User Biolyzer 200

Biolyzer 200 ®
User Manual
Analyticon
Biotechnologies AG
Am Muehlenberg 10
35104 Lichtenfels - Germany
[email protected]
OM-E7224-0A www.analyticon-diagnostics.com
agile - affordable - accurate

Content, Warnings and Specifications
Table of Contents
Foreword. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Warning and notices for safe use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Meanings of warning symbols. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Warning labels. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Warning for safe use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Notices for use (Safety and prevention against danger). . . . . . . . . . . . . . . . . . . . . . . . . . 7
Technical specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
System configuration and equipment list. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Chapter 1: Equipment overview

1.1 Designanality of each unit. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
1.2 Functionality of each unit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
1.3 Measurement flow. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
1.4 Basic operational information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Chapter 2: Procedure of routine check

2.1 Checks prior to work and power-on. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
2.2 Preparation and placement of reagent. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
2.3 Calibration measurement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
2.4 Test selection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
2.5 Settings of measurement conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
2.6 Preparation and placement of sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
2.7 Initiation of measurement and monitoring . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 102
2.8 Addition of sample . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
2.9 Measurement of sample for re-run. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112
2.10 Reproduction of measurement results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114
2.11 Quality control. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125
Chapter 3: Settings and their alterations of operational conditions

3.1 Functional items . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138
3.2 Analytical conditions [Chemistry Prm (F6)]. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
3.3 Method-to-method computation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 150
3.4 Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152
3.5 Order of measurement and printout. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154
3.6 System parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 156
Chapter 4: Maintenance
4.1 Maintenance program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174
4.2 Actions to be taken in the event of trouble. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 177
4.3 Malfunction at the time of power-on. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 178
1
4.4 Anomalous measurement results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179

4.5 Equipment malfunction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182
4.6 Error flags associated with measurement results. . . . . . . . . . . . . . . . . . . . . . . . . 183
4.7 Maintenance picture. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 186
4.8 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 211
4.9 Exchange of parts. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215
Chapter 5: Summary of alarm codes

5.1 Alarm indications and their severity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 228
5.2 Alarm messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 229
5.3 ISE module error codes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243
Appendix
Appendix-A. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 248
Appendix-B. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251
2
Foreword
This clinical chemistry analyzer consists of main analyzer including software, and software
on operational PC. And the analyzer is used with operational PC and printer, and can in-
teract with the host computer.
In the case of applying barcode reader to ASP (Auto Sampler) unit as an optional unit, all of
the samples and reagents for measurements including samples obtained from patients are
fully controlled by bar codes and thus enables the analyzer to perform the entire process
of the analysis automatically.
Analyticon Biotechnologies AG
Am Muehlenberg 10
35104 Lichtenfels - Germany
Fax: +49 64 54 79 91-71
www.analyticon-diagnostics.com
[email protected]
3
WARNING AND NOTICES FOR SAFE USE

Meanings of warning symbols
Warning about
Biohazard
Electric shock
High temperature
Injury
Action to be taken as directed by the “OPERATORS MANUAL”
4
WARNING LABELS
The following warning labels are affixed on the places that are the potentially hazardous.
Warning labels Warning about Places
! WARNING RISK OF ELECTRIC Power supply inlet,

RISK OF SHOCK power supply portion
ELECTRIC SHOCK
! WARNING DO NOT TOUCH Covers of SPT, RPT

DO NOT TOUCH MOVING PARTS and MIX1
MOVING PARTS
! WARNING
HOT HOT SURFACE DTR
SURFACE
RISK OF ELECTRIC
! WARNING SHOCK
RISK OF ELECTRIC SHOCK TURN THE POWER Front frame
TURN THE POWER OFF BEFORE ANY WORK OFF BEFORE ANY
WORK
! WARNING THE TANK CON-

THE TANK CONTAINS TAINS HAZARDOUS Waste tanks (2 tanks)
HAZARDOUS MATERIAL MATERIAL
! WARNING CONTAINS HAZARD-

CONTAINS HAZARDOUS OUS MATERIAL Mosaic 2, SWU panel
MATERIALS SERUM, PLASMA OR on right side cover
SERUM, PLASMA OR URINE URINE
! WARNING RISK OF INJURY Lid for replacing hal-

TURN THE POWER ogen lamp, lid of ISE
RISK OF INJURY OFF BEFORE OPEN- tank, lid for replacing
TURN THE POWER OFF
BEFORE OPENING THIS PANEL ING THIS PANEL ISE electrode
IRU heat insulation
Action to be taken as
plate, fans on rear
directed by the “OP-
frame (2 fans), right
ERATOR’S MANUAL”
frame, left frame
5
WARNING FOR SAFE USE
During operation, do not touch samples, reagents, nozzles and any other
moving mechanical parts in the analyzer. During operation, shut cover all
the time.
Never touch patients’ samples with bare hands to prevent operator from
possible infection. Handle SPT nozzle, RPT nozzle, IRU cuvettes, WU
nozzles and MIX paddles in the same way.
Give special consideration to keep skin and mucous membrane from

contact with reagents to prevent operator from possible infection.
Read the statements of virtues that came with reagents prior to their use.
The contact with the wastes such as used cuvettes and solutions may
cause infection. Handle them with gloved hands without exception. Follow
the national or local laws and rules when they are thrown out. There are
two kinds of liquid wastes drained from this analyzer, i.e. high- and low-
concentrated wastes.
The access to the conductive parts within the analyzer may cause serious
electric shock. Leave any maintenance and repair of electrical parts inside
the equipment to qualified service personnel.
Never leave reagent bottles on the working table (upper surface inside
the analyzer). Careless handling of reagent bottles may cause tumble and
leak.
Do not make a modification to the analyzer.
Exchange the halogen lamp for a new one after a lapse of 30 minutes since
the power switch of the analyzer is turned off to avoid danger of burns.
6
NOTICES FOR USE (SAFETY AND PREVENTION AGAINST DANGER)

The user is requested to read this instruction before he uses the analyzer for the first time
and becomes acquainted with how to operate the analyzer. If the equipment is used in a
manner not specified by the manufacture, the protection may be impaired.
1 Only qualified personnel should use the analyzer.
2 The following precautions should be taken when the analyzer is installed:
a Keep the analyzer out of the rain and any other water splash.
b Avoid areas that are adversely affected by atmospheric pressure, temperature, hu-
midity, ventilation, sunlight, dust and air containing salt, sulfur, etc.
c Pay attention to inclination, vibration, shock (including shock during transportation),
etc.
d When the analyzer is lifted, do it in a team of four or more. Lift carefully the analyzer
by grabbing grips embedded in four bottom corners of the analyzer by one each
hand and supporting the other places of the bottom by another each hand.
e Do not install the analyzer at the place adjacent to the storage room of chemicals or
the place where any gas is likely to be generated.
At the installation of analyzer, the space from wall to the back of analyzer is needed
100 mm more to ventilate.
f Pay attention on the used frequency, voltage and current (or power consumption).
The power cable of analyzer that is accompanied with the accessory package or
specified by the analyzer’s manufacture should be used for the analyzer main unit.
Make sure that the outlet of power source is correctly and well grounded by cus-
tomer’s site.
g When the analyzer is used in the U.S.A. together with accessories including PC, vi-
sual display and printer, use UL-certified accessories.
h When the analyzer is used in the Member states of EC together with accessories
including PC, visual display and printer, use CE-marking accessories.
7
i Connect the analyzer to the operational PC using accompanying LAN cable. When
the other cable is used, this may cause the analyzer to suffer from disturbing noise or
exert an adverse effect on its surroundings.
3 The following cautions should be exercised before the analyzer is operated:
a Check that the contact conditions of switches and indicators are appropriate and
that the analyzer is ready to be activated correctly.
b Make sure that the analyzer is correctly and well grounded. (Refer to 2.6.)
c Make sure that all the necessary electrical cables are correctly connected.
d Extreme care must be taken not to result in misdiagnosis or pose any danger to the
analyzer or human body when the analyzer in conjunction with other equipments.
e Wipe the nozzle tips of SPT and RPT several times with cloth or alikeness impreg-
nated with rubbing alcohol before the analyzer is used. At this time, do not forget to
put medical rubber gloves or alikeness on. Pay also attention to prevent bare skins of
hands or arms from being touched by or pricked with the nozzle tip.
f Exchange the halogen lamp for a new one after a lapse of 30 minutes since the
power switch of the analyzer is turned off to avoid danger of burns. Keep hands away
from glass part of new halogen lamp. Make sure that there is no crack or breakage in
the glass part. Make sure also that gas does not have been leaked.
4 The following cautions should be exercised during operation.
a Pay attentions on not to exceed time and volume which is necessary for diagnosis
and treatment.
b Keep monitoring the behaviour of whole system in order to detect any malfunction.
c Take immediate corrective measures including shutdown of operation when any mal-
function is detected in the analyzer.
d Avoid possibilities of any direct access by patients.
5 The following cautions should be exercised after the use of the analyzer.
a Turn off the power after every operational switch and control is restored to its pre-use
state as directed.
b Do not remove the line cord plugs from receptacles by cords not to give undue stress
to cords.
c Wipe the nozzle tips of SPT and RPT several times with cloth or alikeness impreg-
nated with rubbing alcohol after the analyzer was used. At this time, do not forget to
put medical rubber gloves or alikeness on. Pay also attention to prevent bare skins of
hands or arms from being touched by or pricked with the nozzle tip.
d Pay attentions to the storage area:
– Keep the analyzer out of the rain and any other water splash.
– A
void areas that are adversely affected by atmospheric pressure, temperature, hu-
midity, ventilation, sunlight, dust and air containing salt, sulfur, etc.
– Pay attention to inclination, vibration, shock (including shock during transporta-
tion), etc.
– Avoid areas adjacent to the storage room of chemicals or areas that are likely to
generate gasses.
e Organize and store parts and cords associated with the analyzer after they have been
cleaned.
f Keep the analyzer clean not to cause any inconvenience to the next use.
8
6 In the event of trouble, call authorized service engineer for any repair.
When the safety mechanism is damaged, make contact to authorized service engineer
after pulling out the power cable from the main source outlet.
7 Maintenance and checks
a It is importance for the analyzer and its associated parts to be periodically checked.
b Make sure without fail that the analyzer operates normally and correctly, when it is
reused after being kept unused for some time.
c Do not use any parts and materials for repairs or consumables without being speci-
fied by the analyzer’s manufacture.
8 Prohibit any alteration and/or modification to the analyzer without permission by manu-
facture.
9 The following precautions shall be taken when the cleaning procedure will be per-
formed.
a Appropriate decontamination have to be carried out if hazardous material is split onto
or into the analyzer.
b No decontamination or cleaning agents are used which could cause a HAZARD as a
result of a reaction with parts of the analyzer or with material contained in it.
c Our agent is consulted if there is any doubt about the compatibility of decontamina-
tion 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 ad-
vance.
9
Technical Specifications
1. Kind of Device Clinical Chemistry Analyzer
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, Point to Point, Log Logit, Exponential, Spline
5. Through put 180 tests per hour
6. Incubation time One reagent assay: 10 minutes
Two reagent assay: 5 minutes for R1 + 5 minutes for R2
7. Sample type Serum, Plasma and Urine
8. Number of simultaneous measurement
40 items (Max.) + Electrolyte: 3 items
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)
POW (Power Unit)
CNT (Control Unit)
(2) Optional Accessories
Personal Computer: 1
CRT Display: 1
Keyboard: 1
Mouse: 1
Printer: 1
(3) External Tank
System water tank: 1
Wash solution tank: 3
Waste fluid tank: 2
(4) Optional Unit
Electrolyte measurement unit (ISE)
Bar-code reader for sample tube
Liquid Level Sensor Unit for External Tanks
(External-Tank Rack with Overflow detecting sensors for waste fluid tanks and Emp-
ty detecting sensors for wash solutions / system water tanks)
10
9-1 IRU (Incubation Reaction Unit)

Heating method: Direct heat with silicon-rubber heater
Heating range: 37±0.3°C
9-2 Cuvette
Material: PYREX
Size: 8 mm (W) x 6.23 mm (D) x 30 mm (H)
Light length: 6 mm
Quantity: 45
Minimum volume: 180 μl
Maximum volume: 500 μl
9-3 ASP (Auto Sampler Unit)
Valid tube: Diameter 13~16 mm
Length: 53~100 mm
Turn-table: Removable type
Number of tubes: Maximum 40
9-4 SPT(Sample Pipette Unit)/SPP(Sample Pump Unit)
Number of pipette: 1
Pump type: Syringe pump
Liquid detection: Conjugation of electric-capacitance detection
Sampling volume: 2~35 μl (0.1 μl/1 step)
9-5 RCU(Reagent Container Unit)
Turn-table: Removable type
Number of bottles: Maximum 40 (20 bottles each for 100 ml and 20 ml type)
Cooling method: Cooling with Peltier element
Cooling range: 8°C~15°C
Reagent inventory: Count the dispensing volume of reagent
9-6 RPT (Reagent Pipette Unit)/RPP(Reagent Pump Unit)
Number of pipette: 1
Pump type: Syringe pump
Liquid detection: Conjugation of electric-capacitance detection
Sampling volume: 20~400 μl (1 μl/1 step)
9-7 DTR (Detector Unit)
Measurement: Absorption of light (1 or 2 wavelength measurement)
Selectable wavelength: 8 wavelengths (340, 415, 450, 510, 570, 600, 700, 800 nm)
Wavelength selection: Change of Interference filter
Light source: Halogen lamp
Cooling for light source: Air-cooled by fan
9-8 MIX (Mixing Stirrer Unit)
Stirring mechanism: Stirring-bar rotating by stepping motor
9-9 SWU (Supply Water Unit)
Liquid waste through nozzle of WU: 8 pieces of diaphragm pump
Liquid waste at trough: 1 piece of diaphragm pump
Supply water at trough: 5 pieces of diaphragm pump
Supply detergent at trough: 1 piece of diaphragm pump
9-10 WPP (Wash Pump Unit)
Supply detergent and water for cuvette cleaning: 4 pieces of syringe pump
11
9-11 WU (Wash Unit)

Cleaning mechanism: 8 steps cleaning
1st step: Waste of liquid and discharge of detergent
2nd step: Waste of liquid and discharge of purified water
3rd step: Waste of liquid and discharge of detergent
4th step: Waste of liquid and discharge of purified water
7th step: Waste of liquid
8th step: Waste of liquid with wipe tip
9-12 Power Unit
Source: AC 100~120 V (allowance: ± 10%), 5.5 A (Max.) Or
AC 200~240 V (allowance: ± 10%), 2.8 A (Max.)
50/60 Hz, Less than 700 VA
10. Other functions
Auto start/shutoff, Emergency sample insertion, Automatic sample dilution,
Water blank measurement, Reagent blank measurement, Test selection by profile,
Host communication via RS232C
11. Environment (without condensation and freezing)
Temperature: Operation: +15°C~+30°C, Storage/Transport: -10~+50°C
Humidity: Operation: 45~85%, Storage/Transport: 45~85%
Pressure: Operation: 800~1060 (hPa), Storage/Transport: 500~1060(hPa)
Altitude: Less than 2,000m (indoor use only)
12. Measurements
Figure (Main unit): 770 mm (W) x 620 mm (D) x 505 mm (H)
Weight (Main unit): 135 Kg
13. Connectors on Main Analyzer
1) Electrical Connectors
Appliance inlet (for connection to power line)
RJ-45 modular jack (for connection between Main Analyzer and Operational PC)
D-sub receptacle (for connection between Analyzer and optional External-Tank
Rack)
2) Piping Connectors (for connection between Analyzer and External-Tanks)
System water
High conc. waste
Low conc. waste
Wash solution 1
Wash solution 2
Wash solution 3
14. Maximum sound level
60 dB (When the hatch is closed and the operator is distant 1meter or more from the
Main Analyzer.)
15. Definition of INSTALLATION CATEGORY in IEC60664
Primary circuit: CAT II
Secondary circuit: CAT I
16. Pollution degree in IEC61010-1, UL61010A-1
Pollution degree: 1 and 2
12
17. The rating and the characteristics of fuses
Type Size Rating Characteristics Location and Part No.

Glass tube Time lag- Acting,
5×20mm 1.6A/250V PCB:25P3222(ASP/RCU_DRV) F1
fuse Slo-Blo
Glass tube Time lag- Acting,
5×20mm 3.15A/250V PCB:25P3221(SWU_DRV) F1
fuse Slo-Blo
Glass tube Time lag- Acting, PCB:25P3220(PP_DRV) F1
5×20mm 5A/250V
fuse Slo-Blo PCB:25P3222(ASP/RCU_DRV) F2 & F3
Glass tube Medium-Acting,
5×20mm 10A/125V PCB:25P3216/25P3231(IRU_DRV) F1
fuse MITI
Medium-Acting, Appliance inlet F1 & F2

5×20mm 6A/125V
MITI - For use at source voltage 100V-120V
Glass tube
Time lag- Acting, Appliance inlet F1 & F2
fuse 5×20mm 6.3A/250V
Slo-Blo - For use at source voltage 200V-240V
Check that the source voltage and fuse rating are appropriate.
13
SYSTEM CONFIGURATION and EQUIPMENT LIST
A) SYSTEM CONFIGURATION
Note: Objects are described by solid line are shown standard supplies. When ISE
(Option) is added to the analyzer, its waste liquid tube is connected to the high conc.
tank.
B) EQUIPMENT LIST
No. Equipment Model/Type/Spec. Q’ty Remarks
Optional: Sample bar code reader
1 Main Analyzer 1
and ISE unit.
Personal computer
PC/AT compatible,
With keyboard and mouse.
MS windows XP Pro. Installed and
Operational In the U.S.A, UL-certified PC has
can be operated normally.
2 PC 1 to be used.
Serial port: 1 or more (RS232C)
(Option) In the Member states of EC, a CE-
Parallel port: 1 or more
marking PC has to be used.
LAN port: 1 or more
(10baseT/100baseTX)
In the U.S.A, UL-certified CRT
display has to be used.
CRT display
3 15-inch or larger, XGA 1 In the Member states of EC, a
(Option)
CE-marking CRT display has to
be used.
In the U.S.A, UL-certified printer
Printer has to be used.
4 Accommodates paper size of A4 1
(Option) In the Member states of EC, a CE-
marking printer has to be used.
System water (20 L)
With plastic tube for each tanks.
High conc. waste (10 L)
External 1 set 2 L tanks are for using liquid level
5 Low conc. waste (20 L)
tanks sensor unit only. (Option)
Wash solution (5 L or 2 L )
Liquid level sensor unit 1set Option
14
No. Equipment Model/Type/Spec. Q’ty Remarks

Cable for LAN : 1 10base-T/100base-TX
Power cable for main unit : 1 See the packing list.
Sample tray :1 For ASP unit
ASP lid : 1 For ASP unit
Reagent bottle tray : 1 1 set For RCU unit
RCU lid : 1 For RCU unit
Wash solution No.10-2 : 1
6 Accessories
Packing list : 1
Operation manual : 1
ISE electrode (Na, K, Cl, Ref): 1
ISE Calibrant A: 1 (255ml)
ISE Calibrant B: 1 (125ml)
1 set For optional ISE unit only
ISE Urine Diluent: 1 (125ml)
Cleaning Solution: 1 (125ml)
Waste liquid tube: 1500 mm
Glass tube fuse 1.6A/250V : 1 PCB:25P3222(ASP/RCU_DRV) F1
Glass tube fuse 3.15A/250V : 1 PCB:25P3221(SWU_DRV) F1
PCB:25P3220(PP_DRV) F1,
Glass tube fuse 5A/250V : 3 PCB:25P3222(ASP/RCU_DRV) F2
& F3
Glass tube fuse 6A/125V : 2 Appliance inlet F1 & F2
(- FOR USE IN USA) or 1 set (- FOR USE IN USA)
Glass tube fuse 6.3A/250V : 2 Appliance inlet F1 & F2
(- FOR USE IN OTHER COUN- (- FOR USE IN OTHER COUN-
TRIES) TRIES)
PCB:25P3216/25P3231(IRU_DRV)
Spare parts Glass tube fuse 10A/125V : 1
7 F1
and Tools
Halogen lamp : 1
Syringe tip (PTEF tip)
TEF010 : 1
TEF050 : 1 1 set
TEF250 : 3
TEF500 : 3
Plunger tip insertion die 1
Tool set
(+) Screw driver (No.123-C100) : 1
1 set
Hexagonal wrench (1.5 mm) : 1
Hexagonal wrench (0.9 mm) : 1
C) Packaging
Items 1 and, if provided 2 through 4 in the equipment list, are packed individually in each
designated package. Items 5 (not included Sample tray, ASP lid, Reagent bottle tray and
RCU lid) through 7 are packed in one package. Sample tray, ASP lid, Reagent bottle tray,
RCU lid are packed in another package. All packages are sent at the same time.
15
16
Chapter 1
Equipment overview
This chapter provides the user with necessary background on the analyzer for its use. The
user is requested to read before starting operation.
This chapter consists of:

1.1 Designation of each unit
1.2 Functionality of each unit
1.3 Measurement flow
1.4 Basic operational information
17
1.1 Designation of each unit
View at an angle to the left
View at an angle to the right
18
Main Analyzer
Wash Solution Tanks (2L version)
Option: External Tank Rack (ETNK)

(Main of Liquid Level Sensor Unit)
System Water Tank (20L)

High Conc. Waste Tank (10L)
Low Conc. Waste Tank (20L)
Option: Liquid Level Sensors

(Parts of Liquid Level Sensor Unit)
19
IRU (Incubation reaction unit)
RCU (Reagent container unit)
SPT (Sample pipette unit)
RPT (Reagent pipette unit)

ASP (Auto sampler unit)
RPT (Reagent pipette unit) SPT (Sample pipette unit)
IRU (Incubation reaction unit)

WU (Wash unit)
RCU (Reagent container unit)

ASP (Auto sampler unit)
DTR (Detector unit)
20
1.2 Functionality of each unit

This section contains the description of each unit constituting the system.
1.2.1 Auto sampler unit (ASP)
Aperture for barcode reader
Removable turntable
The auto sampler unit (ASP) consists of a removable turntable with sample tube holder
and rotating mechanism and a bar code reader for identifying samples. But barcode read-
er is option.
The ASP accommodates 40 sample tubes. Each sample is aspirated by the sample pi-
pette unit (SPT) and dispensed into cuvettes of the incubation reaction unit (IRU).
Emergency sample is set at position of which number is instructed in the popped up pic-
ture.
A) Turntable (ASP tray)
Tube holder (20 tubes each on inner and

outer circumferences)
The sample tubes with barcode label affixed are inserted into the tube holder. 40 sample
tubes in total can be accommodated (20 tubes each on inner and outer circumferences).
The types of usable sample tubes are shown below:
Diameter: 13 mm – 16 mm
Length: 53 mm – 100 mm
Extent of label fitting: See right drawing.
21
B) Barcode reader (Option)

The barcode reader reads barcode of the label affixed on the outer surface of the sample
tube.
When the barcode is not read by the reader even if the barcode label exists, the appropri-
ate error message is indicated.
The readable barcodes are as follows:
Symbol Valid character and symbol
NW-7 Numerals (0 – 9), symbols (-, $, /, ., +)
Code39 Numerals (0 – 9), alphabetical characters, symbols (-, $, /, ., +)
ITF numerals only (0 – 9)
UPC numerals only (0 – 9)
Code128: numerals (0 – 9), alphabetical characters (uppercase/lowercase), symbols
Set A, Set B (!, “, #, $, (, ), *, +, . ,/, :, ;, <, >, =, ?, @, [, ])
Note: In the case of Set B, it is not effective to use the alphabetical
characters of lowercase type.
1.2.2 Sample pipette unit (SPT)
IRU
SPT nozzle
Liquid level detecting
and Nozzle down limit
SPT trough detecting board
The sample pipette unit (SPT) consists of an up-and-down movement mechanism, rotat-
ing mechanism, liquid level sensor and nozzle down limit sensor. The sample pipette is
connected to the syringe for sample aspiration via resin tube. The sample on the ASP unit
is aspirated by the pipette and then dispensed into cuvettes (reaction cells) in the IRU
unit.
When an optional ISE unit is fitted and the ISE measurement is performed, the SPT aspi-
rates sample for ISE measurement and dispenses it into the sample port of the ISE unit.
A) Liquid level sensor

When the tip of the nozzle reaches and touches the sample surface, the electrostatic ca-
pacitance of the metallic nozzle varies. The variation of the capacitance is detected and
consequently the level of sample is detected.
B) Nozzle down limit sensor

When the tip of nozzle hits the bottom of sample tube (or sample cup) due to the insuf-
ficient volume of sample in it, the lower limit sensor detects that the tip of nozzle hits the
bottom and stops its downward movement.
22
C) SPT trough
After dispensation is completed, the tip of the SPT nozzle is washed with system water in
the SPT trough.
D) Dummy volume of sample

Necessary dummy volume of sample is 5µL.
When 10µL of sample is needed for measurement, 15µL of sample is aspirated inclusive
dummy volume.
1.2.3 Reagent pipette unit (RPT)
RPT nozzle
Liquid level detecting
and Nozzle down limit
RPT trough detecting board
The reagent pipette unit (RPT) consists of an up-and-down movement mechanism, rotat-
ing mechanism, level sensor and lower limit sensor. The reagent pipette aspirates primary
or secondary reagent contained in the reagent container unit (RCU) and dispenses it into
cuvettes (reaction cells) in the IRU unit.
A) Liquid level sensor

When the tip of the nozzle reaches and touches the reagent surface, the electrostatic ca-
pacitance of the metallic nozzle varies. The variation of the capacitance is detected and
consequently the level of reagent is detected.
B) Nozzle down limit sensor

When the tip of nozzle hits the bottom of reagent bottle due to the insufficient volume of
reagent in it, the lower limit sensor detects that the tip of nozzle hits the bottom and stops
its downward movement.
C) RPT trough
After dispensation is completed, the tip of the RPT nozzle is washed with pure water or
wash solution in the RPT trough.
D) Dummy volume of reagent

Necessary dummy volume of reagent is 15 µL.
When 100 µL of reagent for measurement is needed, the necessary amount of reagent is
115 µL inclusive dummy volume.
23
1.2.4 Incubation reaction unit (IRU)

Incubation reaction unit (IRU)
SPT nozzle
RPT nozzle
Detector unit cover (DTR)
The incubation reaction unit (IRU) consists of the cuvette holder and rotating mechanism.
IRU is provided with 45 hard glass cuvettes on its outer circumference and the tempera-
ture inside is kept at 37ºC constantly. The cuvettes are moved at 20-second step and a
series of process including dispensation, stirring, photometric measurement and washing
are performed.
1.2.5 Reagent container unit (RCU)
The reagent container unit (RCU) consists of a reagent tray (reagent bottle tray), bar code
reader, cooler, sensor and rotating mechanism.
The reagent tray of the RCU accommodates at maximum 40 reagent bottles.
The reagent tray rotates and the required reagent bottle is moved to the position where
the reagent is aspirated. At this position, the reagent is aspirated by the RPT and then
dispensed into cuvettes in the IRU unit.
24
A) Reagent tray
The reagent tray of the RCU accommodates at maximum 40 reagent bottles.

The type of usable reagent bottles is shown below;
(1) Inner circumference: 100 ml
(2) Outer circumference: 20 ml
Note: 20 ml and 50 ml with optional adapter can be set at inner circumference of the
reagent tray.
B) Cooler
Even if the analyzer is in the sleep mode, the temperature inside the RCU unit is kept
within the specified limits by the Peltier element which is controlled by CPU.
1.2.6 Detector unit (DTR)
IRU
Optical filter
Halogen lamp
The detector unit (DTR) consists of the optical measurement system and filter rotating
mechanism.
The absorbance inside the cuvette of the IRU unit is measured by using a photome-
ter. Measurement is performed with any combinations of 2 wavelengths selected from 8
wavelengths.
25
A) Photometer
The photometer consists of an illuminator (halogen lamp), lenses, optical filter and pho-
toreceptor (photodiode). The lenses are comprised of a condenser and focusing lenses.
The condenser lens converts the light from the halogen lamp into collimated light beam
which is then focused through the focusing lens in the cuvette. The optical filter allows
only the light with wavelength to be used for measurement to pass through. The photore-
ceptor converts the strength of light passing through the solution in cuvette into electrical
signal.
1.2.7 Mixing stirrer unit (MIX-1/MIX-2)

The mixing stirrer unit (MIX) consists of the up-and-down mechanism and the paddle ro-
tating mechanism.
MIX-1 MIX-2 Wash unit (WU)
IRU
MIX-1 trough
RPT
MIX-2 trough IRU

RPT trough
MIX-1 (primary reagent side) MIX-2 (secondary reagent side)
A) MIX-1
The sample and the primary reagent dispensed into cuvettes are stirred by rotating the
paddle. The paddle is washed in the MIX-1 trough with system water.
B) MIX-2
The secondary reagent dispensed into cuvettes is stirred by rotating the paddle.
The paddle is washed in the MIX-2 trough with pure water.
26
1.2.8 Wash unit (WU)



Each of these 6 nozzle sets


has 2 nozzles, i.e. for drain- Last drain-only nozzle


age (long nozzle) and injec-

tion (short nozzle).
Residual wipe tip
The wash unit (WU) is to wash the insides of cuvettes in which the measurement of speci-
men have been completed and allow them to be reused. The WU consists of 7 stages of
drainage and injection nozzles (one of them is for drainage only), one stage of residual
wipe tip, nozzle up-and-down mechanism and overflow sensor. The processed solution in
the cuvette is drained at the end of the completion of measurement and then their insides
are washed with system water or wash solution.
The drain nozzle is connected to the drain pump of the SWU unit via resin tube.
The injection nozzle is connected to the syringe of the WPP unit via resin tube.
The overflow sensor observes whether the liquid in the cuvette is fully drained or not.
Injection nozzle
Drain nozzle
Residual
wipe tip
27
1.2.9 Pump unit (PP)
WU-5, 6 water WU-2, 4 water

supply syringe supply syringe
WU-3 wash WU-1 wash

solution supply solution supply
syringe syringe
Solenoid valve Solenoid valve

(SPP-EV) (RPP-EV)
SPP sample RPP reagent

syringe syringe
SPP water sup- RPP water sup-

ply syringe ply syringe
Side view (left)
A) Syringe
The PP unit is provided with 8 syringes each for the WU and for the SPP and RPP, and
solenoid valves.
Aspirates wash solution from the wash solution tank and sup-
(1) WU-1 wash solution
ply it into cuvette via WU-1 nozzle to wash cuvette (4 syringes
supply syringe
moves together).
Aspirate pure water from the system water tank and supply it
(2) WU-2, 4 water sup-
into cuvette via WU-2 and -4 nozzles to wash cuvette (4 syringes
ply syringes
moves together).
Aspirates wash solution from the wash solution tank and sup-
(3) WU-3 wash solution
ply it into cuvette via WU-3 nozzle to wash cuvette (4 syringes
supply syringe
moves together).
Aspirate pure water from the system water tank and supply it
(4) WU-5, 6 water sup-
into cuvette via WU-5 and -6 nozzles to wash cuvette (4 syringes
ply syringes
moves together).
Aspirates sample via SPT nozzle and dispenses it into the cu-
(5) SPP sample syringe
vettes in the IRU (linked with SPP water supply syringe).
28
Aspirates pure water from the system water tank to fill it in SPP
(6) SPP water supply line and at the time of dispensation of sample, the sample at the
syringe tip of the SPP nozzle is pushed out by the water (linked with SPP
sample syringe).
Aspirates reagent via RPT nozzle and dispenses it into the cu-
(7) RPP reagent syringe
vettes in the IRU (linked with RPP water supply syringe).
Aspirates pure water from the system water tank to fill it in RPT
(8) RPP water supply line and at the time of dispensation of reagent, the reagent at the
syringe tip of the RPT nozzle is pushed out by the water (linked with RPP
reagent syringe).
B) Solenoid valve
Each solenoid valve switches pump from aspiration to dispensation line and vice versa.
For switching between aspiration of pure water into and dispen-
(1) SPP-EV
sation from the SPP line.
For switching between aspiration of pure water into and dispen-
(2) RPP-EV
sation from the RPP line.
(3) WPP-EV1 – For switching between aspiration of pure water into syringe and
WPP-EV6 dispensation into cuvette for washing.
1.2.10 Supply water unit (SWU)
Side view (right)
The SWU unit is located on the right-hand side of the analyzer and consists of diaphragm
pumps for drain of the wash unit (WU) and water supply and drain of various troughs.
29
(1) Diaphragm pumps for WU-1 – WU-7 : 7 pcs (PML3912-NF10, DC24V)

(2) Diaphragm pump for WU-8 : 1 pc (PML3914-NF30, DC24V)
(3) D
iaphragm pump for pure water supply to RPT : 2 pcs (at the side of trough and the
trough bottom, PML3911-NF10, DC24V)
(4) Diaphragm pump for wash solution supply to
: 1 pc (PML3911-NF10, DC24V)
RPT trough
(5) D
iaphragm pump for pure water supply to SPT
: 1 pc (PML3911-NF10, DC24V)
trough
(6) D
iaphragm pump for pure water supply to MIX-
: 1 pc (PML3912-NF10, DC24V)
1 trough
(7) D
iaphragm pump for pure water supply to MIX-
: 1 pc (PML3912-NF10, DC24V)
2 trough
(8) Diaphragm pump for drainage from RPT/SPT/
: 1 pc (PML3914-NF30, DC24V)
MIX-1/MIX-2 troughs
1.2.11 Ion selective electrode unit (ISE) (option)
Sample Port
ISE unit
Calibrant A
Top view (Right)
Electrode for Na
Electrode for K
Electrode for Cl
Electrode for Ref.
Supply/Drain pump
Side view (Right)
30
The concentration of electrolyte (sodium: Na, potassium: K, chloride: Cl) contained in se-
rum, plasma or urine is measured by the ion electrode of the ISE unit which is placed on
the right-hand side of the analyzer. This unit is optionally supplied.
The ISE unit consists of ISE module, ion electrode, supply and drain pump.
(1) ISE module This module unit is fitted electrodes (Na, K, Cl and Reference) and con-
trols pumps, measurement of concentration by electrodes and rins-
ing movement. Communication to the analyzer is carried out through
RS232C.
(2) Ion electrode This unit consists of Na, K, Cl and Reference electrodes. The bottles
of Calibrant B and dedicated wash solution are placed in the ASP unit
and both solutions are supplied by the SPT in the same way as for the
sample.
(3) Supply pump This pump performs the infusing of Calibrant A into ISE module.
(4) Drain pump This pump performs the transferring of liquid in ISE module.
The following solutions are requested for the ISE unit:

(1) Calibrant A Calibrant A is used at the time of one-point calibration.
The one-point calibration is carried out at the same time when the Cali-
brant A is dispensed to wash electrodes every time the sample mea-
surement is performed. 120µl of Calibrant A is automatically dispensed
into the ISE unit every 30 minutes to prevent the electrode from drying
during standby cycle.
Its dedicated bottle is placed beside the ISE unit.
(2) Calibrant B Calibrant B is used at the time of two-point calibration.
As necessary, 500µl of Calibrant-B is dispensed into a sample cup
which is placed at No. 18 position of the ASP tray. The two-point cali-
bration should be carried out at the beginning of the day and at least
once every 8 hours.
The dispensation is carried out using [Sequence (F9)] of the job menu
[Maintenance].
(3) Wash solution The wash solution needs to be dispensed into the unit to avoid deposi-
tion of protein on the electrodes.
As necessary, 600µl of the wash solution is dispensed into a sample
cup and it is placed at No. 18 position of the ASP tray.
The dispensation is carried out using [Sequence (F9)] of the job menu
[Maintenance].
This function should be carried out once a day at the end of work.
When more than 50 samples of measurement are carried out, the
washing must be carried out 8 hours interval.
(4) Diluent The diluent is used to dilute urine to one-tenth in concentration. It is
contained in a reagent bottle which is placed in the RCU unit. The nec-
essary volume for diluting one sample is 315µl. The dilution is carried
out using a cuvette in the IRU unit and therefore one cycle of chemistry
analysis is allocated to this processing.
The diluent should be pre-registered as a regent code in the [System
(F9)] picture of the job menu [System Parameters].
31
(5) Sampling volume at each measurement

Measurement Volume
In the case of analytic measurement Sample: 100 µl
In the case of full calibration Calibrant-A: 200 µl, Calibrant-B: 100 µl
Calibrant-A: 120 µl, Calibrant-B: 100 µl
In the case of 1-point calibration Calibrant-A: 120 µl
1.2.12 Liquid level sensor unit for external tank (op-

tion)
Slot for Wash Sol-1 Slot for Wash Sol-2 Slot for Wash Sol-3
Light Detectors for LEDs for liquid

liquid level sensing level sensing
External Tank Rack (ETNK)

(Main of Liquid Level Sensor Unit)
Top view of External Tank Rack (ETNK)
Liquid Level Sensor Liquid Level Sensor

for System Water for High conc. Waste
(A Float Switch) (A Float Switch)
Cable to Main Analyzer
Liquid Level Sensor for Low

conc. Waste (A Float Switch)
Connection of Liquid Level Sensor Unit
The Liquid Level Sensor Unit is located on the outside of the Main Analyzer, and con-
nected to the Main Analyzer (SWU Panel on the right-hand side) with a D-sub cable. The
unit has a Tank Rack for the Wash Solution Tanks, and has optical or float switch sensor
for liquid level sensing against each external tank.
32
A) External Tank Rack (ETNK)

It is the main of the Liquid Level Sensor Unit, and it has 3 slots for the Wash Solution Tanks
(2 L version), a D-sub receptacle for the connection to the Main Analyzer, and receptacles
for the Liquid Level Sensors (Float Switches). Each slot has an optical sensor to detect the
empty of each Wash Solution Tank.
(1) Optical sensors: Each optical sensor is composed by one-pare of the “LLRD”
PCB (25P3141) and the “LLED” PCB (25P3142). The “LLRD”
PCB has a Light Detector (IS-486), and the “LLED” PCB has
an infrared LED (GL-480).
(2) D-sub receptacle: It is for the connection to the Main Analyzer. It has 25 male
contacts.
(3) One-touch receptacles: They are for the connection to the Liquid Level Sensors (Float
Switches). Each has 3 female contacts.
B) Liquid Level Sensors (Float Switches)

Each Sensor assembly is composed by a Float Switch, a Screw Tap of each tank, exclu-
sive column, a one-touch plug, and cable. Each Float Switch is mounted on the tip of each
column. The Sensor for System Water detects empty of the System Water Tank, and the
Sensor for Low or High Conc. Waste detects overflow of each corresponded tank.
(1) Float Switches: Each Float Switch detects empty or overflow of each corre-
sponded Tank. It is mounted on the tip of each exclusive col-
umn.
(2) One-touch plugs: Each One-touch plug is to be connected to each correspond-
ed One-touch receptacle on the External Tank Rack. Each has
3 male contacts.
33
1.3 Measurement flow

1.3.1 Normal measurement flow
Assuming that the required test selection of method has been set on the operational PC
and necessary calibration of method has already existed, or the calibrator for the calibra-
tion measurement is set at the head on the ASP unit, read the following descriptions.
A) Reagent management (RCU Scan)

“RCU Scan” means that the reagent information is drawn up by reading bar code labels
attached to the reagent bottles during one turn of reagent tray in the RCU unit. This pro-
cess is performed prior to pressing the start key [F1].
B) Preparation
The following operations are performed for preparation of measurement by pressing the
start key [F1].
(1) Initialization of hardware
Each unit returns its original position.
(2) Gain setting of absorbance meter
Gain adjustment of halogen lamp is automatically carried out.
(3) Prime
Each pump and syringe operates and sent out solution into each line to release air with
nozzles being situated at their respective troughs.
(4) Readout of bar code of sample (only for with bar code control)
An inquiry is made to the PC about measuring schedule on each sample tube in time for
sampling (to be in consistency with test selection)
C) Primary reagent measurement

Where there is no shortage of the primary and secondary reagents, pure water, wash solu-
tion (and diluent if applicable), the following operational sequence is performed.
(1) Dispensation of primary reagent
The RPT aspirates primary reagent kept in the RCU and dispenses it into cuvettes of the
IRU. The RCU and IRU rotate to the respective positions where the reagent is aspirated
and dispensed by the RPT.
(2) Dispensation of sample
The SPT aspirates sample kept in the ASP unit and dispenses it into cuvettes in which the
primary reagent has already been dispensed. The ASP and IRU rotates to the respective
position where the sample is aspirated and dispensed by the SPT.
(3) Stirring
The primary reagent and sample which have been dispensed into the cuvette of the IRU
are sufficiently stirred by the paddle (MIX-1). The IRU rotates to the stirring position.
(4) Photometering (1 – 13)
The cuvette in which the primary reagent and sample have been stirred is photometered
13 times every 20 seconds and time course data of the primary reagent is collected. The
IRU rotates to the photometering position.
34
D) Secondary reagent measurement

(1) Dispensation of secondary reagent
The RPT aspirates secondary reagent kept in the RCU and dispenses it into cuvettes of
the IRU for which the measurement of the primary reagent has completed.
The RCU and IRU rotate to the respective positions where the reagent is aspirated and
dispensed by the RPT.
(2) Stirring
The secondary reagent which has been dispensed into the cuvette of the IRU is sufficiently
stirred by the paddle (MIX-2). The IRU rotates to the stirring position.
(3) Photometering (14 – 26)
The cuvette in which the secondary reagent has been stirred is photometered 13 times
every 20 seconds and time course data of the secondary reagent is collected. The IRU
rotates to the photometering position.
E) Wash
The cuvette for which the time course data of the secondary reagent has been collected
moves to the WU unit and the liquid in it is drained and its inside is washed.
1.3.2 Dilution of sample

For the sample of high concentration which exceeds the measuring range of the analyzer,
the measurement can be performed after such a sample is diluted. The sample is diluted in
accordance with sample and diluent volumes at the time of dilution, and sampling volume,
which were specified by the analytical conditions (method conditions). The measurement
result is output as the measured concentration corrected in proportion of the volume of
diluent.
1.3.3 Reagent blank measurement

The absorbance of the cuvette is measured when only the primary reagent (R1) is dis-
pensed and when both primary and secondary (R2) regents are dispensed. The measure-
ment result is corrected for the measured reagent blank value of each cuvette and conse-
quently the accuracy of the measurement result can be improved.
1.3.4 Water blank measurement

The absorbance measurement of each cuvette in which only water is dispensed is called
as “Water blank measurement”. The water blank measurement is carried out on individual
cuvettes in which only water is dispensed. The final measurement result is corrected in
terms of cuvette-specific difference for the measured water blank value.
The result of the water blank measurement is also used to serve as a guide for assess-
ing stain on the cuvettes. The water blank measurement is performed by selecting the
job menu [Maintenance] and then implementing “Cuvette Check” of the function menu
[Sequence (F9)].
35
1.3.5 ISE measurement

The ISE measurement is carried out only when the optional ISE unit is incorporated. The
ISE unit measures the concentration of electrolyte (Na, K, and Cl) contained in serum,
plasma or urine by the ion electrode. When urine is measured, it is diluted to one-tenth in
its concentration.
The diluent for urine must be pre-registered as a reagent code on the [System Parameters]
picture.
Test selection is executed using the [Test Selection (F10)] picture of the job menu [Run
Monitor (F5)].
The prime, cleaning and calibration are carried out using [Sequence (F9)] picture of the job
menu [Maintenance].
1.3.6 Emergency interruption ([Ctrl] + [F2])

When the ongoing measurement is interrupted in case of necessity, the operation of the
analyzer can be stopped by pressing [Ctrl] and [F2] keys simultaneously.
Aside from the above, the operation may stop when some kind of abnormal condition
which is unavoidable arises in the analyzer.
If the emergency interruption occurs by any reason, the measurements carried out till then
become invalid. Before the measurement resumed, the following procedures must be fol-
lowed:
(1) The cause of the emergency interruption is resolved. For example, in case of the inten-
tional interruption due to erroneous setting of measurement conditions, such an erroneous
setting must be corrected.
(2) When the emergency interruption occurs in the system, open the cover of the analyzer
and check that there is any item which interferes with the operation of the analyzer. When
the cause of emergency interruption is unknown, please get in touch with our customer
services.
1.3.7 Easy start of measurement ([Shift] + [F1])

When the operator wants to easily start the analyzer for analytic measurement without any
settings of the test selection, the analyzer can be started by pressing [Ctrl] and [F1] keys
simultaneously after the sample cup or tube is set in the slot of ASP at will.
This function is available for ASP with barcode reader and without barcode reader.
For ASP without barcode reader, if there are empty slot on ASP, the error (SS error) will be
occurred for the empty slot.
The measurement is carried out in accordance with the all executable method items as
the chemistry parameter. Of course, the required reagent(s) must be set in the RCU and
registered into the system. If one reagent volume is shortage or becomes shortage, its
method item is not measured.
If the test selection is defined for the particular samples, they are going to carry out the
measurement depending on the present test selection, and for the undefined sample(s),
the execution of measurement is carried out in according to the executable method as
previous description.
This function is very useful for the employment of measurement which is limited number of
measuring items, for example about 5 items or less, as one measurement occasion.
36
1.3.8 Printout of picture ([Ctrl] + [F5])

The current displayed picture on screen can be printed out by pressing [Ctrl] and [F5] keys
simultaneously. But it is not available during measurement.
1.3.9 Stop the alarm sound ([Shift] + [ESC])

To stop the alarm sound, press the [Shift] and [ESC] keys simultaneously.
37

This clause contains the description about functions of each key, menu structure, method
of data entry, layout of operational pictures, etc.
1.4.1 Keyboards
The analyzer is operated by using either keyboards of the PC or a mouse.
The functions of each key except character and numerical keys are shown below. The key
ID’s in the list are the symbols which are used throughout this manual.
Function key ID Function Description
F1 [F1] Start To start or resume measurement.
To stop sampling. Processing of sample

F2 [F2] Stop whose sampling has been completed is car-
ried on.
To display the picture on which emergency or
F3 [F3] Stat/Normal
normal sample is added.
F4 [F4] Alarm To display the alarm picture.
F5 [F5] Run Monitor To display the picture of routine operation.
Chemistry
F6 [F6] To display the picture of analytical conditions.
Parameter
F7 [F7] Calibration To display the calibration picture.
F8 [F8] QC To display the picture of quality control.
F9 [F9]
F10 [F10]
Picture The assigned function (picture) is dependent
selection on the menu.
F11 [F11]
F12 [F12]
To move the pointer for selecting wanted item

in the picture.
Tab [TAB] Tab
The pointer is moved to the reverse direction
by pressing [Shift] + [Tab] keys.
Enter [Enter] Registration To register the entered data.
The pointer is moved to the reverse direction

by pressing [Shift] + [Tab] keys.
To initiate the easy start of measurement by
Shift [Shift] Shift
pressing [Shift] + [F1] keys.
To stop alarm sound intentionally by pressing
[Shift] + [ESC] keys.
38
Back Deletion of To delete characters in the input field one by

Space [B-Space]
character one.
To terminate measurement intentionally by
Control
pressing [Ctrl] + [F2] keys.
Crtl [Ctrl]
To print out the picture by pressing [Ctrl] + [F5]
keys.
To move the cursor to the head of the items in
Home [Home] Home
the scroll or list box.
To move the cursor to the tail of the items in

End [End] End
the scroll or list box.
Page To turn pages forward when a menu consists

Up [PgUp] Page up
of multiple pages.
Page To turn pages backward when a menu con-

Down [PgDn] Page down
sists of multiple pages.
[Space] Space To select item of the menu to be chosen.
To select an item among selectable (fixed)

[Cursor] Cursor items, e.g. qualitative or quantitative selection
of analytical conditions.
Esc [ESC] Escape To interrupt processing or close window.
39
Chapter 1: Equipment
1.4 Basic overview
operational information
1.4.2 Menu structure

The various kinds of operational pictures can be selected by the menu in order to operate
The various kinds of operational pictures can be selected by the menu in order to operate the analyzer as
theshown
analyzer as shown below.
below.

Power on
Initial picture
(Indication of copyright)
Run Monitor [F9]
Test Selection [F10]
Run monitor [F5] Inventory [F11]
Condition [F12]
Chemistry [F9]
Calculate [F10]
Chemistry parameter [F6]
Profile [F11]
Order [F12]
Calibration [F9]
Job Calibration [F7] Checks [F10]
menu
Multi [F11]
Graphics [F9]
Measurement [F10]
QC [F8]
QC settings [F11]
Control [F12]
System [F9]
FD [F10]
System Parameter
ISE [F11]
Result [F12]
Sequence [F9]
Maintenance Wash [F10]
Performance [F11]
Start [F1] Auto Start [F12]
Sample Stop [F2]

Global
menu Emergency Stop [Ctrl] + [F2]
Stat/Normal [F3]
Alarm [F4]
1.4 Basic operation information

1-29
40
Job menu Function menu
Run Monitor [F5] Run Monitor [F9] Run monitor display
Test Selection [F10] Page-1/2 : Normal test selection

Page-2/2 : Emergency test (Only ASP with BCR)
Inventory [F11] Page-1/2 : General information

Page-2/2 : Detail information
Automatic Rerun selection

Automatic Print-out selection
Condition [F12] Serum Information selection
Host Communication Mode selection
Prime Mode selection
Chemistry Prm [F6] Chemistry [F9] Page-1/2 : Chemistry Parameters for each Method
(including Extention Normal Range setting)
Page-2/2 : Serum Indices
Calculate [F10] Calculated test expression
Profile [F11] Profile definition
Order [F12] Page-1/2 : Testing order definition

Page-2/2 : Print out order definition
Calibration [F7] Calibration [F9] Page-1/2 : Calibration settings

Page-2/2 : Auto calibration
Limit Checks (Duplicate, Sensitivity, Linearity, Prozone, Absorbance)

Checks [F10] Sampling Methode for Standard (Duplicate, Triplicate)
Blank measurement selection
Limit checks of Reagent Blank setting
Multi [F11] Multi Standard definition
QC [F8] Graphics [F9] Page-1/2 : QC chrt-1,2 (Levey-Jenning Chart)

Page-2/2 : QC chart-3 (Levey-Jenning Chart)
Measurements [F10] QC Results list
QC Setting [F11] Definition of parameters for QC chart and

Judgement criteria
Control [F12] Registration of Control Sample
Page-1/2: Communication param., Sample BCR param. settings

System Parameters System [F9] Print header input and Reagent code registration.
Page-2/2: Patient information and Number of replicate settings.
And name of Extension normal range setting.
Save to FD of mechanical/user parameters
Backup [F10] Load parameters from FD, Format FD
Data backup to HD, and load data from HD.
Page-1/2 : Registration of urine diluent code of ISE

ISE [F11] Indication of ISE calib. & instrument factor setting
Page-2/2 : Chemistry parameters settings for ISE
Result [F12] Measured results
Initial, Prime, Cuvette check, Cuvette wash, etc

Maintenance Sequence [F9] ISE prime, ISE cleaning, ISE calibration
Sensor testing
Page-1/2 : SPT/RPT wash, W ash program definition

W ash [F10] W orking hour counter
Page-2/2 : Cuvette water blank check
Performance [F11] Temperature.monitor of IRU & RCU

Detector performance monitor
Auto Start [F12] Auto start scheduling & Prep1/Prep2 setting

Auto prime parameter (Short prime/Full prime interval set)
1.4 Basic operation information

1-30
41
Chapter 1: Equipment
1.4 Basic operational information overview
1.4.3
1.4.3 Layout
Layout of operational
of operational picturepicture on the screen
on the screen
Thelayout
The layout of operational
of operational picturepicture of this isanalyzer
of this analyzer displayedis
ondisplayed onshown
the screen as the screen
below. as shown
below.
The picture is selected by pressing displayed function key on the screen (e.g. [F5] key for Run Monitor)
The picture is selected by pressing displayed function key on the screen (e.g. [F5] key for
or by positioning the pointer over the wanted item and clicking the left button of the mouse. The System
Run Monitor) or by positioning the pointer over the wanted item and clicking the left button
Parameters and Maintenance are usually not used at frequent intervals and thus no function key is
of the mouse. The System Parameters and Maintenance are usually not used at frequent
prepared for them.
intervals and thus no function key is prepared for them.
(1) Job menu (4) Status of analyzer (10) STAT information (5) Current data and time
Status Initialize Time and Date 1998/07/01 16:23:03 Shut Down
Run Monitor (F5) Chemistry (F6) Calibration (F7) QC (F8) System Parameters Maintenance
Test Selection (Normal Samples)
(9) Displayed picture mode
(6) Input field
(7) Guidance (8) Page indication
Indication㧦 Page:1/2

Start (F1) Sample Stop (F2) Stat/Norm(F3) Alarm (F4) (F9) (F10) (F11) (F12 )

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





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(2) Global menu (3) Function key
(1) Job
(1) menu
Job menu
The following job menu
The following job tags
menuare
tagsdisplayed.
are displayed.
Run Monitor (F5) (F5)
Run Monitor See See
“2.7.1“2.7.1 Monitoring
Monitoring of measurement”.
of measurement”.
Chemistry Prm Prm
Chemistry (F6)(F6) See See “3.2 Analytical
“3.2 Analytical Conditions”.
Conditions”.
Calibration (F7) (F7)
Calibration See See “2.3 Calibration
“2.3 Calibration Measurements”.
Measurements”.
QC (F8)
QC (F8) See See
“2.11“2.11
QualityQuality
Control”.Control”.
System Parameters
System Parameters See See “3.6 System
“3.6 System Parameters”.
Parameters”.
Maintenance
Maintenance See See “4.7 Maintenance
“4.7 Maintenance picture”. picture”.
(2) Global menu

These menu items are always displayed at the position shown in the above picture and
can be executed in any job menu picture.
Start (F1) When thisoperation
1.4 Basic button is information
clicked on, the analyzer is started or re-
1.4.3 sumed
Layout ofthe measurement.
operational picture on the screen
During measurement,
1-30 this button is flickered with yellow
colour.
Sample Stop (F2) When this button is clicked on during measurement, the action
of sampling by SPT in order to analyze is suspended, and this
button and “Start (F1)” button are flickered with yellow colour
until “Start (F1)” button is clicked on again.
42
Stat/Normal (F3) When operator wants to add the emergency or normal sample,
this button is clicked on.
During the processing of sample addition, this button is flick-
ered with yellow colour. At that time, “Start (F1)” button is not
flickered.
Alarm (F4) When this button is clicked on, the alarm message picture is
displayed.
When the alarm or error is taken place, this button is flickered
with red colour.
(3) Function key
The function keys are used to execute functions and to display information in relation to
each job menu picture. The displayed items are different depending on each job menu
picture.
(4) Status of analyzer

The following operational status of the analyzer is displayed.
Analyzer initialization in progress.
Analyzer initialization completed.
Analyzer initialization interrupted.
Prime sequence in progress.
Prime sequence completed.
Measurement in progress.
Measurement completed.
Sampling restart in progress.
Sampling restart ready.
Sampling stop in progress.
Sampling stop ready.
Emergency stop.
Emergency stop in progress.
Emergency stop completed.
Analyzer restart in progress.
Analyzer restart completed.
Analyzer restart interrupted.
Sensor reading in progress.
Sensor reading completed.
(5) Current date and time
Current date and time are displayed.
(6) Input field

Each picture and window is displayed in this field for entry of data and parameters.
(7) Guidance
Operational instruction is displayed. When moved to the other input window, range of
values to be entered into the window or entry method is displayed.
(8) Page indication

The page is displayed when a certain menu has a multiple pages. The pages can be
turned by [PgUp] or [PgDn] keys.
43
(9) Displayed picture mode

The title of the currently displayed picture mode is indicated.
(10) STAT information

During the emergency sample is executed, “STAT” message, (background is red.) is dis-
played. But when the normal measurement is proceeding fills its block with blank code.
44
Chapter 2
Procedure of routine check
This chapter provides the operational procedures for routine check.

2.1 Checks prior to work and power-on
2.2 Preparation and placement of reagent
2.3 Calibration
2.4 Test selection
2.5 Settings of measurement conditions
2.6 Preparation and placement of sample
2.7 Initiation of measurement and monitoring
2.8 Addition of sample
2.9 Measurement of sample for re-run
2.10 Reproduction of measurement results
2.11 Quality control
45
2.1 Checks prior to work and power-on

2.1.1 Checks prior to work
A) System water tank and waste tank
Confirm that;
1. The system water tank is filled with pure water;
2. Each waste tank is emptied;
3. If waste liquid still remains in waste tank(s), the tip(s) of each waste drain tube stays
above the waste liquid level, and
4. The tip of pure water supply tube is located in the bottom of the system water tank.
During measurement, check periodically that the system water tank is not empty
and the tip of the waste drain tube does not touch the waste liquid level. When the
tip of the waste drain tube touches the waste liquid level, the flow of the liquid is
adversely affected and this may cause a trouble.
B) Wash solution tank

Confirm that;
1. Each wash solution tank is filled with sufficient wash solution, and
2. The tips of wash solution supply tubes are located in the bottom of the tanks.
C) ISE unit (option)

Before performing measurement with the ISE unit, confirm that;
1. Electrode unit (Na, K, Cl and Reference electrodes) whose term of validity is not expired
is installed;
2. The calibrant A bottle beside the ISE unit is filled with sufficient liquid;
3. Cleaning was carried out at the end of the last ISE measurement, and
4. The calibrant A is flowing from the side of sample port by executing of ISE prime.
In the following cases, ISE prime should be carried out 10 times more.
5. First measurement of ISE.
6. At the time of exchanging of the calibrant A.
7. At the time of being pulled up the tube from the calibrant A
When the main unit is on after it was kept off, 2-calibrator calibration must be carried out.
In order to perform 2-calibrator calibration, the sample cup contained the calibrant B is
placed at No. 18 position on the ASP tray. Therefore, 2-calibrator calibration is carried out
by using [Sequence (F9)] of the job menu [Maintenance].
Note: As much as possible, the analyzer should be kept on, because 120 µL of Cali-
brant A is automatically dispensed into the ISE unit every 30 minutes to prevent the
electrodes from drying. Even under the sleep condition, this function is performed.
Just after turning on the analyzer, 5 times of ISE prime are carried out automatically.
All electrodes should be fitted to the ISE module; otherwise the liquid of Calibrant A
is flooded into the inside of analyzer. It may be caused serious problem. Thus, don’t
forget the fitting of electrodes before ISE measurement.
46
2.1.2 Preparation of external tank solutions

The external tanks of the system water, wash solution, low conc. waste and high conc.
waste are to be placed near the right-hand side of the analyzer, and to be connected to
the analyzer (SWU panel) with the corresponded tubes.
At just before measurement, the external tanks of the system water and wash solution are
filled with the corresponded liquids, and the tanks of the low conc. waste and high conc.
waste are to be empty.
And confirm that;
1. The tips of tubes for supplying liquid are located in the bottom of the each tank.
2. The tips of waste drain tubes are out of the liquid level.
High Conc. Waste Tank

(10 L)
Low Conc. Waste Tank

(20 L)
System Water Tank

(20 L)
External Tanks (1)
Wash Solution Tank

(5 L version)
47
Tube connection of SWU Panel (on the right-hand side of the analyzer)
If you use the Liquid Level Sensor Unit for External Tanks (option), you have to place 3
tanks of 2 L on the External Tank Rack (ETNK: Main of Liquid Level Sensor Unit) for Wash
Solutions, and set the Liquid Level Sensors (Float Switches; parts of Liquid Level Sensor
Unit) on the corresponded 10 L and 20 L tanks.
Wash Sol.-3 Tank

(2 L version)
Wash Sol.-2 Tank

(2 L version)
Wash Sol.-1 Tank

(2 L version)
Option: External Tank

Rack (ETNK) (Main of
Liquid Level Sensor
Unit)
Setting of External Tank Rack
48
Liquid Level Sensor for

(Parts of Liquid Level
Sensor Unit)

System Water Tank
Sensor Unit)

Sensor Unit)
Liquid Level Sensors (Float switches)

System Water Tank
Sensor Unit)

Sensor Unit)

Sensor Unit)
Setting of Liquid Level Sensors (Float switches)
2.1.3 Power-on
A) Power-on of main unit
If the main unit is attached the ISE unit, all electrodes and Calibrant A solution should be
fitted to the ISE unit in advance with the power switch is turned on.
The power switch is located on the left side panel of the main unit.
Power supply receptacle Power switch Connector for LAN
49
B) Power-on of personal computer (PC)

Power the PC which is connected to the main unit.
Normally, the software for the main unit starts up automatically when the PC is powered on.
After installation of the analyzer, when the PC is powered on, the analyzer should be car-
ried out the prime sufficiently in order to deflate the tubing line of the water and solution.
And also the prime mode setting should be performed in advance with the starting of
measurement, which is performed in the function menu [Condition (F12)] picture of the job
menu [Run Monitor (F5)]. (Default setting is set to “Auto Prime Mode”.)
Thereafter, when the measurement is started, the priming is performed in accordance with
the prime mode, if operator changes the prime mode setting.
C) Automatic preparation mode in advance of measurement

Before measurement, operator selects one of the below modes.
1. Full prime mode: At the round start, full prime and auto-gain process are performed.
2. Auto prime mode (default setting): When the measurement is started, the priming is per-
formed either the long prime or short prime in accordance with “Auto Prime Parameter”.
“Auto Prime Parameter” is specified in the function menu [Auto Start (F12)] picture of the
job menu [Maintenance].
(1) Full prime: Execution of the long priming as below
Long Prime Mode
Pump or syringe name Operating period
SWU MX1 Pump for Mix-1 trough ON:18 sec
SWU Water Pump for SPT trough ON: 3 sec
SPP-S1 Syringe for SPP unit Water discharge: 1500μl x 10 times
RPT-water1 Pump for RPT trough ON: 3 sec
RPT-detergent Pump for RPT trough ON: 3 sec
RPP Syringe for RPP unit Water discharge: 2000μl x 10 times
WPP-1,3 Syringe for WU1 and WU3 Water prime: 600μl x 10 times
WPP-1,3 Syringe for WU1 and WU3 Solution prime: 500μl x 10 times
WPP-2, 4, 5, 6 Syringe for WU2, 4, 5 and WU6 Water prime: 600μl x 20 times
(2) Short prime: Execution of the short priming as below.

Short Prime Mode
SPP-S1 Syringe for SPP unit Water discharge: 1500μl x 1 time
RPP Syringe for RPP unit Water discharge: 2000μl x 1 time
Number of short prime execution is able to be specified in the function menu [Auto start
(F12)] picture of the job menu [Maintenance].
50
3. Skip mode: If operator selects this mode, when the measurement is started, prime and
auto-gain process are skipped for this round. But this skip mode becomes invalid after this
round is completed.
Function menu [Condition (F12)] picture of the job menu [Run Monitor (F5)]
When the “Auto Prime Mode” is selected from above “Prime Mode”, the priming proce-
dure is automatically executed in accordance with below parameters by system just after
pressing [START] key to start the measurement.
Function menu [Auto Start (F12)] picture of the job menu [Maintenance].
4. When the time of start of measurement is within the time specified in “Short prime inter-
val” from last completion of measurement, system will execute the auto-gain adjustment
without any priming.
5. When the time of start of measurement is greater than the time specified in “Short prime
interval” but less than the time specified in “Full prime interval”, system will execute the
short priming with specified number in “Number of Short Prime” and the auto-gain adjust-
ment.
6. When the time of start of measurement is greater than the time specified in “Full prime
interval” from last completion of measurement, system will execute the long priming and
the auto-gain adjustment.
51
D) Automatic ISE priming

Just after turning on the analyzer, 5 times of ISE prime are carried out automatically. All
electrodes should be fitted to the ISE module; otherwise the liquid of Calibrant A is flooded
into the inside of analyzer. It may be caused serious problem. Thus, don’t forget the fitting
of the electrodes to the ISE.
E) Power-on of printer
Power on the printer. At this time, make sure that the printer paper is correctly loaded.
2.1.4 Power-off
A) Shut-down of PC
The following function is selectable when you click [Shut³Down] on the upper right-hand
corner of the screen. Either one of “Sleep” or “Power Off” is selected.
1. Sleep: Where the “Sleep” mode is selected, the system is kept under the sleep
condition until it will be activated at the time of the day of the week speci-
fied on the [Auto Start [12]] picture of job menu [Maintenance].
During sleeping, the temperature inside the RCU unit is kept at 8 to 15ºC
and the calibrant A is dispensed into the ISE unit every 30 minutes for pre-
vention of the electrodes from drying.
2. Power Off: Where the “Power Off” mode is selected, the system is switched off and the
temperature inside the RCU unit is not controlled.
3. Cancel: When the “Cancel” is selected, the [Shut³Down] mode selection becomes
invalid.
B) Procedure of “Sleep” selection

1. When the [Shut³Down] tag on the upper right-hand corner of the screen is clicked on,
the shut down mode selection picture is popped up.
2. When the [Sleep] button is clicked on, the following popup menu is displayed so that
the items to be performed before going to the sleep mode are designated.
52
(1)
(2)
(3)
(4)
(6) (5)
(1) Select whether the cuvette water placement is performed before going to the sleep
mode. (Refer to “4.7.2 Nozzle Wash [Wash (F10)] Page: 1/2”.)
: All cuvettes are filled with system water (purified water).
: All cuvettes are filled with wash solution where is placed in the RCU.
: Cuvette water placement is invalid.
Note: Beforehand the registered bottle containing the wash solution is placed in the
RCU. Diluted C1 solution (1/100) should be used as the wash solution.
(2) Select whether SPT nozzle wash is performed before going to the sleep mode.
: SPT nozzle wash by wash solution is performed.
: SPT nozzle wash is invalid.
When “Enable” is selected, a sample cup being filled with wash solution should be placed
in the ASP position #18 before clicking on the [OK] button.
It takes about 12 minutes to complete this nozzle wash process.
Note: Diluted C1 solution (1/100) is used as the wash solution.
(3) Select whether RPT nozzle wash is performed before going to the sleep mode.
: RPT nozzle wash by wash solution is performed.
: RPT nozzle wash is invalid.
When “Enable” is selected, the registered bottle containing the wash solution should be
placed in the RCU before clicking on the [OK] button. (Same as “Wash Sol.” of (1).)
It takes about 12 minutes to complete this nozzle wash process.
Note: The sort of applied wash solution and its name should be set in advance. (See
“(5) of 4.7.2 Nozzle Wash [Wash (F10)] Page: 1/2”.)
(4) Select whether ISE cleaning is performed before going to the sleep mode.
: ISE cleaning is performed.
: ISE cleaning is not performed.
When “Enable” is selected, a sample cup being contained ISE cleaning solution should be
placed in the ASP position #19 before clicking on the [OK] button.
53
Note: If ISE unit (option) is not installed in the analyzer, this selection will not ap-
peared.
(5) When click on the [Cancel] button, the system returns to the condition of before crick-
ing on the [Shut³Down] tag on the upper right-hand corner at the screen.
(6) When click on the [OK] button, the system starts to execute the cuvette water displace-
ment and the previous selected items that have been designated in the popup menu. The
analyzer goes to the sleep mode thereafter.
3. Executing the cuvette water displacement and the other selected items.
(1) Carrying out the system initialization.
(2) Carrying out the cuvette water displacement.
(3) Carrying out the system initialization. (Same as previous picture)

(4) Carrying out the rinsing WU1 and WU3 with purified water.

(6) Carrying out the ISE cleaning (3 times) when “Enable” has been selected.

(8) Carrying out the nozzle wash (SPT and/or RPT) when “Enable” has been selected.

(10) C
arrying out the cuvette water placement when “Sys. Water” or “Wash Sol.” has been
selected.
4. Preparing process for going to the sleep mode.

Carrying out the preparation process for the sleep mode.
54
5. Entering the sleep mode.

The [Auto Start (F12)] screen of the job menu [Maintenance] is displayed in the screen and
the “Sleep” mode is established.
C) Shut-down of main unit

1. If the “Sleep” is selected, do not cut the power supply for both main unit and PC and
leave them on to enable them to be reactivated automatically.
2. If the “Power Off” is selected, the temperature control inside the RCU unit is disabled.
D) Power-off of printer
Cut the power supply for the printer as necessary.
55
2.2 Preparation and placement of reagent

Necessary reagents, diluents and wash solutions for analyses are placed in the reagent
tray. The reagent tray accommodates 40 bottles of them in total.
2.2.1 Placement and registration of reagents, diluents

and wash solutions
The bottles of reagent, diluent and wash solution may be placed at any position of the
reagent tray.
The registration of them is carried out in accordance with the following procedures:
1. Remove the lid of the reagent container unit (RCU) and take out the reagent tray.
2. Remove caps of bottles and place them in the tray.
3. Put back the loaded tray into the RCU.
Then turn the tray gently until its pin guide snaps on at the specified position.
4. Close the lid of the RCU.
5. When page 1/2 of [Inventory (F11)] picture of job menu [Run Monitor (F5)] is selected,
the currently registered bottles are indicated.
The number of inside cell except the row of “Test” in the below picture shows the slot
number of RCU where reagent bottle is loaded.
If each cell is coloured with red, pink or yellow, the meaning is;
(1) Red : Insufficient reagent inventory.
(2) Pink : Date expired.
(3) Yellow : Stability overdue.
56
6. When [RCU³Scan] button in the picture is clicked on, the following pop-up window is
displayed. The RCU starts rotating for registration update of the bottles of reagent, diluent
and wash solution in the reagent tray by clicking on [Start] button.
Click on this button.
2.2.2 Check of reagent remaining volume

After [RCU³Scan] has been executed or where the reagent bottles have already been
placed, the remaining volumes of each reagent are checked according to the following
procedures.
The remaining volumes of each reagent can be checked on pages 1/2 and 2/2 of [Inven-
tory (F11)] picture of job menu [Run Monitor (F5)]
A) Page 1/2 picture

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Reagent name Position of Position of Number Name Type Bottle Remaining

R1 bottle R2 bottle of tests position volume
57
B) Page 2/2 picture

More detailed information than the page 1/2 can be seen.
If operator wants to manually input the barcode of any bottles, it is allowable on this picture.
See the following description at item-(9).
(1) (2) (3) (4) (5) (6) (7) (8) (9) (10)
(11) (12) (13) (14)
(15)
(1) RCU Position:

Bottle position (RCU slot number: 1 - 40)
(2) Reagent Name:

This name that is registered in the [System (F9)] picture of job menu [System Parameters]
is applied.
(3) Reagent Type:

Discrimination of reagent type (R1, R2, Wash or Diluent).
(4) Bottle Size:

Distinction of bottle size (L: Large size, M: Middle size, S: Small size) is displayed on this
cell.
(5) Volume (mL):

Remaining volume (minimum unit: 0.1mL).
(6) Tests:
Number of possible tests (R1 or R2 whichever is less number of tests with remaining vol-
ume.).
58
(7) Method Name:

Applied method name.
(8) Vol/Test (μL):

Necessary reagent volume per a test (minimum unit: 1μL). R1 or R2 whichever is greater
volume of use.
(9) Stability Term:

Remaining days of stability terms for respective reagents is displayed. When the stability
is overdue, its line is shown with yellow colour.
(10) Barcode:
Barcode label is displayed.
Barcode can be modified/entered with a keyboard by double clicking the mouse on this
cell.
Note: When the remaining volume for applicable reagent becomes short for mea-
surement, this line is displayed with red colour. When the applicable reagent is ex-
pired, this line is displayed with pink colour. When the stability term for applicable
reagent that has been specified in “System Parameters” screen exceeds, this line is
displayed with yellow colour.
(11) RCU Scan:

When [RCU³Scan] button is clicked on, following menu is popped up in centre of picture.
And the RCU rotates and the reagents are registered by clicking on [Start] button.
(12) Save:
Setting parameters are saved when this button is clicked on.
(13) Delete:
Specify any desired slot line by clicking on the corresponding reagent bottle number and
click on [Delete] button to delete the reagent in that line. If such a deletion is made effec-
tive, click on [Save] button.
(14) Cancel:
Before clicking on [Save] button, if this [Cancel] button is clicked on, any modified param-
eters are returned to original.
(15) Volume Reset:

Specify the desired bottle volume cell by clicking, and click on [Volume³Reset] Volume
Reset button. Its reagent volume is re-set to full volume. If such a modification is made
effective, click on [Save] button.
59
2.3 Calibration Measurement

The periodical calibration is required for each method in order to perform stable and ac-
curate measurement. The calibration measurement for certain method is performed ac-
cording to the settings of “Chemistry Parameters” pictures (Page 1/2 and 2/2).
There are two kinds of calibrations as shown below:
1. Full calibration: The calibration curve is made using all the necessary calibra-
tors for calibration and the master calibration curve is then
updated.
2. Re-calibration: The work calibration curve is corrected and updated using
one or two selected calibrators.
The following two kinds of calibration curves are provided:
3. Master calibration curve: The calibration curve obtained from the full calibration (at
the beginning, Master calibration curve = Work calibration
curve)
4. Work calibration curve: The calibration curve corrected by the re-calibration.
The one used for the routine measurement is the work calibration curve.
In the case of using different lot number of reagent to get the calibration curve, two sets of
calibration curves are respectively stored in the equipment as “New” and “Old”.
[For example]
1st : M
easured calibration curve is stored in the new area.
2nd : Measured calibration curve that was used the different lot number of reagent in the
1st and 2nd measurement is stored in the new area after original curve in the new
area is moved to the old area.
3rd : Measured calibration curve that was used the different lot number of reagent in the
1st, 2nd and 3rd measurement is stored in the new area, after old area’s curve is elimi-
nated and new area’s curve is moved to the old area.
In the case of using same lot number of reagent, the newly obtained calibration curve is
always stored in the new area after the original curve in the new area is moved to the old
area.
When any error is taken place during calibration measurement, the measurement result
does not become available for the calibration curve. But when the valid term of reagent
for the calibration measurement is expired, the measurement result is used for calculation
of calibration curve.
Where a measured variation of absorbance (∆ABS) is out of calibration curve, its result of
concentration is found from low or high end of calibration point or expanded calibration
curve. In both case, the flag of “OVR” is attached to its result. This case is available when
“Spline”, “Point to Point” and “Log-Logit” are selected for equation type as calibration
curve, but in the case of “Factor”, “Linear” and “Exponential” are selected, the flag of
“OVR” is not attached to result even if the concentration is out of calibration curve.
How to specify the extending of min. and max. calibration, refer to “(2) Optional settings –
D: Miscellaneous settings” of “3.6.1 System Parameters [System(F9) Page 1/2]”.
2.3.1 Calibration measurement order

Where the ASP unit is provided with the barcode reader, there is no need to order the cali-
bration measurement with the relevant picture on the screen. The calibration order is given
by placing the required number of calibrators in the equipment. The judgement of full
60
calibration or re-calibration (one-calibrator or two-calibrator calibration) to be performed

is made depending on the number of calibrators placed in the equipment. The calibrator
is normally placed at the front of normal sample in the ASP unit. Where the ASP unit is not
provided with the barcode reader, refer to the input method of sample order in “2.4.10 Test
Selection for Off-line mode (ASP without BCR)”.
2.3.2 Settings of calibrator concentrations

When calibration measurement is performed, concentration values of each calibrator are
entered beforehand.
1. Select job menu [Calibration (F7)] picture.
2. Select function menu [Calibration (F9)] picture.
3. The method may be selected by either one of the following two ways:
Method number
Method name
Symbol of lot No.: new/old
Expired period of calibration curve
Measurement reagent blank
61
(1) Move the cursor on “Method” and enter the required method number in the box using
the numeric keys, or
(2) Press [SPACE] key to display the pop-up window showing registered methods and
click on the desired method number in it.
When the method code is specified, the method name in “Name” column is automatically
displayed.
4. Lot numbers of the reagent bottles which are placed in RCU and are registered to the
analyzer to be used in the calibration measurement are automatically displayed in the lot
number columns as R1 and R2.
5. Next of the lot number boxes for R1 and R2 are for displaying of lot symbol (old or
new).
This symbol is selected by clicking on [Change³Lot] button that is displayed at the bottom
of right-hand side on the screen. Please refer to the picture at previous page.
6. Expired of the calibration curve can be specified in the “Interval” box.

0 day : Expired period is not checked.
1 to 9 days : This number of days mean elapse days from last measured calibration curve
is checked. When the term expires, warning is occurred in the “Test Selec-
tion”.
7. When the reagent blank has measured, its value is displayed in the “Reagent blank”
box.
8. When the calibration curve already exists, its curve is displayed on the right-hand side
of the screen. Otherwise, this region is blank.
9. The standard concentration values of calibrators are then entered. Click on

[Parameters] button to display the following pop-up window.
62
See (2).
Input the lot number.
Input the Standard (Calibrato) con-

centration values.
(1) Enter standard concentration values of required number of bottle into the “Conc.”
boxes as shown in the statement of virtues accompanied with reagent kits.
Absorbance values (mAbs/10) are automatically entered in the “Work” and “Master” boxes
upon the completion of the calibration measurements for each calibrator placed in the an-
alyzer. When “Factor” calibration type is selected, the concentration input is not needed.
(2) Lot number of the standard (calibrator) can be specified by inputting its number.
When “Factor” calibration type is selected, the lot number input is not needed.
Check in the box of “All”;
 All: Only the lot number for S1 is allowed entering but the others (S2 to S’) can not be
entered. After the lot number of S1 is entered, other lot numbers for calibrators are auto-
matically set.
No check in the box of “All”:
 All: Lot number of calibrators can be entered individually (S1 to S7).
(3) Select the required equation for calibration curve calculation from the pull-down menu
of “Calculation” box.
When the “Enable reagent blank” is set to “Enable” in the function menu [Checks (F10)]
of job menu [Calibration (F7)], the type of calibration curve except “Linear” cannot be
selected. If such selection is done, the following error message will be appeared in the
screen. (See “2.3.5 Confirmation of judgement criteria and measuring conditions [Checks
(F10)]”.)
63
(4) Click on [Calculate] button to store data of the standard concentration values neces-
sary for the calibration.
10. To verify the conversion of absorbance to concentration by using current calibration

curve, click on [Recalculate] button.
The following window is popped up and either one of “Master” and “Work” can be se-
lected for applied calibration curve. Input the absorbance value for verification, then con-
verted concentration value is outputted into the conc. box.
Input the absorbance value for verification. Select either one of “Master” and “Work” by
pull-down menu as applied calibration curve.
Converted concentra-
tion value is displayed.
To close the popped up

window, click on this
button.
2.3.3 K Factor
The method to convert a measured absorbance into concentration is usually such that an
equation is obtained based on a calibrator and then a concentration of sample is obtained
using the equation. In this case, the calibration measurement on the calibrator must be
performed before measuring sample.
When it is known that the concentration of sample varies linearly, the measured absor-
bance may be converted into the concentration using the following equation:
Con = K · A + B where Con: concentration, A: measured absorbance, K: factor (conver-
sion gradient), B: initial concentration.
This conversion method by defining the parameter K is called as “K-Factor” method.
When “Factor” is selected as the type of calibration, the calculation equation is defined
only by specifying K factor. At the time of defining the equation, the initial concentration
B is zero, which will however be corrected by S1 blank. (Refer to “2.3.5 Confirmation of
judgement criteria and measuring condition”.)
Note: Don’t set any concentration value in the “Conc.” column. In the case of using
K-Factor, “Lot No.” should be selected “NEW”.
64
“Factor” is selected.
No need to set the lot

number.
Simply enter the value

of K and click on
[Calculate] button.
2.3.4 Full calibration using a single calibrator

The full calibration can be performed using not multiple calibrators but a single calibrator
of highest concentration, by means of automatic dilution measurement.
This type of calibration can be performed provided that the setting of the diluents in the
[Chemistry (F9)] picture of the job menu [Chemistry Prm (F6)] are specified as shown be-
low:
The diluent registered as the above must be placed in the RCU and its volume needs to be
confirmed in the [Inventory (F11)] picture of job menu [Run monitor (F5)].
1. The method, type of calibration curve and necessary concentration for the calibration
need to be specified in page 1/2 of the [Calibration (F9)] of job menu [Calibration (F7)].
2. Select page 2/2 of the [Calibration (F9)] of job menu [Calibration (F7)].
65
The lot number of applied

calibrator that is set at
“Page 1/2” picture in ad-
vance is displayed here.
3. Set the “Serial Dilution” at “Enable” box.
Note: When a normal standard or multi standard has been specified as the sample
type of test selection for the calibration measurement of this method in the [Test
Selection (F10)] menu of [Run Monitor (F5)], don’t set to “Enable” at “Serial Dilu-
tion” box. If set to “Enable”, a calibration measurement for this method will not be
performed.
4. Click on the [Calculation] button, and confirm the ratio of diluent to automatically calcu-
lated calibrator.
The sampling volume in
the “Chemistry Param-
eters” screen is applied
to this post sampling
volume to for the single
calibrator.









These values correspond to the concentration These values (pre-sampling and diluent)
data that are already set in the parameters win- are automatically calculated by clicking
dow (Page 1/2 of “Calibration” picture). on the [Calculation] button.
66
(1) Pre-sampling volume: 2 - 35 µL

(2) Diluent volume: Maximum 400 µL
After automatic calculation of the dilution ratio is done, when the calculated volume of pre-
sampling and diluent are coloured with red, it means that calculated ratio is not harmonize
with target dilution ratio.
Also the automatically calculated pre-sampling and diluent volumes can be changed to
the practical ones if necessary.
Click on the [Save] button after the values have been changed.
When the automatic dilution calculation needs to be performed again, click on
[Calculation] button.
5. After all of the above settings have been completed, place a calibrator of high concen-
tration in the ASP unit and initiate the measurement. The calibrator is automatically diluted
and the full calibration is performed.
2.3.5 Confirmation of judgement criteria and mea-

suring conditions: [Checks (F10)]
The various judgement criteria at the time of measurement are defined in order to ensure
the correct calibration curve.
The criteria and measuring conditions are predefined for each method and thus usually
there is no need to be changed by the user.
The predefined judgement criteria and measuring conditions can be checked and modi-
fied by the following procedures:
1. Select job menu [Calibration (F7)].
2. Select the function menu [Checks (F10)] screen.
(1)
(2)
(3)
(4)
(5)
67
3. The method may be selected by either one of the following two ways:
1 Move the cursor on “Method” and enter the required method number in the box using
the numeric keys, or
2 Press SPACE key to display the pop-up window showing registered methods and
click on the desired method number in it.
4. Applicability of various judgement criteria and their limit values are specified in the
“Limit Checks” rectangle. Enter tick mark into respective small box for each criterion to be
made effective .
(1) Duplicate Limit (allowable variation limit)
The value is entered to check the difference between absorbance values obtained from
the duplicate or triplicate measurements. In the case of triplicate measurements, the dif-
ference between maximum and minimum values is checked.
(2) Sensitivity (allowable sensitivity limit)

This is the value to check the difference in absorbance between the first and last calibrator.
(3) Linearity Limit (linearity check of reaction)

The ratio (%) and minimum check limit (mAbs/10) of the measurement range-2 (Measuring
Points-2) slope are entered. This check is applicable only to Rate method.
(4) Prozone Limit (check of prozone phenomenon: check of immuno-nephelometric mea-

surement)
The prozone check is applied to the End or Rate-assay. In the calibration measurement,
this limit check is not applied.
Prozone Limit value (P) is defined as below formula.
(ABSSL2–F – ABSSL2–S) / (tSL2–F – tSL2–S)
P= x 100
(ABSSL1–F – ABSSL1–S) / (tSL1–F – tSL1–S)
Two type of check method are available;
• Upper: It is assessed whether the prozone value is over than specified value or not.
• Lower: It is assessed whether the prozone value is lower than specified value or not.
And also the check method is selected by means of pull-down menu at the next of “Pro-
zone Limit” input field.
68
Prozone Limit: Maximum allowable prozone limit is entered.

SL1-S: The 1st measuring point number of slope range 1 is entered.
SL1-F: The last measuring point number of slope range 1 is entered.
SL2-S: The 2nd measuring point number of slope range 2 is entered.
SL2-F: The last measuring point number of slope range 2 is entered.
Sens.: Sensitivity limit value is entered.
Prozone check is not performed if the calculated sensitivity value (S) is lower than speci-
fied value (Sens.), i.e. Sens. value > S.
Sensitivity (S) is calculated by below formula.
(5) Absorbance Limit
This is to define the limit of absorbance for the Rate method.
The conditions of “Chemistry Parameter” are therefore as shown below:
Assay Type: Rate
Measuring Point 1:  Disable
2: Start [m1]
End [m2] where 1 ≤ m1 ≤ m2 ≤ 26.
This absorbance limit is valid for the method the conditions of “Chemistry Parameter” of
which are defined as the above.
Selection of reaction curve:
“increase” means increasing curve.
“decrease” means decreasing curve.
The limit of the curve is defined in mAbs/10.

In the case of “increase”: A
bsorbance values which are greater than the limit value are disregarded.
In the case of “decrease“: Absorbance values which are less than the limit value are disregarded.
5. Sampling Method for Standard, number of measurement, is specified.
 Click on “Duplicate” for duplicate measurement.
 Click on “Triplicate” for triplicate measurement.
69
6. Select the “Blank measurement”.

Take care not to mismatch in the reagent blank selection between calibrator and general
sample measurement. When a calibration curve was obtained without reagent blank mea-
surement, a general sample should be measured in condition of without reagent blank.
When click on this point, disable “Reagent blank and S1 blank” measurement.
 When click on this point, disable “Reagent blank and S1 blank measurement.
 When click on this point, enable “S1 blank” measurement for the factor or linear
equation of calibration. But reagent blank is not performed.
 When click on this point, enable “Reagent blank” measurement.
 When click on this point, reagent blank is processed as S1 at 2-point calibration. In
this case, only S2 is placed in ASP for the calibration measurement.
When the “Enable reagent blank for S1 (Linear)” is set to “Enable”, the type of calibration
curve should be designated “Liner” in the function menu [Calibration (F9), Page 1/2] of
job menu [Calibration (F7)]. Otherwise the following error message will be appeared in the
screen.
(See “2.3.2 Settings of calibrator concentrations”)
7. When “Enable reagent blank” is set up to enable, the interval of reagent blank for normal
run and the conditions of reagent blank during calibration measurement are specified.
Date and time of the last

reagent blank measure-
ment are indicated.
Interval of reagent blank measurement for normal run can be selected as below.
Daily: The reagent blank measurement is performed once a day.
Next Run: The reagent blank measurement is performed at the next run.
None: The reagent blank measurement is not performed at future runs.
 Measurement conditions of reagent blank: R1 + R2
 Measurement conditions of reagent blank: R1+R2 + water (as sample volume)
70
8. Specifying the number of measurement for the reagent blank.

In terms of the number of measurement for the reagent blank, if this term is not specified,
its number is defined either “Duplicate” or “Triplicate”.
: T
he number of measurement for the reagent blank depends on the setting of “Sam-
pling Method for Standards”.
: The number of measurement for the reagent blank is carried out one time.
9. Reagent blank limit check

When “Enable reagent blank” is made effective and “Duplicate” or “Triplicate” is selected
for the reagent blank measurement, the deviation of measured results on each same con-
centration is checked.
Allowance range for

deviation check.
: When click on this point, data check is enabled.
10. Saving of judgement criteria and measuring conditions

[Save] button: Click on this button to save entered parameters.
[Cancel] button: Click on this button when the entered parameters are not saved.
2.3.6 Registration of Multi-standard: [Multi (F11)]

For multiple methods, a common calibrator (standard) can be defined.
Ten (10) sets can be specified as the multi-standard and seven (7) kinds of calibrators per
a set can be registered.
Set No. Multi-standard set Barcode
1 MS01 – MS07 95000001 – 95000007
2 MS11 – MS17 95000011 – 95000017
3 MS21 – MS27 95000021 – 95000027
4 MS31 – MS37 95000031 – 95000037
5 MS41 – MS47 95000041 – 95000047
6 MS51 – MS57 95000051 – 95000057
7 MS61 – MS67 95000061 – 95000067
8 MS71 – MS77 95000071 – 95000077
9 MS81 – MS87 95000081 – 95000087
10 MS91 – MS97 95000091 – 95000097
71
The multi-standard is registered according to the following procedures:

1. Select job menu [Calibration (F7)].
2. Select the function menu [Multi (F11)].
3. Open the pop-up window of “Multi Standard Set” and specify the set number.
Select the set number from this pull-

down menu.
4. Enter tick marks  into the boxes of the common methods in the following list of meth-
ods (01 – 60).
In the list of methods, the ones registered in the [Chemistry Parameters] picture are indi-
cated.
72
The above picture shows that the set of MS01 – MS07 is allocated to AST, FERRIT and
ALK.
For example, assuming that the calibrator for full calibration of methods ticked in the
above is common with a set of five (5) calibrators Std-1 to Std-5:
Attach MS01 bar code label (95000001) to Std-1;
Attach MS04 bar code label (95000004) to Std-4; and
Attach MS05 bar code label (95000005) to Std-5.
This defines one set of multi-standard.
5. The registered numbers are saved by clicking [Save] button.
73
2.4 Test Selection

The procedures of test selection are different between the ASP with the barcode reader
(BCR) and without BCR.
The test selection of normal and emergency sample for which measurement has been
normally completed is deleted automatically, but being not normal completion of sample’s
order and profile’s order are not deleted. In addition, all mask conditions are canceled after
completion of measurement.
2.4.1 Masking procedure for ASP with BCR

A) In case of ASP with BCR (Option)
The sample number and method for sample (Test Selection) can be specified selecting the
page 1/2 and 2/2 of the function menu [Test Select (F10)] of job menu [Run Monitor (F5)].
Function buttons
[Function buttons]

[Standard] : to mask the method for standard item. 
[MS] : to mask the method for multi-standard item. 

[QC] : to mask QC method.  For Mask selecting
[Profile] : to mask the profile items. 

[Blank] : to mask the method for blank measurement.

[Save] : to save settings data. 
 For T/S settings making effectiveness or not
[Cancel] : to cancel settings data.
74

[Copy] : to copy test selection.

[Delete] : to delete test selection from list. For T/S editing

[List] : to list saved test selection
[Emergency] : to changeover the screen between normal and emergency selection.
[Online³order] : to request the test selection data to host, in the case of selecting “On Line
Batch1” or “On Line Batch2” mode in the function menu [Condition (F12)]
of [Run Monitor (F5)].
When the identical reagent to QC sample and standard sample is registered to apply the
measurement for more than 2 methods and also one standard sample for multiple meth-
ods is defined as the multi-standard, the mask function is available to selection of wishing
method(s) in order to apply the actual test selection.
The following is procedure of mask function.

1. Clicking on the mask selection button. ([Standard] or [MS] or [QC] or Profile or [Blank])
2. Popped up the mask setting picture in the center of screen as below picture.
The method with blue color is allowed to measure and the method with background color
(pale blue) is inhibited. The method that is clicked on turns to background or blue color
and its test selection is masked or unmasked. When the same method is clicked again, the
method turns over from masked or unmasked to unmask or mask.
(1) In case of [Standard]. (Normal sample)
Input method number. Or specify the

method by means of pressing [Space] key.
Analytic method
To mask all analytic methods

To make effective the masked for specified method num-
methods, push this button. ber, push this button.
To close this picture, To cancel this setting, push this button.

push this button. (Before push “Save” button)
75
(2) In case of MS. (Multi-standard)

Select Multi-standard Set number
from the pull-down menu.
Analytic method
(3) In case of QC. (QC control)

Input Control number. Or define the meth-
od by means of pressing [Space] key.
Analytic method
(4) In case of Profile.
Select Profile name from the

pull-down menu.
Analytic method
(5) In case of Blank. (Blank measurement)
Analytic method
3. After selecting valid item(s), one of following buttons is clicked on.

[Save] : to make masking item(s) effectively.
[Cancel] : to cancel this setting.
[Close] : to close this popped up picture.
Note: All mask conditions are canceled after completion of a measurement.
76
B) In case of ASP without BCR
Function buttons
[Function buttons]
[Standard] : to mask the method for standard item.


[MS] : to mask the method for multi-standard item. 

[QC] : to mask QC method.  For Mask selecting
[Profile] : to mask the profile items. 

[Blank] : to mask the method for blank measurement.
[Clear³All³Mask] : to clear all mask settings.

[Save] : to save settings data. 
For T/S settings making effectiveness or not
[Cancel] : to cancel settings data.

[Copy] : to copy test selection.


[Delete] : to delete test selection from list. For T/S editing

[List] : to list saved test selection
The Masking procedure is in the same way of ASP with BCR. Refer to previous description
“A) In case of ASP with BCR”.
77
2.4.2 Test selection of Normal and Emergency sam-

ple (ASP with BCR: Option)
(1) (5)
(4)
(2) (3)



(6)





The picture of page 1/2 of function menu [Test Select (F10)] is used for Normal and Rep-
licate Sample.
And also the picture of page 2/2 of function menu [test Select (F10)] is used for Emergency
sample.
(1) Specify number of input digit for Sample Number:
: T
he input number of digit is applied same as barcode label of the normal and emer-
gency sample. In this case, the sample number can be entered by handy barcode
reader instead of the keyboard in the following item (3).
: For the normal sample, number of input digit is applied 3 to 12 characters. For the
emergency sample, number of input digit is applied 3 characters. In this case, the
following item (3) is available.
(2) Entry of Sample Number:

In case the [Page: 1/2] (for Normal Sample);
Sample number entry field.

N: 3 to 12 characters
R: 2 characters
Allowed characters for the sample number and patient ID:

Numeral characters : 0 to 9
Alphabetical characters : A to Z and a to z
Symbols : !, #, $, (, ), +, -, ., /, ;, <, =, >, ?, @, [, ], {, }, ~
78
Select either “N” (normal sample) or “R” (replicate sample) by clicking on the correspond-
ing symbol.
The replicate sample is the sample with a certain number for which the measurement is
repeated. The number of replicate runs need to be specified in the page 2/2 of job menu
[System Parameters].
[N]: Don’t use “9” at the top of character string in case of 8 characters expression.
It would be better to avoid entering “xxx” as the sample number because it would be
occurred a sort of confusion with emergency sample in the “Run Monitor” screen.
Where the pediatric cup is assigned, four characters can be entered as the sample
number that is the lower four digits of sample barcode that is attached to the pediatric
tube. (Barcode: 8999XXXX, underlined 4 characters are available.)
[R]: Two characters can be entered.
Where the pediatric cup is assigned, two characters can be entered for replicate sam-
ple number that is the part of barcode number attached to the pediatric tube.
(Barcode: 94006001 to 940099XX or 94006001 to 94009Z01 or 94006001 to 94009z01,
under lined 2 digits are available.)
In the case of “Emergency Sample” ([Page: 2/2]);
Sample number entry field
(3 characters).
For the emergency sample, 3 characters in a string are available.

When the previous “Barcode” box is clicked on, 8 characters should be entered as the
sample number of emergency sample. (Refer to “2.6.3 Types of barcode labels”)
(3) Entry of patient ID:

Patient ID number is entered.
Patient ID input field (Max. 13 char-
acters).
After the setting of the patient ID number is completed, the following picture is popped-up
to select whether the patient information is made valid or invalid.
When click on the [Cancel] button, the processing proceeds to “Selection of method” im-
mediately.
When click on the [OK] button, the picture of patient information settings is popped up on
the screen. The patient information can be newly made or be modified. (See “2.4.3 Entry
of patient information”.)
(4) Specify the normal range type.

Normal range to be applied the measurement is possible to select one of the following
types.
1. Ordinary normal range (Male, Female, Child).
79
If you want to apply the ordinary normal range, select the blank selection.
2. Extension normal range.

If you want to apply the extension normal range, select one of the extension normal ranges
by means of the pull-down menu as below picture.
In advance, the necessary values for normal ranges are set in the chemistry parameters
screen ([Chemistry Prm (F6)] – [Chemistry (F9)]).
(5) Sample type selection for its barcode:

Select whether a normal sample is dealt with STAT (emergency) sample in spite of having
normal sample barcode on it.
Normal (N): Normal sample that is attached normal sample barcode is dealt with nor-
mal sample.
Emergency (E): Normal sample that is attached normal sample barcode is dealt with
emergency sample.
Pediatric (P): Normal sample that is attacked normal sample barcode is dealt with pe-
diatric sample.
E and P: Normal sample that is attached normal sample barcode is dealt with
emergency sample and pediatric sample.
(6) Selection of method:

The list of measurable reagents is shown as below. In the list, only reagents which exist in
the RCU and have been registered are indicated. The RCU can accommodate 40 bottles
of reagents in total and thus 40 methods for normal sample can be displayed here.
80
Normal chemistry analysis

methods list
ISE methods list Profile list
The test selection is executed by selecting required methods from the list by a mouse.
Multiple methods can be selected for one sample.
Red color method of general sample: Calibration curve of its method is expired.
Red color method of ISE: ISE calibration is not yet performed.
Yellow color method: Control measurement is expired.
When the optional ISE unit is installed, the “ISE methods list” is indicated below the “Nor-
mal sample methods list”. When the ISE method is colored with red, its calibration data
is not effective. Therefore, ISE calibration should be performed in advance with ISE mea-
surement.
Maximum 8 selectable method buttons as the profile list are shown under the “ISE meth-
ods list”.
After completion of setting the test selec-
tion, [Save] button should be clicked on to
make effective.
2.4.3 Entry of patient information

When test selection is made, the sample numbers and patient ID’s are defined. In general,
such patient ID’s need to be defined in advance for each patient in the function menu
[System (F9), page 2/2] picture of job menu [System Parameters]. (See “3.6.2 System
parameters (2/2)”.)
But even if there is not defined specified patient ID’s information in advance, it is possible
to newly create or modify the patient information to the patient ID specified in the test
selection.
After the Patient ID has been entered in the “Test Selection” screen, the patient informa-
tion is created or modified in accordance with the following procedures either for the case
of ASP with BCR” or ASP without BCR”.
1. Define whether the Patient ID is made valid or invalid.
(1) Click on the [Cancel] button when the Patient ID is made invalid.
(2) Click on the [OK] button when the Patient ID is made valid.
81
2. In case that the Patient ID has been made valid, the following pop-up picture is dis-
played. It is possible to newly create or modify the patient information.
(1) (2)
(4) (5)
(6) (7)
(3)
(1) Patient ID;

(2) Patient Name (Last name and First name);
(3) Date of Birth (day, month and year);
(4) Age;
(5) Sex (None, Male and Female);
Above mentioned items are outputted automatically, when the patient information has
already been entered in the function menu [System (F9), page 2/2] of job menu [System
Parameters].
Otherwise, these parts are able to be newly added in this test selection. But while execu-
tion of measurement, it is not possible to be modified/edited except that the patient infor-
mation is created newly.
(6) Click on the [Save] button to save the entered patient information.
(7) Click on the [Cancel] button to cancel and not to save the entered patient information.
2.4.4 Copy of Test Selection (ASP with BCR)

The same method can be assigned to multiple samples by means of this function.
The pop-up window “Copy Test Selection” is displayed by clicking on Copy button in the
[Test Select (F10)] picture (see picture below).
Sample No. of copy-origin
Sample No. of copy-destina-

tion (From)
Sample No. of copy-destina-

tion (To)
When this button is pushed,

“Copy Test Selection” window
is popped up.
Enter the sample number of copy-origin whose test selection has already been made into
the “Sample Number” box of “Copy From”. Thereafter, enter the sample numbers into
both “From” and “To” boxes of “Copy to Sample Number” and then click on the [Copy]
82
button in the pop-up window to assign the method defined for the sample of “Copy From”
to samples of “Copy to Sample Number”. Order of sample number applied to “From” and
“To” is in accordance with the selection of “Sample number increment”. (See “3.6.2 Sys-
tem parameters [System (F9)] Page 1/2”.)
2.4.5 Deletion of Test Selection

The test selection of normal and emergency sample for which measurement has been
normally completed is deleted automatically, but being not normal completion of sample’s
order and profile’s order are not deleted. Above is applied to both ASP with BCR and
without BCR.
If necessary, delete such a test selection before the next round of measurement is initi-
ated. When the date is shifted to a new date and further analyzer is re-started, test selec-
tion is deleted the pop-up window of “Delete Test Selection” is displayed by clicking on
the [Delete] button in the [Test Select (F10)] picture.
Order of sample number applied to “From” and “To” is in accordance with the selection of
“Sample number increment”. (See “3.6.2 System parameters [System (F9)] Page 1/2”.)
Starting sample No. for Deletion
Ending sample No. for Deletion
When this button is pushed,

“Delete Test Selection” window
is popped up.
Enter both starting and ending sample numbers for deletion into “From” and “To” boxes
respectively and then click on the [Delete] button in the “Delete Test Selection” window to
delete the test selection for the specified sample numbers (From – To).
When the entire test selections are deleted, click on the [Delete³All] button in the “Delete
Test Selection” window. And the following message is displayed to ascertain operator’s
action.
To perform the deletion of all test selection, click on the [OK] button.
83
2.4.6 Confirmation of Test Selection (ASP with BCR)

The registered test selection can be displayed, confirmed and corrected.
The pop-up window “Test Selection (Normal Samples)” is displayed by clicking on [List]
button in the function menu [Test Select (F10)] picture.
1. Methods underlined and in blue color (e.g. AST): being selected

2. Methods on white background and in black color (e.g. UREA, etc.): being not selected
(Candidates for selection)
3. Gray background: not candidates for selection.
The status of selection can be inverted by specifying the method name indicated in the list
and then pressing the [SPACE] key (or clicking the mouse button). That is that the method
being selected turns to the selection-release status and vice versa.
Click on the [Close] button in the picture to close the list.
2.4.7 Test Selection for QC sample

The test selection for the QC sample does not need to be made. The equipment recog-
nizes the registered method for the QC sample by reading the bar code label attached on
it when it is placed in the equipment and corresponding measurement is automatically
performed.
84
2.4.8 Test Selection of Method-to-Method computa-

tion
There is no need to make the test selection of method-to-method computation. The com-
putation is automatically performed when the measurement result is output for the item
included in the registered method-to-method computation equation.
2.4.9 Expired alarm of Calibration and Control mea-

surement
When the day of expired is set in the following items;
1. Calibration interval: Function menu [Calibration³³(F9)³] of job menu [Calibration³³(F7)³]
2. QC setting interval: Function menu [QC³Setting³³(F11)³] of job menu [QC³³(F8)³]
If its expired date becomes invalid, method corresponded with expired is colored with red
(Calibration) and yellow (Control) in the test selection screen as alarm.
When ISE calibration measurement is not yet carried out, the method of ISE in the test
selection screen is colored with red.
Even if these alarms are issued, the measurement is carried out normally. And error flag is
attached in its result.
85
2.4.10 Test Selection for Off-line mode (ASP without

BCR)
The picture of Test Selection is displayed by selecting the function menu [Test Select (F10)]
of job menu [Run Monitor (F5)]. When the new test selection is made, check the currently
set test selection by moving an arrow key ([³³
³³] or [³³
³³]) in the column of “Pos” number which
corresponds to the slot number of the ASP unit. Press the [Tab] key at the desired position
in the column of “Pos” number to display the test selection picture at right.
Expired check of the calibration curve and control measurement are performed same as
ASP with BCR.
(1)
(2) (3)
(4)
Mask selection buttons
(1) Specify the slot number by a mouse or arrow key.
The numbers in the column of “Pos” correspond to the slot numbers of the ASP unit. The
necessary picture for the test selection is displayed at right by pressing the [Tab] key after the
slot number in which the sample is to be placed is specified by the arrow key ([³³ ³³] or [³³
³³]).
(2) Specify the type of sample.
E: Emergency sample
N: Normal sample
86
S: Normal standard sample

MS: Multi standard sample
SS: Serial dilution standard sample
B: Blank sample (for one point compensation of “Factor” and “Linear”)
C: Control sample
R: Replicate sample
[O: On-line sample (This is appeared in the case of on-line mode.)]
Click on either one of above mentioned to specify the type of sample.
(3) Specify the normal range type.

Normal range to be applied the measurement selected one of the following types.
1. Ordinary normal range (Male, Female, Child).
If you want to apply the ordinary normal range, select the blank selection.
2. Extension normal range.

If you want to apply the extension normal range, select one of the extension normal ranges
by means of the pull-down menu as below picture.
In advance, the necessary values for normal ranges are set in the chemistry parameters
screen ([Chemistry Prm (F6)] – [Chemistry (F9)]).
(4) Entry of sample number and patient ID for emergency sample (E) and normal
sample (N).
Sample Number: Enter 3 to 12 characters.

Patient ID: Up to 13 characters can be entered.
Allowed characters for the sample number and patient ID:
Symbols : !, #, $, (, ), +, -, ., /, ;, <, =, >, ?, @, [, ], {, }, ~
After completion of “Patient ID” setting, the operator can select whether the Patient ID is
made valid or invalid. If the proper information of patient information is selected, the pa-
tient information is possible to make newly or modify the already existing it. Its procedure
is same as the “2.4.1 Test Selection of Normal and Emergency Sample (ASP with BCR)”.
(See “2.4.3 Entry of patient information”.)
When the type of sample is Emergency (E) or Normal (N), follow the below procedure to
specify the method.
87
The method that is clicked on turns to blue color and its test selection is established. When
the same method is clicked on again, the method is released from the test selection.
Normal chemistry analytic

methods list
ISE methods list Profile list
A) Type of sample: Normal Standard (S)

When the type of sample is Normal standard (S), maximum 7 slots are secured as shown
in the following picture (shown in red color in the “Pos” column).
The required number of slots is selected by clicking the corresponding numbering box.



 Select “Normal standard”

Slots shown in red color (max. 7 slots) are
reserved for the calibrator(s).standard”
B) Type of sample: Multi-standard (MS)

When the type of sample is Multi-standard (M), the set number is selected as below pic-
ture. In this case, such numbers must have been set in the [Multi³³(F11)³] screen of job menu
[Calibration³³(F7)³] in advance.
Select “Multi-standard”
Select Multi-standard
 Set number from the
 pull-down menu.


 Method list
When Multi-standard is selected as the type of sample, the analytic method is automati-
cally selected in accordance with the Multi-Standard Set, which has already been regis-
tered (See the [Multi (F11)] picture of job menu [Calibration (F7)]), and thus there is no need
Select “Serial dilution standard”
to select method. But the actual analyzing method of multi-standard can be changeable
by means of the mask function.
C) Type of sample: Serial Dilution Standard (SS)

Analytitic
When the type of sample is the single method
standard (SS),listthe procedure to specify the method
except the blank sample is described below.
88
The method that is clicked on turns to blue color and its test selection is established. When
the same method is clicked on again, the method is released from the test selection.
In the case of the blank sample, the analytic method is not specified in the analytic method
list.
D) Type of sample: Control Sample (B)

In the case of selecting the blank sample (B) as type of sample, the analytic method is
automatically selected in accordance with the setting of “Blank measurement” in the func-
tion menu [Checks (F10)] picture of job menu [Calibration (F7)].
E) Type of sample: Control Sample (C)

When the type of sample is the control sample (C), follow the procedure below to specify
the method.
After selecting of sample type, the number of control sample must be entered in the con-
trol number box at the next of sample type box.
Select “Control sample” Enter the

number of
control sample.
Control sample list
Analytitic method list
The analytic method is automatically selected in accordance with the control sample,
which has already been registered (see the [Control (F12)] and [QC Setting (F11)] of job
menu [QC (F8)]), and there is no need to select the analytic method. But the actual analyz-
ing method of control sample can be changeable by means of the mask function.
F) Type of sample: Replicate Sample (R)

In the case of Replicate (R), enter 2-digit sample number.
G) Saving
Test selection is saved and established by clicking the [Save] button.
89
When requested to move to the newer position number, click the [Next] button.
When requested to move to the older position number, click the [Prev] button.
Note: After completion of the measurement, the color of slot number (ASP) in the list
at left hand side in the screen is changed according to the status of measurement
the same as information of sample proceeding picture in the [Run Monitor] screen.
(See “2.7 Initiation of measurement and monitoring”.)
This indication is also applied to the “2.4.11 Test Selection for On-line mode (ASP without
BCR)”.
Green: Sampling started.
Blue: Range over
Purple: Rerun required
Red: Error
Sky blue: Process completed
White: Not processed
Yellow: Not test ordered
In case of ASP without BCR, this indication is useful for the addition of sample.
90
2.4.11 Test Selection for On-line mode (ASP without

BCR)
In the case of Online Mode (ASP without BCR), following picture is displayed by selecting
the function menu [Test Select (F10)] of job menu [Run Monitor (F5)].
(1)
(2) (3)
(1) Specify the slot number by the mouse or arrow key.

The numbers in the column of “Pos” correspond to the slot numbers of the ASP unit.
(2) Specify the type of sample and sample number for the on-line mode.
Click on “O” button, after that a sample number entry box is appeared just below the
sample type definition button. So, enter the sample number into “Sample Number” box.
Clicking on this button
Clicking on this button
It is allowable to enter the numeric code with number of digit from 3 to 12 (except 90000000
to 99999999) in the Sample Number box.
And [Save] button should be clicked on to define the sample position in the ASP.
91
Repeat the procedure of (1) to (2) for all samples to be measured.

And to define the test order for the samples, the following procedure is needed.
(3) Acquire the test selection from the host computer.

After completion of sample setting and specifying the slot number for the ASP, the test
selection should be acquired from the host computer. In order to get the test selection,
click on the Acquire [Order] button at upper-right corner on the screen.
Click on this button to acquire

the test selection from host.
During the communicating between the host, the following message is popped up.
92
2.4.12 Confirmation of Test Selection (ASP without

BCR)
The following description is for confirming test selection made for the sample placed in the
ASP unit. Even in the case of on-line batch mode (ASP without BCR), you can confirm the
test selection by using same procedure which is described in this paragraph.
Analytic Method buttons
T/S individual T/S all delete button T/S listing button

delete button
Follow the procedures below for confirming the test selection:

1. Select sample position number by moving the arrow key ([³³
³³] or [³³
³³]) in the column of
“Pos” number for which the method buttons are shown in blue colour in the right picture
(including for ISE methods or profile method buttons) and the test selection has been
made.
2. If the test selection of the specified “Pos” number is deleted, click on the [Delete]
button.
3. If the test selection of the entire “Pos” numbers is deleted, click on the [Delete³All]
button.
4. When [List] button is clicked on, the registered test selection can be displayed, con-
firmed.
(1) Methods underlined and in blue colour (e.g. AST): being selected.
(2) Methods on white background and in black colour (e.g. UREA, etc.): being not se-
lected. (Candidates for selection)
(3) Gray background: not candidates for selection.
Note: In the case of ASP without BCR (barcode reader), it is not possible to change
the status of test selection in the displayed list, not same as ASP with barcode
reader.
93
5. When the test selection is copied, click on the [Copy] button to show the pop-up win-
dow “Copy Test Selection” and follow the procedure below:
(1) Enter into “Copy From” (copy origin) box the position number whose test selection is
to be copied.
(2) Enter position numbers into both “From” and “To” boxes of “Copy to Positions” (copy
destination). Sample number needs to be entered to “From” of “Copy to Positions” as
well. The position numbers in the “Pos” column specified by „From” and “To” boxes turn
to red colour and are defined as the copy-destination.
Position number of
copy-origin
Position number of
copy-destination (From)
Position number of
copy-destination (To)
(3) Click on the [Copy] button to execute copying.

(4) Click on the [Cancel] button to execute copying once again.
2.4.13 Operation with Host computer connected

When the host computer is connected to this analyzer, the data entry for the test selection
can be done at the host computer. The data entry is carried out in on-line batch or on-line
real time mode. The mode change is made in the [Condition (F12)] picture of job menu
[Run Monitor (F5)].
94
A) Test selection in the on-line batch mode

In the case of on-line batch mode, the information of test selection is loaded at a time prior
to the initiation of chemistry analysis. Operation for this mode is as follows:
1. When “Online orders” button (ASP with BCR) or “Acquire orders” button (ASP without
BCR) is clicked on at [Test Selection (F10)] screen of job menu [Run Monitor (F5)] , the test
selection data are transmitted from the host computer to the analyzer.
2. After the methods based on the information of test selection are registered and the
necessary reagents and samples are loaded, the measurement is initiated.
3. The test selection for emergency sample can be made on the screen of the analyzer.
4. When the “On Line Batch 1” is selected as “Host Communication Mode”, the measure-
ment results are transferred to the host computer at the time of result obtained for one
method.
5. When the “On Line Batch 2” is selected as “Host Communication Mode”, the measure-
ment results are stored in the analyzer. If necessary, the measurement results are trans-
ferred to the host by using batch function, which is performed by selecting function menu
[Result (F12)] of the job menu [System Parameters].
B) Confirmation of test selection

The information of test selection sent from the host computer can be checked in the pic-
ture or on the printed hard copy prior to the commencement of measurement. The check
procedures are the same as the one without the host computer.
C) Test selection in the on-line real time mode

In the on-line real time mode, a query addressed to the host computer is raised for meth-
ods. The sequence of the operation for this mode is as follows:
1. After the methods are registered and the necessary reagents and samples are loaded,
the measurement is initiated.
2. In the case of the ASP with BCR, the barcode reader in the analyzer reads the sample
barcode and raises a query for the methods to the host computer, and then initiates mea-
surement. This sequence is repeated for each sample.
But in the case of the ASP without BCR, it is not needed to read the barcode of sample
since the sample position in the ASP and its sample code is defined in advance.
3. The measurement results are stored in the analyzer itself and can be transferred to the
host computer in real time.
4. The test selection can be made on the screen of the analyzer only for the emergency
sample.
95
2.5 Settings of Measurement Conditions

The following conditions can be defined in the function menu [Condition (F12)] picture of
the job menu [Run Monitor (F5)].
For respective selections of the condition, they become effective while the analyzer stays
stand-by condition. It means that the selection of condition does not become effective
while the analyzer is running.
2.5.1 Automatic Rerun

The following re-run conditions are specified:
1. No Rerun: Rerun will not be performed.
2. Enable Rerun: Rerun is performed when the re-run situation arises.
Both sample and diluent volumes at the time of re-run need to have been defined in the
[Chemistry³³(F9)³] picture of job menu [Chemistry³Params³³(F6)³].
2.5.2 Automatic Print out

The following printout conditions are specified:
1. Enable: Measurement results (including QC result) are printed out.
2. Disable: Measurement results are not printed out.
96
2.5.3 Serum Information

Whether or not the measurement of serum information (haemolysis, turbidity, icterus) is
performed, is specified.
1. Enable: Serum measurement is performed.
2. Disable: Serum measurement is not performed.
2.5.4 Host Communication Mode

The conditions of communications with the host computer are defined.
1. Off Line:
Measurement is performed in accordance with the test selection specified by the PC and
nothing to do with the host computer.
2. On Line Batch:
3. On Line Batch 2:
Measurement is performed in accordance with the test selection transferred from the host
computer without raising a query to it.
In the case of selecting “On Line Batch 1”, the measurement results of normal, emergency
and control sample are automatically sent to the host computer at each time of obtaining
the measurement result.
In the case of selecting “On Line Batch2”, the measurement results are not sent to the
host, only saved to internal area.
4. On Line Real time:
Every time the barcode of sample is read, a query is raised to the host computer. Or in
the case of ASP without BCR, instead of reading the barcode of sample, the sample code
and its position in ASP are defined in the “Test Selection” picture in advance in order to be
used by analyzer in query. The measurement results of normal and emergency sample are
automatically sent to the host computer.
2.5.5 Host Communication

The communication protocols with host computer are defined.
1. Normal:
“ASTM E1381” protocol is applied to communicate with the host computer, when this item
is selected.
2. No Handshake:
There is no protocol to communicate with the host computer, when this item is selected.
2.5.6 Prime Mode

When the measurement is started by pressing START key, normally the priming of each
pumps and syringes and auto-gain adjustment are performed in accordance with follow-
ing selection.
In the case this mode is changed, after analyzer is re-started by turning power off and
back to on, the changed its mode becomes effective. But the skip mode becomes avail-
able without re-starting the system.
97
1. Skip: In case of this mode being selected, priming and auto-gain adjust-
ment are skipped. After this round is completed, this mode selection
is automatically cancelled.
2. Full Prime Mode: At any time when the measurement is started, the priming of each
pumps and syringes are performed on the long prime mode.
And also auto-gain adjustment is performed.
3. Auto Prime Mode: In the case of this mode being selected, just after the measurement
is started, the priming is performed on short or long prime mode.
The prime mode is automatically selected in accordance with
“Auto Prime Parameter”. And the auto-gain adjustment is also per-
formed.
“Auto Prime Parameter” is specified in the function menu [Auto Start
(F12)] picture of the job menu [Maintenance].
Long Prime Mode

SPP-S1 Syringe for SPP unit Water discharge: 1500 μl x 10 times
RPP Syringe for RPP unit Water discharge: 2000 μl x 10 times
WPP-1,3 Syringe for WU1 and WU3 Water prime: 600 μl x 10 times
WPP-1,3 Syringe for WU1 and WU3 Solution prime: 500 μl x 10 times
WPP-2, 4, 5, 6 Syringe for WU2, 4, 5 and WU6 Water prime: 600 μl x 20 times
Short Prim Mode

SPP-S1 Syringe for SPP unit Water discharge: 1500 μl x 1 time
RPP Syringe for RPP unit Water discharge: 2000 μl x 1 time
98
2.6 Preparation and placement of sample

The analyzer accommodates 40 samples in total (Normal, Emergency, Quality control and
Calibrator) in sample tubes or cups. When the ASP is provided with the bar code reader,
the sample tubes with caps removed and bar code labels attached can be placed directly
in the sample rack. In case that the sample cups are used, they need to be put on tubes
bearing the bar code labels and then placed in the sample rack. In either case, bar code
labels must be affixed on tubes to identify patient and sample.
2.6.1 Sample container

A) Types of sample cup
The following types of sample cup can be used:
(1) Child cup (to be put on the dedicated adaptor bearing bar code label)
(2) Dedicated bottle (to be loaded in the disposable adaptor)
B) Types of sample tube

Sample tubes of 13 and 16 mm in diameter and 53 and 100 mm in length can be used
(adaptor is used as necessary).
2.6.2 Specifications of bar codes

Item Description
Symbols NW-7, Code39, ITF, UPC, Code128 (Set A, B, C)
Maximum number of The bar codes must be in conformity with one of the following
digits bar modules and with bar code printing range. The maximum
allowable number of digits varies depending on symbols.
NW-7: 3 to 12 digits
Code39: 3 to 8 digits
ITF: 3 to 12 digits
UPC: 3 to 12 digits
Code128 (Set A): 3 to 12 digits
Code128 (Set B): 3 to 12 digits
Code128 (Set C): 3 to 12 digits
Bar module • Fine bar: 0.25 to 1.0 mm
• Bar length ≥ 15 mm
Barcode printing range • Bar code printing area ≤ 57 mm
• Blank portions of 4 mm are provided at both side of bar
code.
Printing • Black on white background (B633)
• Numeric coding information is printed beside bar code.
• Printing on thermal paper is not allowed in order to prevent
bar code from time varying degradation.
• Quality standard ANSI MH10.8M applies.
Positioning of barcode • The position is such that there is no obstacle between the
label bar code printing area and the bar code reader.
• Angle alignment deviation: within ±1º
99
A) Barcode attachment to the tube or bottle

Barcode label is attached to the tube or bottle as below drawing.
57 mm or less
12.5 mm
2.6.3 Types of barcode labels

The following four types of barcode labels are used depending on the types of samples.
Allowable characters to the barcode label for normal sample (include online sample),
emergency sample and replicate sample are;
Symbols : !, “, #, $, (, ), +, -, ., /, ;, <, =, >, ?, @, [, ], {, }, ~
A) Normal sample
The barcode labels which can be used are the ones bearing sample numbers in 3 to 12
characters. In the case of 8 characters, don’t use “9” at the top of character string.
B) Emergency sample
The emergency sample barcode label is used for the emergency sample.
The numeric codes in 8 digits can be used for barcode labels of emergency sample.
The bar code is defined as 99000nnn, where “nnn” is allowed using numerical or alpha-
betical or symbolical characters as previous mentioned.
C) Replicate sample
The bar code label is used for the case that the same sample is measured repeatedly.
The bar code is defined as 9400nn01, where “nn” is allowed using numerical or alphabeti-
cal or symbolical characters as previous mentioned.
D) Quality control sample

The numeric codes in 8 digits can be used for barcode labels of quality control sample.
The bar code is defined as 970000nn, where “nn” is from 01 to 30.
100
E) Normal standard sample (Calibrator)

The numeric codes in 8 digits of 980xxxxy can be used for barcode labels of calibrator.
The “xxxx” is from 0001 to 9999, which is applied for reagent code. And the “y” is from 1
to 7.
The calibrator is provided in dedicated bottle and together with disposable adaptor with
barcode affixed. The barcode contains the information about sample type code, method
code, liquid number (concentration, etc.), etc.
Disposable adaptors loaded with these calibrators are placed in the analyzer.
F) Multi standard sample (Calibrator)

The numeric codes in 8 digits of 950000xy can be used for barcode labels of multi stan-
dard calibrator. The “x” is from 0 to 9 and “y” is from 1 to 7. (Refer to “2.3.6 Registration
of Multi-standard”.)
G) Single standard sample (Calibrator to be diluted)

This standard sample is used for normal standard, which is diluted by means of automatic
dilution calculation. (Refer to “2.3.4 Full calibration using a single calibrator”.)
The numeric codes in 8 digits of 930nnnn0 can be used for bar code labels of single stan-
dard calibrator. The “nnnn” is from 0001 to 9999.
H) One point calibration sample

This barcode is defined for one point calibration sample as 95100001. And this code can
be used for S1 compensation on the Factor and Linear calibration method.
2.6.4 Placement of samples

When the samples are placed in the auto sampler (ASP) unit, their positions are not spe-
cifically designated for the types of samples. The ASP unit rotates in the counter clock-
wise direction and the samples are aspirated in the order in which samples reach the SPT
aspirating position.
Place sample following the rules below:
(1) Place calibrators at the front of normal samples. Otherwise, the samples placed at the
front of the calibrators are subject to the calibration curve obtained by the past round.
(2) There is no need for calibrators to be placed in order of their sample number (con-
centration values). However, where the calibrators have the same methods, place them
consecutively.
(3) Quality control sample may be placed at any position but preferably be immediately
after calibrator.
101
2.7 Initiation of measurement and

monitoring
2.7.1 Initiation of measurement
The analyzer performs automatically sample measurement, computation and printout of
measurement results and transfer of the measurement results to the host computer by
pressing [F1] key or clicking on [Start (F1)].
The photo-metering part in the analyzer is stabilized at least 30 minutes after switched on.
Pay particular attention to this fact when the [Start] key is pressed.
2.7.2 Monitoring of measurement

The progress of measurement can be monitored on the [Run Monitor (F9)] picture of job
menu [Run Monitor (F5)].
Just after pressing [F1] key or clicking on [Start (F1)] key, analyzer begins to check for
starting-up and reagent inventory. To announce this checking process for operator, the
following message is popped up at the centre of run-monitor screen.
When reagent short is found the warning message is popped up at the centre of screen
as shown below.
And the alarm code-6101 is simultaneously issued.
[OK]: When this button is clicked on, measurement process is continued.

[Cancel]: When this button is clicked on, measurement process is terminated.
102
Progress of
measurement
Information of
sample processing
The information of sample processing at the previous

time is cleared by clicking on this “Clear” button.
A) Number of tests run

The number of tests to be measured for which the test selection was made is indicated.
Quality control samples and calibrators are not counted.
B) Indication of temperature in Incubation Reaction Unit (IRU)

The current temperature in the IRU is indicated. The measurement can not be initiated un-
less the temperature falls within the specified range (37 ± 0.5ºC).
C) Indication of times of both start and end of measurement

The time at the run started and the estimated time at the run end are indicated.
The time of “Estimated time at run end” is changed as progressing of the measurements.
At the time when the replication sample(s) or calibrator(s) is/are definite for test selection,
its time of processing needed are added to the estimated time at run end.
As a matter of course, ISE is taken account of the processing time in the estimated time
at run end.
Time at run started
Estimated time at the run end
103
D) Information of sample processing

The information of sample processing is displayed in the left half portion of the [Run Moni-
tor (F9)] picture of job menu [Run Monitor (F5)] and identified in colour codes.
Green: Sampling Started

Blue: Range Over
Purple: Re-run Required
Red: Error
Sky-blue: Process Completed
White: Not Processed
Yellow: Not Test Ordered
E) Progress of measurement

The progress of measurement is displayed in the right half portion of the [Run monitor (F9)]
picture and the status of each sample from its sampling to the end of reaction is shown.
The results of measurements (concentration value) are also displayed at nearby below 4
or 5 lines from “WU1”.
(1) Type (2) Sample number (3) Method name (4) Patient ID (5) Result (6) Error



(1) “Type” column
The meanings of information shown in the “Type” column of the above picture are as follows:
1) Normal and emergency samples
None Normal measurement (1st time)
A> Re-run (Greater than higher limit.)
A< Re-run (Less than lower limit.)
D1 Diluted re-run
DF Dilution Factor
104
2) Quality control (QC) sample

C1 Control sample
3) Calibrator
#1 1st measurement
#2 2nd measurement
#3 3rd measurement
(2) “Sno.” column

The meanings of information shown in the “Sno.” column of the above picture are as fol-
lows:
Normal sample 3 to 12 characters (See “2.6.3 Types of barcode labels”.)
Emergency sample Ennn to Ennn (nnn: Numerical/Alphabetical/Symbolical)
Replicate sample Rnn to Rnn (nn: Numerical/Alphabetical/Symbolical)
QC sample C01 to C30
Calibrator S000011 to S999997
Multi calibrator MS01 to MS97
Single calibrator SS000011 to SS999997
Blank sample B
(3) “Method” column

Method numbers are indicated.
(4) “Patient ID” column

The patient identification code entered in the [Test Selection (F10)] picture of job menu
[Run Monitor (F5)] is shown in the “Patient ID” column.
(5) “Error” column

The meanings of information shown in the “Error” column of the above picture are as fol-
lows:
SS Insufficient volume of sample
SI1 Aspiration of sample disabled at ASP position
SI2 Aspiration of diluent disabled at IRU position
R1S Insufficient volume of primary reagent (R1)
R2S Insufficient volume of secondary reagent (R2)
DS Aspiration of diluent disabled at RCU position
WS Aspiration of wash solution disabled at RCU position
TE1 Lower temperature of IRU than 35 centigrade
TE2 Higher temperature of IRU than 39 centigrade
TE3 Higher temperature of RCU than 15 centigrade
R1B R1 reagent bottle not registered
R2B R2 reagent bottle not registered
DB Diluent bottle not registered
WB Wash solution bottle not registered
IE1 No response from ISE
IE2 No measurement result obtained from ISE
EST Error arises during measurement and sampling interrupted
LOT Reserved
CLT Reserved
105
R1W Wash of RPT between methods failed (timing of R1 reagent)

R2W Wash of RPT between methods failed (timing of R2 reagent)
EXP Period of validity of reagent expiry
STB Period of stability of reagent expired

CTO 
OVR 
CA? 
CAL 
LIN  These flags are not outputted on the run monitor screen.
PRO  (Refer to “4.6.2 Measurement result error flags”.)
AB1


AB2 
DUP 
SEN
2.7.3 Interruption and Resumption of measurement

The analyzer comes to rest when all measurement has been completed. During measure-
ment, it can be interrupted and resumed manually.
A) Interruption of sampling ([Stop (F2)])

Sampling is interrupted by pressing [F2] key or by positioning the pointer in [Stop (F2)] and
clicking the left button of the mouse. However, for the samples whose sampling operation
has been completed, their measurements are carried on.
B) Emergency stop ([Ctrl] + [F2])

Entire processing operations come to stop by pressing [Ctrl] and [F2] keys simultane-
ously.
C) Resumption of measurement ([Start (F1)])

The measurement can be resumed by pressing [F1] key or clicking on the [Start (F1)] but-
ton while the (photometric) measurement of samples whose sampling operation has been
completed is ongoing.
2.7.4 The function of Liquid level sensor unit for ex-

ternal tanks (ETNK) (an optional function)
The analyzer watches the following condition by each Liquid Level Sensor corresponding
to the use for each tank.
1. System Water Tank: It is sensed that the System Water is empty.
2. Wash Sol.-1,2, or 3 Tank: It is sensed that each Wash Solution is empty.
3. Low or High Conc. Waste Tank: It is sensed that each Waste is overflow.
When one of the above conditions is detected, the alarm indication, the operation of the
analyzer, and the restoration method are as the following.
106
A) During the prime operation

Name of Tank Alarm In- Operation of Restoration Method
dication Analyzer
System Water E2606 Emergency Stop Fill the tank with System Water, and
register the order, and operate the
start method.
Wash Sol.-1 E2607 Emergency Stop Fill the tank with Wash Solution, and
start method.
start method.
start method.
Low Conc. Waste E2609 Emergency Stop Make the tank empty, and register the
order, and operate the start method.
High Conc. Waste E2610 Emergency Stop Make the tank empty, and register the
order, and operate the start method.
B) During the running operation

Name of Tank Alarm In- Operation of Restoration Method
dication Analyzer
System Water E2676 Sampling Stop Fill the tank with System Water, and
operate the start method. If the factor
of the alarm is cancelled, sampling is
resumed.
Wash Sol.-1 E2677 Sampling Stop Fill the tank with Wash Solution, and
resumed.
resumed.
resumed.
Low Conc. Waste E2679 Sampling Stop Make the tank empty, and operate the
start method. If the factor of the alarm
is cancelled, sampling is resumed.
High Conc. Waste E2680 Sampling Stop Make the tank empty, and operate the
start method. If the factor of the alarm
is cancelled, sampling is resumed.
107
2.8 Addition of Sample

2.8.1 Addition of Emergency Sample (ASP with BCR)
When an emergency sample is added during measurement, make the test selection in
accordance with the following procedures and place it in the analyzer. The placed emer-
gency sample is then processed.
The function of addition of emergency sample is effective, when the replicate sam-
ple is not loaded.
1. When an emergency sample is to be added, the test selection should be made in

advance. Select the function menu [Test Selection (F10)] or press the [F10] key. And by
pressing key of [Page Up], the Test Selection screen of page-2/2 is selected. The testing
order of the emergency sample is able to be set on this screen in the same way as for the
normal sample.
Refer to “2.4.2 Test Selection of Normal and Emergency sample (ASP with BCR: Option).
2. Click on the job menu [Stat/Norm (F3)].
The following pop-up window appears in the centre of the screen.
To add the emergency
sample, click this but-
ton.
To add the normal sam-

ple, click this button.
3. The following message appears on the screen until the sampling interruption process
is completed.
4. The following message is displayed when the ASP is ready to accept the emergency
sample after the sampling interruption process has been completed. And also the avail-
able position number in ASP to set the emergency sample and not removable samples
are instructed.
(1) Rerun condition is set “No reruns”. (See “2.5 Settings of Measurement Conditions”.)
108
Additional sample(s) can be set

to the ASP slot #1 to #37.
As an example, above picture shows the emergency sample(s) is/are able to put at ASP
slot position #1 to #37.
(2) Rerun condition is set “Enable rerun”. (See “2.5 Settings of Measurement Condi-
tions”.)
Additional sample(s) can be

set to the ASP slot #10 to #40
and #1 to #6.
White
Green
Red
Purple
Blue
5. Click on the [OK] button in the popped up message, after the emergency sample is
placed in the ASP unit. Emergency sample is moved to the sampling position, and is going
to be measured in preference to the other normal sample.
Note: The emergency code should be printed on the barcode label of emergency
sample or the sample type should be selected “Emergency (E)” in the [Test Selection
(F10), Page: 1/2] of [Run Monitor (F5)] in advance when the normal sample code is
employed as the emergency sample. Otherwise, the added sample will not be pro-
cessed correctly.
109
2.8.2 Addition of Emergency Sample (ASP without

BCR)
The function of addition of emergency sample is effective, when the replicate sam-
ple is not loaded.
1. Click on the job menu [Stat/Norm (F3)].

The following pop-up window appears in the centre of the “Run Monitor” picture.
To add the emergency
sample, click this but-
ton.
To add the normal sam-

ple, click this button.
2. The following message appears on the screen until the sampling interruption process
is completed.
3. The following message is displayed when the ASP is ready to accept the emergency
sample after the sampling interruption process has been completed.
(1) Rerun condition is set “No reruns”. (See “2.5 Settings of Measurement Conditions”.)

and #1.
(2) Rerun condition is set “Enable rerun”. (See “2.5 Settings of Measurement Condi-
tions”.)
110

and #1 to #6.
White
Green
Red
Purple
Blue
4. Put the emergency sample at the specified place of the sample tray in the ASP unit. And
click on the [OK] button.
5. The [Test Selection] picture is selected automatically and thus, in the picture, speci-
fies the type of sample “E”. (See “2.4.10 Test Selection for off-line mode (ASP without
BCR)”.)
6. Clicking on the job menu [Stat/Norm (F3)] or [Start (F1)], the emergency sample is moved
to the sampling position, and is going to be measured in preference to the other normal
sample.
2.8.3 Addition of Normal Sample

When a normal sample is to be added, click on the job menu [Stat/Norm (F3)] and press
Normal button in the pop-up message. Since then the procedure is to be referred “2.8.1
Addition of emergency sample (ASP with BCR)” and “2.8.2 Addition of Emergency Sample
(ASP without BCR)”. But added normal sample is proceeded in due order placed in the
tray of ASP.
111
2.9 Measurement of Sample for Rerun

Where the “Rerun” volume of a sample was specified in the [Chemistry (F9)] picture of
the job menu [Chemistry Prm (F6)], the sample is identified after the measurement result
of the round has been output and its rerun is automatically initiated in accordance with
the settings in the [Chemistry (F9)] picture of the job menu [Chemistry Prm (F6)].When the
measurement result is out of Technical Range, it is subjected to the rerun.
When the measurement failed due to the insufficient volume of sample or reagent, perform
such a measurement in the next round. The conditions of rerun set in the [Chemistry (F9)]
picture of the job menu [Chemistry Prm (F6)] are shown below:
To enable dilution Dilution name
Normal Range


 Technical Range













As for technical range criterion, concentration value and absorbance value are available.
To disable the technical range for absorbance value (mAbs/10), its range must be set to “–99999
– 99999”.
The following picture is the case of “High”. There are two types of settings (“High” and
“Low”) as the dilution parameter settings for the rerun.
Sampling volume at Rerun

Dilution parameters at

 out of Technical Range
Sampling volume to be diluted Diluent volume
2.9.1 Measurement of sample for rerun.

1. Out of Technical Range “High”.
2. Out of Technical Range “Low”.
3. AB1 error occurs.
The measurement is performed in accordance with the settings of “Dilution” in the [Chem-
istry Prm (F6)]. See “3.2 Analytical Conditions [Chemistry Prm (F6)]” in detail.
112
2.9.2 Resultant value of rerun

1. In the case of diluted rerun, the resultant value is the value corrected for the dilution
ratio.
2. The measurement result that is before rerun executing and the resultant value of rerun
are stored in the analyzer. And also, the flag “r” is attached to the resultant value of rerun
to distinguish from original result.
3. The resultant value of rerun that is out of technical range is dealt like below:
Case Reaction Resultant value (Concentration)
mode (Common to output for display,
print, FD and ASTM)
Measured concentration value before Upper limit value of technical range
rerun execution is greater than upper for concentration is outputted.
limit of technical range for concentra-
tion.
Measured concentration value before Lower limit value of technical range
rerun execution is less than lower limit for concentration is outputted.
of technical range for concentration.
Measured absorbance value before re- Increase Upper limit value of technical range
run execution is greater than upper limit for concentration is outputted.
of technical range for absorbance. Decrease Lower limit value of technical range
for concentration is outputted.
Measured absorbance value before Increase Lower limit value of technical range
rerun execution is less than lower limit for concentration is outputted.
of technical range for absorbance. Decrease Upper limit value of technical range
for concentration is outputted.
See “2.3.5 Confirmation of judgement criteria and measuring conditions”.
113
2.10 Reproduction of Measurement
Results
The measurement results can be reproduced on the display in the function menu [Result
(F12)] picture of the job menu [System Parameters]. Specify the data of measurement to
reproduce the corresponding measurement results on the display or in the form of hard
copy. The reproduced data on the display can not be edited, but the “Delete” function
is only allowed. The time course of the specified measurement results can also be dis-
played.
Retrieval conditions Retrieval function buttons

(See “2.10.1 Settings of retrieval conditions”.) (See “2.10.2 Retrieval functions”.)






Referential data
Picture of retrieved measurement results
2.10.1 Settings of retrieval conditions

In order to extract the measurement result from the internal data base, it is needed to set
the retrieval conditions as below items.
“Sample Type” setting box
The sample type to be retrieved is selected from

Normal, Emergency, Online, Standard, ISE Stan-
dard, Control and Replicate by using pull-down
menu.
114
“Sample # (From – To)” setting box

These settings are effective against the sample type of “Normal”, “Emergency”, “Online”
and “Replicate”.




















Either “Sample number” or “Patient ID” is se- Sample numbers or Patient ID to be retrieved
lected as the retrieval condition of measure- are specified (From / To), “*” is the wildcard
ment result by using pull-down menu. and means all samples are selected.
“Dates from and Date to” setting box

Dates of the measurements to be retrieved are specified. “*” is the wildcard and means
that all samples are selected.
Day of starting data Month Year Day of end data Month Year
“Round #” setting box

The round number of the measurement results to be retrieved is specified.
“*” is the wildcard and means that all samples are selected.
“Send” selecting box (This is available for online data.)

This selection is applied to only the measurement results which have been got by means
of the online measurement.
All: Reference data are all measurement results by measured online mode.
OK: Reference data are the measurement results which were correctly transferred to the
Host.
NG: Reference data are the measurement results which were not correctly transferred to
the Host.
“Result Output” selecting box

Output destination of the measurement results to be retrieved is chosen one among the
destination list from pull-down menu. Destination depends on the sample type.
As for the output of Control result, refer to the “Optional settings” in the function menu
[System (F9)] of job menu [System Parameters].
115
Sample type Destination

Normal, Emergency, Online, Control 1)Monitor, 2)Print, 3)FD, 4)Host(*1)
Standard, ISE standard, Replicate 1)Monitor, 2)Print, 3)FD
*1: To make effective this destination (Host), “Send QC Result”, one of optional setting
flags ([Details] button), should be set effective in the function menu [System (F9)] of
job menu [System Parameters] and choose whichever “On Line Barch1” or “On Line
Batch2” or “On Line Real time” among the “Host Communication Mode” selection pic-
ture in the function menu [Condition (F12)] of job menu [Run Monitor (F5)].
2.10.2 Retrieval functions

(2) (1) (3)
(4)
Click on this button to se-

List of method selection lect all methods in the list.
Click on this button to clear the

selection of all methods in the list.
Click on this button to re-

turn to [Result (F12)] picture.
(1) “Cancel” button

When this button is clicked the settings of “Date from” and “to” are reseted to the wild
card (“*”).
(2) “Select Test” button

The above method selection picture (List of method selection) is displayed by clicking on
this button. Click on the methods to be selected, and then the colour changes to blue.
(3) “Delete” button

If operator wants to delete the extracted data, click on this [Delete] button.
After clicking on the [Delete] button, the pop-up message picture is appeared on the
screen due to confirmation of the deletion as below picture.
When the [Yes] button is clicked on, all of retrieved measurement results are deleted from
the internal database. Thus, the practicing of this function should be fully taken care.
116
(4) “Search” button

When this button is clicked on, the extracting of measurement result begins in accordance
with the retrieval conditions and selected method. And the retrieved results are output-
ted.
A) Sample Type: Normal/Emergency/Online/Replicate (“Monitor” is

selected as “Result Output”.)
When the sample type is selected “Normal”, “Emergency”, “Online” or “Replicate”, the list
block is similar. The difference is the sample number expression.
Referential data block To send the result selected to host.
List of retrieved measurement results

(Maximum1000 lines are available on
this screen.)
List block
A measurement result in the list area is assigned at random by clicking on it by using

mouse to make work the function buttons of “Time Course”. And also, different informa-
tion about the assigned result is outputted to the referential data block.
<Function buttons for “Time Course”>

See “2.10.3 Output of time course data”.
[Graph]: When click on this button, the time course data of assigned measurement result
is plotted graphically on the screen.
[Print]: When click on this button, the time course data of assigned measurement result
is printed on the hard copy.
[FD]: When click on this button, the time course data of assigned measurement result
is outputted to the floppy disk.
<Function button for “Send Selected”>

When the host communication mode is selected to online mode (Online Bach1 or Online
Bach2 or Online Real time), a result or results in the retrieved measurement results can be
outputted to the host by pushing [Send²Selected] button.
The procedures are shown below.
117
1. Put the cursor on a result and click on it by mouse.

2. Push the space key. The colour of record (one line) is changed to blue; it means its re-
cord is ready to be outputted to the host.
3. If there is a yet more result to be sent to the host, repeat above steps (1 to 2).
4. after fulfilment of the record assignment in accordance with above steps,
push the [Send²Selected] button. Then the assigned records are sent to the host.
<Referential data block>

Every referential data such as concentration value, normal range judgement flag, techni-
cal range judgement flag, measurement result flag and QC judgement result (for only QC
result) are displayed to the referential block as to a result selected by mouse among the
list of retrieved measurement results as above picture.
Measured con- Judgment flag of the normal range Error flag

centration value H: Higher than Normal range (See “4.6.2 Measurement
L: Lower than Normal range result error flags”)



































Three kinds of judgment criterions that Judgement flag of the technical When push
have been selected “WARNING” or range this button, a
“ERROR” is displayed in priority order. >: Higher than Technical range selected result
(See “2.11 Quality Control”.) For exam- <: Lower than Technical range by mouse is
ple: QC Judgement [1:4S] [2:2S] [1:2S] deleted.
<Deletion of one by one>

A result which is selected by mouse among the retrieved measurement results can be
deleted one by one. The procedures are shown below.
1. Put the cursor on the unnecessary result and click on it by mouse.
2. Push the [Delete] button. Then the selected result is deleted from the internal data-
base.
When repeat above steps (1 through 2), you can delete consecutively unnecessary result
one by one.
B) Sample Type: Standard (“Monitor” is selected as “Result Output”.)

As for “Standard”, the listed block for retrieved measurement results is shown below.
When a single calibrator of highest concentration was used as the standard sample, the
lot number is shown only one for the highest concentration.
118
Object method of calibration measurement
Lot number for R1 and R2.
Lot number of calibrators
As for the above picture, upper area is for the object method of calibration measurement
and lower area is for measurement result of calibration.
When click on a “*” (asterisk) part in the upper area, its calibration results (absorbance
value) are appeared in the lower area.
<Function buttons for “Result Output” & “Delete”>
[Print]: When click on this button, the calibration result of assigned method in the upper
area is outputted to the printer. (See the example-3 in “2.10.4 Example of print-
out”.)
[FD]: When click on this button, the calibration result of assigned method in the upper
area is outputted to the floppy disk.
[Delete]: When click on this button, the calibration result of assigned method in the upper
area is deleted.
<Function buttons for “Time Course”>

See “2.10.3 Output of time course data”.
[Graph]: When click on this button, the time-course data of calibration result for assigned
method in the upper area is plotted graphically on the screen.
[Print]: When click on this button, the calibration result for assigned method in the upper
area is printed in time sequence on the hard copy.
[FD]: When click on this button, the time-course data of calibration result for assigned
method in the upper area is outputted to the floppy disk.
<Function button for leaving “Standard” picture>

[Close]: When click on this button, you can close this picture.
C) Sample Type: Control (“Monitor” is selected as “Result Output”.)

As for “Control”, the listed retrieved measurement results are shown in the below picture.
119
For each retrieved measurement result in the list, it can be dealt with same as normal
sample.
D) Sample Type: ISE Standard (“Monitor” is selected as “Result Out-

put”.)
As for “ISE Standard”, the listed retrieved measurement results are shown below picture.
These retrieved measurement results are only displayed on the screen.
2.10.3 Output of time course data

The time course of the measurement results appeared in the “Picture of retrieved mea-
surement results” can be plotted graphically on the screen or output in the form of hard
copy or to the floppy disc.
1. Specify the measurement data by clicking on it.
2. The time course is plotted graphically on the screen by clicking on the [Graph] button.
The measurement data is printed in time sequence on the hard copy, when [Print] button
120
is clicked on. Also the measurement data are outputted to the floppy disc by clicking on
the [FS] button.
For the “Standard”, the lot number of standard sample and reagent (R1, R2) are outputted
on the upper-limit scale line.
Plotting line for each wave length

Red line : Primary wave length
Green line : Secondary wave length
Yellow line : Differential value (Primary – Secondary)
Each wave length has a plotting definition box.
: Set check mark. Plotting is enabled.
: Clear check mark. Plotting is disabled.
Automatic scaling for vertical axis

As for plotting area, the scale for horizontal axis is fixed but the scale for vertical axis is
variable and it can be automatically calculated.
 : Set check mark. Automatic scaling is enabled.
 : Clear check mark. Automatic scaling is disabled.

Maximum absorbance value of vertical axis.
Minimum absorbance value of vertical axis.
When the automatic scaling is not selected, plotting range (maximum and minimum value)
should be set by manual.
121
2.10.4 Example of printout
2.10.4 Examples
2.10.4 Example of printout of printout
2.10.4 Examples
A) Example-1 of printout
(Normal sample and ISE)
2.10.4 Examples of printout
A)isExample-1
This sample (Normal
for the date of sample
February and
21, 2002 andISE)
round number of 4.
A)header,
As for the Example-1 refer is
This sample to(Normal
“Print
for the date sample
Header
of February and
“ input
21, 2002ISE)
field in section
and 3.6.1
round number of “System
4. Parameters
Page 1/2”. ThisAssample
for the header, refer to “Print Header “ input field in section 3.6.1
is for the date of February 21, 2002 and round number of 4. “System Parameters Page 1/2”.
As for the header, refer to “Print Header
Date “ofinput field in section
measurement 3.6.1 “System Parameters Page 1/2”.
(YY/MM/DD)
Header (Max. 50ch.)
#$%&*QURKVCN
DatePatient ID
of measurement (YY/MM/DD)
Sample
Header number
(Max. 50ch.)
#$%&*QURKVCN
5PQ+&#$%&CVG4QWPF
Patient ID
Sample number
Method names 0C-%N+5''440C
&
5PQ+&#$%&CVG4QWPF

Result
Method names 0C-%N+5''440C
&
OOQNNOOQNNOOQNNOOQNN

-
&%N
&+5''44#.6(0
Result OOQNNOOQNNOOQNNOOQNN
T Unit
-
&%N
&+5''44#.6(0
OOQNNOOQNNWNPION
Error code for ISE T
6GUV6GUV6GUV6GUV6GUV Unit
OOQNNOOQNNWNPION
.
(See Note-1)
Error code for ISE 6GUV6GUV6GUV6GUV6GUV
OIFNOIFNOIFNOIFNOIFN
.
(See Note-1)
OIFNOIFNOIFNOIFNOIFN
5PQ+& &CVG4QWPF
#.6(06GUV6GUV6GUV
5PQ+& &CVG4QWPF

#.6(06GUV6GUV6GUV
WNPIONOIFNOIFNOIFN

WNPIONOIFNOIFNOIFN
Flag and judgment flag of the
Maximum 5 methods
measurement result.
Flag and judgment flag of the
Note-1: When ISE error code is zero(0000), ISE ERR block ismeasurement
Maximum 5 methods not printed. result.
Note-1: When ISE error code is zero(0000), ISE ERR block is not printed.
When an ISE error is occurred, its result is printed with “̍.
When an ISENote-1: When ISE error code is zero(0000), ISE ERR block is not printed.
error is occurred, its result is printed with “****”.
B) Example-2 (Time
When an ISE course
error is occurred,of normal
its result sample)
is printed with “̍.
B) Example-2 (Time for

B) Example-2 course
This sample is (Time
of
the printed
normal
time course
course sample)
data.
of normal sample)

This sample is sample
This for theisprinted time time
for the printed course data.
course data.

&CVG4QWPF0Q
5PQ+&/GVJQF
Lot number .QV
555
&CVG4QWPF0Q
594594594594
5PQ+&/GVJQF
Lot number /
.QV
555
/
594594594594
/
/
/
/
Total 26 measuring
࡮
/
points
࡮
/
Total 26 measuring ࡮
࡮
points
/
࡮
/
࡮
/
/
Note:/
M1 shows the range of measuring point 1 and M2 shows the range of measuring point 2.
/
Note: M1 shows the range of measuring point

2.10 Reproduction 1 and M2 showsResult
of Measurement the range of measuring point 2.
2.10 Reproduction of 2-99
Measurement Result
2-99
122
2.10.4 Example of printout Chapter 2: Procedure of routine check

C)C)
Example-3
Example-3(Calibration result)
(Calibration result)
C) Example-3 (Calibration result)
C) This
Example-3
This sample (Calibration
sampleisisfor
for theprinted
the printed result)
coefficient
coefficient of calibration
of calibration result.
result.
This sample
sample is for the printed coefficient of calibration result.
Thissample
This
This sampleisisisfor
printed
printed whenthe
when
the printed the calibration
calibration
coefficient measurement
measurement
of calibration result. is performed normally.
is performed normally.
This sample is printed when the calibration measurement is performed normally.
1. Linear
1. sample
This Linear is printed when the calibration measurement is performed normally.
1. Linear
1. Linear
ABC Hospital 2002/03/12 20:28:06
ABC Hospital Date : 20020312 Round No: 003
2002/03/12 20:28:06
ABC Hospital--S1-- -S2- --S3-- Date--S4--
: 20020312--S5-- Round --S6-- --S7--
No: 00320:28:06
2002/03/12
CRP --S1--0 -S2-10 50 Date--S4--
--S3-- :100
20020312 150 Round
--S5-- --S6--
No: 003 --S7--
mg/dl
CRP --S1--02 -S2-105
10 510
50
--S3-- 10030
100
--S4-- 15100
150
--S5-- --S6-- --S7--
mg/dl
CRP 03
2 101
105
10 503
510
50 10044
10030
100 14950
15100
150
mg/dl SS0002 23 SS0002101
105 SS0002
503
510 SS0002
10044
10030 SS0002
14950
15100 Lot number
SS00023 SS0002
101 SS0002
503 SS0002
10044 SS0002
14950 Lot number
Linear SS0002 SS0002 SS0002 SS0002 SS0002
“X” means concentration. Lot number
Delta
LinearABS = aX + b “X” means concentration.
“Delta ABS” means absorbance.
Delta ABS = aX + b
Linear “X” means
“Delta ABS”concentration.
means absorbance.
a = 12345.67
Delta ABS = aX + b “Delta ABS” means absorbance.
a = 12345.67
b 23456.78
ab==12345.67
23456.78
b = 23456.78
2. Point to point
2. Point totopoint
2. Point point
2. Point
ABCto point
Hospital 2002/03/12 20:28:06
ABC Hospital Date : 20020312 2002/03/12
Round No: 003 20:28:06
ABC Hospital --S1-- -S2- --S3-- Date--S4--
: 20020312--S5-- Round No: 00320:28:06
2002/03/12
--S6-- --S7--
GLU --S1--
0 -S2-
10 --S3--
50 Date--S4--
: 20020312
100 --S5--
150 Round --S6--
No: 003 --S7--
300 500
GLU
mg/dl 02
--S1-- 10
-S2-
105 50
--S3--
510 100
--S4--
10030 150
--S5--
15100 300
--S6--
18050 500
--S7--
20560
mg/dl
GLU 032 105
10
101 510
50
503 10030
100
10044 15100
150
14950 18050
300
18000 20560
500
21050
mg/dl SS0002 23 101 SS0002
105
SS0002 503
510 10044
10030
SS0002 14950
15100
SS0002 18000
18050
SS0002 21050
20560
SS0002 Lot number
SS0002 3 SS0002
101 SS0002503 SS0002
10044 SS0002 14950 SS0002
18000 SS0002
21050
Lot number
SS0002
Point to point SS0002 SS0002 SS0002 SS0002 SS0002 SS0002 Lot number
“X” means concentration.
Point to
Delta ABSpoint
= aX + b “X” means concentration.
Delta ABS = aX + b “Delta ABS” means absorbance.
Point to point “Delta
“X” meansABS”concentration.
means absorbance.
Delta ABS = aX + b
S1S2 S2S3 S3S4 “DeltaS4S5ABS” means S5S6 S6S7
absorbance.
a S1S2
23456.78 S2S3
23456.78 S3S4
23456.78 S4S5
23456.78 S5S6
23456.78 S6S7
23456.78
a=
b 23456.78
S1S2
23456.78 23456.78
S2S3
23456.78 23456.78
S3S4
23456.78 23456.78
S4S5
23456.78 23456.78
23456.78 23456.78
S5S6 S6S7
23456.78
ab = 23456.78
23456.78 23456.78
23456.78 23456.78
23456.78 23456.78
23456.78 23456.78
23456.78 23456.78
23456.78
b= 23456.78 23456.78 23456.78 23456.78 23456.78 23456.78
3. Log-logit
3. Log-logit
3. Log-logit
3. Log-logit
ABC Hospital 2002/03/12 20:28:06
ABC Hospital 2002/03/12 20:28:06
Date : 20020312 Round No: 003
ABC Hospital Date : 20020312 Round No: 00320:28:06
--S1-- -S2- --S3-- --S4-- --S5-- 2002/03/12
--S6-- --S7--
--S1-- -S2- --S3-- Date --S4--
: 20020312 --S5-- Round--S6--
No: 003--S7--
GLU 0 10 50 100 150 300 500
GLU 0
--S1-- 10
-S2- 50
--S3-- 100
--S4-- 150
--S5-- 300
--S6-- 500
--S7--
mg/dl 2 105 510 10030 15100 18050 20560
mg/dl
GLU 2
03 105
10 510
50 10030
100 15100
150 18050
300 20560
500
101 503 10044 14950 18000 21050
mg/dl SS0002 23 101
105
SS0002
503
510
SS0002
10044
10030
SS0002
14950
15100
SS0002
18000
18050
SS0002
21050
20560
SS0002
SS00023 SS0002
101 SS0002
503 SS0002
10044 SS0002 14950 SS0002
18000 SS0002
21050 Lotnumber
Lot number
SS0002
Log-logit SS0002 SS0002 SS0002 SS0002 SS0002 SS0002 Lot number
Log-logit
Delta ABS = k / (( r + exp(-aX̯ 3 – bX̯ 2 – cX -
Delta ABS = k / (( r + exp(-aX̯ 3 – bX̯ 2 – cX - d)) + 1) d)) + 1)
Log-logit
Delta ABS = k / (( r + exp(-aX̯ 3 – bX̯ 2 – cX - d)) + 1)
a
a= = 23456.78
23456.78
b
b = 23456.78
= 23456.78
a = 23456.78 “X”means
meansconcentration.
concentration.
cc =
= 23456.78
23456.78 “X”
b = 23456.78 “Delta ABS” meansabsorbance.
absorbance.
d = 23456.78 “Delta ABS”concentration.
means
cd==23456.78
23456.78 “X” means
kk =
= 23456.77
23456.77
d = 23456.78 “Delta ABS” means absorbance.
r = 23456.78
23456.78
kr == 23456.77
r = 23456.78
2.10 Reproduction
2.10 Reproductionof ofMeasurement
MeasurementResultResult
2.10.4 Examples
2.10.4
2.10 ReproductionExamples ofofprintout
printout Result
of Measurement
2.10.4 Examples
2-100of printout
2-100
2-100
123
Chapter
2.10.4
2.10.4 2: ofof
Example
Example Procedure
printout
printout of routine check
4. Spline
4. Spline
4. Spline
ABC Hospital 2002/03/12 20:28:06

ABC Hospital Date: 20020312 2002/03/12
Round No: 003 20:28:06
--S1-- -S2- --S3-- Date: 20020312
--S4-- --S5-- Round No: 003--S7--
--S6--
GLU --S1--
0 -S2-
10 --S3--
50 --S4--
100 --S5--
150 --S6--
300 --S7--
500
GLU
mg/dl 20 10
105 50
510 100
10030 150
15100 300
18050 500
20560
mg/dl 32 105
101 510
503 10030
10044 15100
14950 18050 21050
18000 20560
SS0002 3 101 503 10044 14950
SS0002 SS0002 SS0002 SS0002 SS0002 SS000218000 21050
Lot number
SS0002 SS0002 SS0002 SS0002 SS0002 SS0002 SS0002 Lot number
Spline “X” means concentration.
Spline “X” means concentration.
Delta ABS = aX̯ 3 + bX̯ 2 + cX + d “Delta ABS” means absorbance.
Delta ABS = aX̯ 3 + bX̯ 2 + cX + d “Delta ABS” means absorbance.
S1S2 S2S3 S3S4 S4S5 S5S6 S6S7
a= S1S2
23456.78 S2S3
23456.78 S3S4
23456.78 S4S5
23456.78 S5S6
23456.78 S6S7
23456.78
ba == 23456.78
23456.78 23456.78
23456.78 23456.78
23456.78 23456.78
23456.78 23456.78
23456.78 23456.78
23456.78
cb == 23456.78
23456.78 23456.78
23456.78 23456.78
23456.78 23456.78
23456.78 23456.78
23456.78 23456.78
23456.78
dc == 23456.78
23456.78 23456.78
23456.78 23456.78
23456.78 23456.78
23456.78 23456.78
23456.78 23456.78
23456.78
d= 23456.78 23456.78 23456.78 23456.78 23456.78 23456.78
5. Exponential
5. Exponential
5. Exponential
ABC Hospital 2002/03/12 20:28:06

ABC Hospital Date : 20020312 2002/03/12
Round No: 003 20:28:06
--S1-- -S2- --S3-- Date : 20020312
--S4-- --S5-- Round--S6--No: 003
--S7--
GLU --S1--
0 -S2-
10 --S3--
50 --S4--
100 --S5--
150 --S6--
300 --S7--
500
GLU
mg/dl 20 10
105 50
510 100
10030 150
15100 300
18050 500
20560
mg/dl 32 105
101 510
503 10030
10044 15100
14950 18050
18000 20560
21050
SS00023 SS0002101 SS0002503 SS0002
10044 SS0002 14950 SS000218000 SS000221050 Lot number
SS0002 SS0002 SS0002 SS0002 SS0002 SS0002 SS0002 Lot number
Exponential
Exponential
Delta ABS = aX̯ 3 + bX̯ 2 + cX + d “X” means concentration.
Delta ABS = aX̯ 3 + bX̯ 2 + cX + d “X” means
“Delta ABS”concentration.
means absorbance.
“Delta ABS” means absorbance.
a= 23456.78
ba == 23456.78
23456.78
cb == 23456.78
23456.78
dc == 23456.78
23456.78
d= 23456.78
2.10 Reproduction of Measurement Result

2.10 Reproduction of Measurement
2.10.4 Examples of printout Result
2-101
2-101
124
2.11 Quality Control: [F8]

The measurement results of quality control (QC) sample for a period of approximately 6
months are stored in the database.
After the pointer is positioned in the [QC (F8)] and the left button of the mouse is clicked,
either one of the following function menus can be selected.
1. Graphic: [F9] (Graphic display of measurement results of QC sample)
2. Measurement: [F10] (Display of measurement results of QC sample)
3. QC Settings: [F11] (Settings for graphic display)
4. Control: [F12] (Registration of QC samples)
2.11.1 Graphic display [Graph (F9)]

The Levey-Jennings control chart is applied to representation of the measurement results
of quality control sample.
At the maximum, the measurement data for 3 types of QC samples can be graphically
displayed on a method basis.
3 types of graphic displays, i.e. daily and cumulatively basis, can be shown on the screen.
The third type of display selected is shown in the page 2/2.
(1) Setting of method number
Move the cursor to “Method #” box and enter the required method number in the box us-
ing the numeric key, or
125
Press [SPACE] key to display the pop-up window showing registered methods and click
on the desired method number in it.
When ISE is selected as the method number (61 or 62), ISE testing item box is displayed
at next of “Display Type”. Select one of them (Na/K/Cl).
ISE testing
item box
(2) Type selection of graphic display
(a) Daily: All measurement results of QC sample on each day are displayed separately.
All results in a day are plotted on the separate vertical axis.
(b) Cumulative: All measurement results of QC sample on each day are displayed cumu-
latively.
All results in a day are plotted on the one vertical axis.
(3) Indication of QC sample ID and its name

The name registered in the QC name registration picture [QC Setting (F11)] is automati-
cally indicated.
(4) Number of data (N)/Mean value(X)/Standard deviation (SD)/CV (%)

The number of data, mean value, standard deviation and CV are automatically calculated
from all measurement results of QC sample, but the measurement results which belong
the “ERROR” of which rule is defined in the “2.11.3 Settings for graphic display” are not
included to these calculation.
126
Number of data
Mean value
Standard deviation
CV (%)

Plotting symbol 

2.11.2 Measurement results of QC [Measurement

(F10)]
The measurement results of specified QC sample stored in the database are reproduced
and displayed in order of date on the screen by entering the method number.
This function is performed by selecting the function menu [Measurement (F10)] of job
menu [QC (F8)].
A) Selection of the reproduction type

The following three types are selectable as the reproduction type.
(1) Details
The measurement results of specified QC sample are retrieved in accordance with speci-
fied period (date from and date to).
127
(2) Daily
The measurement results of specified QC sample are retrieved in accordance with speci-
fied day.
(3) Cumulative
It deals with the measurement results of specified QC sample in specified period as the
cumulative result.
Either one of “Details”, “Daily” and “Cumulative” can be selected from the pull-down menu
by clicking on the triangular marks.
 Details
 Daily
 Cumulative
B) Setting of the method number

Move the cursor to “Method #” box and enter the required method number in the box us-
ing the numeric key, or
Press [SPACE] key to display the pop-up window showing registered methods and click
on the desired method number in it.
Depending on the reproduction type, the wildcard (“*”: asterisk) can be used for the meth-
od number. (In the case of “Details”, the wildcard cannot be used for the method number
setting.)
When ISE is selected as the method number 61 or 62, ISE item box is displayed at next of
“Result Output” box. Select either one of “Na”, “K” and “Cl”. (Na/K/Cl).
C) Selection of the output device

 Monitor
 Print
 FD
The output device of retrieved QC result is specified.

Either one of “Monitor”, “Print” and “FD” can be selected from the pull-down menu by
clicking on the triangular marks.
D) Setting of the Date from and Date to

Dates of the measurements to be retrieved are specified by using keyboard. “*” is the
wildcard and means unlimited number.


























Starting date for the result data retrieving. End date for the result data retrieving.
128
E) Retrieving the QC result
[Search] button: When this button is clicked on, the retrieving of the QC result starts under
the condition of specified method number, reproduction type and period
(Date from and Date to).
[Delete] button: When this button clicked on, all retrieved data are deleted from the data
base.
Whatever output device is selected, this deletion procedure is executed.
(1) Reproduction type is selected “Details”:

When the “Details” is selected for the reproduction type, the retrieved results are displayed
on the screen by clicking on the [Search] button. (See below picture.)
Note: In case “Details” is selected for the reproduction type, the wildcard (“*”) can-
not apply to the setting of the method number.
Date Round
Method name
Control data-1 Control data-2 Control data-2
Warning flag-1 Warning flag-2 Warning flag-2
Error flag-1 Error flag-2 Error flag-2
(2) Reproduction type is selected “Daily”:

In case “Daily” is selected for the reproduction type, the retrieving keys are Method num-
ber, Control ID number, Date and Round number.
<Method number setting>

The way of setting is to be referred to the said description “B) Setting of the method num-
ber”.
<Date setting>
A specific day is set for retrieving QC result. The way of setting is similar to the said de-
scription “D) Setting of the Date from and Date to”.
129
<Round number setting>

A specific round number is set for retrieving QC result. When the wildcard is used for
the round number, all rounds in which QC measurement had been performed becomes
retrieval range.
The retrieved QC measurement results are displayed on the screen by clicking on the
Search button as below picture.
Example: “Method #” is set “2” for the “Daily”.
Coefficient
Method name variation
Number of data Minimum value

Mean value Maximum value
Standard deviation (–2SD) Warning / Error flag
Standard deviation (+2SD)
Standard deviation (1SD)
Example: “Method #” is set the wildcard (“*”) for the “Daily”.

In case the wildcard (“*”) is used for the method number, “Control ID” should be set in
advance.
Method name
Coefficient
Number of data variation
Mean value Minimum value
Standard deviation (–2SD) Maximum value
Standard deviation (+2SD) Warning / Error flag
Standard deviation (1SD)
130
(3) Reproduction type is selected “Cumulative”:

In case the “Cumulative” is selected for the reproduction type, the retrieving keys are
Method number, Control ID number, Date and Round number.
<Method number setting>

The way of setting is to be referred to the said description “B) Setting of the method num-
ber”.
<Date setting>
A specific day is set for retrieving QC result. The way of setting is to be referred to the said
description “D) Setting of the Date from and Date to”.
<Round number setting>

A specific round number is set for retrieving QC result. When the wildcard is used for
the round number, all rounds in which QC measurement had been performed becomes
retrieval range.
The retrieved results are displayed on the screen by clicking on the [Search] button.
(See below picture.)
Example: “Method #” is set “2” for the “Cumulative”.
Example: “Method #” is set the wildcard (“*”) for the “Cumulative”.

In case the wildcard (“*”) is used for the method number, “Control ID” should be set in
advance.
Judgment priority
Priority Judgment condition Status expression
1 Current result exceeds 4SD 1:4S
3 Last 2 results exceed 2SD 2:2S
5 2 out of last 3 results exceed 2SD 2/3:2S
6 Range exceeds 4SD R:4S
7 7 continue points trend 7:T[+] · · · Increasing
7:T[–] · · · Decreasing
8 Any 4 results exceed 1SD 4:1S
9 Any 3 results exceed 1SD 3:1S
10 10 results same side of mean 10:T[+] · · · Greater than mean
10:T[–] · · · Less than mean
131
2.11.3 Settings for graphic display [QC Setting (F11)]

The necessary data for the graphic display on each QC sample is to be entered.
(1) Method#: Enter the method number.

When the method number of 61 or 62 (ISE) is selected, ISE testing item box is displayed
at next of “Name” box as below picture.
(2) Name: Method name (No need to enter the name since it is automatically defined by
the method number).
(3) Interval: The term of validity for QC measurement.

If the measured date of the latest QC result(s) is passed the specified valid day, warning
will be occurred in the function menu [Test Selection (F10)] of the job menu [Run Monitor
(F5)].
(4) Control ID: Enter the required QC sample number referring to the list indicated at right
(Registered Controls).
(5) Name: QC sample name (No need to enter the name since it is automatically defined
by the control ID).
(6) Mean Value: Enter the mean concentration value of the specified QC sample.
132
(Data which includes an “ERROR” condition are not included for the calculation.)
(7) SD: Enter the standard deviation value of the specified QC sample. The limits of stan-
dard deviation (SD) are plotted in dotted lines on the graphic display.
(Data which includes “ERROR” condition are not included for the calculation.)
(8) Rules: Select the judgment condition of the QC results.

1) Current result exceeds 2SD
4) Last 2 results exceed 2SD
5) Out of last 3 result exceeds 2SD
6) Range exceeds 4SD
7) Any 3 results exceed 1SD
8) Any 4 results exceed 1SD
9) 10 results same side of mean
10) 7 continue point’s trend
For each judgment condition, select one of the applied classifications from the pull-down
menu as below picture.
INACTIVE: Plotting with symbol “ (black)”

WARNING: Plotting with symbol “ (yellow)”
ERROR: Plotting with symbol “ (red)”
(9) Save: Click on this button to save the data set in the above items.
133
2.11.4 Registration of QC samples [Control (F12)]

The names of QC samples to be used in the analyzer are to be registered.
It means that which control sample is used for which method/methods.
Total 30 QC samples (C1 – C30) can be registered.
(1) Control ID: Enter the control ID number.

(2) Name: Enter the control name.
(3) [Save] Click on this button to save the data set in the above steps.
List of “Use for methods”

Method number and name in terms of a specified Control ID is listed in this area. Individual
method is determined in the menu [QC Setting (F11)] under the job menu [QC (F8)].
To be specified/registered Control ID
and name.
Method name corresponding to method number
Method number to be applied by the specified Control ID
134
List of “Registered Controls”

All control names which have been registered in this function menu are listed, maximum
30 QC samples, and this list is utilized for the [QC Settings (F11)] under the job menu [QC
(F8)].
135
136
Chapter 3: Settings
Chapter 3
Settings and their alterations of operational condi-
tions
This chapter provides the procedures of settings and their alterations of operational condi-
tions including analytical conditions, method-to-method computation, profile registration,
system parameters, new registration of samples, order of printout, etc.

3.1 Functional items
3.2 Analytical conditions
3.3 Method-to-method computation
3.4 Profile
3.5 Order of measurement and printout
3.6 System parameters
137
Chapter 3: Settings
3.1 Functional items

This chapter addresses how to enter and change the operational conditions and param-
eters of each functional item. Such functional items are shown below:
Functional item Description Reference
page
Analytical conditions Analytical conditions have been predefined 139
(Chemistry Parameters) but part of them can be altered as necessary.
Serum Information (Serum Entry of various parameters for the measure- 147
Information) ments of turbidity (L), haemolysis (H) and ict-
erus (I) in the serum.
Method-to-method compu- The equation is defined to derive the comput- 150
tation (Calculate) ed result using results obtained from multiple
methods.
Profile (Profile) The profile (check in a set) is specified to en- 152
able the multiple methods to be selected at
a time.
Order of measurements The measuring order of methods and the 154
and printout printing order of measurement results are
specified.
System parameters Specification of serial communications with 156
host computer, date, time and specification
of bar code are specified.
Optional settings and preparation of print
header can be done.
Registration of reagents Each bottle code and bottle size (large, medi- 162
um or small) of reagents, wash solutions and
diluents placed in the RCU are entered.
Replicate Sample Setting of the number of replication. 164
Patient information defini- Making up the patient information. 165
tion
Backup operation This is the function to save the analyzer-spe- 167
cific parameters and user parameters to and
load them from floppy disc.
ISE parameters (1) The bottle code of diluent for urine measure- 170
ment is entered.
Results of ISE calibration are outputted. 170
Settings of volume adjustment and instru-
ment factor of ISE.
ISE parameters (2) Setting of Normal range for ISE. 172
138
Chapter 3: Settings
3.2 Analytical Conditions
[Chemistry Prm (F6)]
In the function menu [Chemistry (F9)] of the job menu [Chemistry Prm (F6)],
At page 1/2: sampling volumes of reagents and sample for each method and various
measuring conditions can be set, and
At page 2/2: various parameters about serum information can be set.
Normally, the pre-defined conditions are used as they were. The great attention should be
given to the meanings of such pre-defined values before they will be modified. If the pre-
defined values have been modified and they cannot be reset to their original values, this
may result in problems for the measurements afterward.
3.2.1 Method Conditions: [Chemistry (F9)] Page 1/2

This is to define the various parameters including measurement conditions, sampling vol-
ume, dilution conditions, type of reagent, etc. The following conditions need to be defined
for all methods registered in the analyzer.
(10)
(1)
(2) (11)
(3)
(4) (12)
(5)
(13)
(14)
(6) (16)
(15)
(7)
(17)
(18)
(8)
(19)
(9) (20)
(21)
(22)
Each item for which the conditions need to be defined can be selected by moving a cursor
in the above picture with [Tab] key (or [Tab] + [Shift] keys).
(1) Method
There are two ways for selection of method number.
1. Select from the combo box (pull-down menu).
When click on the triangular mark at “Method” box, you can select the necessary method
number from the pull-down menu.
139
Chapter 3: Settings
Pull-down menu for method selection
2. Select from the method list by pressing [SPACE] key.

The following pop-up window is showing the list of methods by pressing the [SPACE] key.
The wanted methods are selected by moving the cursor to and clicking on them.
(2) Name
Enter the method name in alphabets, numeric, symbols or their combination.
The method name is automatically indicated upon entering the method number in the
above step.
Note: It is prohibited to give the name in duplicate, even if the different method
number is applied.
(3) Unit
Enter the unit of concentration value obtained as a result of the measurement.
Up to 6 characters of alphabets, numeric or
symbols can be entered.
(4) Assay Type

This is to select either one of two assay types, i.e. Rate-method and End-method. Select
the required assay type from the pull-down menu.
140
Chapter 3: Settings
(5) Measuring Points

This is to specify the measuring points on the time course.
First of all, whether or not the Measuring Point-1 is enabled is selected.
Where the small box beside “Disable” is clicked on , only the Measuring Point-2 be-
comes effective and thus the measuring points are entered into “Start” and “End” boxes
of the Measuring Point-2.
When the Measuring Points-1 is disabled, the measuring points of Measuring Point-2 are
entered into its “Start” and “End” boxes.
[Measuring Point-2: 14 to 26 and Start < End]

From

 14 to 26
When the Measuring Point-1 is enabled, the measuring points are entered into “Start” and
“End” boxes of both Measuring Point-1 and Measuring Point-2.

From

 1 to 13

From

 14 to 26

(6) Wave Length

The wavelengths of the optical filter are selected for measuring concentration (absor-
bance).
The measurement can be performed using two wavelengths, i.e. primary and secondary-
wavelength. The primary-wavelength is selected from the pull-down menu.
The secondary-wavelength can be selected in the same way as for the primary-wave-
length. When the secondary-wavelength is not used, click on the small box beside the
“Disable”.
: To use secondary-

wavelength
: not to use secondary-
wavelength
141
Chapter 3: Settings
(7) Sampling Volume

Enter the sampling volume whose limit is 2 to 35.
Sampling volume
Volume of sample to be diluted at the time of dilution Volume of diluent, min. 120 µl
Enter the sampling volume of sample in µL (0.1 steps).
Dilution Disable/Enable
 Disable: Sample is not diluted.
 Enable: Sample is diluted. In this case, both volumes of sample (volume of sample to
be diluted at the time of dilution) and diluent are specified. The sampling vol-
ume of the diluted sample is the one set previously.
(8) Rerun (High): Depending on the “Technical Range”

When the measurement result is out of the Technical Range (greater then high limit), it is
effective to apply the re-run function in order to perform the second measurement.
As for the re-run condition, following items are defined in advance with the re-run execu-
tion.
Sampling volume at the re-run
Volume of sample to be diluted at the time of dilution Volume of diluent, min. 120 µl
The sampling volume of sample to be re-run (Rerun Volume) is entered in µL.

When this volume box is filled blank code by using “Delete” key, the re-run for specified
method is inhibited.
Dilution Disable/Enable
 Disable: Sample is not diluted at re-run.
 Enable: Sample is diluted. In this case, both volumes of sample (volume of sample to
be diluted at the time of dilution) and diluent are specified. The sampling vol-
ume of the diluted sample is the Rerun Volume set previously.
(9) Rerun (Low): Depending on the “Technical Range”

When the measurement result is out of the Technical Range (lower then low limit), it is ef-
fective to apply the re-run function in order to perform the second measurement.
When this volume box is filled blank code by using “Delete” key, the re-run for specified
method is inhibited.
Sampling volume for the re-run.
142
Chapter 3: Settings
(10) R1 Reagent Name & Volume

The following pop-up window of the reagent selection list is displayed by moving the cur-
sor onto the entry box “R1 Reagent Name” and pressing the [SPACE] key. Click on the
reagent name to be used in the list.
Reagent selection list
After the R1 reagent name is specified, it’s sampling volume need to be entered.
Note: Aggregated sampling volume of R1 reagent and sample must be 180 µL or

more.
Name of R1 reagent Sampling volume of R1 reagent
(11) R2 Reagent Name & Volume

Where the R2 reagent is to be used, select “Enable”. The pop-up window of the reagent
selection list is displayed by moving the cursor onto the entry box “Reagent Name” and
pressing the [SPACE] key. Click on the reagent name to be used in the list.
R2 Disable/Enable
 Disable: R2 reagent is not used (R1 reagent method).
 Enable: R2 reagent is used.
Enter the bottle code and sampling volume of R2 reagent (in case that "Enable" is se-
lected for R2 reagent).
(12) Wash
As for the nozzle wash function, either one of enable and disable can be selected.
When “Enable” of wash function is selected, the wash solution for washing nozzles (RPT/
SPT) is specified as below;
1. Select “Reagent Type” as the wash solution. Either one of “R1”, “R2” and “Wash” is
selected by pull-down menu at “Reagent Type” box.
2. Move the cursor onto the entry box “Reagent Name” and press the [SPACE] key. Click
on the reagent name to be used in the list.
143
Chapter 3: Settings
Wash Disable/Enable
 Disable: Nozzles are not washed.
 Enable: Nozzles are washed and the name
of the wash solution is entered.
When “Enable” is selected, RPT and SPT nozzles are washed before the measurement
is performed in accordance with the method defined in the [chemistry (F9)] screen. To be
more specific, the wash solution that have been specified at the entry box “Reagent Type”
and “Reagent Name” in advance is initially aspirated by the RPT from the bottle contained
in the RCU. The solution is then dispensed into cuvette of the IRU. Secondarily, the IRU
rotates to the sampling position of the SPT and then the SPT nozzle descends into the
cuvette. The SPT nozzle aspirates the wash solution at the cuvette and moves to SPT
trough position. SPT nozzle dispenses the wash solution to the dispensing position at SPT
trough, and after that SPT nozzle is washed by purified water at there.
(13) Diluent
The diluent is specified.
When “Enable” is selected, the name of diluent bottle is entered. The pop-up window of
the diluent selection list is displayed by moving the cursor onto the entry box “Reagent
Name” and pressing the [SPACE] key. Click on the applicable bottle name to be used in
the list.
(14) Decimal point

The significance number of decimal places is defined for the measurement result.
Either one of 0, 1, 2, 3, 4 or 5 can be selected from the pull-down menu.
(15) Extension button

This button is for defining the additional normal range for the extensional usage.
When [Extension] button is clicked on, the following pop-up window is displayed on the
screen.
The lower and upper limit of the extensional normal range is defined to each criterion box
whose name had been defined in the “Extension Normal Range Name” of the function
menu [System (F9)] of job menu [System Parameters].
144
Chapter 3: Settings
Name of extension Lower limit Upper limit

normal range
After setting of the extensional normal range vale, the setting data are saved when click
on the [OK] button.
When this extended normal range is made effective in the test selection ([Test Select
(F10)] – [Run Monitor (F5)]), they are applied to judgement criterion of normal range to the
measurement result. (Refer to next item “Normal Range”.)
(16) Normal Range

The upper and lower limit of normal range is defined.
There are two types of normal range such as ordinary and extension normal range.
Individually, they are applied to suit the test sample.
When the measured concentration value is lower than the specified lower limit, the flag “L”
goes with the output of the measurement result.
When the measured concentration value is higher than the specified upper limit, the flag
“H” goes with the output of the measurement result.
When the extension normal range is selected, it is given priority to selected extension
normal range as the judgement criterion of normal range.
See procedure (16) at previous page. Lower limit Upper limit
(17) Technical Range

The upper and lower limit of the technically valid range is defined. This range is used to
check the reliability of the measurement results. The range is set in the terms of concentra-
tion and absorbance.
145
Chapter 3: Settings
Concentration
Ascorbance
Lower limit Upper limit
Note: When the technical range (mAbs/10) is defined the range from –99999 to 99999,
the judgement of absorbance becomes inactivation.
(18) RPT Wash

The wash solution for the RPT is specified.
At the time of R1
reagent aspiration
and dispensation
At the time of R2
 Sys. Water: The RPT nozzle is washed with pure water. reagent aspiration
 Wash Sol.-3: The RPT is washed with wash solution (detergent). and dispensation
(19) Bottle Volume

The Bottle maximum volumes of R1 and R2 reagents are displayed.
Large size Middle size Small size
(20) Instrument Factor (Correlation correction factor)

The linear correction is applied to all the measurement results. An inclination (a) and inter-
cept (b) are entered. If 0 (zero) is entered for the inclination (a), no correction is executed.
(21) Stirring Speed

The stirring speed of Mix-1 and Mix-2 is specified.
Either one of Low, Mid or High can be selected from the pull-down menu.
(22) Save/Cancel
Click on the [Save] button to save the parameters for the method set in the above.
Otherwise, click on the [Cancel] button.
146
Chapter 3: Settings
3.2.2 Serum Information [Chemistry (F9)] Page 2/2
3.2.2 Serum Information [Chemistry (F9)] Page 2/2

Where "Enable" of "Serum Information" is selected in the [Condition (F12)] of the job menu [Run
Monitor (F5)], the serum information of a sample can be measured.
Where “Enable”onofthe
Depending “Serum Information”
assay method, is selected
chemical in themay
or its metabolite [Condition
affect the(F12)] of the job
measurement menu
results in
[Run the
Monitor (F5)], the serum information of a sample can be measured.
case of high turbidity, haemolysis, Bilirubin, etc. in the serum. Through the use of this
Depending on the
phenomena, theassay
levels method,
of turbiditychemical or its metabolite
(L), haemolysis may
(H) and icterus (I) affect the measurement
are numerically expressed
results in the case of high turbidity, haemolysis, Bilirubin, etc. in the serum. Through the
and can be determined qualitatively.
use of this phenomena, the levels of turbidity (L), haemolysis (H) and icterus (I) are numeri-
cally <Method
expressed and can be determined qualitatively.
of measurement>
<Method• of
Photometering points: 2 points measurement
measurement>
• Photometering points: 2 points measurement
Turbidity (L) = 1 (a–b)
C/10
Hemolyis (H) = 1 ((g–a) – (B/105)(a–b))
A/10
Icterus (I) = 1 ((d–e) – (E/105)(a–b) – (F/105)(a–b))
D/10
Where A, B, C, D, E and F are constants and client entry items.
Where A,Oxxx
B, C, D, E andthe
represents F are constants
absorbance andofclient
values each entry items.Orxxx which are obtained from
wavelength
lxxx represents the absorbance
measurements values
of sample and of each
phosphoric wavelength
acid lrxxx which
buffer and corrected areblank
by water obtained
Owxxx.from
For
measurements of sample and phosphoric acid buffer
example, in the case of wavelength of 600 nm, and corrected by water blank lwxxx.
For example, in the case of wavelength of 600 nm,
O600 = O r600 - O w600.
l 600 = l r600 – l w600.
Absorbance
Turbidity
NADH Icterus Hemolysis

340 415 450 510 570 600 700 800

3.2 Analytical Conditions [Chemistry Prm (F6)]

3.2.2 Serum Information : [Chemistry (F9)] Page 2/2
3-15
147
Chapter 3: Settings
<Picture for entry of serum information>
(1)


(2)  (6)
(3)
(4) 

 (7)

 
(5)  
(8)
 

Measure range
(9) (10)
Flag mark
(1) Method: 81 (fixed number)
(2) Name: SI (fixed)
(3) Sampling Volume: Sampling volume of sample (µL)
(4) R1 Reagent Name: Specify the reagent which has already been registered. For ex-
ample, the bottle of phosphoric acid buffer solution is specified.
Volume: Sampling volume of R1 reagent (µL)
(5) Factor A to F: 0 – 999999
148
Chapter 3: Settings
(6) Haemolysis range (Example)

5 characters max. From 0 to 999999
The following annotation is printed out with

result:
H0 for hemolysis < 100
H1 for 100 ≤ hemolysis < 200
H4 for hemolysis ≥ 400
(7) Turbidity range (Example)


result:
L-- for turbidity < 10
L- for 10 ≤ turbidity < 20
L+- for 20 ≤ turbidity < 30
L+ for 30 ≤ turbidity < 40
L++ for turbidity ≥ 40
(8) Icterus range (Example)


result:
I--- for icterus < 50
I-- for 50 ≤ icterus < 60
I- for 60 ≤ icterus < 70
I+- for 70 ≤ icterus < 80
I+ for icterus ≥ 80
(9) [Save] button

Click on this button to save the information entered in the above steps.
(10) Cancel button

When click on this button, setting data are not saved.
When the measurement result of serum information is outputted to the printer, its informa-
tion isWhen the measurement
printed together with result
theof serum
result information
of normalis sample
outputtedand
to theISE.
printer,
Anitsexample
information
is isshown
printed
together with the result of normal sample and ISE. An example is shown below.
below.
Sno. : 101 ID: 2001082701 Date: 20020827 Round No: 006

UREA AST
Result of normal sample
15.1 20.5
SI H3 ( 358) L+- ( 32) I-- ( 68)
Method Name Result of Hemolysis Result of Turbidity Result of Icterus
149
Chapter 3: Settings
3.3 Method-to-Method Computation

This is a calculation method that is obtained by specifying the calculation equation and
using the results of two or more methods.
The method numbers assigned to this computation method are the numbers from 71 to
80.
The calculation equation can be set freely but the usable operators are the symbols of four
fundamental operations (+, –, x, ÷) and round brackets "(" and ")". The square brackets "{"
and "}" are used to enclose the method number.
The signs of "*" and "/" are used for multiplication and division respectively.
The method-to-method computation is executed in the function menu [Calculate (F10)]
picture of the job menu [Chemistry Prm (F6)].
3.3.1 Method-to-Method Computation
[Calculate (F10)]
The following explanation is based on the example shown below:
Method No.: 71
Name: TRF
Computation: TRF = (TRIGLY+FERRIT)/2
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(1) Method (71 – 80): Method number can be specified from 71 to 80.
150
Chapter 3: Settings
When move the cursor onto the entry field of "Method" and press the [SPACE] key to
display the pop-up window in the centre of the screen in order to check the list of meth-
od-to-method calculation currently registered. Press the [ESC] key to close this pop-up
window.
(2) Name: Method name can be entered in the form of maximum 6 characters.
(3) Unit: Up to 6 characters can be entered as the unit of concentration for the computed
result.
(4) Decimal Point: The significance number of decimal places is defined for the measure-
ment result.
(5) Expression:
The calculation equation is entered. The usable operators are the symbols of four funda-
mental operations (+, –, *, /), round brackets "(" and ")" and square brackets "{" and "}".
Refer to the list at right screen for necessary method numbers for the computation.
Move the cursor onto the expression input field, and click on the mouse to fix the input
field. Then, move the arrow cursor to the wanted method that is on the list at right (Method
list) and click on the mouse. So, its method number with square brackets, e.g. “{04}”, is
entered automatically in the expression field.
(6) Normal Range Low – High:

Upper and lower limits of the normal range for the computed result are entered.
(7) [Save] button: Click on this button to save the above settings.
151
Chapter 3: Settings
3.4 Profile
The multiple methods are registered together in order to enables the registered methods
to be selected at a time. This function is called as "Profile".
Select the [Profile (F11)] picture of the job menu [Chemistry Prm (F6)] to set the necessary
parameters to use this function.
3.4.1 Profile [Profile (F11)]
A) Profile compilation procedures

Up to 8 files can be registered as the profile.
The profile is compiled in accordance with the following procedures:
(1) Enter the method number to be compiled.
Numeric key entry or

press [SPACE] key.
When move the cursor onto the entry field of “Method” and press the [SPACE] key to
display the pop-up window in the centre of the screen in order to check the list of profile
number currently registered. Press the [ESC] key to close this pop-up window.
(2) Enter the method name.
Key entry of alphabets,
numerics and/or symbols
(3) Select from the list "Selected Method" methods which are to be registered together as
a profile. Move the cursor onto the small box beside the method number and click the left
152
Chapter 3: Settings
button of the mouse. A tick mark  appears in the box and the method is selected. Click
on the box again to cancel the selection.
(4) Click on the [Save] button to register the above selection as a profile. Otherwise, click
on the [Cancel] button.
153
Chapter 3: Settings
3.5 Order of Measurements and Printout

The measuring order of methods and the printing order of measurement results are speci-
fied.
Select the function menu [Order (F12)] picture of the job menu [Chemistry Prm (F6)] and
follow the procedures shown below.
3.5.1 Measuring order of methods

[Order (F12)] Page 1/2
The measuring order of the methods is specified based on the reagents and wash solu-
tions which have been registered in the analyzer. Please note that in the case of ISE mea-
surement, its measuring order cannot be changed.
<How to define the measuring order>

Click on the method number and drag it to the "Measuring order list" at left to define the
measuring order of methods.
(2)
(1)
(3) (4)
(1) Method list: Normal biochemical measurement methods (maximum 60 methods) and
wash solution numbers are indicated. (ISE method is not included.)
(2) Measuring order list: The measuring order of methods is indicated.
(3) [Save] button: Click on this button to save the defined measuring order.
(4) [Cancel] button: Click on this button to cancel the defined measuring order.
154
Chapter 3: Settings
3.5.2 Printing order of measurement results

[Order (F12)] Page 2/2
The order of the measurement results to be printed by the printer is specified.
<How to define the printing order>

Click on the method number and drag it to the "Printing order list" at left to define the
printing order of measurement results.
(1)
(2)
(3) (4)
(1) Method list: Methods are indicated (calculate and ISE methods are included).
(2) Printing order list: The printing order of measurement results is indicated.
(3) [Save] button: Click on this button to save the defined measuring order.
(4) [Cancel] button: Click on this button to cancel the defined measuring order.
155
Chapter 3: Settings
3.6 System Parameters

The conditions of the overall system including registration of reagents, operation of floppy
disk, reproduction of measurement results, etc. can be set.
Either one of the following function menus can be selected after the job menu [System
Parameters] has been selected.
1. System [F9]: Entry of system parameters and registration of reagents and number of
replicate setting.
2. FD [F10]: Operation of floppy disk.
3. ISE [F11]: Registration of ISE diluent code, output of ISE calibration result and in-
strument factor setting of ISE.
4. Result [F12]: Compilation of measurement results.
3.6.1 System Parameters [System (F9)] Page 1/2

The following system parameters need to be checked and entered using the [System Pa-
rameters] screen soon after the analyzer has been newly installed on the site.
(1) Settings of communication conditions in the case that the host computer is connected.
(2) Optional settings.
(3) Initial settings of date and time.
(4) Defining whether or not the ASP unit is provided with barcode reader (BCR).
(5) Specifying the type of barcode to be used if the BCR in the ASP is provided.
(6) Volume setting of audible alarm.
(7) Entry of the header printed on hard copies.
(8) Selection of the sample number increment.
(9) Saving function for above settings.
(10) Reference of program version number.
(11) Registration of reagent names and codes.
156
Chapter 3: Settings
(1) (2)


 (10)
(11)
(3)
(4)
(5)
(8)
(9)
(6)
(7)
(1) Host Communications: Conditions of communications with host computer

Conditions of communications with the host computer are to be set up.
Item Description Remarks
Baud Rate 19200/9600/4800 bps Default: 9600 bps
Data Bit 7/8 bits Default: 8 bits
Stop Bit 1/2 bits Default: 2 bits
Parity Bit None/Even/Odd Default: None
(2) Optional settings

These settings are to restrict the output of data.
A. In case the host communication line is established. (Host Communications)
B. In case the QC results are outputted to the floppy disk in the [Result (F12)] of [System
Parameters]. (FD Output)
C. In case the QC report is outputted to the printer in the real time. (Print Output)
D. Miscellaneous settings
157
Chapter 3: Settings
Because the host computer or customer’s floppy disk may be not accepted some kind of
measurement result such as the normal result with re-run flag, result of “Calculation Test”
and QC result (with judgment flag or not). Depending on the situation of host computer, it
can be selected the condition for the data whether they are transmitted to the host com-
puter or not.
When the Detail button is clicked on, the following popup window is displayed in the
screen.
B C D
A
To make effective the all
settings, click on this button.
A: Host Communications
Add Rerun Flag
: When the result is outputted to the host, the re-run flag is attached, if re-run is per-
formed.
: When the result is outputted to the host, the re-run flag is not attached, even if re-run
is performed.
Send Calc Test
: Outputting the result of “Calculation Test” to the host is enabled.
: Outputting the result of “Calculation Test” to the host is disabled.
Send Calc Test
: Outputting the result of “Calculation Test” to the host is enabled.
: Outputting the result of “Calculation Test” to the host is disabled.
Send QC Result
: Outputting of QC result to the host is enabled.
: Outputting of QC result to the host is disabled.
Add QC Flag
: When QC result is outputted to the host, the judgment flag is attached.
: When QC result is outputted to the host, the judgment flag is not attached.
Patient Name
: Patient name is described in order of last name, first name and middle name.
: Patient name is described in order of last name, middle name, and first name.
Full compliance with ASTM rules
: Online communication is full compatible with ASTM rules.
: Online communication is not full compatible with ASTM rules.
158
Chapter 3: Settings
Individual ISE order from host

: Testing order of ISE that is transmitted from host is individual method such as Method
No-61:Na, 62:K, 63:Cl, 64:Na(diluted), 65:K(diluted) and 66:Cl(diluted).
: Testing order of ISE that is transmitted from host is block form such as Method No-61:
Na, K, Cl and 62: Na (diluted), K (diluted), Cl (diluted).
Send Error Result
: Measurement result is sent to host even if it has error flag.
: Measurement result that has error flag is not sent to host.
B: FD Output
Add QC judge
: When the QC results are outputted to the floppy disk in the [Results (F12)] screen of
[System Parameters], the judgment condition flag (1:4S, 1:3S, etc) is attached to the
QC result.
: The judgment condition flag (1:4S, 1:3S, etc) is not attached to QC result at outputting
to the floppy disk in the [Results (F12)] screen of [System Parameters].
C: Print Output
Live QC Report
: QC report is printed at real-time (during measurement).
: QC report cannot be printed at real-time. After measurement, printout is possible.
D: Miscellaneous settings
Inventory Check
: Inventory check is performed at the time when the measurement is started up.
: Inventory check is not performed at the time when the measurement is started up.
Disable extrapolated result
: Minimum or maximum point of the calibration curve is applied to measurement result
as concentration value.
: Measurement result is calculated from extended calibration curve as concentration
value.
(3) Date and Time settings

Enter the date (month, day, and year) by clicking on the triangular mark.
Enter the time (hour, minute, second) by clicking on the triangular marks.
(4) Making enable or disable sample barcode reader

Make sure that a check mark is put on "Enable" for the ASP with BCR or "Disable" for the
ASP without BCR.
(5) Definition of sample barcode

The type of bar code label to be used is defined.
159
Chapter 3: Settings
Type Description Remarks

OFF: invalid
UPC(JAN) With check digit: valid in case with check digit Default: OFF
Without check digit: valid in case without check digit
OFF: invalid
Default: with
NW7 With check digit: valid in case with check digit
check digit
OFF: invalid
Code39 With check digit: valid in case with check digit Default: OFF
OFF: invalid
ITF With check digit: valid in case with check digit Default: OFF
Selection is not
Code128 With check digit: valid in case with check digit
available.
(6) Alarm Volume and Alarm Setting
Alarm volume: Alarm Setting:

Select the volume of audible alarm Alarm type (Alarm 1 to Alarm 5) can be selected to sound
from the pull-down menu (OFF – 9) alarm. When [Alarm³Setting] button is clicked on, the follow-
for the enabled alarm in the popup ing popup window is displayed. Then you can select the type
window of “Sound Enable”. of alarm to sound alarm among list in the popup window.
Alarm 1: Emergency stop condition is occurred.

Alarm 2: Sampling stop condition is occurred. 
Alarm 3: Warning condition is occurred. 
Alarm 4: Error condition is occurred in the PC. 
Alarm 5: Error condition is occurred at the time 
when the rotation of ASP is completed. 

: Alarm sound is enabled. 
: Alarm sound is disabled.
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Chapter 3: Settings
(7) Printout Header: Define printout header

 Header of the result printout
This header is used for the real time printout. (See the Example-1 of “2.10.2 “Examples of
printout”.)
Enter the header to be printed on hard copies. (Maximum 50 characters)
 Header of the patient report (This function is not available.)
(8) Sample number increment

This combo box is used for definition of ascending order for the sample number.
This definition is applied to the following cases:

 Setting of sample number in the test selection screen.
 Copying of sample number in the test selection screen.
There are three kinds of definition type:
 Numeric only
Allowable characters are only numerical codes.
Ascending order
Example (2-digits): 01 to 99
 Alphanumeric (Upper case)
Allowable characters are numeric and alphabetic but the alphabetic characters of upper-
case are only available.
Ascending order
Example (2-digit): 01 to 09 and 0A to 0Z and 10 to 99 and 9A to ZZ
 Alphanumeric
Allowable characters are numeric and alphabetic and also both of upper-case and lower-
case of alphabetic characters are available.
Ascending order
Example (2-digit): 01 to 09 and 0A to 0Z and 0a to 0z and 10 to 99 and 9A to ZZ and Za
to zz.
(9) Saving faction

The settings entered in the above steps are saved by clicking on the [Save] button.
161
Chapter 3: Settings
(10) Program Version: Program version numbers in use

The program version numbers in use are indicated.
If any of the following three version numbers does not appear in the window, the analyzer
does not work correctly. Make sure that three version numbers are indicated.
(11) Registration of reagent names and codes

The contents in the reagent list can be edited (registered, changed, and deleted).
The reagents to be used by the analyzer need to be registered soon after that it is newly
installed.
The reagent codes of R1 reagent, R2 reagent, Wash solution and diluent can be registered
or edited by clicking on the [Add] or [Edit] button in the following picture.
Usually, this editing function is allowed to the limited reagents that are having open re-
agent code number.
(2) For addition
(1) For deletion
(2) For editing
(3) For saving the ed-

ited or added results
(3) For canceling the

edited results
List of reagent codes and names:

The reagent codes are indicated
in the "Code" column.
The reagent names are indicated
in the "Name" column.
1. Deletion
Select reagent code by clicking on its code or name in the list, and click on the Delete
button to delete the reagent from the list.
2. Addition and editing
Click on the [Add] button to add a reagent and the [Edit] button to edit the reagent.
The following pop-up window is displayed by clicking on the [Add] button or the [Edit]
button.
Then each volume of the reagent and validity term is specified in respective field as below
picture. As click on the [OK] button, the pop-up window is closed.
162
Chapter 3: Settings
Enter the reagent code to be added.
Enter the reagent name to be added.
R1
reagent
R2
reagent
Wash
solution
Diluent
Enter validity period of
the reagents. The entry
is enabled only when
the "Enable" box is in
the state of .
Enter volumes of Enter volumes of Enter volumes of

large bottles (L). Middle bottles (M). small bottles (S).
See below note. See below note. See below note.
: Click the "Enable" boxes to make the respective reagent valid.

When the reagent is made valid, the respective box of "Volume"
changes to white and the volume can be entered.
Note;
Dead volume of S-type bottle (20mL): Approx. 0.6mL
Dead volume of M-type bottle (50mL): Approx. 2.6mL
Dead volume of L-type bottle (100mL): Approx. 5mL
3. Saving or cancelling the edited or added result

After closing the pop-up window, the edited or added result can be saved by clicking on
the [Save] button.
If you want to cancel the edited or added result, click on the [Cancel] button.
3.6.2 System parameters [System (F9)] Page 2/2

Select the function menu [System (F9)] picture of the job menu [System Parameter] and
then press [PgUp] or [PgDn] key to open its page 2/2.
Enter the number of replication for the Replicate Sample and the patient information in the
page 2/2 picture.
163
Chapter 3: Settings
(1) Enter the number

of replication for the
replicate sample
(Replicate Sample)
(2) Make up the

(3) Patient Information: name list for exten-
This button is available even if ana- sional normal range.
lyzer is running for measurement.
(1) Setting of the number of replication for Replicate Sample

The Replicate Sample is the sample to which the specific sample number is assigned and
on which the same method is repeatedly performed (see 2.4 "Test selection").
Specify the number of
replication (1 – 40).
Click the button to

save the specified
number of replication.
(2) Extension Normal Range Name

The name list of extensional normal range should be prepared before definition of the ex-
tensional normal range in the chemistry parameter screen.
When the [Edit] button is clicked on, the following popup window is displayed on the
screen and every extensional normal range is named or edited here.
164
Chapter 3: Settings
After completion of naming, by clicking on the [Save] button, all name information are
saved.
(3) Patient information definition

The different information related to the patient are defined and edited in this picture.
The data for the necessary number of patients can be prepared in advance.
The patient means the person from which the measuring sample is collected.
1. Maximum number of patient information: 9999
9999 of patient information can be saved in the database, and a specified patient data
can be edited.
When the patient information is filled in the database, an operator should delete unnec-
essary patient information to add new patient information.
2. Make up the patient information
Click on the [Patient³information] button to enter the respective data about the following
information:
Even though analyzer is performing the measurement, the [Patient³information] button is

available.
165
Chapter 3: Settings
The information entered will be used to facilitate the compilation of the patient information
at the time of test selection.
In order to edit the patient information, specify to be edited Patient ID by mouse clicking
from the list that is displayed on the screen as the list of patient information.
1. The following screen is pop-upped by clicking on the [Patient³information] button.
(1)
(2)
(4) (5)
(3)
List of patient information
(6) (7) (8)
(1) Patient ID: Enter the patient identification number. (A Maximum of 13 characters.)
This data (Patient ID) is not compilation. If this is changed, separate information will be
added as new patient information.
(2) Patient Name: Enter/edit the patient name. (Maximum 12 characters for each field.)
(3) Date of Birth: Enter/edit the date of patient's birth.
(4) Age: Age is calculated automatically after setting of date of birth.
(5) Sex: Select either “Male” or “Female” by pull-down menu.
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Chapter 3: Settings
(6) [Save]: Click on this button to save the created/edited information.

When the information which is edited or created is newly, it is available as “Save” function.
But the case of already being information of patient, the saving function is not activated.
(7) [Delete]: When this button is clicked on, being selected patient information is deleted.
During measurement, the patient information is not deleted even if [Delete] button is
clicked on.
To delete patient information, target is selected from the “List of patient information” by
mouse clicking in advance.
(8) [Close]: To go out this screen, click on this button.
3.6.3 Backup Operation [Backup (F10)]

Data can be saved to or downloaded from floppy disk or hard disk in the following function
menu [Backup (F10)] picture.
(1) (3)
(2)
(1) Save/download “System Parameters” to/from FD

1. Save mechanical values to the floppy disk
Insert a floppy disk into the FD drive of the NT PC and click on the [Save] button to save
the mechanical values to the floppy disk.
2. Save user parameters to FD

Insert a floppy disk into the FD drive of the NT PC and click on the [Save] button to save
the user parameters to the disk.
167
Chapter 3: Settings
The types of files to which the user parameters are saved and from which they are
loaded.
File name Description
FD1Version.txt Version number of database
FD2Version.txt Version number of database
analysis.DB Methods
AnalysisISE.db ISE Methods
AnalysisISE2.db ISE Methods 2
AnalysisSI.db SI Method
AnalysisSI2.db Sl Method 2
AndCalc.db Method-to-method computation
assaycon.db Chemistry parameters
AttendingList.db Attendant list for patient information
AutoStart.db Time of activation of analyzer
AutoStartPrep.db Setting status of Auto Start Prep
CalcItem.db Method-to-method computation methods
CalibCheck.db Calibration check
CalibRBSet.db Reagent blank settings for calibration
CalibSet.db Settings of calibration
CalibSng.db -----
CtrlList.db QC settings
CtrlName.db QC names
ExNormalRange.db Extensional normal range data
ExRangeName.db Name of extensional normal range
LocationList.db Location list of patient information
Mainte.db Maintenance settings
MultiStd.db Settings of Muti-standard
OrderingList.db Ordering list of patient information
PhlebotomistList.db -----
PrintJunjo.db Printing order
Profile.db Profile conditions
Race.db Race for patient information
RcuRegntRx.db Reagent bottle information of RCU
ReagentBlank.db Reagent blank
ReferralList.db -----
SampleJunjo.db Sampling conditions
SiyakuBottle.db Reagent bottle related information
SiyakuName.db Reagent names
SiyakuType.db Reagent type related information
System.db System parameters
WashProgram.db Settings of Wash program
168
Chapter 3: Settings
3. Load Parameters
Insert the floppy disk to which parameters are saved into the FD drive of the NT PC and
click on the [Load] button to download them from the floppy disk.
4. Format FD
Insert the floppy disk into the FD drive of the NT PC and click on the [Format] button to
initialize the floppy disk.
(2) Load “System Parameters” (Former generation)

The floppy disk that was saved the user parameters at the time of just before software ver-
sion of NT PC is able to be converted to use for this new version’s software.
Insert the floppy disk to which parameters are saved into the FD drive of the NT PC and
click on the [Load] button to download them from the disk.
(3) Data Backup

All data, including the mechanical data, chemistry parameters, QC data and measured
result data, are saved to the HD (hard disk) of PC. And also these saved data can be
loaded from the HD by means of the load function. But the valid data which can be loaded
from H.D are saved at the time of just before software version of PC or this new version’s
software.
As the [Save] button is

clicked on, all internal
data are saved to the
HD.
As the [Load] button is

clicked on, the saved
data are loaded to the
current data areas.
169
Chapter 3: Settings
3.6.4 Entry of ISE parameters-1:

Chemistry Parameter for ISE [ISE (F11) Page: 1/2]
The bottle code of diluent for ISE measurement can be specified in the function menu [ISE
(F11)] page-1/2 picture of the job menu [System Parameters].
Volume adjustment for ISE (3)

(1)

Entry field of diluent
code for urine mea-

(2) surement 


 (4)
 
 
 
 
Result of ISE Calibration


Instrument 
factor for ISE.
(1) Reagent Code for Urine Diluent

Enter the urine diluent bottle code specified in the function menu [System (F9)] page 1/2
picture of the job menu [System Parameters].
Enter the urine diluent
bottle code.
Click on this button

to save the entered
bottle code.
(2) Result of ISE Calibration

When the calibration of ISE finished, each result is outputted this area and printed to the
printer.
170
Chapter 3: Settings
(3) Volume Adjustment for ISE

These are the parameters for adjusting the accuracy of aspiration and dispensation vol-
umes of various ISE solutions and not accessible to the user.
(4) Instrument factor for ISE

The liner correction is applied to the ISE measurement result of Na (Sodium), K (Potas-
sium), and CL (Chlorine).
Inclination Intercept
Click on this button to

save the entered pa-
rameters (each of incli-
nation and intercept).
171
Chapter 3: Settings
3.6.5 Entry of ISE parameters-2 (Normal range):

Chemistry Parameter for ISE [ISE (F11) Page: 2/2]
The normal range of ISE can be specified in the function menu [ISE (F11) Page: 2/2] picture
of the job menu [System Parameters].
Click on this button to make

effective the setting data.
ISE ISE (D)
For ISE measurement, following two kinds of measurement can be accepted to this ana-
lyzer.
(a) ISE: No diluted measurement
(b) ISE (D): Diluted measurement
The measurement result for patient is separated into male, female and child.
In advance with measurement, the normal range of each patient can be defined in order
to judge the result.
After completion of the setting of normal range for each patient, click on the [Save] button
to make effective the setting data.
172
Chapter 4
Maintenance
This chapter provides the procedures of the necessary and minimal amount of mainte-
nance in order to ensure that the analyzer operates correctly and provides the accurate
measurement results.

4.1 Maintenance program
4.2 Actions to be taken in the event of trouble
4.3 Malfunction at the time of power-on
4.4 Anomalous measurement results
4.5 Equipment malfunction
4.6 Error flags associated with measurement results
4.7 Maintenance picture
4.8 Cleaning
4.9 Exchange of parts
173
4.1 Maintenance Program

4.1.1 Maintenance Intervals
Perform each maintenance work at the following intervals.
Interval Check point and action
1. Fill system water tank with purified water (system water).
2. Check if the tip of supply tube is stayed at bottom of the system water
tank.
3. Check the remaining volume of all solution tanks (Sol-1, Sol-2, and Sol-
3).
4. Check if the tip of supply tube is stayed at bottom of the each solution
tank.
Before
5. Empty waste tanks (High and low concentration tank).
initiation
6. Check if the tip of drain tube is stayed at bottom of the each waste tank
of assay
respectively.
7. Check the stain of cuvette. (See 4.1.3)
8. Check the remaining volume of Calibrant A for ISE.
9. Check the term of validity of Calibrant B before practicing of ISE cali-
bration.
10. Before ISE cleaning, check the term of validity of ISE cleaning solution.
11. Check the remaining amount of the printing paper.
1. Wipe out stains on the work table using cloth impregnated with neutral
detergent.
Daily
2. Clean the nozzle for SPT and RPT. (See 4.8.2)
3. Practice ISE cleaning per 50 tests. (See 4.7.1)
1. Clean the ASP unit. (See 4.8.5)
2. Clean the RCU unit. (See 4.8.6)
3. Clean the nozzles for WU unit. (See 4.8.3)
Weekly
4. Clean nozzle covers and stirrers using cotton swabs impregnated with
alcohol.
5. Check the fluency of solution at RPT trough. (See 4.1.2)
Two
1. Clean the supply and drainage system. (See 4.1.5)
weeks
1. Clean the external tanks. (See 4.8.1)
2. Clean the all cuvettes in the IRU unit. (See 4.1.4)
Monthly
Following items should be performed by authorized service engineer.
3. Check the in-line filter at WU unit and waste chamber line.
1. Exchange the halogen lamp (every 1,000 hours of use). (See 4.9.3)
2. Exchange the plunger tips of syringes (every 150 hours of use). (See
4.9.1)
3. Exchange the pipetting nozzles (every one year of use). (See 4.9.2)
As neces- 4. Exchange the ISE electrode (See 4.9.4).
sary Following items should be performed by authorized service engineer.
5. Exchange the pump unit for ISE.
6. Exchange the diaphragm pumps (every 1,000 hours of use).
7. Exchange cuvettes (depending on measurement results of water blank).
8. Exchange the stirrer (every one year of use).
174
4.1.2 Check the fluency of solution at RPT trough

<Procedure>
(1) Perform the RPT nozzle washing “R.P.T (C)”:
Call up the function menu [Wash (F10) Page 1/2] picture of the job menu [Maintenance]
and click on the [Start] button of “R.P.T (C)” to carry out RPT nozzle washing by solution.
(2) While execution of the RPT nozzle washing, confirm the spouting out of solution from
RPT trough. If the solution is not fully spouted out from RPT trough, repeat procedure (1)
several times. Still, you can not see the fully spouting out the solution, please contact the
authorized service engineer.
4.1.3 Check the cuvette condition

This check item is performed to get the proper analytic result in advance of the measure-
ment.
<Procedure>
(1) Select the function menu [Wash (F10) Page 2/2] of the job menu [Maintenance] to
check the cuvette condition. The value of water blank for each cuvette is displayed on the
picture.
When the value is out of the judgment value, its value is displayed with red or yellow
colour. (See “4.7.6 Results of Cuvette Check [Wash (F10)] Page 2/2)”.
(2) If the value which is out of the judgment value exists, practice the following items;
(a) Select the function menu [Sequence (F9)] picture of the job menu [Maintenance].
(b) Click on [Start] button of the “Cuvette Wash” to initiate the cuvette washing.
(See “4.7.1 Combined Operation [Sequence (F9)]”.)
(3) Perform again procedure (1) to assess the cuvette condition after cuvette washing.
If the value which is out of the judgment value still exists, take out its dirty cuvette from
IRU. And wipe the inside and outside of cuvette by using soft cloth or paper to clean the
dirty. If necessary, exchange of dirty cuvette for new one.
Caution: In the case of (3), please contact the authorized service engineer.
4.1.4 Washing the cuvette

This washing item would be performed at a monthly interval in order to get the proper
analytic result.
<Procedure>
(1) Dispense 600 µl of the wash solution (No.10-2) that is diluted 200 times by purified
water to the all cuvettes in the IRU by using hand-pipette. During this action, it should be
to turn the power of the analyzer off for safety.
(2) After dispensing the wash solution to the cuvettes, re-start the analyzer by means of
turning on the power switch of the analyzer. And leave the analyzer for overnight, over than
175
10 hours by selecting “Sleep mode”. At this time, there is no need to perform the “Cuvette
water placement”.
(3) After starting up the analyzer, perform twice the following procedure for the cuvette
washing.
(a) Select the function menu [Sequence (F9)] picture of the job menu [Maintenance].
(b) Click on [Start] button of the “Cuvette Wash” to initiate the cuvette washing.
(See “4.7.1 Combined Operation [Sequence (F9)]”.)
It would be better to prepare the cuvette wash program in the “Prep-1 or Prep-2” of the
automatic start-up menu in advance. (See “4.7.8 Automatic Start-up [Auto Start (F12)]”.)
4.1.5 Cleaning of water supply lines

Wash the water supply lines in accordance with the following procedure to protect them
against breeding of bacteria. (It would be better to be carried out once per two or three
weeks.)
Refer to the tubing wash function in the “4.7.2 Nozzle Wash [Wash (F10)], Page: 1/2”.)
<Procedure>
(1) Remove the tubes of wash solution (Sol-1, 2, 3) from each external tanks and put them
into another tank contained purified water, which would be better to be prepared sepa-
rately from the system water tank.
(2) Call up the function menu [Wash (F10)] of the job menu [Maintenance] and click on the
[Start] button of “Tubing wash” function to carry out the rinsing tubes in purified water
tank.
(See the item 1. of “(8) Tubing wash” at page 4-32.)
(3) Prepare the diluted cleaning solution by using the wash solution(C-1). Dilution ratio as
follows;
One (1) part the wash solution (C-1) solution and ninety-nine (99) parts purified water.
And pour the above diluted solution of 1,000ml more into another external tank which is
prepared additionally. And put the all supply tubes except drain tubes into this tank.
(See the item 3. of “(8) Tubing wash” at page 4-32.)
(4) And continue the “Tubing wash” sequence.

(See the item 3. and 4. of “(8) Tubing wash” at page 4-32.)
(5) Remove the all supply tubes from diluted cleaning solution tank and put them into the
tank contained purified water which is prepared separately from the system water tank.
And continue the “Tubing wash” sequence to rinse the tubes in purified water.
(See the item 5. and 6. at of “(8) Tubing wash” page 4-33.)
(6) Take out the all supply tubes, and put them respectively into the regular tanks (system
water tank and each solution tank).
And continue the “Tubing wash” sequence to restore the original condition.
(See item 7. and 8. of “(8) Tubing wash” at page 4-33.)
(7) Perform the “Cuvette Wash” in the [Sequence (F9)] picture.

(See “4.7.1 “Combined Operation [Sequence (F9)]”.)
176
4.2 Actions to be taken in the event of

trouble
When any abnormal conditions are found in the analyzer, the operator is requested to
check the following items:
1. Preparation and preservation methods of reagents;
2. Preparation and preservation methods of sample;
3. Operational procedures of the analyzer, and
4. Maintenance work.
When such an abnormal conditions is considered to be caused by an electrical or me-
chanical failure, do not try to carry out the inspection of the analyzer's innards by your own
and call for service at our customer service department.
In the event of a trouble, the corresponding alarm message is indicated. Deal with the
trouble referring to in Chapter 5 "List of alarm codes". It is presumed that the trouble will
be solved and the proper operation will be resumed in many cases.
4.2.1 Information requested by our customer service

department
When any technical service will be called for at our customer service department, the fol-
lowing information is requested to be prepared:
A) Trouble in assay
1. Serial number of analyzer in use;
2. Method code in question;
3. Explanation of encountered trouble;
4. Serial number and lot number of reagent, calibrator and QC sample in use;
5. A few calibration results that were carried out recently;
6. A few measurement results of QC sample that were carried out recently and other mea-
surement results.
B) Trouble in analyzer
1. Serial number of analyzer in use;
2. Software version numbers in use (PC, Mechanical and Sub-CPU);
3. Explanation of relevant alarm and problem, and any other information about the ana-
lyzer in use and maintenance;
177
4.3 Malfunction at the time of power-on

If the analyzer cannot be activated, follow the procedures shown below:
1. Check that the main switch located on the left side panel of the analyzer is at "ON" posi-
tion.
2. Check that the main fuses are not burnt.
When the main fuses are checked, turn the main switch off without fail and then pull out
the plug of power supply cable from its receptacle on the analyzer. Open up the fuse cover
and pull the fuses out.
3. Check that the breaker of the power supply system to which the analyzer is connected
is not off.
Fuse cover
Fuse holder
178
4.4 Anomalous measurement results

There may be two cases that the analytical errors are noticed, i.e., by error flag or unex-
pected results. In the following cases, troubleshooting is requested.
1. Error flag is set to the calibration results.
2. Error flag is set to the measurement results of QC sample or normal sample.
3. The measurement results of QC sample are out of range of judgement criteria.
Investigate which situation shown below is applicable to the error in the measurement
results of calibration, QC sample or normal sample. Based on the investigation, further
check may be requested.
4. The resultant values obtained from measurements of a specific method are high for all
samples.
5. The resultant values obtained from measurements of a specific method are low for all
samples.
6. Erroneous results are randomly derived from measurement.
7. Two or more anomalous measurement results are observed:
– from all methods, or
– randomly
4.4.1 Check of preparation of reagent, calibrator or

QC sample
Perform the following checks in order to track down the cause for high, low or random
resultant measurement results.
When a reagent, calibrator or QC sample is prepared, read the respective statement of
virtues carefully and follow its instruction.
A) Preparation of reagent
1. Was there any change of the reagent?
2. Is the term of validity of the prepared reagent still valid?
3. Was the reagent prepared according to the correct procedures?
4. Was the reagent prepared using fresh, non-bacteria contaminated and deionised water
or appropriate diluent?
B) Preparation of QC sample
1. Was the volume used for preparation correct?
2. Does the sample have been preserved as recommended?
3. Is the term of validity of the sample still valid?
4. Was the sample prepared using a pipette calibrated in terms of volume?
5. Is the term of validity of the sample lot still valid?
6. Was the sample prepared using appropriate diluent?
C) Preparation of calibrator
1. Was there any change of the lot number?
2. Was the calibrator prepared using volume correctly?
179
3. Does the calibrator have been preserved as recommended?

4. Is the term of validity of the calibrator still valid?
5. Was the calibrator prepared using a pipette calibrated in terms of volume?
6. Was the calibrator prepared using appropriate diluent?
The further checks are requested to track down the cause referring to the following lists
after the above checks have been completed.
4.4.2 High result values from a specific method for

all samples
Cause Action
Check the preparation of the calibrator.
1. Incorrect calibration results Check that the calibration settings are correct.
The calibration is performed again if necessary.
Check the temperature shown in the [Run Moni-
tor (page 1/2)] picture. Call for service at our
2. Too high inside temperature of
customer service department when the indicated
IRU unit
temperature deviates from the specified value of
37 ± 0.3ºC.
3. Improper preparation of reagent Check the preparation of the reagent.
4. Improper preparation of calibrator Check the preparation of the calibrator.
4.4.3 Low result values from a specific method for

all samples
Cause Action
1. Expiration of the term of validity See the statement of virtues which comes to-
of reagent gether with the reagent kit for its stability.
2. Improper preparation of reagent Check the preparation of the reagent.
3. Improper preservation of reagent See the statement of virtues which comes to-
gether with the reagent kit for its proper preser-
vation method.
4. T
oo low inside temperature of Check the temperature shown in the [Run Moni-
IRU unit tor (page 1/2)] picture. Call for service at our
37 ± 0.3ºC.
5. Improper preparation of calibrator Check the preparation of the calibrator.
6. Excessive volume of reagent dis- Check if there is any leakage or drip at junction
pensed of reagent sampling system.
180
4.4.4 Randomly derived erroneous measurement re-

sults
Cause Action
Perform nozzle washing in the [Wash [F10]] pic-
ture of the job menu [Maintenance] and check
1. Stains on SPT or RPT that the enough wash water is dispensed into
the trough. Call for service at our customer ser-
vice department in vase of trouble.
2. Fibrin clots formed on specific
Clean the SPT nozzle.
sample tube or sample cup
Check if the tip of water or solution tube is posi-
3. Insufficient water or solution sup- tioned below the water or solution level. Call for
ply from respective external tank service at our customer service department in
vase of trouble.
Check if the stirrer rotates in the centre of cu-
4. Insufficient stirring
vette and at the correct speed.
4.4.5 Anomalous result values from all methods for

a sample
Cause Action
Prepare newly the reagent referring to the state-
1. Improper preparation of reagent ment of virtues which comes together with the
reagent kit.
Prepare newly the reagent referring to the state-
2. Expiration of term of validity, con-
ment of virtues which comes together with the
tamination or paleness of reagent
reagent kit.
4.4.6 Two or more anomalous and random measure-

ment results
Cause Action
1. Leakage in the SPT or RPT sam-
Check junctions of probe and syringe.
pling system
Check the temperature shown in the [Run Moni-
tor (page 1/2)] picture. Call for service at our
2. Anomalous inside temperature of
IRU unit
37 ± 0.3ºC.
Check if the stirrer rotates in the centre of cu-
3. Insufficient stirring
vette and at the correct speed. (Mix-1 and Mix-2)
Check if the pipettes and stirrers are washed
4. Stain of Pipettes (SPT and RPT)
well at respective trough. (SPT, RPT, Mix-1 and
and stirrers
Mix-2)
181
4.5 Equipment malfunction

The performance of troubleshooting should be limited to an extent described in this man-
ual. It may be difficult for the user to deal with the problem, the troubleshooting of which
is beyond this limited extent. In such a case, call our customer service department for
service.
4.5.1 Detection of mechanical problem

All the mechanical movements are controlled and monitored by the computer. When a
problem arises, the computer becomes aware of it and generates the visual error message
to call the operator's attention.
In the event of the problem that may affect the performance of the analyzer, the sampling
stop or emergency stop will be executed. In the case of sampling stop mode, the analyzer
carries on and completes the processing of the sample that is not affected by the problem.
In the case of problem that may affect the entire measurements of sample, the emergency
stop will be executed.
The analyzer generates two types of error messages, i.e., result-related flag and equip-
ment alarm.
Problem may arise, which is not monitored by the computer. Any alarm message
may not be indicated on the display for such a problem. Such a problem includes
abrasion of parts, leakage in the sampling system, etc. When this type of problem
occures, decide whether the processing of sample is carried on or the measurement
is terminated, considering that such problem may result in a damage to the analyzer
or erroneous outcome of measurements.
4.5.2 Error messages for each unit

See Chapter 5 "List of alarm codes".
182
4.6 Error flags associated with measure-

ment results
When the measurement result is higher or lower than the defined value, the appropriate
error flag is printed out together with the result.
4.6.1 Measurement result assessment flag

The measurement result assessment flags printed out together with the measurement
result are shown in the following list.
No. Flag Cause Action
1 H The measurement result For information only to the user.
(Higher than upper shows higher value than Chemistry Parameters should
limit of judgement the specified normal be checked.
value) range.
2 L The measurement result For information only to the user.
(Lower than lower shows lower value than Chemistry Parameters should
limit of judgement the specified normal be checked.
value) range.
3 > The measurement result For information only to the user.
shows higher value than Chemistry Parameters should
the technical range. be checked.
4 < The measurement result For information only to the user.
shows lower value than Chemistry Parameters should
the technical range. be checked.
5 r The measurement result For information only to the user.
shows result of rerun Chemistry Parameters should
execution. be checked.
4.6.2 Measurement result error flags

The measurement result error flags printed out together with the measurement result are
shown in the following list.
No. Flag Cause Action
Tip of the SPT hits the bottom at the
time of aspiration of sample at the ASP Check the sample volume in
1 SS
unit. the sample tube or sample cup.
(Sample could not be aspirated.)
time of dispensation of sample at the Check the level sensor and its
2 SI1
IRU. associated parts.
(Sample could not be dispensed.)
Check the level sensor and its
3 SI2 time of aspiration of diluent at the IRU.
associated parts.
(Diluent could not be aspirated.)
183
Tip of the RPT hits the bottom at the

Check the volume of R1 re-
4 R1S time of aspiration of R1 at the RCU.
agent in its bottle.
(Shortage of R1 reagent)
Check the volume of R2 re-
5 R2S time of aspiration of R2 at the RCU.
agent in its bottle.
(Shortage of R2 reagent)
time of aspiration of diluent at the Check the volume of diluent in
6 DS
RCU. its bottle.
(Shortage of diluent)
time of aspiration of wash solution at Check the volume of wash so-
7 WS
the RCU. lution in its bottle.
(Shortage of wash solution)
Inside temperature of the IRU is lower
8 TE1 Check the IRU unit.
than 35ºC.
Inside temperature of the IRU is higher
9 TE2 Check the IRU unit.
than 39ºC.
Inside temperature of the RCU is high-
10 TE3 Check the RCU unit.
er than 15ºC.
R1 reagent bottle has not been regis- Check that the bar code on the
11 R1B
tered. label is the registered one.
R2 reagent bottle has not been regis- Check that the bar code on the
12 R2B
tered. label is the registered one.
Check that the bar code on the
13 DB Diluent bottle has not been registered.
label is the registered one.
Wash solution bottle has not been reg- Check that the bar code on the
14 WB
istered. label is the registered one.
No response from ISE unit to sampling
15 IE1 Check the ISE unit.
start command.
No measurement result is sent from
16 IE2 Check the ISE unit.
ISE unit.
Error arises during run and sampling is
17 EST Check the error number.
interrupted.
Mismatch between R1 and R2 lot num- Use R1 and R2 bears same lot
18 LOT
bers. number.
RPT wash between methods fails.
19 R1W Check the relevant alarm.
(Timing of R1)
RPT wash between methods fails.
20 R2W Check the relevant alarm.
(Timing of R2)
Exchange the reagent to the
21 EXP Term of validity of reagent has expired.
valid one.
Term of validity of reagent stability has Exchange the reagent to the
22 STB
expired. valid one.
23 SPW SPT wash has been failed. Check the relevant alarm.
184
Perform the calibration mea-

Term of validity of calibration has ex- surement for the relevant
24 CTO
ceeded for obtained result. method, and try again the same
measurement, if necessary.
Check the adequacy of value
Variation in calibration results is out of
for the duplicate limit, and per-
25 DUP allowable range. (Variation in duplicate
form again same calibration
and triplicate measurement results)
measurement.
Difference in absorbance between Std
for the sensitivity limit, and
26 SEN (min) and STD (max) is out of allowable
perform again same calibration
range for the calibration measurement.
measurement.
Check the applied calibration
27 CAL Calibration measurement failed.
parameters.
Conversion to concentration is dis- Check the applied calibration
28 CA?
abled. parameters.
Used reagent lot # in the sample or For information to the user.
control measurement is different from Try another measurement after
29 CLT
the reagent in the calibration measure- re-calibration is performed, if
ment. necessary.
for the linearity limit, and per-
30 LIN Linearity is out of allowable range.
form again same calibration
measurement, if necessary.
for the prozone limit, and per-
31 PRO Prozone is out of allowable range.
form again same measurement,
if necessary.
All measured values are out of the ab- Check the adequacy of value
sorbance limit or first one measured for the absorbance limit, and
32 AB1
value is in the absorbance limit but the perform again same measure-
others are out of the absorbance limit. ment, if necessary
There are not more than 3 consecutive
for the absorbance limit, and
33 AB2 measured values in the absorbance
perform again same measure-
limit.
ment, if necessary.
Concentration is out of calibration Check the applied calibration
curve. parameters, and perform again
34 OVR
(Applied calibration curves are Spline, measurement of calibration, if
Point-to-point and Log-logit.) necessary.
185
4.7 Maintenance Picture

The following maintenance picture is indicated by clicking on the job menu [Maintenance].
This picture is provided with test function of individual operations of each unit and moni-
toring function of each sensor state.
4.7.1 Combined Operation [Sequence (F9)]

Several combined operation can be executed or various sensor states can be monitored.
(1)
(2)
(3)
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(12)
Combined operation Sensor test
A) Combined Operation
(1) Initialization
This is to initialize the mechanical parts of each unit.
After click on the [Start] button, the popup message is appeared to prompt operator to
select either [OK] or [Start] button.
[OK]: Initialization is performed.
[Cancel]: The popup message is disappeared without any performance.
(2) Prime Sequence (Long prime)

This is to perform the long prime sequence for all pumps and syringes in order to deflate
the tubing line of water and solution.
186
select either [OK] or [Cancel] button.
[OK]: Prim sequence is performed.
(3) Short Prime Sequence

This is to perform the short prime sequence.
Number of execution count should be entered into the input field.
[OK]: Short prime sequence is performed.
(4) Cuvette Check

This is to perform water blank measurement to assess the degree of stains on cuvettes.
The absorbance data of water blank is stored to the internal data base which is reflected
in the function menu [Wash (F10) Page 2/2] picture of the job menu [Maintenance].
[OK]: Cuvette check is performed.
(5) Pump Test

All pumps can be selectively activated for specified period to check their function.
When clicked on [Start] button, the following popup window is displayed on the screen.
1. Select testing pump by means of clicking at the check mark in the both group “Dia-
phragm Pump” and “Waste Pump”.
2. Enter the operating time into the “Time” box.
3. Click on the [OK] button to start this pump test.
4. To terminate this test, click on [Cancel] button. Then return to original screen.
187
(6) Cuvette Wash

45 cuvettes placed in the IRU unit are washed.
[OK]: Cuvette wash is performed.
(7) Cuvette Water Placement

This is to fill 45 cuvettes in the IRU unit with water.
The purpose of this treatment is to prevent cuvettes from being stained during the period
that the analyzer is left unused for a long time.
The cuvettes are filled with water by the RPT nozzle.
After clicking on [Start] button, the following window is popped up to select the supply
water.
[System³water]: When this button is clicked on, the system water (purified water) is sup-
plied by RPT into each cuvette.
[Wash³solution]: When this button is clicked on, the wash solution is supplied by RPT into
each cuvette. RPT aspirates the wash solution at C-port of RPT trough
and dispenses them into cuvette. Therefore, the line of wash solution-3
must be connected to the wash solution tank.
[Cancel]: When this button is clicked on, the liquid dispensing process for the cu-
vette is not performed.
188
(8) Cuvette Water Displacement

This is to pump out the water which was filled in cuvettes to prevent them from being
stained. The water is pumped out by the wash unit (WU).
[OK]: Cuvette water displacement is performed.
[Cancel]: Cancel : The popup message is disappeared without any performance.
(9) WU1,3 Rinse

This is to perform the movement of syringe for WU-1 and 3 for washing the lines by water.
The aim of this treatment is to prevent the accumulating of impurities contained solution
in the WU1 and WU3 line by means of washing by purified water.
[OK]: WU1,3 Rinse is performed.
(10) ISE Prime

This is to deflate the lines of the ISE unit by means of pouring the Calibrant-A into the
sample port of ISE. Number of execution count should be entered into the input field.
[OK]: ISE prime is performed.
(11) ISE Cleaning

This is to perform the cleaning line of the ISE unit.
In advance of performing this sequence, a cup or tube contained cleaning liquid (600 μl)
should be placed on #19 slot of ASP.
After click on the [Start] button, the following popup message is appeared to prompt op-
erator to select either [OK] or [Cancel] button.
189
[OK]: ISE cleaning is performed. After completing this sequence, 5 times of ISE prime
are carried out.
(12) ISE Calibration

2 point calibration is performed. The cup or tube contained the Calibrant-B (500μl) should
be placed on #18 slot of ASP.
Calibration result is outputted to the function menu [ISE (F11)] picture of job menu [System
Parameters].
After click on the [Start] button, the following popup message is appeared to prompt op-
erator to select either [OK] or [Cancel] button.
[OK]: ISE cleaning is performed. After completing this sequence, 5 times of ISE prime
are carried out.
As the description above, individual operation is initiated by clicking on the [Start] button
beside each operation designation. Upon clicking on the [Start] button, the following pop-
up window is displayed in the centre of the screen.
This message varies

depending on each
individual operation.
If there is no problem, click on the [OK] button. Upon clicking, the following pop-up win-
dow is displayed to show that the operation is in progress.
Click on the [Stop] button to stop the operation in progress.

The following pop-up window is displayed during the emergency stop processing.
190
B) Sensor tests
This is to test whether each sensor in the analyzer is in operating state or not.
When the sensor is ON state, the circle area beside the [Read] button is illuminated in
yellow.
[Read]: The current sensor state is checked by clicking on this button.
The sensor test can be carried out in an individual sensor basis or for all sen-
sors at a time.
[Auto³Read]: This function is to check all sensor state at every 3 seconds.
Just after [Auto³Read] button is clicked on, reading sensor status stars and
[Stop] button is appeared instead of [Auto³Read] button. To terminate this
test, click on [Stop] button.
Button for checking all Automatic sensor reading button

sensor state at a time (Instead of this button, [Stop] button is
appeared during practicing this test.)
Sensor state indicator

Yellow: ON
Grey: OFF
Button for checking sensor

states in an individual basis
Unit
Sensor name Description
designation
Zero position of cuvette turntable
IRU_ZERO IRU
Yellow (ON): Zero position, Disconnection: Yellow (ON)
Ready position of cuvette turntable by cuvette
IRU_READY IRU
Yellow (ON): Normal position, Disconnection: Grey (OFF)
Zero position of optical filter disk
FLT_ZERO DTR
Yellow (ON): Zero position, Disconnection: Grey (OFF)
Zero position (upper limit) of WU nozzle
WU_ZERO WU
Overflow of cuvette
WU_OVER WU
This sensor can not test in the “Maintenance” mode.
Zero position of stirrer (MIX-1)
MIX1_ZERO MIX-1
191
Zero position of stirrer (MIX-2)

MIX2_ZERO MIX-2
SPT Zero position of SPT rotary movement
SPTR_ZERO
(Rotate) Yellow (ON): Zero position, Disconnection: Grey (OFF)
SPT Dispensation position of SPT rotary movement at trough
SPTR_TS
(Rotate) Yellow (ON): Dispensation position, Disconnection: Grey (OFF)
SPT Zero position (upper limit) of SPT up-and-down movement
SPTU_ZERO
(Up & Down) Yellow (ON): Zero position, Disconnection: Yellow (ON)
SPT Zero position (lower limit) of SPT up-and-down movement
SPTU_DL
(Up & Down) Yellow (ON): Lower limit, Disconnection: Yellow (ON)
SPT Level detection of SPT up-and-down movement
SPTU_LL
(Up & Down) This sensor can not test in the “Maintenance” mode.
SPT
SPTU_LOW Not used
(Up & Down)
RPT Zero position of RPT rotary movement
RPTR_ZERO
(Rotate) Yellow (ON): Zero position, Disconnection: Grey (OFF)
RPT Dispensation position of RPT rotary movement at trough
RPTR_TS
(Rotate) Yellow (ON): Dispensation position, Disconnection: Grey (OFF)
RPT Zero position (upper limit) of RPT up-and-down movement
RPTU_ZERO
(Up & Down) Yellow (ON): Zero position, Disconnection: Yellow (ON)
RPT Zero position (lower limit) of RPT up-and-down movement
RPTU_DL
(Up & Down) Yellow (ON): Lower limit, Disconnection: Yellow (ON)
RPT Level detection of RPT up-and-down movement
RPTU_LL
(Up & Down) This sensor can not test in the “Maintenance” mode.
RPT
RPTU_LOW Not used
(Up & Down)
Overflow at waste chamber (SPT, RPT, MIX-1, MIX-2)
TRF_OVER Trough
Yellow (ON): Overflow, Disconnection: Grey (OFF)
Monitor of 24 VDC (IRU motor)
IRU_24Vm IRU
Yellow (ON): 24V
Monitor of 24 VDC (SPP, RPP and WPP motors and solenoid
PP_24Vm PP valve)
Yellow (ON): 24V
Monitor of 24 VDC (SWU pump)
SWU_24Vm SWU
Yellow (ON): 24V
Empty detection of wash solution tank 3
BOT6_EMP External tank
Yellow(ON): Liquid exists (not empty)
Zero position (upper limit) of WPP syringe
WPP_ZERO WPP
Zero position (upper limit) of SPP syringe
SPP_ZERO SPP
Zero position (upper limit) of RPP syringe
RPP_ZERO RPP
Empty detection of pure water tank
Yellow (ON): water exists (not empty)
Yellow (ON): Liquid exists (not empty)
Yellow (ON): Liquid exists (not empty)
Fill-up detection of low concentration waste tank
BOT4_FULL External tank
Yellow (ON): Empty
Fill-up detection of high concentration waste tank
BOT5_FULL External tank
Yellow (ON): Empty
192
Zero position of ASP turntable

ASP_ZERO ASP
Zero position of RCU turntable
RCU_ZERO RCU
ASP/ Monitor of 24 VDC (ASP, RCU motor)
ASP/RCU
RCU_24Vm Yellow (ON): 24V
ASP/ Monitor (1) of 24 VDC (Power supply of Peltier for RCU cooler)
ASP/RCU
RCU24Vp1 Yellow (ON): 24V
ASP/ Monitor (2) of 24 VDC (Power supply of Peltier for RCU cooler)
ASP/RCU
RCU_24Vp2 Yellow (ON): 24V
CONT_YOBI1 Not used
CONT_YOBI2 Not used
CONT_YOBI3 Not used
CONT_YOBI4 Not used
CONT_YOBI5 Not used
Lid detection of RCU
RCU_COVER1 RCU
Yellow (ON): With lid, Disconnection: Grey (OFF)
Lid detection of ASP
ASP_COVER2 ASP
Yellow (ON): With lid, Disconnection: Grey (OFF)
4.7.2 Nozzle Wash [Wash (F10)] Page: 1/2

Select the function menu [Wash (F10)] page 1/2 picture of the job menu [Maintenance].
(1)
(2)
(3)
(4)
(6)
(5)
(7)
(8)
Wash program
display field
Buttons to structure RPT

nozzle wash program
(Wash Program)
193
<Pipette nozzle wash>

The pipette nozzles are washed with pure water in the respective trough (SPT and RPT
trough).
(a) SPT trough that has D-position.
D-position (Drainage position) where is to discharge the holding liquid in SPT, for example
aspirated system water from its inner line, and has the purified water supply hole at the
side in order to clean the outside of nozzle.
(b) RPT trough that has D-position, R-position and C-position.

D-position (Drainage position) where is to discharge the holding liquid in RPT, for example
aspirated system water from its inner line.
R-position (Rinsing position to aspirate the purified water spouted out vertically to rinse
the inside of nozzle.
C-position (Cleaning position) to aspirate the wash solution spouted out vertically to rinse
the inside of nozzle.
(1) S.P.T.: SPT nozzle wash with purified water
By clicking on the [Start] button, SPT discharges the system water at D-position of SPT
trough to rinse the inside of nozzle. And the outside of SPT nozzle is washed by purified
water (system water) at D-position where the purified water is spouted out from the side
hole.
(2) S.P.T. (S): SPT nozzle wash with solution

This function is for SPT nozzle wash by using the wash solution (dilution ratio of C-1:
1/100). Generally, this function is used for SPT to keep clean condition for the next mea-
surement before going to the sleep mode.
When click on the [Start] button, the following message is popped up at the lower part of
screen to urge setting of the cup that is contained wash solution with about 500µl to ASP
slot number 18.
Click on the [OK] button after setting the wash solution to ASP slot number 18. While
washing the SPT, the following message is popped up. Of course, when you do not want
to perform this function, is possible to click on the [Cancel] button at the previous popped
up window.
194
This pop-up message is output-

ted until completion of the nozzle
washing (about 13 minutes).
The sequence of SPT nozzle washing is as below;

1. SPT moves to ASP slot #18.
2. SPT descends into the cup at the ASP.
3. SPT aspirates 240 µL of wash solution from the cup and ascends to the upper limit.
4. SPT moves to D-position of SPT trough.
5. SPT stays there for 10 minutes without any movement.
6. PT descends 27.5 mm to downward and discharges 240 µL of wash solution and 75 mL
of purified water.
7. SPT ascends to the upper limit.
(3) R.P.T. (W): RPT nozzle wash with purified water

By clicking on the [Start] button, RPT is moved to D-position of RPT trough and discharg-
es the purified water. And RPT is moved to R-position where the purified water is spouted
out. Thus, the outside of nozzle is washed by purified water. At the same time, aspirates
1mL of the water spouted out and RPT is moved to D-position and discharges 1mL of
water to rinse the inside of nozzle.
(4) R.P.T.(C) : RPT nozzle wash with solution

The RPT nozzle is washed with wash solution in the RPT trough by clicking on the [Start]
button.
(5) RPT (S) : RPT nozzle wash with solution

This function is for RPT nozzle wash by using wash solution. Generally, this function is
used for RPT to keep clean condition for the next measurement as necessary.
Beforehand to perform this function, type of wash solution should be selected at the “Re-
agent Code for R.P.T(S)” field as below picture.
Solution name entry box Pull-down menu
1. Select one of “R1”, “R2”, or “Wash” from the pull-down menu as the wash solution.
2. Move the cursor onto the solution name entry box and press the [SPACE] key.
Since the name list of wash solution is popped up, select the one of solution name from
the list by using cursor and press the [Enter] key.
3. Click on the [Save] button to determine the solution type.
195
4. Click on the [Start] button to perform the RPT nozzle wash.
(6) S.P.T./R.P.T.(W) : SPT & RPT nozzle wash with purified water
Each pipette nozzle is washed by purified water in the respective trough by clicking on the
[Start] button.
(7) S.P.T./R.P.T.(C)
The RPT nozzle is washed with wash solution in the RPT trough and SPT nozzle is washed
with pure water in the SPT trough by clicking on the [Start] button.
(8) Tubing wash

All tubing line and the waste chamber box are cleaned by achievement of this function.
The procedure is shown below.
1. Click on the [Start] button as below picture.
2. The following message is popped up.

Tubes of Sol-1, Sol-2 and Sol-3 are inserted into the purified water tank.
And click on the [OK] button, then the priming sequence is performed 5 times in order to
supply the purified water into all tubing lines.
3. After execution of priming, the following message is popped up.

Insert the tubes of Systemwater, Sol-1, Sol-2 and Sol-3 into the diluted C1 solution tank
which has been prepared in advance. And click on the [OK] button, then the priming se-
quence is performed 3 times.
4. To rinse the tubes and waste chamber box in C1 solution, it takes for about 12 min-
utes.
196
5. To rinse out the C1 solution, the following message is popped up.

Insert the tubes of Systemwater, Sol-1, Sol-2 and Sol-3 into the purified water tank.
And clicked on the [OK] button, then the priming sequence is performed 5 times.
6. To rinse the tubes and waste chamber box in the purified water, it takes for about 12
minutes.
7. After rinsing with purified water, the following message is popped up.
Return the all tubes to the original tanks. The tube of Systemwater is inserted into the puri-
fied water tank, and the tubes of Sol-1, Sol-2 and Sol-3 are inserted into the tanks of their
original solutions. And click on the [OK] button, then the priming sequence is performed
3 times.
8. At last, the following message is popped up to show the finishing of tubing wash.
After clicking on the [OK] button, the popped up window is closed.
197
4.7.3 Exchange of ISE Electrode

Exchange of the ISE electrode is carried out in accordance with the following procedures
referring to the function menu [Wash (F10)] page 1/2 picture of the job menu [Mainte-
nance].
1. The following message is indicated by clicking on the [Start] button.
2. After [OK] button is clicked on, following message is popped up in the centre of screen,
and the preparation process is started.
3. When the preparation process has been completed and the analyzer has become ready
for exchange of electrode, the following message appears.
When [Shut³down] button is clicked on, Analyzer starts the shut down process.
After completion of the shut down process, the main switch of the analyzer is turned off
so that the work of the electrode exchange is started.
198
For details, see “4.9.4 Procedure for ISE Electrode exchange".

4. After the exchange work has been completed, turn the power switch on and reactivate
the analyzer.
4.7.4 Method-to-Method wash (Wash Program)

This function is to structure the wash program of RPT nozzle.
The RPT nozzle is washed in the RPT trough to prevent the reagent for Method 2 from be-
ing contaminated by the reagent for Method 1.
The wash program is structured in the [Wash (F10)] page 1/2 picture of the job menu
[Maintenance] (See “4.7.2 Nozzle Wash [Wash (F10)] Page 1/2").
(1) (2) (3) (4) (5) (6)
List of wash programs
(7) (8) (9) (11) (10)
(1) Method Name 1

Method name 1 is the method, which is carried out before the RPT wash program is run.
The wildcard "*" as the method name means all methods.
(2) Method Name2

Method number 2 is the method which is carried out immediately after the RPT wash pro-
gram has been run. The wildcard "*" as the method name means all methods.
(3) R1 → R1
This means that the R1 reagent for the method 2 is dispensed after the R1 reagent for
method 1 was dispensed.
The wash solution name for the nozzle wash carried out after dispensation of R1 for meth-
od 1 is indicated.
The blank column means pure water wash.
(4) R1 → R2
od 1 is indicated.
199
(5) R2 → R1
od 1 is indicated. The blank column means pure water wash.
(6) R2 → R2
od 1 is indicated.
(7) Add (Addition of program)

Click on this button to add the method-to-method wash program of the RPT nozzle.
(8) Edit (Editing of program)

Click on this button to edit the method-to-method wash program in the list of wash pro-
grams.
(9) Delete (Deletion of program)

Specify the method-to-method wash program in the list of wash programs and click on
this button to delete it.
(10) Cancel
Click on this button to cancel the above addition, edition and deletion.
(11) Save
Click on this button to save above addition, edition and deletion of the method-to-method
wash program without fail.
The solution names indicated in the steps (3), (4), (5) and (6) are the ones registered in the
[System (F9)] picture of the job menu [System Parameters].
This method-to-method wash has precedence over the "RPT wash" specified in the
[Chemistry Prm (F6)] picture.
The detailed procedure for how to structure the method-to-method wash program is
shown below.
A) How to program the method-to-method wash program

The method-to-method wash program is structured using [Add], [Edit], [Delete], [Save]
and [Cancel] buttons.
The following pop-up window appears at the centre of screen by clicking on the [Add] or
[Edit] button.
200
Click on "All" if all

items are selected.
1. Programming of Method1 and Method2

Move the cursor onto the “Method1” or “Method2” box and press the [SPACE] key to
indicate the pop-up window of the method list. Select the method by clicking on the ap-
plicable method in the list and press the [Enter] key.
Press the [ESC] key to close the pop-up window of the method list.
2. Programming of wash [R1 → R1, R1 → R2, R2 → R1, R2 → R2]

Three choices (System Water, Wash Sol. C or Wash Bottle) are provided.
Click here to use Click here to use Click here to use

pure water. Wash Sol. C. Wash Bottle.
201
Select one of “Sys. Water”, “Wash Sol.C” or “Wash Bottle” as the wash solution.
Sys Water System water (purified water) as the wash solution
Wash Sol.C Wash solution C-1 as the wash solution
Wash Bottle Wash bottle (R1 or R2 or Wash in RCU) as the wash solution
 When “Wash Bottle” is selected as the wash solution.

Select one of “R1”, “R2”, or “Wash” from the pull-down menu.
After definition of reagent name, need to specify its bottle name.
Therefore, move the cursor onto the “Reagent Name” box and press the [SPACE] key to
indicate the pop-up window of the applicable bottle name list. Select the bottle name by
clicking on its name in the list and press the [Enter] key.
 When “Sys Water” or “Wash Sol.C” is selected as the wash solution, it is no need of
setting of “Reagent Name” and “Reagent Type”.
The structured method-to-method wash program is accepted by clicking on the [OK] but-
ton and cancelled by clicking on the [Cancel] button.
B) Establishment of the method-to-method wash program

Click on the [Save] button to save the structured method-to-method wash program.
To establish
the method-to-
method wash
program. Click
on this button.
202
4.7.5 Working hours of expendable parts

The list of working hours of expendable parts which need to be exchanged periodically
is indicated in the function menu [Wash (F10)] page 1/2 picture of the job menu [Mainte-
nance]. The exchange timings should be decided referring to the list.
Effective remaining working hours Initial value
203
Item Action Description

Total Working Hours None Total working hours of the analyzer.
Initial value in parentheses and effective
Click on the [Reset]
remaining hours at left.
Halogen Lamp button after the part
When remaining hours become zero, its
has been exchanged.
colour changes to red.
Drain Pump button after the part
has been exchanged.
Diaphragm Pump Initial value in parentheses and effective
(WPP-1 to 7, SPT- remaining hours at left.
button after the part
Trough, RPT-Trough, When remaining hours become zero, its
has been exchanged.
MIX1 and MIX2) colour changes to red.
Micro syringe Tip Click on the [Reset]
(RPP, SPP and button after the part
WPP) has been exchanged.
Pump Cassette remaining hours at left.
(For ISE unit) When remaining hours become zero, its
has been exchanged.
Electrodes remaining hours at left.
has been exchanged.
Calibrant A remaining hours at left.
has been exchanged.
204
4.7.6 Results of Cuvette Check [Wash (F10)] Page 2/2

The list showing the degree of the stains on the cuvettes in numeric derived from the wa-
ter blank measurement is displayed in the function menu [Wash (F10)] page 2/2 picture of
the job menu [Maintenance]. In this screen, the water blank value for each cuvette can be
monitored in real time during measurement.
(1)




(2)  (4) Judge-
 ment
 results


(3)
(1) Wave Length (Selection of wavelength)

Specify the wavelength to display the corresponding water blank measurement results.
(2) Date (Date of measurement)

Move the key-cursor onto the date displayed at the left side on the picture and clicked
on the mouse to specify the date on which the water blank measurement value was per-
formed.
And click on the [Judge] button, the water blank measurement value for each cuvette is
outputted at right side as the judgement results.
(3) Judgement Value (Criterion)

The degree of the stains on the cuvette shown in numeric is assessed against this judge-
ment value (criterion).
When this judgment value is changed, its value becomes effective by means of clicking
on [Judge] button.
(4) Data (Judgement result)

When the water blank measurement values for 8 of wave length exceed the judgement
value, its value of cuvette is shown in red, and its cuvette will not be used and skipped at
the time of the next measurement.
205
When the water blank measurement value for 1 of wave length among the 8 of wave length
exceeds the judgment value, its value of cuvette is shown in yellow. In this case, its cu-
vette will be used for next measurement.
The water blank measurement is carried out during the normal measurement and the mea-
sured values are stored in the database.
4.7.7 Performance Monitor [Performance (F11)]

The inside temperatures of IRU and RCU and the detector performance can be checked
and monitored in the [Performance (F11)] picture of the job menu [Maintenance]. This per-
formance monitor picture cannot be displayed during measurement.
A) Temperature Monitor
The temperatures of three heaters inside the IRU are shown in numeric (blue, red and yel-
low) and graphically. The temperature inside the RCU are monitored and shown in numeric
(black).
Each temperature is controlled with precision of centesimal degree (0.01 C).
206
Temperature inside IRU

Blue: At cuvette No.-07 (TS-1)


 Red: At cuvette No.-22 (TS-2)
Yellow: At cuvette No.-37 (TS-3)
Temperature inside RCU
Graphic indication of tempera-

ture inside IRU
X-axis: time (current time at the
right end)
Y-axis: temperature value
B) Detector Performance Monitor

The functionality of detector auto-gain is checked and monitored.
Title Description
Wave Length 8 wavelengths
Coarse Coarse gain adjustment
Fine Fine gain adjustment
Offset Not available
Voltage Gain adjustment voltage (to be adjusted within 9.0 ± 0.5 V)
Absorbance Absorbance at the above gain voltage.
[Manual] button Manual gain adjustment (to be normally used at factory adjustment)
[Automatic] button Automatic gain adjustment
Parameter of DTR optical axis adjustment (factory adjusted before
Optical Axis
shipment)
207
C) Volume Adjustment & µL/pulse

This is a parameter factory adjusted before shipment.
4.7.8 Automatic Start-up [Auto Start (F12)]

The sequence of measurement preparation at the time of automatic start-up of the system
is specified in the function menu [Auto Start (F12)] picture of the job menu [Maintenance].
The analyzer need to be shut down in the "Sleep" mode at the end of its operation in
order to enable the sequence of measurement preparation to be executed at the time of
the system start-up.


 Definition
 of Prep1
 and
 Prep2













Auto Prime

Scheduling  Parameter
Save button for setting

parameters
A) Scheduling
The time of system start-up and the sequence of measurement preparation can be speci-
fied for a week (Monday through Sunday).
"Time": Enter the time of system start-up "Prep": S

elect a group of measurement prepara-
of each day (00:00:00 – 24:00:00) tion to be carried out at the time of system
start-up (among Off, Prep1 or Prep2).
Monday through

Sunday 

208
B) Prep1/Prep2
The operational sequence for two selectable types of preparation group (Prep1 and Prep2)
is defined.
(1)
(2)
(3)
(4)
(5)
Actions of measurement preparation

(1) Prime: Selectable from 1 to 5 times (0: Off)
(2) ISE Prime: Selectable from 1 to 5 times (0: Off)
(3) SPT Wash: Selectable from 1 to 5 times (0: Off)
(4) PRT Wash: Selectable from Off, W1 – W5 and C1 – C5
where W2 means 2 times pure water washes and C2 means 2 times
wash solution washes.
(5) Cuvette Wash: Selectable from 1 to 5 times (0: Off)
Two types of preparation group
Prep1: No. 1 group
Prep2: No. 2 group
C) Auto prime parameter

When “Auto Prime Mode” is selected in the function menu [Condition (F12)] of the job
menu [Run Monitor (F5)], following parameters (Short prime interval, full prime interval and
Number of Short Prime) become effective during starting operation of analyzer. (See “2.1.3
Power-on” and “2.5 Setting of Measurement Conditions”)
209
4.7 Maintenance picture
When the measurement Auto gain control

When the measurement is is started for this period,
Time where last started for this period, auto gain and full prime are
auto gain control and executed.
measurement is finished control is only executed. short prime are executed.
Laps of time
Short prime interval Full prime interval

(E.g. 60min.) (E.g. 240min.)
Time-chart of the “Auto Prime Mode”

Time-chart of the “Auto Prime Mode”
In the case of “Auto Prime Mode”, when the analyzer is started for the measurement,
In the case of “Auto Prime Mode”, when the analyzer is started for the measurement, the
the movement of preparation (e.g. auto-gain and prime) is performed in accordance with
movement of preparation (e.g. auto-gain and prime) is performed in accordance with “Auto
“Auto Prime Parameter”.
Prime Parameter”.
4.7 Maintenance Picture

4.7.8 Automatic Start-up [Auto Start (F12)]
4-51
210
4.8 Cleaning
This section addresses the cleaning procedures of each tank and unit.
4.8.1 Cleaning of External Tanks

Since the inside of each external tanks are stained with impurities due to long time using,
it would be better to clean the inside of each external tanks by purified water at an interval
of a month.
Caution: Turn the power switch of the analyzer off without fail before work started.
<Procedure>
(1) Get rid of all liquid or water from each tank. (Sol-1, 2, 3 tank and system water tank)
(2) Clean and wash sufficiently the inside of each tank with purified water.
(3) After cleaning each tanks, take fully away remaining liquid from each tanks.
4.8.2 Cleaning of Pipettes (SPT and RPT)

In the case of using ethanol, should not be close to fire or high temperature parts/units,
because the ethanol is flammable liquid.
<Procedure>
(1) Lift the entire nozzle with one hand.
(2) Wipe the pipette with a gauze or cotton swabs impregnated with ethanol alcohol in the
top-to-bottom direction as shown in the following drawing (left-hand side).
Pipette nozzle
Insert direction
Cleaning needle
Nozzle cleaning jig
Do not apply much pressure to the nozzle when it is lifted and wipe the pipette gently. It
is very important for the nozzle to be vertical to the work table in order that the analyzer
works properly. If not, this may result in damage of pipette or anomalous measurement
results.
211
(3) If the inside of nozzle is blocked, the nozzle cleaning jig is inserted to the inner nozzle
by hand. And take out the stains caused blocking from inner nozzle as shown above men-
tioned drawing (Right-hand side).
The nozzle cleaning jig has two needles. The fine needle is for SPT and thick one is for
RPT/WU.
4.8.3 Cleaning of WU nozzles

In the case of using ethanol, should not be close to fire or high temperature parts/
units, because the ethanol is flammable liquid.
WU unit has two independent draining nozzles and 6 sets of nozzles that consist of drain-
ing nozzle and injection nozzle. Each nozzle should be cleaned with ethanol alcohol.
Before cleaning of WU nozzles, SWU cover is removed as below drawing.
<Procedure>
(1) Lift the entire nozzle with one hand.
(2) Wipe the each nozzle with a gauze or cotton swabs impregnated with ethanol alcohol.
(3) If the inside of nozzle is blocked, the nozzle cleaning jig is inserted to the inner nozzle
by hand. And take out the stains caused blocking from inner nozzle in the same way as
SPT/RPT nozzle cleaning.
4.8.4 Cleaning of stirrer (MIX-1/MIX-2)

The analyzer is provided with two stirrers (MIX-1 and MIX-2).

MIX-1 is located behind the RPT and MIX-2 is located toward the back of the SWU cover
behind the ASP. When the MIX-2 is cleaned, first of all, remove the SWU cover.
212
<Procedure>
(1) Hold the arm cover and lift the entire stirrer with one hand.
(2) Wipe the paddle with a gauze or cotton swabs impregnated with ethanol alcohol care-
fully.
(3) Furthermore, wipe the paddle with another gauze or cotton swabs impregnated with
pure water.
4.8.5 Cleaning of Auto Sampler Unit (ASP)

<Procedure>
(1) Make sure that the SPT nozzle is not located over the ASP unit. If so, move it off the
ASP with hand.
(2) Remove the lid and take the tray out of the ASP unit.
(3) Wipe the four sides of the aperture for the bar code reader with gauze impregnated
with ethanol.
(4) Wipe inside surface of the ASP unit with a gauze or paper towel as shown below. Wipe
up water drops completely.
(5) Put back the ASP tray and lid where they were.
4.8.6 Cleaning of Reagent Container Unit (RCU)

<Procedure>
(1) Make sure that the RPT nozzle is not located over the RCU. If so, move it off the RCU
with hand
(2) Remove the lid and take the tray out of the RCU.
(3) Wipe the window glass of the aperture for the bar code reader with gauze impregnated
with glass cleaner.
213
(4) Wipe inside surface of the RCU with a gauze or paper towel as shown below. Wipe up
water drops completely.
(5) Put back the RCU tray and lid where they were.
4.8.7 Cleaning of work table of the analyzer (mosaic

plate)
In the case of using ethanol, should not be closed to fire or high temperature parts/
<Procedure>
(1) Wipe the surfaces of each mosaic plate with a gauze or paper towel impregnated with
ethanol.
4.8.8 Cleaning of dust filter

There are two each dust filters provided inside both side covers. Clean the as necessary
and replace them with new ones in case that they are smeared by greasy dust or mechani-
cal damaged.
214
4.9 Exchange of parts

At the occasion of the parts exchange, the following special tools, jigs and dies are re-
quired.
1. Allen wrench: distances to subtense of 0.9 mm and 6 mm
2. Nozzle height adjustment die (common to both SPT and RPT)
3. Stirrer height adjustment die (common to both Mix-1 and Mix-2)
4. Plunger tip insertion die
4.9.1 Exchange of Syringe Tip

Plunger tips of syringes need to be exchanged every 150 hours of use.
On the assumption that a number of hours worked is 8 hours a day and 5 days a week,
they need to be exchanged about every 4 weeks. If a net working rate is higher than the
assumption, they must be changed more frequently.
<Procedure>
 Turn the power switch of the analyzer off without fail before work started.
 Do not fold or bend the tubes connected to each syringe.
 Put on rubber gloves when syringes are handled in order to prevent them from being
polluted or infected.
(1) Unfasten a fixing screw (M5) located at the lower portion of the plunger and remove
the plunger.
(2) Remove the plunger tip using a pair of long-nose pliers.
215
(3) Put a new plunger tip into the hole of the plunger tip insertion die.
(4) Hold the plunger vertically and insert it into a hole of the plunger tip.
(5) Insert the tip of the plunger into the syringe slowly and straight up.
(6) Put the silicon-oil (KF-96H-50000CS) thin around plunger tip as below drawing.
Of course, don’t put the silicon-oil on the plunger shaft and bottom of the tip.
(7) Fasten the fixing screw removed in the step (1).
4.9.2 Exchange of pipette (SPT/RPT)

Take care not to get hurt while handling nozzle.
<Procedure >
(1) Move the pipette to the position where the work can be carried easily.
(2) Loosen two M3 screws and remove the arm cover.
216
(3) Disconnect plugs (J2) from the pipette arm.

(4) Remove the tube from the pipette nozzle.
(5) Loosen the socket head screw (W-point, M2x4) of the pipette.
(6) Remove the pipette nozzle from the pipette arm while the nozzle is lifted up.
217
(7) Set the new pipette nozzle with joint screw (male) to the nozzle base plate.
(8) Connect the male joint screw (nozzle) and female joint screw (resin tube) firmly by us-
ing spanner (5.5 mm).
Since the pipette nozzle may be twisted by screwing joint, the spanner should be used for
prevention such problem.
218
(9) Adjust nozzle height using the PT nozzle height adjustment jig.
And fix the PT nozzle height position by PT-nozzle height fixing screw.
(10) Connect the connector (J2) to PCB on the nozzle base plate.
(11) Confirm that PT nozzle can move up and down smoothly.
(12) Put the nozzle cover to pipette unit (SPT/RPT).
4.9.3 Exchange of halogen lamp

Halogen lamp needs to be changed every 1000 hours of use.
Call up the [Performance [F11]] picture of the job menu [Maintenance] and click on the
[Automatic] button of the "Detector Performance Monitor". When any voltage of each
wavelength does not fall within 9.0 ± 0.5 V, the lamp needs to be exchanged.
Follow the procedure shown below to exchange the halogen lamp.
219
<Procedure>
1. Turn the power switch of the analyzer off without fail before work started.
2. Do not touch the glass part of the lamp.
3. Do not apply force at the joint portion of the lead wire to prevent it from being dam-
aged.
(1) Take off the mosaic plate 9. (See “4.8.7 Cleaning of work table of the analyzer".)
(2) Disconnect the plug (CN10B).
(3) Unscrew off the two screws (M3x30) from the lamp case.
(4) Lift up the lamp case holding its resin handle.
(5) Unscrew the two screws for fixing the lamp to the lamp case and pull out the lamp.
(6) Place a new lamp in its position and fasten two screws while pressing the lamp case
in the direction of an arrow as shown below.
(7) Connect the plug (CN10B). Take care that the lamp cable is not contact with the optical
filter and motor.
4.9.4 Exchange of ISE Electrodes

The ISE is optionally supplied and the need arises for the analyzer fitted with the ISE unit
to exchange the electrode.
<Procedure>
(1) Where the analyzer is still on, call up the [Wash [F10]] picture of the job menu [Main-
tenance] and click on the [Start] button of "Electrode Exchange" (see “4.7.3 Exchange of
ISE Electrode").
220
(2) Turn off the power supply switch of the analyzer.

(3) Take off the ISE cover on the right side panel of the analyzer.
(4) Pull the knob shown in the above drawing so that the electrode becomes visible.
(5) Press down the compression plate to ease removal of the electrode.
(6) Pull out the electrode.
(7) Slip a new electrode into the given position.
221
Note: Make sure that the “O”-ring is fitted to the liquid flowing hole of electrode.
When the drying protection tube (brown colour) is inserted to the liquid flowing hole
of electrode, take away its tube in advance of setting the electrode to the ISE unit.
4.9.5 Exchange of ISE Calibrant-A bottle

Follow the procedure shown below to exchange the ISE Calibrant A bottle.
<Procedure for exchange>

(1) Take off the ISE tank cover located on the right side of the upper panel by removing a
M3 screw and a latch.
(2) Exchange the Calibrant-A bag with new one. (Refer to the following procedures.)
1 Pull out the liquid supply tube from the short thick tube that is added to the tip of bag.
2 Pull out the short thick tube from Calibrant-A case and keep it for reusing.
3 Discard the useless Calibrant-A bag.
222
4 Prepare the new Calibrant-A bag, and put it into the bag fitting place.
5 Remove the red tube cap from the bag. Take care not to spout the liquid from bag.
6 Reconnect the liquid supply tube and the short thick tube, and plunge it to the Calibrant-
A bag.
(3) After exchanging the Calibrant-A, ISE prime should be performed more than 10
times.
4.9.6 Exchange of ISE Pump Cassettes

Periodical exchanging the pump cassettes are needed to maintain ISE measurement
properly.
The working time to know the replacement timing of the pump cassette is shown at the
function menu [Wash (F10)] of the job menu [Maintenance].
<Procedure for exchange>
(1) Pull out the liquid supply tube from the short thick tube that is added to the tip of bag
and prime ISE more than 5 times to purge the liquid from the flow path.
223
(2) Click on “Shut down” to terminate the analyzers software on PC and then turn the
power analyzer off.
(3) Remove the right side cover of analyzer and swing out ISE unit.
(4) Pull out two tubes of pump cassette from the connection parts.
(5) Release the pump cassette from the motor shaft by pressing two hooks at both side of
pump cassette with fingers. (See the following drawings.)
(6) Replace the pump cassette.

When replacing, replace both cassettes at the same time.
Beware that there is no markings on the tubes for the cassette. Exchange the cassette
carefully not to make wrong tube connection.
224
Tube marker
(1): Output of the supply
pump
Waste pump (This line is connected to
Supply pump the sample port of ISE
unit.)
(2): Input of the supply
pump.
(This line is connected to
the bottle of Calibrant-
A.)
(3): Output of the drain
pump.
the external drain tank.)
(4): Input of the drain
pump.
the termination port of
ISE unit.)
(1) (2) (3) (4)
(7) Attach the bottle cap for Calibrant-A bottle and turn on the power for analyzer.
Then prime the ISE more than 10 times.
(During the ISE priming, check whether the fluid flows correctly into the each tube and the
liquid leaking is not occurred at tube connection.)
After confirming that ISE is properly functioning, attach side covers.
(8) Reset the working hour of pump cassette at function menu [Wash (F10), Page: 1/2] of
the job menu [Maintenance].
225
226
Chapter 5
Summary of alarm codes
This chapter provides the summary of various alarm codes, which may be generated
during the operation of the analyzer. When any error or alarm condition arises, reference
should be made to this list and get in touch with our customer service department if nec-
essary.

5.1 Alarm indications and their severity levels
5.2 Alarm messages
5.3 ISE module error code
227
5.1 Alarm indications and their severity

levels
The information about any malfunction that may be mechanical, electrical or detected by
software is indicated as an alarm message. In case an error occurs, the [Alarm³³[F4]³] box at
the bottom of the screen flashes in red colour. Press the [F4] key to display "Alarm screen"
showing error the relevant code and its detail.
When [Clear³All] Clear All button at right side in the Alarm screen is clicked on, all alarm
records are deleted from internal data base.
Click on this button to
delete all alarm records.
5.1.1 Types of alarms

Severity
Type of alarm Description
level
1 Emergency stop This is a critical error and the operation stops immediately.
Sampling is interrupted but for the sample whose sam-
2 Alarm 1 pling operation has been completed, their measurements
are carried on.
Only message is displayed and the measurements are
3 Alarm 2
carried on.
5.1.2 Place to which alarm message is output

The alarm message is normally output on the display of the analyzer except the judgement
flag for the measurement result which is only printed out by the printer.
(See “4.6 Error flags associated with measurement results".)
5.1.3 Numbering system of alarm codes

The alarm code is assigned in the form of the combination of unit and error numbers to
each error. Each alarm code has 4-digit numeric and consists of 2-digit each of unit and
error number (e.g. 2252).
1. Unit number: 01 – 99
2. Error number: 01 – 99
228
5.2 Alarm Messages

5.2.1 System Error
Error
Message Action
code
System file “/home/kogata/sysboot/system/
E0075 System file is not recognized. system.txt or khan.txt” can not be found.
Contact technical support.
Check sample level in ASP. If sample level is
Sample short. Ordered test not
E2875 normal (the cup is not empty). Re-initialize If
completed.
fault returns, contact technical support.
Concentration calculation from measured
E6002 Concentration calculation error. results not possible. Check the settings in
the calibration screen are correct.
Full calibration has failed. Check the calibra-
E6003 Full calibration failed. tion concentration values at the calibration
screen. Check the calibrator set in the ASP.
Full, one point or two point calibration has
Full, one point or two point cali- failed. Check the calibration concentration
E6004
bration failed. values at the calibration screen.
Check the calibrator set in the ASP.
Check printer cable connections and that the
E6005 Printer output failed.
printer is in a ready condition.
Found standard without concentration value.
E6008 Invalid standard sample found. Go to screen “Calibration (F7)” – “Calibration
(F9)” and input the concentration value.
Concentration value is not defined. Check
Concentration information not the concentration values for the neces-
E6009
available. sary number of calibrators at the calibration
screen.
The message received from mechanical con-
E6011 Data reception error. trol software is longer than maximum allowed
data length. Check the software version.
Software interruption occurred at the time of
E6012 Software interrupted. calculation of concentration overflow or divi-
sion by zero.
Bcc error occurred during host Check the communication settings at system
E6013
communication. parameters.
Time out error occurred during There is no response from the host computer.
E6014
host communication. Check the connection to host.
There is no response to the communication
Re-transmission error occurred
E6015 of data from the host computer. Check the
during host communication.
connection to host.
Replace or wash cuvettes until at least 15 are
E6051 Shortage of good cuvettes.
available.
229
Error
Message Action
code
There are less than 15 good
Replace or wash cuvettes until at least 15 are
E6100 cuvettes and testing can not
available.
begin.
Not enough reagent inventories Check the reagent volume, and exchange it
E6101
to initiate the run. with new bottle, if necessary.
Calibration curve type “Factor” does not re-
Standard has been set for “Fac-
E6120 quire calibration. Check for correct standard
tor” assay.
or calibration curve settings.
Found calibrators other than
S2. As Blank Measurement is
E6121 set to enable reagent blank as This is for only warning. Calibration measure-
S1, only S2 can be used for ment is performed normally.
calibration. But it would be better to confirm the cali-
Found series dilution calibra- bration type and selection of blank mea-
tion. As Blank Measurement surement in screen “Calibration (F9)” and
E6122 is set to enable reagent blank “Checks (F10)” of job menu Calibration (F7).
as S1, only S2 can be used for
calibration.
RCU bottle #1: Bottle barcode Check label on bottle to ensure it is free from
E6201
is not usable. any damage and is clearly in the RCU slot.
E6202
· ·
· ·
E6239
E6240
RCU bottle #1: Bottle barcode Barcode has already been used in this ana-
E6301
has already been assigned. lyzer. Use another bottle/barcode.
E6302
· ·
· ·
E6339
E6340
RCU bottle #1: Reagent code is Check reagent is registered under system
E6401
not registered. parameters.
RCU bottle #2: Reagent code is Check reagent is registered under system
E6402
not registered. parameters.
· ·
· ·
RCU bottle #39: Reagent code Check reagent is registered under system
E6439
is not registered. parameters.
230
Error
Message Action
code
RCU bottle #40: Reagent code Check reagent is registered under system
E6440
is not registered. parameters.
The process has been inter-
E6500 rupted due to mechanical inter- Contact technical support.
ference.
Check the halogen lamp. Perform automatic
Automatic gain adjustment
E6501 gain adjustment. If fault returns, contact
failed.
technical support.
Found maintenance parts due Check working hour counter for the parts on
E6502
exchange. Wash (F10) screen in Maintenance menu.
Existing order for a sample has The order received from host for a sample
E7001 been over written with order has already been registered. The order for
from host Sample. the sample is over written with new order.
Communication error occurred Communication error has occurred while
E7002 during order reception from inquiring order to host. Check connection to
host. host then retry order inquiry to host.
Communication error occurred Communication error has occurred while
E7003 during result transmission to sending results to host. Check connection to
host. host then retry result transmission to host.
Received order from host for tests without
enough reagent inventory for the following
Received order with short re-
E7004 sample number and method number. Take
agent received from host.
corrective action and inquire host for the or-
der.
Host has ordered tests for sample type
Sample number with invalid
other than normal and emergency. The order
E7005 character received from host
for the following sample has been deleted.
and discarded it.
Check at host for proper order.
Communication error has occurred while
sending results to host to memory allocation
Failed to allocate memory for error. Check for proper memory capacity and
E7006
result transmission. terminate any application running on the PC
then retry result transmission to host. If the
error repeats, re-booting of PC is required.
The host communication protocol may not
Host transmission retries time
E7007 be set correctly. Check the settings at sys-
over error.
tem parameter screen.
Communication error has occurred while
sending results to host due to memory al-
location error. Check for proper memory ca-
Failed to allocate memory for
E7008 pacity and terminate any application running
order acquire.
on the PC then retry result transmission to
host. If the error repeats, re-booting of PC is
required.
Sample number with invalid Received an order for following sample from
E7010 character received from host host but it has been deleted as the sample
and discarded. was not registered.
231
Error
Message Action
code
Failed to allocate memory while
E7011
acquiring QC data.
Failed to load serum indices file. The param-
Failed to read serum indices
E7030 eter setting file is either missing or corrupted.
setting file.
Contact technical support.
Received more than allowed maximum
Received more orders from host
E7051 (1,000) orders from host. Check with host for
than the analyzer can handle.
order transmission.
The lot number of reagents currently on RCU
No valid calibration curve for is different from the ones used to obtain cali-
E7075
reagent lots on RCU. bration curve. Check lot number of reagents
on RCU and perform calibration if necessary.
5.2.2 Unit Error

1) RPT rotation
Error
Message Action
code
Reagent pipette rotation sensor is on
E0102
after rotation.
Reagent pipette rotation sensor is on
E0103
before rotation. (while not at its origin)
Check RPT is free to move within its
Reagent pipette rotation sensor is off
E0104 normal operational range. Re-initialize
after returning to its origin.
analyzer. If fault returns contact techni-
Reagent pipette up sensor is off at cal support.
E0106
initiation of rotation command.
Reagent pipette up sensor is off at
E0156 initiation of rotation command. (while
not at trough or RCU position)
232
2) RPT up-and-down movement (origin: RPT upper limit)

Error
Message Action
code
Reagent pipette, up origin sensor, is
E0201
off before descent.
Reagent pipette, up origin sensor, is
E0202
still on after descent.
Reagent pipette, ascent to origin sen-
E0203
sor, is on before ascent.
Reagent pipette origin sensor is off at Check unit is free to move within its
E0204 the initiation of movement command. normal operational range. Re-initialize.
(from a position other than its origin) If fault returns contact technical sup-
Reagent pipette origin sensor is on at port.
E0205 the initiation of movement command.
(From a position other than its origin.)
IRU safety sensor is off at reagent
E0206
pipette movement command.
RPT ascend/descend; RPT safety
E0207
sensor (RPTR_TS) is off.
Reagent pipette up position sensor
E0251 is off at initiation of reagent pipette
downward command.
Reagent pipette up position sensor is
E0253 on at initiation of reagent pipette up- Check unit is free to move within its
ward command. normal operational range. Re-initialize.
Reagent pipette up sensor is on at ini- If fault returns contact technical sup-
tiation of reagent pipette up or down port.
E0255
command. (from a position other than
its origin)
RPT ascend/descend; RPT safety sen-
E0257
sor (RPTR_TS) is off. (RCU position)
Clean the pipette with ethanol. Check
that reagent pipette detection mecha-
nism is not jammed up (the pipette
Reagent pipette crash detection sen-
should move up and down freely).
E0275 sor is on before reagent pipette has
Move the pipette a few mm by hand,
reached the bottom of the RCU.
while holding the pipette arm. Re-ini-
tialize. If fault returns contact technical
support.
Reagent pipette cannot detect RCU
E0276
liquid level. Visually check liquid levels within the
Reagent pipette hardware is function- reagent bottles inside the RCU. Re-
E0278
ing abnormally. initialize the analyzer. If fault persists
RPT liquid level detection at RCU; contact technical support.
E0279
Liquid level is not detected.
Not enough wash solution left in the
Not enough wash solution for RPT reagent bottle. Retry the wash after
E0280
special wash. either adding the wash solution to the
bottle or exchange to a new bottle.
233
3) RPP (origin: upper limit of syringe)

Error
Message Action
code
Reagent syringe pump origin sensor is
E0301
off at initiation of aspiration command.
Reagent syringe pu mp origin sensor
E0302 is still on although syringe has left is
origin.
E0303
on before dispensation command.
Reagent syringe pump origin sensor
E0304 is still off although the reagent syringe
has returned its origin.
Check unit is free to move its normal
operational range. Re-initialize ana-
on at initiation of reagent pump move-
E0305 lyzer. If fault returns contact technical
ment. (While reagent syringe is not at
support.
its origin.)
E0351
off at initiation of aspiration command.
E0353 is on at initiation of dispensation com-
mand.
is on at initiation of reagent pump
E0355
movement. (While reagent syringe is
at trough or RCU position.)
4) SPT rotation

Error
Message Action
code
Sample pipette origin rotation sensor
E0402 is still on although the pipette has left
its origin.
E0403
is on before rotation to its origin.
Check unit is free to move its normal
operational range. Re-initialize ana-
E0404 is still off although the pipette has re-
lyzer. If fault returns contact technical
turned to its origin.
support.
Sample pipette up origin rotation sen-
E0406 sor is off at initiation of pipette rota-
tion command.
Sample pipette origin sensor is off at
E0456
initiation of pipette rotation command.
234
5) SPT up-and-down movement

Error
Message Action
code
Sample pipette up origin sensor is off
E0501 at initiation of pipette descent from
origin command.
Sample pipette up origin sensor is on
E0502
after pipette descent.
Sample pipette up sensor is on at ini-
E0503 tiation of pipette return to origin com-
mand.
SPT ascend to origin; SPTU origin
E0504 sensor (SPTU_ZERO) is off after as-
cend. (At initialization)
Sample pipette up origin sensor is on
E0505 at initiation of pipette movement. (The
pipette is not at its origin.) Check the unit is free to move within
its normal operational range. Re-ini-
The IRU safety sensor is off at initia-
E0506 tialize. If fault returns contact technical
tion of sample pipette movement.
support.
SPT ascend/descend; SPT safety
E0507
sensor (SPTR_TS) is off.
Sample pipette origin sensor is off at
E0551 initiation of pipette downward move-
ment.
Sample pipette origin sensor is on at
E0553
initiation of upward movement.
Sample pipette origin sensor is on at
E0555 initiation of pipette movement. (The
pipette is not at its origin.)
SPT ascend/ descend; SPT safety
E0557 sensor (SPTR_TS) is off. (ASP posi-
tion)
that reagent pipette detection mecha-
nism is not jammed up (the pipette
Sample pipette crash sensor is on but
E0575 the pipette is not at the bottom of the
ASP.
support.
Check sample level in ASP. If sample
Sample pipette cannot detect the liq- level is normal (the cup is not empty).
E0576
uid level at ASP. Re-initialize. If fault returns contact
technical support.
235
Error
Message Action
code
Clean the pipette with ethanol and
gently check free vertical movement of
Sample pipette crash sensor is on but
pipette. (There should be a few mm of
E0578 the pipette has not reached the bot-
movement up and down.) Re-initialize
tom of the cuvette.
the instrument. If fault returns contact
technical support giving detail.
Check for liquid in cuvette. Re-initialize
Sample pipette cannot detect the liq-
E0579 if fault persists contact technical sup-
uid level at IRU
port.
Check the sample levels in ASP if
sample levels are normal (the cup is
not empty) check for free vertical pi-
pette movement.
Sample pipette liquid level hardware is that reagent pipette detection mecha-
E0581
abnormal at ASP. nism is not jammed up (the pipette
support.
Check for liquid in cuvette. Re-initialize
Sample pipette liquid level hardware is
E0582 if fault persists contact technical sup-
abnormal at IRU.
port.
Check condition of sample in ASP if
SPT liquid level detection as ASP;
sample has air bubbles. Remove air
E0583 Liquid level not detected at duplicate
bubbles. Re-initialize. If fault returns
detection.
contact technical support.
236
6) SPP (origin: upper limit of syringe)

Error
Message Action
code
Sample syringe origin sensor is off at
E0601
initiation of aspiration instruction.
Sample syringe origin sensor is still on
E0602
after the syringe has left its origin.
Sample syringe origin sensor is on
E0603 before initiation of syringe movement
to discharge.
Sample syringe origin sensor is still off
E0604
after syringe has returned to its origin. Re-initialize analyzer. If fault returns
Sample syringe origin sensor is on at contact technical support.
E0605 initiation of syringe movement com-
mand. (The syringe is not at its origin.)
Sample syringe origin sensor is off
E0651 before aspiration. (At trough or ASP
position)
Sample syringe origin sensor is on
E0653 before dispensation. (At trough or ASP
position)
7) Mix-1 rotation

Error
Message Action
code
Check mixer is free to move within its
Mixer 1 origin sensor is on at initiation normal operational range. Re-initialize
E0706
of stirring paddle rotation. analyzer. If fault returns contact techni-
cal support.
8) Mix-1 up-and-down movement

Error
Message Action
code
Mixer 1 up origin sensor is off at initia-
E0801
tion of descent command.
Mixer 1 up origin sensor is still on al-
E0802
though mixer 1 has left its origin.
Mixer 1 up origin sensor is on at initia-
E0803
tion of return to origin command. Check the mixer is free to move within
Mixer 1 up origin sensor is still off its normal operational range. Re-ini-
E0804 although mixer 1 has returned to its tialize analyzer. If fault returns contact
origin. technical support.
At the initiation of movement the mix-
E0805 er 1 origin sensor is on although the
mixer is not at its origin point.
IRU safety sensor is off at initiation of
E0806
mixer 1 up movement.
237
9) Mix-2 rotation

Error
Message Action
code
Check the mixer is free to move within
Mixer 2 origin sensor is on at initiation its normal operational range. Re-ini-
E0906
of stirring paddle rotation command. tialize analyzer. If fault returns contact
technical support.
10) Mix-2 up-and-down movement

Error
Message Action
code
Mixer 2 up origin sensor is off at initia-
E1001
Mixer 2 up origin sensor is still on al-
E1002
though mixer 2 has left its origin.
Mixer 2 up origin sensor is off at initia- Check mixer is free to move within its
E1003
tion of return to origin command. normal operational range. Re-initialize
Mixer 2 up origin sensor is still off analyzer. If fault returns contact techni-
E1004 although mixer has returned to its cal support.
origin.
Check mixer and IRU are free to move
The IRU safety sensor is off at the within their normal operational range.
E1006
initiation of mixer 2 movement. Re-initialize analyzer. If fault returns
11) WU up-and-down movement

Error
Message Action
code
Wash unit origin sensor is off at initia-
E1101
Wash unit origin sensor is still on
E1102 although the wash unit has left its ori-
gin.
Wash unit origin sensor is on at initia-
E1103 tion of wash unit return to origin com- Check wash unit is free to move within
mand. its normal operational range. (Remove
Wash unit origin sensor is still off al- wash unit cover behind sample pi-
E1104 though the wash unit has returned to pette.) Re-initialize analyzer. If fault
its origin. returns contact technical support.
The IRU safety sensor is off at initia-
E1106 tion of wash unit movement com-
mand.
238
12) WPP (origin: upper limit of syringe)

Error
Message Action
code
WPP aspiration; WPP origin sensor
E1201
(WPP_ZERO) is off before aspiration.
Wash pump syringe origin sensor is
E1202 still on although the wash pump has
left its origin.
Wash pump syringe origin sensor is
on before initiation of wash pump
E1203
movement command. (from fully dis-
pensed position)
Wash pump syringe origin sensor is Re-initialize analyzer. If fault returns
on at initiation of wash pump move- contact technical support.
E1204
ment although the unit is not at its
origin.
WPP aspiration/dispensation at off-or-
E1205 igin; WPP origin sensor (WPP_ZERO)
is on.
WU over flow (WU_OVER=1) (During
E1206
Prime)
E1256 WU overflow during run.
E1276 WU over flow (WU_OVER=1)
13) IRU
Error
Message Action
code
IRU origin sensor is still on although
E1302
the IRU has left its origin. Re-initialize analyzer. If fault returns
IRU origin sensor is still on although contact technical support.
E1304
the IRU has returned its origin.
Sample pipette rotation origin sensor
E1306 is on at initiation of IRU rotation com- Check sample pipette is free to move
mand. within its normal operational range.
Reagent pipette rotation origin sensor Re-initialize analyzer. If fault returns
E1307 is on at initiation of IRU rotation com- contact technical support.
mand.
Check wash unit is free to move within
its normal operational range. (Remove
Wash unit origin sensor is off at initia-
E1308 wash unit cover behind sample pi-
tion of IRU rotation command.
pette.) Re-initialize analyzer. If fault
returns contact technical support.
Check reagent pipette is free to move
Reagent pipette vertical origin sensor within its normal operational range.
E1309 is off at initiation of IRU rotation com- (Remove wash unit cover behind sam-
mand. ple pipette.) Re-initialize analyzer. If
fault returns contact technical support.
239
Error
Message Action
code
Check sample pipette is free to move
Sample pipette vertical origin sensor
within its normal operational range.
E1310 is off at initiation of IRU rotation com-
Re-initialize analyzer. If fault returns
mand.
14) RCU
Error
Message Action
code
RCU sensor is on although the RCU
E1402
has left its origin.
RCU origin sensor is on at initiation of Check RCU is free to move within its
E1404
return to origin command. normal operational range. Re-initialize
Reagent pipette up origin sensor is off analyzer. If fault returns contact techni-
E1406
at initiation of RCU rotation command. cal support.
RCU origin sensor is still off although
E1454
the RCU has returned to its origin.
15) FLT
Error
Message Action
code
Filter wheel origin sensor is on al-
E1502 though the filter wheel has left its
origin. Re-initialize analyzer. If fault returns
Filter wheel origin sensor is off al- contact technical support.
E1504 though the filter wheel has returned to
its origin.
Perform a manual DTR gain check at
the maintenance performance screen.
Re-initialize the analyzer. If fault con-
E1508 Automatic gain settings are abnormal. tinues contact technical support giving
details as found at detector perfor-
mance monitor on maintenance per-
formance screen.
16) ASP
Error
Message Action
code
ASP rotation origin sensor is on al-
E1602
though the ASP has left its origin.
ASP rotation origin sensor is off al-
Check ASP is free to move within its
E1604 though the ASP has returned to its
normal operational range. Re-initialize
origin.
analyzer. If fault returns contact techni-
Sample pipette up origin sensor is off
E1606 cal support.
at initiation of ASP rotation command.
ASP origin sensor is off although the
E1654
ASP has returned to its origin.
240
18) ISE
Error
Message Action
code
E1775 ISE serum sample error Refer to “ISE Module Error Code”.
E1776 ISE urine sample error Refer to “ISE Module Error Code”.
ISE result measurement data is not
E1777 Refer to “ISE Module Error Code”.
available.
No acknowledge from ISE module for
E1780
“Electrode Exchange” command.
Possible broken communication or
E1781 poor contact at connectors. If fault
“Prime” command.
returns contact technical support.
E1782
“Cleaning” command.
18) Tank (During prime operation)

Error
Message Action
code
E2605 Wash solution 3 is low.
E2606 Purified water supply is low.
Refill tank and prime analyzer.
E2609 Waste tank 1 is full to capacity. Empty tank 1.
19) Tank (During running operation)

Error
Message Action
code
E2676 Purified water supply is low.
Refill tank and prime analyzer.
20) Cover and Waste liquid chamber

Error
Message Action
code
E2701 ASP lid is open. Secure ASP lid.
E2702 RCU lid is open. Secure ASP lid.
E2703 Waste chamber over flow Check liquid and waste levels. Perform
prime function twice. If fault returns
check the waste pump performance at
E2753 Waste chamber over flow
maintenance sequence screen. Con-
tact technical support with detail.
241
21) IRU and RCU

Error
Message Action
code
IRU temperatures lower than 37 - 2 Temperature of incubator (IRU) is
E3051
degree. watched during measurement if the
temperature is within 35 to 39 degree.
When the temperature is out of range,
this error is issued and sampling is
IRU temperature higher than 37 + 2
E3052 terminated. Watch the indication of
degree.
temperature of incubator in the moni-
tor screen during run. Contact techni-
cal support with detail.
During measurement, temperature of
RCU is watched and when RCU tem-
perature is higher than 15 degree, this
RCU temperature higher than 15 de-
E3053 error is issued and sampling is termi-
gree.
nated. Take care to treat the reagent
bottles in RCU. Contact technical sup-
port.
22) Barcode reader

Error
Message Action
code
Clean barcode window with ethanol
Reagent barcode reader; Initialization
E5001 and re-scan. If fault returns contact
error.
technical support.
Clean barcode window with ethanol
Sample barcode reader; Initialization
E5002 and re-scan. If fault returns contact
error.
technical support.
Sample barcode could not be read to
E5075 Check for barcode label.
character out of specification.
242
5.3 ISE Module Error Codes

Serum, Plasma and Urine
Byte 1 Byte 2 Byte 3 Byte 4 Byte 4
Out of Out of
Noise or
Noise or Range for Range
Air for Drift in
Air for Sample/ and/or Na
Sample/ Cal A
Cal A Cal B and Error for
Cal B
Urine Urine Only
No error 0 0 0 0
Na 1 1 1 1
K 2 2 2 2
Noise,
Drift or Na, K 3 3 3 3
out of Cl 4 4 4 4
range Na, Cl 5 5 5 5
K, Cl 6 6 6 6
Na, K, Cl 7 7 7 7
Air S A - - S: Sample
B - - - A/B: Cal-A/B
SPT liquid detection
9 9 9 7
error.
SPT movement is
9 9 9 8
wrong.
Communication er-
ror occurs between 9 9 9 9
ISE and analyzer.
Urine Only
Byte 1 Byte 2 Byte 3 Byte 4 Byte 4
Na urine error
No error 0 0 0 0 K only, no out of
range error
Na 1 1 1 1 L
K 2 2 2 2 M
Noise, Na, K 3 3 3 3 N Na Urine er-
Drift of
Cl 4 4 4 4 O ror and out of
out of
Na, Cl 5 5 5 5 P range error
range
K, Cl 6 6 6 6 Q
Na, K, Cl 7 7 7 7 R
SPT liquid detection
9 9 9 7
error.
SPT movement is
9 9 9 8
wrong.
Communication er-
ror occurs between 9 9 9 9
ISE and analyzer.
243
E9997: SPT liquid detection error. E9997 will appear when error is detected at ASP.
When this error occurs, the global menu button [Alarm (F4)] at the bottom of
the screen flashes in the red colour. The following error/errors can be find when
the [F4] key is pressed.
E-code Alarm message Meaning
Sample pipette crash sensor is on
If there is no remaining sample when sam-
E0575 but the pipette is not at the bot-
ple cup is used, this error will appear.
tom of ASP.
Sample pipette cannot detect the If there is no remaining sample when sam-
E0576
liquid level at ASP. ple cup is not used, this error will appear.
It is not detected not only liquid level but
Sample pipette liquid level hard-
E0581 also sample pipette crash sensing after
ware is abnormal at ASP.
moving down the sample pipette (SPT).
SPT liquid level detection at ASP;
It shows the remaining sample volume in
E0583 Liquid level not detected at dupli-
the cup or tube may be shortage.
cate detection.
E9998: SPT movement is wrong. E9998 will appear at the time when error is detected
at SPT trough or ASP or ISE sample port.
When this error occurs, the global menu button [Alarm (F4)] at the bottom of
the screen flashes in the red colour. The following error/errors can be find when
the [F4] key is pressed.
ISE sample is not diluted.
Sample pipette origin sensor is SPT cannot start the rotating because
E0456 off at initiation of pipette rotation sample pipette is not at upper limit posi-
command. tion.
SPT cannot start the descending at ASP
E0507 because sample pipette is not at the prop-
sensor (SPYR_TS) is off.
er position.
Sample pipette up origin sensor SPT cannot start the descending at ASP
E0501 is off at initiation of pipette de- because sample pipette is not at upper
scent from origin command. limit position.
Sample pipette up sensor is on at Since SPT upper origin sensor shows its
E0503 initiation of pipette return to origin position at the origin, sample pipette can-
command. not return to upper origin.
ISE sample is diluted.
Sample pipette origin sensor is SPT cannot start the rotating because
E0456 off at initiation of pipette rotation sample pipette is not at upper limit posi-
command. tion.
Since SPT rotation sensor shows its po-
Sample pipette origin rotation
sition at the origin, SPT cannot start the
E0403 sensor is on before rotation to its
rotating to the cuvette at IRU (SPTR origin
origin.
position).
SPT cannot start the descending at ISE
E0507 sample port because sample pipette is not
sensor (SPYR_TS) is off.
at proper position.
244
SPT cannot start the descending into the

cuvette at IRU because sample pipette is
Sample pipette up origin sensor
not at upper limit position.
E0501 is off at initiation of pipette de-
SPT cannot start the descending at ASP
scent from origin command.
because sample pipette is not at upper
limit position.
Since SPT upper origin sensor shows its
Sample pipette up sensor is on at
position at the origin, sample pipette can-
E0503 initiation of pipette return to origin
not return to upper origin. (At IRU or ISE
command.
sample port)
E9999: Communication error between ISE and analyzer.

The analyzer did not receive the acknowledgment from ISE module within the
time.
5.3.1 Troubleshooting of ISE

Symptom Problem Action
Check the electrode.
Misalignment of Electrode Remove and replace electrode to
Calibration value is
re-seat.
low;
Na or K < 45 Deterioration of calibrator Replace Cali-B first and retest, if still
Cl < 35 solutions low, replace Cal-A and retest.
Deterioration of Electrode Replace problem electrode and test.
or
Air bubble on Reference Remove electrode, tap to dislodge
Calibration value is electrode membrane bubble, replace, and recalibrate.
high; Deterioration of Reference Replace reference electrode and
Na or K > 63 electrode retest.
Cl > 60
Interaction between sens-
Replace Cl electrode only and retest.
ing Electrodes
Deterioration of sensing Replace problem sensor (electrode)
Electrode and test.
Noise error flag; a) Check for electrical noise coinci-
Single electrode Electrical noise spike from dent with activation.
environmental source b) Component failure on module
board. Replace board.
Deterioration of sensing Replace reference electrode and
Electrode retest.
Noise error flag; a) Check for electrical noise coinci-
Multiple electrodes Electrical noise spike from dent with activation.
environmental source b) Component failure on module
board. Replace board.
Deterioration of sensing Replace problem sensor (electrode)
Electrode and test.
Purge the Cal-A (ISE Prime) and
Drift error flag; Occur when new sensor
recalibrate the module. If the sensor
Single electrode (electrode) or new bottle
(electrode) is new it may initially drift
of Cal- A is installed on
as it dehydrates over the course of
system.
15 minutes.
245
Symptom Problem Action

Deterioration of Reference Replace reference electrode and
Electrode retest.
a) Check for electrical noise coinci-
Electrical noise spike from dent with activation.
Drift error flag; environmental source b) Component failure on module
Multiple electrode board. Replace board.
Occur when new sensor
(electrode) or new bottle Purge the Cal-A (ISE Prime) and
of Cal- A is installed on recalibrate the module.
system.
Insufficient sample/Cal-B Operator must place sufficient sam-
pipetted into ISE sample ple/Cal-B in sample cup to account
Air flag; port. for all test programmed.
Sample/Cal-B a) Pumps not operated normally.
Sample/Cal-B not run
b) Pump tubing obstructed or tubing
properly to the electrode
length is excessive.
Replace Cal-A bottle with a new one,
Cal-A bottle is empty.
purge (ISE Prime) and recalibrate.
Tubing of Cal-A is discon-
Reconnect tubing.
nected.
Air flag;
a) Check electrical connectors.
Cal-A Cal-A pump is not work-
b) Replace pump cassette.
ing properly.
c) Replace motor.
Tubing is plugged, split or
Replace tubing.
crimped.
a) Sensors (electrodes) are not prop-
erly compressed. Check com-
Air in Cal-B and Cal-B and Cal-A are seg-
pression plate, spring and seal.
Air in Cal-A mented with air.
b) Ensure that all sensors and O-
rings are in place.
RS232 cable is discon-
Error code - 9999 Reconnect or replace cable.
nected or damaged.
(It has been impos-
Module connector has
sible to make com- Replace board.
been damaged.
munication between
ISE and Analyzer.) Component failure on
Replace board.
board.
246
Appendix
Appendix
Consists of:
Appendix A PC software upgrading procedure
Appendix B Supplement ISE
247
Appendix
Appendix A
PC Software Upgrading Procedure
PC software upgrading procedure for the Clinical Chemistry Analyzer unit is explained
here.
1. Backup of System Parameters

As for the backup procedure, refer to “Operator’s Manual” (3.6.3 Backup Operation).
(1) Start the analyzer system.
(2) Click on [System Parameters] of the job menu.
(3) Click on [Backup (F10)] of the function menu.
(4) Insert the floppy disk into the drive.
If the inserted floppy disk is unformatted, click on the [Format] button of “Format FD”.
(5) Click on the [Save] button of “Save mechanical Values to FD”.
(6) Click on the [Save] button of “Save user parameters to FD”.
(7) Click on the [Save] button of “Save Data” at the data backup block.
2. Terminate all programs on the PC.

For the User-interface Program, terminate it as follows:
(1) While holding down the [Ctrl] key, press the [.](Period) key. Soon the following buttons
are displayed:
"Sleep”
“Power Off”
“Cancel”
(2) Click on the [Power Off] button and wait until the Windows desktop reappears.
3. User-interface Software Upgrade (on Windows XP)

A. Deinstallation of Old User-interface Program
(1) On the Windows desktop, start "ADD/REMOVE PROGRAMS" as follows:
1 Click on the [Start] button.
2 Select "Setting".
3 Click on "Control Panel".
4 Double-click on "Add/Remove Programs", and soon its window opens.
(2) Click on “Analyzer” on the selection box, and then click on the [Add/Remove] button.
In a while the installer/uninstaller "Install Shield Wizard" starts up.
(3) Click on the [Next>] button, and the "Program Maintenance" screen appears.
(4) Select the "Remove" radio button, then click on the [Next>] button. Soon, the "Remove
the Program" screen appears.
(5) Click on the [Remove] button. After a bar graph is displayed, "Install Shield Wizard
Completed" is displayed.
(6) Click on the [Finish] button, and the Windows desktop reappears.
(7) Proceed to B (1) below.
248
Appendix
B. Installation of New User-interface Program

(1) Insert the New Software CD into the drive, and soon the following message reads au-
tomatically:
"Welcome to the Install Shield Wizard …"
(2) Click on the [Next>] button, and the "Customer Information" screen appears.
(3) Fill out the blanks as follows:
User Name: [Analyzer]
Organization: [FEC]
NOTE: Type "Analyzer" and "FEC" as shown above. Do not change the case of let-
ters.
(4) Click on the [Next>] button, and "Destination Folder" appears.

(5) Click on the [Next>] button, and "Ready to Install the Program" appears.
(6) Click on the [Install] button, and a bar graph is displayed. Wait until "Install Shield Wiz-
ard Completed" appears.
(7) Click on the [Finish] button, and the Windows NT desktop reappears.
(8) Proceed to C (1) below.
C. Restoration of System Parameters

(1) Start the newly-installed User-interface Program.
([Start] -> "Programs" -> "analyzer" -> "analyzer“)
(2) Click on the [System Parameters] tab of the job menu, and the "System Parameters"
screen appears.
(3) Click on the [Backup (F10)] tab of the function menu.
(4) Insert the saved floppy disk (you made this in "1. Backup of System Parameters") into
the drive.
(5) Click on the [Load] button of “Load Parameters.
The saved mechanical parameters and user parameters are reloaded into the current suit-
able areas.
(6) Click on the [Load] button of “Load Data” at the data backup block.
All data saved into the HD are reloaded to the current suitable areas.
Note: this function becomes valid when data have been saved by the one previous
version’s software of PC or this new version’s software.
(7) Terminate the User-interface Program as follows:

1 While holding down the [Ctrl] key, press the [.](Period) key. Soon the following buttons
are displayed:
“Sleep”
“Power Off”
“Cancel”
2 Click on the [Power Off] button and wait until the Windows desktop reappears.
(8) Proceed to D (1) below.
D. Final Check
(1) Perform the power shut-down procedure on the PC and main analyzer.
(2) Turn on the Clinical Chemistry Analyzer.
(3) Turn the PC on again, and start the Windows.
249
Appendix
(4) Start the User-interface Program.

([Start] -> "Programs" -> "analyzer" -> "analyzer“)
(5) Click on the [System Parameters] tab of job menu, and then click on the [System (F9)]
button of function menu.
(6) make sure that the new PC version number (printed on the CD label) is displayed on the
upper-right portion of the screen as shown in the following example:
Program Version
Main: 25501641xx
Sub: 25501651xx
PC: 25501631xx
<PC PROGRAM VERSION NUMBER PRESENTATION>
NOTE: 2-digit number “xx” indicates a program version number.
(7) Click on the [Maintenance] tab of job menu.

(8) Click on the [Sequence (F9)] button of function menu, and the "Mechanical Mainte-
nance" screen appears.
(9) Click on the [Start] button for "Initialization", and make sure that the operation is per-
formed properly.
250
Appendix
Appendix-B
Supplement of ISE unit
Table of Contents
General notation of ISE.................................................................................................. 252
1. General Description.................................................................................................... 253
1-1 Parts Location.......................................................................................................... 253
1-2 Solutions.................................................................................................................. 254
1-3 Solution life: Storage life and Use life...................................................................... 254
1-4 Storage and Usage of the Reagents........................................................................ 254
1-5 When turning off the power..................................................................................... 255
1-6 Shutdown Procedure: Preparing the ISE module for storage.................................. 255
1-7 Exchanging Calibrant-A bag.................................................................................... 255
1-8 Exchanging electrodes............................................................................................ 257
1-9 Exchanging Pump Cassettes................................................................................... 258
2. ISE Calibration............................................................................................................ 260

2-1 Procedure for ISE calibration................................................................................... 260
3. ISE Cleaning............................................................................................................... 262

3-1 Procedure for the ISE cleaning................................................................................ 262
4. Error flag..................................................................................................................... 263
5. Trouble shooting......................................................................................................... 264
251
Appendix
General notation of ISE

1. Electrodes are marked with an “INSTALL BY date”.
If the electrode is installed in the ISE unit by that day, the electrode is warranted on a
prorated basis for up to 10,000 samples or 6 months, whichever comes first.
2. Electrodes require Calibrant-A to be flushed at 30 minutes interval for stable measure-

ment. Therefore, the analyzer should be kept to “Sleep” mode even if the analyzer is not
in use.
3. When turning off the power of the analyzer, perform purge at the procedure described
below. Leaving the fluid in the path with power turned off results in potassium measure-
ment drift. Perform the purge by using “Electrode Exchange” command in [Wash (F10),
Page 1/2] at [Maintenance] menu.
4. It is recommended to perform 2-point calibration of the ISE module is required at least

once a day prior to running the first sample of the day.
Also, at the end of the day when running more than 50 samples a day, ISE cleaning is
required.
5. It is expected to perform the ISE cleaning at the end of the day when the ISE unit per-
forms more than 50 samples per day by using wash solution to prevent protein build-
up.
But do not over clean the electrode as certain amount of protein on electrode con-
tributes to stable measurement. Please be aware that wash solution effects electrode
performance and may require several hours to recover. Therefore, it is recommended to
perform the wash at the end of the day and leave the analyzer at “Sleep” mode.
6. Swirl Calibrant-A bottle daily to prevent growth of dewdrop in the bottle.
7. When only sodium (Na) value at ISE calibration is high, probably a bubble in the fluid
has effected the measurement.
Perform “ISE Prime” three times from [Sequence (F9)] at [Maintenance] menu to take
away the bubbles. Perform calibration and prime three more times if symptom stays.
8. The acceptable variation of calibration results between two consecutive calibration

measurements is within 2.0.
9. Calibrant-A, B and cleaning solution should be stored in a dark and cool place at room
temperature.
252
Appendix
1. General Description

ISE (Electrolyte Measurement System) is placed at right side of the chemistry analyzer,
and it measures the concentration of Na, K and Cl of serum, plasma or diluted urine with
the ion electrodes.
The ISE unit consists of ISE module, ion electrode and two pumps, for supply and waste.
ISE module This module consists of electrodes (Na, K, Cl and Reference) and pumps.
Measurement of concentration is done at electrodes and rinses/calibrates
after every measurement.
Communication to the analyzer is carried out through RS232C.
Ion electrode This unit consists of Na, K, Cl and Reference electrodes.
Supply pump This pump supplies Calibrant-A into ISE module.
Waste pump This pump drains liquid in ISE module.
All waste liquid are discharged into the external tank for high concentration waste liquid.
1-1 Parts Location
Sample port
Ion electrodes
(Na, K, Cl, Ref from top
Supply and waste pump
Calibrant-A bag
253
Appendix
1-2 Solutions
Calibrant-A: Used as wash solution and single point calibrator.
The single point calibration is carried out at the same time when Cal-
ibrant-A is dispensed to wash the electrodes every time the sample
measurement is performed.
120μL of Calibrant-A are automatically dispensed into the ISU unit ev-
ery 30 minutes to prevent the electrodes from drying.
Calibrant-A is pumped into the sample port by supply pump.
The dedicated bottle for Calibrant-A is placed beside the ISE unit.
Calibrant-B: Used as the two-point calibrator.

Calibrant-B is aspirated from a sample cup on the ASP (Slot #18) at
least once a day or every 8 hours. The cup with a volume of 500μL is
placed at No.18 position of ASP just before use to prevent a change in
values from evaporation.
(See the section “2 ISE Calibration”.)
Cleaning solution: Should be run once a day to prevent protein build-up or at 8 hours
intervals if the ISE measurement is performed greater than 50 samples
per day and when measurement of control is effected.
Cleaning solution is aspirated from sample cup with 600 µL that is
placed at No.18 position of ASP.
After cleaning processing, the analyzer should be left at standby for 30
minutes before any measurement to stabilize the membrane of elec-
trode. While at standby, perform prime more than 5 times.
The cleaning can be done at, [Sequence (F9)] - [Maintenance].
(See the section “3 ISE Cleaning” for detail.)
Urine Diluent: This is used to dilute urine sample. Urine sample must be diluted by a
factor of 10 to perform urine measurement.
Put a reagent bottle with urine diluent in RCU. A volume of 315μL is
necessary for diluting one sample. The dilution is carried out using a
cuvette in IRU. Therefore one cycle for analysis sequence is allocated
to the process.
The code of diluent should be pre-registered in the [System (F9)] - [Sys-
tem Parameters].
1-3 Solution life: Storage life and Use life

A reagent shelf life is defined by the expiration date printed on the solution label and the
solutions should not be used after the date. The shelf life is good in an unopened bottle.
Once the bottle is opened, use them within short period and do not attempt to store
opened bottle. Discard the contents when the expiration date is due. Using a solution past
expiration date will result in poor measurement performance.
1-4 Storage and Usage of the Reagents

(1) Store all solutions in a dark and cool place at room temperature.
Don't preserve the reagents such as Calibrant-B or cleaning solution once they are dis-
pensed to sample cup.
254
Appendix
(2) Don't use the expired solution.

(3) When opening new bottle for a solution, don't mix remaining solution from the previous
bottle.
(4) Calibrant-A has one month of on board stability.
Having the bottle more than one month requires swirling the bottle every day to assure
homogeneity of the solution.
(5) Dispense Calibrant-B into a sample cup just before ISE calibration to avoid evapora-
tion.
1-5 When turning off the power

As Calibrant-A is automatically dispensed into ISE unit every 30 minutes to prevent elec-
trodes from drying out; it is not recommended to turn off the power of analyzer. After using
the analyzer for the day, put it to sleep. This will keep the above function activated.
When Calibrant-A remains in fluid path for over two hours without flowing, the Na ion from
reference electrode can reach Na electrode and saturate the membrane resulting in ef-
fected Na measurement.
When the power to the analyzer needs to be turned off for a reason such as maintenance,
follow the procedure below to purge Calibrant solution in the path. Also refer to the pro-
cedure when turning off the power for more than several hours, as it requires storage of
the electrodes.
1-6 Shutdown Procedure: Preparing the ISE module for storage

(1) Unscrew the bottle cap for Calibrant-A.
(2) Prime ISE more than 10 times.
(Function menu [Sequence (F9)] of job menu [maintenance])
(3) Remove all electrodes from ISE unit. (See “1-8 Procedure for exchanging the elec-
trode”.)
(a) Na, Cl electrodes
Place the Reference, Na and Cl electrodes into individual sealed bags.
(b) K electrode
Inject Calibrant-A into the lumen of K electrode until fluid fills the lumen.
Cover both ends of the lumen (both side of the K electrode) with cellophane tape to hold
the Calibrant-A in place. Insert the K electrode into a sealed bag.
(4) Remove the Calibrant-A from the analyzer and discard it.
1-7 Exchanging Calibrant-A

Follow the procedure below to exchange the Calibrant-A bottle.
(1) Remove ISE cover on the upper-right side of the analyzer by loosening a M3 screw and
pulling the plastic clip.
(2) Pull out the liquid supply tube from the short thick tube that is added to the tip of bag.
255
Appendix
(3) Pull out the short thick tube from Calibrant-A case and keep it for reusing.
(4) Discard the useless Calibrant-A bag.
(5) Prepare the new Calibrant-A bag, and put it into the bag fitting place.
(6) Remove the red tube cap from the bag. Take care not to spout the liquid from bag.
(7) Reconnect the liquid supply tube and the short thick tube, and plunge it to the Cali-
brant-A bag.
(8) Reset the working hour counter for Calibrant-A at the function menu [Wash (F10), Page:
1/2] of the job menu [Maintenance].
Note: Don’t mix Calibrant-A solution from old bottle with the new bottle.
After exchanging Calibrant-A, perform ISE priming more than 10 times.
If any water drop is found in the back of Calibrant-A bottle cap, wiped out
with clean gauze.
256
Appendix
1-8 Exchanging electrodes

Electrodes are marked with an “Install-by date”. If the electrode is installed in ISE unit by
that date, the electrodes can be used for up to 10,000 samples or 180 days (6 months),
whichever occurs first.
Follow the procedure below to exchange electrodes.
(1) Before removing electrodes, it is necessary to perform “Electrode Exchange” in order
to purge all fluid from the fluid path.
Select the function menu [Wash (F10), Page: 1/2] from [Maintenance].
Click on the [Start] button at the following pup-up screen.
(2) Click on the [OK] button at the following pop-up screen.
(3) The following pop-up screen is displayed until the analyzer is ready for electrode ex-
change.
(4) The following pop-up screen is displayed when the analyzer is ready for electrode ex-
change.
257
Appendix
(3) Clicked on the [Shut³down] button.

When PC has been shut down, turn off the power to the analyzer.
(4) Exchange the electrodes.
a) Remove ISE cover by loosing the two screws (M3) and pulling two plastic clips at the
right side of analyzer.
b) Pull the knob at ISE unit and swing out to gain access to the electrodes.
c) Press down and hold the compression plate (blue resign) while pulling the electrode
handle out with your fingers to release the electrode.
d) Insert the new electrode in position while pressing down the compression plate.
(5) Turn on the power of analyzer and PC.

(6) When the electrodes are exchanged to new ones, reset the working hour counter of the
electrodes at function menu [Wash (F10), Page: 1/2] of the job menu [Maintenance].
(7) Perform “ISE Prime” more than 10 times from the function menu [Sequence (F9)] of the
job menu [Maintenance]. Leave the analyzer for 15 minutes or more to settle the solution
in each electrode before measurement.
Note: Confirm that “O” ling is fitted firmly between each electrode.
Remove a brown tube stuck in electrode, if it exists.
Prime the ISE several times when a measurement result could not be ob-
tained properly after installing new electrodes.
1-9 Exchanging Pump Cassettes

Periodical exchanging the pump cassettes are needed to maintain ISE measurement
properly.
The working time to know the replacement timing of the pump cassette is shown at the
function menu [Wash (F10)] of the job menu [Maintenance].
(1) Detach bottle cap of Calibrant-A and prime ISE more than 5 times to purge the liquid
from the flow path.
258
Appendix
(2) Click on “Shut down” to terminate the analyzers software on PC and then turn the
power analyzer off.
(3) Remove the right side cover of analyzer and swing out ISE unit.
(4) Pull out two tubes of pump cassette from the connection parts.
(5) Release the pump cassette from the motor shaft by pressing two hooks at both side of
pump cassette with fingers. (See the following drawings.)
Don’t remove the metal pipe from this tube.
Motor shaft
Push this Push this

hook. hook.
In order to release the pump cassette, nip the

Pump cassette both side of hooks by fingers as above drawing.
In order to fit the pump cassette, push it toward
shaft while nipping the both side hooks by fingers.
(6) Replace the pump cassette.

When replacing, replace both cassettes at the same time.
Beware that there is no markings on the tubes for the cassette. Exchange the cassette
carefully not to make wrong tube connection.
259
Appendix
Tube marker
1: Output of the supply
pump
Waste pump (This line is connected
to the sample port of
Supply pump ISE unit.)
2: Input of the supply
pump.
(This line is connected
to the bottle of Cali-
brant-A.)
4
3 3: Output of the drain
pump.
2 (This line is connected
1 to the external drain
tank.)
4: Input of the drain
pump.
(This line is connected
to the termination port
of ISE unit.)
(7) Attach the bottle cap for Calibrant-A bottle and turn on the power for analyzer.
Then prime the ISE more than 10 times.
(During the ISE priming, check whether the fluid flows correctly into the each tube and the
liquid leaking is not occurred at tube connection.)
After confirming that ISE is properly functioning, attach side covers.
(8) Reset the working hour of pump cassette at function menu [Wash (F10), Page: 1/2] of
the job menu [Maintenance].
2. ISE Calibration

It is mandatory to perform calibration (two points) before ISE measurement. It is recom-
mended to make it a routine operation to run calibration before running first sample of the
day.
One point calibration is automatically performed at each sample processing by Calibrant-
A and Calibrant-B is used for two-point calibration.
The calibration is required at the following cases;
(1) The power switch of analyzer is turned off.
(2) Eight hours have passed since the last ISE calibration.
(3) Environmental temperature has changed more than 4 degrees C since the last ISE
calibration.
2-1 Procedure for ISE calibration

Perform the ISE calibration from function menu [Sequence (F9)] at the job menu [Mainte-
nance].
(1) Prime the analyzer at least once, twice preferable prior to ISE calibration.
(2) Prime ISE more than 3 times.
(3) Put 500 µL of Calibrant-B into a sample cup, and place it at ASP position 18.
Click on the [Start] button at the pop-up screen shown below.
260
Appendix
(4) Click on the [OK] button at the pop-up screen shown below.
(5) The following at the pop-up screen will be displayed while ISE calibration is made.
(6) At completing of ISE calibration, the above message window will be closed.
The result of calibration will be shown on the function menu [ISE (F10)] of the job menu
[System Parameters] and ISE calibration results will be printed when printer output is set
to “Enable”.
ISE calibration results are

outputted in this area
Once the calibration results are with in the acceptance limit as shown below, repeat the
steps (3) to (6) again. Check the calibration results stays within 2.0 in the two consecutive
measurements.
261
Appendix
If not, prime ISE unit twice and run calibration again then compare the calibration results.
Repeat as necessary.
Acceptable limits of ISE calibration results
Na 50-66
K 50-63
Cl 40-59
3. ISE Cleaning

Use ISE cleaning solution for ISE cleaning and it should be performed once a day to
prevent protein build-up or at 8 hours intervals if the ISE unit performs greater than 50
samples per day and measurement of standards are affected.
The cleaning solution effects electrode performance and it takes about 30 minutes for it to
be recovered. After the cleaning, it is required to perform ISE priming more than 5 times
and wait 30 minutes or more to ensure the measurement performance. It is recommended
to perform ISE cleaning at the end of the day in order to minimize protein build-up in the
fluid line and to save analyzer from down time.
3-1 Procedure for the ISE cleaning

(1) Put 600 µL of the cleaning solution into the sample cup, and place it at ASP position
#19.
Click on the [ISE³Cleaning] button as shown below.
(2) Pop-up window confirming the cleaning will be displayed as below.
Click on the [OK] button to start cleaning.
(3) The following at the pop-up screen will be displayed while ISE cleaning is made.
262
Appendix
(4) At completing of ISE cleaning, the above message window will be closed.
4. Error flag

Byte1 Byte2 Byte3 Byte4 Byte4
Noise or Out of
Noise
Measure- Air for Drift in Range for
Cause or Air
ment Item Sample Cali- Sample of
for Cali-
or Cali- brant-A Calibrant-
brant-A
brant-B B or Urine
No error 0 0 0 0
Na 1 1 1 1
K 2 2 2 2
Noise, Drift
Na, K 3 3 3 3
or Out of
Cl 4 4 4 4
Range
Na, Cl 5 5 5 5
K, CL 6 6 6 6
Na, K, Cl 7 7 7 7
S or B A
Air – –
(Note-1) (Note-1)
No
out of
No error 0 0 0 0 K
range
error
Noise, Drift Na 1 1 1 1 L
or Out of K 2 2 2 2 M
Range
Na, K 3 3 3 3 N Out of
(Urine)
Cl 4 4 4 4 O range
Na, Cl 5 5 5 5 P error
K, CL 6 6 6 6 Q
Na, K, Cl 7 7 7 7 R
SPT liquid detection error 9 9 9 7
SPT malfunction 9 9 9 8
Communication error 9 9 9 9
Note-1: “S” means sample.

“A” means Calibrant-A.
“B” means Calibrant-B
Note-2: When there is only a Na urine error and no out of range error, the error
code is “K”.
263
Appendix
5. Trouble shooting

Error Cause Action
Out of Swirl Calibrant-A bottle to assure homogeneity of the
range solution.
Stability of Calibrant-
The onboard stability of Calibrant-A is one month.
A
When the Calibrant-A is on the analyzer for more than
one month, it requires swirling.
Calibrant-B must be kept in a dark and cool place at
room temperature.
Stability and storage If the Calibrant-B is expired, it should be replaced with
of Calibrant-B new one. Calibrant-B should be pipette into a sample
cup on the analyzer just before the performing of cali-
bration to avoid the evaporation.
Check that the Electrodes are within expiry date and
total measurement count is less than 10,000 samples.
Validity of Electrode
If they are expired, the Electrodes must be replaced
with new ones.
Check that the Electrodes are properly installed into
Fitting of Electrode the ISE module without any fluid leaking from tubing
connectors and between electrodes.
Environment tem- Check that the environmental temperature is within 15
perature to 30 degrees centigrade.
After ISE cleaning, it requires about 30 minutes for
Cleaning
electrodes to recover to stable measuring condition.
Noise Check that Electrodes are not expired and total mea-
surement count is less than 10,000 samples.
with new ones.
the ISE module without any fluid leaking from tubing
Fitting of Electrode
connectors and between electrodes. Also check for
crystallization in the path.
Check that the electrical noise spike from environmen-
tal source (such as refrigerator and centrifuge) is not
Surrounding equip- affected.
ments Check for ground condition.
The power source should be separated from other
equipments.
Drift Prime ISE several times.
Just after electrode
Leave the analyzer for 15 minutes or more without any
exchange
operation until settling the solution in each electrode.
After ISE cleaning, it requires about 30 minutes for
Caused by cleaning
electrodes to recover to stable measuring condition.
Check that Electrodes are not expired and total mea-
surement count is less than 10,000 samples.
with new ones.
Fitting of Electrode
264
Appendix
Error Cause Action

Exchanging Cali-
Prime ISE to purge the remaining air in the fluid path.
brant-A bottle
Check for viscosity of sample.
When the viscosity of sample is abnormally high such
Glutinous of Sample.
as hyperproteinemia sample, the “Drift error” may oc-
cur.
When the sample tube is not anti-coagulator (heparin)
type, the measurement should be performed after
Caused by Fibrin. leaving the sample for 30 minutes to settle the fibrin
down. Measurement can be interfered when fibrin is
pipette into ISE unit.
Check for the bent, twisted and loose connection of
Tubing
ISE unit tubing. Correct if any.
Air Prime the analyzer and try ISE measurement again.
Caused by air in the
When air exists in the sampling line, it can be intro-
SPT.
duced to ISE unit resulting in measurement error.
Shortage of Cali-
Exchange Calibrant-A bottle to a new one.
brant-A.
Check for tubing condition.
Or the tip of supply
Prime ISE more than 10 times, and try measurement
tube is placed above
again.
the liquid level.
Shortage of Cali- Pour 500 uL of Calibrant-B in a fresh sample cup and
brant-B. run calibration again.
Air bubbles in Cali- Pour 500 uL of Calibrant-B in a fresh sample cup and
brant-B. run calibration again.
Add sample to a sample cup and try again the mea-
Shortage of Sample
surement.
Air bubbles in a
Get rid of air from the sample.
sample.
Check for the working hour counter on the job menu
Abnormal movement
[Maintenance]. When the working hour of pump cas-
of pump (Supply or
sette exceeds the use period (180 days), exchange the
Waste pump.)
supply and drain pump with new pumps.
Check for the bent, twisted and loose connection of
Tubing
ISE unit tubing. Correct if any.
Poor connection of
Electrode
Check for displaced compression plate spring.
Check for proper fitting of “O”-ring between elec-
Bad of “O”-ling of trodes.
Electrode When “O”-ring has some defect or is deformed, ex-
changed with new “O”-ring.
Check for misalignment of Electrodes, movement of
Occurring ISE com- supply or waste pump and tubing connection.
9999 or munication error Check for a dirty of sample port at the top of ISE unit.
others between analyzer Prime ISE and prime analyzer.
and ISE module. When above does not solve the situation, call for ser-
vice.
265
Appendix
Trouble shooting guidance of ISE

Category Symptom Possible Cause Measures Remarks
Drift (Multi analytes); Misalignment of Take out all of elec-
The calibration electrodes. trodes and reinstall
slopes for all ana- them to the proper
lytes shift little by position.
little and finally one Cal-A concentrated Replace Cal-A. Cal-A con-
of them shifts out of due to evaporation. tainer will be
the normal range. changed from
tank to bag
In many cases, the type.
slopes for sodium
and chloride shift in Cal-B concentrated Replace Cal-B.
the same direction due to evaporation.
but the slope for Defective reference Replace reference
potassium shifts in electrode. electrode.
the opposite direc- Contaminated elec- Perform the clean-
tion from sodium and trode. ing procedure using
chloride. specified cleaning
solution.
Poor grounding. Improve grounding
Unstable calibration Dirt on the sample Wipe out the dirt
(Single analyte); port. with moist paper or
All of the slopes cotton swab.
move suddenly and Cal-B left on ASP Put Cal-B on ASP
one of the slopes be- tray too long. tray just before
comes out of range. calibration.
(Associated error
code 00X0 or 000X.) Insufficient flow Replace pump unit Minimum flow
Other slopes are rate for Cal-A or with enough flow rate for Cal-A
often in the range. waste pump. rate pump: 140μL/
sec
In many cases, the Liquid leakage to Replace bubble
Calibration
slopes for sodium the bubble detec- detector.
and chloride shift in tor.
the same direction Expiration of the Replace pump cas- Minimum flow
but the slope for pump cassette sette. rate for Cal-A
potassium shifts in for Cal-A or waste pump: 140μL/
the opposite direc- pumps. sec
tion from sodium and Use of not recom- Use only recom-
chloride. mended solution. mended cleaning
solution.
Misalignment of Detach all elec-
electrode. trodes and align
them to the proper
position.
Defective reference Replace reference
electrode. electrode.
Contaminated elec- Perform the clean-
trode. ing procedure with
cleaning solution.
Insufficient priming Perform additional
for ISE. ISE priming.
Leakey SPP sy- Replace SPP sy-
ringe tip. ringe tip.
Drift & unstable Defective elec- Replace electrode.
calibration (Single trode.
analyte); Expired electrode. Replace electrode.
One slope moves
sharply and the oth-
ers are stable.
266
Appendix
Category Symptom Possible Cause Measures Remarks

QC & Sample Shifting of result; Sample diluted in Apply a correction
measurement The measurement SPT. equation.
results of control or Dirty inside surface Perform cleaning
specimen shift from of SPT. procedure using C1
criterion range or solution.
separate reference
value that has been Cleaning too often. Control the fre-
measured by other quency of clean-
analyzer. ing. Or perform
All of the results be- the cleaning with
come low value, but specimen.
there is little chance Cal-A concentrated Replace Cal-A. Cal-A con-
to find out the result due to evaporation. tainer will be
of shifting for potas- changed to a
sium in the many bag type.
cases. Insufficient priming Perform additional
of ISE. ISE priming.
Unstable measure- Dirt on the sample Wipe out the dirt by
ment (Multi analyte); port. using moist paper
In the measurement or cotton swab.
of control material, Insufficient flow Replace pump unit. Minimum flow
the measurement rate for Cal-A or rate for Cal-A
result of every item waste pump. pump: 140μL/
is not stable, and Sec
in any of the item,
result becomes out Liquid leakage to Replace bubble
of criterion range. As the bubble detec- detector.
for other electrode, tor.
even if the result Expired pump cas- Replace pump cas- Minimum flow
is within criterion sette on Cal-A or sette. rate for Cal-A
range, the tendency waste pump. pump: 140μL/
of result is toward Sec
same in case of out Use of not recom- Use only recom-
of criterion range, in mended solution. mended solutions.
many cases. Misalignment of Detach all elec-
electrode fixing. trodes and align
them to the proper
position.
Defective reference Replace reference
electrode. electrode.
Contaminated elec- Perform cleaning
trode. procedure by solu-
tion.
Insufficient priming Perform additional
for ISE. ISE priming.
QC & Sample Unstableness (Single Defective elec- Replace electrode.
measurement analyte); trode.
Only single item Expired electrode. Replace electrode.
whose measurement
result becomes out
of criterion range.
Good results are
obtained on others
items.
267

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Chapter 1: Equipment overview

Chapter 2: Procedure of routine check

Chapter 3: Settings and their alterations of operational conditions

4.4 Anomalous measurement results. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 179

Chapter 5: Summary of alarm codes

WARNING AND NOTICES FOR SAFE USE

Action to be taken as directed by the “OPERATORS MANUAL”

! WARNING RISK OF ELECTRIC Power supply inlet,

! WARNING DO NOT TOUCH Covers of SPT, RPT

! WARNING THE TANK CON-

! WARNING CONTAINS HAZARD-

! WARNING RISK OF INJURY Lid for replacing hal-

WARNING FOR SAFE USE

Give special consideration to keep skin and mucous membrane from

NOTICES FOR USE (SAFETY AND PREVENTION AGAINST DANGER)

9-1 IRU (Incubation Reaction Unit)

9-11 WU (Wash Unit)

17. The rating and the characteristics of fuses

Type Size Rating Characteristics Location and Part No.

Medium-Acting, Appliance inlet F1 & F2

SYSTEM CONFIGURATION and EQUIPMENT LIST

No. Equipment Model/Type/Spec. Q’ty Remarks

This chapter consists of:

1.1 Designation of each unit

View at an angle to the left

View at an angle to the right

Wash Solution Tanks (2L version)

Option: External Tank Rack (ETNK)

System Water Tank (20L)

Low Conc. Waste Tank (20L)

Option: Liquid Level Sensors

IRU (Incubation reaction unit)

RCU (Reagent container unit)

SPT (Sample pipette unit)

RPT (Reagent pipette unit)

RPT (Reagent pipette unit) SPT (Sample pipette unit)

IRU (Incubation reaction unit)

RCU (Reagent container unit)

DTR (Detector unit)

1.2 Functionality of each unit

1.2.1 Auto sampler unit (ASP)

Aperture for barcode reader

A) Turntable (ASP tray)

Tube holder (20 tubes each on inner and

B) Barcode reader (Option)

1.2.2 Sample pipette unit (SPT)

A) Liquid level sensor

B) Nozzle down limit sensor

D) Dummy volume of sample

1.2.3 Reagent pipette unit (RPT)

A) Liquid level sensor

B) Nozzle down limit sensor

D) Dummy volume of reagent

1.2.4 Incubation reaction unit (IRU)

Detector unit cover (DTR)

1.2.5 Reagent container unit (RCU)

The reagent tray of the RCU accommodates at maximum 40 reagent bottles.

1.2.6 Detector unit (DTR)

1.2.12 Liquid level sensor unit for external tank (op-