RX Imola Op Manual v1.0 TYB40

SECTION 1 Version 1.
0 Rev Sep 2005
FOREWORD
Rx Imola is an automated clinical chemistry analyser complete with dedicated
analyser software. Software functions of the analyser include the facility to interact
with a host computer for direct download of test method selection details for individual
samples.
A barcode system is used for the rapid identification of patient samples, reagents and
QC samples.
This analyser is an “in vitro diagnostic (IVD) medical device” and conforms to the IVD
directive (98/79/EC) and the EMC directive (89/336/EEC) of EU. This analyser has
been evaluated to canadian safety requirements.
C lin ic a l
C h e m is tr y
A n a ly s e r
3X A6
This manual is written for personnel that have completed the Rx Imola training
course, or those that have been fully trained by individuals that have attended the
training course.
The aim of the manual is to familiarise the user with all the features and functions of
the analyser to ensure analysis is performed under safe and optimal conditions.
2005 by Randox Laboratories Ltd,. 55 Diamond Road, Crumlin,

Co Antrim, BT29 4QY, United Kingdom.
All rights reserved. No part of this publication may be reproduced, stored

in a retrieval system, or transmitted in any form or by any means,
electronic, mechanical, photocopying, microfilming, recording or
otherwise without the written permission of the publisher.
ABC Page 1
Rx Imola Operator Manual
SECTION 1 SAFETY PRECAUTIONS AND INSTALLATION Version 1.0 Rev Sep 2005
SECTION 1
SAFETY PRECAUTIONS AND INSTALLATION
ABC Page 2
1.1 WARNING SYMBOLS
WARNING
Biohazard
Electric Shock
High Temperature
Injury
Action to be taken as
directed in Operators
manual
ABC Page 3
1.2 WARNING LABELS
WARNING LOCATION
RISK OF Power supply inlet.

ELECTRIC
SHOCK
DO NOT Covers of SPT,

TOUCH RPT1, RPT2,
MOVING MIX1, MIX2 and
PARTS
WU
HOT DTR
SURFACE
RISK OF Lid for replacing

INJURY halogen lamp, lid
of ISE tank, lid for
POWER OFF replacing ISE elec-
BEFORE trode, mainte-
OPENING
nance cover 1/R1/
PANEL
R2
THIS TANK Waste tanks

CONTAINS
HAZARDOUS
MATERIAL
CONTAINS
HAZARD-
OUS MATE- Mosaic 1, SWU
RIAL cover, Right side
SERUM, panel.
URINE AND
PLASMA
ABC Page 4
WARNING LOCATION
Class 1 Laser Barcode reader of

ASP and RCU.
Caution Class
2 Laser light
when open.
Do not stare
into beam.
Action to be IRU head insula-

taken as tion plate, fans on
detailed in rear frame (2
OPERATOR fans), lid for ASP
MANUAL
and RCU.
ABC Page 5
1.3 WARNINGS FOR SAFE USE
During operation, do not touch samples, reagents, nozzles and

any other moving mechanical parts in the analyser and ensure
that the cover is kept closed at all times.
Ensure that gloves are worn when handling patient samples to

minimise infection. Gloves should be worn when handling the
SPT nozzle, RPT nozzle, reaction cells, wash nozzles and
waste nozzles.
Keep skin and mucous membranes from contact with reagents

to prevent operator from possible infection.
Follow the instructions supplied by the manufacturer with

reagents, control sera and calibrators.
Gloves should be worn when handling waste solutions and

reaction cells to minimise infection. All waste solutions should
be disposed of according to the local pollution and effluent
discharge standards. There are two types of liquid waste
produced by the analyser, i.e. high- and low-concentrated waste
solutions.
Conductive parts within the analyser may cause serious electric

shock. Qualified service personnel should only carry out
maintenance and repair of internal electrical parts.
Reagent bottles should never be placed on the analyser as

careless handling may result in spillage or leakage of liquids into
the internal parts of the analyser.
Do not make any modifications to the analyser. Unauthorised

modifications to the analyser will invalidate your warranty
agreement.
Ensure that the analyser is switched off at the mains for at least
30 minutes prior to changing the halogen lamp. This precaution
is necessary to enable sufficient time to cool the lamp and
reduce the risk of burns. Keep hands away from the glass on the
bulb and ensure there are no cracks or breakages and that the
gas has not leaked.
ABC Page 6
1.4 SAFETY PRECAUTIONS

PLEASE READ THIS INSTRUCTION MANUAL BEFORE USING THE ANALYSER
AND BECOME ACQUAINTED WITH THE RECOMMENDED SAFETY ISSUES AND
PROCEDURES.
Prevention of system damage

• Ensure installation of the system is carried out according to the recommendations
provided with the RX Imola Installation Guide.
• Do not make any modifications to the analyser.
Prevention of electric shocks

• Do not remove any covers secured by screws only, as there is a risk of electric
shock. Covers secured with plastic clips may be removed as demonstrated in the
RX Imola Operator Training Course. Contact your service department if the
system requires attention.
• In the event of a liquid spill inside the system, contact the service department.
Prevention of personal injury

• Do not touch moving mechanical parts such as the reagent or sampling probes,
while the system is in operation. During operation, ensure that the cover is closed.
• Observe the warning labels described in this manual.
• Ensure the system has been switched off at the mains for at least 30 minutes
before changing the halogen lamp. This precaution is necessary to enable
sufficient time to cool the lamp and reduce the risk of burns. System calibration
should be performed when a lamp is changed. Keep hands away from the glass
on the bulb and ensure there are no cracks or breakage or that the gas has
leaked.
System accuracy and precision

• Ensure the cover is closed while the system is in operation.
• When the analyser is operating do not open the RCU cover lid or ASP cover lid. If
these lids are removed the run will be aborted.
ABC Page 7
• Perform the system preparation checks described in this manual before starting
routine operation.
• Follow the instructions supplied by the manufacturer with reagents, control sera
and calibrators.
• Do not place reagent bottles or sample cups on the analyser to prevent spillages
and system malfunction.
Waste Liquids
• All waste solutions should be disposed of according to the local pollution and
effluent discharge standards. There are two types of waste generated by this
analyser, low-concentration and high-concentration waste.
• Please refer the disposal of waste substances according to the instructions of
relevant manufacturers and suppliers to comply with the facility wastewater
standards.
Prevention of Infection
• Gloves should be worn at all times when handling patient samples and waste
liquid, to protect from possible infection.
• Gloves should always be worn when handling the SPT nozzle, RPT nozzle,
reaction cells, wash nozzles and waste nozzles.
Reagent Handling
• Ensure that your hands and clothing do not come into contact with reagents as
they may contain strong acid or alkali.
General Precautions
• The system is designed to run serum, plasma, supernatants, urine, and CSF.
Please contact Technical Support department if you want to run any other sample
types.
• Ensure that samples are free from clots and debris to prevent blockage of the
reagent and sampling probes.
• Ensure that the correct reagent volume is available to perform the necessary
number of tests.
ABC Page 8
• Do not leave samples unsealed for extended periods as they may evaporate and
concentrate the sample.
• Follow the instructions in this manual for loading samples, reagents and
calibration samples.
• Ensure that calibration analysis is complete before routine operation.
• Ensure that periodic system checks are performed and parts are replaced as
required.
• If reagents or samples come into contact with the mucous membranes, flush with
copious amounts of water for at least 15 minutes. Ensure adequate flushing of
eyes by separating eyelids with fingers. If swallowed, wash out mouth with water
providing that the person is conscious. Then contact a doctor as soon as possible.
In case of skin contact immediately wash skin with soap and copious quantities of
water.
• Never use the system for a purpose other than its intended use.
Handling of reagents, standard substances, and accuracy control substances

• Follow the manufacturer’s instructions regarding storage, handling and use of
reagents, standard substances and control samples.
• Refer to the manufacturer’s recommendation regarding safety after opening the
package of reagents.
• Make sure to calibrate the analyzer whenever reagents are replaced.
• If hemolysis, turbidity or bilirubin is contained in serum at high concentrate rate,
the medical agent or its metabolic products may adversely affect analysis results.
Refer to the relevant manufacturers and suppliers for details.
Operational environment of the analyzer

• Operate the analyzer with temperature: 15 to 30 C humidity: 45 to 85% and tem-
perature variation: less than 2 C per hour.
• Use ion-exchange water (pure water) at water temperature 5 to 25 C. If used out-
side the specified range, analysis performance by the analyzer may not be guar-
anteed.
• Do not operate a portable radio or cellular phone near the analyzer. Abnormal
noise or electromagnetic waves generated may affect the analyzer.
ABC Page 9
• Do not use medical equipment that may be affected by electromagnetic waves

near the analyzer.
Points to check when analyzing

Refer to Randox recommendations when using the analyser, incuding:
· Water quality
· Levels of reagents and wash solutions
· Calibration results
· Control data
· Analysis results
· Leakage in pipettes (SPT and RPT) or piping system
· Ensure samples are free from dust, fibrin or foam.
· Ensure sufficient sample volume for analysis
Emergency Shutdown Procedure

During routine analysis, an emergency stop is possible by pressing [Control] and [F2]
keys simultaneously. The software will also interrupt routine operation when there is a
fault in the analyser.
ANALYSIS DATA WILL BE LOST when an emergency stop is initiated. The

following procedures should be followed before resuming operation:
1. The cause of the emergency interruption must be resolved. For example, in case
of the user interruption due to the settings of erroneous measuring conditions, the
correct settings are required.
2. In the case of an automatic system emergency interruption, open the cover of the
equipment and check that there are no items interfering with the mechanical
operation of the equipment. When the cause of emergency interruption is
unknown, contact Technical Support to resolve the problem.
ABC Page 10
1.5 INSTALLATION REQUIREMENTS

PLEASE READ THIS INSTRUCTION MANUAL BEFORE USING THE ANALYSER
AND BECOME ACQUAINTED WITH THE RECOMMENDED SAFETY ISSUES AND
PROCEDURES.
The recommended installation instructions detailed in the RX Imola Installation Guide

should be followed to ensure that system operation is unaffected by external facilities
and conditions.
Recommended installation environment

• Avoid exposure to direct sunlight.
• Minimum exposure to dust and other airborne particles.
• Site should be flat.
• Minimum vibration.
• Site should be of suitable construction to accommodate the weight of the
analyser.
• Adequate uninterrupted power source.
• Ensure adequate air circulation around the back of the analyser.
• Site should be well ventilated.
• Ensure adequate atmospheric pressure.
• Do not install the analyser adjacent to a chemical storage room or any other
facility where gases are likely to be generated.
• Do not install the analyser adjacent to a localized heat source such as a
refrigerator or freezer.
Temperature/Humidity conditions
• Indoor temperature: 15 to 30 C, Temperature variation: less than 2 C per hour
• Indoor humidity: 45 to 85% (No condensation shall be formed.)
• Install the analyzer in a place with good ventilation or with ventilation system.
• Do not install the analyzer in a place subject to direct wind from the air
conditioning
ABC Page 11
Installation Precautions
• Only qualified personnel should install and use the analyser.
• Protect the analyser from liquid spillage or splashes.
• Ensure the analyser is appropriately grounded.
• Analyser use in the USA requires UL-certified accessories.
• Connect the analyser to the PC using LAN cable provided. Other cables may
cause background noise or interference.
• Ensure that all electrical cables are correctly connected.
• Water quality of feed water into analyser should conform to NCCLS Type II
specification or better.
Space
Refer to the figure below for space required for installation including space for
maintenance and for exhaust ventilation.
Secure the space (minimum 300mm) at the left side of analyzer in order to easily
power off the analyzer at emergency situation.
Figure
<space for exhaust ventilation> 150 and up
300 PC 300 300

Main Analyzer 690
and up Control Unit and up and up
1340
600 970
500 and up
Front
2470 (Unit: mm)
Power Supply
Install a 3-pronged power outlet with a ground terminal (A-Type, S-Type or O-Type)
within the reach of the analyzer's accessory power cable (2 m). Ground resistance
shall be less than 100 .
ABC Page 12
Figure
3-Pronged
Power Outlet
Cable Plug
NB: Power outlet installation should be carried out by qualified personnel only.
Water supply and drainage

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

wastewater Inside diameter: 3mm wastewater tank (length:1m)
Outside diameter: 7mm
WU high-concentrated Main analyzer - High-concentrated

wastewater wastewater tank (length:1m)
WU low-concentrated Pressure-resistant hose

wastewater Inside diameter: 15mm Main analyzer - Low-concentrated
Trough low-concentrated Outside diameter: 22mm wastewater drainage system
wastewater
Overflow
Before installation of the analyzer, install a water supply system (ion-exchange water
generator) and a low-concentrated wastewater drainage system. For high-
ABC Page 13
concentrated wastewater, place a tank close to the main analyzer. Before this tank
becomes full, dispose of high-concentrated wastewater in accordance with the
specified wastewater standards.
Water Supply
• Water pressure: 0.15 to 0.34 megaPa
• Capacity: 18 L per hour or more
• Connection tube: Pressure-resistant hose (Inside diameter: 12mm, Outside diam-
eter: 18mm)
Drainage system
• Capacity: 18 L per hour
• Position: Drainage system shall be at a position that is 500mm or more lower than
the wastewater outlet of the main analyzer.
Main Analyser
500mm
Installation table
• Lay the exhaust hose in the wastewater outlet so that the wastewater is drained
by a natural drop.
• Open the end of the exhaust hose to the atmosphere. (Don't soak it in the liquid.)
Operation Precautions
• Observe the recommended installation environment and precautions as described
above.
• Ensure that the ambient temperature of the laboratory is between 15-30°C to
ensure effective cooling of the reagents.
ABC Page 14
• Ensure that electric cables are correctly connected.

• Follow daily maintenance procedure before operating analyser. Ensure that
gloves are worn when handling sample nozzles, reagents and samples.
• Ensure sufficient reagent volumes for routine operation.
• Follow the recommended maintenance schedule to ensure efficient operation of
the system.
• Shutdown the system completely when a serious malfunction is detected in the
analyser.
IMPORTANT
Warranty agreements will be invalidated if any of the following specifications are
ignored.
• The environmental conditions do not adhere to the specifications listed in this
manual.
• The analyser is operated by untrained personnel.
• The analyser is serviced or modified by unspecified engineers.
• If any replacement parts are not sourced from an authorised supplier.
ABC Page 15
1.6 TECHNICAL SPECIFICATIONS

NOTE: Replacement fuses MUST be of the same value and type as the original
fuse. All fuses used must be UL approved.
1. Analyser Description Clinical Chemistry Analyser
2. Recommended Use General chemistry as photometric assay
Immunology as photometric assay (Latex
reagent available)
3. Analysis Method 1 point end, 2 point end, 1 point rate, 2 point
rate
4. Calibration Options Factor, Linear, Log Logit, Exponential,
Spline, Point to Point.
5. Test Capacity 400 tests per hour ( 560 with ISE’s)
6. Incubation Time One reagent assay 10 minutes (R1)
Two reagent assay 5 minutes for R1 +
5 minutes for R2
On reagent assay and two reagent assays
may be selected at same time.
7. Sample Type Serum, Plasma, CSF, Urine, supernatants
8. Number of simultaneous mea- 60 items (Max.) + Electrolyte (3 items)
surements
9. Components
9. 1. Main Analyser 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)
WU (Wash Unit)
PSU (Power Supply Unit)
CNT (Control Unit)
ISE (Ion Selective Electrode Unit)
TR (Trough)
STK (Subtank)
ABC Page 16
9. 2. Optional Accessories Personal Computer

CRT Display
Key-board
Mouse
Printer
9. 3. External Tanks Wash Solution No. 1
Wash Solution No. 2
9. 4. Optional Unit Electrolyte measurement unit (ISE unit)
10. 0 Component Details
10. 1. IRU (Incubation Reaction Heating method Direct heat with silicon
Unit) rubber heater
Heating range 37±0.3ºC
10. 2. Cuvette Material PYREX
Size 8mm(W) x 6.23mm(D)
x30mm(H)
Path length 6mm
Quantity 90
Minimum volume 150µl
Maximum volume 450µl
10. 3. ASP (Auto Sampler Unit) Normal Sample cups
Valid tube Diameter 13 ~ 16mm
Length 75 ~ 100mm
Paediatric sample cup and tube
Sample cup with lid 46mm x 10.8mm
Tube 85mm x 13mm
Turntable Removable type

Number of tubes Maximum 92
Cooling method Peltier Modules (only
cools tubes on inner ring)
(Normal/Emergency samples - 36 tubes on

outer ring + 36 on inner ring
Standard samples/ISE cleaning - +20 cups on
inner ring)
10. 4. SPT/SPP (Sample Pipette Number of pipettes 1
Unit/Sample Pump Unit) Pump type Syringe pump
Liquid detection Detection of electrical
capacitance
Sampling volume 2 ~ 35µl (0.1µl/ step),
ISE:100µl
ABC Page 17
10. 5. RCU (Reagent Container Turntable Removable type

Unit) Number of bottles Maximum 60
(30 bottles for 100/50ml
and 30 for 20ml type)
Cooling method Cooling with 4 Peltier
elements
Cooling range 8ºC ~ 15ºC (when
ambient temperature is
between 15-30ºC)
Reagent inventory Monitors the dispensing
volume of reagent
10. 6. RPT 1/2 (Reagent Pipette Number of pipette 1per unit
Unit) Pump type Syringe pump
RPP 1/2 (Reagent Pump Unit) Liquid detection Detection of electric-
capacitance
Reagent volume RPT1/RPP1:150 ~ 350µl
(1µl / step)
RPT2/RPP2: 20 ~250µl
(1µl / step)
10. 7. DTR (Detector Unit) Absorbance measurements
(1 or 2 wavelength
measurement)
Selectable wavelength 12 wavelengths
(340, 380,415, 450, 510,
546, 570, 600,660, 700,
750 and 800nm)
Wavelength select Grating method
Light source Tungsten Halogen lamp
Cooling for Air-cooled by fan
light source
10. 8. MIX 1/2 (Mixing Stirrer Unit) Stirring mechanism Stirring-bar rotated by
stepping motor
(5speed)
10. 9. SWU (Supply Water Unit)
WU wastewater 8 diaphragm pumps
Trough wastewater Free fall
Trough pure water supply 5 diaphragm pumps
(1 per trough, RPT1, RPT2, SPT, MIX1 &2)
10. 10. PT Trough 3 PT troughs (SRT, RPT1 and RPT2)
Mix Trough 2 mix troughs (MIX-1 and MIX-2)
Trough chamber 1 Trough chamber
10. 11. Subtank (with water level
detector)
Subtank R 1 subtank
Subtank L 1 subtank
ABC Page 18
10. 12. WPP (Water Pump Unit) Wash solution for cuvette cleaning
6 syringe pumps
10. 13. WU (General Wash Unit)
Cleaning mechanism 8 cleaning steps
1st step Aspirate liquid and then add wash solution
2nd step Aspirate liquid and then add purified water
3rd step Aspirate liquid and then add wash solution
4th step Aspirate liquid and then add purified water
7th step Read water blank
8th step Aspirate liquid
9th step Dry
10. 14. Power Supply Unit
Power requirement Source AC 100~120V, 9A(Max.)/AC
200~240V, 4.5A(Max.), 50-60Hz.
Power consumption 900V (max)
Permissable voltage variation +/- 10% Max)
11. Other Functions Auto start/shutdown
Emergency sample insertion
Automatic sample dilution
Water blank measurement
Reagent blank measurement
Test selection profile
Host communication by RS232 with PC.
12. Environment (Operation) Temperature 15ºC ~ 30ºC
2ºC/hr
Transport -10 to+50ºC
Humidity 45 ~ 85% (without

condensation
Transport 45-85%)
Altitude Less than 2,000m
Pressure 800 to 1060hPa

Transport 500-1060hPa
Definition of Installation Category in

IEC60664
Primary Circuit CATII
Secondary Circuit CATI
Pollution degree in IEC61010-1

Pollution Degree 2 (indoor use only)
for system start up.

For ISE unit only
ABC The components are only
suppied in quantities sufficient
Page 19
13. Measurements Dimensions (Main unit)

970mm(W), 690mm(D), 582mm(H)
Weight (Main unit)
150 Kg
14. Connectors on Main Analyser
14. 1. Electrical Connectors Appliance inlet
RJ-45 modular jack (for connection between
Main Analyser and Operational PC)
D-sub receptacle
14. 2. Piping Connectors Pure water
(for connection between Analyser WU high conc waste
ISE high conc. waste
and External-Tanks)
WU Low conc. waste
Trough low conc waste
Overflow
Wash solution 1
Wash solution 2
15. Maximum Sound level 60dB (When the cover is closed and the oper-
ator is 1m or more from the analyser.)
16. Rating of Fuses
Type Size Rating Characteristics Location and Part no.

Glass tube 5x 20mm 2A /250V Slo-Blo PCB: 25P3503 (ASP-
fuse DRV) F1
Glass tube 5x 20mm 4A /250V Slo-Blo PCB: 25P3502 (RCU-
fuse DRV) F1
Glass tube 5x 20mm 5A /250V Slo-Blo PCB: 25P3503 (ASP-
fuse DRV) F2
PCB: 25P3506 (SWU-
DRV) F1
Glass tube 3AG 10A / Fast Acting PCB: 25P3502 (RCU-
fuse 250V DRV) F2,F3,F4,F5
PCB:25P3505 (SWU-
DRV2) F1
PCB:25P3509
(IRU_DRV)F1
Glass tube 3AG 4A /250V Slo-Blo PCB:25P3507
fuse (SWU_DRV3) F1
Ceramic 3AB 10A/ Slo-Blo Fuse holder (AC input)
tube fuse 250V F1& F2
ABC Page 20
1.7 SYSTEM CONFIGURATION AND EQUIPMENT LIST
High Con.
Wastewater
Tank
Printer
Drain
Main Overflow
Analyzer
XP PC
Purified water
system
Wash Wash
AC Power Outlet Sol.1 Sol.2
5 8
1
2 6 7 10
3
4
No. Use Note
1 Output line for high conc. wastewater for WU (Pressure-resistant hose) standard
2 Output line for low conc. wastewater for WU (Pressure-resistant hose) preparation
by customer
3 Output line for low conc. wastewater for troughs (Pressure-resistant preparation
hose) by customer
ABC Page 21
4 Output line for high conc. wastewater for ISE (Silicon tube) standard
5 Connecter for external tank rack cable Option
6 Input line for wash solution 2 (P.V.C tube) standard
7 Input line for wash solution 1 (P.V.C tube) standard
8 Input line for pure water (Pressure-resistant hose) preparation

by customer
9 Output line for overflowing (Pressure-resistant hose) preparation

by customer
10 Hose clamp standard
FIGURE POWER CABLE LOCATION
4
1. POWER CABLE
2. FUSES
3 3. POWER SWITCH
4. LAN CONNECTOR AND PC
CABLE
ABC Page 22
1.8 EQUIPMENT LIST

Component List
No. Equipment Model/Standard Qty Remarks
1 Main RX imola 1
Analyzer
2 Operational Personal computer 1 With keyboard and mouse

PC PC/AT compatible
(Optional)
3 Display 1
(Optional)
4 Printer 1
(Optional)
5 External 3 Wash solution (5l): 2

tanks
6 Accessories 1 set Refer to the standard

accessories list.
7 Spare parts Halogen lamp NFK64258 1 set

12V20W: 1
Fuse 218 002 (2A/250V) : 1
Fuse 218 004 (4A/250V) : 1
Fuse 218 005 (5A/250V) : 1
Fuse 312 010 (10A/250V) : 1
Fuse 313 004 (4A/250V) : 1
Fuse 326 010 (10A/250V) : 1
Standard Accessories List
No. NAME TYPE Qty. REMARKS
1 Power 25S1031 (2m) 1 For analyzer main unit

cable
(VDE)
2 LAN cable Cross cable (2m) 1 For between PC and analyzer main
unit
3 5L plastic 5L 2 For wash solution

tank
ABC Page 23
4 Plastic SR1554 3 × 7 1 Line for high conc. wastewater for

tube high Silicon tube: 1m ISE
conc. 3mm (Inside) × 7mm
Waste (Outside)
(ISE)
5 Plastic Pressure-resistant hose 1 Line for high conc. wastewater

tube high : 1m
conc. 15mm (Inside) × 22mm
Waste (Outside)
(chemistry)
6 Plastic 25-023-4011 2 For detergent

tube wash P.V.C tube 1.59 mm
solution 1 (Inside) × 4.76 mm
(Outside): 1m
Inline filter: 1
Pipe: 1
7 Plastic 25-023-4012 For detergent

tube wash P.V.C tube 1.59 mm
solution 2 (Inside) × 4.76 mm
(Outside): 1m
Inline filter
Pipe: 1
8 Syringe tip 25-012-4101 1 For exchange of syringe tip

insertion
tool
9 Screw No.123-S75 1
driver
10 Hexagonal 1.5mm 1
wrench 1
11 Hexagonal 3.0mm 1
wrench 2
12 Hose 2269-08 1
clamp
ABC Page 24
SECTION 2 SYSTEM OVERVIEW Version 1.0 Rev Sep 2005
SECTION 2 .
SYSTEM OVERVIEW
ABC Page 25
2.1 ANALYSER OVERVIEW

RX IMOLA
RX IMOLA WITH OUTER LID OPEN AND UNIT LIDS IN PLACE
WU
RPT2
SPT
MIX2
IRU MIX1
RPT1
RCU ASP
ABC Page 26
RX IMOLA WITH OUTER LID OPEN AND UNIT LIDS OFF

DTR MIX2 RPT2 RPT1
Trough Trough Trough
SPT MIX1 ISE

Trough Trough
2. 1. 1 MAJOR FUNCTIONS OF EACH UNIT
Unit Major Functions

(Abbreviation)
IRU Incubation Reaction Unit:
The cuvette table (turntable) of the IRU holds 90 cuvettes. It rotates and brings the
designated cuvettes to where samples/reagents are dispensed by the SPT/RPT.
DTR DeTectoR unit:

The DTR measures the absorbance of solutions during the reaction (mixing and incu-
bation) process in cuvettes. Light from the halogen lamp is dispersed using a diffrac-
tion grating enabling measurement of 12 different wavelengths.
SPT Sample PipeTte unit:

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

The RPT aspirates a reagent from a reagent bottle (in RCU) by using the RPP, then
dispenses it into a cuvette (in IRU). The RPT consists of the RPT1 for the reagent #1
and the RPT2 for the regent #2. Each nozzle is cleaned in the RPT Trough after use.
ABC Page 27
MIX MIXing stirrer unit:

After a sample and a reagent are dispensed into a cuvette, the MIX brings down the
paddle-type stirrer and stirs the mixture in the cuvette by rotating the stirrer. This
ensures the reagent is dispersed evenly witihn the reaction chamber. This unit consists
of the MIX 1 for the reagent #1 and MIX2 for the reagent #2. The stirrer is cleaned
with pure water after every use.
WU Wash Unit:
The WU consists of six supply/drain nozzle pairs, one drain nozzle and one wipe tip.
This unit drains the reaction liquid out of each cuvette after the completion of mea-
surement and cleans the inner surface of each cuvette by pipetting wash solution or
pure water into the cuvette.
ASP Auto SamPler unit:

The ASP holds 72 sample tubes (normal samples and emergency samples), and 20
sample cups (standard samples and the ISE wash solution) and brings the required
sample to the SPT pipetting position by rotating the turntable.
RCU Reagent Container Unit:

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

The SPP aspirates/dispenses both samples and pure water by moving the plungers up
and down. Since the sample syringe and the cleaning syringe have separate motors,
they can operate independently.
RPP Reagent PumP unit

The RPP aspirates/dispenses both reagents and pure water by moving its plungers up
and down. This unit consists of the RPP1 for the reagent #1 and the RPP2 for the
regent #2. The reagent syringe and the cleaning syringe have separate motors, and
can operate independently.
WPP Wash PumP unit:

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

The SWU consists of SWU1, SWU2 and SWU3.
This unit
- controls pure water supply from the purified water generator to the subtanks R/L
(SWU1-1),
- supplies pure water from the sub-tank R to the SPT Trough and the MIX1 and 2
Troughs (SWU2),
- supplies pure water from the sub-tank L to the RPT1 and 2 Troughs (SWU3),
- drains wastewater from the WU (SWU1-2).
ABC Page 28
TR TRough unit:
The TR consists of 5 troughs and one trough chamber.
This unit collects wastewater from the nozzles of the SPT and the RPT-1 and 2, and
cleans the external surfaces of these nozzles of the SPT and the RPT-1 and 2 and also
cleans the stirrers of the MIX-1 and 2 with pure water, then collects the wastewater
after cleaning.
ST SubTank:
The ST consists of the sub-tanks R and L. These tanks store pure water, which will be
supplied to the SPP, the WPP and the RPP-1 and 2, and each trough for the SPT, the
MIX-1 and 2, and the RPT-1 and 2.
ISE Ion Selectable Electrode unit:

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

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

External tanks supply wash solutions that are used by the analyzer and store the
wastewater discharged from the analyzer. The external tank sensor(s) monitor the
amount of liquid in each tank. (Optional)
This analyser is used for the determination of clinical chemistry parameters in serum,
plasma, supernatants, urine, and CSF samples. The process is completely
automated using mechanical components for sample and reagent dispense, mixing
and measurement.
2. 1. 2 REAGENT MANAGEMENT (RCU SCAN)

Information of onboard reagents is recorded by scanning the reagent barcode labels
attached to the reagent bottles. This is performed during one turn of the reagent tray
in the RCU unit. This process should be performed prior to pressing the START F1
key.
The following operations are performed after pressing the START [F1].
ABC Page 29
2. 1. 3 PREPARATION
• Initialisation of hardware.
Each unit returns to its original position.
• Prime
Nozzles are situated at their respective troughs. Each pump and syringe operates
and sends out solution into each line to expel air. SPP, RPP-1 and RPP-2 are
primed. ISE unit is primed.
• Water blank measurement is performed for the first cuvette.
• Readout of bar code on the sample label (with barcode enabled only)
An inquiry is made to the host computer about measuring schedule on each sam-
ple tube in time for sampling.
2. 1. 4 FIRST REAGENT MEASUREMENT

The following processes describe the sequence of events for routine analysis,
assuming that all reagent, and system checks have been carried out.
• First reagent dispense

The reagent container unit (RCU) and the reaction table (IRU) rotate to the posi-
tion where the reagent is aspirated and dispensed by the reagent pipette unit
(RPT) into a cuvette on the IRU.
• Sample dispense
Sample is then aspirated and dispensed from the auto sampler unit (ASP) into the
cuvette on the reaction table (IRU) containing the pre-dispensed primary reagent.
The IRU rotates to the position where the sample pipette unit (SPT) dispenses the
sample.
• Stirring
The IRU then rotates to the position where the mixture in the cuvette is stirred
(MIX-1).
ABC Page 30
• Measurement of absorbance (1 - 34)

The IRU rotates to the position where the absorbance is measured. Absorbance
measurements of the cuvette are taken every 9 seconds and the time course data
of the first reagent is stored.
2. 1. 5 SECOND REAGENT MEASUREMENT

• Second reagent dispense
The reagent container unit (RCU) and the reaction table (IRU) rotate to the posi-
tion where the second reagent is aspirated and dispensed by the reagent pipette
unit (RPT) into the cuvette on the IRU which contains the primary reagent and
sample mixture.
• Stirring
The IRU then rotates to the position where the mixture in the cuvette is stirred
(MIX-2).
• Measurement of absorbance (35-68)

The IRU rotates to the position where the absorbance is measured. Absorbance
measurements of the cuvette are taken every 9 seconds and the time course data
of the second reagent is stored.
2. 1. 6 WASH
After assay completion the cuvette moves to the wash unit (WU). The reaction
solution is drained from the cuvette and the cuvette is then washed thoroughly.
2. 1. 7 EMERGENCY STOP
During routine analysis, an emergency interruption is possible by pressing [Control]
and [F2] keys simultaneously. The software will also interrupt routine operation when
there is a fault in the analyser.
ANALYSIS DATA WILL BE LOST when an emergency stop is initiated. The

following procedures should be followed before resuming operation:
ABC Page 31
1. The cause of the emergency stop must be resolved. For example, in case of the
user emergency stop due to the settings of erroneous measuring conditions, the
correct settings are required.
2. In the case of an automatic system emergency stop, lift the lid and check that
there are no items interfering with the mechanical operation of the equipment.
When the cause of emergency stop is unknown, contact Technical Support to
resolve the problem.
2. 1. 8 AUTOMATIC RERUN
When a sample concentration is greater or lower than the technical range of the
equipment and automatic reruns are enabled the sample is re-run (please see ?? for
detailed description of automatic re-runs). Rerun volumes are based on pre-defined
system settings for sample volume, diluent volume and diluted sample volume for
analysis. Sample dilution may be carried out using a defined diluent according to the
defined settings in the Chemistry Parameters screen. The analytical result reported
for the diluted sample is already corrected for the dilution.
2. 1. 9 REAGENT BLANK MEASUREMENT

The absorbance of a cuvette without sample is measured. Sample results may then
corrected with the reagent blank value. There are four types of reagent blank
measurement carried out:
• R1
• R1 + R2
• R1 + water
• R1 + R2 + water
Requirements for reagent blank measurement may be set in the Chemistry
Parameters screen.
2. 1. 10 WATER BLANK MEASUREMENT (CUVETTE CHECK)

The absorbance of a cuvette containing only water is measured. The result is used as
a guide for assessing the degree of staining on the cuvette.
ABC Page 32
The analyser will perform a cuvette check at the beginning of each run by washing the
cuvettes and then checking the absorbance measurement.
2. 1. 11 ISE MEASUREMENT
This measurement is carried out when the optional ISE unit is present in the analyser
and an ISE test is requested. Urine samples require a 1 in 10 dilution prior to analysis
and a dedicated urine diluent must be used. This diluent needs to be pre-registered
as a diluent reagent code in the SYSTEM PARAMETERS section and be present on
board the analyser to perform ISE tests on urine samples. ISE priming, cleaning and
calibration are performed via the Maintenance/ Sequence (F9) screen.
ABC Page 33
2.2 SYSTEM COMPONENTS

This section describes each component of the system in detail. Refer to ‘Analyser
Overview’ section for location of individual system components.
2. 2. 1 AUTOSAMPLER UNIT (ASP)

The auto sampler unit (ASP) consists of the removable turntable with two
components, an outer sample tray section (tubes and cups for normal and
emergency samples ) and a removable inner cup section (cups only for calibrator and
control samples). A sample barcode reader identifies sample tubes in the outer
sample tray.
AUTOSAMPLER UNIT (ASP)
Outer sample tube section
Inner sample cup section
The ASP accommodates 72 sample tubes. The outer sample tube section consists of
an outer ring (sample numbers 1 to 36) and a middle ring (sample numbers 37 to 72).
The inner sample cup section houses sample numbers I1 to I20.
Each sample is aspirated by the sample pipette unit (SPT) and dispensed into a
cuvette in the incubation reaction unit (IRU). The sample pipette unit can dispense
ABC Page 34
serum, plasma, supernatants, urine, and CSF.The sample turntable rotates counter
clockwise.
2. 2. 1. 1 TURNTABLE
The turntable is removable and guide pins are used when replacing the sample tray
in the ASP to ensure the correct orientation.
Guide pins
The turntable consists of two components, an outer sample tray and an inner sample
cup tray.
2. 2. 1. 1. 1 OUTER SAMPLE TUBE SECTION

The outer sample tube accomodates 72 sample tubes (36 tubes on the middle and 36
tubes on the outer ring), for normal and emergency samples. When placing samples
ensure barcode labels face outwards to enable barocde scanning and identification of
samples (as shown in the figure below).
ABC Page 35
Figure Placement of the Sample tubes
2. 2. 1. 1. 2 THE INNER SAMPLE CUP SECTION

The inner sample cup section accommodates 20 sample cups , and can be removed
independently. Calibrator and control samples are stored in this section and
refrigerated at approximately 10C to ensure onboard stability. The inner cup section
does not have a barcode reader and sample positions for calibrator and control
samples must be assigned within the software
Figure Removable inner sample cup section
Removable inner tray section
2. 2. 1. 2 BARCODE READER
Barcodes are read on labels attached to sample tubes in the outer section of the ASP
carousel. Tubes should be orientated with the barcode label facing outwards so that
they can be scanned by the barcode reader. The types of usable sample tubes are
shown below:
Diameter: 13 mm – 16 mm
Length: 53 mm – 100 mm
ABC Page 36
Extent of label fitting:Refer to drawing below.
5mm
47mm } Printable Barcode

area
5mm
12.5 – 14.5mm
Valid barcode types for the Rx Imola analyser

Type Data digit number Check digit Effective characters
UPC(JAN) From 3 to 12 digits 1 digit, Modulus 10 Numbers (from 0 to 9)
NW7 From 3 to 12 digits 1 digit, Modulus 16 Numbers (from 0 to 9)

Symbols (-, $,/,.,+)
CODE39 From 3 to 8 digits 1 digit, Modulus 43 Numbers (from 0 to 9), Alphabet

Symbols (-, $,/,.,+)
ITF From 3 to 12 digits 1 digit, Modulus 10 Numbers (from 0 to 9)
CODE128 From 3 to 12 digits 2 digits, Modulus Numbers (from 0 to 9), Alphabets (capital
(Set A, B 103 letters and small letters)
and C) Symbols (!,”,#,$,(,),*,+,.,/,:,;,<,>,=,?,@,[,])
Note: Small Roman letters cannot be used
for the Set B.
Barcode Specifications for sample

Bar module width From 0.25mm to1.00mm
Barcode height 15 mm or higher
Barcode length 60 mm or shorter, including quiet zone.
Quiet zone Blank areas before/after the barcodes.
4 mm or 10 times length of the
minimum module width, whichever the
greater.
Printing Black on the white background. Quality
standard shall comply with the ANSI
MH10.8M standard.
Barcode label Refer to the drawing
location
ABC Page 37
Two sensors are used to detect when the ASP lids are in place, one on the lid for
sample tubes and the other on the lid for the emergency samples.
2. 2. 2 REAGENT CONTAINER UNIT (RCU)

The reagent container unit (RCU) can accomodate up to 60 reagent bottles and
consists of reagent bottle rack, bar code reader, cooler and sensor.
REAGENT CONTAINER UNIT
2. 2. 2. 1 REAGENT BOTTLES
The reagent container unit can use reagents presented in three types of bottle.
ABC Page 38
REAGENT BOTTLE TYPES

100ml bottle
50ml bottle
20ml Bottle
2. 2. 2. 2 REAGENT TRAY
The reagent tray of the RCU accommodates at maximum 60 reagent bottles. The
reagent tray rotates and the required reagent bottle is moved to the position where
the reagent is aspirated by the reagent pipette. Ensure reagent bottles are positioned
with the barcode facng outwards to enable identification of the reagent.
REAGENT CAROUSEL
Outer ring for

Inner ring for 50ml 20ml bottles
& 100ml bottles
ABC Page 39
2. 2. 2. 3 COOLER
When the equipment is switched on, including during sleep mode, the temperature in
the RCU is controlled by the cooling power unit (CPU). A temperature sensor in the
RCU ensures that the temperature of the reagent is kept within the specified range.
The specified range is 8 -15ºC provided that the ambient temperature is between 15-
30ºC.
2. 2. 3 SAMPLE PIPETTE UNIT (SPT)

The sample pipette unit (SPT) consists of a vertical movement mechanism, level
sensor and lower limit sensor. A pipette connected to the sample aspiration syringe
via a resin tube performs the sampling.
When an ISE unit is fitted and ISE measurement is performed, the SPT aspirates
sample for ISE measurement and dispenses it into the sample port of the ISE unit.
SAMPLE PIPETTE UNIT (SPU)
SPT trough
SPT nozzle
2. 2. 3. 1 LEVEL SENSOR
When the tip of the nozzle touches the sample surface, the electrostatic capacitance
of the metallic nozzle varies. This variation is used to determine the level of liquid in
the sample tube.
Level sensors are not utilised with paediatric sample cups. The pipette head
descends to a pre-defined height, based on the dimensions of the recommended
ABC Page 40
sample cups and tubes. It is important that only the recommended sample cups and
tubes are used for analysis of small sample volumes.
2. 2. 3. 2 LOWER LIMIT SENSOR
The lower level detector will detect when the tip of the nozzle hits the bottom of the
sample cup due to insufficient sample volume. Downward pipette movement is then
prevented.
2. 2. 3. 3 SPT TROUGH
After sampling is completed, the tip of the SPT nozzle is washed with system water in
the SPT trough.
2. 2. 4 REAGENT PIPETTE UNIT (RPT 1 & 2)

The reagent pipette units (RPT1& 2 ) consist of vertical movement mechanism, level
sensor and lower limit sensor. The RPT1 aspirates primary reagent, RPT2 pipettes
R2 reagent and dispenses into a reaction cell in the IRU. RPT also dispenses water
for washing the cuvette.
REAGENT PIPETTE UNIT
RPT trough
RPT nozzle
ABC Page 41
2. 2. 4. 1 LEVEL SENSOR
When the tip of the nozzle touches the reagent surface, the electrostatic capacitance
of the metallic nozzle varies. This variation is used to determine the level of liquid in
the reagent bottle.
2. 2. 4. 2 LOWER LIMIT SENSOR
The lower level detector will detect when the tip of the nozzle hits the bottom of the
reagent cup due to insufficient reagent volume. Downward pipette movement is then
prevented.
2. 2. 4. 3 RPT TROUGH
After dispensing is completed, the tip of the RPT nozzle is washed in the RPT trough.
2. 2. 5 INCUBATION REACTION UNIT (IRU)

The incubation reaction unit has 90 Pyrex reaction cuvettes on the outer
circumference, which are kept at a constant temperature of 37ºC by heating
elements. Sample dilution (where applicable), dispensing, stirring, and measurement
of sample and reagent mixtures are performed in the IRU and the cells are rotated
periodically at 9 sec intervals. The Pyrex cuvettes are washed after each use in the
IRU.
ABC Page 42
Incubation heating
elements
INCUBATION REACTION UNIT
Wash Unit
Photometer lamp
SPT
2. 2. 5. 1 CUVETTE HOLDER
The cuvette holder is provided with slots to accommodate 90 reaction cells.
2. 2. 5. 2 TEMPERATURE SENSOR AND HEATER
Three silicone rubber heaters and six sensors (2 per heater) on the cuvette holder
ensure that the IRU is thermostatically maintained at 37ºC.
2. 2. 6 DETECTOR UNIT (DTR)

The detector unit (DTR) consists of the optical measurement system and grating
mirror. The light passing through the cuvette is dispersed using a mirror giving
different reflection angles with respect to wavelength.
The absorbance inside the cuvette of the IRU unit is measured using a photometer.
Measurement is performed with any 1 or 2 wavelengths selected from the following
12 wavelengths: 340, 380, 415,450, 510, 546, 570, 600,660, 700, 750 and 800 nm.
2. 2. 6. 1 PHOTOMETER
The photometer consists of a halogen lamp, lens, grating mirror and photoreceptor
(photodiode). The lens is comprised of a condenser and a focusing lens. The
condenser lens converts the light from the halogen lamp into a collimated light beam
ABC Page 43
that is then dispersed by the grating mirror and detected by employing the
photodiodes of 12 wavelengths.
The photoreceptor converts the light passing through the solution in the reaction cell
into an electrical signal.
2. 2. 7 STIRRING UNIT (MIX-1 & MIX-2)

The analyser has two stirring units MIX-1 and MIX-2. (See location of MIX units on
main analyser photograph).
2. 2. 7. 1 MIX-1
After dispense of the sample and the first reagent into the reaction cell the liquid is
stirred by rotation of a paddle attached to the tip of the nozzle on the MIX-1 unit. The
tip of the stirrer nozzle is then washed in the MIX-1 trough with water.
2. 2. 7. 2 MIX-2
After dispense of the second reagent into the reaction cell the liquid is stirred by
rotation of a paddle attached to the tip of the nozzle on the MIX-2 unit. The tip of the
stirrer nozzle is then washed in the MIX-2 trough.
2. 2. 8 WASH UNIT (WU)

After completion of the assay steps and absorbance measurement, the wash unit
(WU) washes the reaction cell to prepare it for re-use.
WASH UNIT
Pour
nozzle
Drain
nozzle
Residual Wipe
chip
ABC Page 44
WASH UNIT
Cuvette wipe block
The wash unit consists of 6 dispense nozzles and 7 drain nozzles (including the final
drain nozzle), and a residual wipe chip. The nozzles move over the reaction cuvettes
and are then lowered into the cuvette by the vertical movement mechanism.
The solution inside the reaction cuvette is drained and then either pure water or wash
solution is dispensed into the cell to wash it. This is then aspirated from the cuvette
and the process repeated according to pre-set wash directions.
The drain nozzle is connected to the drain pump of the supply water unit (SWU) via a
resin tube. The dispense nozzle is connected to the syringe of the WPP unit via a
resin tube.
2. 2. 9 PUMP UNITS
There are three pump units including the sample pump unit (SPP), the reagent pump
unit (RPP) and the wash pump unit (WPP).
ABC Page 45
Figure Pump location at rear of analyser

Sub tank L RPP 1 RPP 2 SWU 3
WPP
SPP (washing)
SPP (Sample)
SWU2
Subtank R
SWU1 (Inside)
2. 2. 9. 1 PUMPS
The SWU unit is located on the right side of the analyser and consists of various
diaphragm pumps for water supply and drain of the wash unit (WU).
Pumps for WU-1 to WU-8 8pcs (NF30)

Pump for pure water supply into RPT1 and RPT2 troughs 2pcs (Iwaki)
Pumps for pure water supply into SPT trough 1pc (Iwaki)
Pump for pure Water supply into Mix-1 and Mix-2 troughs 2pcs (Iwaki)
ABC Page 46
2. 2. 9. 2 SYRINGES
There are 12 supply syringes,SPP has two syringes, RPP has four syringes (2 for
RPT1 and 2 for RPT2) and the WPP has six syringes. All wash unit syringes are
linked in their operation.
WU-1 water supply syringe This syringe aspirates purified water from the water
tank and dispenses via WU-1 nozzle into the
cuvette.
WU-2,4 water supply This syringe aspirates purified water from the water
syringe tank and dispenses via WU-2 and 4 nozzles into the
cuvette.
WU-3 water supply syringe This syringe aspirates purified water from the water
tank and dispenses via WU-3 nozzle into the
cuvette.
WU-5,6 water supply This syringe aspirates purified water from the water
syringe tank and dispenses via WU-5 and 6 nozzles into the
cuvette.
SPP sample syringe This syringe aspirates sample via the SPT nozzle
and dispenses it into the cuvette on the cuvette
holder. (This syringe is linked with the SPP purified
water supply syringe in its operation.)
SPP system water supply This syringe aspirates purified water from the
syringe system water tank to draw water into the SPP line.
During sample dispense, the sample at the tip of the
SPP nozzle is pushed out by the water. (This
syringe is linked with the SPP sample syringe in its
operation.)
RPP reagent syringe This syringe aspirates reagent via RPT1 or RPT2
nozzle and dispenses it into cuvettes on the cuvette
holder. (This syringe is linked with the RPP pure
water supply syringe in its operation.)
RPP pure water supply This syringe aspirates purified water from the
syringe system water tank to draw water into the RPT line.
During reagent dispense, the reagent at the tip of
the RPP nozzle is pushed out by the water. (This
syringe is linked with the RPP sample syringe in its
operation.)
ABC Page 47
2. 2. 9. 3 SOLENOID VALVE
The solenoid valve switches the syringe operation between aspiration and drain.
There are eight solenoid valves in the wash unit, six connected to the WU 1 to WU6
and two connected to WU1 and WU3..
SPP-EV For switching between aspiration into and dispense from the SPP line.
RPP-EV For switching between aspiration into and dispense from the RPP line.
2. 2. 10 ELECTROLYTE MEASUREMENT UNIT (ISE OPTION)

The electrolyte concentration (sodium, potassium, chloride) contained in blood
serum, plasma or urine is measured by the Ion Selective Electrode (ISE) unit, which is
located on the right-hand side of the analyser.
LOCATION OF ISE UNIT
ISE
ABC Page 48
ISE UNIT WITH DOOR OPEN
ELECTRODES
Sodium
Potassium
Chloride
Reference
LOCATION OF CALIBRANT A FOR ISE UNIT
Sample port
ISE unit
Calibrant A
The ISE unit consists of ion selective electrodes, supply and drain pump, pre amplifier
board and I/O board.
Ion selective elec- This consists of Na+, K+, Cl- and reference electrodes.
trode The thermo-regulator heater is located at the rear of the
ISE unit where the electrode connections are situated.
Calibration solution A is installed in a special
compartment as shown above.
Calibration solution B (or wash solution) is placed in the
ASP unit at position number #18.
Supply and drain The motor and position sensor control the pump. It is
pump used to supply and drain calibration solution, sample,
diluent solution and wash solution.
ABC Page 49
Pre amplifier board To convert the analogue signals from electrode and
temperature sensor to digital signal.
The following solutions are supplied for the ISE unit:
Calibrant A Calibrant A is supplied in a sealed bag and used for

calibration and flushing the electrode each time a sample
measurement is performed. 120µl of calibrator A is
automatically dispensed into the ISE unit every 30 minutes to
prevent the electrode from drying out. Its dedicated bottle is
placed beside the ISE unit. 320µl of calibrator A is aspirated
during ISE calibration.
Calibrant B This is used for calibration of the ISE unit.

500µl of calibrator B is placed in a sample cup at position
number 18 in the ASP tray. 200µl calibrator B is aspirated
during ISE calibration. Calibration is carried out at the
beginning of each day and at least every 8 hours.
Calibrant B is dispensed using the following menu options
• Select MAINTENANCE menu option from the job menu
• Select [SEQUENCE (F9)]
ISE Cleaning ISE cleaning solution is dispensed into the unit to avoid
Solution
contamination of the electrode with protein. When necessary,
600µl of cleaning solution is placed in a sample cup at a
defined position in the inner ASP tray. ISE cleaning is
recommended at the end of the day via automatic sleep
function and at least every 8 hours if greater than 50 samples
are processed per day. Cleaning solution is dispensed using
the following menu options.
NB: See section 9. 5. 2“ISE Cleaning” on page 324.
• Select MAINTENANCE menu option from the job menu
• Select [SEQUENCE (F9)]
ABC Page 50
Diluent Urine diluent is used to dilute urine samples 1 in 10.

Diluent is presented in a reagent bottle, which is placed on the
RCU unit. Approximately 315µl of diluent is required for the
dilution of each sample. The dilution is carried out using a
cuvette on the IRU unit and one cycle of chemistry analysis is
allocated to the dilution.
The diluent is pre-registered with a reagent code under the
SYSTEM PARAMETERS section of the job menu under
[SYSTEM (F9)].
Sampling 100µl sample is aspirated for each ISE measurement.
Volume
ABC Page 51
2.3 ANALYSIS SPECIFICATIONS

Analyser Capabilities
Item Specifications
Number of analysis methods stored Up to 240 methods (Common: 60, Serum: 60, Plasma:
60, Urine: 60)
Input of Normal ranges 50 programmable ranges

6 types = gender (2) x age (3 generations), others: 44
types
Multi standard details Capable of storing details for 10 multistandards
Control sample Capable of storing details for 40 controls
Profile Up to 20 profiles
Method to method calculation Up to 40 calculations
Test selection capability Normal sample: Up to 1,000 samples

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

bottles
Measurement results Sample measurement results: 1,000,000 tests

Sample time course: 60,000 tests
Calibration results: 25,000 tests
Calibration time course: 6,000 tests
Calibration curve storage Number of methods x 2 (Old and New): 480 curves in
total
QC measurement results Up to 50,000 tests (approximately for one year)
Number of identifiable patients 30,000 patients
Maximum number of rounds per day. 99 rounds per day
ABC Page 52
2.4 SOFTWARE OVERVIEW

This section gives an overview of the software including the location and function of
keys, and the menu layout for operator use.
2. 4. 1 KEYBOARD LAYOUT
To perform screen operations it is important to become familiar with the keyboard
layout, functions of each key, menu structure and methods of data entry.
The equipment may be operated using the keyboard of a PC or a mouse. The

functions of each key except character and numerical keys are shown below. The
‘Key ID’ numbers listed below are used throughout the manual.
Key Key ID Function Description
F1 [F1] Start To start or resume measurement.
To stop further sampling.

F2 [F2] Stop Processing will continue for
samples that have already been
dispensed into the IRU.
F3 [F3] Emergency To display on screen menu for

(STAT/NORM) addition of an emergency or normal
sample.
F4 [F4] Alarm To display the alarm log.
F5 [F5] Run For on screen display of routine

operation progress.
ABC Page 53
F6 [F6] Parameter For on screen display of analytical

conditions.
F7 [F7] Calibration For on screen display of calibration

details.
F8 [F8] QC For on screen display of quality

control details.
F9 [F9] System Determined by the menu option

selected.
F10
[F10]
F11
F12 [F11]
[F12]
[Contrl}
Ctrl F5 + Print screen To print out on screen display to

[F5] printer.
[Scroll
Scroll Lock] Print stop To interrupt printing.
Lock
To move the pointer for on screen

Tab [TAB] Tab selection.
The pointer may be moved in the
reverse direction by pressing [Shift]
+ [Tab] keys.
Enter [Enter] Registration To register the entered data.
ABC Page 54
To convert character between

Shift [Shift] Shift uppercase and lowercase.
The pointer may be moved in the
reverse direction by pressing [Shift]
+ [Tab] keys.
Back [B-Space] Character To delete characters in the input

Space
deletion field.
User termination of assay by
Ctrl
[Ctrl] + Emergency Stop pressing [Control] + [F2] keys.
F2
[F2]
To move the cursor to the top of the

Home [Home] Home items in the scroll or list box.
To move the cursor to the end of the

End
[End] End items in the scroll or list box.
Page
[PgUp] Page up To move up through the pages on
Up
the menu.
Page [PgDn] Page down To move down through the pages

Down
on the menu.
[Space] Space Selection menu
Cursor To select an item among selectable

(fixed) items, e.g. qualitative or
quantitative selection of analytical
conditions.
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Esc [ESC] Escape To close window.
SHIFT + Alarm sound stop This turns off the alarm sound.
[ESC]
SHIFT + Simple Simple measurement option
F2 [F2] measurement available with or without barcodes*

start
* The "Simple measurement start" function is available either with or without the ASP
barcodes. This function allows the analyzer to measure all available samples positioned in the
ASP for all methods that are set by the chemistry parameter regardless of test selection. The
measurement methods for the Orderless measurement can also be selected in advance. The
necessary reagents that have been registered must be positioned in the RCU for this operation.
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2. 4. 2 JOB MENU LIST
Job Menu Tab Menu Description
Run (F5) Monitor Measurement status monitor
Round Measurement details status monitor
Selection Test order (patient sample, standard sample, control

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

Scheme
Std QC Test order settings for standard samples and control

samples positioned in the innermost circle of the ASP.
(Barcode label is not applicable)
Patient Patient information registration
Parameter Normal Setting for the analysis condition per method.

(F6) (Settings for analysis method, measurement point,
dispensing amount, normal range, technical range,
stirring speed etc.)
Normal2 Setting for the analysis condition 2 per method.

(Settings for limit check, blank measurement condition,
inter-equipment coefficient etc.)
ISE Analysis condition setting for the ISE.
SI Condition setting for serum information.
Calc Definition of method to method calculation
Profile Profile setting
Order Settings for measurement order and printout order.
Wash Method to method wash setting
Calibration Reg Calib Registration and setting for calibration curve

(F7)
Serial (Serial) Dilution standard setting

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

SYSTEM Set up Setup for system parameter 1
(F9) (Host communication parameters, higher-order digits in
the sample numbers, settings for sample barcode type
etc., settings for various selection condition flags and
the RPT special wash solution code, header settings for
real-time printing.)
Reagent Registration and settings for reagent codes, reagent

names, bottle sizes etc.
Versions Display of various program numbers
Backup Backup for system parameter and measurement data
Setup2 Setup for system parameter 2

(Settings for open reagent code, technical range value,
and age and generation of patients etc.)
Define Definition and editing for patient information
Range Definition and editing for normal range name(s).

MAINTE Water B1 Display for water blank value of cuvettes
(F10)
Work Hour Display for operating time of the equipment and
consumable parts
Sequence Single operation and specific sequence operation of

units
Sensor Test and display for sensor status
Perform Temperature status monitor for IRU, RCU and ASP.

Sensitivity status monitor for various wavelengths of
DTR.
Adjust For factory adjustment (volume adjustment)
DTR Pos Execution of DTR light path adjustment for cuvettes and
adjustment amount display
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2. 4. 3 MENU STRUCTURE
Power on Monitor
Round
Selection
Result
Run (F5)
Inventory
Sleep Scheme Normal
Std QC Normal2
Patient ISE
SI
Parameter (F6) Calc
Reg Calib Profile
Serial Dilution Order
Calibration [F7] Multi-Std Wash
ISE
Graph
Job Details
Menu QC [F8] Daily
Cumulative
Setup Settings
Reagent Registration
Login
System (F9) Backup
Setup2
Define
Range
Water Bl
Work Hour
Sequence
Mainte (F10) Sensor
Perform
Adjust
DTR Pos
Combination
Emergency stop
Start (F1) (Cntrl) + (F2)
Stop (F2) Print-screen

Global (Cntrl) + (F5)
STAT (F3)
Menu
Simple measurement start
Alarm (F4) (Shift) + (F2)
TabUP (F11)
Alarm sound stop
TabDOWN (F12) (Shift) + (ESC)
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2.5 LAYOUT OF SCREEN DISPLAY

The on screen display for system software is presented below. JOB MENU items are
displayed on screen and may be selected by clicking directly on screen or using the
function keys F5 to F8. System Parameter and Maintenance options cannot be
selected using function keys.
STAT information
Equipment Status JOB MENU Mode display
Shutdown button
TAB Menu
GLOBAL MENU TAB MENU SELECTION
2. 5. 1 JOB MENU
Job Menu items cover all routine operation commands including maintenance and
system settings.
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2. 5. 2 GLOBAL MENU
The Global menu includes accessory operations such as emergency stop and
alarms. These options are displayed on all the job menu screens throughout the
software.
2. 5. 3 TAB MENU
The TAB Menu is used for extra options within each Job Menu.
2. 5. 4 FUNCTION KEYS
The function keys are used to execute a function within a selected job menu screen.
Functions keys are displayed on screen and are specific to each job menu option.
2. 5. 5 EQUIPMENT STATUS
Details the operational status information displayed on screen. ‘Main status’ and
‘Sub-status’ messages that indicate the status of the analyzer are displayed.
Main status display message (left display box)

Not ready Communication with each CPU in the analyzer has not
been established.
Pre-ready The PC is on, however,cuvette water dispensing and
prime have not yet been performed.
Ready Ready to perform measurement any time.
Measurement Measurement for normal sample(s) is now in
process.
STAT-measurement Emergency samples are being measured as a priority.
Standard sample and QC samples are not measured.
MSStopping Sample dispensing is completed or being stopped, or
samples are being added to the ASP.
ESStopping Sample dispensing cannot be continued due to an
error
Sleeping The analyzer is in a sleeping status.
Maintenance Units of the analyser are operated from the
[Maintenance] screen.
Emergency Stop The analyser has stopped emergently due to
equipment abnormality or user command.
Sampling stop in progress An error that disables sample dispensing occurred.
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Sampling stop complete The measurement(s) have been completed after an

error that disables sample dispensing occurred.
Maintenance complete Operation from the [Maintenance] screen has been
completed.
Em Stop in progress The process enabling Emergency Stop is in progress.
Em Stop complete in progressRestoring from Emergency Stop status.
Sub status display message (right display box)

PowerOn The power-on process is in progress.
Preparation Either initialization of units or the SPP/RPP prime is in
progress.
Startup Process to start measurement is in progress.
AddSTAT The process to add emergency sample is in progress.
STAT measurement complete Emergency sample measurement has been
completed.
Sampling Complete Sample dispensing to cuvettes has been completed.
Measurement complete All measurement processes have been completed.
Sleep Progress Shift to the sleep mode is being prepared.
Wakeup The analyzer is booting from the sleep mode.
STATStop Emergency sample dispensing to cuvettes is stopped.
STATReStart Emergency sample dispensing to cuvettes is restarted.
ReStart Normal sample dispensing to cuvettes is restarted.
CancelSleep Preparation for the shift to sleeping status is cancelled.
Maintenance in process [Performance] Tab in the Maintenance Menu is in
progress.
Maintenance Complete [Performance] Tab in the Maintenance Menu has been
completed.
Passing The analyzer is ready after the completion of priming,
Shutdown The analyzer has been shut down.
Sampling stop in process Sample dispensing to cuvettes is stopped due to an
error.
2. 5. 6 MENU DESCRIPTION (INDICATION)

Description of information required in the selected field.
2. 5. 7 PAGE NUMBER
Page number displayed.
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2. 5. 8 STAT INFORMATION
When an emergency sample is being processed the message “STAT” (background is
red.) is displayed.
2. 5. 9 SHUTDOWN BUTTON
Pressing the Shutdown button will result in an on screen dialog box offering the
options to ‘Power Off’, ‘Sleep’ or to ‘Cancel’. Use ‘Power Off’ option to shut down the
analyser and restart PC.
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SECTION 3 SYSTEM PREPARATION AND ROUTINE ANALYSIS Version 1.0 Rev Sep 2005
SECTION 3
SYSTEM PREPARATION AND ROUTINE ANALYSIS
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3. 1 PREPARATION FOR ANALYSIS

The following checks MUST be carried out prior to commencing analysis.
3. 1. 1 INITIALISATION OF HARDWARE
Depending on Shut Down mode selected at the time of power down, the analyser can
be turned on in one of two ways:
If SLEEP MODE was selected, the unit is automatically activated according to the
conditions specified on the [MAINTENANCE / AUTOSTART F12] screen. The SLEEP
MODE can be cancelled by clicking on the [CANCEL] button displayed on screen.
This will re-initialise the analyser and make it ready for use.
If POWER OFF MODE was selected at power down, follow the instructions below:-
A) Power-on of main unit

The power switch is located on the rear panel of the main unit.
LAN connection
Power switch
Power supply point
B) Power-on of personal computer (PC)

Power on the analyser PC.
The software for the main unit starts up automatically when the PC is powered on.
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3. 1. 1. 1 MAINTENANCE SUMMARY
The table below lists the maintenance required for each run and on a daily and
weekly basis. Please see Section 6 for more details.
Interval Check point

Before • Fill system water tank with water (at least NCCLS type II water).
analysis • Check the remaining volumes of wash solutions in tanks and
refill if necessary.
• Check cuvette water blanks in [Maintenance][Wash (F10)]
(Page 2/2).
• Empty waste tanks and ensure there is sufficient printer paper.
Daily • Wipe any stains on the internal surface (inside outer lid) using a
clean damp cloth.
• Use an absorbent cloth to remove any condensation in the RCU
tray
• Clean the outside of sample and reagent probes with a swab
soaked with alcohol.
• If ISE unit is present, check the remaining volume of calibrator A
and ensure tip of calibrator A tube is at the bottom of the bottle.
• At the end of analysis perform ISE cleaning if appropriate.
Weekly NB Analyser must be switched off during weekly cleaning to

allow mechanical parts to be moved easily.
• Clean the ASP unit.

• Clean the reagent container unit (RCU).
• Clean pipette cover, trough and mosaic plates thoroughly.
• Remove wash unit cover and clean wash probes with a swab
soaked with alcohol.
• Carefully raise mixers and clean with a swab soaked with
alcohol taking care not to bend or break the mixers
• Use C1 solution as prompted when entering ‘Sleep’ mode to
clean SPT probe.
As required • Use probe cleaning tool to clean inside of the sample probe and
reagent probe.
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EXTERNAL WASTE & WATER TANKS
TUBE CONNECTION OF SWU PANEL (ON THE RIGHT-HAND-SIDE OF THE ANALYSER)
WU High Concentration waste
WU Low Concentration waste
Trough Low Concentration waste
ISE High Concentration waste
Overflow line
Pure water supply line
Wash solution Line 1
Wash solution Line 2
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3. 1. 2 SYSTEM INITIALISATION AND PRIME

After switching on the analyser and the PC, system initialisation is performed. Then 5
ISE primes, each lasting approximately one minute, will be performed.
NB Please ensure that all electrodes are installed in the ISE unit otherwise Calibrator
A may be flooded into the interior of the analyser potentially causing serious
problems.
3. 1. 2. 1 AUTOMATIC INITIALISATION
After switching on the analyser system initialisation is performed automatically and
takes around 1 minute. The analyser moves all onboard items to the home/starting
position e.g. pipettes, cuvettes, reagent wheel and sample wheel. The system will
remain in stand-by mode for 30 minutes after power on to ensure the lamp reaches
optimal intensity. It is not possible to start any measurements during this time.
3. 1. 2. 2 MANUAL INITIALISATION
Manual initialisation may be required if the operator has manually moved the probes,
for example during cleaning.
To manually initialise the instrument select the MAINTENANCE option on the Job
Menu.
1. Select MAINTENANCE option on job menu screen.
2. Select SEQUENCE [F9] screen.
3. Using the cursor press ‘Start’ button for Initialisation.
A prompt box will appear ‘Starting system initialisation’
4. Select OK
The instrument will automatically initialise.
3. 1. 2. 3 SYSTEM PRIME
Priming of the water lines within the analyser is necessary to remove trapped air
within the system ensuring optimum analytical performance.
After initialisation a pop up box will appear as shown below:
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• Click OK and the analyser will begin the preparatory mode, which fills the pure
water line and/or the wash solution line.
• When complete the analyser Status will be displayed as ‘READY’.
• Click CANCEL to bypass the preparatory mode.
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3. 2 GENERAL OPERATING PROCEDURE

The following information provides a general overview of the operating procedure for
routine use of the instrument.
Recommendations include calibration of assays exceeding their calibration interval

before any patient samples are assayed and quality control measurements at least
twice each day.
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3. 2. 1 LOAD REAGENT/ DILUENTS AND WASH SOLUTIONS

Reagents, diluents and wash solutions for analysis are located in the reagent
carousel. Up to 60 bottles in total can be stored in the cooled RCU unit.
• The reagent carousel is removed from the RCU and reagents, diluents and
wash solutions are placed in the carousel.
• Bottle caps MUST BE REMOVED before placing bottles in the carousel.
• 50 ml or 100 ml bottles are inserted on the inner ring of the carousel
• 20 ml bottles are inserted into bottle holders on the outer ring of the carousel.
• Bottles must be inserted into the holders in a position that enables the barcode to
be read.
• The reagent carousel is replaced in the RCU and the carousel is turned until the
guide pin fits into the specified position. The RCU lid is then replaced.
The analyser will only function if the lids for the RCU and ASP are correctly
placed on the analyser.
3. 2. 2 REGISTRATION OF REAGENTS, DILUENTS AND WASH SOLUTIONS
3. 2. 2. 1 REGISTRATION OF BARCODED (CLOSED CHANNEL) BOTTLES

Details of Randox closed channel reagents are pre-registered in the software.
After loading the bottles in the reagent carousel, initiate a barcode scan as below to
register the reagent bottles on the carousel. The system will then offer test options
based on the reagents registered.
1. Select RUN [F5] on the job menu
2. Select INVENTORY on the TAB menu.
3. Select the ‘RCU SCAN’ button.
4. Press START on the message box and the reagent registration will proceed.
Once complete, the software will display reagent inventory screen complete with
details based on the bottles located in the RCU.
RCU scan
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Pos
Shows the RCU position number.
The outer circumference: 1 - 30 / The inner circumference: 31 -60
Name
Displays registered reagent names.
Reagent names will be displayed by RCU scan or a manual input of a barcode.
Type
Shows reagent type.
By double clicking on the column heading, registered reagent types for open
channels will be displayed on a drop down list. (options include "R1", "R2", "Dil" and
"Wash".)
Lot
Shows Lot numbers.
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By double clicking on the column heading, details may be modified. Reagent

barcodes without a Lot number will be displayed with blank.
Size
Displays reagent bottle sizes.
By double clicking, the information can be modified.
Position numbers 1 - 30 offer options 100ml, 70ml and 50ml bottle sizes.
Position numbers 31 - 60 offer option for a 20ml bottle size.
When you change the size of a bottle, it will update its barcode.
When the bottle size is changed to a smaller option, the software will update the Vol
(or Reagent remaining) according to the initial volume of that bottle.
When the bottle is changed to a larger option, the softtware will not update the Vol.
Vol (mL)
Displays the remaining volume of the reagent (unit: 0.1mL).
When the reagent volume is low, the line of information for that position number will
be displayed in red.
When reagents are registered the software will automatically insert the maximum
reagent volume for the required bottle size in this column. Double click on the cell to
alter the details.
Tests
Shows the number of test measurements available, based on the remaining volume.
Method
Shows the method associated with the reagent.
If the reagent has been registered for several methods, the method that requires the
largest volume is displayed.
This will become blank when "Wash " is selected in "Type".
Total
The total number of tests available for the measurement is displayed, based on
volumes of each reagent in the Inventory.
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When the number of tests is less than 1, the line entry for that position is displayed in
red.
Valid
Displays the expiry date (Day /Month/ Year) for the reagent.
You can change it by double clicking on the entry and amending as required.
If reagent expiry detail is not input, its expiry date will be blank. If the expiry date has
passed, the line entry will be displayed in pink.
Stability
Displays the number of days remaining within the reagent expiry date.
‘Stability term’ is displayed for each reagent and represents the number of days
stability remaining for the reagent. When the reagent has exceeded the stability term
the information is highlighted yellow.
The software will only display this information when the ‘Stability check’ has been
enabled. To enable this check:
• Go to SYSTEM F9 on Job menu
• Go to REAGENT on the Tab menu. The following screen will be displayed:
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Enable stabliity check
• Click on the box to enable the stability check.

• Enter the required number of days in the ‘Term’ box to indicate how many days in
advance the software should notify the user. The entry should be a value of 1 to
99. If the value remains at 0 the software will not present the stability information
in the reagent registration screen.
• The Stability will be calculated based on " Valid" date and the current date, and
the value (number of days) will be displayed.
BCR
Shows reagent barcode data which can be input or altered manually by double
clicking on the entry and typing the required data.
The software will not allow the user to enter a barcode that is the same as a
registered code.
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RCU Scan
This is used to initiate a scan for reagent bottles. It will scan barcodes of bottles in
RCU and register them automatically. RCU Scan will start when you press this button.
RCU barcode scan information will automatically overwrite barcode information that is
input manually for that reagent position.
Barcode information for reagent positions will remain in the software even when the
RCU scan can not read the barcodes.
An RCU Scan may be performed with or without the RCU lid in place.
Save
Stores the updated data in this screen.
Cancel
Restores the editing data as before.
Delete
Deletes the information about the "Pos" position.
When this button is selected a confirmation message will appear on screen. Click
OK to delete, or Cancel to cancel.
Volume Reset
It will reset the remaining volume of the "Pos" position selected back to default.
When this button is selected a confirmation message will appear on screen. Click
OK to reset, or Cancel to cancel.
The position and number of tests possible for each assay is displayed. If there is a
problem with the reagent a colour coded warning will be displayed.
1 Red - Insufficient reagent inventory

2. Pink - Reagent expired
3. Yellow - On board stability period exceeded
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DELETE option will remove the relevant test from the [Run Monitor] [Test Select (F5)]
screen. When the reagents expiry are outside the ’Stability’ requirements all result
sobtained for those reagent will be flagged ‘STB’ to indicate the stability period has
been exceeded. Please note that expired reagents cannot be used on the analyser.
If a reagent bottle is not located on the RCU, or does not have a barcode or the
barcode is obstructed from the reader, the analyser will not assign a reagent position
on the carousel and will not offer the test parameter to the user on the test selection
screen. Furthermore, the parameter will not be available on the test selection screen
if a wash or diluent is enabled in the chemistry parameters but is not on board the
analyser or does not have a readable barcode.
If the barcode label is unreadable due to damage it may be necessary to enter the
barcode number printed on the label below the barcode manually.
3. 2. 2. 2 REGISTRATION OF OPEN CHANNEL BARCODED BOTTLES

For open channel barcoded bottles reagent details are not pre-registered and the
procedure described below must be carried out BEFORE loading reagents and
performing an RCU scan.
1. Select SYSTEM F9 on job menu
2. Select REAGENT on the Tab keys. The system parameters are displayed on
screen as shown below.
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SYSTEM/REAGENT screen
Reagent Code
Input a regent code. The detail of the code will be displayed when the code you input
matches one of the codes in the reagent list.
When a new code is input, all setting items will be initialized.
Reagent Name
Input a reagent name in alphanumeric within 6 digits.
The list of the reagents registered

Reagent names and codes that have been registered will be displayed.
Specify reagent bottles (R1, R2, Wash solution, and Dilution)

Input the initial volume of each bottle.
Check the "Enable " box to enable either R1/R2/ Wash / Dil . Input the volume
capacity of each bottle (mL). The software will default to the maximum capacity
volume of the specified bottle.
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Stability Check
Enable
·When the checkbox is set "ON";
It will execute a stability check for the reagent, and the stability term begins on the
day the reagent bottle is registered to the end of the reagent stability term.
·When the checkbox is set "OFF";

No stability term is defined for this reagent
Term
Input the number of the days of onboard stability for the reagent, between "0" and
"99"
Save
Saves the editing details.
When you edit the setting, this Save button will be available.
After clicking the Save button, this button is masked again.
Cancel
When you edit the setting, this Cancel button will be available.
After clicking the Cancel button, this button is masked again.
Delete
Click the item that you want to delete on the registration list, and then click the Delete
button.
When the Save button is clicked to exit the screen and save modifications, a warning
message will be displayed. (For specifying a delete, you have to save the setting.)
It will execute the delete by clicking the OK button, and stop the delete by clicking the
Cancel button.
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The following REAGENT REGISTRATION screen will display fields in which the
reagent information should be entered.
3. Enter the open channel code in the REAGENT CODE field. This is the first two
characters of the barcode only, for example OA.
4. Enter the reagent description in the REAGENT NAME field (up to 6 characters).
5. Click the ENABLE button to activate reagent fields for R1, R2, Wash or Diluent as
appropriate.
6. Enter exact volume of R1 contained in either large bottle (100ml; Volume L),
medium bottle (50ml; Volume M) or small bottle (20ml; Volume S) as appropriate.
This volume will be used initially to calculate the number of tests possible from the
bottle.
7. Repeat for R2 if necessary. If there is no R2 ensure that the R2 ENABLE box is
not activated.
8. Click on the ENABLE button for a STABILITY CHECK if reagent stability monitor-
ing is required. Then enter a number in the TERM field to indicate the on board
stability period in days.
9. Click on the OK button and then the SAVE button on the reagent code screen.
3. 2. 3 REGISTER CALIBRATORS, CONTROLS AND PATIENT SAMPLES

Periodical calibration is required for each item in order to perform stable and accurate
measurement (see kit insert for details). Calibrator and control details need to be
registered in the software. Multi-controls and calibrators can be used for a number of
tests. Please see Section 4.3 for more detailed description of how to perform
calibration using single standards (S), multi standards (MS) and automatic
preparation of calibration dilution series from a single standard (SS).
3. 2. 3. 1 CALIBRATION TYPE
There are two possible types of calibration. The software determines whether a full
calibration (MASTER) or re-calibration (WORK) is performed based on the number of
calibrators placed in the unit.
Calibrator samples can be placed in either the internal cooled ring of the ASP
(position numbers 73-90) with manual identification of each sample, or the external
ring of the ASP (Pos No. 1-72) with barcode identification of the samples.
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Calibrator samples placed in the outer ring of the ASP are generally placed in
positions prior to the patient samples. In non-barcoded mode (inner cooled ring) the
calibrator series must be placed on the ASP in order of increasing concentration
(lowest concentration first).
The software will select the calibration type based on the number of calibrators placed
on the sample carousel.
• Full calibration (MASTER)
A Full calibration is carried out using all calibrators and the results are used to
update the master calibration curve. The calibration curve produced with full cali-
bration is the ‘Master calibration curve’. We recommend that a full calibration is
carried out for each assay after it has exceeded its defined calibration interval.
• Re-calibration (WORK)
The work calibration curve is updated using one or more selected calibrators. The
calibration curve produced with re-calibration is the ‘Work calibration curve’. This
curve is used to calculate the final result. In most cases the WORK and MASTER
curves will be the same unless recalibration is carried out. However we do not rec-
ommend re-calibrating with less than the full number of calibrators.
3. 2. 3. 2 CALIBRATION FOR DIFFERENT REAGENT LOTS

It is possible to store 2 different calibration curves in the analyser that correspond to
different lots of reagent. These are stored as ‘New’ and ‘Old’ calibration curves.
When a full calibration is first carried out the reagent lots used to generate the curve
are displayed under ‘Lot No (R1)’ and ‘Lot No (R2)’ fields on the [Calibration] [Reag.
Calib] screen. Since this is the first calibration the reagent lots are marked as ‘New’. If
another calibration is performed using the same or different lot numbers of reagent
the most recent calibration is then displayed as ‘New’ and the previous calibration is
moved to ’Old’. Switch between viewing the ‘New’ and ‘Old’ calibrations by using the
drop down box provided.
Processing of reagent lot numbers at calibrations
Full / Part Lot numbers Process
Full Different It will store the calibration result in “Old”, update the time
stamp and make it “New”.
Full Same It will overwrite the existing data with the lot number, update the time
stamp and make it “New”.
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Full No Lot Nos It will overwrite “New” from “Old” without comparing the lot numbers
and update the time stamp.
Part Different It will update “New” and time stamp both.
Part Same It will update the lot numbers that matched, and update the time
stamp.
Part No Numbers It will overwrite “New” from “New” without comparing the lot num-
bers and update the time stamp.
Full ------ It will update the number currently being displayed.
Part ------ It will update the number currently being displayed.
3. 2. 3. 3 REGISTRATION OF STANDARDS AND DEFINING CONCENTRATIONS

Before calibration is performed, concentration values of each calibrator must be
entered in the software as described in this section. When a new round of
measurement is initiated, the software checks that a valid calibration is available for
the reagent lots registered in the inventory. If a valid calibration is not available the
results are displayed with a ‘CLT’ flag.
1. Click on CALIBRATION (F7) on Job Menu and REAG CALIB in the Tab menu.
The following screen will appear:
CALIBRATION SCREEN
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2. To select a test, move the cursor on the METHOD field and click on the arrow to
view the scroll down list of all registered methods.
3. Select the test of interest and press RETURN. The software will automatically
present the test as a method number (according to the registered methods). The
reagent lot numbers for the selected test are displayed on screen if the test has
been previously calibrated.
4. To select sample type click on the SAMPLE scroll down button to view the
options. Options include ‘Common’ (all sample types), ‘Serum’, ‘Plasma’ and
‘Urine’. This information is used to specify the sample type to enable comparison
of results with normal range values for the same sample matrix.
5. Click on the SAMPLING scroll down button to view options which include ‘Dupli-
cate’ or ‘Triplicate’. This will determine the number of repeats required per calibra-
tion sample.
6. The expiry of the calibration curve can be entered manually in the CHECK INTER-
VAL (days) field. This field defaults to ‘0 days’ when the option is not in use.
7. If this option is selected a warning will appear in the TEST SELECTION screen
when the calibration has expired.
8. Click on the TYPE scroll down box to select the calibration type. Options include
Factor, Linear, Point to Point, Log-Logit, Spline and Exponential.
9. The software stores two calibration graphs for each lot number. In the LOT field
the software offers two options: NEW -most recent calibration graph and OLD -
the previous calibration graph for the specified lot number.
10. Click on the VALI D TERM scroll down box and select the date of expiry for the
calibrator. When the calibrator expires the measurement methods will be dis-
played in Orange in the RUN/SELECTION screen.
11. Click on the MATERIAL NAME field and input the required information for identifi-
cation of the calibration material lot number. (alphanumeric, 8 letters).
12. When available, the calibration curve will be displayed on the right side of the
screen.
13. Move the cursor to the first field in the CONC column and enter the calibrator con-
centrations for each calibrator. The WORK and MASTER columns will automati-
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cally display the absorbance measurements obtained during the previous

calibration and display results on the graph.
14. In the LOT NO(S) column input the lot number details for each calibrator. To apply
a lot number to all calibrators in the series input the Lot number Check the ‘All’ tick
box to apply a lot number to all calibrators in the series.
15. Click on the SAVE button to save the details.
3. 2. 3. 4 K FACTOR
For some assays (e.g. most enzymes) the reaction is always linear and a factor may
be used to calculate the results of unknown samples. In this case a calibration does
not need to be performed.
• To use a factor to calculate results select FACTOR for the calibration calculation
TYPE. Input the factor in the K field at the bottom of the screen.
• Click on SAVE to store the details.
When the factor option is selected the concentration of a sample is calculated using
the following equation:
C = K*A + B
where
C= concentration
A= measured absorbance
K factor = (pre-defined factor)
B =Reagent blank concentration.
This conversion method by defining the parameter K is called the "K-Factor" method.
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Concentration calculations for out of range calibrators

Calibration Range OVR flag Calculations for conversion of The conversion of
curve types Concentration concentrations concentration value
unless the calibration
curve is extended.
Factor Whole NO An extended line of a calibration

curve is used.
Linear ・Below S1 NO An extended line of a calibration

・Over Sn curve is used.
Spline ・Below S1 YES A tangent line of a calibration S1

curve in S1 is used.
・Over Sn YES A tangent line of a calibration Sn

curve in Sn is used.
Point to Point ・Below S1 YES An extended calibration curve S1

between S1 and S2 is used.
・Over Sn YES An extended calibration curve Sn

between Sn-1 and Sn.
Log Logit ・Below S1 YES The conversion of concentration is S1

(S1 concentra- executed by using the collinear
tion=0) approximation.
・Below S1 NO A tangent line of a calibration

(S1concentrati curve in S1 is used.
on<>0)
・Over Sn NO A tangent line of a calibration

curve in Sn is used.
3. 2. 3. 5 RECALCULATION OF RESULTS
This enables the user to re-calculate patient results from an absorbance
measurement using either a WORK or MASTER calibration curve. This option is
useful when developing a user defined open channel assay.
1. Click on the scroll down option in the TYPE field on screen and select WORK or
MASTER option.
2. Enter the absorbance value in the ABSORBANCE field below.
3. Click on RECALCULATION to view the corresponding concentration.
4. Repeat the process for each sample value. The software will NOT store the re-cal-
culated values.
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RECALCULATE SCREEN FOR ABSORBANCE VALUES
3. 2. 3. 6 DEFINITION OF CALIBRATOR CONDITIONS OF MEASUREMENT

The conditions of measurement default to predefined values for closed channel
assays but may be changed as required.
1. Go to CALIBRATION / REAG CALIB screen.
2. The calibraton screen which include S1 BLANK and REAGENT BLANK FOR S1.
These options are only available if activated in the PARAMETER/NORMAL 2
screen. The S1 BLANK option applies only to ‘Factor’ or ‘Linear’ whereas the
REAGENT BLANK FOR S1 applies only to ‘Linear’ calibration graphs.
3. Go to PARAMETER/NORMAL2 screen. This allows the user to set parameters for
each test method which then applies to all samples including calibrators and con-
trol samples.
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1. Move the cursor to the METHOD field on the screen and select the method using
the scroll down key.
2. Select the test of interest and press RETURN.
3. Go to the SAMPLE field and select the sample type. Options include ‘Common’,
‘Serum’, ‘Urine’ or ‘Plasma’.
The user can then define the Limit checks and the Blank measurement checks.
3. 2. 3. 6. 1 DEFINITION OF LIMIT CHECKS

There are several limit checks available for the calibration and reaction that detect if
the reaction has taken place within acceptable criteria. Appropriate flags are given on
calibration report or results screen to those measurements outside acceptable limits.
Please note these limits are predefined for closed channel assays and we
recommend that they are not altered.
Limit Checks
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Duplicate Limit Enter a value between 1 and 35000mabs / 10.

This is the maximum acceptable absorbance difference between duplicate and
triplicate measurements.
Triplicate – if the calibrators are measured in triplicate and 1 result exceeds the limit
and the other two are within the limit, the third value will be excluded and only the two
acceptable values will be used for the calculation. If calibrators are measured in
triplicate and two of the three measurements are not within the duplicate limit, a DUP
flag will be printed and the calibration will fail.
Duplicate – if the calibrators are measured in duplicate and the duplicate limit is
exceeded, a DUP flag will be printed and the calibration will fail.
Sensitivity Limit Enter a value between 0 and 35000mabs / 10.

The minimum acceptable absorbance difference between first and last calibrators in a
series. If the difference in absorbance between the first and last calibrator in a series
is less than the sensitivity limit a SENS flag will be printed and the calibration will fail.
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Linearity Limit
The linearity of kinetic assays (RATE calculation) is calculated by measuring the
deviation of the reaction curve from the linear behaviour. If the specified value is
exceeded, the system gives a LIN flag indicating that the sample has failed the
linearity check, with the result.
1. measuring point of
ABS the measuring range
dABS total
n. measuring point of
the measuring range
dABS first
dABS last
time
Change 4 measurement points by the
calculation using the moving average.
ABS Calculate slope by least squares method
dABS first
dABS last
time
The linearity value L is the difference in absorbance change between the first four and
the last four measured points (of the measuring range defined in chemistry
parameters) as a percentage of the total slope of the measuring range. If the linearity
value exceeds the given linearity value (chemistry parameters), the result is flagged
with LIN.
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Formula of linearity value L in %:
dABS first – dABS last

L = ----------------------------------------------------- × 100 %
dABS total
dABSfirst and dABSlast are both differences between two ABS values. dABStotal is
calculated using the least squares method as described above. The water blank
corrected absorbance values are used. Absorbances are in mAbs/min.
The linearity check is not performed in the following cases:
(1) The number of measuring points in the measuring range used for calculation of
dABStotal is 4 or less
(2) dABS total ≤ x (mABS/min)
(3) dABS first – dABS last ≤ x (mABS/min)
The value of x should be specified for each assay.
Prozone Limit Enter a value between 0.00000001 and 9.9999999 %

This option is used to detect decreasing absorbance (prozone) in a method. Input the
required limit value and then select UPPER or LOWER option, to indicate whether the
limit is applied to the max or minimum value in the Prozone Limit.
Specify an absorbance rage and sensitivity;

(a) SL1 - S: the first number of measuring point of Slope Range-1
(b) SL1 - F: the last number of measuring point of Slope Range-1 (SL1S < SL1F)
(c) SL2 - S: the second number of measuring point of Slope Range-2
(d) SL2 - F: the last number of measuring point of Slope Range-2 (SL2S < SL2F)
(e) Sens: Input a number between 1and 999999 (mAbs/10) for the sensitivity setting.
A Prozone error will appear if the limit value is exceeded. A PRO flag will be attached
to the result.
Prozone check will no be executed in the following cases;
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(a) Measurement of control samples

(b) A case that the sensibility cannot exceed the value of "Sensitivity Limit".
Absorbance Limit Applies to the rate method only.

Enter a value between 1 and 35000 mabs / 10.
This is the maximum allowable absorbance obtained during the measuring range for
an increasing reaction and the minimum allowable absorbance obtained during the
measuring range for a decreasing reaction. If the absorbance at one or more of the
measuring points exceeds the limit the results will be recalculated based on the
remaining points that are within the limit.
When none or only one ABS at the primary wavelength in the measuring range is
within the absorbance limit, calculation of concentration is not possible. The result is
output with flag AB1
When only 2 or 3 ABS at primary wavelength in the measuring range are within the
absorbance limit, the concentration is calculated and the result output with flag AB2
The limit of the curve is defined in mAbs/10

Selection of a reaction curve: ‘Increase’ means increasing absorbance
over measuring time and ‘decrease’ means descreasing absorbance
over measuring time.
In case of increase: Absorbance values greater than the limit value are
disregarded.
In case of decrease: Absorbance values less than the limit value are
disregarded.
3. 2. 3. 6. 2 DEFINITION OF BLANK MEASUREMENTS

On the right of the screen the software enables the user to define the blank
measurement criteria.
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1. Click on the BLANK MEASURMENT scroll down box and select the option of
interest. Options include
•DISABLE REAGNT BLANK AND S1 BLANK - Reagent or S1 blank not used for
calibration.
•ENABLE S1 BLANK (factor or linear) - calibration performs an S1 blank (factor or
linear).
•ENABLE REAGENT BLANK - calibration performs a reagent blank.
•ENABLE REAGENT BLANK OR S1 (linear) - uses the reagent blank as the S1 in
the calibrator series.
2. Select the option required and press return.
3. Click on the MEASURMENT OF REAGENT BLANK DURING RUN field scroll
down box to select how often the blank measurement is performed. Options
include Daily (every day), Next Run (performs a reagent blank at the start of each
round) or None (no reagent blank).
4. Click on the REAGENT BLANK MEASUREMENT AT CALIBRATION and select
an option. Options include :
• Reagent blank with no sample R1 + R2
• Reagent blank with system water R1 + R2 + x µl system water (x=sample vol-
ume)
5. Click on the NUMBER OF MEASURMENT and select either Single, Duplicate and
Triplicate as required.
6. Click on the REAGENT BLANK LIMIT CHECK box to activate the limit check.
Then input the absorbance value in the adjacent field (Enter a value between 1
and 35000). This is the maximum acceptable absorbance difference between
blank measurements.
3. 2. 3. 7 QUALITY CONTROL SAMPLES

The software enables registration of up to 40 quality control sample types.
• Select QC [F8] on the job menu.
• Select REGISTRATION from the TAB keys.
• Move cursor to the Control ID field and type the control ID number (select from
C1-C40)
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• Move cursor to the NAME field and enter a user-defined name for the control.(e.g.
Level 2, 236UN). Tests that have already been registered will be visible on screen.
• Click on the scroll down bar of the SAMPLE field and select the sample type.
Options include Common, Serum, Urine and Plasma.
• Click on the LOT NO field and enter the lot number details.
• The software displays the methods that use the current control sample in the USE
FOR METHODS field.
• Click on the SAVE button to save the information.
• A list of registered controls are displayed on the right of the screen.
QC REGISTRATION SCREEN
After registering the QC sample name, the next step involves registration of tests to
be performed on each QC sample. For each analyte the mean value and SD for the
QC sample must be entered so that a Levy-Jennings plot and QC statistics can be
generated.
1. Select QC [F8] on job menu.
2. Select QC SETTINGS [F11] on Tab keys and the following screen will appear:
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QC settings field
3. Move the cursor to the METHOD field and select the method name from the scroll
down box in the field. The software identifies test methods numerically and the
user can input a method number, if known. The number of methods stored in the
software are as follows:
•General Biochemistry (nos 1-60) : 60 methods
•ISE (nos 1001-1003) : 3(6) methods
•ISE (nos 1005-1007) : 3 methods
•SI (2001-2003) : 3 methods
•Calculated methods(3001-3040) : 40 methods
•Common : 3 methods for ISE and 3 methods for ISE(D)
•Serum/Plasma :3 methods of ISE
•Urine :3 methods of ISE (D)
4. Select a test method by clicking on the name and press RETURN. The software
will automatically display any previous QC results for the different levels.
5. Click on the SAMPLE field and select the sample type, options include Common,
Serum, Plasma and Urine.
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6. Click on the INTERVAL field and input the time interval between each control run.
Input values between 0 and 999 minutes. When the interval time from the previous
control run has passed the software will display the method name in the RUN/
SELECTION field in yellow and a CXP flag will be attached to the measurement
result.
7. In the MODE field select between options MEAN-R and X-R.
•MEAN-R - the software uses the value input in the MEAN VALUE and SD field to
produce the Levey-Jennings graph.
•X-R - the software uses the a cumulative mean value and SD from a previous
number of runs. The number of runs is specified in the No. field.
8. The user can input up to three control materials per method name. Click on the
field under the CONTROL NAME.
9. Enter the required information by clicking on the field of interest and entering the
values for mean and SD.
10. Select QC Multirules as appropriate. Click on the scroll bar adjacent to the
required rule and three options will appear, INACTIVE, ERROR and WARNING.
Click on the option of interest and the rule will be activated if appropriate.
11. Click SAVE to save the information.
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QC SETTINGS
Rules (QC Multi-rules)

The limits of standard deviation are plotted in dotted lines on the graphic display.
QC Multi-rules are used to define the judgment condition of the QC results. The
options are as follows:
Current result exceeds 2SD Current result exceeds 3SD

Current result exceeds 4SD Last 2 results exceed 2SD
2 out of last 3 result exceeds 2SD Range exceeds 4SD
Any 3 results exceed 1SD Any 4 results exceed 1SD
10 results same side of mean 7 continue point trend
For each test there is an option to select any combination of the ten rules displayed
above. Select one of the following - INACTIVE, WARNING, or ERROR.
INACTIVE – The software will default to this option and the adjacent QC Multi-rule will
not be applied.
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WARNING – When this option is selected for a given rule the software will display any
QC result that violates the rule as a YELLOW dot on the QC chart. These results will
be included in the overall mean and SD statistics displayed on the QC chart.
ERROR – When this option is selected for a given rule the software will display any
QC result that violates the rule as a RED dot on the QC chart. These results will NOT
be included in the overall mean and SD statistics displayed on the QC chart.
3. 2. 4 TEST SELECTION FOR PATIENT SAMPLES

The user must specify for each sample which tests to perform on the Run (F5) on the
job menu and Monitor on the TAB menu. The procedure for selecting tests is different
depending on whether the sample barcode is enabled or disabled. [SYSTEM (F9)/
SETUP].
The software also offers the facility to download test sample selection information
directly from a host computer.
3. 2. 4. 1 ACTIVATE THE BARCODE OPTION

• Click on SYSTEM (F9) on the job menu and SETUP on the Tab menu. The follow-
ing screen is displayed.
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• SYSTEM /SETUP menu
• In the SAMPLE section (highlighted on the above screen) the user must activate
the barcode option.
• Click on the ‘Sample Number Increment’ option and select as required, options
include Numeric only, Alphanumeric (Upper case) and Alphanumeric (Upper and
Lower cases). This facility specifies how the software automatically increments
sample numbers e.g. 1, 2, 3 vs A, B, C. This will default to Numeric Only.
• The ‘Upper Sample Number’ field specifies the upper digits of the sample bar-
code. The software will input this prefix before sample barcode numbers when the
BCR option is active. This field should remain blank is a barcode prefix is not
required.
• The ‘Length’ field specifies the number of digits in the sample barcode. For exam-
ple when the prefix is 999999999 and the length is 12, when the user inputs the
digits 001 the software will identify the sample as 999999999001(12 digits).
• To enable the barcode facility click on the ENABLE option or DISABLE to deacti-
vate the barcode facility.
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• The user can define the barcode types for sample barcodes by selecting from the
scroll down menu in each field.
Types Selection items Details
UPC(JAN) Blank No use
With check digit Use with check digits
NW7 Blank No use
Without check digit Use without check digits
Code39 Blank No use
ITF Blank No use
Code128 Blank No use
• Click on the SAVE option to store the details
3. 2. 4. 2 TEST SELECTION FOR BAR-CODED PATIENT SAMPLES

A barcode scanner in the ASP will identify the sample in each position number on the
carousel. The instrument accomodates 72 positions with a barcode facility, and the
software automatically removes a sample from the test menu when the tests have
been completed.
The user must select the test options required for each sample in the carousel.
Alternatively a handheld barcode scanner can be used to input sample details.
• Go to RUN (F5) on the job menu and SELECTION on the Tab menu to view the
test selection screen as shown below.
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Test Selection
ISE selection
Profile selection
• The POS is the sample position number and should remain blank when barcoded
samples are placed in the ASP. The blank option is available above the 01 option
in the scroll down box. The software will apply a sample position number to this
selection when the barcode is scanned in the ASP.
• Select the sample type in the TYPE field. Click on the scroll down bar in this field
and select as required, options include Normal, STAT, Replicate, Standard, Multi
Standard, Serial Dilution, Control, Blank, Mask, Orderless, Online, ISE Calibra-
tion, ISE Clenaing, SPT Wash. For details of options see section ????.
• Select the NORMAL option and the software will display SID (Sample identifica-
tion) and PID (Patient Identification) fields.
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Normal sample xxxxxxxxxxxxnn1 (3 to 12 digit display)
Normal Pediatric sample 8999xxxxnn1
STAT sample 99000xxxnn1
STAT Pediatric sample 990009xxnn1
Control sample 970000xxnn1
Standard sample 98xxxxxynnm
Multi-Standard sample 950000xynnm
Serial Dilution sample 93xxxxxynnm
Replicate sample 9400xx0111
ISE Standard sample 960000xx11
ISE Cleaning 960001xx11
Orderless sample 920000xx11
Blank sample 9510000xnnm
Reagent Blank sample 91xxxxx1nnm
Water Blank sample 000000xx
“nn” indicates the measurement times, “m” indicates repeat times, and “y” indicates the
solution number(1 to 7).
• Click on the scroll down bar in the CUP field and select NORMAL (other option is
Pediatric, when using paediatric sample cups).
• Click on the BCR tick box.
• Click on the SID field and enter the sample number exactly as printed on the bar-
code label. For a Normal sample a 3 to 12 digit numerical code from 001 to
999999999999 is acceptable. Do not use codes from 94000001 to 99999999 for
patient samples.
• When using a handheld barcode scanner, click on the SID field and then hold the
scanner over the sample barcode label and click to read the label. The software
will automatically input the sample details on screen.
• Click on the PID scroll down box and select the patient details (if required).
• Click on the Physician scroll down box and select an option (if required).
• Click on the Location scroll down box and select an option (if required).
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• Click on the SAMPLE field scroll down box and select an option to specify the
sample type. Options inlcude Common, Serum, Urine, Plasma.
• Click on RANGE to select a normal range applicable for the sample. There are
various sex and age related options available. The HUMAN-AUTO option is used
when the patient details have been input in the RUN/PATIENT screen. The soft-
ware will automatically apply a normal range value based on the sex and age
inputs specified. When the age of the patient is not specified the software will use
the middle generation G2 option.
• To select a test option click on the tick box beside each test listed in test section
on screen. Methods are displayed on screen for reagents present in the RCU only.
ISE and profile selection options are also displayed on screen. See section ?? for
details.
• Click on the NUMBER field to specify the number of replicates required for the
sample. This will default to 01 and will enable the instrument to perform up to 99
replicates of the same sample. This option is only available when a NORMAL
sample type is selected.
Please note that methods utilising a diluent will NOT appear for selection
unless the diluent is registered on board the analyser.
Methods are flagged with different colours to warn the user as follows:
RED colour (general methods) Calibration has expired
RED colour (ISE) No valid ISE calibration stored
YELLOW colour QC interval has been exceeded
12. Click on the SAVE icon to confirm selection. This process is performed individually
for each sample or the user can use the COPY facility to apply a test selection to
multiple samples.
PLEASE NOTE: Position numbers 1-72 are located on the outer ring of the ASP and
accommodate sample tubes with a barcode reading facility. Position numbers 73-92
are located on the inner ring of the ASP and accommodate sample cups only, without
a barcode reading facility.
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3. 2. 4. 3 COPYING TEST SELECTIONS FOR BARCODED PATIENT SAMPLES

When a number of samples are presented for the same test profile, the test sample
selection details may be applied to the samples using the C/D facility in th RUN/
SELECTION screen.
The first sample must already have had a test sample selected and saved before the
copy facility is used. After entry of a test menu for a sample follow the instructions
below.
• Click on the sample number in the SID list on the left of the screen which has the
test selection required. The software will display the selected SID in the upper
field.
• Click on the C/D tick box to activate the copy function. The lower SID field will
become activated. In this field enter the barcode number of the sample to which
the test selection is required.
• Click on SAVE to store the test selection details.
• Test selection details may be copied to multiple samples in a series with seqen-
tially increasing sample barcode numbers. After activating the C/D function enter
the sample barcode number of the last sample in the series. When the user clicks
on SAVE the software will automatically apply the test selection to all samples in
the series and display them in the SID list.
3. 2. 4. 4 DELETING TEST SELECTIONS FOR BARCODED PATIENT SAMPLES

When measurement is complete the test selection for each sample is deleted
automatically. The same measurement will not be performed if the sample is re-
introduced into the ASP at a later date.
This facility offers the option to delete a test selection before starting the run.
• Click on the sample number in the SID list on the left of the screen. The software
will display the selected SID in the upper field.
• Click on the DELETE button to delete the current sample from the test list.
• Click on SAVE to confirm the deletion.
• To delete multiple samples in the test list, click on the C/D tick box to activate the
copy/delete function. The lower SID field will become activated. In this field enter
the barcode number of the last sample in a series to be deleted.
SID (upper) 12345001 SID (lower) 12345009
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• Click on DELETE button.

• Click on the SAVE function to confirm the deletion.
• Click on the DELETE ALL button to delete all the test selections in the current list.
3. 2. 4. 5 TEST SELECTION FOR NON BAR-CODED PATIENT SAMPLES

The user must select the test options required for each sample in the carousel.
The user must ensure that the barcode option is disabled in the SYSTEM (F9)/
SETUP screen. Click on the DISABLE option in the ‘Sample Barcode’ field.
• Go to RUN (F5) on the job menu and SELECTION on the Tab menu to view the
test selection screen as shown below.
•
Test Selection
ISE selection
Profile selection
• The POS field represents the sample position number. Click on the scroll down
box and select the sample position number. The software will only offer sample
position numbers 1-72 on this screen. Position numbers 73-92 are located in the
inner sample cup ring and test selection is performed as described in ???.
ABC Page 105

• Select the sample type in the TYPE field. Click on the scroll down bar in this field
and select as required, options include Normal, STAT, Replicate, Standard, Multi
Standard, Serial Dilution, Control, Blank, Mask, Orderless, Online, ISE Calibra-
tion, ISE Clenaing, SPT Wash. For details of options see section ????.
• Select the NORMAL option and the software will display SID (Sample identifica-
tion) and PID (Patient Identification) fields.
• Click on the scroll down bar in the CUP field and select NORMAL (other option is
Pediatric, when using paediatric sample cups).
• Click on the SID field and enter the sample number as required.
• Click on the PID scroll down box and select the patient details (if required).
• Click on the Physician scroll down box and select an option (if required).
• Click on the Location scroll down box and select an option (if required).
• Click on the SAMPLE field scroll down box and select an option to specify the
sample type. Options inlcude Common, Serum, Urine, Plasma.
• Click on RANGE to select a normal range applicable for the sample. There are
various sex and age related options available. The HUMAN-AUTO option is used
when the patient details have been input in the RUN/PATIENT screen. The soft-
ware will automatically apply a normal range value based on the sex and age
inputs specified. When the age of the patient is not specified the software will use
the middle generation G2 option.
• To select a test option click on the tick box beside each test listed in test section
on screen. Methods are displayed on screen for reagents present in the RCU only.
ISE and profile selection options are also displayed on screen. See section ?? for
details.
• Click on the NUMBER field to specify the number of replicates required for the
sample. This will default to 01 and will enable the instrument to perform up to 99
replicates of the same sample. This option is only available when a NORMAL
sample type is selected.
Please note that methods utilising a diluent will NOT appear for selection
unless the diluent is registered on board the analyser.
Methods are flagged with different colours to warn the user as follows:
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RED colour (general methods) Calibration has expired

RED colour (ISE) No valid ISE calibration stored
YELLOW colour QC interval has been exceeded
13. Click on the SAVE icon to confirm selection. The software will automatically prefix
the sample description with digits to form a 12 character sample identification
code. e.g. if sample user types REF1, the software will present the sample ID in
the SID field as 99999999REF1 when clicking on the SAVE button.
14. This process is performed individually for each sample or the user can use the
COPY facility to apply a test selection to multiple samples.
3. 2. 4. 6 COPYING TEST SELECTIONS FOR NON BARCODED PATIENT SAMPLES

When a number of samples are presented for the same test profile, the test sample
selection details may be applied to the samples using the C/D facility in th RUN/
SELECTION screen.
The first sample must already have had a test sample selected and saved before the
copy facility is used. After entry of a test menu for a sample follow the instructions
below.
• Click on the sample number in the SID list on the left of the screen which has the
test selection required. The software will display the selected SID in the upper
field.
• Click on the C/D tick box to activate the copy function. The lower POS field will
become activated. In this field enter the position number of the last sample in the
series to which the test selection is applied.
• Click on SAVE to store the test selection details.
• The software will automatically apply the test selection to all the position numbers
specified, and will use the information in the SID field of the first sample and
numerically increment each position in the series. For example: when copying the
test selection from position 1 (SID = ED001) to position number 10, the SID of
each sample is described as ED0**, where the ** is numerically incremented.
POS (upper) = 01 SID= ED001
POS (lower) = 10 SID= ED010
•
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3. 2. 4. 7 DELETING TEST SELECTIONS FOR NON BARCODED PATIENT SAMPLES

When measurement is complete the test selection for each sample is deleted
automatically. The same measurement will not be performed if the sample is re-
introduced into the ASP at a later date.
This facility offers the option to delete a test selection before starting the run.
• Click on the sample number in the SID list on the left of the screen. The software
will display the selected SID in the upper field.
• Click on the DELETE button to delete the current sample from the test list.
• Click on SAVE to confirm the deletion.
• To delete multiple samples in the test list, click on the C/D tick box to activate the
copy/delete function. The lower SID field will become activated. In this field enter
the barcode number of the last sample in a series to be deleted.
SID (upper) 12345001
SID (lower) 12345009
• Click on DELETE button.

• Click on the SAVE function to confirm the deletion.
• Click on the DELETE ALL button to delete all the test selections in the current list.
3. 2. 4. 8 MASKING OPTION (BAR CODED AND NON BARCODED SAMPLE MODES)

The mask feature allows the user to switch ON/OFF the availabiltiy of test methods.
When tests are masked, they are switched OFF and will not be performed until the
user un-masks the test.
Procedure:
1. Click RUN on the job menu and SELECTION on the Tab menu.
2. Click on the scroll down bar on the TYPE field and select MASK. The software will
display a list of test options on the right of the screen.
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MASK OPTION FOR STANDARD (NORMAL SAMPLE)
Test options are presented with a ‘tick box’.
Tick mark absent 2 Method

Tick mark present
list
Mask ON Mask OFF
Test Not available Test available
All tests available for assay are presented with a ‘tick mark’. Click on the MASK ALL
function to inactivate all test methods or CLEAR ALL function to un-mask the test
options.
NB: When the MASK ALL function is applied the software will not perform any tests.
The mask function applies to all samples including patient samples, profiles, controls
and calibrator samples.
3. Click on the SAVE button to store test selection.
Please note that the MASK options selected here applies to all future runs and must
be reversed before test options are made available.
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3. 2. 4. 9 TEST SELECTION FOR BARCODED STANDARD AND CONTROL SAMPLES

A barcode scanner in the ASP will identify the sample in each position number on the
carousel. The instrument accomodates 72 positions with a barcode facility, and the
software automatically removes a sample from the test menu when the tests have
been completed.
The software will identify the sample from the barcode as a control or calibrator and
will automatically select all test options selected in the QC/Registration screen for
controls and CALIBRATION/Multi-Std for calibrators. The MASK function can be used
to deselect test options, see section 3. 2. 4. 8“Masking option (Bar Coded and Non
Barcoded Sample Modes)” on page 108.
• Controls or calibrators are placed in the sample tube tray of the ASP and the soft-
ware recognises the sample and runs all tests registered. Test selection is not
required.
3. 2. 4. 10 TEST SELECTION FOR NON- BARCODED STANDARD AND CONTROL SAMPLES

Position numbers 73-92 are located on the inner ring of the ASP and accommodate
sample cups only, without a barcode reading facility. Control and calibrator samples
should be placed in the inner, cooled ring to ensure onboard stability of the samples.
The inner ring does not have a barcode reading facility.
• Click on RUN (F5) on the job menu and StdQC on the tab menu.
• Click on the TYPE field and select an option. Options include Standard, Multi-
standard, Serial dilution, Control, Blank, ISE Cleaning and SPT wash.
• When click on multi-standard, select the SAMPLE TYPE and the name of the
standard in the MS field.
• When click on Control, select the control name from the scroll down bar in the
CONTROL field.
• When click on Standard, select the sample type.
• The software will automatically perform all registered tests on the control or cali-
brator sample. To deselect tests for a run use the MASK function, see section 3. 2.
4. 8“Masking option (Bar Coded and Non Barcoded Sample Modes)” on
page 108.
ABC Page 110

• Click on the SAVE function to store the selections. The software will automatically
assign a sample position number to each sample.
3. 2. 4. 11 CALIBRATION AND CONTROL EXPIRY ALARM

Expiry of the calibration interval or the QC interval is indicated in the test selection
screen. Test names will be displayed in different colours according to which interval
has expired.
Calibration interval expired - test displayed in RED
QC setting interval expired - tests displayed in YELLOW
No stored ISE calibration - ISE button displayed in RED
If these intervals have expired a new calibration or QC run is required. However if this
is not carried out the sample will be analysed and the results will be flagged.
NB ISE calibration MUST be performed if ISE button is displayed in RED to obtain

results for ISE measurement.
3. 2. 5 LOADING CALIBRATORS, CONTROLS AND BARCODED PATIENT

SAMPLES
Normal samples, emergency samples, control samples and standard samples can be
placed into the two types of trays in the Auto Sampler Unit (ASP) of the analyzer.
The ASP tray mechanism is equipped with a removable, double structure, which can
hold samples as described below.
1. Outer Tube tray (accomodates 72 samples):

Affixing barcode labels to the tubes enables barcode control. Sample cups placed in
tubes with barcode labels can also be barcode controlled.
2. Inner Sample cup tray (accomodate 20 samples):

The sample cup tray is located in the innermost layer of the ASP and used to place
samples such as calibrator and control samples. Barcode control is not available for
ABC Page 111

sample cups placed in the inner ring. The inner ring is cooled and may be removed
independently of the outer ring.
Measurement begins with the test order for the sample cup tray in the innermost
circle, and then the test order for the tube tray is performed
Load the ASP carousel with calibrators, controls and patient samples respectively.
The ASP rotates in a counter clockwise direction and samples are aspirated in the
order in which they reach the SPT position. Place samples in the outer tube tray
according to the following guidelines:
• Place calibrators in front of patient samples.
• Calibrators in a series should be placed in increasing order of concentration.
• Quality Control samples can be placed in any position but ideally should be placed
after the calibrators.
• CAL B or wash solution should be placed at position 18 on the ASP, when appro-
priate.
Please note: Calibrators and controls should be placed in the inner cup tray in the
ASP as it is cooled and will offer better onboard stability.
3. 2. 5. 1 SAMPLE TUBES
The following sample tubes can be used.
Diameter: 13 mm ~ 16 mm
Length: 75 mm ~ 100 mm
Ensure that barcode labels are applied correctly to the sample tubes. This enables
the barcode reader to identify the sample. (See Accessory functions section).
3. 2. 5. 2 SAMPLE CUPS
Sample cups may be used in the analyser by placing them in either the inner ring of
the ASP, or on the outer ring in a bar coded patient sample tube as shown below. The
sample tube with cup can be loaded into the ASP carousel and identified by the
barcode on the sample tube.
ABC Page 112

3. 2. 5. 3 PAEDIATRIC CUPS
Sarstedt Cup- Cat No. 72.730.006- Micro tube 0.5ml PP
Dedicated cups are available for paediatric sample analysis. Dedicated screw cap
cups (46mm x 10.8mm) are inserted in the accompanying tubes (85 x 13mm), in the
same way as sample cups, as presented in the diagram below. Barcodes may be
placed on the accompanying tube which can be loaded into the ASP directly.
Sample cup
placed into
the sample tube
SAMPLE CUP
SAMPLE
3. 2. 5. 4 PLACEMENT OF THE TUBE TRAY IN THE ASP

The ASP has two components that include an outer Tube tray labelled 1-72
(corresponds to positions 1-72 on the software) and an inner Cup Tray with sample
positions labelled 1-20 (corresponds to positions 73-92 on the software). Calibrators
must be placed in positions prior to patient samples in the ASP to ensure adequate
calibration.
• Take out the tube tray from the Auto Sampler Unit (ASP).
• Place the sample into a slot of the tray. The tube with a barcode label must be
positioned in such a way that its label faces the slit of the slot.
• Set the tray into the ASP unit so that the inner guide pins can be fit into the two pin
holes (located between Slot #40 and #41, and between Slot #57 and #58) of the
tray.
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Guide pins
3. 2. 5. 5 PLACEMENT OF THE CUP TRAY IN THE ASP

• Take out the sample cup tray from the Auto Sampler Unit.
• Place the cups containing samples (standard samples, control samples etc.) into
the cup placement holes.
• Set the sample cup tray into the unit inside so that the inner guide pin can be fit
into the pin-hole (at Slot #10) of the sample cup tray.
3. 2. 5. 6 SAMPLE BARCODES
Barcode labels should be attached to all sample tubes. When sample cups are used
the barcode label should be attached to the adapter tube, as shown, 12.5-14.5mm
from the bottom of the tube.
ABC Page 114

Check digits are incorporated in barcodes of control samples and calibrators for
identification purposes. Normal and emergency samples may carry check digits
depending on the system menu requirements.
Barcode labels and position on the sample tube or reagent bottles must adhere to the
recommendations described in this manual. Alterations in these specifications will
present problems for the barcode reader.
3. 2. 5. 6. 1 SPECIFICATIONS OF SAMPLE BARCODE LABEL

Extent of label fitting:Refer to drawing below.
5mm
47mm } Printable Barcode

area
5mm
12.5 – 14.5mm
Valid barcode types for the Rx Imola analyser

Type Data digit number Check digit Effective characters
UPC(JAN) From 3 to 12 dig- 1 digit, Modulus 10 Numbers (from 0 to 9)

its
NW7 From 3 to 12 dig- 1 digit, Modulus 16 Numbers (from 0 to 9)

its Symbols (-, $,/,.,+)
CODE39 From 3 to 8 digits 1 digit, Modulus 43 Numbers (from 0 to 9), Alphabet

Symbols (-, $,/,.,+)
ITF From 3 to 12 dig- 1 digit, Modulus 10 Numbers (from 0 to 9)

its
CODE128 From 3 to 12 dig- 2 digits, Modulus Numbers (from 0 to 9), Alphabets (capi-
(Set A, B its 103 tal letters and small letters)
and C) Symbols (!,”,#,$,(,),*,+,.,/
,:,;,<,>,=,?,@,[,])
Note: Small Roman letters cannot be
used for the Set B.
ABC Page 115

Barcode Specifications for sample

Bar module width From 0.25mm to1.00mm
Barcode height 15 mm or higher
Barcode length 60 mm or shorter, including quiet zone.
Quiet zone Blank areas before/after the barcodes.
4 mm or 10 times length of the
minimum module width, whichever the
greater.
Printing Black on the white background. Quality
standard shall comply with the ANSI
MH10.8M standard.
Barcode label Refer to the drawing
location
Two sensors are used to detect when the ASP lids are in place, one on the lid for
sample tubes and the other on the lid for the emergency samples.
3. 2. 5. 6. 2 TYPES OF BARCODE LABEL

The following types of bar code labels are used depending on the types of samples.
Type of sample Identification Digit General identifi- Details

number cation code
code
(Refer to above
(SID)
*)
Normal sample xxxxxxxxxxxx 3 - 12 xxxxxxxxxxxxnn xxxxxxxxxxxx: Sample identi-

1 fication code
nn: Number of measurement
Pediatric sample 8999xxxx 8 8999xxxxnn1 xxxxx: Sample identification

code
Emergency sample 99000xxx 8 99000xxxnn1 xxxxx: Sample identification

code
Pediatric emergency 990009xx 8 990009xxnn1 xxxxx : Sample identification

sample code
nn : Number of measurement
ABC Page 116

Control sample 970000xx 8 970000xxnn1 xxxxx : Sample identification

code
Standard sample 98xxxxxy 8 98xxxxxynnm xxxxx : Reagent code

y : Classification (from 1 to
7)
m : Number of repetition
Multi-standard sam- 950000xy 8 950000xynnm x : Set number

ple y : Classification (from 1 to
7)
Serial dilution stan- 98xxxxx0 8 93xxxxxynnm xxxxx: Reagent code

dard sample y : Classification (from 1 to 7)
Replicate sample 9400xx01 8 9400xxnn111 xx: Sample identification

code
ISE Standard 960000xx 8 960000xx111 xx: Sample identification

code
ISE Cleaner 960001xx 8 960001xx111 xx: Sample identification

code
Orderless sample 920000xx 8 920000xx111 xx : ASP position code
Blank sample 9510000x 8 9510000xnnm x: Sample identification code

m: Number of repetition
Reagent blank 91xxxxx1 8 91xxxxx1nnm xxxxx : Reagent code

Water blank 000000XX 8 000000XX XX : Cuvette number
SPT Wash 960002xx 8 960002xx111 xx: Sample identification

code
ABC Page 117

3. 2. 5. 6. 3 INFORMATION ON SAMPLE BARCODE
A Emergency sample, Calibrator, Control sample
Digits Code information Description
1–3 Sample type On screen:

990: Emergency sample Emergency sample: E
970: Control sample Control sample: C
I
4,5 00
6–8 Sample number For example, 99000001 to E001

001 – 999: Emergency sample
001 – 999: Calibrator
001 – 999: Accuracy control sample
B-1 Standard (assigned for single method)

980: Calibrator Calibrator: S
4 -5
6-7 Method code Two digit method code registered at

"System parameter" screen
8 Standard number For example, 98050011 to S01

1–7
B-2 Multi-standard (assigned for multiple methods)

950: Calibrator Calibrator: MS
4-6 000
7 Standard set number Refer to the table below

0-9
8 Standard number For example, 95000011 to M01

1–7
ABC Page 118

The standards can be grouped in 10 as follows
Set Code Barcode
1 M01 – M07 95000001 – 95000007
2 M11 – M17 95000011 – 95000017
3 M21 – M27 95000021 – 95000027
4 M31 – M37 95000031 – 95000037
5 M41 – M47 95000041 – 95000047
6 M51 – M57 95000051 – 95000057
7 M61 – M67 95000061 – 95000067
8 M71 – M77 95000071 – 95000077
9 M81 – M87 95000081 – 95000087
10 M91 – M97 95000091 – 95000097
B-3 Standard series
1-3 Sample type: On screen:

930: Standard Series Calibrator: SS
4,5 00
6,7 Reagent code For Example, Albumin: A2
8 0
C-1 Normal sample (Online/Offline)
1 – 12 Sample number Any number of digits may be used within 4

– 12 digits.
Except for the ones starting with 950 to 990:
invalid due to being reserved as section A
and B.
ABC Page 119

C-2 Normal replicate sample

940: Replicate sample Replicate sample: R
4 0
5,6 Sample number

01 – 99: Replicate sample
7, 8 01 Fixed to "01". All numbers other than "01"

Sequence number will be ignored as the analyser will automat-
ically generate "02" and further numbers
depending on the setting at "Condition"
screen.
D One Point Calibration Sample

951: One point calibration sample One point cal sample: S1
4,5,6 0
7,8 Sample number

01 – 99: One point cal sample
E1 Paediatric Sample (Normal)

8999 Paediatric sample:
5-8 Any number
E2 Paediatric Sample (Emergency)

990009 Paediatric sample:
ABC Page 120

7-8 Any number
E3 Paediatric Sample (Replicate)

94006 - 94009 Paediatric sample:
6 Any number
7-8 01
3. 2. 5. 6. 4 LABEL ERROR CHECK OF SAMPLE BARCODE

• The analyser will not sample from a tube if the barcode check digit shows an error.
• When barcodes contain digits outside the ranges defined in the above tables, an
alarm will appear and the tube will not be subject to sampling.
• When 2 or more samples carry the same barcode within a sample run, the first
sample is valid and the subsequent samples are rejected and not sampled.
• Normal samples can be placed in any order.
ABC Page 121

3. 2. 6 START ANALYSIS
1. Analysis is initiated by pressing START [F1] key on the global menu.
2. A pop up screen will appear to remind the user to perform water, waste and wash
bottle checks. Click on OK.
The system will begin analysis.
The progress of analysis can be viewed in the RUN/ ROUND screen.
The status of each sample is displayed using a colour-coded system at each sam-
ple position, displayed on the left side of the RUN/ MONITOR screen.
The instrument status is indicated in the STATUS field on the top left corner of the
RUN/MONITOR screen.
RUN MONITOR SCREEN
The RUN/MONITOR screen above also gives the following details:

• Incubation temperature – Current temperature in the IRU is displayed. Sample
measurement will not proceed if the temperature is outside the specified range (37
± 0.5ºC).
ABC Page 122

• Estimated time at sampling complete - indicates the estimated time at completion

of sampling.
• Time at start of run and estimated time at end of run. – QC and calibrator samples
will not be taken into account.
• Halogen - will display the time (minutes) until the Halogen lamp is ready for use.
When the lamp is turned OFF, this will count down for 20 minutes.
• Auto Rerun - to specify the need for an auto-rerun. When this is enabled the soft-
ware will execute a re-run of the test when the result is outside the specified tech-
nical range, or a predefined error has occurred.
• The screen presents a number of buttons for the following actions:
ISE Calibration - starts the ISE calibration procedure.
ISE Cleaning - Implements ISE cleaning procedure.
SPT wash - starts the cleaning process for the ISE nozzles.
Rotation - this action rotates the ASP tray. After clicking on this button,
click on the ASP position number required. The position will appear as
ORANGE on screen. Click on the Rotation button again to turn the carousel.
Add STAT - This button is used for adding emergency sample(s).Click on
this button, and then click the required positions on the ASP monitor. Click on
this button again to complete the selection for the STAT sample(s). The STAT
position appears red on screen for the STAT sample.
Add Normal - This button is to determine a position for an additional sample.
Click on this button, then click the positions on the ASP monitor for the added
samples. Click on this button again for to complete the selection for the added
sample(s). The established position mark's frame is colored with red.
Please note: Add STAT, Add Normal and Rotation buttons are only active when the
sampling process has been stopped.
• SSTOP (F2) - When this button is clicked the software will suspend sampling until
the START button is clicked again.
• STAT (F3) - This is used to add a sample. When this button is clicked the ASP on
the MONITOR scren will become blue and sampling will be suspended. The ADD
STAT, ADD NORMAL and ROTATION buttons will then become active. The
ABC Page 123

START (F1) and the SSTOP(F2) buttons will begin to flash. Select either ADD
STAT (Emergency sample) or ADD NORMAL sample( normal sample) and pro-
ceed as described in ??
•
• Colour-coded system used for sample carousel.
Green – Sampling Started
Dark Blue – Range Over
Purple – Re-run required
Red – Error
Light Blue – Process completed
White – Not processed
Yellow – No Test Ordered
When the analyser is in operation the START (F1) button will flash yellow to notify the
user that the system is busy.
ASP Monitor Display options for position numbers

Display Status Additional
Color samples
Grey The sample is not processed. This is the color at the start of Available
(Unknown) a run.
Purple It means that at least one method for rerun is included. If only Unavailable
(Rerun a case of “Rerun Required” setting, in order to rerun the sam-
Required) ple that has been technical range over (Normal samples,
Emergency samples), it will be changed from (Green) to (Pur-
ple). This sample required a rerun will be taken a rerun when
its barcode is read at the re-circulation of ASP then its color is
changed from (Purple) to (White).
Red It means that at least one error is included. (Except for STB Unavailable
(Error) error) In the case that the measurement has completed
except a calibration curve, or that its conversion concentra-
tion has been failed such as a calibration curve error, the
color will change from (Green) to (Red).
Blue It means that at least one range-over method is included. The Unavailable
(Range measurement has completed then the conversion of concen-
Over) tration of the measurement has normally done, but if even
one of either Technical range, which is set on Chemistry
Parameters screen, it will be changed from (Green) to (Blue).
ABC Page 124

Yellow It means that no order has been set all the methods. As the Available
(No test sample barcode can be read, however, there is no order for
Ordered) its sample; its color will be changed from (Grey) to (Yellow).
This status indicates no order.
Light blue It means all methods have been normally completed (STB Unavailable
(Process error is deemed as normal completion.). In the case that a
Complete) measurement has completed, its concentration conversion
has normally done, all methods are within the technical range,
set on the Chemistry Parameters screen. The color will be
changed from (Green) to (Light blue).
White It means all methods are unprocessed sampling. If the sam- Unavailable
(Not Pro- ple barcode can be read and its order is registered, the sam-
cessed) ple screen will change from (Grey) to (White) and the status
means that it is waiting for a sampling process.
Meanwhile, it will remain (Grey) in the case that the barcode
could not be read, or will turn (Yellow) in the case that bar-
code could be read but no test order.
Green It means that the process from the completion of the first sam- Available
(Sampling pling to the normal completion of all methods (Except for
Started) occurrences of reruns, errors and range over). The color will
change from (White) to (Green) at the time the sample has
dispensed in cuvettes.
3. 2. 6. 1 MONITORING MEASUREMENT PROGRESS

Progress of measurement is displayed in the software:
• Click on RUN in job menu and ROUND in the Tab menu. The progress of each
sample is displayed from sampling to the end of the reaction. The information is
displayed in columns and includes the SID, PID, Method sample type column,
Sample Number (Sno.), Method, Description and Error column.
POS ASP position number

PID Patient Identification
SID Sample Identification
Method Measurement name
ABC Page 125

R1 R1 reagent dispense complete

S Sample dispense complete
M1 R1 stirring is complete
O1 First absorbance reading complete
R2 R2 reagent dispense complete
M2 R2 stirring is complete
O2 Second absorbance reading complete
Result Measurement result (concentration)
CN Number of the cuvette used for the measurement
WU Cuvette cleaning complete
Error Error code displayed
Error Column
Indicates errors with the sample progress.
Error Error flags Descriptions Matter of error

ranks
<None> Normal
(1) IE1 Requirement of ISE mea- No correspondence for the mea-

surement is abnormal surement requirement is from ISE.
IE2 Not received ISE mea- The measurement result from ISE
surement result data could not be received.
IE ISE unit abnormal An error has been detected on the

ISE unit.
(2) SS Sample shortage The liquid level of SPT is not

detected or a hit of the bottom is
detected in ASP.
SS Out of the range of the The result of SPT liquid level detec-
liquid level of sample tion is out of the range in ASP.
SI1 Non detection of the liq- The liquid level of SPT is out of the
uid level of sample dis- range or a hit of the bottom has
charge been detected in IRU.
SI1 Out of the range of the The result of SPT liquid level detec-
liquid level of sample dis- tion is out of the range in IRU.
charge
ABC Page 126

SI2 Dilution sample shortage The liquid level of SPT is out of the
range or a hit of the bottom has
been detected in IRU.
SI2 Out of the range of the The result of SPT liquid level detec-
liquid level of Dilution tion is out of the range in IRU.
sample
R1S R1 Reagent shortage When R1 reagent aspirating, the

RPT liquid level is not detected or a
hit of the bottom is detected.
R1S Out of the range of the When R1 reagent aspirating, the

liquid level of R1 Reagent result of the RPT liquid level deten-
tion is out of the range.

R2S Out of the range of the When R2 reagent aspirating, the

liquid level of R2 Reagent result of the RPT liquid level deten-
tion is out of the range.

RPT liquid level is not detected a hit
of the bottom is detected.
DS Dilution shortage When dilution aspirating, the RPT

liquid level is not detected or a hit of
the bottom is detected.
DS Out of the range of the When dilution aspirating, the result

liquid level of dilution of the RPT liquid level detention is
out of the range.
WS Wash solution shortage When wash solution aspirating, the

WS Out of the range of the When wash solution aspirating, the

liquid level of the wash result of the RPT liquid level deten-
solution tion is out of the range.
R1B No R1 reagent bottle R1 reagent bottle has not been reg-

istered.
R1S Volume Zero in R1 The remaining volume of R1

reagent reagent has reached zero.
R2B No R2 reagent bottle R2 reagent bottle has not been reg-

istered.
R2S Volume Zero in R2 The remaining volume of R2

reagent reagent has reached zero.
ABC Page 127

DB No dilution bottle The dilution bottle has not been reg-

istered
DS Volume Zero in dilution The remaining volume of the dilution

bottle bottle has reached zero.
WB No wash solution bottle Wash solution bottle has not been

registered
WS Volume Zero in wash The remaining volume of the wash

solution bottle solution bottle has reached zero.
LOT Lot inconsistency The reagent lot number has not

been inconsistency.
SPW Failure of SPT wash SPT wash has been failed. Check
the alarm to determine the reason
for its fail.
R1W Failure of RPT 1 wash Method to Method washing, an

operation in advance to R1, has
failed. Check the alarm to determine
the reason for its fail.
R2W Failure of RPT 2 wash Method to Method washing, an

operation in advance to R2, has
failed. Check the alarm to determine
the reason for its fail.
(3) TE1 IRU temperature IRU temperature < 37-2(ºC)

extremely low
TE2 IRU temperature IRU temperature > 37+2(ºC)

extremely high
TE3 RCU temperature RCU temperature > 15ºC

extremely high
TE4 ASP temperature ASP temperature > 10ºC

extremely high
EST Anomalous measurement Error sampling stop. Check the

alarm for the reason.
(4) EXP The reagent is no longer An expired reagent was used in the
valid. measurement
STB Reagent stability expired Invalid reagent stability was used

with the measurement.
CTO Calibration expired The reason is that the measurement

was taken by a method of which cal-
ibration has not been implemented
within a setting term.
ABC Page 128

CXP Control expired The reason is that the measurement

was taken by a method of which QC
measurement has not been imple-
mented within a setting term.
SXP Calibrator expired The measurement was taken with

an expired calibrator.
(5) CA? An error of concentra- No calibration curve, or ISE calibra-

tions of conversions. tion ever has been executed after
the startup.
(6) OVR An error out of the range The value is not between Calibra-
of calibrator. tor’s minimum and maximum.
LIN Linearity Limit Error Linearity Limit Error
PRO Prozone Limit Error Prozone Limit Error
AB1 Absorbance Limit1 Error Only one of the measured values is

in Absorbance Limit.
(7) AB2 Absorbance Limit2 Error One ore more of the measured val-
ues are out of Absorbance Limit, but
2 or more of them are in the Limit.
(8) STM Sample type Inconsistent The measurement was taken by

sample type of each method that
does not match the sample type.
The concentration value was con-
verted with a calibration curve that
does not match the sample type.
(9) DUP Duplicate Limit Error Duplicate Limit Error
SEN Sensitivity Limit Error Sensitivity Limit Error
CAL Failure of calibration An operation of calibration has filed

in shortage of points etc.
3. 2. 7 FINISH ANALYSIS
Analysis will proceed until the process is complete. Then the system will perform a
ROUND termination protocol during which time the user cannot enter patient
information, print data or save details.
3. 2. 8 SYSTEM ALARMS
When errors occur in the analysis the ALARM key on the Global menu will flash RED.
• Click on the ALARM(F4) key to determine the source of the error.
ABC Page 129

• Double click on the error field for further details of the error.
3. 2. 9 ANALYSER SHUT DOWN

When required, click on the SHUTDOWN button.
It is recommended that SLEEP mode is selected when the analyser is not in use. In
SLEEP mode the reagent cooling and ISE priming is maintained. This function allows
the user to use the AUTOSTART function at defined times.
1. When the Shut Down option at the upper right-hand corner of the screen is
selected, the shut down mode dialog box is displayed.
3. 2. 10 ANALYSER RE-START
The analyser will restart automatically according to the time settings defined in the
[Run (F5)] [Sleep Scheme] screen.
The user can re-start the analyser by clicking on the SHUT DOWN button displayed
on screen when the sleep mode is active.
POWER OFF should only be used when the instrument is serviced or if the
instrument will not be in use for an extended period of time.
WARNING If POWER OFF is selected the reagents will not be cooled and the ISEs
may dry out and become unusable.
ABC Page 130

SECTION 4 ACCESSORY OPERATIONAL FUNCTIONS Version 1.0 Rev Sep 2005
SECTION 4
ACCESSORY OPERATIONAL FUNCTIONS
ABC Page 131

4.1 INTERRUPTION AND RESUMPTION OF

MEASUREMENT
This section describes the accessory operational functions available with the system.
These functions are in addition to the routine operation of the system.
During routine operation analysis may be interrupted and resumed manually.
4. 1. 1 EMERGENCY STOP
An emergency stop may be initiated if there is a severe malfunction with the analyser.
When this is initiated, unprocessed data from the run will not be retrievable.
• Press SSTOP [F2] to initiate an emergency stop. In some circumstances the sys-
tem will automatically initiate an emergency stop.
• After the emergency stop has been initiated the analyser will perform system ini-
tialisation and then perform a cuvette wash to clean those cuvettes that were used
during measurement.
• The STATUS field in the top left corner of the RUN MONITOR screen will display
the message ‘Emergency Stop in progress’.
4. 1. 2 INTERRUPTION OF SAMPLING
Sampling may be interrupted for two reasons; to add more samples or load
emergency samples.
4. 1. 2. 1 SAMPLE INTERRUPTION TO LOAD EMERGENCY SAMPLES

This enables the user to load emergency samples into the sample carousel during
analysis. When this mode of interruption is utilised the analyser will stop analysis
immediately and perform analysis of the emergency samples before resuming routine
sampling.
Normal samples may be added using this facility if the user wants to give them priority
of analysis, if the system is operated in a non-barcode mode.
There are three options available when running emergecny samples. They include:
ABC Page 132

1. Barcode Disabled.
2. Barcode Enabled: using a NORMAL sample barcode and then tagging the
barcode as an emergency sample.
3. Barcode Enabled: using an EMERGENCY sample barcode. The software will
automatically recognise the sample as an emergency sample.
NB: It is important to identify samples as ‘Emergency’ to facilitate rapid searching of

the database for results.
The procedure for adding emergency samples is slightly different if the sample
barcode reader is enabled or disabled. This is defined in the [System Parameters]
[System (F9)] screen.
4. 1. 2. 1. 1 EMERGENCY SAMPLE ADDITION (SAMPLE BARCODE DISABLED)

1. Press the STAT (F3) button on the global menu. This will pause sampling, how-
ever the system will continue to process samples that have been dispensed into
the IRU.
2. The software will present available sample positions in the ASP as blue or yellow
in the RUN/MONITOR screen.
3. To rotate the sample carousel click on the ROTATION button on the RUN/MOMI-
TOR screen and then click on the sample position required. The sample position
will turn orange on screen.
4. Click on the ROTATION button again and the system will rotate the sample carou-
sel to present the selected sample position at the sample addition cover position
as shown below.
5. Remove the sample addition cover and place the emergency sample in the
required position. Replace the sample addition cover and make a record of the
position number.
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Sample addition cover
6. To add more than one STAT sample, click on the AddSTAT button and go through
the steps as described above.
7. When all samples are added, click on the AddSTAT button again to finalise the
selection. The outer frame of the sample position will turn ‘red’ on screen.
8. Go to the SELECTION option on the TAB screen of the RUN option.
9. Select the position number in the POS field from the drop down menu. The user
can select the type of sample cup in the CUP field. Options include ‘Normal’ or
‘Pediatric’. The software will default to NORMAL.
10. Select STAT from the drop down in the ‘Type’ field.
11. Input the sample ID number in the SID field. Input a numeric code (3 digits). When
the NORMAL sample cup option is selected the software uses the prefix of 99000,
and requires the user to input 3 digits. When the Pediatric option is selected the
software uses the prefix 990009, and requires the user to input 2 digits.
12. Input the patient ID in the PID field (if required).
13. Select the test options by clicking on the tick box.
14. When the selections are complete click on the SAVE button.
15. Click on the START (F1) button to recomence analysis. The ASP then rotates and
prioritises sampling and measurement of the emergency sample(s). The system
will then proceed to recommence sampling of other samples in the carousel.
Note there is a range of appropriate positions available, the emergency

sample(s) should be placed in a vacant position if possible to minimise impact
on other samples.
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4. 1. 2. 1. 2 EMERGENCY SAMPLE ADDITION (SAMPLE BARCODE ENABLED)

1. Select RUN MONITOR [F6] on the job menu.
1. Press the STAT (F3) button on the global menu. This will pause sampling, how-
the IRU.
as shown below.
position number.
8. Go to the SELECTION option on the TAB screen of the RUN option.
9. Select the position number in the POS field from the drop down menu. The user
can select the type of sample cup in the CUP field. Options include ‘Normal’ or
‘Pediatric’. The software will default to NORMAL.
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10. When using a NORMAL sample barcode, select NORMAL from the drop down in
the ‘Type’ field. Then click on the ‘E’ tick box to tag the sample as an emergency
sample.
11. When using an EMERGENCY sample barcode, select STAT in the Type field.
12. Input the sample ID number in the SID field. Enter all digits presented on the sam-
ple barcode in the SID field when using a NORMAL sample barcode, tagged as an
emergency sample. Only enter the last three digits in the EMERGENCY sample
barcode, when using an emergency sample barcode with normal cups or two dig-
its when using pediatric sample cups.
NORMAL SAMPLE BARCODE xxxxxxxxxxxx (3-12 digits)
PEDIATRIC SAMPLE BARCODE 990000xx (8 digits)
EMERGENCY SAMPLE BARCODE 99000xxx ( 8 digits)
Enter the digits (x) as indicated above.
13. Input the patient ID in the PID field (if required).
14. Select the test options by clicking on the tick box.
15. When the selections are complete click on the SAVE button.
When the emergency sample(s) has been sampled the probe will go back to sam-
ple from the position number where it was interrupted. The status field in the top
left corner of the screen will display STAT in a red box whilst processing the emer-
gency sample.
4. 1. 2. 2 SAMPLE INTERRUPTION TO LOAD NORMAL SAMPLES

When a normal sample is to be added follow the instructions below.
1. Click on the RUN/MONITOR screen
1. Press the SSTOP (F2) button on the global menu. This will pause sampling, how-
the IRU.
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as shown below.
position number.
8. Go to the SELECTION option on the TAB screen of the RUN option and select the
test options as described in section 3. 2. 4. 2 Test Selection for bar-coded patient
samples” on page 100, or 3. 2. 4. 5 Test Selection for non bar-coded patient sam-
ples” on page 105.
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4.2 SAMPLE RE-RUNS

Identification of samples for automatic re-run is available in the software. Reruns can
be performed for samples that are either greater than or less than the defined
technical range. Re-run results are flagged with the letter ‘r’ in the RUN/RESULTS
screen and on results printout.
4. 2. 1 AUTOMATIC RE-RUNS
The software can be programmed to perform sample re-runs automatically for STAT
and NORMAL samples when the results are outside the measuring range or exceed
check limits e.g. Prozone. There are three conditions in which the auto re-run can be
implemented.
1. When an error flag occurs (LIN, PRO, ABS).
In this case the re-run is implemented under the ‘RERUN (HIGH/PROZONE)’
conditions.
2. Outside technical range (HIGH).
In this case the re-run is implemented under the ‘RERUN (HIGH/PROZONE)’
conditions.
3. Outside of technical range (LOW)
In this case the re-run is implemented under the ‘RERUN (LOW)’ conditions.
When two or more error flags (LIN, PRO, ABS) occurs simultaneously, a re-run will be
executed under the condition of RERUN (HIGH/PROZONE).
To activate the automatic re-run follow the instructions below.

1. To activate the re-run facility go to the RUN/MONITOR screen and click on the
Auto re-run tick box.
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Auto re-run
tick box
2. Then go to PARAMETER on the job menu and NORMAL in the tab menu to spec-
ify the re-run conditions.
Re-run options
Re-run specifications Enable Diluent
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Re-run specifications
3. SAMPLING - specifies the amount of sample for dispense (2-35ul) and measure-
ment after dilution.
4. SAMPLE (uL) - Specifies the sample volume required for the dilution. When the
re-run (High/Prozone) or re-run (Low) are not active, input 0 in the sampling field.
5. DILUENT (uL) - Specifies the diluent volume required for the dilution.
4. 2. 2 RESULT OUTSIDE THE MEASURING RANGE

The re-run is performed according to ‘Rerun (high)’ and ‘Rerun (Low) settings in
PARMETER/NORMAL screen. The measurement is performed under the same
conditions as the initial measurement. A re-run is performed if the sample result
(concentration or absorbance) is outside the technical range specified in the screen
below. The conditions of re-run are shown below:
RE-RUN SETTINGS FOR OUT OF RANGE RESULTS
4. 2. 2. 1 SAMPLE RE-RUN WITHOUT DILUTION

When a sample result is outside the technical range a re-run may be required using a
smaller or greater sample volume. In this case the sample does not require dilution.
The rerun is performed according to the Re-run / Dilution settings in PARAMETER/
NORMAL screen.
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Minimum sample + diluent = 120ul
4. 2. 2. 2 SAMPLE RE-RUN WITH DILUTION

If the concentration of a sample is greater than the technical range it is possible to
perform a rerun with automatic sample dilution. The software will report the final result
corrected for the appropriate dilution factor.
Rerun dilution conditions are predefined for Randox closed channel chemistries
however if you wish to enter dilution conditions for open channel chemistries follow
the procedure below
1. Select PARAMETER on the job menu and NORMAL on the tab menu.
2. Click on the METHOD field and click on the drop down box to view the available
methods. Select the test option required. The screen will display the pre-defined
settings. Pre-defined settings are generally used for sample re-runs.
3. Click on the tick box next to the Re-run (High/Prozone) to activate a re-run for a
result above the technical range (High) or the Re-run tick box to activate a re-run
for a result below the the technical range (Low).
4. Conditions for the re-run are then input in the screen below
5. In the DILUENT field click on the ENABLE tick box and then click on the drop
down box to view the available diluents. Click on the required diluent. (SALINE is
the usual option).
6. Enter the volume of neat sample (sample uL) and the diluent volume (Diluent
uL)in the required fields. A minimum total volume (sample + diluent) of 120µl
should be specified.
7. In the Sampling field enter the sampling volume (of diluted sample) required.
8. Click on the SAVE button.
NB Automatic sample dilution conditions cannot be entered unless a diluent is

enabled and selected.
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4.3 CALIBRATION
This section describes features for system calibration. There are three calibration
options available:
Single Calibrator - 2-point to 7-point calibration using 2 to 7 separate
calibrators.
Serial Dilution - Onboard serial dilution of a single calibrator to generate a
standard series.
Multi-Standards - Calibrator series for multiple tests.
4. 3. 1 STANDARDS
Two to seven calibrators are required for a single test.
4. 3. 2 SERIAL DILUTION
A multi-point calibration can be performed by loading a single calibrator (of the
highest concentration in the calibrator series), from which the system can prepare a
series of standards automatically.
The software requires the DILUENT option to be enabled in the PARAMETER screen
as described below.
1. Select PARAMETER on the job menu.
2. Select NORMAL on the tab menu.
3. Click on the tick box next to the ENABLE option in the DILUENT field . To select
the diluent click on the drop down box. Select the diluent name required, usually
SALINE. The bottle must be placed in the RCU.
4. Select RUN option in the job menu.

5. Select INVENTORY in the tab menu. Check that the diluent volume is sufficient.
To specify the conditions of the serial dilution follow the procedure below.
1. Select CALIBRATION on the job menu.
2. Select REG CALIB in the Tab menu.
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3. Ensure that standards are registered as described in 3. 2. 3. 3 Registration of

Standards and Defining Concentrations” on page 83.
4. Click on CALIBRATION/SERIAL DILUT screen.
5. Select the required method in the Method field. The system will present details of
method name and Lot No (S), and sample and diluent volumes that are used to
produce each standard in the series.
6. For example if there are 6 standards in the series the highest concentration should
be entered in position number S6. When entering concentrations please note that
for auto dilution:
minimum volume of [sample + diluent] = 80µl

maximum pre-sampling volume = 35µl
For example if the neat sample had a concentration

of 30 mmol/l then the following standard concentrations would be prepared:
Standard Concentration Calculation

Standard solution 1 0
Standard solution 2 1.875 (0.0625 * 30)
Standard solution 6 30 (1 * 30)
7. Click on SAVE to store the selection.
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8. In the SERIAL DILUTION field click on the ENABLE button.

9. Confirm the ratio of pre-sampling to diluent displayed on screen. Click on the CAL-
CULATION button. If invalid concentrations are entered in the PARAMETERS
screen [PAGE 1 / 2] the volumes here will be displayed in RED. The user must
alter the concentrations according to the minimum and maximum volumes
described above.
10. When all the settings are entered place the highest concentration calibrator in the
ASP and initiate calibration measurement.
4. 3. 3 REGISTER MULTI-CALIBRATOR DETAILS (MS)

This facility allows the user to register multiple tests to a single calibrator series. Ten
multi-standard sets can be specified with up to 7 calibrators per set.
Set No. Multi standard set Bar code

1 MS01 – MS07 95000001 – 95000007
2 MS11 – MS17 95000011 – 95000017
3 MS21 – MS27 95000021 – 95000027
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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
1. Select CALIBRATION [F7] on the job menu.

2. Select MULTI-STD on the TAB menu.
3. Select the multi-standard set (calibrator) number (10 available), by clicking in the
SET field and selecting the appropriate number.
4. Click on the NAME field and enter the name of the mutli-standard series. (alpha-
numeric, 6 digits).
5. Click on the Sample field and select as required.
6. Move the cursor to the test required and click on the tick box to select the test. A
tick will appear on selection. Repeat this process for the tests required for the
multi-calibrator set selected. Tests can be deselected by clicking on the tick box.
7. Click on SAVE to save the selection.
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MULTI-CALIBRATOR SCREEN
For example, assuming that the same calibrator set is required for a full calibration of
methods ticked above;
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 a multi-standard set. It is possible to edit the selection for the next run
using the mask function, see section 3. 2. 4. 8 Masking option (Bar Coded and Non
Barcoded Sample Modes)” on page 108.
All tests selected in this screen will be calibrated each time this muti-set is run. Use
the Masking function to de-select tests.
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4.4 OPERATIONAL CONDITIONS AND PARAMETERS

This section provides information on how to change operational conditions and
parameters for each functional item.
Functional item Description

PARAMETER(F6)/ Chemistry Parameters for Randox closed
NORMAL channel assays are pre-defined and mostly
non-editable. Open channel assays allow the
user full access to define parameters used.
Re-run specifications are detailed in this
screen.
PARAMETER(F6)/ Define limit checks, blank measurement and
NORMAL2 instrument factors.
PARAMETER(F6)/ISE Define chemistry parameters for ISE.
PARAMETER(F6)/SI Entry of various parameters for the
measurements of turbidity (L), haemolysis (H)
and icterus (I) in serum samples.
PARAMETER(F6)/CALC Equations are defined for calculated tests.
PARAMETER(F6)/ Test profiles can be specified to enable
PROFILE multiple methods to be selected at one time.
PARAMETER(F6)/WASH Specifies the wash programme.
PARAMETER(F6)/ The measuring order and printing order are
ORDER specified.
SYSTEM (F9)/SETUP Specification of serial communications with
host computer, date, time, print out options,
alarm settings and specification of bar code
type.
SYSTEM (F9)/REAGENT Each bottle code and bottle size (large,
medium or small) of reagents, wash solutions
and diluents placed in the RCU are specified.
SYSTEM (F9)/LOGIN Specifies the software programme version
details. Entry of log in details.
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SYSTEM (F9)/DEFINE Define details of physician name, location,

Race and Sample comments.
SYSTEM (F9)/RANGE Define normal ranges
SYSTEM (F9)/SETUP2 Definition of technical range and patient
generations details.
SYSTEM (F9)/BACKUP Back up and loading of analyser settings.
4. 4. 1 ANALYTICAL CONDITIONS (PARAMETER (F6) / NORMAL

Conditions for analysis of patient samples are generally pre-defined for closed
channel reagents and do not need alteration. The software offers the facility to alter
the analytical conditions for open channel chemistries. For closed channel
chemistries the operator can only alter the settings for Normal Range, Number of
decimal Points, and Instrument Factors, Technical Range fields and Units. All other
fields in the Chemistry Parameters screen will be inactivated for closed channel
chemistries.
1. Select PARAMETER [F6] on the job menu.
2. Select NORMAL on the TAB menu. The screen will display CHEMISTRY PARAM-
ETERS screen.
3. Move the cursor to the field of interest and enter as required. TAB key may be
used to scroll through the list.
4. Click on the SAVE button to save the settings.
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Chemistry Parameters screen
Method (Method number)

With the cursor in the METHOD click on the drop down box and select the assay
number required. Press return to confirm the selection. For a new open channel enter
any unused number. To view a complete list of methods press ‘Space’ key and select
desired method by a mouse double-click or highlight with cursor keys and press
‘Return’.
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Name (Method name)

Input or specify a method name (should be within 6 digits). The lsit of registered
methods will be displayed . With the cursor in the NAME field enter the name of the
new test. A method name can be entered in the form of letters, numbers, symbols or
a combination, up to 6 characters. When the method number is selected, the
corresponding name is displayed in the "Name" box.
Print Name
Specifies the name for printing. With the cursor in the PRINT NAME field enter the
name of the new test. A method name can be entered in the form of letters, numbers,
symbols or a combination, up to 15 characters. When the method number is selected,
the corresponding name is displayed in the "Print Name" box
Sample
Select a sample category. Options include plasma, serum ,urine or common. Click on
the drop down box and select as required.
Unit
With the cursor in the UNIT field enter the unit required for result reporting. (Up to 6
characters may be entered.)
Assay Type
There are two assay types, i.e. Rate method and End method. Options are displayed
by clicking on the scroll arrow of "Assay Type" box. The required option is selected by
pointing the cursor and a single click.
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Measuring Points
The software offers the facility to specify the photometric measuring points for
analysis. Options facilitate single or two point assays by using measuring range-1 and
measuring range-2 options.
The analyser always uses an average number of absorbance measurements over a

specified range, rather than a single measurement. Details of the measurement
intervals are listed below.
RX IMOLA TIME READING INTERVALS
Measurement Measurement
Time/sec Time/sec
Point Point
R1 -54 R2 304
S 0 MIX 308
MIX 4 35 311
1 5 36 320
2 14 37 329
3 23 38 338
4 32 39 347
5 41 40 356
6 50 41 365
7 59 42 374
8 68 43 383
9 77 44 392
10 86 45 401
11 95 46 410
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Measurement Measurement
Time/sec Time/sec
Point Point
12 104 47 419
13 113 48 428
14 122 49 437
15 131 50 446
16 140 51 455
17 149 52 464
18 158 53 473
19 167 54 482
20 176 55 491
21 185 56 500
22 194 57 509
23 203 58 518
24 212 59 527
25 221 60 536
26 230 61 545
27 239 62 554
28 248 63 563
29 257 64 572
30 266 65 581
31 275 66 590
32 284 67 599
33 293 68 608
34 302
For single point endpoint assays and single rate assays measurement range 2 is not
required and a tick mark should NOT appear in the ENABLE box. Both measurement
ranges are required for two-point and blanked end point and double rate assays. To
activate the second measuring range click on the ENABLE box.
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Measuring points (refer to the read time intervals) are entered into "Start" and "End"
boxes for each Measuring Range (where appropriate). When an End method is
required the measuring points START and END should be the same.
Measuring points of Measuring Range-1: 1 – 68 and Start < End,

Measuring points of Measuring Range-2: 1 – 68 and Start < End.
Endpoint assays – 2 consecutive read points (e.g. 23 and 24) should be chosen and
the average absorbance of the two points is used in the calculation.
Single reagent endpoint assay – Measuring range-2 should be disabled, and 2
consecutive read points chosen.
Two reagent endpoint assay – Consecutive read points prior to R2 addition should be
entered for Measuring range-1. Then 2 consecutive read points several minutes after
addition of R2 should be entered for Measuring range-2. Results are calculated by
subtracting the average of the read points before R2 addition i.e. Measuring range-1
from the average of the read points from Measuring range-2.
2 point or Fixed Time assays – A delta absorbance between fixed time points is
measured. Both Measuring range –1 and –2 are used. The same read point is
entered for the START and END options of range-1 and for range-2. The absorbance
of measuring range 1 is subtracted from measuring range 2.
Rate Assays – The START and END points for the kinetic measurement is entered in
measuring range-1. Measuring range-2 is disabled unless a blank rate measurement
is required. The average delta absorbance per minute is calculated by using linear
regression through the read points in the measuring range.
Wave Length (Wavelength of optical filter)

The measurements can be performed using two wavelengths as a main and
secondary-wavelength. The primary wavelength is selected by clicking on the arrow
key of the wavelength selection box. A secondary-wavelength is selected in the same
way as the primary-wavelength. If the secondary wavelength is not required, click on
the DISABLE box.
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Sampling Volume
The sampling volume entered in µl.
A sample dilution facility is available by clicking on the ENABLE button to activate the
DILUENT on the same screen. Click on the drop down box and select the diluent
required..
When the Diluent option is enabled click on the Dilution box to activate the Dilution
facility on the left of the screen.
Volumes of sample and diluent are entered in µl. The volume of diluted sample is
equal to the sampling volume.
Sampling: Specify the volume of sample dispensed for measurement.

. 2 to 35µL (0.1µL step)
Dilution: Specify the setting for dilute conditions.
Sample (µL): Specify sample volume for dilution.
2 to 35µL (0.1µL step)
Diluent (µL): Input an amount of dilute dispensed.
20 to 350µL (1µL step)
Re-run (High)
Two types of sample re-run criteria may be specified.
1. Re-run (High/Prozone)- when results are higher than the technical range or errors
have occurred.
2. Re-run (Low) - when results are lower than the technical range.
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To activate the sample re-run dilution facility click in the Dilution box in the Re-run
(High/Prozone) field, or the Re-run (Low) field as shown below. To disable the re-run
facility click on the box again.
Enter the sample volume to be diluted and diluent volume in µl. The volume of diluted
sample is equal to the rerun volume. Please note that the minimum volume for
sample + diluent is 120µl.
Reagent name
Specifications for R1 and R2 dispense.
R1
Click on the drop down box in the Reagent Name field and a list of registered bottle
codes are presented for available tests. Select the reagent name by clicking on the
option. The reagents that cannot be used are displayed with a grey background.
Reagent (µl)
Specify the volume of reagent. The range for R1 reagent is 20-350µl (1µl increments)
and R2 range 20-250µl (1µl increments).
This screen also offers the option to use a second reagent.

De-select "Enable" when R2 reagent is not used. (Single reagent method)
Select "Enable" when R2 reagent is used.
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R2 Reagent name and reagent volume are entered when "Enable" is selected.
Entries should be made in the same way as described for reagent 1.
Water (µl)
Specify the volume of water. The range for water is 100-350µl (1µl increments).
Decimal Points
Specify the number of decimal points used for output of results.
Normal Range
Normal Ranges are displayed, maximum 50 types ( defined in SYSTEM / RANGE
screen).
Input the limit of minimum and maximum at normal values in Normal Range, which
have been registered.
The setting value should be from 0 to 9999999 (The number of digits specified in
"Decimal Points" will be effective after the decimal point).
Min: The flag "L" will be attached with the measurement result when the normal value
is less than this value.
Max: The flag "H" will be attached with the measurement result when the normal
value is greater than this value.
Normal Range criteria will not be applied to results when the Min - Max setting is 0 - 0.
Define a registration of the Range Name at the "System (F9) - Range screen".
The settings for an age ranges of each generation that have been registered can be
modified in the tab menu [Setup2] of the job menu [System (F9)].
Technical Range (Conc.)

Input the minimum and maximum concentration value for the measurement range.
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When the measurement result exceeds the minimum and maximum, the sign "> "or "<
"will be added to the result. In that case the "Conc." value specified in the list will be
output as its minimum and maximum value. It will implement an automatic rerun when
the automatic rerun function is active.
Technical Range (mAbs. /10)

It will display the technical range set in the tab menu [Setup2] of the job menu
[System (F9)].
SPT Wash
Specify a reagent name for SPT cleaning. Select to display the list on this line by
pressing the SPACE key, or select a reagent to use from the drop-down menu.
The reagent registered as "Wash" in the tab menu [Reagent] of the job menu [System
(F9)] will be displayed.
Stirring Speed
Specify a stirring speed. 5 levels for the setting are available to define depending on
the viscosity of the reagent.
UH: stirring for reagents with extremely high viscosity.
VH: stirring for reagents with particularly high viscosity.
High: stirring for reagents with high viscosity
Middle: standard stirring.
Low: stirring for reagents with low viscosity
None: stirring OFF
Copy
This facility will copy the chemsitry parameter details from one method to another.
Select the method with the desired settings.
Check the copy box "ON", and then click on METHOD field and select the method to
which the settings will copied. Click on the Save button, and the settings are copied to
the new method.
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It will copy all for any types if "Sample" (sample category) of the destination side for
copy is "Common", and if not, it will copy only the specified sample category.
Save
Press Save button to save the method parameters. Otherwise, press Cancel button.
4. 4. 2 PARAMETER /NORMAL2
This section enables the user to specify Limit checks, blank measurements and
instrument factor.
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Method (Method number)

With the cursor in the METHOD click on the drop down box and select the assay
method required. The cursor is used to select a method number. Press return to
confirm the selection. For a new open channel select any unused number.
Sample
Select a sample category. Options include plasma, serum ,urine or common. Click on
the drop down box and select as required.
Limit Checks
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Duplicate Limit
This facility will check for variation in replicate sample measurements.
Input a number between 1 and 99999 (mAbs/10) for the limit value, as duplicate or
triplicate measurements may be carried out for each sample.
When the results exceeds the limit, a DUP error is applied to the result.
Sensitivity Limit
This facility will check the range of sensitivity limit.
Input a tolerance range of the delta ABS between 1 and 99999(mAbs/10).
Any result less than the limit will have a SEN error, and the calibration value will not
be updated.
Linearity Limit
This facility will check the linearity of a time course.
Input the tolerance range at a rate between 0.1 and 99.9(%).
Input a threshold value between 1 and 99999 (mAbs/10)/min to the Linearity Limit
box.
A linearity error is applied when the linearity rate calculated is greater than the
tolerance rate defined. In that case LIN flag will be attached to the result.
The Measurement range used for judgment will use the measurement range 1 for 1-
point Rate method, and the Measurement range 2 for 2-point Rate method.
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The following cases will not execute a linearity check. Cases that are not RATE
method.
(a) dABSslope - check threshold value case
(b) dABSfirst - dABSlast - check threshold value case
(c) When less than 4 points are in the measurement range.
(d) When another error of higher priority occurs.
(e) It may not execute a linearity check depending on sample types (Control, ISE).
Prozone Limit
The prozone check is used to detect a high dose Hook effect occurring with
turbidimetric immunoassays under antigen excess conditions.
This has the effect that very high activity samples produce ABS equivalent to low
samples and therefore an incorrect result can be reported for rate assays.
For further details on the theory of prozone checks see Appendix 1.
Click on the Prozone limit, input a limit value between 0.00000001 and 9.9999999%
in the ratio of the reaction. Then specify whether the limit applies to a maximum
(Upper) or minimum (Lower) limit.
SL1-S the first number of the measuring point of Slope Range 1
SL1-F the last number of the measuring point of Slope Range 1
SL2-S the first number of the measuring point of Slope Range 2
SL2-F the last number of the measuring point of Slope Range 2
Sens Input a number between 1 and 999999 (mAbs/10) for sensitivity setting.
A prozone error flag (PRO) will appear next to the result if the limit value is exceeded.
A prozone check will NOT be carried out for:
1. Measurement of control samples
2. When the sensitivity does not exceed the sensitivity limit.
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Absorbance Limit
A check limit level is applied to the absorbance value.
This check will be applied to only the measurement method of 1- point Rate reaction.
Reaction
Specify whether the reaction is an increasing reaction "Increase" or a decreasing
"Decrease" from drop-down menu as reactive tendency.
Limit
Input a number between 1 and 999999 (mAbs/10) as a limit value.
Get an absorbance from the following formula:
Absorbance of Primary Wavelength - Water blank of Primary Wavelength < Limit
The absorbance value must be within this range.

If none or only one ABS at primary wavelength in measuring range is within the
absorbance limit the software will assign an AB1 flag to the result. Calculation of
concentration is not possible.
If only 6 or 7 ABS at primary wavelength in the measuring range are within the
absorbance limit, the concentration is calculated and the result output with flag AB2
Blank measurement
Choose a calibration method for the reagent blank from the drop-down list.
Disable reagent blank and S1 blank
This does not use a reagent blank or a S1 blank during calibration.
Enable S1Blank (Factor or Linear)

This executes a calibration, using S1 blank (Factor or Linear method)
Enable reagent blank

This will execute a calibration, using reagent blank.
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Enable reagent blank for S1 (Linear)

This will use reagent blank as S1 sample (Only Linear method)
Measurement of Reagent Blank during Run

Specify when the reagent blank measurement is executed.
Choose whether to execute an auto measurement or not when measuring, from the
drop-down menu.
Daily (Everyday)
A reagent blank measurement is carried out each day. The result of a sample will be
calibrated, using this value.
Next Run (Every time)

This will execute a reagent blank at the beginning of each round.
None (Invalid)
This will not execute reagent blank. (In this case a past reagent blank result is applied
as reagent blank.)
Reagent blank measurement at calibration

Specify whether to use pure water as a sample when using a reagent blank.
Reagent blank (no sample)

It calibrates using reagent blank without sample.
Reagent blank (system water)

It calibrates using reagent blank with pure water (system water).
The number of measurement

Specify the number of replicates for the reagent blank.
Choose from (Single), (Duplicate), or (Triplicate) by means of the drop-down menu.
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Reagent Blank Limit Checks

This will check the variation of multiple measurement of reagent blank.
As the Limit value, set a number, absorbance measurement differential (deltaABS),
between 1 and 99999 (mAbs/10) when it is executed the duplicate or triplicate.
Instrument Factor
Specify a slope and intercept for factor correction of the measurement result.
They are the slope (a) and intercept (b) from the linear equation, y = ax + b
It will correct for the concentration value.
a: -99.9~99.9
b: -999.99~999.99
Save
To store the settings
Cancel
To cancel the changes.
4. 4. 3 SERUM INFORMATION
Some assay methods may be affected by high turbidity, haemolysis, bilirubin, etc. in
serum samples. The levels of turbidity (L), haemolysis (H) and icterus (I) can be
determined and numerically quantified by the analyser.
A serum indices check should be requested when the user suspects abnormalities in
a sample that may affect assay methods. The user must activate the option as
described below.
To activate this facility follow the instructions below:

1. Select PARAMETER (F6) on the job menu
2. Select SI on the TAB keys.
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Method of measurement
2 points of photometric measurement
where A,B,C,D,E and F are constants and client entry items.
= λ600, =λ700, = λ570, = λ415, = λ510

λxxx represents the absorbance values of each wavelength λrxxx which are obtained
from measurements of sample and phosphoric acid buffer and corrected by water
blank λwxxx. For example, in the case of wavelength of 600 nm,
λ600 = λ r600 - λ w600.
Absorbance Turbidity
NADH Icterus Hemolysis
340 415 450 510 570 600 700 800
L = Turbidity Index
C = Scaling factor for Lipemia.
H = Hemolysis Index
A = Scaling factor for hemoglobin
B = Corrects hemoglobin measurement for lipemia.
I = Icterus index
D = Scaling factor for bilirubin
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E = Corrects bilirubin measurement for for hemoglobin

B = Corrects hemoglobin measurement for lipemia
F = Corrects bilirubin measurement for lipemia.
Follow the instructions below to access the serum information screen.

1. Select PARAMETER (F6) on the job menu
2. Select SI on the TAB keys.
3. Click on the REAGENT TYPE and select either ‘Dil’ or ‘R1’ for the serum indices
determination. The ‘Dil’ option is recommended, however the user must ensure
that a registered diluent is onboard. If the user selects the ‘R1’ option, the reagent
must be specified in the REAGENT NAME field.
4. To select the REAGENT NAME click on the drop down box and select as appro-
priate. Please note that using R1 for this purpose will reduce the number of tests
available for that method.
5. Enter the required Factors A to F. Input a numeric value 0 to 999999 for Factor
A,B,C,D,E,F.
6. Input the SAMPLING VOLUME by clicking on the field and type in the required
volume of the sample for SI check.
7. Input the reagent voume (between 20-350ul) required for the dilution in the VOL-
UME by clicking on the field and type in the required volume of the reagent for the
SI check.
8. Instrument factor (H, L and I) is used as a correction factor (0 – 999999) for a lin-
ear equation.
9. Click on the SAVE button to store the details and CANCEL to restore previous set-
tings.
10. When the settings are entered and the diluent is onboard the software will auto-
matically offer the SI option on the Test Selection screen. The user can then
select the SI option for the required sample numbers.
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Serum Information screen
FLAG MARK
Measurement range
Haemolysis range
(Example)
5 characters max From 0 to 999999

THE FOLLOWING ANNOTATION IS PRINTED
OUT WITH RESULT
H0 for haemolysis < 100

H1 for 100 ≤ haemolysis < 200
H4 for haemolysis ≥ 400
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Turbidity range
(Examp
OUT WITH RESULT
L-- turbidity < 10
L- 10 ≤ turbidity < 20
L+- 20 ≤ turbidity < 30
L+ 30 ≤ turbidity < 40
L++ turbidity ≥ 40
Icterus range
(Example)

OUT WITH RESULT
I--- icterus < 50
I-- 50 ≤ icterus < 60
I- 60 ≤ icterus < 70
I+- 70 ≤ icterus < 80
I+ icterus ≥ 80
When a result is printed, the result of normal sample and ISE is printed with the serum
information. An example is shown below.
Sno. : 101 ID:2001082701 Date : 20020827 RoundNo : 006

UREA AST
Normal 15.1 20.5
sample
result SI H3 ( 358) L+- ( 32) I-- ( 68)
Method Name Result of Hemolysis Result of Turbidity Result of Icterus
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4. 4. 4 METHOD TO METHOD COMPUTATION

The software provides the facility to report a calculated value of test result(s) using a
defined equation.
For example total cholesterol (TC) and HDL cholesterol values may be requested as
a ratio of TC/HDL. Therefore the user can program the software to perform the
calculation automatically using this facility.
The software uses test method numbers 1 to 60 to identify individual test parameters.
Test method numbers 71 to 80 are assigned for calculation values.
1. Select PARAMETER [F6] on job menu
2. Select CALC on the TAB keys. The screen appears as shown below. The soft-
ware will display a range of test numbers on the right of the screen.
3. Move cursor to the method No. field and input a method number from 3001 to
3040. The software uses numbers 3001 to 3040 for method-to-method calcula-
tions.
4. Select a name in the NAME field by clicking on the drop down box or input a new
name. Input up to 6 digits.
5. Click on the PRINT NAME field and input the method name for printing. The user
can input up to 15 digits in this field. If there is no information in this field the soft-
ware will print the method name.
6. Click on the SAMPLE field and select a sample type from the drop down box.
Options include SERUM, PLASMA, COMMON, URINE.
7. Click on the UNIT field and specify the unit reqired for printing and sending results.
The user can input up to 6 alphanumeric or symbol characters.
8. Click on the Decimal points field and select as required. Select between 0 to 5 dig-
its.
9. Click on the EXPRESSION field to input the calculation. The expression can use
a maximum of 10 methods. To formulate an expression double click on the
method on the right of the screen and the software will enter the method number
in the EXPRESSION field. Then use the calculation symbols (+ , -, *, /, ( , ) )at the
top of the screen to input the calculation. The software will check the expression
for errors and will prevent input if the calculation is incorrect.
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10. Input normal range values in the NORMAL RANGE field. Simply double click on
the field of interest and input the values directly.
11. Click on the SAVE button to save the information.
METHOD TO METHOD COMPUTATION SCREEN
Expression symbols
List of Methods
If results are available for all methods specified in the EXPRESSION field the
software automatically calculates the expression and presents the values.
4. 4. 5 TEST PROFILE
This facility enables the user to define a profile of tests that are performed on a
regular basis. This profile is then selected during the test selection process, rather
than repetitive selection of a number of individual tests.
1. Select PARAMETER [F6] on job menu
2. Select PROFILE on TAB keys.
3. Move cursor to the METHOD field and click on the drop down box. Profiles 1 –20
will be presented. Double click on the profile number required.
4. Enter the required name of the profile in the NAME field.
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5. Select the tests by clicking on the appropriate boxes in the SELECTED METHOD
field.
6. Click on the SAVE button to store the information. When selecting methods for
profiles only the available onboard options will be presented.
Test Profile
Test selection field
A tick mark represents the tests selected for the profile. To deselect the test click on
the field to reverse the selection.
4. 4. 6 TESTING ORDER AND RESULT PRINTOUT ORDER

This facility enables the user to select the order of test measurement and then specify
the order in which the results are printed.
4. 4. 6. 1 TESTING ORDER
1. Select PARAMETER [F6] from job menu screen.
2. Select ORDER from TAB keys. The software will present two lists, for MEASURE-
MENT ORDER and PRINT ORDER.
3. On the left of the screen a list of tests are displayed showing the order of test anal-
ysis. To modify the test order simply click and hold on the test of interest. Simply
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drag and drop the test method into the position of interest. Methods and wash
solutions may be specified. ISE’s cannot be selected.
4. Click on SAVE button to store the information.
TESTING ORDER
It may be necessary to change the testing order if particular assays are found to
interfere with each other. In this case one assay could be assigned a low test number
and the other a high number meaning that these assays would be separated by other
assays in a test profile.
4. 4. 6. 2 RESULT PRINTOUT ORDER

Result Printout order is defined in the same way as the testing order.
Click on the SAME ORDER button to use the same order of tests for measurement
and printout.
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4. 4. 7 NOZZLE WASH PROGRAM

This option is used to program the instrument to wash pipette nozzles between
specified assays, Method 1 and Method 2.
1. Select PARAMETER [F6] on the function menu.

2. Select WASH on the Tab menu.
3. The software will display the wash program as shown below:
Wash screen
4. Select Method 1 by clicking on the drop down box in the METHOD 1 field and then
clicking on the required method. To wash between all methods check the box
labelled ‘ALL’, beside method 1.
5. Select Method 2 by clicking on the drop down box in the METHOD 2 field and then
clicking on the required method. To wash between all methods check the box
labelled ‘ALL’, beside method 1.
6. Select the wash solution for the R1-> R2 wash and the R2-> R2 wash. The soft-
ware will default to Sys Water (water). When a specific wash solution is required
click on WASH BOTTLE and input the reagent type and name from the drop down
boxes in the adjacent fields.
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7. Reagent Type options include R1, R2 or WASH.

8. Click on SAVE to store the settings. The software will display the reagent wash
selections in the fields to the right of the screen.
9. To edit wash settings, click on the wash program of interest and the settings will
be displayed on screen. Alter as required and click on SAVE to store the settings.
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4.5 ENTRY OF SYSTEM PARAMETERS

This facility enables the user to define the system parameters, for host
communication, Alarms, sample barcodes, and printout details.
4. 5. 1 SYSTEM/SETUP
1. Select SYSTEM [F6] on job menu
2. Select SETUP on the TAB keys. The system parameters are displayed on screen
as shown below.
3. Move the cursor to the field of interest and use the scroll arrow to view the list for
selection.
SYSTEM PARAMETERS
Host Communication Mode

The software offers the facility to download test method selections for individual
patient samples directly from a host computer system. Patient Demographic
information for each sample may be transferred to the analyser PC if desired.
Data download is carried out in on-line batch or on-line real time mode.
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This defines the communication mode to the host computer.

OFF LINE If the checkbox is ON, results are kept on the PC.
ON LINE BATCH If the checkbox is ON, the analyser is connected to the host and
sample information is ordered in batches. The results are automatically sent to the
host computer when they become available.
ON LINE REALTIMEIf the checkbox is ON, (Host Query Mode) – the analyser is in
constant communication with the host computer. Sample information is requested for
each sample when the analyser reads the barcode. Results are automatically
transferred back to the host computer as they become available
The default setting is OFF LINE.
Host Details Mode

This facility is only available when the checkbox of ON LINE REAL TIME of Host
Communications Mode is ON.
No Re-query Re-run not performed.
ENABLE RE-QUERY Enables a samples re-run
ENABLE HOST RERUN Enables a sample re-run at the request of the Host.
Host Communications
The conditions for communication with the host computer are defined as follows.
Item Description Remarks

Baud Selection of baud rate: 19200/9600/ Default: 19200 bps
Rate 4800/2400/1200/300 bps
Data Bit Data bit length: 7/8 bits Default: 8 bits
Stop Bit Stop bit length: 1/2 bits Default: 2 bits
Parity Bit Parity bit: None/Even/Odd Default: None
Protocol Normal / No handshake Normal
(E1381)
Alarm sound
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An audible alarm on the analyser alerts the user throughput the assay procedure. The
default setting is set to ON.
To disable the alarm click on the checkbox. To reactivate the alarm click on the
checkbox ENABLE SOUND SAMPLING COMPLETE.
ENABLE ERROR LEVEL and ALARM VOLUME enables the user to set the level of
the alarm sound. The alarm volume range is 1-9, with 9 the maximum.
Levels Select methods Descriptions Alarm Levels

1 Off Ineffective
2 Emergency Emergency stop 2 is effective
Stop
3 Sampling Stop Sampling Stop 2,3 are effective
4 Unit Alarm Warning 2,3 and 4 are
effective
Click on the drop down box and select as required.
SAMPLE
Sample number increment : Select an auto generating method of sample numbers.
Select from the following on the list by clicking the pull-down menu.
Numeric only:
· Alphanumeric (Upper case)
· Alphanumeric (Upper and lower cases)
Upper sample number and Length: Specify the upper digit numbers of the sample
barcode and the number of digits. Based on the specifications, the setting number will
be incremented on sample input.
The length of the input range is a maximum 12 digits.
It will complement some digits that the digits of Length were subtracted from the SID
digits that were input order.
(E.g.)
Upper sample number:11234567891 Length: 1121
Assuming that the "SID" of the tab menu [Selection] in the job menu [Run (F5)]
is 001, the barcode due to complement the upper 7 digits would be
"123456789001".
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Auto generating numbers for sample number =

(The number of the whole digits) - (The number of the upper sample number)
Sample Barcode Click on the checkbox to Enable or Disable the sample barcodes.
When this checkbox is set "ON", the setting will be changed as using ASP's barcode
reader.
When the barcode ENABLE checkbox is on the barcode type of UPC (JAN), NW7,
Code39, ITF and Code128 can be applied. And it is applicable either with or without
sample barcodes.
When the barcode DISABLE checkbox is ON the barcode type options are inactive.
Barcode type 1-4

Define barcode types to use in samples. ( max 5 types.)
When the "Enable" checkbox of Sample Barcode is set "ON"", the sample barcode
can be applied.
Select from the following on the list by clicking the pull-down menu.
Types Selection items Details

UPC(JAN) Blank No use
NW7 Blank No use
Code39 Blank No use
ITF Blank No use
Code128 Blank No use
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To define sample barcodes, click on the drop down box and select as appropriate.
Others
Disable extrapolated results: Click on the checkbox to disable extrapolation of results.
.·When the checkbox is set "ON", it will extend the calibration curve to the range of the
S1 or Sn, and then calculate the concentration by conversion.
·When the checkbox is set "OFF", it will convert the calibration curve out of the range
by using the concentration values of S1 (Min.) or Sn (Max.).
The default setting is set "ON".
Enable Auto Scan for RCU: Specify whether the RCU scan will be carried out or not.
·When the checkbox is set "ON", it will execute the RCU scan automatically whetrher
the RCU lid is open and closed.
Enable Check of ASP Temp: When the checkbox is set "ON", it will monitor the
temperature for ASP at a round start.
Enable Check Inventory: ·When the checkbox is set "ON", it will check the reagents at
a round start.
The default setting is "ON
Full compliance with ASTM rules: Specify whether the data transfer format to the Host
computer applies to ASTM rules or not.
·When the checkbox is set "ON", it will apply ASTM rules. In this case it will not send
the rerun flags, QC measurement results, and QC flags except method-to-method
calculation results.
·When the checkbox is set "OFF", it will NOT apply to ASTM rules. In this case it will
send the rerun flags, QC measurement results, and QC flags.
The default setting is "ON"
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ASTM ISE Separation: When ordering ISE from the Host computer, select whether it
needs to separate ISE or not.
When the checkbox is set "ON", it will execute ISE separation and present the ISE
order as Na, K and Cl.
Reagent Code for RPT (S): Specify the reagent code and name of the special wash
solutions for 1: RPT1 and 2: RPT2 washing.
Select the reagent by clicking the pull-down menu or on the reagent list registered by
pressing the Space key.
On the list box registered reagent codes will be displayed.
Select reagent type by clicking the drop down menu.
· R1: R1 reagent
R2: R2 reagent
· Wash: Wash solution
Remaining test calculation: When the checkbox is set "ON", specify the calculation
method for number of available measurements.
·Reagent Code:It will calculate the number with the remaining volumes of each
reagent code.
·Reagent Lot: It will calculate the number with the remaining volumes of each reagent
code + reagent lot.
In the tab menu [Inventory] of the job menu [Run (F5)], specify a calculation method
for the number of available measurement tests that is calculated from all of the
regents registered on "Total"
Live Print out

Enable: When the Enable checkbox is "ON", it will execute an auto- printing during
measurement.
Select a printing form from the following on the list by clicking the pull-down menu.
· Nomal
· Report
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Enable Live QC Report: When the Enable checkbox is "ON", it will execute an auto-
printing during QC measurement.
Following the QC data printing, it will execute a QC report printing per a method at the
completion of one sample in measureing.
Printout Header
1 :The header of a list can be edited within 20 digits.
2 : The header of a list can be edited within 50 digits.
The edited letters will be printed on the list as header.
Click on the SAVE button to store the system settings.
4. 5. 2 SYSTEM / REAGENT
This screen enables the user to register reagents. See section 3. 2. 2. 2 Registration
of open channel barcoded bottles” on page 78 for further details.
4. 5. 3 SYSTEM/LOGIN
The software enables the manager to set up different users with unique login
passwords. Users can log in by inputting a password in the PASSWORD field. Then
click on SAVE to store the settings.
The software also displays the the PROGRAM VERSION in this screen.
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Program version
UI Main: Presents the version number of software for user I/F processing.
UI UC: Presents the version number of software for communications
processing both of the PC and the analyzer.
UI PRT: Presents the version number of software for live printing processing.
UI LIS: Presents the version number of software for communication
processing both of the Host computers and the communications
processing
Unit Main
It will show the number of version of main software for the analyzer.
Unit LIQ: It will show the version number of software for a process of detecting of the
liquid level.
Unit DTR: It will show the version number of main software for photometric
processing.
4. 5. 4 SYSTEM / BACKUP
When the software is upgraded the user should backup settings for the measurement
conditions and user interface. This menu option enables the user to backup the
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settings onto to Floppy Disc. The function will back up measurement data, data
received from other units, and patient information.
System Parameters backup (FD)

Save Parameters: When the SAVE option is selected it will backup a database for
system parameters on FD. Depending on the amount of information, it will save the
database on multi FDs.
After clicking the Save button, a warning message will be displayed:
"Warning! Overwriting FD with system parameter."
When clicking the OK button, the parameters are saved to FD.
If the backup is saved on several FDs, the following message will be displayed.
"This FD has been full. Please insert a new FD."
After inserting a floppy disk, clicking the OK button, it will save the rest of the
parameters.
Load Parameters
This option will enable the user to restore the parameters from the backup FD.
The following warning message will be displayed after clicking the Load button.
"Warning!
Loading system parameters from FD will overwrite the settings in the
analyzer."
After clicking the OK button, the parameters will start to restore into the PC.
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If multiple backup FDs are used to reload, the following message will notify you.
"Please insert the next FD."
After inserting the FD and clicking the OK button, it will save the rest of the
parameters.
Format FD Format
This will initialize the FD.
After inserting the FD in the PC click the Format button, the following warning
message will be displayed.
"Warning! Formatting the FD will delete all contents stored in the FD."
It will start to initialize the FD when you click the OK button.
Data backup (HD)

Save Data
The function will backup the databases for the measurement data, the received data
from other units, or patient information etc on the HDD of the PC.
After clicking the Save button, it will automatically check the database and then when
DB check is "OK", the following warning message will be displayed;
"Warning! any data to existing be over written. OK?"
After clicking the OK button, it will execute the backup.
·When DB check is "NG" or not OK, the following warning message will be displayed,
and will cancel the save;
"Warning! a database is corrupted. Recovery with backup data required."
Load Data
This option will restore the backed up data on the analyzer.
After clicking the Load button, the following warning message will be displayed;
"Warning!
Retrieving the data will over write existing data. OK ?"
After clicking the OK button, it will load the data.
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Directory ...
Specify the destination to save and the load directory.
After clicking ... button, select the destination to save and the load directory.
By clicking the Save button, the "DBBackupsave" directory will be created in the place
you selected and then the data will be saved.
When the Load button is clicked, all of the data will be loaded to the selected
destination.
A list of user parameter files that are saved to floppy disc are displayed in the table
below.
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 Methode
AnalysisSI2.db Sl Methode 2
AndCalc.db Calculated test information
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 Calculated test item
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
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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
4. 5. 5 SYSTEM/SETUP2
This facility enables the user to set minimum and maximum absorbance tolerances
and patient generation groups. When settings are input the software will perform a
credibility check for each measurement result, based on the effective technical range
and 3 patient generations.
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MIN-MAX ABS -999999 - -999999

Define the limit ABS for technical range.
Define the upper and lower limit for the technical range, for the result check.
Input the value between -999999 and 999999.
Generation G1 < -9999 < G2 < -9999 < G3

Define the ages for patient 3 generations. Input the ages for the patient's 3 generation
(G1, G2, G3) within 1 to 99
Click on SAVE to store the settings and CANCEL to delete the settings.
4. 5. 6 SYSTEM/DEFINE
Patient details can be input such as attending physicians, addresses, race and
sample comment.
1. Select SYSTEM on the function menu.
2. Select DEFINE on the TAB menu.
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3. Click on the drop down menu to select an option for patient details. Options
include Physician, Location, Race, and Sample comment. The software will dis-
play the list of options on the screen.
4. Click on the ADD button and the entry field will become active. Input the required
information.
6. To edit details click on the list option and then click on EDIT. The entry foeld will
become active. Alter the information as required and click on the SAVE button to
store the amendments.
7. To delete an option click on the entry and then click on the DELETE button.
4. 5. 7 SYSTEM/RANGE
This facility enables the user to set up groups for normal range values.
1. Click on SYSTEM in the function menu.
2. Click on RANGE in the TAB menu.
3. Fixed options 01- 06 for male and female generations are preesnted on screen.
The user has the option to input range names for 07-50 in the list shown above.
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4. To create a new range name, double click on an empty cell and the software will
present an active entry field.
5. Type in the range name(max 10 alphanumeric digits) as required and then click
SAVE to store the settings.
6. To modify an entry, double click on the entry of interest, modify as appropriate and
then click on SAVE to store the details.
4. 5. 8 AUTOSTART
This facility enables the user to preset the timing of system initialisation and prime for
each day of the week. The system can automatically initialise and prime outside
normal working hours ensuring the analyser is ready for operation as soon as the
user arrives in the laboratory. Options for automatic settings include:
• time at which the analyser is switched on;
• number of times the prime process is performed when initiated
• number of times the wash process is performed when initiated.
The SLEEP MODE must be selected on analyser shutdown to use this facility.
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AUTOSTART SCREEN
Select RUN on the job menu and SLEEPSCHEME in the TAB menu.
Scheduling
The time of system start-up and the sequence of measurement preparation group can
be specified for a week (Monday through Sunday).
"Time": Enter the time of system start-up of each day (00:00:00 – 24:00:00)
"Prep": Select the type of preparation to be carried out at the time of system
start-up (Off, Prep1 or Prep2).
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Before Sleep
Specify the operations that should have been processed before with Sleep.
ISE Cleaning
Specify the number of times to perform the ISE cleaning. (You can choose from 0 to 5
times.)
SPT Wash (W)/ (S)

Specify the number of SPT cleaning times. "(W)" On the screen will execute water
wash, and "(S)" will do wash using special solution. The number of the execution
times can be chosen from 0 to 5, and SPT wash will not be executed when the
number of SPT cleaning is zero.
Note that you cannot select both "(W)" and "(S)" at a time.
RPT1or 2 Wash (W)/ (S)

Specify the number of the SPT cleaning times. "(W)" on the screen will execute water
wash, and "(S)" will do wash using special solutions. The number of the execution
Cuvette Fill
Choose whether or not to fill the pure water or wash solutions into the cuvettes of the
IRU.
For Nozzle Wash and Mix Wash operations, specify either one of the pure water or
wash solutions in the Cuvette Fill.
Nozzle Wash
When this check is ON, nozzle-soaking operation will be implemented before Sleep.
The soaking nozzle wash will be executed in IRU cuvettes (10 minutes).
Mix Wash
When this check is ON, mixer wash operation will be implemented before Sleep.
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After Sleep
Specify the settings that will be processed in start-up operation.
Prime
Specify the number of Prime. (You can choose from 0 to 5 times.)
SPT Wash "(W)"/ "(S)"

Specify the number of the SPT cleaning times. "(W)" on the panel will execute water
times can be chosen from 0 to 5, and SPT wash will not execute when zero.
RPT1, or 2 Wash "(W)"/ ("S)"

Cuvette Wash "(W)"/ ("S)"

Specify the number of the cuvettes cleaning times. "(W)" on the panel will execute
water wash, and "(S)" will do wash using special solution. The number of the
execution times can be chosen from 0 to 5, and SPT wash will not execute when
zero.
RCU Scan
Specify whether or not to implement RCU Scan. When this check is ON and Open/
Close of the lid of RCU has been executed, RCU Scan will be taken after Sleep
release.
ABC Page 192

RPT1or 2 Wash (W)/ (S)

Specify the number of the SPT cleaning times. "(W)" on the screen will execute water
Cuvette Fill
Choose whether or not to fill the pure water or wash solutions into the cuvettes of the
IRU.
For Nozzle Wash and Mix Wash operations, specify either one of the pure water or
wash solutions in the Cuvette Fill.
Nozzle Wash
When this check is ON, nozzle-soaking operation will be implemented before Sleep.
Mix Wash
When this check is ON, mixer wash operation will be implemented before Sleep.
After Sleep
Specify the settings that will be processed in start-up operation.
Prime
Specify the number of Prime. (You can choose from 0 to 5 times.)
SPT Wash "(W)"/ "(S)"

ABC Page 193

RPT1, or 2 Wash "(W)"/ ("S)"

Cuvette Wash "(W)"/ ("S)"

Specify the number of the cuvettes cleaning times. "(W)" on the panel will execute
water wash, and "(S)" will do wash using special solution. The number of the
execution times can be chosen from 0 to 5, and SPT wash will not execute when
zero.
RCU Scan
Specify whether or not to implement RCU Scan. When this check is ON and Open/
Close of the lid of RCU has been executed, RCU Scan will be taken after Sleep
release.
Save
It can store the editing data.
Cancel
It can restore the editing data as before.
ABC Page 194

Time Chart for Auto Prime Mode
Auto gain
control only Auto gain & short prime Auto gain & full prime
executed sequence executed sequence executed
Time
Previous
measurement
finish time
Short prime interval (60min)

Full prime interval (240min)
4. 5. 8. 1 TIME AND SETTINGS

The user simply clicks on the TIME box and alters the preset time accordingly for
each day of the week.
4. 5. 8. 2 PREPARATION FOR AUTOSTART

The user can select the conditions of prime by clicking on the scroll arrow and
selecting either PREP 1 or PREP 2. PREP 1 and 2 conditions are entered on the right
side of the screen as shown below.
PRESET PREPARATION CYCLES FOR AUTOSTART.
Type of Prep1 Prep2

operation
Prime Number of prime operation: 0 – 5 Same as
Prep1
ISE Prime Number of prime operation: 0 – 5 Same as
Prep1
SPT Wash Number of prime operation: 0 – 5 Same as
Prep1
ABC Page 195

RPT Wash Off: Not washed

W1: Wash with pure water – once
W2: Wash with pure water – twice
W3: Wash with pure water – three times
W4: Wash with pure water – four times Same as
W5: Wash with pure water – five times Prep1
C1: Wash with Wash solution 3 – once
C2: Wash with Wash solution 3 – twice
C3: Wash with Wash solution 3 – three times
C4: Wash with Wash solution 3 – four times
C5: Wash with Wash solution 3 – five times
Cuvette Number of washes: 0 – 5 Same as
Wash Prep1
ABC Page 196

SECTION 5 RETRIEVAL OF RESULTS Version 1.0 Rev Sep 2005
SECTION 5
RETRIEVAL OF RESULTS
ABC Page 197

5.1 AUTOMATIC PRINTOUT OF RESULTS

The software offers two options for printout and retrieval of patient results.
• Automatic Printout
• Retrieval of stored results
The software offers an option to automatically print out hard copies of patient results
when they become available.
The facility offers two options:

• To print the results list when the sample run is complete.
• To print results in the form of a patient report which would include all the patient
details and test results required.
The automatic printout facility is activated according to the instructions below.

1. Select RUN (F5) on the job menu.
2. Select SETUPon the TAB keys.
3. In the LIVE PRINTOUT field click on the ENABLE button to activate the automatic
printout.
4. Then select one of the two options, NORMAL and REPORT by clicking on the one
of interest.
Report – Print results in the form of a patient report
Normal – Print result list only
5. The user can also request an automatic printout of QC results by clicking on the
ENABLE LIVE QC REPORT box.
ABC Page 198

AUTOMATIC PRINTOUT SELECTION SCREEN
ABC Page 199

5.2 RETRIEVAL OF STORED RESULTS

All results can be accessed in the SYSTEM PARAMETERS / RESULTS (F12) screen.
1. Select RUN on job menu.
2. Select RESULT on the TAB keys. The results screen will be displayed as shown
below. This screen enables the user to search for results on the basis of sample
type, sample number, date of analysis and Round number. Enter an * in fields,
except sample type, to represent the wild card and display the results of all sam-
ples.
3. Click on the drop down box in the SAMPLE TYPE field and select by clicking on
the option of interest. The options include:
Normal – normal patient samples
STAT - emergency patient samples
Online - patient samples requested online
Standard - Calibrators
ISE standard - ISE calibrators
Control - Quality Control samples
ABC Page 200

Replicate - Replicate samples

ALL - All Normal, Replicate and Control samples
4. Click on the drop down box and select the matrix in the SAMPLE field. Options
include ALL, COMMON, SERUM, URINE, and PLASMA.
5. Select either option SID (Sample Identification Number, 12 digits) or PID (Patient
Idenification Number, 20 digits) to determine the sample search criteria.
6. In the FROM field enter sample search details. Enter an * in the field to represent
the wild card and display the results of all sample numbers.
7. To search by date, click on the drop down box in the DATE FROM field and enter
the YEAR MONTH and DAY as required. Then click on the DATE TO field and
enter the YEAR, MONTH and DAY as required. Enter an * in the field to represent
the wild card and display the results of all samples.
8. When the DISABLE checkbox is ticked in the Date From field the software will
search all past data. When the DISABLE box is ticked in the Date To field. the soft-
ware will search all results to the latest date.
9. Click on ROUND # field and enter the number of the sample run if required. Enter
an * in the field to represent the wild card and display the results of all runs. Enter
a number from 1 to 99.
10. Click on the drop down box in the SEND field and and select by clicking on the
option of interest. The options include: ALL - All results, OK - Results that have
been successfully transferred to host, NG - Results that have not been success-
fully transferred to host
11. Click on the drop down box of the RESULTS OUTPUT screen and select MONI-
TOR (to view on screen), NORMAL PRINT (to print out results), FILES (to save to
floppy disc).
12. Click on the SELECT TEST button on screen. Select the test(s) of interest by
clicking directly on the relevant button and deselect by clicking on a test button.
Click on the SELECT ALL button to select all tests or the CLEAR ALL button to
cancel the test selection. Selected tests are highlighted in blue.
ABC Page 201

13. When the CONTROL option is selected in the sample type field the software will
offer a METHOD option. Click on the drop down box and select the method as
required. The name of the method will automatically appear in the NAME field.
14.Click on the SEARCH button. The software will display a list of results for all sam-
ples specified by the search criteria.
15.Click on DELETE to remove the search settings.
16.Click on the sample result(s) of interest and press the SPACEBAR to select. Then
click on the SELECT OUTPUT button. Use the CONTROL and SHIFT buttons to
select more than one sample result.
The software will present information on each selected sample:
RESULT the measurement value.
JUDGEMENT H (High) or L(Low) than the judgement limits.
RANGE < or > to indicate whether the result is above or below the
technical range.
FLAG Error codes are listed
QC Judgment QC judgment for the measurement result. The judgment
result will be shown into 3 items with 7 digits each. In a
QC judgment result some errors or warnings are included,
these are displayed in order from highest to lowest
priority.
ABS Absorbance value is shown. This value will not be
displayed in the case that "Sample Type" is "Standard" or
ABC Page 202

"ISE Standard".
Conc (S) The concentration value is shown. The value will be
shown only in the case that "Sample Type" is "Standard".
Delete It will delete the selected measurement result. By pressing
this button, a confirmation message will be shown. Press
the OK button for implementing the delete, or Cancel
button for cancel
Output Time Course GRAPH - will show the time course graph of the
measurement result on the screen.
Output Time Course Print - will print the time course data of the
measurement result.
Output Time Course File - It will output the time course data.
Search result list

The search result will be shown by the specified conditions.
Date: Measured Date
Round: Round Number
PID: Patient ID (Control Name for Control sample)
SID: Sample ID
Method: Method Names
Result: Measurement results
ABC Page 203

RESULT SELECTION SCREEN FOR NORMAL SAMPLES
RESULT SELECTION SCREEN FOR CONTROL SAMPLES
ABC Page 204

RESULT SELECTION SCREEN FOR REPLICATE SAMPLES
5. 2. 1 RETRIEVAL OF CALIBRATION RESULTS

Results from previous calibrations can be sourced and displayed.
5. 2. 1. 1 RETRIEVAL OF NON-ISE CALIBRATION

2. Select RESULT on TAB keys. This screen enables the user to search for results
on the basis of sample type, sample number, date of analysis and Round number.
Enter an * in any of the selection fields to represent the wild card and display the
results of all samples.
‘Standard’.
4. Set the search criteria for sample number, date, round number etc. as described
above.
ABC Page 205

TOR (to view on screen), NORMAL PRINT (to print out results) or FILE (to save to
disc).
7. Click on the SELECT TEST button on screen. Select the test(s) of interest by
clicking directly on the test button and deselect by clicking on a selected test but-
ton. Click on the ALL SELECT button to select all tests or the CLEAR ALL button
to cancel the test selection. Selected tests are highlighted in blue.
8. Click on the OK button.
9. Click on the SEARCH button. The software will display a list of results for all tests
specified by the search criteria.
10. To view calibration curves for a specific test click on the method box displayed in
the results list. The software will then display results for the selected test at the
bottom of the screen. Select a calibration series by clicking on the # number. The
software will display details of the date, round number, method and Lot number for
the calibration series selected. Results are displayed for up to seven calibrators
and the calibrator concentrations are also displayed.
11. To view a plot of the calibration curve go to the TIME course field and select the
option required. Options include GRAPH – to view time course, PRINT – to print
time course data, or FD – to save the data to floppy disc.
RESULT SELECTION SCREEN FOR STANDARD SAMPLE
5. 2. 1. 2 RETRIEVAL OF ISE CALIBRATIONS

ABC Page 206

2. Select RESULT on TAB keys. This screen enables the user to search for results
on the basis of sample type, sample number, date of analysis and Round number.
Enter an * in any of the selection fields to represent the wild card and display the
results of all samples.
‘ISE Standard’.
4. Set the search criteria for sample number, date, round number etc, as described
above.
TOR (to view on screen), NORMAL PRINT (to print out results), FILE (to save to
floppy disc) or HOST (to send results to host computer).
7. Click on the SELECT TEST button on screen. Select the ISE test option by click-
ing directly on the button. Selected tests are highlighted in blue.
8. Click on the RETURN button.
9. Click on the SEARCH button. The software will display a list of results for all ISE
tests specified by the search criteria.
ISE CALIBRATOR RESULTS
ABC Page 207

5. 2. 2 RETRIEVAL OF RESULTS BY PATIENT ID

The software offers the option to display results for individual samples identified by
patient ID number (Search Patient Report).

2. Select RESULT on TAB keys.
3. Select NORMAL in the SAMPLE TYPE feild and PID in the adjacent field.
4. Enter the required patient information ID in the FROM and TO fields.
5. Click on the DATE FROM and TO and enter the required date range.
6. Click on the PRINT button to print the results.
7. In the RESULT OUTPUT field click on the drop down box and select REPORT
PRINT.
8. Click on the SEARCH field and the software will display the required information.
5. 2. 3 VIEWING A TIME COURSE

This facility enables the user to view a time course for individual samples
1. Select RUN menu option.
1. Select RESULT in the TAB options.
2. Set the results search criteria as previously described.
3. Select one of the options in the TIME COURSE box. They are GRAPH, PRINT or
FILE.
The time course will be displayed on screen when the GRAPH option is selected.
The software enables the user to auto-define the axes by clicking on the MAX and
MIN boxes on the screen and entering the limits.
The raw data will be printed as hard copy when the PRINT option is selected.
The raw data will be saved to floppy disc when the FD option is selected.
ABC Page 208

VIEWING A TIME COURSE
Y axis set to Auto

or manual Max &
Min values
Both primary (Red), secondary (green) and primary – secondary (yellow) wavelength
data are displayed if appropriate.
The scale on the time course is automatically set when a ‘tick’ mark appears in the
box adjacent to AUTO. For manual setting of y axis click on the box again to de-
activate the selection and enter Max and Min values as required.
When the ‘Standard’ has been selected the reagent Lot numbers are displayed above
the timecourse as shown below.
ABC Page 209

5.3 RETRIEVAL OF CALIBRATION VALUES

Calibration curves for non-ISE standards and values for ISE standarsd can be viewed
on screen.
5. 3. 1 CALIBRATION CURVES FOR NON-ISE STANDARDS
The software can store up to two calibration curves (OLD and NEW) for each Lot
number of reagent.
1. Select CALIBRATION on the job menu.
2. Select REAG CALIB on the TAB keys.
3. Click on the drop down box in the METHOD field and select as required.
4. Click on the drop down box in the SAMPLE field and select the sample type. The
software will display the current calibration curve for the selected method.
5. To view the OLD calibration click on the LOT field and select OLD to view. The
software will display the MASTER and WORK calibration curves on screen.
5. 3. 2 RESULTS FOR ISE STANDARDS

The software will present the results of the most current ISE standards.
1. Select CALIBRATION on the function menu.
2. Select ISE on the TAB keys.
3. The software will present the ISE results as shown below:
ABC Page 210

5.4 RETRIEVAL OF QUALITY CONTROL VALUES

Results of quality control samples can be viewed and searched as described above
by selecting the option CONTROL in the SAMPLE TYPE field in the [RUN / RESULT]
screen.
The software also offers the option to view the results of quality control samples and
display the information as Levy-Jennings plots. The software can store quality control
results for up to 6 months. The software offers the facility to view up to three levels of
QC data.
The results options on the QC [F8] job menu include

• Graphs: for graphical display of QC results over a 6-month period
• Details: view QC details of samples.
• Daily: to view DAILY test method means and SDs for different
• controls.
• Cumulative: to view CUMULATIVE test method means and SDs for
• different controls.
•
5. 4. 1 GRAPHIC DISPLAY
This function offers the facility to view QC results on Levy-Jennings graphs for three
levels over a period of 6 months. There are two display options, daily and cumulative.
It is important to ensure that the QC details, mean value and SDs, have been entered
in the QC SETTINGS screen. The software requires this information to generate the
QC graphs.
2. Select GRAPH on function keys.
3. Move the cursor to the METHOD field and click on the drop down box to view the
list of test methods.
· General Biochemistry (1-60): 60 methods
ISE (1001-1003): 3(6) methods
ISE diluent (1005-1007): 3 methods
· SI (2001-2003):3 methods
Method to method calculation (3001-3040):
ABC Page 211

Select one from a sum of 40 methods, 106(109) methods

Some related ISE methods depending on the setting definitions in samples will be
displayed.
· Common : 3 methods (Na, K, Cl) of ISE and 3 methods (Na, K, Cl) of ISE (D)
· Serum, Plasma : 3 methods (Na, K, Cl) of ISE
· Urine : 3 methods (Na, K, Cl) of ISE
4. Click on SAMPLE field and select as appropriate.
5. Click on the DATE feild and select as required.
6. Click on the CONTROL NAME field and select the control level. The software will
present graphs for two control levels on screen. Thse user can select to compare
Levey Jennings graphs for any combination of controls, Level 1 to 3.
7. Click on the SEARCH and the software will automatically display Levy-Jennings
plots for the control levels.
Control details including the mean, number, SD and CV of the QC results are dis-
played on screen for two control levels.
8. In the DISPLAY TYPE field select the DAILY button to display QC results for each
day and CUMULATIVE to display cumulative values.
Results are plotted in black for normal values. If Westgard rules are applied,
results are plotted in YELLOW if they violate a WARNING rule and RED if they
violate an ERROR rule. Results indicated as an ERROR will not be included in the
overall mean, CV and SD values presented on screen.
ABC Page 212

QC RESULTS DISPLAY SCREEN.
Results summary
for both levels
Daily display: Individual QC sample results are displayed for each day.
Cumulative results QC sample results are plotted cumulatively for each day.
All the results in one day are plotted on the one vertical axis.
N = Number of results
X = Mean value
SD = Standard Deviation
CV Coefficient of Variation
Plotting symbols
ABC Page 213

5. 4. 2 MEASUREMENT VALUES
This function offers the facility to view QC results for three levels over a period of 6
months for each test method. QC results for a specific parameter are displayed in
order of date when the Method code is entered.

2. Select DETAILS on function keys to view control results between specified dates.
3. Select DAILY (to view results fora specified day including standard deviations).
4. Select CUMULATIVE (to view cumulative results for a time period).
5. Move the cursor to the METHOD field and click on the drop down box to view the
list of test methods.
6. Select a test method by clicking on the name and press RETURN. The software
will automatically display the QC results for the three different levels.
Date Date of measurement result displayed in the format "yyyy/mm/dd".
R# The round number will be displayed between 0 and 99.
No. When the result was measured more than one time at the same round,
it will display the number of how many times the result was executed.
Method Method name will be displayed in alphanumeric within 6 digits.
Ctrl ID Control sample name displayed in alphanumeric within 20 digits.
Conc The measurement result of the control sample will be displayed in 7
digits between 9999999 and 9999999.
Any invalid values will be displayed with " ***** ".
WARNING
Any "WARNING" flags associated with the sample is in this column.
A higher priority error should be displayed if more than 2 errors are found in the
judgment result.
ERROR
If an "ERROR" is associated with the sample it will be displayed in this column.
A higher priority error should be displayed if more than 2 errors are found in the
judgment result.
Flag
Any error flags associated will be displayed with the result.
ABC Page 214

7. Results may be printed by clicking on the PRINT button in the RESULTS OUTPUT
field or saved to file by clicking on the FILE button in this field.
8. When ISE method number is selected (61 or 62) the ISE testing item box is dis-
.
played as shown below. Click on the required options to select the items of choice.
ISE METHOD NUMBER DISPLAY
QC MEASUREMENT RESULTS (DETAILS)SCREEN
ATS
ATS Cont1
ATS Cont1
ATS Cont1
ATS Cont1
ATS Cont1
ATS Cont1
ATS Cont1
ATS Cont1
ATS Cont1
ABC Page 215

QC MEASUREMENT RESULTS (DAILY)SCREEN
To view daily results for a number of test methods enter * in the METHOD field as
shown in the screen above. To view information on a single test method enter the test
method name.
QC MEASUREMENT RESULTS (CUMULATIVE)SCREEN
SD - Standard Deviation
Min - Minimum QC value obtained
ABC Page 216

Max - Maximum QC value obtained
5. 4. 3 QC SETTINGS
The software requires the user to enter the details of QC samples, mean and SD, as
the information is necessary for the production of QC graphs. (See Section ??? for
details)
WARNING/ERROR CODES FOR QC VALUES

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
10:X(-)F Reject when 10
consecutive control
measurements fall on one
side of the mean.
ABC Page 217

5.5 RESULTS FLAGS AND ERROR FLAGS

Results are presented in the RUN/RESULT screen with a series of flags to alert the
user either that the result is outside the specified range or that there has been a
problem with measurement.
To view details of a result simply click on the result value of interest and details of
concentration, judgement value, range and flag will be displayed.
To delete a result click on the result entry line to highlight the value and then click on
the DELETE button. This will delete the results from the internal results data base.
Result flags outside the specified range
No Flag Cause Action

1 H The measurement User information only.
(Higher than upper result is above the Check Chemistry
limit of judgment specified normal Parameters.
value) range.
2 L The measurement User information only.
(Lower than lower result is below the Check Chemistry
limit of judgment specified normal Parameters.
value) range.
3 > The measurement User information only.
result is above the Check Chemistry
technical range. Parameters.
4 < The measurement User information only.
result is below the Check Chemistry
technical range. Parameters.
Error flags on Routine measurement screen and Results printout
Flag Brief explanation Description

SS Sample short Insufficient sample in primary tube or sample cup.
ABC Page 218

SI1 No reagent in Reagent not detected in cuvette on sample

cuvette dispense.
SI2 No diluent in cuvette Diluent not detected in cuvette on sample dispense.
R1S Insufficient Reagent Insufficient reagent in bottle or reagent volume is
1 zero on inventory.
2 zero on inventory.
3 zero on inventory
DS Insufficient Diluent Insufficient diluent in bottle or diluent volume is zero
on inventory.
WS Insufficient Wash Insufficient wash solution in bottle or volume is zero
Solution on inventory.
SPW SPT wash failure SPT wash has failed. Check the alarm for reason of
the failure.
TE1 IRU temperature low IRU temperature is lower than 36.5ºC.
TE2 IRU temperature IRU temperature is higher than 37.5ºC.
high
TE3 RCU temperature RCU temperature is higher than 15 ºC.
high
TE4 ASP temperature ASP temp > 10 ºC
high
EST Anomalous Error in the sampling stop.
measurement
R1B No Reagent 1 bottle Reagent 1 bottle is not registered.
R2B No Reagent 2 bottle Reagent 2 bottle is not registered.
DB No diluent bottle Diluent bottle is not registered.
WB No wash solution Wash solution bottle is not registered.
bottle
IE1 No response from ISE module is not responding to sample start
ISE command sent from analyser.
IE2 No result from ISE ISE module is not sending result data to analyser.
ABC Page 219

IE ISE unit fault ISE unit malfunction.

EST Error during run Sampling has been terminated with an error.
LOT Erroneous lot number details input
R1W RPT 1 wash failed Reagent 1 probe wash between defined methods
failed.
R2W RPT 2 wash failed Reagent 2 probe wash between defined methods
failed.
EXP Reagent expired The reagent has expired its expiry date.
STB Reagent stability The reagent has exceeded the onboard stability
exceeded period.
CTO Calibration expired Measurement result calculated with an expired
calibration.
CXP Control expired Measurement result produced when QC was out of
range.
DUP Duplicate error Calibrator results have exceeded duplicate limit.
SEN Sensitivity error Calibration results have exceeded sensitivity limit.
CAL Calibration failed Calibration has failed.
CA? Concentration Concentration could not be calculated due to
calculation error missing calibration curve.
CLT No valid calibration No valid calibration available for onboard reagent
for reagent lot lot.
LIN Linearity error Sample has exceeded linearity limit.
PRO Prozone check error Sample has exceeded Prozone limit.
AB1 Absorbance limit None or only one point is within absorbance limit
error and result calculation is not possible.
AB2 More than one point is outside the absorbance limit
but two or three are within the limit, therefore result
calculation is possible.
STM Sample type Measurement result calculated from a calibration
inconsistent curve that does not match the sample type.
ABC Page 220

5.6 EXAMPLES OF RESULTS PRINTOUTS
EXAMPLE-1. PRINTOUT OF RESULTS LIST (AUTOMATIC OR SEARCH)

2005/06/15 13:27
Sample number Sample ID
Sno.:001011 ID: Date:2005/06/15 Round No:10
AST ALT LDH G-GTP AMY
00046.0 00042.0 00235.0 00036.0 00125
IU/L IU/L IU/L IU/L IU/L
TP ALB CRE
00005.2 00003.5 00001.25
g/dl g/dl mg/dl
Results flag
EXAMPLE-2. PRINTOUT OF PATIENT REPORT (SEARCH)

PrintDate: 2005/07/04 PrintTime 13:39
Name: Date:2005/07/04
Sno.: Time:13:32
Sample: Sex:
Comment: Age:
Physician: SSNo.:
Location:
Method Units Results Flag Normal Range
TP g/dl000 05.2 SS 0.0- 6.5
CHO Mg/dl 18.2 SS 0.0- 199.0
｜｜｜｜｜｜
｜｜｜｜｜｜
The SEARCH patient report prints out the last 3 sets of test result for the patient.
ABC Page 221

EXAMPLE-3. PRINTOUT OF PATIENT REPORT (AUTOMATIC)
EXAMPLE-4. PRINTOUT OF RESULTS FOR CONTROLS
QC Report Date: 2005/06/15 17:31
Control:C12 QCL3 RoundNo:2
Method Conc Unit Set Mean Set –2SD Set +2SD Warning Error
Test01 12.3 mg/dl 12.0 10.0 14.0
Test02 5.6 mg/dl 5.0 4.5 5.5 1:2S
CONTROL: CONTROL NUMBER/ CONTROL NAME

ROUNDNO: ROUND NUMBER
METHOD: METHOD NAME
CONC: THE RESULT CONCENTRATION
UNIT: UNIT FOR CONCENTRATION VALUE
SET MEAN: THE MEAN CONCENTRATED VALUE OF THE QC SAMPLE THAT HAS
BEEN INPUT
SET -2SD: THE VALUE CALCULATED BY THE SD THAT HAS BEEN INPUT.
SET +2SD: THE VALUE CALCULATED BY THE SD THAT HAS BEEN INPUT.
ABC Page 222

EXAMPLE-5. PRINTOUT OF TEST ORDER IN RUN/SELECTION MENU

2005/06/15 17:31
Test Selection
Pos.:01 SID: 123456789012 ID: PATIENT01234 R:03 S:Common
TEST01 TEST02 TEST03 TEST04 AST ALT
Pos.:02 SID: 123456789013 ID: PATIENT01235 R:02 S:Common
TEST01 TEST02 TEST03 TEST04 AST ALT
POS.: SAMPLE POSITION

SID: SAMPLE ID
ID: PATIENT ID
R: RECOGNITION NUMBERS OF STANDARD VALUES
S: SAMPLE TYPE
EXAMPLE-6. PRINTOUT OF CHEMISTRY PARAMETERS IN PARAMETER/NORMAL MENU
ABC Page 223

2005/06/15 17:31
No Name Print Name Unit Assay Wave D

P
01 AST AST IU/L Rate 0340 415 1
Type Sample Pre Reagent Vol Speed Point

Common N 03.0 - R1 AST 180 Middle 48-64
H 02.0 - R2 AST 090
L 03.0 -
D1
W
Photometry
point
Technical Range
0000.00-0600.00
Normal Range
01 Male-G1 0000.00- 0000.00 11 0000.00-
02 Male-G2 0000.00- 0000.00 12 0000.00-
03 Male-G3 0000.00- 0000.00 13 Standard Value
0000.00-
04 Female-G1 0000.00- 0000.00 14 0000.00-
05 Female-G2 0000.00- 0000.00 15 0000.00-
06 Female-G3 0000.00- 0000.00 16 0000.00-
| |
49 0000.00-
50 0000.00-
Dup 00050
Sen 00350
Lin 30.0 00060
Pro 0.00500000 U 01-02 03-04 000250 Settings of “Normal2”
ABS I 025000
Blank
Type Disable
WHEN None
Sample No Sample
MNum 3
Dup -
Inst Factor a: 01.00 b: 00.00
ABC Page 224

EXAMPLE-7. PRINTOUT OF ISE PARAMETERS

2005/06/15 17:35
Name Reagent
ISE DI ISE(D)
Method
criteria
Type ISEType
Common ISE(D)
Normal Range
Na K Cl
01 Male-G1 000.0-000.0 00.00-00.00 000.0-000.0
02 Male-G2 000.0-000.0 00.00-00.00 000.0-000.0 Standard value setting
03 Male-G3 000.0-000.0 00.00-00.00 000.0-000.0
04 Female-G1 000.0-000.0 00.00-00.00 000.0-000.0
05 Female-G2 000.0-000.0 00.00-00.00 000.0-000.0
06 Female-G3 000.0-000.0 00.00-00.00 000.0-000.0
07 000.0-000.0 00.00-00.00 000.0-000.0
08 000.0-000.0 00.00-00.00 000.0-000.0
000.0| 00.00| 000.0|
000.0| 00.00| 000.0|
49 000.0-000.0 00.00-00.00 000.0-000.0
50 000.0-000.0 00.00-00.00 000.0-000.0
Inst Factor Na a: 01.00 b: 00.00

K a: 01.00 b: 00.00 Correction Value
Cl a: 01.00 b: 00.00
EXAMPLE-8. PRINTOUT OF SERUM INFORMATION PARAMETERS

2005/06/15 17:31
Name Reagent Type Factor

SI AST R1 A 000001
B 000001
C 000001
D 000001
E 000001
F 000001
Normal Range
H L I
0 < 000001 0 < 000001 0 < 000001
1 < 000002 1 < 000002 1 < 000002 JUDGEMENT STRINGS
2 < 000003 2 < 000003 2 < 000003
3 < 000004 3 < 000004 3 < 000004
4 4 4
CORRECTION VALUES
Inst Factor H a: 01.00 b: 00.00
L a: 01.00 b: 00.00
I a: 01.00 b: 00.00
ABC Page 225

EXAMPLE-9. PRINTOUT OF METHOD TO METHOD CALCULATION

No Name Print Type Unit DP
1 Calc1 Common 2
Expression
({11}/({11}+{12}))*100 Calculating formula
Normal Range
01 Male-G1 0000.0-0000.0 11 0000.0-

02 Male-G2 0000.0-0000.0 12 0000.0-
03 Male-G3 0000.0-0000.0 13 0000.0-
04 Female-G1 0000.0-0000.0 14 0000.0-
05 Female-G2 0000.0-0000.0 15 0000.0-
06 Female-G3 0000.0-0000.0 16 0000.0-
07 000.0-000.0 17 0000.0-
08 000.0-000.0 18 0000.0-
0000.0| 0000.0|
0000.0| 0000.0|
49 000.0-000.0
50 000.0-000.0
EXAMPLE-10. PRINTOUT OF PROFILE

2005/06/15 17:31
Profile
Name:Prof01 Sample:Common
TEST01 TEST02 TEST03 TEST04 AST ALT ISE
Name:Prof02 Sample:Common
TEST06 TEST07 TEST08 TEST09 CRP ISE
EXAMPLE-11. PRINTOUT OF WASH PROGRAM

2005/06/15 17:32
Wash Programs
Reagent
Method - Method Type Name
- AST R1-R1 Wash - AST
- AST R2-R2 000005 - Water
Method: Method names are printed out. The mark "*" will be printed out if
all methods are the targets.
R1-R1 (R2-R2): Each target reagent by reagent
Type: Washing reagent by reagent (It will be blank if pure water
washing is applied. In this case, "Water" is printed out
ABC Page 226

as reagent name.)
Name: Washing reagent name
This sample is for the printed time course data.
S2 Absorbance measurement of sample at primary wavelength

W2 Absorbance measurement of reagent blank at primary wavelength
S1 Absorbance measurement of sample at secondary wavelength
W1 Absorbance measurement of reagent blank at secondary wavelength
EXAMPLE-5 (CALIBRATION RESULT)

This sample is for the printed coefficient of calibration result.
This sample is printed when the calibration measurement is performed normally.
ABC Page 227

EXAMPLE-12. PRINTOUT OF CALIBRATION DETAILS

NEW
0R1Lot: R2Lot:
0DateTime:
Conc Work Master LotNo Sample Diluent

S1 0000.00 000000 000000
Calibration curve data (New)
S2 1000.00 010000 010000
S3
S4
S5
S6
S7
K 00001000
OLD
0R1Lot: R2Lot:
0DateTime:
Conc Work Master LotNo Sample Diluent

S1 0000.00 000000 000000
Calibration curve data (Old)
S2 1000.00 010000 010000
S3
S4
S5
S6
S7
K 00001000
Reagent Blank
Blank
1. Linear
ABC Page 228

EXAMPLE-13 QC SETTINGS
2005/06/15 16:15
QC Settings
Name Type Interval Mode:MEAN-R No.:-

Test04 Common 000
Control Name Mean SD

1 Ctrl1 5.00 1.00
2 Ctrl2 10.00 2.00
3 Ctrl3 15.00 3.00
Current result exceeds 2SD WARNING

Current result exceeds 3SD ERROR
Current result exceeds 4SD INACTIVE
Last 2 results exceed 2SD INACTIVE
2 out of last 3 results exceed 2SD INACTIVE
Range exceeds 4SD INACTIVE
Any 3 result exceed 1SD INACTIVE
Any 4 result exceed 1SD INACTIVE
10 results same side of mean INACTIVE
7 continue points trend INACTIVE
Name: Method name

Sample: Sample type
Interval: Check interval
Mode: Mode for calculation
With a calculation mode, either "MEAN-R" or "X-R" can be printed out.
No.: Data number
It will be printed out when the calculation mode is "X-R".
"No." will be put "-" when the mode is "MEAN-R".
Control Name:Control Name
Mean: Mean value
SD: Standard Deviation
ABC Page 229

EXAMPLE-14 PRINT SAMPLE OF QC REPORTS

2005/06/15 17:32
QC Report
Name Unit Sample

Test01 IU/L Common
Data From: 2005/07/25 RoundNo:02

Data To : 2005/07/25 RoundNo:02
Data Control Name Control Name

Round No. Conc Warning Error Conc Warning Error
2005/07/25 Ctrl1 Ctrl2
02 30.5 1:2S 45.2 1:3S
Name Measurement method name

Unit: Unit
Sample: Sample type
Date From: Search period
Date To: Search period
Round No: Round number
Control Name: Control name
Conc: Measurement result
Warning Error: Warning/Error strings
EXAMPLE-15 PRINT SAMPLE OF QC REPORT (CUMULATIVE)

2005/06/15 17:32
Cumulative QC List
Control:C01 Ctrl01
Date From:2005/07/24 To:2005/07/26
Method N Mean -2SD SD CV Min Warn/Err

+2SD Max
Test01 1 45.0 40.0 2.5 1.0 45.0
50.0. 45.0
Test02 1 22.0 20.0 1.0 2.5 22.0

24.0 22.0
Control: Control number and name

Date From To: Search start date and end date
Method:: Method name
N: The number of the search data
Mean: Mean value of concentration calculated by the target
measurement results
-2SD: The value -2SD calculated by the target measurement results
ABC Page 230

+2SD: The value +2SD calculated by the target measurement results

SD: The value SD calculated by the target measurement results
CV: The value CV calculated by the target measurement results
Min: The minimum value calculated by the target measurement results
Max: The maximum value calculated by the target measurement results
Warn/Err: Error or warning strings
EXAMPLE-16 PRINT SAMPLE OF QC REPORT (DAILY)

2005/06/15 17:32
Daily QC List
Control:C01 Ctrl01
Date:2005/07/24 Round:01
Method N Mean -2SD SD CV Min Warn/Err

+2SD Max
Test01 3 45.0 40.0 2.5 1.0 45.0
50.0. 45.0
Test02 3 22.0 20.0 1.0 2.5 22.0

24.0 22.0
Control: Control number and name

Date: Search starts date and end date
Round: Round number
Method: Method name
N: The number of the search data
Mean: The value -2SD calculated by the target measurement results
+2SD: The value +2SD calculated by the target measurement results
SD: The value SD calculated by the target measurement results
CV: The value CV calculated by the target measurement results
Min: The minimum value calculated by the target measurement results
Max: The maximum value calculated by the target measurement results
Warn/Err: Error or warning strings
ABC Page 231

EXAMPLE-17 (PATIENT REPORT)

EVERYONES HOSPITAL
A STREET, TOWN, CITY, COUNTRY
TEL: 1234567 FAX: 222222
EMAIL: ADMIN@.HOSPITAL.COM
2003/04/10 16:31:32
Live Patient Report
Patient Details Sample Details

Patient Name Mrs Smith ij12,abcdefghij12
Patient ID 123 Location abcdefghij1234567890abcdefghij12
Social Security No. 123456789 Date Drawn 2003/09/02
Date of Birth 2001/12/12 Phlebotomist cdefghij12,abcdefghij12
Age 1 Sample Comments abcdefghij12345
Sex Female Sample No. 001
Race xxx
Ordering Physician Mr Jones
Attending Physician Mr Black
Referral Physician Mr White
Patient Comments Very sick
Method Units Results Flag Normal Range

Na mmol/l 71.0000 0000 20- 99.99
ABC Page 232

SECTION 6 MAINTENANCE Version 1.0 Rev Sep 2005
SECTION 6
MAINTENANCE
ABC Page 233

6.1 MAINTENANCE INTERVALS

This chapter details the maintenance procedures required to ensure the highest
standard of performance and safe operation of the Rx Imola.
The following maintenance procedures should be performed at the intervals

suggested below. Following this table procedures are explained in more detail.
Interval Check point

Before Fill system water tank with water (at least NCCLS type II water).
analysis Check the remaining volumes of wash solutions in tanks and refill
if necessary.
Check supply tube end is at bottom of system water tank.
Check waste tube at top of waste tank.
Check cuvette water blanks in [Maintenance][WBlank].
Check volumes and expiries of ISE reagents.
Empty waste tanks and ensure there is sufficient printer paper.
Daily Wipe any stains on the internal surface (inside outer lid) using a
clean damp cloth.
Use an absorbent cloth to remove any condensation in the RCU
tray
Clean the outside of sample and reagent probes with a swab
impregnated with alcohol.
If ISE unit is present, check the remaining volume of calibrator A
and ensure tip of calibrator A tube is at the bottom of the bottle.
Perform ISE cleaning as prompted when entering ‘Sleep’ mode.
ABC Page 234

Weekly NB Analyser must be switched off during weekly cleaning to

allow mechanical parts to be moved easily.
Clean the ASP unit.
Clean the reagent container unit (RCU).
Clean pipette cover, trough and mosaic plates thoroughly.
Remove wash unit cover and clean wash probes with a cotton
swab soaked with alcohol.
Carefully raise mixers and clean with a cotton swab soaked with
alcohol taking care not to bend or break the mixers
Visually check that solution is supplied to RPT trough.
Perform SPT clean with CI solution as prompted during automatic
probe wash when entering ‘Sleep’ mode.
Monthly Use reagent (RP3857) and sample (RX3856) precision test

solutions to check pipetting precision.
(See Sec- Check the remaining hours left for parts in [Maintenance][Work
tion 6. 2.
Hour] screen.
4“WORK-
ING Check Alarm (F4) screen.
HOURS Check IRU and RCU temperature
OF
Check water and wash solutions at all troughs
EXPEND-
ABLE Perform decontamination and cleaning of internal tubing
PARTS” on Clean external tanks using Randox C1 wash solution (Rx 3973) to
page 235
remove any microbial contamination. Wash tubes.
Clean cuvettes by switching connectors for system water and
wash solution 3
Check operation of fans at the rear of the analyser
Visually check WU filters are clean.
ABC Page 235

As required Exchange of halogen lamp (every 1000 hours).

Exchange of syringe plunger tip (every approx. 600 hours).
Exchange of diaphragm pump (every 2000 hours).
Exchange of cuvette (based on the measurement of water blank).
Exchange of stirrer
Exchange of pipette nozzle
Replace ISE electrodes
Use probe cleaning tool to clean inside of the sample probe and
reagent probe.
6. 1. 1 DAILY MAINTENANCE
1. Pure Water and Effluent Tanks
Checks: pure water tank is full (fill as necessary)
effluent tanks are empty (empty as necessary)
tube tip of water tank is in contact with bottom of tank
tube tip of effluent tank is well above effluent level to avoid
back flow.
2. Detergent Tank
Checks: wash solution tanks are full (fill as necessary)
tube tip of detergent tank is in contact with bottom of tank
3. Click on [Maintenance] [Sequence] to perform a cuvette check. To view the

cuvette water blanks go to [Maintenance] [WBlank] screen. If any cuvettes are
flagged as being over the judgement value perform a cuvette wash and recheck
screen. If still above judgement value, remove affected cuvette from IRU and
wash manually in 0.1 M HCl. Replace cuvette and perform cuvette check - contact
Randox if this does not resolve the problem.
4. Clean the inside of the sample and reagent probes with the probe cleaning tool.
Clean the outside of the probes with a piece of gauze soaked in methanol. Always
wipe downwards from nozzle body to tip.
ABC Page 236

5. Wipe all surfaces with a clean damp cloth.
6. Use an absorbent cloth to remove any condensation in the RCU tray.
7. Check printing paper and replace as necessary.
8. If ISE unit (optional) is present carry out additional checks below.
Ensure sufficient volume of Calibrator A – gently agitate Calibrator A bottle.

Ensure tip of the Calibrator A tube is in contact with the bottom of the bottle
In the event that the tube comes out of the calibrator A bottle perform ISE prime
10 times.
Remove ISE cover and swing out ISE module, checking for any spillage around
the sampling port. Clean with a swab impregnated with alcohol if requiredto
remove any crystalline deposits, taking care not to contaminate the sampling port.
Swing ISE module back into unit and replace ISE cover.
Daily cleaning procedure should take less than 5 minutes.

9. Perform ISE cleaning procedure at end of daily analysis by placing 500µl of ISE
cleaning solution in a sample cup at position 18 in the ASP tray and use the ‘ISE
Clean’ function in the [Maintenance] [Sequence (F9)] screen.
6. 1. 2 WEEKLY MAINTENANCE
Please note that to carry out these procedures effectively the analyser must be
completely powered off so that mechanical parts can be moved easily. It is suggested
that the RCU tray be removed and placed in a refrigerator while the cleaning is being
carried out.
1. Clean Automatic Sampling Unit (ASP) with a clean damp cloth.
2. Clean Reagent Container Unit (RCU) with a clean damp cloth.
ABC Page 237

3. Clean pipette cover, trough and mosaic plates thoroughly with a clean damp cloth
removing relevant sections if necessary.
4. Remove wash unit cover, carefully lift wash unit up to allow better access and
clean wash unit probes with a swab impregnated with alcohol.
5. Carefully raise mixers and clean with a swab impregnated with alcohol taking care
not to bend or break the mixers.
6. At the end of each day prior to putting the system into sleep mode, place a cup of
wash solution C1 in sample position 18 for the automatic probe wash.
Once cleaning procedure has been finished replace RCU tray and power on the
analyser and PC. Weekly cleaning procedure should take approximately 5 – 10
minutes. Please see Section ??? for details of cleaning procedures.
6. 1. 3 MONTHLY MAINTENANCE
1. Carry out a sample and reagent precision check using Reagent Precision Test
solution (Cat. No. RX3857), Sample Precision Test solution (Cat. No. RX3856)
and Acid Wash Solution (WS3853). See kit inserts for procedures. If the results of
these checks are outside defined acceptable limits please contact Randox Techni-
cal Support.
2. Check the remaining hours of parts on the maintenance wash screen.
3. Check Alarm Log and refer to error code section of this manual for any unex-
plained error codes.
4. Check IRU and RCU temperature.
5. Perform SPT/RPT (W) and SPT/RPT (C) washes from the [Maintenance]
[Sequence] screen.
ABC Page 238

6. Visually check water and wash solutions at all troughs.
7. Perform decontamination and cleaning of internal tubing using the Tubing Wash
instructions .
8. Clean waste tanks using dilute hypochlorite solution to remove any microbial con-
tamination.
9. Check the condition of the three fans located at the rear of the chassis to ensure
that they are operating normally.
6. 1. 4 PERIODIC MAINTENANCE
Periodic checks should be carried out at regular intervals based on the use and
throughput of the analyser. To determine hours of use for various parts go to
[Maintenance][Work Hour ] screen and perform the following if countdown timer has
reached zero hours.
• Exchange the halogen lamp
• Replace syringe tips
• Replace diaphragm pumps
• Replace pipette nozzles
• Replace cuvettes.
• Use probe cleaning jig to remove blockages if they occur.
During analysis, periodically check the levels and tube positions in the purified water
and waste tanks.
ABC Page 239

6.2 MAINTENANCE SCREEN

The maintenance screen provides test function operations performed by each unit
and displays the status of various sensors.
6. 2. 1 SENSOR CHECKS
The MECHANICAL MAINTENANCE screen enables the user to check various
operating functions and sensors in Rx Imola analyser.
1. Select MAINTENANCE on the job menu.

2. Select SENSOR on the TAB keys.
3. Select the sensor type from the drop down box on the screen. The software will
display the status of the sensor on screen. The options are as follows:
Names Meanings
Sensor All photo sensors
SPT_PULSE Detection sensor for the SPT liquid level
RPT1_PULSE Detection sensor for the RPT1 liquid level
RPT2_PULSE Detection sensor for the RPT2 liquid level
WU1_PULSE WU1 overflow sensor
4. Click on the READ START button to perform a status check on each sensor. This
will change to STOP during the check process. Pressing STOP will cancel the
sensor check.
RED CIRCLE SENSOR ON
GREY CIRCLE SENSOR OFF
ABC Page 240

MAINTENANCE SCREEN
Sensor Check list

Sensor Names Unit Names Meanings
ASP_Zero_Pos ASP The zero position of ASP’s turn table

Red (ON): Zero position Disconnecting state: Red (ON)
RCU_Zero_Pos RCU The zero position of RCU’s turn table

RPP1R_Up_Zero_Pos RPP1 The zero position of RPP1R’s syringe (The upper limit of
(Reagent) Syringe)
Red (ON): Zero position Disconnecting state: Gray (Off)
RPP1W_Up_Zero_Pos RPP1 The zero position of RPP1W’s syringe（The upper limit of

(Washing) Syringe）
Red (ON): Zero position Disconnecting state: Gray (Off)
SPARE_SENSR1 Not Used
SPARE_SENSR2 Not Used
ASP_COVER_F ASP Detecting the cover of ASP emergency samples

Red (ON): Found the cover Disconnecting state: Gray (Off)
ASP_COVER_B ASP Detection of cover for ASP Normal samples

ABC Page 241

ASP_COVER_C Not Used
RCU_COVER_F RCU RCU cover detection

RCU_YOBI Not Used
ISE_COVER ISE ISE cover detection

LEAK_RCU_YOBI Not Used
LEAK_RPP1 RPP1 Not Used

Detection of RPP1 leaking
Red (ON): Found a leak Disconnecting state: Gray (Off)
LEAK_ASP ASP Not Used

Detection of ASP leaking
Red (ON): Found a leak Disconnecting state: Gray (Off)
+12_RCU_PE RCU DC 12V monitor (Peltier power supply for RCU cooler)
Red (ON): 12V
+12_ASP_PE ASP DC 12V monitor (Peltier power supply for ASP cooler）
Red (ON): 12V
+24_MON_RCU RCU DC 24V monitor (RCU power supply)

Red (ON): 24V
+24_MON_ASP ASP DC 24V monitor (ASP power supply)

Red (ON): 24V
ASP_TRAY Not Used
SPARE_SENSE4 Not Used
RCU_PE1_FAN RCU Radiating fan for RCU peltier-1 cooler (Rotation stop detecting
function)
Gray (ON): Rotate Stop state: Red
function)
function)
function)
ASP_PE1_FAN ASP Radiating fan for ASP peltier-1 cooler (Rotation stop detecting
function)
ABC Page 242

ASP_PE2_FAN ASP Radiating fan for ASP peltier-2 cooler (Rotation stop detecting
function)
SPARE_FAN3 Not Used
SPARE_FAN4 Not Used
WPP_Up_Zero_Pos WPP The zero position of WPP syringe (The upper limit of Syringe)
SPP_Up_Zero_Pos SPP The zero position of SPP syringe (The upper limit of Syringe)
(Samples) Red (ON): Zero position Disconnecting state: Red (ON)
SPPW_Up_Zero_Pos SPPW The zero position of SPPW syringe (The upper limit of
(Washing) Syringe)
SUBTANK1_ENP Sub-Tank Detecting empty in Sub tank R

(R) Red (ON): Found pure water Gray (OFF): Not found pure
water
SUBTANK1_FLL Sub-Tank Detecting full of water for Sub tank R

(R) Red (ON): Found pure water Gray (OFF): Not found pure
water
SUBTANK1_SET Sub-Tank Detecting Sub tank R

(R) Red (ON): Found sub tank R Gray (OFF): Not fitted sub tank
R
LEAK_SPP SPP SWU1-1 leaking liquid

Detecting SPP leaking liquid
Red (ON): Found leaking liquid Disconnecting state: Gray
(OFF)
LEAK_SWU_1 SWU1-2 leaking liquid
BOT1_EMP External tanks Detecting empty for pure water tank

Yellow (ON): Liquid found (Not empty)
BOT2_EMP External tanks Detecting empty for wash solution tank -1

BOT3_EMP External tanks Detecting empty for wash solution tank -2

BOT4_ENP External tanks Detecting full of water for the Low-concentrated waste water
tank
Yellow (ON): Empty
BOT5_FULL External tanks Detecting full of water for the High-concentrated waste water
tank Yellow (ON): Empty
BOT6_FULL External tanks Detecting empty for wash solution tank -3

ABC Page 243

LEAK_SWU2 SWU2 Detecting SWU2 leaking liquid

Red (ON): Leaking found Disconnecting state: Gray (OFF)
+24_MON_SWU_DR SWU DC 24V monitor (SWU-DRV1 power supply)

V1 Red (ON): 24V

V2 Red (ON): 24V
CSE_FAN1 Not Used
SPARE_FAN2 Not Used
SWU_FAN Not Used
MIX1U_Zero_Pos MIX1 The zero position for MIX1’s up-and-down operation (The
upper limit)
Yellow (ON): Zero position Disconnecting state: Yellow (ON)
MIX1R_Zero_Pos MIX1 The zero position of MIX1’s rotating operation

MIX2U_Zero_Pos MIX2 The zero position of MIX1’s up-and-down operation (The

upper limit)
MIX2R_Zero_Pos MIX2 The zero position of MIX1’s rotating operation

Yellow (ON): Zero position Disconnecting state: Yellow
(OFF)
RPT1U_Zero_Pos RPT1 The zero position of RPT1’s up-and-down operation (The

upper limit)
(OFF)
RPT1R_Zero_Pos RPT1 The zero position of RPT1’s rotating operation

(OFF)
RPT2U_Zero_Pos RPT2 The zero position of RPT2’s up-and-down operation (The

upper limit)
(OFF)
RPT2R_Zero_Pos RPT2 The zero position of RPT2’s rotating operation

(OFF)
ABC Page 244

SPTU_Zero_Pos SPT The zero position of SPT’s up-and-down operation (The upper
limit)
(OFF)
SPTR_Zero_Pos SPT The zero position of SPT’s rotating operation

(OFF)
IRU_Zero_Pos IRU The zero position of cuvette turn table in the IRU
WU_Zero_Pos WU WU nozzle’s point of origin (The upper limit)

RPT1RCU RPT1 RPT1 position

ON: RPT1 is on the RCU. OFF: RPT1 is not on RCU.
RPT2RCU RPT2 RPT2 position

ON: RPT2 is on the RCU. OFF: RPT2 is not on RCU.
SPTASP SPT SPT position

ON: SPT is on the RCU. OFF: SPT is not on RCU.
Note that it will be ON when SPT turns to ISE unit also.
MIX1R_TS MIX1 The tough position of MIX1’s stirring paddle

Red (ON): the paddle is at trough. Disconnecting state: Gray
(OFF)
MIX2R_TS MIX2 The tough position of MIX2’s stirring paddle

Red (ON): the paddle is at trough. Disconnecting state: Gray
(OFF)
RPT1R_TS RPT1 The position of trough discharging for RPT1 rotating operation
Red (ON): RPT1 is at the discharging position in trough.
Gray (OFF): Disconnecting state
RPT2R_TS RPT2 The position of trough discharging for RPT2 rotating operation
Red (ON): RPT2 is at the discharging position in trough.
SPTR_TS SPT The position of trough discharging for SPT rotating operation
Red (ON): SPT is at the discharging position in trough.
Note that it will be ON when SPT turns to ISE unit also.
IRU_READY Not Used
ABC Page 245

RPT1U_DL RPT1 The lower limit where RPT1 moves up and down (The lower
limit)
Red (ON): The lower limit Disconnecting state: Gray (ON)
RPT2U_DL RPT2 The lower limit where RPT2 moves up and down (The lower
limit)
SPTU_DL SPT The lower limit where SPT moves up and down (The lower
limit)
WU_COVER Not Used
TRGH1_EKIMEN TR Detecting the liquid level of trough chamber

ON: Found liquid OFF: Liquid not found
TRGH2_EKIMEN Not Used
LEAK_IRU WPP Leaking WPP part

ON: Found leaking OFF: Not found leaking
R1PTU_EKIMEN RPT1 Detecting the liquid level of RPT1

This cannot check in sensor mode.
R2PTU_EKIMEN RPT2 Detecting the liquid level of RPT2

S1PTU_EKIMEN SPT Detecting the liquid level of SPT

WU1_EKIMEN WU Detecting the liquid level of WU1







+24V_MON_IRU IRU DC 24V monitor (SWU-DRV1 power supply)

Red (ON): 24V
ABC Page 246

DTR_FAN DTR Detecting DTR fan stop

Gray (ON): rotation Condition Stopping: Red
+24V2_MON_IRU IRU ON: Power ON OFF: Power OFF
LEAK_RPP2 RPP2 Detecting RPP1, 2 leaking (common in rpp1, 2)

Red (ON): Found leaking Disconnecting state: Gray (OFF)
RPP2R_UP_ZERO_P RPP2 The zero position of RPP2R syringe (The upper limit of
OS (Reagents) Syringe)
Red (ON): Zero position Disconnecting state: Gray (OFF)
RPP2W_UP_ZERO_P RPP2 The zero position of RPP2W syringe (The upper limit of
OS (Washing) Syringe)
Red (ON): Zero position Disconnecting state: Gray (OFF)
YOBI1_SENSE_A Not Used
SUBTANK2_ENP Sub-Tank Detecting empty sub tank L

(L) Red (ON): Found pure water Gray (OFF): No pure water
SUBTANK2_FULL Sub-Tank Detecting empty sub tank L

(L) Red (ON): Found pure water Gray (OFF): No pure water
SUBTANK2_SET Sub-Tank Detecting sub tank L

(L) Red (ON): Found sub tank
POW_FAN1 Power supply Heating-release fan -1 for Power supply unit (Rotation stop
unit detecting function) Multi power supply unit
Gray (ON): Rotation Condition Stop: Red
POW_FAN2 Power supply Radiating fan-2 for Power supply unit (Rotation stop detecting
unit function)
POW_FAN3 Power supply Radiating fan-3 for 24V and 12 V Power supply units (Rotation
unit stop detecting function)
POW_FAN4 Not Used
POW_FAN5 Not Used
POW_FAN6 Not Used
POW_FAN7 Not Used
ABC Page 247

DTR_SPARE_IN1 Not Used
DTR_SPARE_IN2 Not Used
RCU_BCR_OK RCU Not Used
RCU_BCR_NG RCU Not Used
ASP_BCR_OK ASP Not Used
ASP_BCR_NG ASP Not Used
ISE_READY ISE Not Used
CSE_FAN5 CSE Stop the fan attached to the back of CSE

ON: Stop OFF: Rotating
CSE_FAN6 CSE Stop the fan attached to the back of CSE

ON: Stop OFF: Rotating

V3 Red (ON): 24V
YOBI1_SENSE_B Not Used
6. 2. 2 SYSTEM CHECKS
The MECHANICAL MAINTENANCE screen enables the user to check various
operating procedures.
ABC Page 248

2. Select SEQUENCE on the TAB keys. The software will display the following
screen:
6. 2. 2. 1 INITIALISATION
This action initialises the mechanical parts of each unit.
6. 2. 2. 2 PRIME SEQUENCE
This action primes the tubes for aspiration and dispense of samples and reagents in
the SPT and RPT units. It will fill the tubes with water and wash solution and then
discharge air. Define the number of primes required by specifying a figure in the
adjacent box.
6. 2. 2. 3 ISE PRIME
The software will doscharge air through the tubing. Define the number of primes
required by specifying a figure in the adjacent box.
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6. 2. 2. 4 ISE CALIBRATION
The system will execute a 2-point calibration using the ISE calibrator (Calibrator B).
This should be performed prior to ISE measurement each day.
6. 2. 2. 5 ISE CLEANING
The system will wash ISE electrodes' sample paths and tubing using ISE cleaning
solution. This should be carried out on a daily basis, every 50 samples, or every 8
hours when measuring for more than 50 samples per a day.
6. 2. 2. 6 WU 1,3 RINSE
When click on this button, the WU1 and WU3 lines are filled with pure water. At the
end of a round, pure water will be filled automatically.
6. 2. 2. 7 CUVETTE CHECK
This action assesses the degree of staining in cuvette by running a cuvette water
blank measurement. The results of the cuvette check may be viewed on the
MAINTENANCE/WBLANK screen.
6. 2. 2. 8 CUVETTE WASH
This will execute a cuvette wash.
6. 2. 2. 9 CUVETTE WATER PLACEMENT

This will dispense water or wash solution into each cuvette. Select SYS WATER or
WASH BOTTLE on the pull down menu.
6. 2. 2. 10 CUVETTE WATER DISPLACEMENT

This will drain water from the cuvette.
6. 2. 2. 11 WU ASCEND/ WU DESCEND
This will move the WU unit upwards after initialisation of each unit and the button will
then change to WU DESCEND. This is used when the nozzles require cleaning. After
cleaning click on the WU DESCEND to lower the unit again.
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6. 2. 2. 12 ROUND PREP SKIP

When this box is checked it will not carry out the preparation process at the start of
the round.
6. 2. 2. 13 PUMP TEST
The following window will appear:
Click on the box of the respective pumps to activate the pump check for either the
Diaphragm pump, Waste pump or Drain pump. Enter the required test time in the
Time box and click EXEC to start the check.
6. 2. 2. 14 NOZZLE WASH SEQUENCE

In the WASH field the user can specify whether to use Water or Special solution for
washing the nozzle.
SPT Click on the check box, and select "Water" or "Special" for the SPT wash.
RPT1 Click on the check box, and select "Water" or "Special" for the RPT1 washes.
RPT2 Click on the check box, and select "Water" or "Special " for the RPT2 wash
Exec Click on this button, to start the nozzle washing.
When any one of the checkboxes among SPT, RPT1 and RPT2 is "ON", the Exec will
be effective.
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When any one of the "Special" among SPT, RPT1 and RPT2 is "ON" and the Exec
button is clicked, it will require approximately 13 minutes to complete the wash. Click
on OK to execute a wash, or click on Cancel to stop. The following screen will appear:
When both "Water" and "Special" are "ON" , a message is displayed to "Specify
either water or wash solution" and the wash will not be executed.
In the special washing for RPT, special washing solutions for RPT nozzle should be
registered in the tab menu [Setup] of the job menu [System (F9)] in advance.
If reagent codes and types are not defined, a message "The bottle code for wash
solution is "0"." will appear to notify the user and it will not execute a special washing
for RPT nozzles.
When there is insufficient wash solution on board the software will display the
following message: "Not enough wash solution inventory" after clicking on the EXEC
button. It will not execute a special washing for RPT nozzles.
6. 2. 2. 15 MOVE UNIT
The software will move the unit and check the operation.
Motor: Select a motor to be run on the pull-down menu. When you select a motor, its
corresponding "Mode" and "Position" will be switched over.
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01: MIX1 MIX1 revolving 11: SPT SPT revolving motor

R motor R
02: MIX1 MIX1up-and-down 12: SPT SPT up-and-down
U motor U motor
03: MIX2 MIX2 revolving 13: WU WU up-and-down
R motor motor
04: MIX2 MIX2 up-and-down 14: IRU IRU revolving motor
U motor
05: MIX1 MIX1 stirring motor 15: WPP WPP washing
S syringe
06: MIX2 MIX2 stirring motor 16: SPP SPP sample syringe
S
07: RPT1 RPT1 revolving 17: ASP ASP revolving motor
R motor
08: RPT1 RPT1 up-and-down 18: RCU RCU revolving motor
U motor
09: RPT2 RPT2 revolving 19: RPP RPP1 reagent
R motor 1 syringe
10: RPT2 RPT2 up-and-down 20: RPP RPP1W pure water
U motor 1W syringe
21: RPP RPP2 reagent
2 syringe
22: RPP RPP2W pure water
2W syringe
23: SPP SPP pure water
W syringe
Mode:Select a mode from Search (Search for origin)/Move (Move to the specified
position)/Check (Check for drive) on the pull-down menu.
Position: In the Mode it is only available when Move (Move to the specified position)
is selected, and a position map of a motor selected in Motor can be selected on the
pull-down menu.
Origin Sensor: It will display the information of detection for Origin sensor. (ON:
Origin, OFF: Not Origin)
ABC Page 253

Click on the EXEC button to move the unit.
6. 2. 3 CUVETTE CHECK
This facility enables the operator to check the cuvettes in the IRU.
1. Select MAINTENANCE on job menu.

2. Select WBLANK on the TAB keys.
3. The wavelength is specified and the readings for each cuvette are displayed on
screen. The degree of stains in the cuvettes is assessed with reference to the
judgment value. The water measurement blank is carried out during routine mea-
surement and the values are stored in the database. The software automatically
measures the absorbance at a number of different wavelengths during a cuvette
check. When the ‘Judge’ button is selected cuvettes are given a colour coded
warning flag on the screen as follows.
RED – Cuvette has exceeded judgement value at the selected wavelength.
YELLOW - Cuvette has exceeded judgement value at another wavelength
4. Date time: Select a measurement date of water blank measurement for display.
The software will display readings for the last 20 water blank measurements.
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5. Click on a cuvette and the software display the last 20 water blank readings for the
selected cuvette in graphical format. In the CUVETTE NO. field, specify the
cuvette for water blank display.
6. 2. 3. 1 JUDGEMENT VALUE
The maximum accepted value for the water blank at each wavelength. Specify a
threshold value.
If a cuvette water blank measurement exceeds the judgment value, the cuvette will
NOT be used in the next sample run.
When the AUTO box is checked ON, the software will autoscale the graph. When this
option is OFF the user may input the MAX and MIN values.
Click on PRINT to print the water blank values.
6. 2. 4 WORKING HOURS OF EXPENDABLE PARTS

The list of remaining working hours for analyser parts is displayed on the WORK
HOUR function of the MAINTENANE screen.
2. Select WORK HOUR on the TAB keys.
3. Click on the RESET button after the system part has been changed. The software
will reset the values to the initial values displayed in brackets.
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TOTAL WORKING HOURS

IT WILL DISPLAY THE TOTAL OF POWER-ON HOURS ON THE ANALYZER.
TOTAL TEST
IT WILL DISPLAY THE TOTAL NUMBER OF TEST ON THE ANALYZER.
HALOGEN LAMP
IT WILL DISPLAY THE REMAINING HOURS OF THE HALOGEN LUMP. THE CALCULATION OF THE
REMAINING HOURS IS SUBTRACTED FROM 1000 HOURS UNTIL 0 HOURS. WHEN IT GOES
UNDER 0 HOURS THE VALUE WILL BE DISPLAYED IN RED AND AFTER THAT THE VALUE WILL
BE DISPLAYED IN MINUS. BY CLICKING THE RESET BUTTON, THE EARNED HOURS WILL BE
UPDATED IN THE INITIAL VALUE. (INITIAL VALUE: 1000H, THE LOWER LIMIT VALUE: -9999H)
DIAPHRAGM PUMP
IT WILL DISPLAY THE REMAINING HOURS OF THE DIAPHRAGM PUMP. THE CALCULATION OF
THE REMAINING HOURS IS SUBTRACTED FROM 1000 HOURS UNTIL 10 HOURS. WHEN IT
GOES UNDER 10 HOURS THE VALUE WILL BE DISPLAYED IN YELLOW AND WHEN IT GOES
UNDER 0 HOURS THE VALUE WILL BE DISPLAYED IN RED AND AFTER THAT THE VALUE WILL
ABC Page 256

BE IN MINUS. BY CLICKING THE RESET BUTTON, THE REMAINING HOURS WILL BE UPDATED
IN THE INITIAL VALUE.
WU: WORKING HOURS OF WU DRAINAGE PUMP (SELECT THE WU NUMBER BETWEEN 1

AND 8 FROM THE PULL DOWN MENU.)
RPT: HOURS SUPPLYING WATER FOR WASHING NOZZLES ON THE RPT TROUGH (SELECT
THE RPT TYPE, 1-T OR 2-T FROM THE PULL DOWN MENU.)
SPT-T: WORKING HOURS OF SPT TROUGH SUPPLY WATER
MIX: WORKING HOURS OF SUPPLY WATER PUMP OF MIX TROUGH (SELECT THE MIX
TYPE, 1-T OR 2-T FROM THE PULL DOWN MENU)
MICROSYRINGE TIP
IT WILL DISPLAY THE REMAINIG HOURS OF THE MICROSYRINGE TIP. THE CALCULATION OF
THE REMAINING HOURS FOR RPP, RPPW, SPP, AND PPW IS SUBTRACTED FROM 150
HOURS, AND FOR WPP IS SUBTRACTED FROM 400 HOURS. WHEN IT GOES UNDER 10
HOURS THE VALUE WILL BE DISPLAYED IN YELLOW AND WHEN IT GOES UNDER 0 HOURS THE
VALUE WILL BE DISPLAYED IN RED AND AFTER THAT THE VALUE WILL BE IN MINUS. BY
CLICKING THE RESET BUTTON, THE REMAINING HOURS WILL BE UPDATED IN THE INITIAL
VALUE.
RPP: RPP SYRINGE TIP HOURS (SWITCH OVER 1 OR 2 FROM THE PULL-DOWN MENU.)
RPP: RPPW SYRINGE TIP HOURS (SWITCH OVER 1W OR 2W FROM THE PULL-DOWN
MENU.)
SPP: SPP SYRINGE TIP HOURS

SPPW: SPPW SYRINGE TIP HOURS
WPP: WPP SYRINGE TIP HOURS (SWITCH OVER BETWEEN 1 AND 8 FROM THE PULL-
DOWN MENU.)
CHECK
IT WILL DISPLAY THE REMAINING DAYS UNTIL 6 MONTHS OR 1-YEAR (ANNUAL) REGULAR
CHECK.
THE CALCULATION OF THE REMAINING DAYS IS SUBTRACTED FROM 6 MONTHS (OR 180
DAYS) 1 YEAR (OR 360 DAYS; THINKS OF A MONTH AS 30 DAYS). WHEN IT GOES UNDER 0
DAYS, THE VALUE WILL BE DISPLAYED IN RED AND AFTER THAT THE VALUE WILL BE
ABC Page 257

DISPLAYED IN MINUS. BY CLICKING THE RESET BUTTON, THE REMAINING HOURS WILL BE
UPDATED IN THE INITIAL VALUE.
WORKING HOURS OF ISE

PUMP CASSETTE: IT WILL SHOW HOW MANY REMAINING DAYS AVAILABLE FOR THE ISE
PUMP.
CALIBRANT A:IT WILL SHOW THE REMAINING VOLUME OF THE SOLUTION CALIBRANT A.
ELECTRODES:IT WILL SHOW WHEN THE EXPIRATION DATE IS REACHED AND THE NUMBER OF
REMAINING TESTS OF ISE ELECTRODES.
180D: SUBTRACTED FROM 180 DAYS. WHEN IT GOES UNDER 0 DAYS, THE VALUE WILL BE
DISPLAYED IN RED AND AFTER THAT THE VALUE WILL BE DISPLAYED IN MINUS
10000S: SUBTRACTED FROM 10000 TESTS. WHEN IT GOES UNDER 0 TESTS, THE VALUE
WILL BE DISPLAYED IN RED AND AFTER THAT THE VALUE WILL BE DISPLAYED IN MINUS
BY CLICKING THE RESET BUTTON, THE REMAINING DAYS AND TESTS WILL BE UPDATED IN
THE INITIAL VALUE.
PRINT
IT WILL PRINT OUT THE INFORMATION OF TRANSFERRING TIME.
6. 2. 5 PERFORMANCE CHECK FACILITY

The software offers a facility to check the temperature of the IRU and RCU during
operation and to perform a wavelength check of onboard filters.
2. Select PERFORM on the TAB keys. The temperatures of the heaters in the IRU
and the temperature inside the RCU and ASP, are displayed.
ABC Page 258

ONBOARD SENSOR PERFORMANCE
Earlier instruments were supplied with alternative filters, therefore this screen will
display the corresponding wavelength filters on board the analyser.
Detector Performance Monitor

The functionality of detector auto-gain is checked and monitored.
Title Description
Wave Length 12 wavelengths
Gain Measuring wavelengths (12 wavelengths)
Automatic Auto Gain control
Check Lamp Execute a check of t ehalogen lamp. The result will

be shown in voltage, and when it goes over the tre-
shold value will be displayed in red.
Voltage Gain adjustment voltage (to be adjusted within

9.0Å ± 0.5 V)
Absorbance Absorbance at the above gain voltage.
Automatic button Automatic gain adjustment
ABC Page 259

SAVE Save the settings
6. 2. 6 VOLUME ADJUSTMENT
You can specify dispensing values for correction of amounts for each pipette.
It will show the parameters that have been adjusted before shipping.
Volume Adjustment
SPP Define the measurement parameters for 2uL and 20uL.
RPP1 Define the measurement parameters for 20uL and 100uL
RPP2 Define the measurement parameters for 20uL and 100uL
Save It will save the editing data.
Cancel It will restore the editing data as before.
ISE Volume Adjustment

Sample Define the measurement parameters for 70uL.
ISE Calibrator A Define the measurement parameters for 100uL.
ABC Page 260

ISE Diluted Sample 1 Define the measurement parameter for the first time of
dispensing volume in 70uL dilution.
ISE Diluted Sample 2 Define the measurement parameter for the second time of
ISE Diluted Sample 3 Define the measurement parameter for the third time of
ISE Calibrator B1 Define the parameters for the first dispensing of Calibrant
B in 70uL.
ISE Calibrator B2 Define the parameters for the second dispensing of
Calibrant B in 70uL.
Save It will save the editing data.
Cancel It will restore the editing data as before.
6. 2. 7 DTR OPTICAL AXIS AUTO-CALIBRATION POSITION

This calibration will automatically choose the best photometry point for each cuvette.
This operation is supposed to execute after maintenance such as cuvettes exchange.
2. Select DTR POS on the TAB menu.
ABC Page 261

DTR calibrating position>

On the screen, calibrating positions for photometry measurement for 90 cuvettes.
Exec It will execute a calibration and then display the results.
File It will output calibrating positions for photometry measurement which is
displayed on the screen, at the file specified (CSV format)
… Specify where you want to place the output. Unless the place has
enough space to copy, the following error message will notify you;
"Not enough disk space to copy files."
Print It will print out the calibrating positions for photometry measurement.
6. 2. 8 PASSWORD SETUP
Select the MAINTENANCE / PASSWD in the menu options. The software will display
a list of password options for the USER, MANAGER and MAINTENANCE options.
Simply input the passwords as required and SAVE to store the settings.
ABC Page 262

6. 2. 9 CLEANING PROCEDURES
Cleaning procedures are necessary to ensure optimal performance of the analyser.
6. 2. 9. 1 CLEANING EXTERNAL TANKS

Discard the wash solution from the detergent tank and replace with water. Wash
thoroughly, then replace with "Fullclean" solution (1% solution of the concentrate
cleaning solution in de-ionised water). Leave the solution in the detergent tank to
soak for around 10 minutes.
Then discard the cleaning solution and wash the tank with water.
6. 2. 9. 2 PIPING AND INTERNAL TANK

Please follow the cleaning procedure as described below.
6. 2. 9. 2. 1 CLEANING PROCEDURE
PREPARATION
(1) Prepare the pure water (1L)
(2) Prepare the C1 solution (3L)
(3) Connect the wash1, 2 to the pure water.
(4) Perform the wash by purified water (Prim 1 time) for the wash solution line.
(5) Close the valve of the purified water generator and stop the supply of the pure
water and release the pressure in the tubes.
(6) Turn "OFF" the analyzer and Operational PC).
(7) Open the maintenance cover R1 and the maintenance cover L.
(8) Open the lids of the subtanks and take out the tubes.
(9) Detach the connectors of the level sensors of the Subtank R, L.
(10) Take out the Subtank R, L from the analyzer.
C1 CLEANING
(11) Open the lids in the upper part of subtanks and remove the vinyl tubes and the
level sensors.
(12) Put the C1 solution in the Subtank R, L and wash them while shaking them
enough.
ABC Page 263

(13) Put the C1 solution to the High level of the Subtank R, L.

(14) Install the vinyl tubes and the level sensors of the Subtank R, L and then put
the lids on them.
(15) Connect the connectors of the level sensors of the Subtank R, L to them.
(16) Install the Subtank R, L in the analyzer.
(17) Connect Wash1, 2 to the C1 solution.
(18) Remove the tubes of the connection for purified water supply (Sys.Water) that
is connected to the purified water generator and attach the jig (injector).
(19) Turn "ON" the equipments (Operational PC and the analyzer).
(20) Open the electromagnetic valve R of the connection for purified water supply
(Sys.Water) (for 10 seconds) and infuse 30ml of C1 solution into it.
(21) Open the electromagnetic valve L of the connection for purified water supply
(Sys.Water) (for 10 seconds) and infuse 30ml of C1 solution into it.
(22) Perform the Prime 2 times.
(23) Pour the pure water into the cuvette.
(24) Leave it for 10 minutes.
WATER WASH
(25) Remove the jig (injector) connected to the connection for purified water supply
(Sys.Water).
(26) Connect the tubes connected to the purified water generator to the connection
for purified water supply (Sys.Water) and open the valve.
(27) By the screen operation,
[Mainte / [Sequence] screen and click ON Sub-Tank R/L EV of Pump Test section
and Input 1(Execution for one second) in Time box and click Exec button.
(28) Turn "OFF" the equipment (Operational PC and the analyzer).
(29) Detach the connectors of the level sensors of the Subtank R, L
(30) Open the lids of the subtanks and take out the tubes.
(31) Take out the Subtank R, L and put the pure water in them and wash them
while shaking them.
(32) Open the lids of Subtank R, L and remove the vinyl tube guides and the level
sensors and wipe off slipping of the surface with cloth (gauze etc.) moistened with
pure water.
ABC Page 264

(33) Remove the filters attached to the weights and wash it (with brushes etc.) with
the pure water and then put them back together.
(34) Install the tubes and the vinyl tube guides and the level sensors of the Subtank
R, L to in the Subtank R, L.
(35) Put the pure water (to low level) in the Subtank R, L and wash them while
shaking them enough.
(36) Open the lids of the Subtank R, L and remove the tubes and the weights and
then dispose the pure water.
(37) Return the tubes and the weights of the Subtank R, L to the original position
and then put the lids on them and install them in the analyzer.
CLEAN UP
(38) Connect the Wash1, 2 to the pure water.
(39) Turn "ON" the equipment (Operational PC and the Analyzer).
(40) Perform the wash by purified water for the wash solution line (prime: 1 time)
(41) Perform the cuvette wash 1 time.
(42) Return Wash1, 2 to the former detergent tanks.
(43) Perform the wash by purified water for the wash solution line (prime: 1 time)
(44) Perform the cuvette wash 1 time.
(45) Install the maintenance cover R1 and the maintenance cover L
6. 2. 9. 2. 2 CLEANING DETAILS
PREPARATION
1 Preparation for the diluted solution for wash (diluting) and the tank for the
diluted solution for wash.
2 Wash the wash solution line of the analyzer with water.
•If the wash solution used in the analyzer is mixed with acid detergent, hazardous
gaseous chlorine may be generated due to chemical reaction. Before washing ,
completely wash the inside of the tubes by taking the following steps.
•Prepare the pure water in another tank. (About 1L)
ABC Page 265

•Put the tank tubes of each line of wash1, 2 of the analyzer in the prepared pure
water tank.
•Perform "Prime" to wash away and remove the remaining wash solution from the
tubes completely by the following operation.
Select [Mainte (F10)] / [Sequence]1 screen and input 1 (Number of times of
execution) in Prime1 and click Prime button.
3 Preparation for cleaning
•Close the valve of the purified water generator and stop the supply of the pure
water (ion-exchanged water) and release the pressure from the tubes.
CAUTION: Do this operation after enough confirming about the piping system
between the used purified water generator and the analyzer.
• By the screen operation,

[Mainte (F10)] / [Sequence] screen and click ON Sub-Tank R EV and Sub-Tank
L EV of Pump Test section and input 5 (Execution for five seconds) in Time box
and click Exec button.
• Turn "OFF" the Analyzer and Operational PC. Open Maintenance cover R1 on the
right side of the analyzer and Maintenance cover L on the left side of it.
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Screw × 2
Screw × 2
Mainten ance
cover R1
Main tenance cover L Wash-2 Wash-1 (Sys.Water)
Left side Right side

Figure 6.1.2-1 Figure 6.1.2-2
• Remove the connection of connectors (SUBL1,2) (SUBR1,2) of the level sensors.

Open the screw lids in upper part of the Subtank R, L and remove the tubes.
(Refer to Figure 6.1.2-3.)
• Take out the Subtank R, L from the analyzer.
Level Sensor R
(Connector SUBR1,2) Connector (SUB1,2)
Subtank R
Level sensor L
(Connector SUBL1,2)
Subtank L
CLEANING
To clean the nozzles, the inside of tubes and the cuvettes with the diluted solution for
wash of C1- solution , take the steps below.
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1 C1 Cleaning for Subtank R, L

• Open the lids in the upper part of subtanks and remove the vinyl tubes and the
level sensors.
• Put the C1 solution prepared by "preparation 1" in the Subtank R, L taken out from
the analyzer and wash the inside of them while shaking them enough.
• Put the C1 solution to the High level in the washed Subtank R, L.
• Install the vinyl tubes and the level sensors of the Subtank R, L and then put the
lids on them.
• Install the Subtank R, L to the analyzer and connect the connectors of the level
sensors (SUBL1,2) (SUBR1,2) to them.
• Put the tank tubes of each line of wash1, 2 of the analyzer in the tank prepared
only for the C1-solution.
2 Infusing C1 solution into the connection for purified water supply (Sys.Water)
• Remove the tubes of the connection for purified water supply (Sys.Water) of the
analyzer and connect the jig (injector) to the connection for purified water supply
(Sys.Water).
• Turn "ON" the equipment (Operational PC and the analyzer).
• Infuse 30 ml of C1 solution into the jig (injector).
• Select [Mainte (F10)] / [Sequence] screen and click ON Sub-Tank L EV of Pump
Test section. Input 10 (the open time of the electromagnetic valve L) in Time
Sec and click Exec button.
Push the jig (injector) and infuse 30 ml of C1 solution into the connection for purified
water supply (Sys.Water) within 10 seconds. (Open the electromagnetic valve L of the
connection for purified water supply (Sys.Water) and infuse 30 ml of C1 solution into
it.)
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• Infuse 30 ml of C1 solution into the jig (injector) again and infuse the C1 solution
into the connection for purified water supply (Sys.Water) according to the same
procedure as the procedure of subtank L.
• Select Mainte (F10)] /[Sequence] screen and click ON 11 Sub-Tank R EV of Pump
Test section. Input 10 (the open time of the electromagnetic valve R) in Time 111
Sec and click 1Exec1 button.
Push the jig (injector) and infuse 30 ml of C1 solution into the connection for purified
water supply (Sys.Water) within 10 seconds. (Open the electromagnetic valve R of
the connection for purified water supply (Sys.Water) and infuse 30 ml of C1 solution
into it.)
• Select [Mainte (F10)] / [Sequence] screen and input 2 (Number of times of execu-
tion) in Prime and click Prime button.
3 Cleaning of the inside of glass cuvettes

• Select [Mainte (F10)] / [Sequence] screen and click Cuvette Water Placement
button to infuse the C1 solution into cuvette.
• After infusing the C1 solution into cuvette, keep this state for 10 minutes
. Wash by purified water for Subtank R, L

• Remove jig (injector) connected to the connection for purified water supply
(Sys.Water).
• Connect the tube of the connection for purified water supply (Sys.Water) of the
analyzer removed by "C1 Cleaning 2" to it as before (piping from the purified water
generator)
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• Open the valve of the purified water generator that was closed by "Preparation 3"
and then supply the pure water (ion-exchange water).
• By the screen operation, 1[Mainte (F10)] / [Sequence] screen and click ON 11
Sub-Tank R EV and 11 Sub-Tank L EV of Pump Test section. Input 1 (Execution
for one second) in Time box and click Exec button.
• Turn "OFF" the analyzer and Operational PC.

• Remove the connection of connectors (SUBL1,2) (SUBR1,2) of the level sensors.
Open the screw lids in upper part of the Subtank R, L and remove the tubes.
• Take out the Subtank R, L from the analyzer and put the pure water in them and
wash the inside of them while shaking them enough.
• Open the lids of Subtank R, L and remove the vinyl tube guides and the level sen-
sors and wipe off slipping of the surface with cloth (gauze etc.) moistened with
pure water. (Refer to figure 6.1.2-4.)
ABC Page 270

Tube weight
Connector
(SUBL1,2) Packing
or
Filter
A
Vinyl tube
Unfasten
Fasten
Level sensor
Tube weight
Subtank L
or Subtank R
Cleaning of
Subtank
• Rotate the tube weights (A part) to the right and remove the filters and wash it
(with brushes etc.) with the pure water and then put them back together. (Refer to
figure 6.1.2-4.)
• Put the pure water to the Low level in the Subtank L, R and put the vinyl tube
guides and the level sensors in the Subtank R, L. (Refer to figure 6.1.2-4.)
• Put the tubes in the Subtank R, L and wash them while shaking them enough.
• Open the lids of the Subtank R, L and remove the tubes and the weights and then
dispose the pure water. (Refer to figure 6.1.2-4.)
• Install the tubes and the weights in the washed Subtank R, L and put the lids on
them.
• Install the Subtank R, L in the analyzer and connect connectors (SUBL1,2)
(SUBR1,2) of the level sensors to them.
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After treatment
Completely wash away the C1 solution with pure water, or the remaining solution may
cause incorrect measurement results by the analyzer.
• Take out the tank tubes of each line of wash1, 2 that were placed in the tank only
for the C1 cleaning by "C1 cleaning 1" and then wash them enough with the pure
water and put them in the tank only for pure water.
• Turn "ON the analyzer and Operational PC.
• By the screen operation, [Mainte (F10)] / [Sequence] screen and input 1 (Number
of times of execution) in Prime field and click Prime button to wash the wash solu-
tion line with water.
• By the screen operation, [Mainte (F10)] / [Sequence] screen
• and click 1Cuvette Wash1 button to perform Cuvette wash (1 time).
• Take out the tubes of each line of wash1, 2 that were placed in the tank only for
the cleaning and put them in the tank for the wash1, 2.
• and input 1 (Number of times of execution) in 1Prime1 12 1 and click 1Prime1 but-
ton for the wash by purified water of the wash solution line.
• and click 1Cuvette Wash1 button to perform Cuvette wash (1 time).
• Put the removed maintenance cover R1, L on right and left side of the analyzer
back in place.
6. 2. 9. 2. 3 FREQUENCY OF CLEANING
Perform cleaning with Fclean (C1) every three months for average use (approx. four
hours per day).
CAUTION:Usually the cleaning interval is every three months. If the cleaning

interval becomes long, diatomaceous attachment develops in the tubes. When
washing, the filters may be clogged with the removed attachments and the life
of the filters become short. Therefore, do not lengthen the cleaning interval
extremely.
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6. 2. 9. 2. 4 STORAGE OF "FULLCLEAN (C1)"

The storage life of concentrate solution "Fullclean" (commercial product) is 24
months. Concentrate solution can be stored for 24 months as long as the cap is
closed tightly even after first opening the cap. Since diluted solution is not
preservable, make fresh diluted solution for every use.
6. 2. 9. 2. 5 PRECAUTIONS FOR USE OF "FULLCLEAN (C1)"

The following are chiefly precautions for cleaning of the analyzer. For other general
precautions, obey the instructions given on the label of the "Fullclean" container.
(1) Use this product after diluting in accordance with the above mentioned
instructions.
(2) Make sure to use pure water (ion-exchanged water) to dilute the product. Do
not use tap water to dilute it.
(3) If the product expires (storage life: 24 months), sodium hypochlorite contained
in the product is decomposed and effective chlorine is reduced. Therefore, dispose of
an expired product in an appropriate manner. (Before disposal, neutralize it and dilute
it with a large amount of water.)
(4) Do not mix the product with acid material.
(5) Do not make the product contact with zinc plating or metals including iron,
ferric oxide, copper, copper alloy, etc. to prevent corrosion of them.
(6) Before putting the product into another container, completely clean the
container by rinsing it with pure water and completely dry it.
ABC Page 273

6. 2. 9. 3 PIPETTES (FOR RPT1/RPT2/SPT)
WARNING: Be sure to turn off the main analyzer before starting the work.
Wear medical rubber gloves so that the liquid does not adhere
directly to the skin.
(1) Moisten gauze with ethanol.
(2) Lift up the nozzle assembly by hand.
(3) Wipe the whole pipette with the moistened gauze. Wipe the pipette from the
upper part of it to the direction of the point of it, as shown in Figure 6.1-3-1.
WARNING: When wiping the nozzle, do not apply extra force to it. It is very
important that the nozzle is vertically set so that the analyzer can function
correctly. Improper alignment can cause the damages of the pipette and / or
incorrect analysis results.
Cleaning the nozzles
(4) Insert the cleaning pointer of the SPT/RPT nozzle cleaning jig into the point of
the nozzle in order to clean the inside of the nozzle.
Note that the cleaning pointer for SPT is thinner than the pointer for RPT.
ABC Page 274

(5) Wipe SPT/RPT1/RPT2 with gauze or paper towel moistened with neutral
detergent.
(6) After cleaning the inside of the nozzle, clean the nozzle with pure water
according to the following procedure.
Selet [Mainte (F10)] / [Sequence] screen and click ON of SPT, RPT1 or RPT2 on
Wash section and click Exec button to start washing
If the inside of the nozzle is blocked, the nozzle cleaning jig can be inserted to remove
the blockage. Insert the nozzle cleaning jig by hand into the pipette nozzle. The
nozzle jig has two needles, a thin needle for the SPT and a thick needle for the RPT
and WU.
6. 2. 9. 4 CLEANING THE WU NOZZLES

Turn off the power to the instrument before starting any work.
The WU unit has two independent drainage nozzles and six pairs of nozzles, each
pair consists of one draining and one injection nozzle.
Each nozzle should be cleaned with ethanol. Before clenaing the nozzles remove the
SWU cover as shown below.
(1) Hold up the knob of the WU unit (direction of the arrow).
Cleaning the WU nozzles
WU
C
K nob
W U n o z z le
W U U N IT
F i g u r e 6 .1 .4 - 1
ABC Page 275

(2) Wipe the nozzles (six supply nozzles and seven drain nozzles) using gauze
moistened with ethanol. Make sure not to bend the nozzles.
(3) Wipe the WU cover with gauze or paper towel moistened with neutral
detergent.
6. 2. 9. 5 MIX-1/MIX-2 (STIRRING PADDLES)
WARNING: BEFORE STARTING THE FOLLOWING STEPS, MAKE SURE THAT

THE ANALYSER IS TURNED OFF.
There are two stirring paddles:the MIX1 stirrer is located at the right rear of the SPT2
and the MIX2 stirrer is located at the right rear of the RPT1.
(1) Moisten gauze with ethanol.

(2) Lift up the stirrer by holding its arm cover.
(3) Wipe the whole stirrer with the gauze moistened with ethanol. Be careful not to
bend the paddle.
(4) Wipe the cover of MIX1 / MIX2 with gauze or paper towel moistened with
neutral detergent.
6. 2. 9. 6 AUTO SAMPLER UNIT

Wear medical rubber gloves to prevent direct contact with nozzles or liquid.
(1) Make sure that the SPT nozzle is not above or in the Auto Sampler Unit (ASP).
If it is, remove it by hand.
(2) Take out the ASP tray (inner circumference, outer circumference).
(3) Wipe the frame of the barcode reader window (without glass) with gauze
moistened with ethanol.
ABC Page 276

Barcode reader
i d
Barcode reader
Auto Sampler Unit

Figure 6.1.6-1
(4) Wipe the inner surface of the Auto Sampler Unit (ASP) with gauze or paper
towel as illustrated above. Make sure that water drops are wiped off completely.
(5) Install the ASP tray (inner circumference, outer circumference) and the lid as
before.
6. 2. 9. 7 REAGENT CONTAINER UNIT (RCU)

(1) Make sure that the RPT nozzle is not in the Reagent Container Unit (RCU). If it
is, remove the nozzle by hand.
(2) Take out the RCU tray.
(3) Wipe the barcode reader window with gauze moistened with ethanol or glass
cleaner. Then, be careful not to damage the window surface.
ABC Page 277

Barcode reader
i d Barcode reader
(4) Wipe the inner surface of the Reagent Container Unit (RCU) with gauze or
paper towel as illustrated above. Make sure that water drops are wiped off
completely.
(5) Install the RCU tray and the lid as before.
6. 2. 9. 8 WORKTABLE
(1) Wipe the surface of the mosaic plates with gauze or paper towel moistened
with neutral detergent.
ABC Page 278

MOSAIC PLATES
ABC Page 279

6. 2. 10 PART REPLACEMENT
As part replacement procedures, only dismounting procedures are explained here.
Mounting procedures are omitted because they are simply the reverse of the
dismounting procedures. Exceptionally, mounting procedures or remarks are given in
cases where adjustment or special care is required.
The following items are required for Part Replacement.
ITEM DESCRIPTION
Liquid Gasket (1212) Required for WU wipe tip replacement.
Silicon Grease Required for syringe chip.
(KF-96H-50000CS)
Jig: (accessories) Syringe chip insertion jig
Screwdriver: Required types:
(accessories) + Screwdrivers No.1 and No.2
Hex Wrench: Required sizes:
(accessories) 1.5 mm (for PT Nozzle), 3 mm (for syringe)
Spanner Required sizes (for PT Nozzle):
5.5 mm
CAUTION: Contact the suppliers about the details regarding Liquid Gasket
(1212), and Silicon Grease (KF-96H-50000CS).
6. 2. 10. 1 SYRINGE TIPS (FOR SPP/RPP/WPP)
This section explains syringe plunger tip replacement procedures which can apply to
all the syringe pumps used in the analyzer. Replace plunger tips at the provided cycle
according to the following procedures.
ABC Page 280

Procedure
(1) Turn "OFF" the analyzer and Operational PC
(2) Open the maintenance covers on the sides. (Refer to Figure 6.2.1-1 and
Figure 6.2.1-4.)
WPP1 -
SPP (Wash)
Maintenance cover
Scre w × 1
Scre w × 2
SPP (Sample)
M a in ten anc e cov er R1

Right side M a in ten an ce cov er (R1,R2) WPP, SPP Sy ringe pump s placement
Scre w × 2
RPP1W
RPP2W
RPP1R
RPP2R M a in ten anc e cov er L
RPP S y r inge pum ps placement Left side Ma in ten an ce cove r L

ABC Page 281

(1) Remove the plunger block by removing one screw (M4×22).

(2) Pull down the plunger and remove it.
Plunger
Plunger block
Screw
(M4 X 22 with
Hex socket head)
(3) As shown by the Figure below, remove the plunger tip by using pliers (long-
nose pliers).
Plunger Tip
Removing plunger
Figure 6.2.1-6
(4) Insert a new plunger tip in the hole on the syringe tip insert jig.
(5) Hold the plunger vertically by hand, and insert it vertically into the hole of the
plunger tip.
ABC Page 282

P lunger tip P lunger
Syringe T ip Insert
Inserting plunger tip by Jig

Figure 6.2.1-7
Table 1: Plunger tip table
NAME T-0510 TEF050 TEF250
SPPS o
SPPW o
RPP1R o
RPP1W o
RPP2R o
RPP2W o
WPP(1-6) o
(6) Apply silicone grease (Shin-Etsu Silicones, KF-96H-50,000cs) to the plunger

with the attached tip, then insert this plunger into the syringe and slowly push it
upward.
ABC Page 283

Syringe Tip
Grease Application
Grease Application Range

Figure 6.2.1-9
(7) Install the plunger to the syringe pump by the reverse procedure to Procedure
(1) and (2).
(8) Turn on Operational PC and the main analyzer.
(9) Lastly, by the screen operation, [Mainte (F10)] ? [Work Hour] screen,
and to clear the used hours of RPP(1, 2), RPP(1W, 2W) , SPP, SPPW , WPP (1-6)
that correspond to the exchanged syringes on Microsyringe Tip section, click RESET
button.
6. 2. 10. 2 WIPE TIP (IN WU)
Wear medical rubber gloves to prevent the contaminant from infiltrating.
Procedure
(1) Hold up the knob of the WU unit. (Refer to Figure 6.1.4-1.)
(2) While holding the wipe nozzle by fingers, pull out the wipe tip downward.
(3) Apply liquid gasket to all circumferences of the wipe nozzle so that applied
liquid gasket width becomes 2 to 3 mm and the applied area is in the range of 5 to 10
mm from the tip of the wipe nozzle. (Refer to Figure 6.2.2-1.)
(4) Insert a new wipe tip into the wipe nozzle until it hits the bottom.
ABC Page 284

Wipe
2- 3mm
10mm
5mm
Liquid Gasket Application
Range
Wipe Tip

By the screen operation, [Mainte (F10)] ? [Sequence] screen, and click Initialization
button.
(6) Hold the knob of the WU unit and lower it below. Put the wipe nozzle in the
cuvette (IRU) and adjusts it while rotating the wipe tip so that the interspaces between
the cuvette and the wipe tip ((A , A") , (B , B")) becomes even. (Refer to Figure 6.2.2-
2.)
Wipe
Nozzle
Ｂ
A
A"
B"
Cuvette
Ad ju sting Wipe Tip

Figure 6.2.2-2
(7) When you normally install the wipe tip, the length between the lowest end of
the wipe base and the top end of the wipe tip is 69.1 0.2mm. (Refer to Reference
figure 6.2.2-3 "Wipe Nozzle Dimension".)
ABC Page 285

Wipe Base
Wipe Nozzle
69.1 ±0.2mm
Wipe Tip
Wipe Nozzle
Dimension
6. 2. 10. 3 PIPETTE (FOR SPT/RPT)

Wear medical rubber gloves to prevent the contaminant from infiltrating
The replacement procedures of SPT and procedures of RPT are common. Replace
them according to the following procedures.
Procedure
(1) Turn "OFF" the analyzer and Operational PC.
(2) Remove the SPT / RPT arm cover. (The arm cover has tabs on its internal
surface and these tabs fix the cover to the SPT/RPT arm base.)
(3) Remove the connector (J2).
ABC Page 286

PT Arm Cover
Connector
( 2)
SPT/RPT Arm Base
Removing PT arm cover

Figure 6.2.3-1
(4) While holding the nozzle side (on the joint S/R side) by using spanner (5.5
mm), turn the PT Nozzle joint (the tube side) by hand to remove the joint S/R. Use
tissue paper, etc. to prevent drops of liquid from falling out of the removed tube and
the removed nozzle.
PT Nozzle
j i
Spanner
(5.5mm)
Tube
Joint S/R
CAUTION: Do not turn the spanner (Nozzle side)
Removing Joint S/R

Figure 6.2.3-2
ABC Page 287

(5) Loosen the screw (M3×5 with hex socket head) which fixes the nozzle. Lift up
the nozzle and remove it.
Connector (J2)
CAUTION: Do not turn this

screw with hex
Nozzle
assembly
CLOSEUP
Hex
Wrench
PT Arm Base
Removing S/R nozzle

assembly
Fi 622 3
(6) Install new pipette nozzle. Do the assembling work in the reverse way of the
Procedure (3) to Procedure (5).
(7) Confirm the installation state of the pipette nozzle.
• Make sure that the pipette nozzle is not bent.
• Make sure that the pipette nozzle is installed parallel to the PT arm base.
• Make sure that the pipette nozzle does not contact with the sensor.
(8) When you normally install the pipette, the length between the lowest end of the
pipette nozzle and the PT arm base is 130.5mm. (Refer to figure 6.2.2-4.)
ABC Page 288

(9) Have the pipette nozzle by the hand and make sure that it can move smoothly
up and down (direction of the arrow).
Nozzle
assembly
PT Arm Base
130.5m m
Confirm the smooth vertical movement

(direction of the arrow).
Installation confirmation of pipette

nozzle
Fi 622 4
(10) Return the pipette arm to the trough position by holding it up.
6. 2. 10. 4 HALOGEN LAMP

WARNING: The lamp case may be very hot. Before starting halogen lamp
replacement, turn off power and leave it for at least 30 minutes.
CAUTION: When installing a new halogen lamp, do not touch the glass of the
halogen lamp by bare hands. Grease from hands may cause malfunction.
ABC Page 289

Procedure
(1) Pick up the Pipette of the reagent or sample, and move it to the place where
you work easily.
(2) Remove the DTR cover by removing one screw (M3) and one plastic clip.
DTR
Plastic Clip
Screw (M3)
Mosaic plate for halogen lamp replacement

Figure 6.2.4-1
(3) Remove the lamp case by unplugging the connector of the halogen lamp and
removing one screw (M3×35).
(4) Hold the handle (blue part) and hold up the lamp case.
(5) As shown by the Figure below, slacken two screws (M3×6) that are attached to
the halogen lamp and take out the halogen lamp.
ABC Page 290

Screw
(M3×35)
Screw (M3×6) × 2
Connector
Halogen
Lamp
Removing Halogen
lamp
(6) Install a new halogen lamp.

(7) In the reverse way of the installation procedure, install a new halogen lamp,
connect the connector plug, and install the mosaic plate. Return the moved pipette to
the trough position.
(9) Lastly, by the screen operation, [Mainte (F10)] ? [Work Hour] screen and click
RESET button of Halogen Lamp on Work Hour Counters section to clear the used
hours.
6. 2. 10. 5 CUVETTES (IN RCU)

Wear medical rubber gloves to prevent direct contact with
nozzles or liquid.
The condition of cuvettes can be checked according to the following procedure.

By the screen operation, [Mainte (F10)] ? [W Blank] screen
and check the condition of cuvettes by the cuvette check of Water Blank.
(Refer to Chapter 3 6 1"The result of water blank".)
Procedure
ABC Page 291

(1) Pick up the Pipette of the reagent or sample, and move it to the place where
you work easily.
(2) Slacken the two screws and remove the Mosaic 3.
Mosaic
Screw × 2
Mosaic 3
Figure 6 2 5-1
(3) Rotate IRU (in the direction of arrow A or B) and take out cuvettes to replace.
CAUTION: When you rotate the IRU, make sure that there is not the nozzle and the
stirrer in the cuvette
Cuvette CAUTION: Replace the cuvette by

(Closeup) holding the upper side
of it (refer to Arrow).
1A1 1B1
IRU
Removing Cuvette
Figure 6.2.5-2
(4) Install the new cuvette. As shown by the above the Figure, replace the cuvette
by holding the upper side of it.
ABC Page 292

(5) Install the Mosaic plate removed by Procedure (2), and return the moved
pipette to the trough position.
6. 2. 10. 6 MESH FILTER (OR INLINE FILTER)

Procedure
(1) Turn "OFF" the analyzer and Operational PC.
(2) Open the Maintenance cove R1 on the right side of the analyzer. (Refer to
Figure of Right side 6.2.6-1.)
M esh Filter (or In lin e Filt er) 1-7
Scre w × 2
Closeup
M ain ten ance Co ve R1
Maintenance Cove R1(right side) Remov ing Mesh F ilter (or In lin e Filter)
(3) Remove the tube connected to the Mesh filter (or Inline filter).
CAUTION: Seven Mesh filters (or Inline filters) in total are used. Replace the
Mesh filters (or Inline filters) one by one to avoid wrong insertion.
(4) Insert the tube to the bottom of the Mesh filter (or Inline filter).
CAUTION: The arrow is drawn in the Mesh filters (or Inline filters). Before
installing, make sure that the direction of the arrow is downward.
ABC Page 293

6. 2. 10. 7 AIR FILTER

The side of this main Analyzer has five air filters as shown by the Figure below.
Clean the filters if necessary. When the filters is damaged or is awfully dirty, replace
them.
SIDE Panel LU Maintenance Cove R2

Screw × 3 Screw × 1
Detaching order: 1 11Air filter 12
1Air filter 31
11Air filter 51 11Air filter 41 11Air filter 21

Maintenance Cove L SIDE Panel LD Maintenance Cove R1
Screw × 2 Screw × 2 Screw × 2
Detaching order: 2
Air filter placemen on the left side Air filter placemen on the r ig h t side
The air filter is fixed with hook and loop fasteners and it can be easily mounted and
dismounted by hand. (Refer to Figure 6.2.7-1 and Figure 6.2.7-2 for the installation
place.)
ABC Page 294

M oun ting/Dismou nting Air f ilter

Figure 6.2.7-3
6. 2. 10. 8 ELECTRODE (IN ISE)
WARNING: Wear medical rubber gloves to prevent direct contact with nozzles
or liquid.
Procedure
(1) Work on the preparation of electrode exchange according to the following
procedures.
(a) By the screen operation, click 1SHUT DOWN1 button in the upper right of the
screen of Operational PC and the pop-up screen is displayed. Click 11Power Off11
button for end.
ABC Page 295

Click this “SHUT

DOWN” button.
Preparation for Replacing Electrodes

Figure 6.2.8-1
(b) Confirm that the UI screen on Operational PC is closed and ended, and turn
"OFF" the main analyzer.
(2) Remove the maintenance cove R1. (Refer to Figure 6.2.7-2.)
(3) Depress the compression plate and pull out an electrode while holding the
handle of it.
ABC Page 296

ISE
Electrode
Electrode handle
Compression Plate
Replacing Electrodes
Figure 6.2.8-2
CAUTION: Inserting order of electrodes: Na, K, Cl, and Ref from top down.
CAUTION: When you open a new electrode package for use and remove a
brown tube from a Ref electrode.
(4) Insert new electrodes to the predefined position (Inserting order of electrodes:
Na, K, Cl, and Ref from top down).
6. 2. 10. 9 PUMP CASSETTE 9FOR ISE)

Wear medical rubber gloves to prevent direct contact with
nozzles or liquid.
ABC Page 297

Reference: To ensure the proper liquid supply/drain operation of the ISE, it is required
to replace pump cassettes on a regular basis. You can check the used hours
according to the following procedure.
By the screen operation, [Mainte (F10)] ? [W Blank] screen
and check the used hours by Water Blank on the screen.
Procedure
(1) Remove the ISE cover by removing the two plastic clips. (Refer to figure
6.2.10-1.)
(2) Remove the tube from the Calibrant A bag. (Refer to figure 6.2.10-1.)
(3) Be sure that the cap is set to the Calibrant A bag during work.
(4) By the screen operation, [Mainte (F10)] ? [Sequence] screen
and input 5 (Number of times of execution) in ISE Prime 11
and click ISE Prime button to perform ISE Prime and discharge the liquid from the
tube.
(5) Turn "OFF" the operational PC and the main analyzer.
(6) Remove the maintenance cove R1. (Refer to Figure 6.2.7-2.)
(7) Pull and remove the four tubes from the pump cassettes (two tubes / pump
cassette). (Refer to Figure 6.2.9-1.)
(8) Remove the pump cassettes from the motor shaft by pressing the stoppers on
both sides of the cassette.
ABC Page 298

Do not pull out and remove the metal pipe

for connection from side of the transparent
tube
Motor
Pump Cassette
When removing the pump cassette, press the

stoppers on the both sides and pull it forward.
When installing the pump cassette, make sure
to insert the pump cassette into the shaft
Replacing ISE pump properly until a click sound is heard.
cassette
(9) Install new pump cassette to the motor. (Refer to Figure 6.2.9-1.)
(10) Insert the four tubes into the new two pump cassettes. Since the new pump
cassettes have no tube maker (instruction), carefully connect the tubes to the
cassettes in accordance with the tube maker (instruction) marked on the piping tube
of the side of the analyzer.
ABC Page 299

High Conc. Waste ISE Unit Sample Port
1
ISE Unit Bottom Port 3 4
2
Calibrant A bag
Drain Pump Supply Pump
Tube Marker Location

1 : Supply Pump (Output side)
(Connected to ISE Unit Sample Port)
2 : Supply Pump (Input side)
(Connected to Calibrant A bag)
23 : Drain Pump (Output side)
(Connected to High Conc. Waste)
4 : Drain Pump (Input side)
(Connected to ISE Unit Bottom Port)
Mounting cassette pump

Figure 6.2.9-2
(11) Turn on the operational PC and the main analyzer.

(12) Connect the tube to the Calibrant A bag,
and by the screen operation, [Mainte (F10)] ? [Sequence] screen
and input 10 (Number of times of execution) in 1ISE Prime1 11
and click 1ISE Prime1 button to perform ISE Prime.
At that time, check that the liquid is correctly pumped and there is no liquid leakage at
the junctions.
(13) Install the maintenance cove R1 of the right side. (Refer to Figure 6.2.7-2.)
(14) Install the ISE cover. (Refer to Figure 6.2.10-1.)
(15) Lastly, by the screen operation, [Mainte (F10)] ? [Work Hour] screen
and click 1RESET1 button of Pump Cassette on Work Hour of ISE section to clear the
used hours.
ABC Page 300

6. 2. 10. 10 CAL-A BAG (IN ISE)

WARNING: Wear medical rubber gloves to prevent direct contact with nozzles
or liquid.
Procedure
(1) Remove the ISE cover by pulling up the two plastic clips. (Refer to Figure
6.2.10-1.)
(2) Pull out the tube from the Calibrant A bag and remove the Calibrant A bag.
(Refer to Figure 6.2.10-1.)
ISE cover
Plastic clip × 2
Tube
Calibrant A bag
Replacing Calibrant A bag

Figure 6.2.10-1
(3) Pull out the connection tube on the point of the Calibrant A bag and takeout the
used Calibrant A bag.
(4) Install a new Calibrant A bag in the predefined position and connect the tube to
the Calibrant A bag by the connection tube that belongs to the Calibrant A bag.
CAUTION: Be sure to hold the lower part of the opening of the bag for inserting
the tube.
ABC Page 301

Insert the connection tube to the lower part of the opening of the bag.
(5) Install the SE cover.

By the screen operation, [Mainte (F10)] / [Sequence] screen
and input 10 (Number of times of execution) to 1ISE Prime1 1 1
and click 1ISE Prime1 button to perform ISE Prime.
(6) Lastly, by the screen operation, [Mainte (F10)] / [Work Hour] screen
and click 1RESET1 button of Calibrant A on Work Hour of ISE section to clear the
used hours.
ABC Page 302

SECTION 8 ALARM CODES Version 1.0 Rev Sep 2005
SECTION 8
ALARM CODES
ABC Page 303

8.1 DEFINITIONS AND CLASSIFICATION OF ALARM

CODES
This chapter provides a summary of various alarm codes that may appear on screen.
When an error or alarm occurs during operation, reference is made to the lists
contained in this chapter. Contact Randox Technical Support if necessary.
8. 1. 1 ALARM CODE DEFINITIONS

All mechanical and electrical malfunctions detected by the software will appear on
screen as an alarm message. When an error occurs, the visible alarm is generated
immediately.
When an error occurs, the Alarm (F4) button at the bottom of the screen starts
blinking in red. Pressing the [F4] key switches the current screen to [Alarm screen]
which displays the error code and error description.
ABC Page 304

No. Explanation
(1) Alarm No.
Alarm number for the current alarm event is displayed.
Refer to “4.2 User Interface Alarm” and “4.3 Unit Alarm”.
(2) Date Time
Date and time when the alarm occurs is displayed.
(3) Message
Alarm contents are displayed.
(4) Alarm Message Details
Alarm detail description is displayed.
(5) Clear All
Deletes all alarms.
8. 1. 2 ALARM TYPE
Last two digits of the error code are defined as follows;
Level Alarm type Definition of Description

last two digits
1 Emergency stop “00” ~ ”49” The analyzer emergently stops the
operation due to a fatal error.
2 Alarm 1 “50” ~ ”74” Sampling operation for new samples
stops.
The measurement for the already dis-
pensed samples will be continued.
3 Alarm 2 “75” ~ ”99” Only the message is displayed, the
measurement operation continues.
8. 1. 3 ALARM OUTPUT
Alarm messages are normally output on the screen of the operational PC. Evaluation
flags for the measurement results are printed out at the printer.
ABC Page 305

8. 1. 4 ALARM CODE NUMBERS

Alarm code, which is a combination of unit number and error number, is assigned to
each error event. This 4-digit code consists of 2-digit unit number and 2-digit error
number. (Ex. 1310 etc.)
ABC Page 306

8.2 USER INTERFACE ALARMS
Code Message Explanation and Action
6002 Concentration calculation error. The measurement result(s) could not be converted into
concentration.
Check the setting details on the [Calibration] screen and
also verify if the calibration is performed correctly.
6003 Full calibration failed. Full calibration was not performed appropriately. The con-
centration value input on the [Calibration] screen may be
wrong or standard sample may not be placed in the ASP
appropriately. Check and try again.
6004 Full, one point or 2-point cali- Full calibration, one-point or two-point calibration failed.
bration failed. The concentration value input on the [Calibration] screen
may be wrong or standard sample may not be placed in
the ASP appropriately. Check and try again.
6005 Printer output failed. Printer output failed. Verify if the cable is connected
appropriately or the printer is in the [Ready] state.
6008 Invalid standard sample found. Standard sample whose concentration value has not
been set was found. Make sure to input the concentration
value for the standard sample which you calibrate.
6009 Concentration information not Input concentration values are less than 3. Input 3 or
available. more concentration values for the standard sample to be
calibrated.
6011 Data reception error. Received invalid data from the Host. Check with the Host.
6012 Software interrupted. Overflow or zero divide error occurred during concentra-
tion conversion.
6013 Bcc error occurred during host Bcc error occurred during host communication. Check the
communication. communication setting details on the [System setting]
screen.
6014 Time out error occurred during No response from the Host. Verify if the communication
host communication. cable to the Host is appropriately connected. Check the
communication setting details on the [System setting]
screen.
6015 Re transmission error occurred Data was resent to the Host, however, no response. Ver-
during host communication. ify if the communication cable to the Host is appropriately
connected. Check the communication setting details on
the [System setting] screen.
6030 Database update failure. Database may be corrupt or damaged. Contact our cus-
tomer service section for technical support.
6031 Database insertion failure. Database may be corrupt or damaged. Contact our cus-
ABC Page 307

6032 Database deletion failure. Database may be corrupt or damaged. Contact our cus-
6033 Database SelectOpen failure. Database may be corrupt or damaged. Contact our cus-
6100 There are less than 30 good Conduct cuvette cleaning. If you still have an error,
cuvettes and testing cannot replace no-good cuvette(s) with good cuvette(s).
begin.
6101 Not enough reagent inventory The amount of the required reagent(s) for the measure-
to initiate the run. ment shown bellow is not sufficient. Replace reagent bot-
tle(s) with new ones.
6102 Calibrant A remaining volume Remaining amount of Calibrant A is insufficient. Replace

is running short. the bottle with new a one.
6103 Possible shortage of reagent Following reagent remaining amount required for the
for measurement. measurement may be running short.
6104 Error detected As the sensor has detected an error, the measurement
cannot be started. Check the situation.
6120 Standard has been set for “Fac- Factor computation is included among the placed stan-
tor” assay. dard samples. Check the situation.
6121 Found calibrators other than Even if the selection of “Enable reagent blank as S1” is
S2. As Blank Measurement is set, a calibrator (standard sample) other than S2 is
set to enable reagent blank as placed. Check the situation.
S1, only S2 can be used for
calibration.
6122 Found series dilution calibra- Even if the selection of “Enable reagent blank as S1” is
tors. As Blank Measurement is set, a standard sample except for S1 is placed. Check the
set to enable reagent blank as situation and place S2 standard sample.
S1, only S2 can be used for
calibration.
6123 Calibration is performed due to Check the sample number and method number:
lack of calibration curve for
method.
6124 Measurement is not performed Check the sample number and method number:
due to lack of calibration curve
for method.
6125 Disagreed reagent lot number. There is no agreed reagent lot numbers with the mea-
surement result data. Try again after check.
6201 RCU bottle barcode number Check if there are any smears and/or damages on the
~ (1~60) is not usable. barcode label applied to the reagent bottles
6260
6301 RCU bottle number (1~60) bar- The barcode is already assigned for the bottle that has
~ code has already been been already placed in other position.
6360 assigned.
ABC Page 308

6401 RCU bottle number (1~60) Check the reagent registration status at the [System]
~ reagent code is not registered. screen.
6460
6500 The process has been inter- Contact our customer service section for technical sup-
rupted due to mechanical inter- port.
ference.
6501 Automatic gain adjustment Check the halogen lamp. Perform automatic gain adjust-
failed. ment. If fault returns, contact our customer service section
for technical support.
6502 Restart failed. While dealing with the emergency stop situation, an emer-
gency stop occurred in the main analyzer. Hardware prob-
lems may be occurring. Check the situation.
6510 Error detected Sensor detects the error. Check the sensor and sensor
number. Check the situation.
6520 IRU temperature is less than The temperature in the IRU must be kept within a range of
36.5 degrees. 36.5 ×C to 37.5×C (not including 37.5×C). Observe the
temperature monitor on the [Mainte]-[Perform] screen and
contact our customer service section for technical sup-
port.
6521 IRU temperature is more than The temperature in the IRU must be kept within a range of
37.5 degrees. 36.5 ×C to 37.5×C (not including 37.5×C). Observe the
temperature monitor on the [Mainte]-[Perform] screen and
contact our customer service section for technical sup-
port.
6522 RCU temperature is more than Temperature in the RCU must be kept at 15×C or lower.
15 degrees. Observe the temperature monitor on the [Mainte]-[Per-
form] screen and contact our customer service section for
technical support.
6523 ASP temperature is more than The temperature in the ASP must be kept at 10×C or
10 degrees. lower. Observe the temperature monitor on the [Mainte]-
[Perform] screen and contact our customer service sec-
tion for technical support.
6600 Omitted order registration of Order registrations for the following position numbers and
position and sample numbers. sample numbers have not been performed yet. Check the
orders.
6601 Measurement is not performed Measurement cannot be performed because the order
due to overlaps of sample num- registrations for the following sample numbers are over-
bers. lapped. Check the orders.
6602 Existing order for a sample has As a new order was sent by the ASP Scan to the existing
been overwritten with new sample, the existing order has been renewed into the new
order by ASP Scan. order.
7001 Existing order for a sample has As a new order for the existing sample was sent by the
been overwritten with new Host, the existing order has been renewed into the new
order from host. order.
ABC Page 309

7002 Communication error occurred Verify that the communication cable to the Host is con-
during order reception from nected appropriately. Perform an order inquiry to the Host
host. again. If you still have an error, contact our customer ser-
vice section for technical support.
7003 Communication error occurred Verify that the communication cable to the Host is con-
during result transmission to nected appropriately. Retry sending the result to the Host.
host. If you still have an error, contact our customer service
section for technical support.
7004 Received order with short Received order(s) with following reagent shortage
reagent received from host. method(s). Add a new reagent and perform an order
inquiry to the Host again.
7005 Sample number with invalid Because the sample number other than normal sample is
character received from host received, following orders were discarded. Check the cor-
and discarded it. rect order with the Host.
7006 Failed to allocate memory for Check the memory capacity of the PC, and stop the
result transmission. unnecessary applications, then resend the result(s) to the
Host.
7007 Host transmissions retry time Communication protocol may not be set appropriately.
over error. Check the communication setting details on the [System
setting] screen.
7008 Failed to allocate memory for Check the memory capacity of the PC, and stop the
order acquire. unnecessary applications, then perform an order inquiry
to the Host again.
7010 Sample number with invalid As an unregistered sample number is received, the fol-
character received from host lowing orders were discarded.
and discarded.
7011 Failed to allocate memory while Reboot the PC. If you still have an error, contact our cus-
acquiring QC data. tomer service section for technical support.
7030 Failed to read serum indices Either the serum information definition file does not exist
setting file. or the file format is not correct. Contact our customer ser-
vice section for technical support.
7051 Received more orders from Received more orders than the maximum sample num-
host than the analyzer can han- bers (1,000) for order registration. Check with the Host.
dle.
7052 ISE calibrator B is not regis- Registration of calibrator B to the standard sample tray
tered. position is required to execute the calibration.
7053 ISE wash solution is not regis- Registration of wash solution to the standard sample tray
tered. position is required to execute the ISE wash.
ABC Page 310

8.3 UNIT ALARM
Cod Message Action

e
0075 System file is not recognized. System file cannot be found.
Contact our customer service
8. 3. 1 REAGENT PIPETTE 1 (RPT1)

Reagent Pipette's Rotation Movement (RPT1R)
Code Level Message Location of Problem & Action

Cause
0102 1 Reagent pipette Nozzle position is out Turn off the power, and
(RPT1) rotation sen- of the IRU side normal verify if the RPT1 Unit
sor is on after rotation. movable area. can move smoothly
within its normal mov-
Rotary drive unit able area.
Reinitialize the ana-

lyzer, and check if it
recovers correctly.
If you still have an

error, contact our cus-
tomer service section
0103 1 Reagent pipette

(RPT1) rotation sen-
sor is on before rota-
tion. (while not at its
origin)
0104 1 Reagent pipette Nozzle position is out

(RPT1) rotation sen- of the RCU side nor-
sor is off after returning mal movable area.
to its origin. Rotary drive unit
RPTR origin sensor
ABC Page 311

0106 1 Reagent pipette Nozzle position is

(RPT1) up sensor is off beyond the lower limit.
at initiation of rotation The nozzle cannot
command. return to its origin due
to an external force.
Up-down driving
mechanism
Upper origin sensor
0156 2 Reagent pipette The nozzle cannot

(RPT1) up sensor is off return to its origin due
at initiation of rotation to an external force.
command. (while not Up-down driving
at trough or RCU posi- mechanism
tion) Upper origin sensor
Reagent Pipette's Vertical Movement (RPT1U)

Cause
0201 1 Reagent pipette Up-down driving Turn off the power, and verify
(RPT1), up origin sen- mechanism if the RPT1 Unit can move
sor, is off before Upper origin sensor smoothly within its normal
descent. movable area.
Reinitialize the analyzer, and
check if it recovers correctly.
If you still have an error, con-
tact our customer service

(RPT1), up origin sen- beyond the upper limit.
sor, is still on after Up-down driving
descent. mechanism
Upper origin sensor

(RPT1), ascent to ori-
gin sensor, is on
before ascent.

(RPT1), ascent to ori- beyond the lower limit.
gin sensor, is off after The nozzle cannot
ascent. return to its origin due
Upper origin sensor
ABC Page 312


(RPT1) origin sensor is beyond the upper limit.
not off at the initiation Up-down driving
of movement com- mechanism
mand. (from a position Upper origin sensor
other than its origin)
0206 1 IRU safety sensor is Positional relation Turn off the power, and verify
off at reagent pipette between IRU and if the IRU Unit can move
(RPT1) movement RPT1 smoothly within its normal
command. IRU Drive unit movable area. Reinitialize
IRU Ready position the analyzer, and check if it
sensor recovers correctly. If you still
have an error, contact our
customer service section for
technical support.
0209 1 Reagent pipette RPT1R Origin sensor Turn off the power, and verify
(RPT1) is not above RPT1R Rotary drive if the RPT1 Unit can move
IRU at initiation of the unit smoothly within its normal
pipette up or down movable area. Reinitialize
command. the analyzer, and check if it
recovers correctly. If you still
technical support.
0251 2 Reagent pipette RPT1U Drive unit Turn off the power, and verify
(RPT1) up position if the RPT1 Unit can move
sensor is off at initia- smoothly within its normal
movable area.
tion of reagent pipette
downward command. check if it recovers correctly.

(RPT1) up position
sensor is on at initia-
tion of reagent pipette
upward command.
0255 2 Reagent pipette Turn off the power, and verify

(RPT1) up sensor is if the RPT1 Unit can move
on at initiation of smoothly within its normal
reagent pipette up or movable area.
down command. (from Reinitialize the analyzer, and
a position other than check if it recovers correctly.
its origin) If you still have an error, con-
ABC Page 313

0257 2 Reagent pipette RPT1 nozzle position

(RPT1) safety sensor at the RPT 1 Trough.
is off at initiation of the RPT1U Drive unit
pipette up or down
command at RCU.

(RPT1) position sen- at the RCU reagent
sor for RCU is off at aspiration point.
initiation of the pipette RPT1U Drive unit
up or down command RPT1 Ready position
at RCU. sensor
0275 3 Reagent pipette Reagent shortage Wipe the pipette nozzle with
(RPT1) crash detec- alcohol.
tion sensor is on Lower limit sensor Check if the liquid level
before reagent pipette RCU Drive unit detection mechanism of the
has reached the bot- RPT1U Drive unit RPT1 has not been inhibited.
tom of the RCU. While holding the pipette
arm, verify if the nozzle can
be moved vertically by a few
millimeters with hands. Reini-
tialize the analyzer, and
0276 3 Reagent pipette Reagent shortage Verify if there is enough

(RPT1) cannot detect Liquid level sensor reagent quantity in the
RCU liquid level. RCU Drive unit reagent bottle(s) placed in
the RCU. If there is enough
reagent quantity in the bot-
tles, then verify the vertical
movement of the RPT1.
Check if the liquid level
detection mechanism of the
RPT1 has not been inhibited.
While holding the pipette
millimeters with hands.
Wipe the pipette nozzle with
alcohol.
0278 3 Reagent pipette Reagent

(RPT1) hardware is Liquid level sensor
functioning abnor-
mally.
ABC Page 314

0279 3 RPT1 liquid level Check the condition of the

detection at RCU; Liq- reagent bottle(s) placed in
uid level not detected. the RCU. Remove the bub-
bles, if any, on the surface of
reagent. Reinitialize the ana-
lyzer, and check if it recovers
correctly.
0281 3 Reagent pipette IRU Drive system When the RPT1 descended,
(RPT1) crash detec- RPT1R Rotary drive the IRU did not stop at the
tion sensor is on at ini- system center. Check if there are any
tiation of dispensation plays in the IRU Drive sys-
command at IRU. tem.
Syringe Pump for Reagent Pipette 1 (RPP1)

Cause
0301 1 Reagent syringe pump RPPÇPOrigin sensor This indicates that the RPP1
(RPP1) origin sensor RPP1Drive unit syringe is not located appro-
is off at initiation of priately. Visually check the
aspiration command. syringe movement.

0302 1 Reagent syringe pump RPPÇPDrive unit

(RPP1) origin sensor RPP1 Piping section
is still on although Solenoid valve
syringe has left its ori- Syringe tip
gin. Upper origin sensor
Installation position of
the gobo for the Upper
origin sensor is too
high.

is on before dispensa- Solenoid valve
tion command. Syringe tip
Upper origin sensor
ABC Page 315


is still off although the Solenoid valve
reagent syringe has Syringe tip
returned to its origin. Upper origin sensor
0305 1 Reagent syringe pump

(RPP1) origin sensor
is not off at initiation of
reagent pump move-
ment. (while reagent
syringe is not at its ori-
gin)

(RPP1) origin sensor
is off at initiation of
aspiration command.
0352 RPT1 nozzle is RPT1 nozzle is Clean the RPT1 nozzle with
clogged. clogged the nozzle-cleaning jig.
0353 2 Reagent syringe pump RPPÇPDrive unit This indicates that the RPP1
(RPP1)origin sensor is RPP1 Piping section syringe is not located appro-
on at initiation of dis- Solenoid valve priately. Visually check the
pensation command. Syringe tip syringe movement.
Upper origin sensor

(RPP1)origin sensor is
not off at initiation of
reagent pump move-
ment. (while reagent
syringe is at trough or
RCU position)
0356 2 Reagent syringe pump RPT1 Safety sensor

(RPP1) safety sensor
is off at initiation of dis-
pensation command.
ABC Page 316

Syringe Pump of Water for Reagent Pipette 1 (RPP1W)

Cause
4001 1 Reagent syringe pump RPP1W Origin sensor This indicates that the
for wash (RPP1W ) RPP1W Drive unit RPP1W syringe is not
origin sensor is off at located appropriately. Visu-
initiation of aspiration ally check the syringe move-
at origin. (Trough or ment.
RCU) Reinitialize the analyzer, and
4002 1 Reagent syringe pump RPP1W Drive unit

for wash (RPP1W) ori- RPP1W Piping section
gin sensor is on Solenoid valve
although the syringe Syringe tip
has left origin. (at ini- Upper origin sensor
tialization) Installation position of
high.

gin sensor is on before Solenoid valve
initiation of the syringe Syringe tip
movement command. Upper origin sensor
(from fully dispensed
position)

for wash (RPP1W) ori-
gin sensor is still off
although the syringe
has returned to origin.
(at initialization)
4005 1 At the initiation of

movement the reagent
syringe pump for wash
(RPP1W) origin sen-
sor is not off although
the syringe is not at
origin.
ABC Page 317


gin sensor is off at initi-
ation of aspiration at
origin. (Trough or
RCU)

gin sensor is on before
initiation of the syringe
movement command.
position) (Trough or
RCU)

(RPP1W), the origin
sensor is not off
although the syringe is
not at origin.
4056 2 Reagent pipette RPT1 Safety sensor Turn off the power, and verify
(RPT1) safety sensor if the RPT1 Unit can move
is off before initiation smoothly within its normal
of RPP1W movement movable area.
command. (from fully Reinitialize the analyzer, and
dispensed position) check if it recovers correctly.
8. 3. 2 REAGENT PIPETTE 2 (RPT2)

Reagent Pipette's Rotation Movement (RPT2R)

Cause
4102 1 Reagent pipette Nozzle position is out Turn off the power, and verify
(RPT2) rotation sen- of the IRU side normal if the RPT2 Unit can move
sor is on after rotation. movable area. smoothly within its normal
Rotary drive unit movable area.
ABC Page 318


(RPT2) rotation origin
sensor is on at initia-
tion of return to origin
command.
4104 1 Reagent pipette Nozzle position is out

(RPT2) rotation origin of the RCU side nor-
sensor is still off mal movable area.
although the RPT2 has Rotary drive unit
returned to origin. (at RPT2R Origin sensor
initialization)

(RPT2) up origin sen- beyond the lower limit.
sor is off at initiation of The nozzle cannot
RPT2 rotation com- return to its origin due
mand. to an external force.
Up-down driving
mechanism
Upper origin sensor
4156 2 Reagent pipette The nozzle cannot

(RPT2) up origin sen- return to its origin due
sor is on at initiation of to an external force.
RPT2 rotation com- Up-down driving
mand. (Trough or mechanism
RCU) Upper origin sensor
Reagent Pipette's Vertical Movement (RPT2U)

Cause
4201 1 Reagent pipette Up-down driving Turn off the power, and verify
(RPT2) up origin sen- mechanism if the RPT2 Unit can move
sor is off at initiation of Upper origin sensor smoothly within its normal
the pipette descent movable area.
from origin command. Reinitialize the analyzer, and

(RPT2) up origin sen- beyond the upper
sor is on although the limit.
RPT2 has left up ori- Up-down driving
gin. (at initialization) mechanism
Upper origin sensor
ABC Page 319


(RPT2) up origin sen-
sor is on at initiation of
return to origin com-
mand.

(RPT2) up origin sen- beyond the lower limit
sor is still off although The nozzle cannot
the RPT2 has returned return to its origin
to up origin. (at initial- due to an external
ization) force.
Upper origin sensor
4205 1 At the initiation of Nozzle position is

movement the reagent beyond the lower limit.
pipette (RPT2) up ori- Up-down driving
gin sensor is not off mechanism
although the RPT2 is Upper origin sensor
not at up origin.
4206 1 IRU safety sensor is Positional relation Turn off the power, and verify
off at initiation of the between IRU and if the IRU Unit can move
reagent pipette (RPT2) RPT2 smoothly within its normal
up or down command. IRU Drive unit movable area. Reinitialize
IRU Ready sensor the analyzer, and check if it
position recovers correctly. If you still
technical support.
4209 1 Reagent pipette RPTÇQR Origin sen- Turn off the power, and verify
(RPT2) is not above sor if the RPT2 Unit can move
IRU at initiation of the RPTÇQR Rotary drive smoothly within its normal
pipette up or down unit movable area.
command. Reinitialize the analyzer, and
4210 1 Mixer2 is not above its MIX2 is not located MIX2 must be located above
trough at initiation of above its trough. its trough at initiation.
movement command. Turn off the power, and move
(at initialization) the MIX2 to above its trough.
ABC Page 320

4251 2 Reagent pipette RPT2U Drive unit Turn off the power, and verify
(RPT2) up origin sen- if the RPT2 Unit can move
sor is off at initiation of smoothly within its normal
the pipette descent movable area.
from origin command.
(at trough or RCU) Reinitialize the analyzer, and

(RPT2) up origin sen-
mand. (Trough or
RCU)

movement, the
reagent pipette (RPT2)
up origin sensor is not
off although the RPT2
is not at up origin.
(Trough or RCU)

(RPT2) safety sensor at the RPT 2 Trough.
is off at initiation of the RPT2U Drive unit
pipette up or down RPT2 Ready position
command at RCU. sensor

(RPT2) position sen- at the RCU reagent
sor for RCU is off at aspiration position.
initiation of the pipette RPT2U Drive unit
up or down command RPT2 Ready position
at RCU. sensor
ABC Page 321

4275 3 Reagent pipette Reagent shortage Wipe the pipette nozzle with
(RPT2) crash detec- Lower limit sensor alcohol.
tion sensor is on RCU Drive unit Check if the liquid level
before reagent pipette RPT2U Drive unit detection mechanism of the
has reached the bot- RPT2 has not been inhibited.
tom of the RCU. While holding the pipette
4276 3 RCU liquid level has Reagent shortage Check if the reagent amount
not been detected by Liquid level sensor in the reagent bottle placed in
reagent pipette RCU Drive unit the RCU is sufficient. If there
(RPT2). is enough amount of reagent
in the bottle, check the verti-
cal movement of the RPT2.
RPT2 has not been inhibited.
Wipe the pipette nozzle with
alcohol.
4278 3 Level detection of Reagent

RCU with reagent Liquid level sensor
pipette (RPT2) indi-
cated erroneously H/
W.
ABC Page 322

4279 3 RCU liquid level has Check the condition of the

not been detected by reagent bottle(s) placed in
reagent pipette (RPT2) the RCU. Remove the bub-
at retrial. bles, if any, on the surface of
reagent.
4281 3 Reagent pipette IRU Drive system When the RPT2 descended,
(RPT2) crash detec- RPT2R Rotary drive the IRU did not stop at the
tion sensor is on at ini- center. Check if there are any
system
tiation of dispensation plays in the IRU Drive sys-
command at IRU. tem.
Syringe Pump for Reagent Pipette 2 (RPP2)

Cause
4301 1 Reagent syringe pump RPPÇQOrigin sensor This indicates that the RPP2
(RPP2) origin sensor is syringe is not located
RPPÇQDrive unit
off at initiation of aspira- appropriately. Visually check
the syringe movement.
tion at origin.
If you still have an error, contact
our customer service section for
technical support.
4302 1 Reagent syringe pump RPP2 Drive unit

(RPP2) origin sensor is RPP2 Piping section
on although the syringe Solenoid valve
has left origin. (at initial- Syringe tip
ization) Upper origin sensor
origin sensor is too high.
4303 1 Reagent syringe pump RPP2 Drive unit

(RPP2) origin sensor is RPP2 Piping section
on before initiation of the Solenoid valve
syringe movement com- Syringe tip
mand. (from fully dis- Upper origin sensor
pensed position)
ABC Page 323


(RPP2) origin sensor is
still off although the
syringe has returned to
origin. (at initialization)
4305 1 At the initiation of move-

ment the reagent syringe
pump (RPP2) origin sen-
the syringe is not at ori-
gin.

off at initiation of aspira-
tion at origin. (at trough
or RCU)

on before initiation of the
syringe movement com-
mand. (from fully dis-
pensed position) (Trough
or RCU)
4355 2 At the initiation of move-

ment the reagent syringe
pump (RPP2) origin sen-
the syringe is not at ori-
gin.
4356 2 Reagent pipette (RPT2) RPT2 Safety sensor

safety sensor is on before
initiation of RPP2
syringe movement com-
pensed position)
Syringe Pump of Water for Reagent Pipette 2 (RPP2W)

Cause
ABC Page 324

4401 1 Reagent syringe pump RPP2W Origin sensor This indicates that the
of water (RPP2W) ori- RPP2W Drive unit RPP2W syringe is not
gin sensor is off at initi- located appropriately. Visu-
ation of aspiration at ally check the syringe move-
origin. (Trough or ment.
RCU)

although its syringe Syringe tip
position has left origin. Upper origin sensor
(at initialization) Installation position of
high.

initiation of syringe Syringe tip
movement command. Upper origin sensor
position)

although its reagent
syringe has returned to
origin. (at initialization)

(RPP2W) origin sen-
the syringe position is
not at origin point.

gin sensor is off at initi-
ation of aspiration at
origin. (Trough or
RCU)
ABC Page 325


initiation of syringe
movement command.
RCU)

(RPP2W), the origin
sensor is not off
position is not at origin.
4456 2 Reagent pipette RPT2 Safety sensor Turn off the power, and verify
(RPT2) safety sensor if the RPT2 Unit can move
is off before initiation smoothly within its normal
of syringe of RPP2W movable area.
movement command.
(from fully dispensed Reinitialize the analyzer, and
position) check if it recovers correctly.
8. 3. 3 SAMPLE PIPETTE (SPT)

Sample Pipette's Rotation Movement (SPTR

Cause
0402 1 Sample pipette (SPT) Nozzle position is out Turn off the power, and verify
origin rotation sensor of the IRU side normal if the SPT can move
is still on although the movable area. smoothly (vertical & rota-
pipette has left its ori- tional movement) within its
gin. SPTR Drive unit normal movable area.

ABC Page 326

0403 1 Sample pipette (SPT)

origin rotation sensor
is on before rotation to
its origin.
0404 1 Sample pipette (SPT) Nozzle position is out

origin rotation sensor of the RCU side nor-
is still off although the mal movable area.
pipette has returned to SPTR Drive unit
its origin. SPTR Origin sensor
0406 1 Sample pipette (SPT) Nozzle position is

up origin rotation sen- beyond the lower limit.
sor is off at initiation of The nozzle cannot
pipette rotation com- return to its origin due
mand. to an external force.
SPTR Drive unit
SPTU Origin sensor
0456 2 Sample pipette (SPT) SPTU Drive unit

origin sensor is off at Upper origin sensor
initiation of pipette
rotation command.
Sample Pipette's Vertical Movement (SPTU)

Cause
0501 1 Sample pipette (SPT) SPTU Drive unit Turn off the power, and verify
up origin sensor is off Upper origin sensor if the SPT can move
at initiation of pipette smoothly (vertical & rota-
descent from origin tional movement) within its
command. normal movable area.


up origin sensor is on beyond the upper limit.
after pipette descent. SPTU Drive unit
Upper origin sensor
ABC Page 327


up sensor is on at initi-
ation of pipette return
to origin command.
0504 1 SPT ascend to origin; Nozzle position is

SPTU origin sensor beyond the upper limit.
(SPTU_ZERO) is off The nozzle cannot
after ascend. (At ini- return to its origin due
tialization) to an external force.
Upper origin sensor

up origin sensor is not beyond the upper limit.
off at initiation of Upper origin sensor.
pipette movement.
(the pipette is not at its
origin)
0506 1 IRU safety sensor is IRU Drive unit Turn off the power, and verify
not on at the sample IRU Ready position if the IRU Unit can move
pipette (SPT) up or sensor smoothly within its normal
down command. movable area.
0510 1 MIX1 is not above MIX1 is not located MIX1 must be located above
trough at initiation of above its trough when its trough when starting ini-
movement. (at initial- initializing the SPT. tialization.
ization) Turn off the power and move
the MIX1 to its trough.
0511 1 Sample pipette (SPT) SPTR Origin sensor Turn off the power, and verify
rotation origin sensor SPTR Rotary drive unit if the SPT can move
is off at initiation of the smoothly (vertical & rota-
pipette up or down tional movement) within its
command at IRU. normal movable area.
ABC Page 328

0551 2 Sample pipette (SPT) SPTU Drive unit Turn off the power, and verify
origin sensor is off at Upper origin sensor if the SPT can move
initiation of pipette smoothly (vertical & rota-
downward movement. tional movement) within its
normal movable area.


origin sensor is on at
initiation of upward
movement.

origin sensor is not off
at initiation of pipette
movement. (the
pipette is not at its ori-
gin)
0557 2 Sample pipette (SPT) Nozzle position is out

safety sensor is off at of the normal movable
initiation of the pipette area.
upward command at T/S Position sensor
ASP.
0558 2 Sample pipette (SPT) SPTASP Sensor

position sensor for SPTR Rotary drive unit
ASP is off at initiation
of the pipette upward
command at ASP.
0559 2 Sample pipette (SPT) SPT_TS Sensor

trough sensor is on at SPTR Rotary drive unit
initiation of the pipette
up or down command
at ASP.

trough sensor is not on SPTR Rotary drive unit
at initiation of the
pipette up or down
command at the
trough.
ABC Page 329


trough sensor is off at SPTR Rotary drive unit
initiation of the pipette
up or down command
at ISE.
0563 2 SPT position sensor SPT_TS Sensor

for ASP is off at initia- SPTR Rotary drive unit
tion of the pipette up or
down command at
ISE.
0575 3 Sample pipette (SPT) Sample shortage Wipe the pipette nozzle with
crash sensor is on but Lower limit sensor alcohol.
the pipette is not at the ASP Drive unit Check if the liquid level
bottom of the ASP. SPTU Drive unit detection mechanism of the
SPT has not been inhibited.
millimeters with hands. Reini-
0576 3 Sample pipette (SPT) Sample tube may not Check the amount of the
cannot detect the liq- exist in the ASP slot or sample placed in the ASP. If
uid level at ASP. the sample amount in the sample amount is suffi-
the tube may not be cient, check the vertical
sufficient. movement of the SPT. Check
Liquid level sensor if the liquid level detection
ASP Drive unit mechanism of the SPT has
not been inhibited. While
holding the pipette arm, ver-
ify if the nozzle can be
moved vertically by a few mil-
limeters with hands. Wipe the
SPT nozzle with alcohol.
ABC Page 330

0579 3 Sample pipette (SPT) Cuvette condition is Check the presence of the
cannot detect liquid abnormal. reagent (Reagent R1) in the
level at IRU. cuvette. If Reagent R1 is
Reagent has not been present in the cuvette, check
dispensed yet. the vertical movement of the
SPT. Check if the liquid level
Liquid level sensor. detection mechanism of the
millimeters with hands. Wipe
the SPT nozzle with alcohol.
0581 3 Sample pipette (SPT) SPTU Drive unit Check the amount of the
liquid level hardware is Liquid level sensor sample placed in the ASP. If
abnormal at ASP. the sample amount is suffi-
cient, check the vertical
movement of the SPT.
Wipe the SPT nozzle with
alcohol.
ABC Page 331

0582 2 Sample pipette (SPT) Liquid level sensor Check the presence of the
liquid level hardware is reagent (Reagent R1) in the
abnormal at IRU. cuvette. If Reagent R1 is
present in the cuvette, check
the vertical movement of the
SPT. Check if the liquid level
millimeters with hands. Wipe
the SPT nozzle with alcohol.
0583 2 SPT liquid level detec- Check the condition of the

tion at ASP; Liquid sample placed in the ASP.
level not detected at Remove the bubbles, if any,
duplicate detection. on the surface of sample.
Syringe Pump for Sample Pipette (SPP)

Cause
0601 1 Sample syringe (SPP) SPP Drive unit This indicates that the SPP is
origin sensor is off at SPP Piping section not located appropriately.
initiation of aspiration Solenoid valve Visual check the syringe
instruction. Syringe tip movement.
Upper origin sensor
ABC Page 332

0602 1 Sample syringe (SPP) SPP Drive unit

origin sensor is still on SPP Piping section
after the syringe has Solenoid valve
left its origin. Syringe tip
Upper origin sensor
high.

origin sensor is on SPP Piping section
before initiation of Solenoid valve
syringe movement Syringe tip
command to dis- Upper origin sensor
charge.
0604 1 Sample syringe (SPP)

origin sensor is still off
after syringe has
returned to its origin.
0605 1 Sample syringe (SPP)

origin sensor is not off
at initiation of syringe
movement command.
(the syringe is not at its
origin)

origin sensor is off SPP Piping section
before Aspiration. (at Solenoid valve
trough or ASP posi- Upper origin sensor
tion)
0652 SPT nozzle is clogged. SPT nozzle is clogged. Clean the SPT nozzle with
the nozzle-cleaning jig.
0653 2 Sample syringe (SPP) SPP Drive unit This indicates that the SPP is
origin sensor is on SPP Piping section not located appropriately.
before dispensation. Solenoid valve Visual check the syringe
(at trough or ASP) Upper origin sensor movement.

ABC Page 333

0655 2 Sample syringe pump SPP Drive unit

(SPP) origin sensor is SPP Piping section
on at initiation of the Solenoid valve
syringe movement Syringe tip
command although the Upper origin sensor
syringe is not at origin.
0656 2 Sample pipette (SPP) SPT Safety sensor

safety sensor is off
before initiation of SPP
movement command.
position)
0657 2 Sample pipette (SPP) SPTASP Upper sensor This indicates that the SPP
position sensor for syringe is not located appro-
ASP is on before initia- priately. Visually check the
tion of the sample syringe movement.
syringe pump (SPP)
movement command. Reinitialize the analyzer, and
(from fully dispensed check if it recovers correctly.
position) If you still have an error, con-
Syringe Pump of Water for Sample Pipette (SPPW)

Cause
ABC Page 334

4501 1 Sample syringe pump SPPW Drive unit This indicates that the SPPW
for wash (SPPW) ori- SPPW Piping section syringe is not located appro-
gin sensor is off at initi- Solenoid valve priately. Visually check the
ation of aspiration at Syringe tip syringe movement.
origin point. Upper origin sensor
4502 1 Sample syringe pump SPPW Drive unit

for wash (SPPW) ori- SPPW Piping section
although the syringe Syringe tip
position has left origin. Upper origin sensor
(at initialization) Installation position of
high.
4503 1 Sample syringe pump SPPW Drive unit

for wash (SPPW) ori- SPPW Piping section
initiation of the syringe Syringe tip
pump movement com- Upper origin sensor
pensed position)
4504 1 Sample syringe pump

for wash (SPPW) ori-
has returned to origin.
(at initialization)

movement the sample
syringe for wash
(SPPW) origin sensor
is not off although the
syringe position is not
at origin.
4551 2 Sample syringe for SPPW Drive unit

wash (SPPW) origin SPPW Piping section
sensor is off at initia- Solenoid valve
tion of aspiration at ori- Upper origin sensor
gin. (at trough or RCU)
ABC Page 335

4553 2 Sample syringe pump

for wash (SPPW) ori-
initiation of the syringe
movement command.
ASP)
4555 2 At the initiation of SPPW Drive unit

movement the sample SPPW Piping section
syringe pump for wash Solenoid valve
(SPPW) origin sensor Syringe tip
is not off although the Upper origin sensor
syringe position is not
at origin.
4556 2 Sample pipette (SPT) SPT Safety sensor Turn off the power, and verify
safety sensor is off if the SPT can move
before initiation of smoothly (vertical & rota-
SPPW movement tional movement) within its
command. (from fully normal movable area.
dispensed position)
4557 2 Sample pipette (SPT) SPTASP Upper sensor

position sensor for
ASP is on before initia-
tion of the sample
syringe of water
(SPPW) movement
command. (from fully
dispensed position)
8. 3. 4 MIXER UNIT 1 (MIX-1)

Cause
ABC Page 336

0701 1 IRU safety sensor is IRU Rotary drive unit Turn off the power, and verify
off at initiation of if the IRU Unit can move
Mixer1 stirring paddle smoothly within its normal
rotation command. movable area.
(Mixer1 is not above Reinitialize the analyzer, and
IRU position.) check if it recovers correctly.
0702 1 Mixer1 arm rotation MIX1R Origin sensor Turn off the power, and verify
origin sensor is off at MIX1R Rotary drive if the MIX1 can move
initiation of the stirring unit smoothly within its normal
paddle rotation com- movable area.
mand.
0703 1 Mixer1 safety sensor is MIX1_TS Sensor

off at initiation of the MIX1R Rotary drive
stirring paddle rotation unit
command.
0706 1 Mixer1 up origin sen- MIX1U Drive unit

the stirring paddle
rotation command.
0751 2 Mixer1 arm rotation MIX1R Drive unit

origin sensor is on at Rotation origin sensor
initiation of the stirring
paddle rotation com-
mand for paddle wash-
ing.
(Mixer1 is not at trough
position for paddle
washing.)
0752 2 Mixer1 safety sensor is MIX1R Drive unit

off at initiation of the MIX1 Safety sensor
stirring paddle rotation
command for paddle
washing.

sor is on at initiation of Origin sensor
the stirring paddle MIX1U_Zero
rotation command for
paddle washing.
ABC Page 337

0801 1 Mixer 1 up origin sen- MIX1U Drive unit

sor is off at initiation of Origin sensor
descent command.
0802 1 Mixer 1 up origin sen- MIX1U Drive unit

sor is still on although Origin sensor
mixer 1 has left its ori-
gin.
0803 1 Mixer 1 up origin sen-

mand.
0804 1 Mixer 1 up origin sen- Mixing stirrer cannot

sor is still off although return to its origin due
the mixer has returned to an external force.
to its origin. Origin sensor
0805 1 At the initiation of Mixing stirrer cannot

movement the mixer 1 return to its origin due
origin sensor is on to an external force.
although the mixer is MIX1U Drive unit
not at its origin point. Origin sensor
off at initiation of IRU Ready position if the IRU Unit can move
Mixer1 descent com- sensor smoothly within its normal
mand. movable area.

ABC Page 338

0807 1 Mixer1 arm rotation MX1R Origin sensor Turn off the power, and verify
origin sensor is off at MIX1 Rotary drive unit if the MIX1 can move
initiation of the mixer smoothly within its normal
downward command movable area.
above IRU.
off at initiation of the MIX1 Rotary drive unit
mixer downward com-
mand above IRU.
0851 2 Mixer1 up origin sen- MX1U Origin sensor
sor is off at initiation of MX1 Up-down driving
the mixer descent mechanism
command.
0852 2 Mixer1 arm rotation MX1R Origin sensor

origin sensor is on at MIX1 Rotary drive unit
initiation of the mixer
downward command
above trough.
0853 2 Mixer1 safety sensor is MX1U Origin sensor

off at initiation of the MX1 Up-down driving
mixer downward mechanism
movement above
tough.
0854 2 At the initiation of MX1U Origin sensor

movement Mixer1 up MX1 Up-down driving
origin sensor is on mechanism
although the mixer is
not at origin.

sor is on at initiation of MX1 Up-down driving
return to origin com- mechanism
mand.
ABC Page 339

Mixing Unit 1 Rotary Drive Unit (MIX1R)

Cause
4601 1 Mixer1 up origin sen- MX1U Origin sensor Turn off the power, and verify
sor is off at initiation of MX1 Up-down driving if the MIX1 can move
the mixer movement mechanism smoothly within its normal
command. movable area.

4602 1 Mixer1 arm rotation MX1R Origin sensor

origin sensor is still off MIX1 Rotary drive unit
although the mixer has
returned to origin. (at
initialization)

sor is off at initiation of MX1 Up-down driving
the mixer movement mechanism
command.
8. 3. 5 MIXER UNIT 2 (MIX-2)

Cause
0901 1 IRU safety sensor is IRU Rotary drive unit Turn off the power, and verify
off at initiation of if the IRU Unit can move
Mixer2 stirring paddle smoothly within its normal
rotation command. movable area.
(Mixer2 is not above
IRU position.) Reinitialize the analyzer, and
ABC Page 340

0902 1 Mixer2 rotation origin MIX1R Origin sensor Turn off the power, and verify
sensor is off at initia- MIX1R Rotary drive if the MIX2 can move
tion of the stirring pad- unit smoothly within its normal
dle rotation command. movable area.


off at initiation of the MIX1R Rotary drive
stirring paddle rotation unit
command.
0906 1 Mixer2 origin sensor is MIX2 Drive unit

on at initiation of stir- Origin sensor
ring paddle rotation
command.
0951 2 Mixer2 arm rotation MIX2 Drive unit

origin sensor is on at Rotation origin sensor
initiation of the stirring
paddle rotation com-
mand for paddle wash-
ing.
(Mixer2 is not at trough
position for paddle
washing.)
0952 2 Mixer2 safety sensor is MIX2R Drive unit

off at initiation of the MIX2 Safety sensor
stirring paddle rotation
command for paddle
washing.

sor is on at initiation of Origin sensor
the stirring paddle
rotation command for
paddle washing.
1001 1 Mixer2 up origin sen- MIX2 Drive unit

sor is off at initiation of Origin sensor
descent command.
1002 1 Mixer2 up origin sen- Mixing stirrer cannot

sor is still on although return to its origin due
mixer has left its origin. to an external force.
MIX2 Drive unit

Origin sensor
ABC Page 341

1003 1 Mixer2 up origin sen-

mand.
1004 1 Mixer 2 up origin sen- Mixing stirrer cannot

sor is still off although return to its origin due
the mixer has returned to an external force.
to its origin. Origin sensor
1005 1 At the initiation of Mixing stirrer cannot

movement the Mixer2 return to its origin due
origin sensor is on to an external force.
not at its origin point. MIX2 Drive unit
Origin sensor
off at initiation of IRU Ready position if the IRU Unit can move
Mixer2 descent com- sensor smoothly within its normal
mand. movable area.

1007 1 Mixer2 arm rotation MIX2R Origin sensor Turn off the power, and verify
origin sensor is off at MIX2 Rotary drive unit if the MIX2 can move
initiation of the mixer smoothly within its normal
downward command movable area.
above IRU.

off at initiation of the MIX2 Rotary drive unit
mixer downward com-
mand above IRU.
ABC Page 342

1051 2 Mixer2 up origin sen- MX2U Origin sensor Turn off the power, and verify
sor is off at initiation of MIX2 Up-down driving if the MIX2 can move
the mixer descent mechanism smoothly within its normal

1052 2 Mixer 2 arm rotation MIX2R Origin sensor

origin sensor is on at MIX2 Rotary drive unit
initiation of the mixer
downward command
above tough.
1053 2 Mixer2 safety sensor is MX2U Origin sensor

off at initiation of the MIX2 Up-down driving
mixer downward com- mechanism
mand above tough.
1054 2 At the initiation of MX2U Origin sensor

movement the Mixer2 MIX2 Up-down driving
up origin sensor is on mechanism
not at origin.

sor is on at initiation of MIX2 Up-down driving
return to origin com- mechanism
mand.
Mixing Stirrer Unit 1 Rotary Drive unit (MIX2R)

Cause
4701 1 Mixer2 up origin sen- MIX2U Origin sensor Turn off the power, and verify
sor is off at initiation of MIX2 Up-down driving if the MIX2 can move
the mixer descent mechanism smoothly within its normal

ABC Page 343

4702 1 Mixer2 arm rotation MIX2R Origin sensor

origin sensor is still off MIX2 Rotary drive unit
although the mixer has
returned to origin. (at
initialization)
4751 2 Mixer2 up origin sen- MIX2U Origin sensor

sor is off at initiation of MIX2 Up-down driving
the mixer descent mechanism
command.
8. 3. 6 WASH UNIT (WU)

Cause
1101 1 Wash unit origin sen- WU Drive unit Turn off the power, and verify
sor is off at initiation of Upper origin sensor if the WU can move vertically
descent command. and smoothly within its nor-
mal movable area. (Remove
the WU cover behind the
SPT.)

1102 1 Wash unit origin sen- WU position is beyond

sor is still on although the upper limit.
the wash unit has left WU Drive unit
its origin. Upper origin sensor
1103 1 Wash unit origin sen- WU position is beyond

sor is on at initiation of the upper limit.
wash unit return to ori- WU Drive unit
gin command. Upper origin sensor
1104 1 Wash unit origin sen- WU Drive unit

sor is still off although Upper origin sensor
the wash unit has
1105 1 WU ascend/descend WU Drive unit

at off-origin; WU origin Upper origin sensor
sensor (WU_ZERO)
should be off before
action but not.
ABC Page 344

off at WU movement if the IRU Unit can move
command. smoothly within its normal
movable area. Reinitialize
the analyzer, and check if it
technical support.
1201 1 WPP aspiration; WPP WPP Drive unit This indicates that the WPP
origin sensor Upper origin sensor syringe is not located appro-
(WPP_ZERO) is off priately. Visually check the
before aspiration. syringe movement. Reinitial-
ize the analyzer, and check if
it recovers correctly. If you
still have an error, contact our
technical support.
1202 1 Wash pump syringe WPP Drive unit

origin sensor is still on Upper origin sensor
although the wash
pump has left its origin.

origin sensor is on Upper origin sensor
before initiation of
wash pump move-
ment command. (from
fully dispensed posi-
tion)

origin sensor is off Upper origin sensor
although the unit has
1205 1 WPP aspiration/dis- WPP Drive unit This indicates that the WPP
pensation at off-origin; Upper origin sensor syringe is not located appro-
WPP origin sensor priately. Visually check the
(WPP_ZERO) is not syringe movement.
off before movement. Reinitialize the analyzer, and
ABC Page 345

1206 1 WU1 has detected Inline filter for the WU1 Wipe the WU1 nozzle with
excess water in a wastewater line. alcohol. Make sure that the
cuvette. WU1 Wastewater line inline filter is not clogged
(WU1_EKIMEN=1) pump and/or damaged.
(During Prime) Reinitialize the analyzer, and
section for technical support
ABC Page 346

(During Prime)
off at WU movement if the IRU Unit can move
command. smoothly within its normal
movable area.

1214 1 At the initiation of WU Drive unit Turn off the power, and verify
movement the WU, the Upper origin sensor if the WU can move vertically
origin sensor is on and smoothly within its nor-
although the WU is not mal movable area. (Remove
at origin. the WU cover behind the
SPT)
ABC Page 347

1251 1 Wash syringe pump WPP Drive unit This indicates that the WPP
(WPP) origin sensor is Upper origin sensor syringe is not located appro-
off at initiation of aspi- priately. Visually check the
ration at origin. syringe movement.

1253 1 Wash syringe pump WPP Drive unit

(WPP) origin sensor is Upper origin sensor
on before initiation of
wash pump move-
ment command. (from
fully dispensed posi-
tion)
1255 1 At the initiation of WPP Drive unit

movement the wash Upper origin sensor
pump syringe (WPP),
the origin sensor is not
off although WPP is
not at origin.
1256 1 WU1 has detected Inline filter used for the Wipe the WU1 nozzle with
excess water in a WU1 wastewater line. alcohol. Make sure that the
(During run) Reinitialize the analyzer, and
ABC Page 348

(During run)
ABC Page 349

off at the wash unit if the IRU Unit can move
(WU) movement com- smoothly within its normal
mand. movable area.
1264 2 At the initiation of WU Drive unit Turn off the power, and verify
movement of wash Upper origin sensor if the WU can move vertically
unit (WU), the origin and smoothly within its nor-
sensor is not off mal movable area. (Remove
although the WU is not the WU cover behind the
at origin. SPT)
1276 WU1 has detected WU1 Wastewater Waste pump may be dam-
excess water in a pump aged or the filter is clogged.
cuvette. Inline filter Contact customer service
(WU1_EKIMEN sen- section for technical support.
sor =1) (During run)
1277 WU2 has detected WU2 Wastewater

excess water in a pump
cuvette. Inline filter
(WU2_EKIMEN sen-

(WU3_EKIMEN sen-

(WU4_EKIMEN sen-

(WU5_EKIMEN sen-
ABC Page 350


(WU6_EKIMEN sen-

(WU7_EKIMEN sen-
8. 3. 7 INCUBATION REACTION UNIT (IRU)
Code Level Message Location of Problem Action

&Cause
1301 1 IRU origin sensor is on IRU Drive unit Waste pump may be dam-
although the IRU has Origin sensor aged or the filter is clogged.
left origin. Contact customer service
1302 1 IRU origin sensor is Rotary encoder

still on although the IRU Drive unit
IRU has left its origin.
1303 1 ACK signal cannot be Communication with Cannot electrically communi-

received after IRU ori- the DTR control CPU cate with the sub CPU.
gin search command Contact our customer service
has been given to DTR section for technical support.
control CPU.
1304 1 ACK signal cannot be

received after IRU
rotation stop instruc-
tion has been given to
DTR control CPU.
1305 1 ACK signal cannot be

received after request
command for number
of pulses has been
given to DTR control
CPU.
1306 1 IRU origin sensor is on Rotary encoder Turn off the power, and verify
after origin-centered IRU Drive unit if the IRU can be rotated
process. smoothly with hands. Reini-
ABC Page 351

1307 1 Number of drive Communication with Cannot electrically communi-

pulses cannot be the DTR control CPU cate with the sub CPU. Con-
received from DTR tact our customer service
control CPU after ori- section for technical support.
gin-centered process.
1308 1 Sample pipette (SPT) SPT Origin sensor This indicates that the SPT is
rotation origin sensor SPTR Drive unit located above the IRU during
is on at initiation of IRU the IRU rotation.
rotation command. Turn off the power, and verify
if the SPT can move
smoothly within its normal
movable area. Reinitialize
the analyzer, and check if it
technical support.
1309 1 Reagent pipette RPT1 Origin sensor This indicates that the RPT1
(RPT1) rotation origin RPTR Drive unit is located above the IRU dur-
sensor is on at initia- ing the IRU rotation.
tion of IRU rotation Turn off the power, and verify
command. if the RPT can move
movable area.
1310 1 Reagent pipette RPT2 Origin sensor This indicates that the RPT2
(RPT2) rotation origin RPT2R Drive unit is located above the IRU dur-
sensor is on at initia- ing the IRU rotation.
tion of IRU rotation Turn off the power, and verify
command. if the RPT can move
movable area.
ABC Page 352

1311 1 Mixer1 rotation origin MIX1R Origin sensor This indicates that the MIX1
sensor is on at initia- MIX1R Drive unit is located above the IRU dur-
tion of IRU rotation ing the IRU rotation.
command. Turn off the power, and verify
if the MIX can move smoothly
within its normal movable
area.
1312 1 Mixer2 rotation origin MIX2R Origin sensor This indicates that the MIX2
sensor is on at initia- MIX2R Drive unit is located above the IRU dur-
tion of IRU rotation ing the IRU rotation.
command. Turn off the power, and verify
if the MIX can move smoothly
area.
1313 1 Wash unit origin sen- WU Drive unit This indicates that the WU is
sor is off at initiation of WU Origin sensor located above the IRU during
IRU command. the IRU rotation.
Turn off the power, and verify
if the WU can move smoothly
area.
ABC Page 353

8. 3. 8 REAGENT CONTAINER UNIT (RCU)

Cause
1402 1 RCU sensor is on RCU Origin sensor Turn off the power, and verify
although the RCU has RCU Drive unit if the RCU can be rotated
left its origin. smoothly with hands.
1404 1 RCU origin sensor is RPT nozzle cannot

on at initiation of return return to its origin due
to origin command. to an external force.
RPT Upper origin sen-
sor
1406 1 Reagent pipette RPT1 nozzle cannot This indicates that the RPT1
(RPT1) up origin sen- return to its origin due is located above the RCU
sor is off at initiation of to an external force. during the RCU rotation.
RCU rotation com- RPT1 Upper origin Verify if the RPT can move
mand. sensor smoothly (vertical and rota-
tional movement) within its
1407 1 Reagent pipette RPT2 nozzle cannot This indicates that the RPT2
(RPT2) up origin sen- return to its origin due is located above the RCU
sor is not on at initia- to an external force. during the RCU rotation.
tion of RCU rotation RPT2 Upper origin Verify if the RPT can move
command. sensor smoothly (vertical and rota-
tional movement) within its
ABC Page 354

1454 1 RCU origin sensor is RCU cannot return to This indicates that the RCU
still off although the its origin due to an failed to rotate appropriately.
RCU has returned to external force. Turn off the power, and then
its origin. RCU Origin sensor verify if the RCU can be
rotated smoothly with hands.
8. 3. 9 DETECTOR UNIT (DTR)

Cause
1501 1 Program number can- Communication with Cannot electrically communi-

not be received from the DTR control CPU cate with the sub CPU.
DTR control CPU. Contact our customer service
1502 1 There is no response

to transmission of pho-
tometric position com-
pensation from DTR
control CPU.

to rotary photometric
command from DTR
control CPU.

to inquiry command for
photometric data from
DTR control CPU.
1505 1 Photometric data is not

sent from DTR control
CPU.
1506 1 There is an anomaly in

reception of photomet-
ric data from DTR con-
trol CPU.

transmission of offset
voltage.
ABC Page 355

1508 1 Negative absorbance Halogen lamp (light

occurs. Automatic gain intensity shortage)
is requested.
8. 3. 10 AUTO SAMPLER UNIT (ASP)

Cause
1601 1 Sample pipette (SPT) SPTU Origin sensor Turn off the power, and verify
up origin sensor is on SPT Up-down driving if the SPT can move
at initiation of ASP mechanism smoothly (vertical & rota-
rotation command with tional movement) within its
SPT being above ASP. normal movable area.
1602 1 ASP rotation origin ASP Origin sensor Turn off the power, and verify
sensor is on although ASP Rotary drive unit if the ASP can be rotated
the ASP has left its ori- smoothly with hands.
gin. Reinitialize the analyzer, and
1604 1 ASP rotation origin ASP Origin sensor

sensor is off although ASP Rotary drive unit
the ASP has returned
to its origin.
1605 1 Sample pipette (SPT) SPTU Origin sensor Turn off the power, and verify
up origin sensor is off SPT Up-down driving if the SPT can move
at initiation of ASP mechanism smoothly (vertical & rota-
rotation command. tional movement) within its
ABC Page 356

1606 1 Sample pipette (SPT) SPT nozzle position is

up origin sensor is not beyond the lower limit.
on at initiation of ASP SPT nozzle cannot
rotation command. return to its origin due
SPT Upper origin sen-
sor

up origin sensor is off
at initiation of ASP
rotation command with
SPT being above ASP.
1654 2 ASP rotation origin ASP Origin sensor Turn off the power, and verify
sensor is off although ASP Rotary drive unit if the ASP can be rotated
the ASP has returned smoothly with hands.
to origin. Reinitialize the analyzer, and
8. 3. 11 ION SELECTABLE ELECTRODE UNIT (ISE)

Cause
1775 3 There is an anomaly in ISE Cannot electrically communi-

response to Serum ISE Communication cate with the ISE.
Sample inquiry. cable Contact our customer service

response to Urine
Sample inquiry.
1777 3 ISE result measure- Refer to the “error flag”

ment data is not avail- added to the ISE measure-
able. ment results.
1780 3 No acknowledge from ISE Check the possibility of dis-

ISE module for "Elec- ISE Communication connection or faulty contact
trode Exchange" com- cable of the communication cable.
mand. If you still have an error, con-
1781 3 No acknowledge from ISE

ISE module for "Prime" ISE Communication
command. cable
ABC Page 357

1782 3 No acknowledge from ISE

ISE module for "Clean- ISE Communication
ing" command. cable
1790 3 Failed to detect clean- Cleaning solution Failed to detect the liquid
ing solution for S.P.T shortage level of the SPT special
(S) Liquid level sensor cleaning solution.
Set the specified cleaning
solution in place.
1791 3 Failed to detect clean- Cleaning solution Failed to detect the liquid
ing solution for R.P.T shortage level of the RPT special
(S) Liquid level sensor cleaning solution.
solution in place.
1792 3 Failed to detect ISE Cleaning solution Failed to detect the liquid
cleaning solution shortage level of the ISE cleaning
Liquid level sensor solution.
solution in place.
1793 3 Failed to detect Cali- Calibrant-B shortage Failed to detect ISE Cali-
brant-B for ISE Liquid level sensor brant-B liquid level.
Set the ISE Calibrant-B in
place.
1875 3 Failed to detect clean- Cleaning solution Failed to detect cleaning

ing solution for S.P.T shortage solution for the SPT nozzle.
(S) Liquid level sensor Set the cleaning solution in
place.

ing solution for R.P.T1 shortage solution for the RPT nozzle.
place.

ing solution for R.P.T2 shortage solution for the RPT nozzle.
place.

ing solution for Cuvette shortage solution for Cuvette Water
Water Placement. Liquid level sensor Placement (detergent).
Set the cleaning solution in
place.
ABC Page 358

8. 3. 12 TANK

Cause
2605 1 Purified water supply Purified water short- Fill the purified water tank
is low. age with purified water, and then
Sensor execute the prime.
2606 1 Wash solution 1 is low. Wash solution 1 short- Fill the wash tank 1 with the
age liquid and then execute the
Sensor prime.
age liquid and then execute the
Sensor prime.
2608 1 Waste tank 1 is full to Waste tank for low- Drain the (low-concentrated)
capacity. concentrated waste- wastewater in the waste
water is full. tank.
2609 1 Waste tank 2 is full to Waste tank for high- Drain the (high-concentrated)
Sensor execute prime.
age liquid and then execute
prime.
prime.
2659 1 Waste tank 2 is full to Waste tank for high- Drain the (high-concentrated)
Sensor execute prime.
Sensor prime.
Sensor prime.
ABC Page 359

2679 3 Waste tank 2 is full to Waste tank for high- Drain the (low-concentrated)
8. 3. 13 SENSOR STATUS

Cause
2701 1 ASP lid is open. ASP Lid is not closed Make sure to set the ASP
properly. Lid.
ASP Lid sensor
2702 1 RCU lid is open. RCU Lid is not closed Make sure to set the RCU
properly. Lid.
RCU Lid sensor.
2703 1 ISE maintenance lid is ISE Maintenance lid is Make sure to set the ISE Lid.
open. not closed properly.
ISE Maintenance lid
sensor
2704 1 ASP sample insertion (ASP) Sample inser- Make sure to set the ASP
lid is open. tion lid is not closed sample insertion lid.
properly.
(ASP) Sample inser-
tion lid sensor
2720 1 Trough chamber over- Trough piping section Cannot drain water.
flows. External piping section Check if the drain line at the
Trough overflow sen- right side of the analyzer is
sor clogged or not.
2731 1 Sub-tank L is not exis- Sub-tank L has not The sub-tank has not been
tent. been set. set on the left side of the ana-
Sensor lyzer. Make sure to set the
sub-tank.
2732 1 Sub-tank R is not exis- Sub-tank R has not The sub-tank has not been
tent. been set. set on the right side of the
Sensor analyzer. Make sure to set
the sub-tank.
2733 1 Full capacity sensor of Sensor Full capacity sensor of the

sub-tank L does not sub-bank is abnormal. Con-
give OFF signal after a tact our customer service
lapse of given time. section for technical support.
ABC Page 360

2734 1 Full capacity sensor of

sub-tank R does not
give OFF signal after a
lapse of given time.
2735 1 Full capacity sensor of Water supply pres- Water supply capacity of the
sub-tank L does not sure is insufficient. purified water generator is
give ON signal after Sensor insufficient.
feed water of given
time.

sub-tank R does not
give ON signal after
feed water of given
time.
2737 1 Sub-tank L sensor is in Sensor Full capacity sensor and/or

trouble. empty sensor of the sub-
bank are abnormal. Contact
our customer service section
2738 1 Sub-tank R sensor is

in trouble.
sub-tank.
the sub-tank.
2753 2 Full capacity sensor of Sensor Full capacity sensor of the

sub-tank L does not sub-bank is abnormal. Con-
give OFF signal after a tact our customer service

sub-tank R does not
2755 2 Full capacity sensor of Water supply pres- Water supply capacity of the
give ON signal after Sensor. insufficient.
feed water of given
time.
ABC Page 361


sub-tank R does not
feed water of given
time.
sub-tank.
the sub-tank.
2777 3 Full capacity sensor of Sensor Sub-tank full capacity sensor

sub-tank L does not is abnormal.
give OFF signal after a Contact our customer service

sub-tank R does not
2779 3 Full capacity sensor of Water supply pres- Water supply capability of the
give ON signal after Sensor insufficient.
feed water of given
time.

sub-tank R does not
feed water of given
time.
2781 3 Trough chamber over- Trough piping section Cannot drain water.
flows. External piping sec- Check if the drain line on the
tion of the analyzer. right side of the analyzer is
Trough overflow sen- clogged.
sor
2801 1 Water leakage is Water leakage Contact our customer service

detected under the section for technical support.
middle WPP
2802 1 Water leakage is

detected under the
middle RCU.

detected under the
middle ASP.
ABC Page 362


detected under the
middle SPP.

detected under the
middle RPP.

detected under the
middle RPP2.

detected at the lower
SWU.

detected at SWU2.

middle WPP

detected under the
middle RCU.

detected under the
middle ASP.

detected under the
middle SPP.

detected under the
middle RPP.

detected under the
middle RPP2.

SWU.

detected at SWU2.

middle WPP.

detected under the
middle RCU.
ABC Page 363


detected under the
middle ASP.

detected under the
middle SPP.

detected under the
middle RPP.

detected under the
middle RPP2.

SWU.

detected at SWU2.
2951 2 Fan motor1 for power Power supply fan Contact our customer service
supply is at rest. section for technical support.
2952 2 Fan motor2 for power

supply is at rest.

supply is at rest.

supply is at rest.

supply is at rest.
2956 2 Fan motor at the bot- Cabinet fan Contact our customer service
tom of right-hand side section for technical support.
of cabinet is at rest.
2957 2 Fan motor in the top of

right-hand side of cabi-
net is at rest.
2958 2 Fan motor at the bot-

tom of left-hand side of
cabinet is at rest.

left-hand side of cabi-
net is at rest.
2960 2 Fan motor 1 for RCU Peltier fan Contact our customer service
Peltier is at rest. section for technical support.
ABC Page 364

2961 2 Fan motor 2 for RCU

Peltier is at rest.

Peltier is at rest.

Peltier is at rest.
2964 2 Fan motor 1 for ASP

Peltier is at rest.

Peltier is at rest.
2975 2 Fan motor1 for power Power supply fan Contact our customer service
supply is at rest. section for technical support.

supply is at rest.

supply is at rest.

supply is at rest.

supply is at rest.
2980 2 Fan motor at the bot- Cabinet fan Contact our customer service
tom of right-hand side section for technical support.
of cabinet is at rest.

right-hand side of cabi-
net is at rest.
2982 2 Fan motor at the bot-

tom of left-hand side of
cabinet is at rest.

left-hand side of cabi-
net is at rest.
2984 2 Fan motor 1 for RCU Peltier fan Contact our customer service
Peltier is at rest. section for technical support.

Peltier is at rest.

Peltier is at rest.

Peltier is at rest.
ABC Page 365


Peltier is at rest.

Peltier is at rest.
8. 3. 14 TEMPERATURE

Cause
3051 2 IRU temperature is IRU Heater 1 During measurement, the

less than 35 degrees. IRU Slip ring temperature in the IRU must
IRU_DRV PC board be kept within a range of 35
IRU Thermal fuse for ×C to 39×C.
Heater 1 Observe the temperature
Fuse F1 on the monitor display of “Mainte-
IRU_CN2 PC board nance” at the standby time,
and contact our customer
service section for technical
support.
3052 2 IRU temperature is IRU Slip ring

more than 39 degrees. IRU_DRV PC board
3053 2 RCU temperature is RCU Peltier During measurement, the

more than15 degrees. RCU Peltier fan temperature in the RCU must
be kept at 15 ×C or lower.
Observe the temperature
monitor display of “Mainte-
nance” at the standby time,
support.
3054 2 ASP temperature is ASP Peltier During measurement, the

more than 15 degrees. ASP Peltier fan temperature in the ASP must
be kept at 15 ×C or lower.
Observe the temperature
monitor display of “Mainte-
nance” at the standby time,
support.
ABC Page 366

8. 3. 15 OTHERS
Code Level Message Location of Problem Action

&Cause
5001 1 Reagent barcode Connection Wipe the reading window of

reader; Initialization BCR main body the barcode reader with alco-
error. hol.
5002 1 Sample barcode

reader; Initialization
error.
5051 2 Order buffer is full to Contact our customer service

capacity. section for technical support.
5052 2 The analyzer is lacking Cuvette contamination More than 30 contaminated

in cuvettes. cuvettes are present. Per-
form cuvette cleaning at the
cuvette cleaning of the
“Maintenance”.
5075 3 Sample barcode could Abnormal character Examine the barcode label
not be read due to that is out of the speci- attached to the sample tube.
character out of specifications.
fication.
ABC Page 367

ABC Page 368

SECTION 9 ISE USE AND MAINTENANCE Version 1.0 Rev Sep 2005
SECTION 9
ISE USE AND MAINTENANCE
ABC Page 369

9.1 GENERAL INFORMATION FOR ISE MEASUREMENT

1. Electrodes are marked with an ‘INSTALL BY’ date. The electrode is warranted for
up to 10,000 samples.
2. Once installed, electrodes require a flush with Calibrant A every 30 minutes.
Therefore the analyser should be kept in SLEEP mode even when not in use.
3. When turning off the power to the analyser, a purge procedure should be
performed. If fluid is left in the unit it could result in potassium measurement drift.
The purge procedure may be performed using the Electrode Exchange command.
4. A 2-point calibration of the ISE module should be performed daily prior to running
samples. ISE cleaning is required at the end of each day when running more than
50 samples a day.
5. Do not clean the electrode more than recommended as small levels of protein
build up help stabilise the measurements. Wash solution can affect electrode
performance.
6. Swirl the Calibrant A bottle daily to prevent condensation within the bottle.
7. High measurements for sodium only may be caused by a bubble in the fluid line.
Perform an ISE prime procedure (Sequence [F9] in MAINTENANCE menu and
then calibrate the ISE. If problems persist perform the prime procedure three more
times.
8. Acceptable variation of calibration results between two consecutive calibration
measurements is 2.0.
9. Calibrant A, B and Wash solution should be stored in a dark place at room
temperature.
The ISE unit consists of an ISE module, ion exchange electrode and two pumps for
supply and waste.
ISE module Consists of electrodes (Na, K, Cl and Reference) and pumps.
RS232C port used for communication with the analyser.
Ion Electrode Consists Na, K, Cl and Reference electrodes.
Supply Pump Supplies Calibrant A to ISE module.
Waste Pump Drains liquid from ISE module.
Waste is transferred to the external tank for high concentration waste.
ABC Page 370

9.2 ISE THEORY

Electrolyte measurements in blood samples were traditionally performed using flame
photometry, in which a sample, diluted with a known concentration of a reference ion
(usually lithium or caesium), is aerosolised and passes through a flame which excites
the cations. They re-emit the energy as light of different frequencies, the amplitude of
emission is proportional to the ion concentration in the sample. The development of
selective organic compounds for sodium, potassium, chloride and other electrolytes
has permitted the development of sensors capable of directly measuring biological
fluids throughout the physiological range. These sensors are known as Ion Selective
Electrodes or ISEs.
The Rx Daytona electrolyte measurement system measures sodium, potassium and

chloride in biological fluids, using ion selective electrode technology. A diagram of the
electrode measurement system is shown below.
ELECTRODE MEASUREMENT DIAGRAM
ABC Page 371

The flow-through sodium electrode uses selective membrane tubing, specially

formulated to be sensitive to sodium ions. The potassium and chloride electrodes
employ similar designs with appropriate selective membrane materials. The potential
of each electrode is measured relative to a fixed, stable voltage established by the
double-junction silver/silver chloride reference electrode. An ion selective electrode
develops a voltage that varies with the concentration of the ion to which it responds.
The relationship between the voltage developed and the concentration of the sensed
ion is logarithmic, as expressed by the Nernst equation:
where E = The potential of the electrode sample solution

E° = The potential developed under standard conditions
RT/nF = A temperature dependent ‘constant’, termed the slope
Log = Base ten logarithm function
µ = Activity coefficient of the measured ion in the solution
C = Concentration of the measured ion in the solution
A comparative method of measurement is utilised. First, the ISE module measures

the potentials developed when the sample is positioned in the electrodes. Then,
calibrant A is positioned in the electrodes. The difference in the two potentials is
related logarithmically to the concentration of measured ions in the sample divided by
their respective concentrations in the calibrant solution. Since the difference in
potentials and the concentration of the sodium, potassium or other ions in the
calibrant solution are known, the computer can calculate the concentration of the ions
in the sample solution, in accordance with the Nernst equation, rewritten as:
ABC Page 372

E - E° = S log ( Cx / Cs) or Cx = Cs x 10 [(E - E°) / S]
where E = ISE potential developed in sample solution

E° = ISE potential developed in Calibrant A solution
S = Electrode slope calculated during calibration with Cal A
and B.
Cx = Concentration of ion in the sample
Cs = Concentration of ion in the Calibrant solution
‘S’, the slope, is determined during the calibration using Calibrants A and B, which
have known levels of sodium, potassium and chloride.
ABC Page 373

9.3 ISE TECHNICAL SPECIFICATIONS

Sample Serum, Plasma or Urine (Urine requires 1+10 dilution)
Sample size 70µl serum; (70µl X 3) + 50µl urine
Reproducibility Maximum imprecision Typical carry over, %serum

Serum (within run)
Na CV < 1.5% (100 – 160mmol/L) < 0.5%
K CV < 2% (3.0 – 6.0mmol/L) < 1.5%
Cl CV < 2% (80 – 120mmol/L) < 1.0%
Urine (within run)

Na CV < 5% (20 – 500mmol/L)
K CV < 5% (1 – 500mmol/L)
Cl CV < 5% (20 – 500mmol/L)
Serum (between day)

Na CV < 2% (100 – 160mmol/L)
K CV < 2.3% (3.0 – 6.0mmol/L) < 1.5%
Cl CV < 2.3% (80 – 120mmol/L) < 1.0%
Analysis Time Serum – 30 seconds, including one point calibration

Urine - 100 seconds, including one point calibration
Throughput Serum – 270 tests per hour, 90 samples per hour

Urine - 108 tests per hour, 36 samples per hour
Power 12VDC, 0.6A
Module size 100mm H x 102mm W x 91mm D
Reagents Calibrator A
Calibrator B
Cleaning Solution
Urine Diluent
Max. Temperature 38ºC
ABC Page 374

9.4 ISE OVERVIEW

9. 4. 1 ISE MODULE
The ISE electrodes are installed by following the instructions described below.
• Remove ISE access panel from right side of analyser. (See 2. 2. 10“ELECTRO-
LYTE MEASUREMENT UNIT (ISE OPTION)” on page 48 for location of ISE unit).
• The ISE unit can be accessed by removing the relevant panel. The ISE elec-
trodes are inserted in the following order:
FRONT VIEW OF ISE UNIT WITH MODULES FITTED IN SEQUENCE SHOWN.
1. The reference electrode is larger than the others and is inserted first, in the posi-
tion shown above. Remove ISE Reference module from its protective packaging.
2. Remove the thin plastic insert inside the ISE module.
3. Place the Reference electrode inside the ISE unit by pressing down the compres-
sion plate.
4. Push the electrode into the required position, as shown above, and release the
compression plate. Ensure it cannot move once the lever is released.
5. Analyte electrodes for Na, K and Cl are the same size and shape. Connection pins
at the rear of each electrode are different, ensuring that the electrodes are
inserted in the correct order and orientation as shown above.
6. Remove the Chloride electrode from its protective packaging and place it in the
unit in the same way as the Reference electrode.
7. Repeat the process for the Potassium electrode followed by the Sodium electrode.
ABC Page 375

8. Once all four electrodes have been inserted push all three electrodes in simulta-
neously to ensure correct alignment. Close the ISE unit and replace the ISE unit
access cover.
9. Once installed, the electrode should be primed and calibrated. (Refer to section
10.3.3 for details.)
IMPORTANT NOTE
When ISE electrodes are installed, the analyser should be closed down in SLEEP
MODE only and should never be switched off at the mains power supply. The
analyser pumps CAL A solution through the ISE electrodes at intervals to hydrate
them and prevent them from drying out. If the electrodes dry out, the recommended
expiry date is invalid. Also ensure that sufficient CAL A is onboard to hydrate the ISE
electrodes.
9. 4. 2 DESCRIPTION OF ISE REAGENTS

Four reagents are required for ISE operation.
1. Calibrator A
Used as a wash solution, during calibration and to prime the ISE electrodes. Cal A
is located in a dedicated compartment with an access door on the top section of
the analyser (see overleaf). Please note that when the analyser is switched on
from power off, Cal A is pumped through the ISE unit for approximately 1 minute
to ensure it is fully primed. Every 30 minutes while the analyser is switched on
120µl Cal A is pumped through the electrodes to prevent them drying out.
ABC Page 376

LOCATION OF CALIBRATOR A BOTTLE
CAL A
2. Calibrator B
Used for ISE calibration (2 point calibration). During calibration Cal B is aspirated
from a user defined position on the sample tray. Calibration should be performed
at least once a day or every 8 hours, depending upon the laboratory schedule. Cal
B should be placed on the analyser just before use to prevent a change in value
due to evaporation.
3. Cleaning Solution
Used to clean the ISE electrodes. Cleaning should be performed once at the end
of the day to prevent protein build up or at 8-hour intervals if the ISE module per-
forms more than 50 samples per day. During cleaning 600 µ l cleaning solution
should be placed in a user defined position in the sample carousel. After cleaning
the analyser should remain on Standby for 30 minutes to stabilise the membrane.
4. Urine Diluent
ABC Page 377

Urine samples are automatically diluted by a factor of 11 with urine diluent prior to
measurement. Urine diluent is located in a reagent position in the RCU tray and
should be registered as a reagent in the [System (F9)] [Reagent] screen. A vol-
ume of 315µl is dispensed into a cuvette in the IRU where the dilution takes place.
The diluted sample is then dispensed into the ISE module.
9. 4. 3 STORAGE AND USAGE OF ISE REAGENTS

All ISE reagents should be stored in a cool dark environment. Cal B and ISE Cleaning
Solution should be dispensed from their containers just before use and once used
should not be kept since evaporation will alter the concentration of the solutions.
Reagents past the expiry date must never be used.
When using a new bottle of any reagent be careful never to mix it with the old
solution. Cal A bottle should be gently agitated before use to ensure it is
homogeneous.
9. 4. 4 ISE UNIT POWER OFF

Since Cal A is pumped through the electrodes every 30 minutes it isn’t recommended
to switch the analyser power off for any extended periods. At the end of the day the
analyser should be placed into sleep mode as described in section 3.2.11 so that Cal
A is pumped through the electrodes every 30 minutes. If the electrodes are kept for
over 2 hours without regular Cal A flow then it is possible for Na+ ions to pass from
the reference electrode into the Na electrode and affect sodium measurement.
If the ISE unit is switched off for more than 2 hours then the procedure below should
be followed to ensure correct storage of the electrode.
9. 4. 5 ISE MODULE STORAGE

If the ISE module is switched off for over 2 hours for any reason perform the following
steps to prevent the electrodes from drying out.
1. Unscrew Cal A bottle cap

2. Prime ISE 10 times from [Mainte][Sequence] screen
ABC Page 378

3. Remove all electrodes from ISE unit (see Section 10.3.10). Place Na, Cl and Ref
electrodes into individual sealed bags. Inject Cal A into the lumen of the K elec-
trode and seal both sides of electrode with cellophane to ensure Cal A is retained.
Place K electrode into a sealed bag.
4. Remove Calibrator A bottle from the analyser and discard if storage period is
greater than the on board stability.
9. 4. 6 LOADING CALIBRATOR A
Calibrator A is loaded on the analyser using the following instructions.
• Remove Calibrator A access panel from top right of the analyser by loosening the
plastic clips.
• Remove tube and attached lid from existing Cal A bottle if present, ensuring any
remaining liquid on the lid is removed and insert the new bottle of Calibrator A into
the CAL A section of the ISE unit.
• Place the feed tube from the pump into the Calibrator A bottle. Screw on the bottle
cap attached to the feed tube, and ensure that the feed tube is touching the bot-
tom of the container.
• Reset working hour counter for Calibrant A in the [Mainte][Work Hour] screen
• Perform ISE prime in the [Mainte][Sequence] screen 10 times to ensure that the
new Cal A has been thoroughly primed through the unit.
DO NOT MIX OLD CALIBRANT A SOLUTION WITH NEW SOLUTION. AFTER

CHANGING CALIBRANT A SOLUTION PRIME THE ISE 10 TIMES. WIPE ANY
MOISTURE ON THE CALIBRANT A BOTTLE CAP WITH CLEAN GAUZE.
9. 4. 7 ISE OPERATING CYCLES

The electrolyte measurement system performs 8 cycles.
Serum sample cycle

Calibrator A is pumped out of the electrodes, and sample is pumped in from the
sample port. The module acquires a sample reading, pumps Calibrator A to flush the
electrodes, and then acquires a Cal A reading.
ABC Page 379

Urine sample cycle

Calibrator A is pumped out of the electrodes, and a diluted urine sample is pumped in
from the sample port. Module acquires sample reading, pumps Calibrator A to flush
the electrodes, acquires a Cal A reading. The software then calculates the patient
result accounting for the 1+10 dilution.
Calibration cycle
Calibrator A is pumped from the electrodes. Module pumps Calibrator B from sample
port to the ion selective electrodes, acquires Calibrator B reading, pumps Calibrator A
to flush the ion selective electrodes, and then acquires a Calibrator A reading. The
software calculates the slope (S) from the two readings.
Prime cycle
Purges air from the electrodes by pumping Calibrator A from the container until
Calibrator A fills the lumens of all electrodes. Several cycles may be required to fully
purge air from the fluid lines.
Electrode exchange
Purges all fluid from the ISE module to allow removal of electrodes without fluid spills.
The cycle disables the automatic sipping (Stand-by cycle).
ISE Cleaning cycle

Pumps cleaning solution from the sample port into the ISE electrode, until cleaning is
complete. Pumps Calibrator A to flush ion selective electrodes, and then acquires a
Cal A reading.
Stand-by cycle
Pumps 120µl of Calibrator A into the lumen of the ISE electrodes every 30 minutes to
keep electrodes moist. If the power supply is switched off the analyser will be unable
to perform this cycle and the electrodes may dry out. If electrodes dry out it will affect
the recommended expiry of the electrodes.
ABC Page 380

9. 4. 8 ISE PARAMETERS SCREEN

Various functions relating to the ISE unit can be viewed and altered from the
[Parameters(F6)][ISE] screen.
ISE PARAMETERS
Reagent Code for Urine Diluent

Enter the urine diluent code as outlined below.
1. Firstly, ensure a urine diluent has been registered as a reagent code as described
in Section 3. 2. 2. 2“Registration of open channel barcoded bottles” on page 78,
and is present on board the analyser as a reagent visible in the [Run (F5)][Inven-
tory] screen.
2. Go to [Parameters (F6)][ISE] screen shown above.
3. Select ISE(D) from the ‘ISE Type’ drop down menu.
4. Click on the field entitled ‘Urine Diluent Reagent Name’. Select the ISE diluent,
code [ISEDIL] from the drop down menu. Click SAVE to store the settings.
ABC Page 381

Normal Ranges
Normal ranges for different age ranges and defined ranges can be set up here. Press
Save to store the settings.
Instrument Factor for ISE

The operator can input linear correction factors for ISE and ISE diluent to adjust for
small variations between different analyser systems.
9. 4. 9 SAMPLE PROCESSING
• Sample is dispensed into ISE module sample port by the analyser.
• Sample is pumped into the electrodes by the waste pump.
• Sample equilibration and reading occurs over a 7 second period.
• Sample is pumped out.
• Calibrator A pumped into the electrode module to flush the channel.
• Calibrator A equilibration and reading occurs over a 7 second period.
• Results transmitted to the host analyser.
• ISE module ready for next cycle.
When the analyser is in STANDBY MODE Cal A is pumped into the electrodes every
30 mins to prevent them from drying out.
Each sample requires approximately 200µl of Calibrator A solution for flushing the
electrodes and obtaining a Cal A measurement. A volume of 120µl is used for each
flush.
9. 4. 10 ISE CALIBRATION
ISE calibration must be carried out before ISE measurement is performed in the
following cases:-
• ISE unit has been switched off
• Eight hours have passed since the last ISE calibration
• Environmental temperature has changed by more than 8ºC since last ISE calibra-
tion.
ABC Page 382

It is suggested that normal practice is to carry out ISE calibration at the beginning of
the day before any measurement. If more than 50 samples are run per day, cleaning
and calibration must be performed every 8 hours. A volume of 120µl Calibrator B is
used during a ISE calibration.
During ISE calibration, electrode calibration slopes are transmitted by the module for
QC purposes and may be used by the operator to diagnose module performance.
The slope is defined as:
where CA = Calibration A concentration in mmol/L

CB = Calibration B concentration in mmol/L
EA = ISE potential developed by Cal A solution in mV
EB = ISE potential developed by Cal B solution in mV
The module’s electronic processor checks the slope and an error code will be
generated if they are outside the required range. Typical slopes are approximately
55mV/decade for Na+ and K+ and approximately 45mV/decade for Cl-. Acceptable
slope limits are:
Analyte Slope (mV/decade) Range (mmol/l)
Na+ 50 – 66 Serum 20 – 200 Urine 20 - 1000
K+ 50 – 63 Serum 0.2 – 20.0 Urine 1 - 50
Cl- 40 - 59 Serum 25 – 200 Urine 20 - 500
Procedure
ISE calibration is performed from the [Mainte (F10)][Sequence] screen of the analyser
software.
ABC Page 383

1. Condition electrodes as described in 9. 5. 2“ISE Cleaning” on page 392 , if previ-

ous ISE cleaning has been performed.
2. Prime ISE 3 times by clicking ‘Start’ for the ’ISE Prime’ option
3. Place 500µl of Calibrator B in a sample cup user defined sample position.
4. Click ‘Start’ for the ‘ISE Calibration’ option.
5. During calibration an ‘ISE Calibration in progress’ message is displayed
6. Once this message disappears the results of the ISE calibration are automatically
printed (if result printout is enabled) and can be viewed on the [Calibration
(F7)][ISE] screen.
7. Check the calibration falls within the acceptable limits shown on the software (also
see above) and there are no error codes (0000 means no error).
8. Repeat ISE calibration until two consecutive measurements display no errors and
the values fall within 2.0 units.
9. 4. 11 REPLACING CALIBRATOR A REAGENT

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

1. Remove the cover from the right side of the analyser.
2. Replace Calibrant-A bottle, place the feed tube in the bottle and screw on the
attached cap.
3. Go to [Mainte (F10)][ Work Hour] in the software screen.
4. Click on the RESET button adjacent to Calibrant A.
NB Confirm new electrodes have ‘O’ ring firmly fitted and any tubing is removed from
the lumen of the electrode. Perform additional ISE primes if an acceptable calibration
cannot be obtained with the new electrodes (see troubleshooting section).
ABC Page 384

9. 4. 12 EXCHANGE OF ISE PUMP CASSETTES

Pump cassettes must be changed at regular intervals to ensure accurate ISE
measurement. To view the excahnge time of the pumps go to [Mainte (F10)][Work
Hour] screen.
1. Detach the bottle cap of Calibrant A and prime the ISE 5 times to purge the liquid.
2. Click on SHUTDOWN button on screen to switch off the analyser.
3. Remove the right side cover of the analyser and pull out the ISE unit.
4. Pull out the two tubes of the pump cassette.
Removing the ISE pump cassette
Do not remove
metal pipe
from tube
Motor shaft
Push this Push this

hook hook
Nip both sides of hooks with fingers to release

the pump cassette. To fit the pump push it
towards the shaft while nipping both hooks
with fingers.
5. Replace the pump cassette. Both pumps must be replaced when performing this
procedure.
ABC Page 385

4
3
1 2
Waste
Pump
Supply
Pump
Tube number 1. Output of supply pump. (connect to sample port of ISE unit).
2. Input of supply pump (connect to Calibrant A bottle)
3. Output of drain pump (connect to external drain tank)
4. INout of drain pump (connect to termination port of ISE unit)
6. Attach the bottle cap for Calibrant A, turn the analyser power on and prime 10
times. During priming check that the fluid flows correctly into each tube and that
there are no leakages.
7. Reset the working hours of the pump cassette in the [Mainte (F10)][Work Hour]
screen.
ABC Page 386

9.5 ISE MAINTENANCE

Correct maintenance procedures should be followed to ensure optimal performance
of ISE electrodes.
• When properly maintained, each ISE can analyse up to 10,000 samples.
• Cleaning solution, aspirated from the sample cup in position #19, is used at least
once a day at the end of each day.
• An ISE calibration should be performed every 8 hours.
• If the ISE is performing more than 50 samples per day, then the cleaning proce-
dure should be performed every 8 hours.
• The entire double junction electrode is disposable. The reference electrode is
filled with sufficient KCl to ensure that no refilling of the solution is required
throughout the lifetime of the electrode.
• Electrodes require a Cal A flush every 30 minutes
• Urine samples are automatically diluted 1+10 before measurement.
• The ISE module is not refrigerated. Therefore, the operator must ensure that the
ambient temperature does not exceed 38ºC.
• Sampling port should be kept free from crystalline depositsat at all timesas these
can adversely affect the results.
9. 5. 1 MAINTENANCE SCHEDULE
The ISE module requires minimal operator maintenance and the only daily
maintenance is the cleaning procedure at the end of each day. Recommendations for
replacement of expendable items are listed below.
ABC Page 387

RECOMMENDED MAINTENANCE/REPLACEMENT INTERVALS
Pump cassette 9 months

Na Electrode 6 months
K electrode 6 months
Cl electrode 6 months
Ref. electrode 6 months
Reagent Refill as necessary
HIGH VOLUME USER

Pump cassette 6 months
Na Electrode 10,000 samples
K electrode 10,000 samples
Cl electrode 10,000 samples
Ref. electrode 10,000 samples
Reagent Refill as necessary
9. 5. 2 ISE CLEANING
ISE unit requires cleaning at least once a day or every 8 hours if the number of
samples measured is greater than 50 to prevent protein build up. It is recommended
that the cleaning procedure be performed at the end of the day to avoid down time
since the electrodes must be left to stabilise for 30 minutes after the cleaning
procedure. During this 30 min period it is recommended that the electrodes are
‘conditioned’ by performing ISE measurements on any control serum. The values of
this measurement are not significant. The purpose of the conditioning is to establish a
fine layer of protein over the ISE electrode membranes. Start ISE cleaning as
follows:-
1. Go to the [Run (F5)][Std QC] screen
2. Define a position for ISE Cleaning solution (I1 - I20).
3. Place 600 µ l of ISE Cleaning solution in a sample cup at the defined sample tray
position.
4. Go to [Mainte (F10)][Sequence] screen.
5. Click on “ISE Cleaning“ to initiate the process.
ABC Page 388

6. The following pop-up is displayed while cleaning is in process
7. When this pop-up disappears ISE cleaning has been completed

8. ISE unit should be primed 5 times by clicking ‘Start’ for the ‘ISE Prime’ option if fur-
ther measurement is required after cleaning or system should be placed into
‘Sleep’ mode.
9. Further measurement should not be performed for 30 minutes after ISE cleaning
to allow the electrodes to stabilise.
10. Perform ISE conditioning if further measurements are required or place the analy-
ser into sleep mode if appropriate.
ABC Page 389

ISE Conditioning
1. Load sample positions 1 - 5 with any control serum – the results are not significant
so any control serum may be used.
2. Go to [Run (F5)][Selection] screen.
3. Select an ISE measurement to be performed as a normal (N) sample on each of
the samples in positions 1 - 5. See Sections 3.2.4 & 3.2.6 for full instructions on
test selection for barcoded and non-barcoded samples.
4. Press Start (F1).
5. Once analysis has been completed remove samples from the sample tray.
ABC Page 390

9.6 ERROR MESSAGES & ALARM CODES

This section provides a summary of the alarm codes that may appear on screen.
When an error or alarm occurs during operation, a reference can be made to the table
below. Contact the customer service department if necessary.
ISE UNIT ERROR CODES
Error Cause Action

1775 There is an anomaly in
response to Serum Sample Cannot electrically communicate with
inquiry. the ISE.
177 There is an anomaly in Contact our customer service section for
response to Serum Sample technical support.
inquiry
1777 ISE result measurement data Refer to the "error flag" added to the ISE
is not available. measurement results.
1780 No acknowledge from ISE
module for "Electrode Check the possibility of disconnection or
Exchange" command. faulty contact of the communication
1781 No acknowledge from ISE cable.
module for "Prime" com- If you still have an error, contact our cus-
mand. tomer service section for technical sup-
1782 No acknowledge from ISE port.
module for "Cleaning" com-

mand.
1790 Failed to detect cleaning solu- Failed to detect the liquid level of the
tion for S.P.T (S) SPT special cleaning solution.
Set the specified cleaning solution in
place.
ABC Page 391

1791 Failed to detect cleaning solu- Failed to detect the liquid level of the
tion for R.P.T (S) RPT special cleaning solution.
place.
1792 Failed to detect ISE cleaning Failed to detect the liquid level of the ISE
solution cleaning solution.
place.
1793 Failed to detect Calibrant-B Failed to detect ISE Calibrant-B liquid
for ISE level.
Set the ISE Calibrant-B in place.
1875 Failed to detect cleaning solu- Failed to detect cleaning solution for the
tion for S.P.T (S) SPT nozzle.
Set the cleaning solution in place.
tion for R.P.T1 (S) RPT nozzle.
tion for R.P.T2 (S) RPT nozzle.
1878 Failed to detect cleaning solu- Failed to detect cleaning solution for
tion for Cuvette Water Place- Cuvette Water Placement (detergent).
ment. Set the cleaning solution in place.
ABC Page 392

ISE MODULE ERROR CODES
Measurem
Cause Byte1 Byte2 Byte3 Byte4 Byte4
ent Item
Noise or Noise or Drift in Out of

Air for- Air for Calibrant- Rangefor-
Sample or Calibrant- A Sample or
Calibrant- A Calibrant-
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
orOut of Range Cl 4 4 4 4
Na, Cl 5 5 5 5
K, CL 6 6 6 6
Na, K, Cl 7 7 7 7
Air S or A(Note-1) -- --
B(Note-1)
No error 0 0 0 0 K(Note-2)
Na 1 1 1 1 L
K 2 2 2 2 M
Noise,Drift Na, K 3 3 3 3 N
orOut of
Range(Urine) Cl 4 4 4 4 O
Na, Cl 5 5 5 5 P
K, CL 6 6 6 6 Q
Na, K, Cl 7 7 7 7 R
SPT liquid 9 9 9 7
detection error
SPT 9 9 9 8
malfunction
Communication 9 9 9 9
error
Note-1: “S” = Sample

“A” = Calibrator A
“B” = Calibrator B
Note-2: When there is only a Na urine error and no out of range error, the error
code is “K”.
ABC Page 393

9.7 TROUBLESHOOTING
When troubleshooting the Rx DAYTONA ISE unit, the following initial checks should
be carried out:
• Correct electrode installation procedure has been followed
• ISE unit is receiving power from host analyser (check red LED is ON)
• Equipment is used according to the recommendations by trained personnel.
• System maintenance has been performed.
Please contact RANDOX Technical Support department if electrical or mechanical

system faults are identified. For safety reasons the user should NOT carry out internal
inspections of the analyser.
9. 7. 1 ANALYTICAL PROBLEMS
When contacting our Technical Support department for analytical troubleshooting
problems please have the following information available:
a. Analyser serial number

b. ISE unit serial number
c. Explanation of the problem
d. Serial number and lot number Reference, Na+, K+ and Cl- electrodes.
d. Serial number and lot number of Calibrator A and B, wash solution, diluent and
quality controls used.
e. Recent results of calibrations
f. Recent results of quality control samples
g. Measurement results.
For further investigation, refer to the following list after the above checks have been
completed.
ABC Page 394

Error Cause Action

Out of Stability of Calibrator Agitate calibrator A bottle prior to use to assure a homogeneous
range A solution. The onboard stability of Calibrant-A is one month.
Stability and storage Calibrator B must be kept in a dark and cool place at room tem-
of Calibrator B perature.
If the Calibrator B is expired, it should be replaced with a new bot-
tle. Calibrator B should be pipetted into a sample cup on the anal-
yser just before performing the calibration to avoid evaporation
Validity of Electrode Check that the electrodes are within expiry date and total mea-
surement count is less than 10,000 samples.
If they are expired, the electrodes must be replaced.
Fitting of Electrode Check that the Electrodes are properly installed into the ISE mod-
ule
without any fluid leaking from tubing connectors and between
electrodes.
Environment temper- Check that the environmental temperature is within 15 to 30

ature degrees centigrade.
Cleaning After ISE cleaning, it requires about 30 minutes for electrodes to

stabilise before further measurement.
Noise Validity of Electrode Check that electrodes are not expired and total measurement
count is less than 10,000 samples.
Fitting of Electrode Check that the electrodes are properly installed into the ISE mod-
ule without any fluid leaking from tubing connectors and between
electrodes. Also check for crystallization in the path.
Surrounding equip- Check that the electrical noise spike from environmental sources
ment (such as refrigerator or centrifuge) is not affecting the ISE unit.
Check for ground condition.
The power source should be separated from other equipment.
Drift Just after electrode Prime ISE several times.

exchange Leave the analyser for 15 minutes or more without any operation
to allow the electrodes to stabilise.
Caused by cleaning After ISE cleaning, it requires about 30 minutes for electrodes to
stabilise before any further measurement.
ABC Page 395

Validity of Electrode Check that electrodes are not expired and total measurement
count is less than 10,000 samples.
Fitting of Electrode Check that the electrodes are properly installed into the ISE mod-
ule without any fluid leaking from tubing connectors and between
Exchanging Calibra- Prime ISE to purge remaining air in the fluid path.
tor A bottle
Glutinous Sample Check for viscosity of sample.

When the viscosity of sample is abnormally high for example in a
hyperproteinemia sample, a “Drift error” may occur.
Caused by Fibrin When the sample tube is not anti-coagulator (heparin) type, the
measurement should be performed after leaving the sample for
30 minutes to settle the fibrin down. Measurement can be inter-
fered when fibrin is pipetted into ISE unit.
Tubing Check for bent, twisted and loose connection of ISE unit tubing.
Air Caused by air in the Prime the analyser and try ISE measurement again.
SPT. When air exists in the sampling line, it can be introduced to the
ISE unit resulting in measurement error.
Shortage of Calibrator Exchange Calibrator A bottle.

A or the tip of supply Check tubing condition.
tube is placed above Prime ISE more than 10 times and try measurement again.
the liquid level.
Shortage of Calibrator Pour 500 µ l of Calibrator B in a fresh sample cup and run calibra-
B tion again.
Air bubbles in Cali- Pour 500 µ l of Calibrator B in a fresh sample cup and run calibra-
brator B. tion again.
Shortage of sample Add sample to a sample cup and try again the measurement.
Air bubbles in a sam- Remove air from the sample.

ple
Abnormal movement Check for the working hour counter on the job menu [Mainte-
of pump. (Supply or nance].
Waste pump.) When the working hour pump cassette exceeds the use period
(180 days), replace the supply and drain pumps.
Tubing Check for bent, twisted and loose connection of ISE unit tubing.
ABC Page 396

Poor connection of Check that the Electrodes are properly installed into the ISE mod-
Electrode ule without any fluid leaking from tubing connectors and between
Check for displaced compression plate spring.
Electrode “O”-ring Check for proper fitting of “O”-ring between electrodes.

When “O”-ring has some detect or is deformed, exchange with
new “O”-ring.
9999 Occurring ISE com- Check for misalignment of Electrodes, movement of supply or
or munication error waste pump and tubing connection.
others between analyser and Check for a dirty of sample port at the top of ISE unit.
ISE module. Prime ISE and prime analyser.
When above does not solve the situation, call for service.
9. 7. 2 EQUIPMENT PROBLEMS
When contacting our Technical Support department for equipment troubleshooting
problems please have the following information available:
a. Serial number (see plate on rear of analyser)

b. Software version number in use (See [System (F9)][Login] screen.
c. Explanation of the problem and details of relevant alarm codes
d. Any other information about equipment or maintenance.
ABC Page 397

ABC Page 398


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SECTION 1 Version 1.

0 Rev Sep 2005

2005 by Randox Laboratories Ltd,. 55 Diamond Road, Crumlin,

All rights reserved. No part of this publication may be reproduced, stored

1.1 WARNING SYMBOLS

1.2 WARNING LABELS

RISK OF Power supply inlet.

DO NOT Covers of SPT,

RISK OF Lid for replacing

THIS TANK Waste tanks

Class 1 Laser Barcode reader of

Action to be IRU head insula-

1.3 WARNINGS FOR SAFE USE

During operation, do not touch samples, reagents, nozzles and

Ensure that gloves are worn when handling patient samples to

Keep skin and mucous membranes from contact with reagents

Follow the instructions supplied by the manufacturer with

Gloves should be worn when handling waste solutions and

Conductive parts within the analyser may cause serious electric

Reagent bottles should never be placed on the analyser as

Do not make any modifications to the analyser. Unauthorised

1.4 SAFETY PRECAUTIONS

Prevention of system damage

Prevention of electric shocks

Prevention of personal injury

System accuracy and precision

Handling of reagents, standard substances, and accuracy control substances

Operational environment of the analyzer

• Do not use medical equipment that may be affected by electromagnetic waves

Points to check when analyzing

Emergency Shutdown Procedure

ANALYSIS DATA WILL BE LOST when an emergency stop is initiated. The

1.5 INSTALLATION REQUIREMENTS

The recommended installation instructions detailed in the RX Imola Installation Guide

Recommended installation environment

<space for exhaust ventilation> 150 and up

300 PC 300 300

Water supply and drainage

ISE high-concentrated Silicon tube ISE - High-concentrated

WU high-concentrated Main analyzer - High-concentrated

WU low-concentrated Pressure-resistant hose

• Ensure that electric cables are correctly connected.

1.6 TECHNICAL SPECIFICATIONS

9. 2. Optional Accessories Personal Computer

Turntable Removable type

(Normal/Emergency samples - 36 tubes on

10. 5. RCU (Reagent Container Turntable Removable type

Humidity 45 ~ 85% (without

Altitude Less than 2,000m

Pressure 800 to 1060hPa

Definition of Installation Category in

Pollution degree in IEC61010-1

for system start up.

13. Measurements Dimensions (Main unit)

Type Size Rating Characteristics Location and Part no.

1.7 SYSTEM CONFIGURATION AND EQUIPMENT LIST

No. Use Note

5 Connecter for external tank rack cable Option

6 Input line for wash solution 2 (P.V.C tube) standard

7 Input line for wash solution 1 (P.V.C tube) standard

8 Input line for pure water (Pressure-resistant hose) preparation

9 Output line for overflowing (Pressure-resistant hose) preparation

10 Hose clamp standard