay in red.
Remaining volume of reagents registered for the first time will be displayed as the maximum size of an
each bottle.
Tests: Click this column and “Tests” column is rearranged by numerical

nu merical order.
This shows the number of tests you can measure with each reagent and the number depends on a method
which needs a reagent the most.
This tests number will be displayed in pail color when measurement has not been performed due to
uncertain remaining volume.
Method: Click this column and “Method” column is rearranged by alphabetical / numerical order.
Reagents names which methods use will be displayed.
If same reagents are used for different methods, methods which use the reagents the most will be
displayed.
It will become blank when “Wash “ is selected in ”Type”.
Total: Click this column

col umn and “Total” column is rearranged by numerical order.
Number of tests which is available for measurement will be displayed.
If measurable number of tests is less than 1 (test), the whole line will be displayed
d isplayed in red.
Valid: Click this column and “Valid” column is rearranged by alphabetical / numerical order.
“Valid”
This shows the validation date (Day / MoMonth
nth / Y
Year)
ear) for the reagent.
Double click this date and you can change the date.
When barcodes do not specify an expiry date, the expiry date will be proceeded with blank and need to set
an expiry date manually
manually..
Put * (asterisk mark) not to specify
sp ecify valid date.
In case expired, the whole line will be displayed in pink.
Stability : Click this column and

a nd “Stability” column is rearranged by numerical order.
This displays remaining days
d ays of reagent stability.
This stability check will be available when “Stability Check” of [System] - [Reagent] is set ON and
“Term”
“Term” is set to more than one day. This Stability is calculated based on “ Valid”
Valid” and the current date.
Stability 0 (zero) means the last day for stability. When stability day becomes less than 0 (no remaining
days), minus (-) will added to stability
s tability day
day.. (-1, -2, -3….)
The whole line will be displayed in yellow when expired.
This stability will be displayed with blank when stability check is not set.
BCR : Click this column and “BCR” column is rearranged by alphabetical / numerical order.
This shows reagent barcode data and can be modified manually
manually..
It is not allowed to enter same barcodes as are registered already.
already.
Remaining volume, stability and tests will be recovered
r ecovered when the same barcodes number is re-entered.
3.1 Run
3.1.5 Inventory
3-21
No. Descriptions
(2) RCU Scan

This button is used to scan bottles set in the RCU. Barcodes of bottles will be read and reagents will be
registered to the analyzer automatically.
RCU Scan will start when you press this button.
Barcodes by entered manually will be overwritten with barcodes by RCU Scan at the same RCU position.
If no reagents have been set in the same position,
po sition, barcodes entered manually will be remained.
RCU Scan will not delete any reagents.
Automatic RCU Scan (when RCU lid is opened / closed) can be set in the tab menu [Setup] of the job
menu [System (F9)].
Save
This button will save the edited data in this screen.
s creen.
Cancel
This button will not save the editing data.
Delete
This button will delete the information of selecting position (items).
( items).
Press this button and you will see a confirmation massage on the screen. Choose OK button to implement
Press
the delete and Cancel for cancel.
Print
Click this button and the information about reagent inventory is printed out. But this function works only
during ready state (not run state).
Print format example is shown below.
Header is set in the [setup] of [System

[ System (F9)] in advance.
ABCDEFGHIJKLMNOPQRST 2006/03/09 11:21

Inventory
Size Vol
Pos Name Ty
Type
pe Lot (mL) (mL) Tests Method Total Valid STB BCR
01 400RUN R1 999 100 94.8 441 400RUN 441 2007.12.31 50 100012180101200010
02 400RUN R2 100 68.3 1050 400RUN 441 49 100012380101200014
03 SPTS R1 100 94.8 441 SPTS 441 39 100022180108700015
04
Volume Reset
This button will reset reagent’s remaining volume of position selected.
Click this button and you will see a confirmation message on the screen. Click OK button to implement the
reset of the remaining reagent volume and the maximum volume of the registered reagent amount will be
set. Cancel button will cancel the procedure.
Clear added information

Set Reagent Lot Number & Valid
Valid Date to the initial value (* mark).
3.1 Run
3.1.5 Inventory
3-22
3.1.6 [Sleep Scheme]:Sleep

Scheme]:Sleep Conditions
Operations before and after sleep can be defined on this screen.
(1)
(2)
(3)
No. Functions
(1) <Start-up
<Start-up time Setting>
Specify time for preparation
pr eparation operations to start each day
d ay..
Time
Specify a start-up time. Set the time on 24 hours and this operation will start at tthe
he time set.
Prep
Select one operation from 3 types of (Prep1, Prep2
Pr ep2 and OFF) in the drop-down menu.
3.1 Run
3.1.6 Sleep Scheme
3-23
No. Descriptions
(2) After Sleep

Specify settings processed in start-up operation.
Prime
Specify number of Prime. (0 - 5 times.)
SPT Wash “(W)”/ “(S)”

Specify number of the SPT cleaning times. “(W)” means the SPT will be washed with system water and
“(S)” means the SPT will be washed with wash solution.
Number of the wash times can be chosen from 0 to 5 and SPT wash
wash will not be executed when zero.
Note that you cannot select both “(W)”
“(W)” and “(S)” at the same time.
RPT1, or 2 Wash “(W)”/ (“S)”

Specify number of the RPTs cleaning times. “(W)” means the RPTs will be washed with system water and
“(S)” means the RPTs will be washed with wash solution.
Number of wash times can be chosen from 0 to 5 and RPTs
RPTs wash will not be executed when zero.
zero.
Cuvette Wash “(W)”/ (“S)”

Specify number of cuvettes cleaning times. “(W)” means cuvettes will be washed with system and “(S)”
means cuvettes will be washed with wash solution.
Number of wash times can be chosen from 0 to 5 and cuvette
cuvette wash will not be executed when zzero.
ero.
RCU Scan
Specify whether or not to implement RCU Scan.
RCU Scan will be executed after Sleep mode is released if RCU lid’s is opened during Sleep mode with
this RCU Scan.
(3) Save
This will save the editing data.
Cancel
This will cancel to save the editing data.
3.1 Run
3.1.6 Sleep Scheme
3-24
3.1.7 [Std QC]:Order for Standard or Control samples

You can register orders for the inner position in ASP
ASP..
Orders registered on this screen will not be deleted after measurement or Shut Down.
Samples registered here will be measured prior to samples
sa mples on [Selection].
(1)
(2)
(3)
No. Functions
(1) Pos
Specify an ASP position to place a sample. (I01 – I20)
Type
Specify a sample type.
Select one type on the drop-down menu: Standard / Multi-Standard / Serial Dilution / Control / Blank /
ISE Calibration / ISE Cleaning and SP
SPTT Wash.
Wash.
Specify sample positions of ISE Calibration, ISE Cleaning and SPT Wash and proceed each operation on
[Run (F5)] – [Monitor] or [Mainte (F10)] – [Sequence].
No.
This item will be shown when you select a method of calibration curve except Factor at Standard or
Multi-Standard.
Choose number of calibrators when each concentration of calibration curves is registered individually
i ndividually..
Choose “Full” if you register all calibrators.
3.1 Run
3.1.7 Std QC
3-25
No. Descriptions
(2)
<Sample>
Select a sample category on the drop-down menu: Common / Serum / Urine / Plasma.
Select sample category and each measurement method that has been registered will be displayed on the order
list.
<Auto>
Measurement will be started automatically in those modes bellow
bellow..
This function will be applied for Standard / Multi-Standard / Serial Dilution / Control
Co ntrol / Blank samples.
Invalid The measurement of this test order is suppressed.
Start The measurement is automatically performed when the first round of this test order is started.
After the measurement is completed, this selection is changed to “Invalid”.
Auto At the time when the lot number of reagent is changed or the time-out period for calibration
goes over, the measurement of this test order is automatically performed. These conditions
should be set in the tab menu [Calibration] – [Reg Calib] in advance.
Start + Auto The measurement of this test order is automatically performed when the first round of this
test order is started or the lot number of reagent is changed or the time-out period for calibration
goes over. These conditions should be set in the tab menu [Calibration] – [Reg Calib] in
advance. After the measurement is completed, this selection is changed to “Auto”.
<Order List>
An order list will be displayed and can be edited to select orders.
This shows orders clicked from the list become editing targets.
l ist and these orders will become
Pos : ASP position
SID : Sample ID
<Methods>
Methods will be displayed as test orders. These methods can be edited in Standard / Multi-Standard / Serial
Dilution samples. Methods names will not be displayed in ISE I SE Cleaning / SPT Cleaning.
(3) Delete
This button will delete the information of position selected.
Press this button and you can see a confirmation message on the screen. Choose OK button for
implementing the delete and Cancel for cancel.
Delete All
This button will delete information of all positions.
Press this button and you can see a confirmation message on the screen. Choose OK button for
implementing the delete and Cancel for cancel.
Save
Click this button to save editing data.
Cancel
Click this button to cancel to save editing data.
Print
Click this button to print out a list for registered orders by
b y specifying sample numbers.
3.1 Run
3.1.7 Std QC
3-26
3.1.8 [Patient]:Patient
[Patient]:Patient Registration Information
The screen of Patient Registration Information
(2)
(1)
(3)
No. Descriptions
(1) <Patient registration information >

Patient ID
You can input patient ID. (Should be less than 20 digits iin
n alphanumeric)
Having been registered the information of the patient, its details will be displayed automatically and the
cursor will move to the target ID.
Patient Name
You can input patient name within 18 digits iin
n alphanumeric.
All space codes are unacceptable.
Classification
Select a class from a drop down
do wn menu. Classes need to be defined on [System] – [Define] beforehand.
Ward
Select a ward from a drop down menu. Wards need to be defined on [System] – [Define] beforehand.
Bed No.
Input a bed number within 10 digits in alphanumeric.
Blood Type
Select a blood type from a drop down menu.
3.1 Run
3.1.8 Patient
3-27
No.
No. Descriptions
(1)
Medical Chart
Input a medical chart number within 10 digits in alphanumeric.
Social Security #
You can input social security number within 13 digits in alphanumeric.
Date of Birth
Input
Whendate of birth.
Disable check is “ON”, the box will be space.
Age
This is an age calculated automatically based on its birthday.
Sex
Choose one on the drop-down menu from the value, Male / Female / Space (or Non specified).
Race
It can be selected from the drop-down menu.
The registration for your selecting value is available in the tab menu [Define] of the job menu [System
(F9)].
Comments
You can enter comments within 40 digits in alphanumeric.
Reference 1
You can input any comments within 10 digits. The title “Reference 1” will be defined on [System] –
[Define].
Reference 2
You can input any comments within 10 digits. The title “optional 2” will be defined on [System] –
[Define].
(2) <Patient information list>

This displays the information of the registered
r egistered patients.
In “Record Count”, number of the patients will be shown.
s hown.
Select a patient and the patient’s information will be shown on the left side.
(3) Save
This will save editing information.
30,000 patients can be registered.
When your register over 30,000 patients, those patients will be deleted who have not had any history in
last 2 years (this will be prior)
prior ) or who are the oldest in the patient history
histor y record.
Cancel
This button will not save editing data.
Delete
Select this button to delete patient data.
Note that this will delete all the information related to the patient such as patient, sample, order and
measurement history.
3.1 Run
3.1.8 Patient
3-28
3.2 [Parameter (F6)]:Setup Menu 1
3.2.1 [Normal]:Chemistry
[Normal]:Chemistry Parameters
Parameters (1)
You can specify measurement conditions for each method.
(1) (4)
(2)
(5)
(3)
(6)
No. Descriptions
(1) <The specification of the method number>

Method
Specify
You canorselect
input methods
the number of a method.
registered from (1
the- 60)
list by pressing SPACE key or from the dropdown menu.
When you specify a method number, the method information will be displayed.
Name
Specify or input a method name within 6 digits with alphanumeric and signs.
You can select methods registered from the list by pressing SPACE key or from the dropdown menu.
When you specify the method name, the method information will be displayed.
All method names once registered will be displayed on the list (Max ( Max 200 methods).
Print Name
You can specify a method name to print within 15 digits with alphanumeric and signs.
Define a “Print Name” and the name will be printed out as a method name in printing
pr inting or file outputting. If
not (“Print Name” is space), method name will be printed the same sa me name as registered in “Name”.
Sample
Select a sample category
category.. You
You can specify Chemistry Parameter depending on its sample category.
Select a sample category from Common / Serum / Urine / Plasma on the list.
Select “Common” to set all sample’s conditions as the same.
Unit Specify a unit used for printing, host communications within 6 digits with alphabets and signs.
3.2 Parameter
3.2.1 Normal
3-29
No. Descriptions
(2) <Photometry settings>

Assay Type
Select a photometry method from “Rate” Method or “End” Method.
Measuring Points
Specify the photometry range by a measuring point number. You can specify 2 photometry ranges
depending on the measurement method, 1 - 34 and 35 - 68.
Photometry ranges will be specified by “Start” and “End” measuring points. “End” point needs to be
bigger than “Start” point.
However, if the measurement is “End” Method, “Start” point = “End” point will be allowed.
Check “Enable” box ON to use “Measurement range 2” and measuring range of Photometry range1 needs
to be smaller than that of Photometry range2.
Wavelength Prim.
Select a main wavelength for measuring. You can select from 12 wavelengths displayed on the dropdown
menu. (340 / 380 / 415 / 450 / 510 / 546 / 570 / 600 / 660 / 700 / 750 / 800)
Wavelength Sec. (Disable)
Select a sub wavelength for measuring.
Check the “Disable” box ON if you don’t use a sub wavelength.
(3) <The setting for sample dispensing>

Specify sampling conditions for samples. Check the “Diluent Check” box ON to use a sample diluent
function. Note that you need to register diluent solutions.
Normal
Specify sampling conditions for the first sample.
Sampling: Specify sample dispense volume from 2 to 35 μL (0.1 μL step)
Dilution: When you dilute the sample, check the box “ON”.
Specify dilute conditions.
Sample (μL): Input an amount of sample diluted from 2 to 35 μL (0.1 μL step)
Diluent (μL): Input an amount of dilute dispensing from
fro m 20 to 350 μL (1 μL step)
Rerun (High / Prozone): Define sampling conditions for a high value rerun.
Setting procedure is the same as above “Normal” description.
(μL)”.
When you don’t execute the high value rerun, input 0 in a box of “Sample (μL)”.
Rerun (Low): Define sampling conditions for a low value rerun.
Setting procedure is the same as above “Normal” description..
When you don’t execute the low value rerun, input 0 in a box of “Sample (μL)”.
(μL)”.
3.2 Parameter
3.2.1 Normal
3-30
NO. Functions
(4) < The setting for reagents dispensing >

Specify dispensing conditions for R1and R2 reagents. Check the “R2 Enable Diluent Check” ON to use R2
reagent.
Reagent Name
Click SPACE key to display reagents list or select a reagent from the dropdown menu.
Reagent (μL)
Specify an amount of reagent consumption.
The range for R1 reagent consumption is from 20 to 350 μL (1 μL step) and that of R2 is from 20 to 250
μL(1 μL step).
Water (μL)
μL step).
Specify an amount of dispensing pure water to dilute reagents. The range is from 100 to 350 μL (1 μL
This box should be blank (space) when reagents are not diluted.
Note that the total volume (sample, R1 / R2 reagents, R1 / R2 dilution) used for measuring should be between
150 and 450 μL.
μL.
Diluent Enable
Check the box “ON” to use diluents.
Click SPACE key to display diluents list or select a reagent from the dropdown menu.
Water
Input an amount of pure water to dilute reagents between 100 and 350 μL (1 μL step).
(5) <The setting for display or operational conditions>

Decimal Points
Specify number of decimal points for concentrated value used for display, printing, FD and host computer
output.
Select number from the dropdown menu (0 - 5).
Normal Range
This displays the setting information of Normal Ranges. (Maximum 50 types)
Input minimum and maximum values in Normal Range.
The value should be from 0 to 9,999,999 (number of digits specified in “Decimal Points” will be
effective ).
Min: Fla
Flag
g “L” w
will
ill b
bee attac
attached
hed with
with m
meas
easure
uremen
mentt res
result
ult when
when its
its conce
concentr
ntrate
ated
d value
value is unde
underr thi
thiss
value.
Max: Flag “H” will be attached with the measurement result when its concentrated value is over this value.
This Normal Range check (L / H) will not be available when Min / Max settings are 0 / 0.
Register Range Names at the [System (F9)] – [Range screen].
Settings for age ranges of each generation can be modified on the job menu [System (F9)] – [Setup2].
Technical Range (Conc.)
Input the minimum and maximum range for measurement range (a concentration).
When measurement result exceeds its minimum or maximum, the sign “>” or “<” will be added to the
result.
“Conc.” value specified in this list will be output as its minimum and maximum value and an automatic
rerun will be implemented when you set the automatic rerun function effective.
Technical Range (mAbs. /10)
Technical range set in the job menu [System (F9)] – [Setup2] is displayed.
3.2 Parameter
3.2.1 Normal
3-31
No. Descriptions
(5) SPT Wash

Specify a reagent name for SPT cleaning.
Click SPACE key to display the list or select a reagent from the drop-down menu.
Reagents registered as “Wash”
“Wash” in the job menu [System (F9(F9)]
)] – [Reagent] will be displayed.
Stirring Speed
Specify a stirring speed.
5 levels are available depending on the stickiness of the reagent.
UH: stirring for reagents that are extremely high stickiness.
VH: stirring for reagents that are very high stickiness.
High: stirring for reagents that are h
high
igh stickiness.
Middle: standard stirring.
Low: stirring for reagents that are low stickiness.
None: stirring OFF
(6) Copy
This will copy settings.
Click copy check box “ON” and specify a destination method to be copied with “Method” or “Name”.
Then press Save button and settings can be copied.
When “Sample” (sample category) of the destination method is “Common”, all sample categories will
be copied.
Save
This button will save editing data.
Cancel
This button will not save editing data.
Delete
This will delete selecting methods.
Press this button and a confirmation message will be shown and then click OK to implement the delete.
Click Cancel to cancel.
Print
Click this button to print out the condition list
li st for methods.
3.2 Parameter
3.2.1 Normal
3-32
Auto Rerun Conditions

Normal, STA
STAT and Online sample types will be implemented
implemented auto rerun.
Auto rerun conditions are as follows:
1. Error Flag (LIN, PRO, ABS)
Rerun will be implemented under the condition of “Rerun (High / Prozone)”
2. Technical Range (High)
Rerun will be implemented under the condition of “Rerun (High / Prozone)”.
3. Technical Range (Low)
Rerun will be implemented under the condition of “Rerun (Low)”.
(When two or more error flags (LIN, PRO, ABS) happens simultaneously, a rerun will be executed under
the condition of “Rerun (High / Prozone)”.
Sampling Volume Correction in rerun

You can set different sample volume in rerun from normal round and correction for results in rerun will be
done as follows:
[Results in Rerun after correction] = [Results in Rerun] × [Sample Ratio in Normal Round / Sample Ratio in
Rerun]
Sample Ratio in Normal Round = [S / (S

( S + R1 + R2)]
Sample Ratio in Rerun = [SR / (SR + R1 + R2)]
R1: R1 Volume
R2: R2 Volume
S: Sample Volume in Norma
Normall Round
SR: Sample volume in R
Rerun
erun (High / Prozone or Low
Low))
3.2 Parameter
3.2.1 Normal
3-33
3.2.2 [Normal 2]:Chemistry Parameters

Parameters (2)
(1)
(3)
(2)
(4)
(5)
No. Description
(1) Method
Select method number
number..
Select a method number from the list to press the SPACE key or choose a number from the drop-down
menu. You
You can also input a method number directly.
Specify method number and its information will be displayed.
Name
Method name will be displayed when you specify method number
number..
Sample
category..
Select a sample category
Choose a sample category from drop-down menu, Common / Serum / Urine / Plasma.
P lasma.
Select “Common” if you do not need to specify a sample category.
3.2 Parameter
3.2.2 Normal 2
3-34
No. Description
(2) <Limit Check>

Duplicate Limit
This is for dispersion check in duplicate / triplicate calibration measurement.
Input a threshold of an absorbance difference value (ΔABS) of each measurement result between 1 and
99,999 (mAbs / 10).
When ΔABS exceeds this threshold, DUP error will be displayed and calibration value will not be
updated.
Sensitivity Limit
This is to check sensitivity in calibration measurement.
Input a threshold of sensitivity range of the
t he ΔABS betwe
between
en 1 and 99,999 (mAbs / 10).
When ΔABS is under this threshold, SEN error will be displayed and the calibration value will not be
updated.
Linearity Limit
This is to check the linearity for a time course in Rate Method.
Input a threshold ratio between 0.1 and 99.9(%) in the left side and input a threshold value between 1 and
99,999 (mAbs / 10) / min in the right side.
Judgment
This judgment is decided by ratio (%) between the slope calculated by the moving average of previous
3 points measurement range and the slope calculated by the moving average of following 3 points
measurement range
.
(a) A span of Measurement range (the number of photometry points) = n (n≥4)
(b) The slope of the moving average 1 – 3, calculated by regression analysis: ΔABSfirst
(c) The slope of the m
moving
oving average (n - 3) - (n - 1), calculated
calculated by regression analysis: ΔABSlast
(e) The slope of the moving average 1 - (n - 1), calculated by regression analysis: ΔABSslope
Linearity Rate will become as follows:
[Linearity Rate] = [ | ΔABSfirst - ΔABSlast | / | ΔABSslope | ] × 100 (%)
When the linearity rate calculated is greater than the threshold, linearity error will be displayed and LIN
Flag will be attached to the result.
Measurement range applied for this linearity check will be the Measurement Range 1 for 1-point Rate
Method and the Measurement Range 2 for 2-point Rate Method.
This Linearity Limit Check will not be applied for following cases.
(a) Not Rate Method
(b) | ΔABSslope | Thresh
Threshold
old Value
(c) | ΔABSfirst - ΔABSlast | Threshold
Thres hold Value
points
(d) Measurement Range of photometry point is under 4 points
(e) Higher priority errors happen
(f) Sample Types are Control / ISE
3.2 Parameter
3.2.2 Normal 2
3-35
No. Descriptions
(2) Prozone Limit

This is to check a decreasing phenomenon (Prozone phenomenon) in high concentration of photometry.
Input a threshold value (limit rate) between
bet ween 0.00001 and 99.99999 in a ratio of reaction speed.
Specify a value from “Upper” or “Lower” by drop-down menu depending on max or min value in the
“Prozone Limit”.
Specify an absorbance rage and sensitivity;
(a) SL1 - S: the first
firs t number of measuring point of Slope Range-1
(b) SL1 - F: the last number of measuring point of Slope Range-1 (SL1S < S SL1F)
L1F)
(c) SL2 - S: the second number of measuring point of Slope Range-2
(d) SL2 - F: the last number of measuring point of Slope Range-2 (SL2S < S SL2F)
L2F)
(e) Sens: a number between 1 and 999,999 (mAbs / 10) for the sensitivity
When a result exceeds this limit, error

err or PRO Flag will be attached to the result.
Prozone check will no be executed in following cases;
(a) Control sample measurement
(b) Sensitivity does not exceed “Sensitivity Limit” value.
Absorbance Limit
This is to check a limit level of absorbance reaction.
This check will be applied to 1- point Rate Method.
Reaction
Specify a value “Increase” or “Decrease” from drop-down menu as reactive trend.
Limit
Input a number between 1 and 999,999 (mAbs / 10) as a threshold value.
Get an absorbance value within bellow conditions;
[Absorbance value of Primary

P rimary Wavelength
Wavelength]] – [Water
[Water blank of Primary Wave
Wavelength]
length] < [Threshold]
When absorbance value of all measuring points or all points except the first measuring point exceeds this
threshold, error AB1 Flag will be displayed.
When the first two or more points are within this limit and measuring points which exceed this limit are
within 1 minute, result (ΔABS) will be calculated by measuring points within the limit and add an error flag
AB2 to the result.
(3) < Blank measurement >

Blank measurement
Choose a calibration method for reagent blank from the drop-down list.
Disable reagent blank and S1 blank
This does not execute a calibration using a reagent blank or a S1 (zero concentration) blank.
Enable S1 Blank (Factor or Linear)
This executes a calibration using S1 blank.
Enable reagent blank
This will execute a calibration using reagent blank.
Enable reagent blank for S1 (Linear)
( Linear)
This will use reagent blank as S1 sample.
sa mple.
3.2 Parameter
3.2.2 Normal 2
3-36
No.
No. Descriptions
Measurement of Reagent Blank during Run
(3)
Specify time when to run Reagent Blank Measurement.
Choose whether Reagent Blank is executed or not in measurement.
Daily (Everyday)
When there are orders which Reagent Blank Measurement have not been implemented in a day, Reagent
Blank Measurement will be executed. Result of samples will be calibrated with this Reagent Blank.
Next Run (Every time)
Reagent Blank Measurement will be executed at the beginning of measurements of each round.
None (Invalid)
Reagent Blank Measurement will not be executed. (previous blank result will be applied as reagent blank.)
Reagent blank measurement at calibration
Specify whether to use system water as a sample or not on Reagent Blank Measuring.
Reagent blank (no sample)
Reagent Blank Measurement will be executed without sample.
Reagent blank (system water)
Reagent Blank Measurement will be executed with system water.
The number of measurement
Specify number of measurement for Reagent Blank Measurement.
Choose Single / Duplicate / Triplicate from the drop-down menu.
Reagent Blank Limit Checks
This will check the variation of Reagent Blank Measurement when Duplicate or Triplicate is selected.
Enter limit value, absorbance measurement differential (ΔABS), between 1 and 99,999 (mAbs / 10).
(4) Instrument Factor

Specify a slope (a) and intercept (b) to correct measurement result.
(a) is a slope and (b) is an intercept of linear equation, [Y = aX + b].
a: -99.9 to 99.9
b: -999.99 to 999.99
(5) Save
Cancel
Click this button not to save editing data.
3.2 Parameter
3.2.2 Normal 2
3-37
3.2.3 [ISE]:ISE Parameters

Parameters
You can specify measurement conditions for ISE.
(1)
(2)
(3)
No. Functions
(1) Sample
Select one category from Common / Serum / Urine / Plasma from drop-down menu.
Select “Common” when all sample categories are the same conditions.
ISE Type
Select one type from drop-down menu.
When sample category is “Common”, select “ISE”, or “ISE (D)”.
( D)”.
When “Serum”, or “Plasma” is selected as sample category, “ISE” should be selected.
When “Urine” is selected as sample category, “ISE (D)” should be selected.
Urine Diluent Reagent Name

Specify ISE diluent to use when “ISE (D)” is specified.
Select a diluent from drop-down menu.
Instrument Factor
Specify a slope (a) and an intercept (b) to correct the measurement result.
To correct the result with a liner equation [Y= aX + b], input slope (a) and intercept (b) of Na, K, and Cl.
a: -99.99 to 99.99
b: -999.99 to 999.99
3.2 Parameter
3.2.3 ISE
3-38
No. Descriptions
(2) Normal Range

Specify Normal Range.
Range.
Input the lower limit and the upper limit in normal value for Na, K, and Cl.
Validation Range: Na:0 to 999.9

K : 0 to 99.99
Cl: 0 to 999.9
Min: The flag “L” will be attache

attached
d with the measurement result when the result is under this
this value.
Max: The flag ““H”
H” will be attached with the measurement result when the result is over
over this value.
(3) Save
Cancel
Print
Click this button to print out setting list.
3.2 Parameter
3.2.3 ISE
3-39
3.2.4 [SI]:Serum Information Parameters

Define measurement conditions of the serum information.
(2)
(1) (3)
(4)
Criteria
Depending on assay method, high turbidity, hemolysis and bilirubin in serum may affect measurement results.
This analyzer can describe a degree of Turbidity (L), Hemolysis (H) and Icterus (I) of serum by numeric
expression. In addition, it is possible to display SI criteria as numeric value.
No. Descriptions
(1) Factor A to Factor F

Input a numeric value between 0 and 999,999 for Factor A, B, C, D, E and F.
Sampling Volume
Input a volume of dispensing sample ( μL).
Instrument Factor (H, L, I)

To correct results with liner equation (Y = aX + b), input each slope (a) and intercept (b) of H, L and
I.
a: - 99.9 to 99.9
b: - 999.99 to 999.99
Input “a=1” and “b=0” when correction

cor rection is not necessary.
3.2 Parameter
3.2.4 SI
3-40
No. Descriptions
(2) Reagent Type
Select a reagent type from drop-down menu, R1 or Dil.
Reagent Name
Select a reagent name from drop-down menu.
Volume
Input reagent dispense volume between 20 and 350 ( μL).
(3) <Abbreviations for SI criteria>

H: setting for Hemolysis judgments.
L: setting for Turbidity judgments.
I: setting for icterus judgments.
(The left side box)
Input an abbreviation of SI criteria. (Within 5 letters)
*Example for Hemolysis) If setting is “ 0 < 1”, the result will be “H0” when hemolysis is lower than
1.
(The right side box)
Input threshold value for SI criteria (between
(bet ween 0 to 999,999).
(4) Save
Cancel
Print
Click this button to print out a setting list.
The serum information will be calculated with following formula:
– 5
A, C, D are 10 multiplied values and B, E, F are 10 multiplied values.
(the value α ,β, γ, δ, ε are considered as λxxx. The λxxx means a value that an absorbance λrxxx of each primary
wavelength is corrected with water blank λwxxx.)
Moreover, you have to divide the value by 10 because units are different between the output of the measured
absorbance and the serum.
Take a 450nm case for an example.
λ450 = (λr450 -λw450) / 10
The default settings are:

α: 600nm
β: 700nm
γ: 570nm
δ: 415nm
ε: 510nm
3.2 Parameter
3.2.4 SI
3-41

3.2 Parameter
3.2.4 SI
3-42
3.2.5 [Calc]:Method-to-Method
[Calc]:Method-to -Method Calculation
Calculati on
You can define a method-to-method calculation.
(1)
(3)
(2)
(4)
No. Descriptions
(1) No.
Specify number of method.
Numbers for method-to-method calculations are 71 - 80 and 3001 - 3040.
Name
Specify a method name.
Input name with alphanumeric or symbol characters within 6 digits.
Specify a method name and information of the name will be shown.
Print Name
Specify a method name for printing.
Input print name with alphanumeric or symbol characters within 15 digits
This specified name will be printed out as the measurement name in printing or outputting. Method name
which you have defined in “Name” will be printed out if this Print Name is unset.
Sample
Select a sample category from Common / Serum / Urine / Plasma from drop-down menu.
Unit
Specify a unit used for printing or sending result data to host computer with alphanumeric or symbol
characters within 6 digits.
3.2 Parameter
3.2.5 Calc
3-43
No. Descriptions
(1) Decimal Points

Specify number of digits of decimal point of the concentration printed out as measurement result.
Select the number 0 - 5 (digits).
Expression
Input an expression formula.
Up to 10 methods can be used for one formula.
Select methods from a list and double click them, then those methods can be used to expression formula.
Expression formulas will be checked when registering and if there are any errors, the expression cannot be
registered.
(2) <The list of Normal Range>

Input a normal range.
Select the number you want to update from the list and double click it, then the number can be edited. The
lower limit should be less than the upper limit.
When the upper limit is not specified, the upper limit will not be checked and when the lower limit is not
specified, then lower limit will not be checked.
Results which are lower than the lower limit will have “L” and results which are higher than the upper
limit will have “H”.
(3) <The list of method numbers>

“+”, “-”, “*”, “/”, “(”, “)” buttons are available for this calculation.
Click these buttons and the buttons will be entered in the ”Expression”
”E xpression” cell.
The list of method numbers
Select a method name or number and double click them, then they will be entered in the expression.
(4) Save
Cancel
Cancel this button not to save editing data.
Print
3.2 Parameter
3.2.5 Calc
3-44
3.2.6 [Profile]:Profile
(1)
(2)
(3)
No. Functions
(1) No.
Specify number of a profile.
p rofile. Y
You
ou can register method numbers between 1 and 20. (20 types)
When a number you specified is already registered, profile name and methods will be shown.
Name
Input a profile name with alphanumeric or symbol characters within 6 digits.
Sample
Select a sample category from Common / Serum / Urine / Plasma
P lasma from drop-down menu.
(2) <The list of measurement methods>

The registered measurement method based on selected “Sample” (category) will be displayed.
Select measurement method(s) to apply in the profile and click the check box “ON”.
(3) Save
Cancel
Print
3.2 Parameter
3.2.6 Profile
3-45
3.2.7 [Order]:Measurement Order

You can define measuring or
orders
ders and print or
orders.
ders.
(1)
(2)
(3)
No. Functions
(1) <Measurement Order>
Specify a measurement order.
Drag a target method where you want to move and you can change measurement order.
Same Order
Check “Same Order” check box ON and the print order will be set as the same order as the measurement
order.
(2) <Print Order>

Specify a print order.
Drag a target method where you want to move and you can change print order.
Check “Same Order” check box ON and the print order will be set as the same order as the measurement
order.
(3) Save
Click this button to save editing data
Cancel
3.2 Paramter
3.2.7 Order
3-46
3.2.8 [Wash]:Nozzl
[Wash]:Nozzlee Wash Program
This is RPT nozzles wash program.
(1)
(2)
(4)
(3) (5)
(6)
No. Functions
(1) <Selecting target methods>

Select numbers of methods and Nozzle Wash Program will be performed between Method1 and
Method2.
Method1
Select a number of Mehod1 and check “ALL check box” if all methods are target.
Method2
Select a number of Mehod2 and check “ALL check box” if all methods are target.
(2) <Reagent setting>

Specify details for R1 (RPT1) and R2 (RPT2).
(RPT 2).
R1 -> R1
Define details of RPT1 wash program (from
(fro m R1 to R1 operations).
R2 -> R2
Define details of RPT2 wash program (from R2 to R2 operations).
3.2 Parameter
3.2.8 Wash
3-47
No. Descriptions
(3) <The setting Wash method>

Select a wash solution to use.
Sys. Water
Execute a wash program with system water (pure water).

Wash Bottle
Execute a wash program with wash solution in RCU specified in reagent bottle setting.
(4) <The setting reagent bottles>

Select a reagent bottle for this wash program.
Reagent Type
Select a reagent type from “R1”, “R2”, and “Wash”.
Reagent Name
Select a reagent name from drop-down menu.
(5) <The setting list>

Method list registered will be displayed.
You can select methods in this list and edit them.
(6) Delete
Click this button to delete contents selected.
Select this button and a confirmation message will be displayed. Then press OK button to execute the
delete and press Cancel button to cancel.
Save
Cancel
Print
Click this button to print out a setting list.
li st.
3.2 Parameter
3.2.8 Wash
3-48
This page is intentionally left blank.

3.2 Parameter
3.2.8 Wash
3-49
3.3 [Calibration (F7)]:Setup Menu 2
3.3.1 [Reg Calib]:Calibration

Calib]:Calibration
You can define a content of calibration for each measurement method.
(3)
(1)
(2)
(4)
(5)
No. Functions
(1) Method
Select a method number. Input a method number directly in a cell or get a number form drop-down menu.
Or press a space key and methods registered will be popped up at the
t he center of screen, then you can select
the method from the list.
Name
A selected method name will be displayed.
Sample
Sampling
Select a number of measurements for Standard sample and Blank sample, “Duplicate” or “Triplicate”
from drop-down menu.
Check Interval
Define a validation for a calibration.
Input an interval between 0 and 99 (days). Setting 0 will skip a validation check.
Methods will be red color on [RUN (F5)] - [Selection] and CTO error flag will be added with results
when this valid interval has been passed since the previous calibration date.
3.3 Calibration
3.3.1 Reg Calib
3-49
Chapter 3 Explanation of Menu
No. Functions
(1) Auto (Refer to “3.1.7 [Std QC]”)

Select an automatic measurement condition from drop-down menu shown below.
- Change
Change Lot: When lot numbers of reagents for the ccalibration
alibration are changed, calibration
calibration m
measurement
easurement is
executed.
- Timeout: When a valid interval at “Auto Interval” is passed, calibration measurement is executed.
<Type
<Ty pe of Automatic measurement for calibration>
Select details of the measurement in a cell beside “Auto” from drop-down
drop-do wn menu.
- Blank: Blank measurement
- One: One-point calibration
- Tw
Two:
o: Tw
Two-points
o-points calibration
- Full Calibration: Full calibration
Auto Interval (Refer to “3.1.7 [Std QC])
Input an interval between 0 and 99 (hours) for automatic measurement.
This setting is available when the “Timeout” is selected as automatic measurement conditions.
Type
Select a type for a calibration curve.
Select a type from Factor / Linear / Point
P oint To Point / Log-Logit / Spline
Sp line / Exponential from drop-down menu.
Lot
Select Old / New from drop-down menu as reagent lot.
Each method has two types of calibration results depending on reagetn lot.
“New” is a newer calibration result and “Old” is an older result.
Material Name
You can input a material name for a calibrator with alphanumeric within 8 letters.
(2) S1, S2, S3, S4, S5, S6, S7

These are concentrations of Standard Samples. You can define Standard Samples up to 7 points. (S1 is the
lowest concentration.)
Conc
Input each concentration value at 7 points of the standard sample.
Valid range: 0 – 9,999,999 (This range should be within 5 decimal places and concentration value should be
S1 < Sn < S7.)
Numbers of standard samples defined here will be numbers of Standard Samples when you registor
Standard Samples on [Run (F1)] – [Selection].
[ Selection].
WORK
Measurement results (absorbance value) will be displayed here at a full calibration or re-calibration (a
measurement by 1 point or 2 points) measurement.
MASTER
Measurement results (absorbance value) will be displayed here at a full calibration.
Note that WORK
W ORK / MASTER can be input manually and these value should be between –999,999 - 999,999
(mABS / 10).
Lot No(S) All
You can input a lot number of a calibrator with alphanumeric within 6 digits.
This input “Lot No (S)” can be seen following screens;
Measurement Result Search Screen, Calibration Result Printing and Result for File Output.
Check “All” check box ON and S1 lot number can be input, then the same lot number as S1 will be
displayed from S2 to S7.
3.3 Calibration
3.3.1 Reg Calib
3-50
No. Functions
(2) K
This value will be available on selecting “Factor “ in “Type” as calibration type.
t ype.
Input value K Factor between –99,999.999 and 99,999.999 (“0” is not effective).
S1This
Blankwill be available when “Factor” or “Linear” is selected in “Calculation”.
This check box will be available when “Enable S1 Blank (Factor or Linear)” is chosen on [Parameter (F6)] -
[Normal2].
Reagent Blank for S1
This will be displayed when “Linear” is selected in “Calculation”.
This chek box will be ON when “Enable reagent blank for S1 (Linear)” is chosen on [Parameter (F6)] -
[Normal2].
(3) R Lot No (R1) / (R2)

Reagent lot numbers used for calibration will be displayed.
Last
The last date of a full calibration will be displayed.
disp layed.
<Graph display of calibration curve>
Calibration curves will be displayed here.
2 types of calibration curves will be described in 2 colors, blue for “Work” and red for “Master”.
Any results containing an error flag will not be used for a calibration curve.
Reagent blank / Last
The last result of a reagent blank measured without error and its date will be displayed.
Reagent blank value (Delta-ABS) is obtained from conditons of each method based on the last reagent blank
time course and cuvette blank value.
Blank / Last
The last result of a blank sample without error and its date will be displayed.
(4) <Recalculation>
Type
Select a calibration curve used for recalculation from “Work” or “Master” from
Absorbance
Input an absorbance value to recalculate between –999,999 and 999,999.
Conc
Concentration value recalculated will be displayed from 0 to 9,999,999.
Recalculation
Click this button to execute a recalculation.
(5) Save
Cancel
Click this butoon not to save editing data.
Print
Click this bottun to print out setting details.
3.3 Calibration
3.3.1 Reg Calib
3-51
Processes of reagent lot numbers at calibrations:
Full / Part Lot Numbers Process

Previous calibration result will be stored as “Old” and new calibration will be
Full Different
stored as “New”.
Full Same Previous calibration of the same lot number as new calibration will be overwritten.
Full No Numbers Previous calibration will be overwritten.

Part Different Previous calibration will be overwritten.
Part Same Previous calibration of the same lot number as new calibration will be overwritten.
Part No Numbers Previous calibration will be overwritten.
Full ------ It will update the number currently being displayed.
Part ------ It will update the number currently being displayed.
A calculation
calculation for concentrations out of the range of
o f a calibrator:
Concentration Value when
Calibration Concentration Conversion “Disable Extrapolated
Concentration Range OVR Flag
Curve Types Formula Results” is ON
([System (F9)] – [Setup])
Extended Calibration Curve
Factor All Not Added
will be applied.
· Below S1 Extended Calibration Curve
Linear Not Added
Added
· Over Sn will be applied.
Tangent line of a Calibration
Tangent S1
Spline · Below S1 Added
Curve at S1 will be applied.
Tangent
Tan gent line of a Calibration Sn
· Over Sn Added
Curve at Sn will be applied.
Extended Calibration Curve S1
Point to Point · Below S1 Added between S1 and S2 will be
applied.
Extended Calibration Curve Sn
· Over Sn Added between Sn-1 and Sn will be
applied.
·Below S1 Linear Approximation will be S1
Log Logit Added
(S1 concentration=0) applied.
·Below S1 Tangent line of Calibration
Tangent
Not Added
Added
(S1concentration<>0) Curve at S1 will be applied.
Tangent line of Calibration
Tangent
· Over Sn Not Added
Added
Curve at Sn will be applied.
3.3 Calibration
3.3.1 Reg Calib
3-52
3.3.2 [Serial Dilut]:Serial Dilution

You can define the setting for auto-dilution calibration.
(1)
(2)
(3)
No. Functions
(1) Method
Select a method name from drop-down menu.
Name
Method name selected will be displayed.
Sample
Select a sample category Common / Serum / Urine / Plasma from drop-down menu.
Lot No(S)
This shows a number of a calibrator
calibr ator lot.
When different lot numbers are used in each concentration, lot number of the highest concentration
calibrator registered at [Calibration (F7)] - [Reg Calib] will be shown.
3.3 Calibration
3.3.2 Serial Dilution
3-53
No. Descriptions
(2) Conc
Concentration values of standard samples registered at [Calibration (F7)] - [Reg Calib] will be displayed.
Sample (uL)
Diluent (uL)
The best suite volume calculated by the highest concentration calibrator and specified concentration value
will be displayed as a default.
Approximate value will be in red when a target dilution rate cannot be calculated within the range. You
can edit sample volume within available dispensing range if necessary.
Available dispensing range

Sample: 2 – 35 (0.1 μL step)
Diluent:45 – 350 (1 μL step)
Total amount of dispensing “Sample” and “Diluent” should be between 80 μ L and 450 μ L.
(3) Reset
Click this button to show the best volume calculated from the target dilution rate.
Save
Cancel
3.3 Calibration
3.3.2 Serial Dilut
3-54
3.3.3 [Multi-Std]:Multi Standard

You can define multi standard samples
(1)
(2)
(3)
No. Functions
(1) Set No.

Select a number of Multi Standard Sample between 1 and 10 from
Name
Input Multi Standard Set name in alphanumeric within 6 digits.
Sample
(2) <Measurement method>

Select measurement methods to register.
Select methods registered in a list for every Multi
M ulti Standard Set. Click the check box ON to register.
(3) Save
Cancel
Print
Click this button to print out settings.
3.3 Calibration
3.3.3 Mult-Std
3-55
3.3.4 [ISE]:ISE Calibration Result

You can see the latest ISE calibration result on this screen.
(1)
No. Functions
(1) Date Time

The last measurement date and time will be displayed.
Na (50-66)
These values are permissible range of each method. The last measurement results
K (50-63) will be shown on the right side.
When the result exceeded the range, “H” or “L” flag will be added to results in red.
Cl (40-59)
ERROR CODE
The last measurement error code will be shown.
3.3 Calibration
3.3.4 ISE
3-56
Chapter 3 Explanetion of Menus
3.4 [QC (F8)]:QC Menu

The results of Quality Control samples are kept in a database for half a year. Each method of the result can be
displayed in a graph or list.
Click QC (F8) button on the job menu and you can select one of tthe
he following on the tab menu.
- Graph (Quality Control graph display)
- Details
- Daily
- Cumulative
- Settings (for judgment criteria)
- Registration (for QC sample)
When the “Enable live QC report” in the tab menu [System (F9)] – [Setup], which is printing setting for
printers, is set to effective, a measurement result (the information of quality control) will be printed out
automatically after a measurement of QC sample was executed.
3.4.1 [Graph]:QC Graph
You can see the measurement data of 3-types of control samples in graph, by selecting a display type from
“Daily” or “Cumulative”.
Click to select the tab menu [QC (F8)] – [Graph].
(1)
(5)
(2)
(4) (3)
(6)
3.4 QC
3.4.1 Graph
3-57
No. Descriptions
(1) Method
As for the setting, 3 ways are available. The first one is to click and select a measurement method
number on the list by pressing Space, the second is to select a number displayed on the pull-down
menu, the third is to input a number with the
t he keyboard.
-- General Biochemistry (1-60): 3(6) 60
ISE (1001-1003): methods
methods
- ISE diluent (1005-1007): 3 methods
- SI (2001-2003): 3 methods
- Method to method calculation (3001-3040):
Select one from a sum of 40 methods, 106(109) methods
Some related ISE methods depending on the setting definitions in samples will be displayed.
- Common: 3 methods (Na, K, Cl) of ISE and 3 methods
methods (Na, K, Cl) of ISE (D)
- Serum, Plasma: 3 methods (Na, K, Cl) of ISE
- Urine: 3 methods (Na, K, Cl) of ISE (D)
Name 1111
1111
The method name registered on the tab menu [QC (F8)] – [Registration] will be displayed in
the cell box when its number was specified.
Sample
Select a sample category from pull-down menu.
-- Serum
Common
- Urine
- Plasma
(2) Date
Specify the starting date for the graph.
You can input the date from keyboard or pull-down menu to display a calendar.
Scroll bars for

Year / Month
(3) Display Type

Select a display type for graph from pull-down menu.
- Daily: Measurement results in a day specified on “Date” will be displayed.
- Cumulative: Cumulative measurement results for recenrecentt 30 days
days from the day you specified
or in a day will be displayed.
(4) Control Name

The registered sample name in the tab menu [QC (F8)] – [Settings] will be displayed from pull-down
menu.
Control name which method number and sample are matched can be selected.
Select a sample to display from up to 3 samples.
(5) Search
Click Search button to start a search and a measurement result of Quality Control sample will
be displayed in graphic.
3.4 QC
3.4.1 Graph
3-58
No. Descriptions
(6) <Graph display>

(6)
(E.g.)
Display Type 1Daily
Daily1
1
+3SD line >+3 154.5
+2SD line +2 151.5
+1SD line +1 148.5
Mean value 145.5
-1SD line -1 142.5
-2SD line -2 139.5
-3SD line < -3 136.5
Jun
5 6 7 8
Scrolling available
Display Type 1Cumulative
Cumulative11
+3SD line >+3 154.5

+2SD line +2 151.5
+1SD line +1 148.5
Mean value 145.5
-1SD line -1 142.5
-2SD line -2 139.5
-3SD line < -3 136.5
May Jun
2 3 4 5 6 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 1 2
Scrolling not available
Number of data / Average value / Standard deviation / CV (%)

Number of data, Average value, Standard deviation and CV (%) will be displayed by using the data
calculated automatically from all of the measurement results.
N: Number of data
X: Average value
SD: Standard deviation
CV: Coefficient of variance
Any measurement data determined as an error in the measurement results are removed from
calculation.
For those calculations, the conditions of the graph display are supposed to apply defined in the tab
menu [QC (F8)] – [Settings].
The display color Graph plot
The judgment of the measurement results will be displayed
displa yed by plotting in colors of the following.
Black symbol: Normal “(plot black)”
Yellow symbol: WARNING “(plot yellow)”
Red symbol: ERROR “(plot red)”
3.4 QC
3.4.1 Graph
3-59
3.4.2 [Details]:QC
[Details]:QC Results
Records of the judgment of the QC results will be displayed one by one, specifying the measurement methods and
date.
Click to select the tab menu [QC (F8)] – [Details].
(1) (2)
ATS
*
(3)
* (4) (5)
ATS Cont1
ATS Cont1
ATS Cont1
ATS Cont1
ATS Cont1
ATS Cont1
ATS Cont1
ATS Cont1
ATS Cont1
(6)
No. Descriptions
(1) Method
The way
[Graph].
[Graph]. of selecting the number of the measurement method is the same as the tab menu
As for the setting, 3 ways are available. The first one is to click and select a measurement
method number on the list by pressing Space, the second is to click a number by means of
pull-down menu, and the third is to input a number with a keyboard typing.
Name nnn
The measurement method name registered will be displayed when its number was specified.
Sample
Select a sample category from pull-down menu;
- Common
- Serum
- Urine
- Plasma
3.4 QC
3.4.2 Details
3-60
No. Descriptions
(2) Result Output

Select the destination for an output from pull-down menu.
- Monitor
- Print
- File
… (
The specification of the output folder: …(
When “File” is selected, a folder will be shown by a click of the …, and you can specify the
destination directory where the extracted result should be placed.
The error messages for search output
When you specified a floppy disc as an output device and a disc is not inserted or an unformatted
disc is inserted,
“Floppy disk is not either inserted or formatted.”
The warning will be displayed.

When there are not enough volume;
“Not enough disk space to copy files.”
The error message will be displayed.
(3) Date From 11 Disable

Specify the starting date for search.
11 Disable
- When the check box “OFF”;
You can input the date from keyboard or pull-down menu to display
d isplay a calendar.
- When the check box “ON”;
This means to search all records in the past and
a nd you cannot specify the search starting date.
Round # 111111(
Input the measurement round number for the starting search date between 1 and 99.
Entering asterisks “* ” means all rounds are applied.
To 11 Disable
Specify the ending date for search.
11 Disable
- When the check box “OFF”;
You can input the date from keyboard or pull-down menu to display a calendar.
- When the check box “ON”;
This setting is to search all records
r ecords in the past and you cannot specify a search sstart
tart date.
Setting date should be [From (the search starting date)] ≤ [To (the search ending
ending date)].
Round # 111111(
Input the measurement round number for the ending search date between 1 and 99.
Entering asterisks “*” means all rounds are applied.
(4) 1Search
Search11
This will search results with specified
s pecified details.
Click the Search button to start extracting results of the specified details and the term days so
that the measurement result(s) of Quality Control sample will be output in the place you specified.
3.4 QC
3.4.2 Details
3-61
No. Descriptions
(5) Delete
This will execute a delete process.
Clicking the Delete button, a confirmation-warning message will be displayed.
“Warning!
Is this all right if the measurement data is deleted?”
Click OK button to delete the measurement methods and date range of the measurement results.
Cancel button
Click Cancel button to cancel the deleting.
If the search result exceeds more than 1,000 lines, the following message will notify you. You
cannot delete those data though you click Delete button.
“Too many results meet search condition. Narrow the condition any try again.”
Click OK button to change the contents of the search conditions and retry it.
(6) <The result list display for details>
Date
The date of the measurement result will be displayed in the format ”yyyy / mm / dd”.
R#
The round number will be displayed between 0 and 99.
No.
No.
When the result was measured more than one time at the same round, the round number on
which the result was executed will be displayed.
Method
The measurement method name will be displayed in alphanumeric within 6 digits.
Ctrl ID
The Control sample name will be displayed in alphanumeric within 20 digits.
Conc
The measurement result of the control sample will be displayed in 7 digits between -9,999,999
and 9,999,999.
Any invalid values will be displayed with “ ***** ”.
WARNING
If the Control sample is specified for “WARNING” as the judgment criterion in the tab menu
[QC (F8)] – [Settings], the judgment
j udgment result will be displayed in this column.
A higher priority error should be displayed if more than 2 errors are found in the res
result.
ult.
ERROR
If the Control sample is specified for “ERROR” as the judgment criterion in the tab menu [QC
(F8)] – [Settings], the judgment result will be displayed in this column.
A higher priority error should be displayed if more than 2 errors are found in the res
result.
ult.
Flag
If the measurement result you selected contains any errors, an error flag will be displayed with
the result.
For further details of error flags, refer to “3.4.5 [Settings]”.
3.4 QC
3.4.2 Details
3-62
3.4.3 [Dairy]:QC Results
This will sum up QC measurement data of control samples you specified a day and display them in each
measurement method.
Click the tab menu [QC (F8)] – [Cumulative].
(2)
(1)
(3)
(4) (5) (6)
(7) The list of the detail search results
No. Descriptions
(1) Method
How to select the number of the measurement method is the same as the tab menu [Details].
As for the setting, 3 ways are available. The first one is to click and select a measurement
method number on the list by pressing Space, the second is to click a number displayed the
pull-down menu, the third is to input a number with a keyboard typing.
typing.
Name
Same as the tab menu [Details], the measurement method will be displayed.
Sample
Same as the tab menu [Details], you can select a sample from pull-down
pull-do wn menu.
(2) Result Output

Same as the tab menu [Details], you can specify the output destination and an output folder for
a measurement result.
(3) Control Name

Select a name of Control Samples.
- When Method is blank: Select a Control Name.
- When Method is not blank: Select a control sample name registered in the tab menu [QC (F8)] –
[Settings] from pull-down menu.
3.4 QC
3.4.3 Daily
3-63
No. Descriptions
(4) Date: From 11 Disable / To 11 Disable

Specify the searching date.
11 Disable
- When thepull-down
Click check boxarrow
“OFF”on the Combo Box and a calendar will be displayed, then you can click
the search date on it to select.
-·When the check box “ON”;
This setting is to search all records
r ecords in the past and you cannot specify a search sstart
tart date.
Round # 111111(ランド番号)
Input the measurement round number for the ending search date between 1 and 99.
Entering asterisks “* ” means all rounds are applied.
(5) Search((検索)
Search
This will execute the extraction of the result with specified details.
Click this bottun to seach specified Method and control sample results then you can out put all data
to specified field.
(6) Delete((削除)
Delete
This will delete data you are editing.
Click Delete button and a confirmation message for the delete notifies you.
“Warning!
Is this all right if the measurement data is deleted?”
The measurement result of Method and the raging dates you specified will be deleted by clicking
OK button, and will stop the delete by clicking Cancel.
(7)
(7) <The result list display for details>
Method
The measurement method name will be displayed in alphanumeric within 6 digits.
digits.
N
displayed.
The number of the data samples will be displayed.
Mean (X)
The average concentration calculated from the measurement result will be displayed.
The digit numbers of the fraction part will be displayed in the digit numbers specified at the
“Decimal Points” in the tab menu [Parameter (F6)] – [Normal].
Note that any data that QC judgment removed.
judgment resulted in an error are removed.
-2SD
The latest measurement results out of the range of -2SD
-2S D
The -2SD value calculated from the target measurement result will be displayed with a form of
“-999.999”.
When the calculation is invalid because there is less than 1 point, the value will be displayed in
blank.
blank.
+2SD
The latest measurement results out of the range of +2SD
The -2SD value calculated from the target measurement result will be displayed with a form of
“999.999”.
When the calculation is invalid because there is less than 1 point, the value will be displayed in
blank.
blank.
3.4 QC
3.4.3 Daily
3-64
No. Descriptions
(7) SD
The standard deviation (or SD) value calculated from the target measurement result will be displayed
with a form of “999.999”.
When the calculation is invalid because there is less than 1 point, the value will be displayed in blan
CV
The coefficient of variance (or CV) value calculated from the target measurement result will be
displayed with a form of “Z9.999”.
When the calculation is invalid because there is less than 1 point, the value will be displayed in blank.
Min
This will show the minimum value of the measurement result.
The digit numbers of the fraction part will be displayed in the digit numbers specified at the “Decimal
Points” in the tab menu [Parameters (F6)] – [Normal].
Note that any data that QC judgment resulted
resulted in an error are removed.
Max
This will show the maximum value of the measurement result.
The digit numbers of the fraction part will be displayed in the digit numbers specified at the “Decimal
Points” in the tab menu [Parameters (F6)] – [Normal].
Note that any data that QC judgment
judgment resulted in an error are removed.
Warning/Error
[Settings] screen as “WARNING” or “ERROR” will be
QC judgment results (10 digits) defined on the [Settings]
displayed.
The higher priority result will be displayed if the judgment
j udgment contains some errors.
Settings” as the letters the judgment results for order of priority.
Refer to the “3.4.5 QC Settings” priority.
3.4 QC
3.4.3 Daily
3-65
3.4.4 [Cumulative]:QC
[Cumulative]:QC Results
This will sum up the QC measurement data of control samples you specified the cumulative days and then display
them in each measurement method.
Click to select the tab menu [QC (F8)] – [Cumulative].
(1) (2)
(3)
(4) (5) (6)
(7) The list of the detail search results
No. Descriptions
(1) Method
Selecting the number of the measurement method is the same as the tab menu [Details].
number on the list by pressing Space, the second one is to click a number displayed a pull-down
menu of the Combo Box and the third is to input a number with a keyboard typing.
Name 1 1
The measurement method name registered will be displayed when its number was specified.
s pecified.
Sample
Same as the tab menu [Details], you can select a sample from pull-down menu.
(2) Result Output

Same as the tab menu [Details], you can specify the output destination and an output folder for a
measurement result.
(3) Control Name (Control Sample name)
Same as the tab menu [Daily], you can select a control name.
3.4 QC
3.4.4 Cumulative
3-66
No. Descriptions
(4) Date From 11 Disable

Same as the tab menu Details, you can select a search start date as well.
To 11 Disable
Same as the tab menu Details, you can select a search end date as well.
well.
(5) Search
Same as the tab menu Daily, you can select a control name
(6) Delete
Same as the tab menu Daily, you can execute a delete.
(7) <The result list display for cumulative>

The result list display for details is the same as the result of the Daily.
3.4 QC
3.4.4 Cumulative
3-67
3.4.5 [Settings]:QC
[Settings]:QC Results
You can specify the control name to use and its criteria to determine in each method.
Click the tab menu [QC (F8)] – [Settings].
(1)
(2) (5)
(3)
(4)
(6)
(7)
(8)
(9) (10) (11)
No. Descriptions
Method
(1)
number onthe
menu and thethird
list by pressing
is to input aSpace,
numberthe second
with one is to select a number displayed on the pull-down
the keyboard.
- General Biochemistry (1-60): 60 methods

- ISE (1001-1003): 3(6) methods
- ISE diluent (1005-1007): 3 methods
- SI (2001-2003): 3 methods
- Method to method calculation (3001-3040): Select one from a sum of 40 methods, 106(109)
methods
Some related ISE methods depending on the setting definitions in samples will be displayed.
- Common : 3 methods (Na, K, Cl) of ISE and 3 methods (Na, K, Cl) of ISE (D)
- Serum, Plasma : 3 methods (Na, K, Cl) of ISE
- Urine : 3 methods (Na, K, Cl) of ISE (D)
Name 1111
1111
The measurement method name registered will be displayed when its number is specified.
3.4 QC
3.4.5 Settings
3-68
No. Descriptions
(2) Sample
Select a sample category on the list from pull-down menu.
- Common
- Serum
- Urine
- Plasma
(3) Interval 1111 Minutes

1111 Minutes
Input the number of the Quality Control valid interval minutes for the control samples between 0 and
9,999 (min). If you set ‘0’ to the interval minute, valid term will not be checked.
When the valid interval has passed the date from the previous measurement of the control sample.
method name in the tab menu [Run (F5)] – [Selection] will be displayed in yellow and a CXP flag will be
attached to the measurement result.
(4) Auto test Interval Tests ; (Refer to “3.1.7 [Std QC]”.)

1111 Tests
1111
Input the number of QC test count (0 to 9,999). When the QC test has been passed the desiginated
counts since the last QC measurement was performed, the newly
ne wly QC measurement will be performed.
When 0 (zero) is inputted, the automatic QC measurement is not performed.
Minutes; (Refer to “3.1.7 [Std QC]”.)
1111 Minutes
Auto test Interval 1111
Input the number of minutes (0 to 9,999). When the time has been passed the desiginated minutes since
the last QC measurement was performed, the newly QC measurement will be performed.
p erformed.
When 0 (zero) is inputted, the automatic QC measurement is not performed.
(5) Mode
Select a calculation method on the list from pull-down menu.
- Mean-R (calculated by a differential from input mean value)
- X-R (calculated by specified one sample)
When you select “Mean-R”, the cell of “No. 1 ” will be masked and QC data will be calculated by a
differential from the values set in the ” Mean Value”.
The mask of No. 111 will
111 will be released when you select “X-R”.
“X” is an average measurement result from some previous data to the latest data.
You can deceide how many privious data you apply at No. 111 . .
No. 111
111
Specify target data in the “X-R” mode.
When the “Mean-R” is selected in “Mode”, the cell of “No. 11 ” will be masked. The number
specified in ”X-R” will be displayed here.
When the “X-R” is selected in “Mode”, you can specify how many data to use. Input the number
between No.1 and 99.
(6) Control Name
Select the name of control sample.
You can select the name from control sample names defined in the tab menu [QC (F8)] –
[Registration].
Mean Value
Input the concentration value for the Control sample you specified between “0” and “9,999,999”. This
value represents the center of the Y-axis on the graph chart.
When the “Mean-R” is selected in “Mode”, you can input a value in this cell.
When the “X-R” is selected”, this method will be masked. (In this case, it will display the value of
“Mean Value” specified in “X-R”.)
When this Mean Value is blank, an error message will be displayed and your cursor will jump on
where the error is occurring.
“Input proper values.”
3.4 QC
3.4.5 Settings
3-69
No. Descriptions
(6) SD
Input a standard deviation value, which is the concentration of the measurement for the control
sample you specified, between 0.001 and 999.999 (value 0 is not acceptable.).
When you input SD, its range will be displayed in a dotted line on the Graph.
When this SD is blank, an error message will be displayed and your cursor will jump on where the
error is occurring.
“Input proper values.”
(7) Rules
Current result exceeds 2SD
Select a judgment method for “Current result exceeds 2SD” from
fro m pull-down menu;
- INACTIVE (Black symbol): displayed in black on Graph chart.
Any judgment is not performed for the current result of QC sample.
- WARNING (Yellow symbol): displayed in yellow on Graph chart.
When the current result of QC sample exceeds the 2SD, the flag
“1:2S” will be displayed on the column of the “WARNING” in
[Details], [Daily] and [Cumulative] screen..
- ERROR (Red symbol): displayed in red on Graph chart.
If the current result of QC sample exceeds the 2SD, the flag “1:2S”
will be displayed on the column of the “ERROR” in [Details],
[Daily] and [Cumulative] screen.
Select a judgment method for “Current result exceeds 3SD” from pull-down menu.
When the current result of QC sample exceeds 3SD, the flag “1:3S” will be displayed on the
[Daily] and [Cumulative]
column of the “WARNING” or “ERROR” of each [Details], [Daily] [Cumulative] screen.
Select a judgment method for “Current result exceeds 4SD” from pull-down menu.
When the current result of QC sample exceeds 4SD, the flag “1:4S” will be displayed on the
Last 2 results exceed 2SD
Select a judgment method for “Last 2 results exceed 2SD” from
fro m pull-down menu.
When the last 2 results of QC sample exceeds 2SD, the flag “2:2S” will be displayed on the
2 out of last 3 results exceed 2SD
Select a judgment method for “2 out of last 3 results exceed 2SD” from pull-down menu.
When the 2 out of last 2 results of QC sample exceeds 2SD, the flag “2/3:2S” will be displayed on
the column of the “WARNING” or “ERROR” of each [Details], [Daily][Daily] and [Cumulative]
[Cumulative] screen.
Range exceeds 4SD
Select a judgment method for “The max and min value exceed ±2SD (4SD) within the term (days,
months)” from pull-down menu.
When the judgment result is applied this case, the flag “R:4S” will be displayed on the column of
the “WARNING” or “ERROR” of each [Details], [Daily][ Daily] and [Cumulative]
Any 3 Results exceed 1SD
Select a judgment method for “Any 3 Results exceed 1SD within the term (days, months)” from
pull-down menu.
When the judgment result is applied this case, the flag “3:1S” will be displayed on the column of
the “WARNING” or “ERROR” of each [Details], [Daily][ Daily] and [Cumulative]
3.4 QC
3.4.5 Settings
3-70
No. Descriptions
(7) Any 4 results exceed 1SD

Select a judgment method for “Any 4 Results exceed 1SD within the term (30 days)” from
pull-down menu. (Under the condition of this setting, the term is determined by the
t he data for a day in
the daily graph and cumulative data, from the measurement day back to 30 days ago, of the
cumulative
When thegraph chart.)result is applied this case, the flag “4:1S” will be displayed on the column of
judgment
the “WARNING” or “ERROR” of each [Details], [Daily] [Daily] and [Cumulative]
10 results same side of mean
Select a judgment method for “The results is greater or smaller in consecutive 10 points” from
pull-down menu.
When the judgment result is applied this case, the flag “10:X[+]” or “10:X[-]” will be displayed on
the column of the “WARNING” or “ERROR” of each [Details], [Daily] and [Cumulative]
[ Details], [Daily] [Cumulative] screen.
7 continue points trend
Select a judgment method for “The results is likely to increase or decrease in consecutive 7 points”
from pull-down menu.
When the judgment result is applied this case, the flag “7:X[+]” or “7:X[-]” will be displayed on
the column of the “WARNING” or “ERROR” of each [Details], [Daily] and [Cumulative]
[ Details], [Daily] [Cumulative] screen.
(8) Registered Controls

The display the registration name of the control sample.
The control sample names registered in the tab menu [QC (F8)] – [Registration] will be displayed within
40 digits.
(9) Save
Click this bottun to save editing data.
(10) Cancel
Click this bottun not to save editing data.
(11) Print
Click this button to print out the details of editing data.
3.4 QC
3.4.5 Settings
3-71
3.4.6 [Registration]:QC
[Registration]:QC Registration
You can register the name of Quality Control samples (or Control serum) to be used on the list. Maximum 40
types of Control (C1 to C40) can be registered on the list.
Click to choose the tab menu [QC (F8)] – [Registration].
(1) (4)
(2)
(3)
The registration list for
methods
(5) (6) (7)
No. Descriptions
(1) Control ID C 1111

1111
Select the number of a method on the list from pull-down menu or input a number between 1 and 40
with keyboard typing.
Name 1111
1111
Input the name of a control sample in alphanumeric within 20 digits.
(2) Sample
Select a sample type of the following on the list from pull-down arrow on the Combo Box.
-Common
- Serum
- Urine
- Plasma
Lot No. 1111
1111
Input the number of a control sample’s lot number in alphanumeric within 6 digits.
(3) Use for methods
The method registered in the tab menu [QC (F8)] – [Settings] will be displayed by its name selected in
the Control ID.
3.4 QC
3.4.6 Registration
Registration
3-72
No. Descriptions
(4) Registered Controls

The display for the registration name of the control samples.
Control sample name (C1 to C40) registered in the tab menu [Regisration] will be displayed.
(5) Save
Click this button to save editing settings up to 40 records.
(6) Cancel
Click this button not to save editing settings and this button will become invalid again by clicking
the Cancel button.
(7) Delete
Click this button to delete editing contents.
Click this button then Save and Cancel button will become available. The following warning
button.
message will notify you when you click the [Save] button.
“Warning !
Is it all right if the selected sample informatiion is deleted.”
It will delete your editing contents by clicking the OK button and stop deleting by clicking the
Cancel button.
3.4 QC
3.4.6 Registration
3-73
3.5 [System (F9)]:System Menu

Here, you can setup system configuration, reagent registration, operation for FD / HDD backup and
printing conditions etc.
Click the job menu [System (F9)] and you can select a menu from the following on the tab menu.
- Setup: System Configuration
- Reagent: Registration of Reagent Information
- Login: Login / Logout and Software Version
- Backup: Data Backup
- Setup2: Technical
Technical Range
- Define: Editing for Patient Information
- Range: Editing for Normal Range Names
3.5.1 [Setup]:System
[Setup]:Syste m Settings
On the screen you can define conditions of the system communications, alarm sounds, sample barcodes,
special wash solutions and printing conditions.
Click to select the tab menu [QC (F9)]
( F9)] – [Setup].
(2)
(1)
(5)
(3)
(6)
(4) (7)
(8)
(9) (1)
3.5 System
3.5.1 Setup
3-74
No. Descriptions
(1) Host Communication Mode

This will setup a communication mode to the Host computer.
- Off Line
Check this checkbox “ON” and the analyzer will execute measuring along with the orders set in the
PC.
- On Line Batch
Check this checkbox “ON” and the analyzer will execute measuring using the orders transferred by
the Host computer (without inquiring the Host computer), and the measurement result will be
transferred to the Host computer.
- ON Line Real time
Check this checkbox “ON” and the analyzer will read the barcode label of the sample and inquire to
the Host computer each time. The measurement result will be transferred to the Host computer. When
measuremant starts, the analyzer will check the connection setting to the host computer.
The default setting is “Off Line”.
(2) Host Rerun Mode

This will setup the Host Rerun mode. This setup is only available when the checkbox of “On Line Real
time” of “Host Communication Mode” is set “ON”;
- No Re-query
Host Rerun will not be executed.
- Enable Re-query
Host Rerun will be executed only in the case that the Host computer
c omputer requires rerun.
- Enable Host Rerun
Host Rerun will be executed.
(3) Host Communication

Define the communication configuration methods of the connection to the Host computer from
pull-down menu.
Communication
Communication configuration methods Defaults
configurations
Baud Rate 19200, 9600, 4800, 2400, 1200, 300 bps 19200
Date Bit 7, 8 bits 8 bits
Stop Bit 1, 2 bit(s) 2 bits
Parity Bit None, Even, Odd None
Protocol (E1381) Normal, No Handshake Normal
<Alarm Sound>
(4)
11 Enable Sound Sampling Complete
When you set “ON” the checkbox, the setting will make the alam sound effective after the
completion of the muasurement at the end of the ASP circulation.
The default setting is set “ON”.
Enable Error Level
You can set the level of the alarm sound, making it effective.
Select error levels from pull-down menu.
Levels Select methods Descriptions Alarm Levels

1 Off Ineffective
2 Emergency Stop Emergency stop 2 is effective
3 Sampling Stop Sampling Stop 2,3 are effective
4 Unit Alarm Warning
Warning 2,3 and 4 are effective
An alarm sound will be played only in the case that the

t he level of the alarm you selected is emerging.
3.5 System
3.5.1 Setup
3-75
No. Descriptions
(4) Alarm Volume

Define the alarm sound volume.
Select the number of volume sound from pull-down menu.
- Off: Speakers “Off”
- 1～9: Volume Sounds (“9” is the maximum )
The default setting is “3”.
(5) <Sample>
Sample number increment
Select an auto generating method of sample numbers.
Select a type of increment from pull-down menu.
- Numeric only:
- Alphanumeric (Upper case)
- Alphanumeric (Upper and lower cases)
Upper sample number Sample Length 1111

Specify the upper digit numbers of the sample barcode and the number of its whole digits.
Based on the specified contents, the setting number will be complemented in the upper digits at order
registration.
The input range (Max 12 digits) will work with the value of Length and blank will be ineffective.
This will complement some digits that the digits of Length were subtracted from the SID digits that
were input order.
(E.g.)
number: 1123456789
Upper sample number:1 12345678911 Length: 112
1211
When the “SID” of the tab menu [Run (F5)] – [Selection] is 001, the barcode will be “123456789001”
because the upper nine digits will be supplied.
[Auto generating digits for sample number] =

[whole digits] – [digits of the upper sample number]
Sample Barcode Enable Disable

Enable;
When this checkbox is set “ON”, the setting will be changed as using ASP’s barcode reader.
When you select this, the barcode type of UPC (JAN), NW7, Code39, ITF and Code128 can be applied.
And it is applicable either with or without sample barcodes.
Disable;
When this checkbox is set “ON”, the setting will be changed as not using ASP’s barcode reader.
This case is only available without sample barcodes.
3.5 System
3.5.1 Setup
3-76
No. Descriptions
(5) Barcode type 1-4

Define barcode types to use in samples. (5 types settings
setti ngs are available.)
When the “Enable” checkbox of Sample Barcode is set “ON”, the sample barcode can be
applied.
Select a barcode type from pull-down menu.
Types
Types Selection items Details
Blank Not used
UPC(JAN)
W/ Check Digit Used with check digits
Blank Not used
NW7 W/ Check Digit Used with check digits
W/o check digit Used without check digits
Blank Not used
Code39 W/ check digit Used with check digits
Blank Not used
ITF W/ check digit Used with check digits
Blank Not used
Code128 W/ check digit Used with check digits
When you define barcode types as duplicate, the following message will be pop-upped on Save
button’s click.
“BCR Type is over lapped.”
Then clicking the OK button, it retuns to before.
(6) <Others>
Clot detection sensitivity

Specify the sensitivity level of clot detect function from
fro m “0” to “3”.
“0” means invalid and “3” will be the most sensitive.
11 Disable extrapolated results

Specify the conversion method of concentration when the result exceeds the calibration curve.
- When this checkbox is set “ON”, calibration curve will be extended to the range of the S1 or Sn,
and then convert it concentration.
- When this checkbox is set “OFF”, results exceed the calibration curve will be S1 (Min.) or Sn
(Max.).
(Max.).
11 Enable Auto Scan for RCU

Specify whether the RCU scan will be carried out or not.
- When this checkbox is set “ON”, RCU scan will start automatically at the case of the lid of RCU’s
open and close.

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Original issue : Mar / 2008

(1) Failure/damage caused by the result of misuse.

COPYRIGHT OF THIS MANUAL

Warranty / Trademark / Copyright of This Manual

REV DATE REVISION HIGHLIGHT

1B July 2008 [0.7 Component List] :

1D Aug. 2009 Modified [Foreword].

Chapter 2 Measurement Procedures

2.2 Reagent Registration ..........

2.3 Settings for Chemistry Parameters ..........

2.4 Placement for Reagent Bottles (RCU) ...................

2.6 Confirmation of System Parameters ............

2.7 Test Selection Setting ....................................................................2-42

2.7.1.3 .................................................................. 2-50

2.7.1.4 Standard Sample (Standard)

2.7.1.6 Dilution Standard Sample (Serial Dilution) ............................................ 2-54

2.7.1.7 Blank Sample (Blank) ............................................................................. 2-55

2.7.1.8 ........................................................................ 2-56

2.7.1.9 ............................................................................... 2-57

2.7.1.10 Orderless Sample (Orderless) ................................................................. 2-58

2.7.1.11 .......................................................................... 2-59

2.7.1.12 ........................................................................................ 2-63

2.7.1.13 ISE Cleaning ........................................................ ................................. 2-64

2.7.2 Special Test Selection: [Run (F5)] – [Std QC] .........................................

2.7.2.2 Standard) ................................................ 2-68

2.7.2.3 Dilution Standard Sample (Serial Dilution) ............................................ 2-69

2.7.2.4 ........................................................................ 2-70

2.7.2.5 Blank Sample (Blank) ............................................................................. 2-71

2.7.2.6 ........................................................................................... 2-72

2.7.2.7 SPT Wash ................................................................................................ 2-73

2.9 Confirmation of Reagent Remaining Volume...............................2-77

2.11 Sample Addition ........................................................................... 2-81

Chapter 3 Explanation of Menus

3.4 QC (F8) ...............

3.4.5 Settings ............................................

3.5 System (F9) ..............................

3.5.7 Range ...........................................

4.2 User Interface Alarm .........

4.3.4 Mixer Unit 1 (MIX-1) .........................................

5.2 Abnormality of Power On..........

6.2 Part Replac

FURUNO ELECTRIC CO., LTD.

9-52, Ashihara-cho, Nishinomiya-City, 662-8580 Japan

<Precaution for Use and Installation Environment>

Prevention of electric shock

To ensure the accuracy of measurement data

· Whenever the analy

touch them, make sure to wear protective gloves, masks an

Handling of test reagents

Prevention of affect on other facility/equipment

2. Precautions for Use

General precautions for use of the analyzer

(4) Make sure to calibrate the analyz

5. Reagent interference of assay method-to-method

and suppliers for details.

temperature:: 15 to 30°C humidity: 45 to 85% and temperature variation:

12. Maintenance checks and periodical parts replacement

General Precautions for Use of Medical Electrical Equipment

1. Only qualified personnel shall use the analyzer.