WARRANTY

The term of warranty of this analyzer is one year from the date of purchase.
Our company shall not be responsible for the following failures and damages for the
warranty period.
1. Failure/damage caused by the result of misuse.
2. Failure/damage caused by repair or alternation performed by any company other
than our company.
3. Failure/damage caused by the phenomenon which is due to other than our
product.
4. Failure/damage caused by the condition beyond the normal operating condition of
this analyzer such as the power supply and the installation environment.
5. Failure/damage caused by fire, earthquake, flood damage or other natural
disaster.
6. Failure/damage caused by shift or transportation performed by other than our
company after our installation.

TRADEMARKS
Windows 10 and .NET FrameWork3.5 are registered trademarks of Microsoft
Corporation.

COPYRIGHT
Copyright of this document belongs to FURUNO ELECTRIC CO., LTD.
No part of this document shall be reproduced, transmitted, transcribed, stored in any
retrieval system, or translated into any language by any means, electronic or
mechanical, including photocopying and recording, for any purpose other than the
purchase’s personal use without the express written permission of FURUNO
ELECTRIC CO., LTD.

COPYRIGHT OF INDY SOFTWARE

Portions of this software are Copyright © 1993-2003, Chad Z. Hower (Kudzu) and the
Indy Pit Crew – http://www.IndyProject.org/
 REVISION RECORD
The latest edition supersedes any preceding ones. If you have old editions, discard
them to avoid possible confusion.
REV. DATE REVISION HIGHLIGHT

0A Apr., 2010 Published as first version.

0B Dec., 2010 ⚫ Collections for wordings and figures

⚫ Added an explanation of “Spline 2” (chapter 2)
⚫ Added an explanation for the procedure of starting measurement (chapter 7).
⚫ Added an explanation for “Add” button in “Calibration Registration” screen
(chapter 15).
⚫ Added system function explanations (chapter 17).
⚫ Added an explanation for Login users (chapter 17).
0C Jul., 2012 ⚫ Revised an explanation about Sleep Mode. (Chapter 4)
⚫ Added an explanation for the procedure of registering the test order. (Chapter
6)
⚫ Added an explanation for the procedure of starting measurement (Chapter 7)
⚫ Added an explanation for the “Continuous Measurement Mode” (Chapter 7)
⚫ Revised the explanation about barcode specifications. (Chapter 12)
⚫ Added “19.8 Troubleshooting for ISE module (option)”. (Chapter 19)
0D Aug., 2014 ⚫ Added precautions to “1. Safety precautions” and “2. Precautions for Use”.
(Foreword)
⚫ Revised “3. Warning and caution labels”. (Foreword)
⚫ Revised “12.2.3 Barcode label specifications for sample and reagent ”.
⚫ Added periodical check items (Chapter 18)
⚫ Added a precaution to “18.1.1 Sample/reagent pipette” (Chapter 18)
⚫ Added “18.1.6 Water blank check” and “18.1.11 Halogen lamp”. (Chapter 18)
⚫ Revised “18.2.1 Halogen lamp” and “18.2.3 Cuvettes”.
0E Sep., 2016 ⚫ Revised “Back cover”.

0F Oct., 2018 ⚫ Revised software operating environment (Foreword)

⚫ Added “Product life” and “Holding period of maintenance parts” in
specifications (Chapter 20)
REV. DATE REVISION HIGHLIGHT

0G May, 2022 ⚫ Revised “TRADEMARKS”

⚫ Revised “1.1 Prevention of damage and ignition”. (Foreword)
⚫ Revised “1.2 Prevention of electric shock”. (Foreword)
⚫ Revised “1.3 Prevention of injury”. (Foreword)
⚫ Revised “1.7 Prevention of infection”. (Foreword)
⚫ Added "1.10 Precautions for Handling of C-1 Solution". (Foreword)
⚫ Added "1.11 Precautions for Handling of Detergent". (Foreword)
⚫ Revised “X General precautions on ISE unit”. (Foreword)
⚫ Revised “3. Warning and caution labels”. (Foreword)
⚫ Corrected descriptions for "4.2 Power Supply". (Foreword)
⚫ Revised “4.4 Component list”. (Foreword)
⚫ Revised “4.5 Software operating environment”. (Foreword)
⚫ Added " 6. In case of serious incident ". (Foreword)
⚫ Revised “19.2.1 Procedure”. (Chapter 19)
⚫ Revised “9-16 Power Supply Unit”. (Chapter 20)
⚫ Revised “17 The rating and characteristics of fuses”. (Chapter 20)
⚫ Revised “18 Safety regulations”. (Chapter 20)
⚫ Revised “19 EMC regulations”. (Chapter 20)
⚫ Revised address of EMERGO EUROPE. (Back cover)
0H July, 2022 ⚫ Revised “W Software version check”. (Foreword)
⚫ Revised “3. Warning and caution labels”. (Foreword)
⚫ Added " 4.5 Preparation equipment and supplies ". (Foreword)
⚫ Added "2.1 Principles". (Chapter 2)
⚫ Revised “B Consumable parts”. (Chapter 18)
⚫ Revised address of manufacturer. (Back cover)
0I September, ⚫ Added “Intended Use”. (Foreword)

2022

0J January, 2023 ⚫ Change the European Authorized Representative. (Back cover)

0K March, 2024 ⚫ Added "1.12 Cyber security precautions ". (Foreword)

⚫ Revised “4.4 Component list”. (Foreword)
⚫ Revised “4.6 Software operating environment”. (Foreword)
 Table of Contents

Table of Contents

Foreword 1
Precaution for use and installation environment 2
1. Safety precautions 2
2. Precautions for Use 6

General precautions for use of medical electrical equipment

(For safety and prevention of danger) 13
3. Warning and caution labels 16
4. Installation environment 18
5. Statement for EMC requirement 25
6. In case of serious incident 25

CA-270 Operator's Manual <Basic>

Chapter 1 Unit name and its function 27
1.1 General 27
1.2 Unit name 28
1.2.1 Analyzer overview 28
1.2.2 Function for each unit 30

Chapter 2 Basic operation and analysis procedure 34

2.1 Principles 34
2.2 Measurement flow 36
2.2.1 Basic measurement flow 36
2.2.2 Normal sample measurement 38
2.2.3 ISE measurement (option) 41
2.3 Analysis process 44
2.3.1 Sample and reagent dispensing 44
2.3.2 Absorbance measurement 50
2.3.3 Assay Techniques 51
2.3.4 Blank measurement 57
2.3.5 Calibration curve parameters 58

Chapter 3 Basic operation 65

3.1 Key operation 65
3.2 Operation screen 67
3.2.1 Icons 67
3.2.2 Status 75
3.3 Data save 77
Table of Contents

Chapter 4 Preparation and ending procedure for measurement 79

4.1 Checks prior to use (at the beginning of the day) 79
4.1.1 External Tanks 79
4.1.2 Supply/drain Tubes 81
4.1.3 ISE unit (option) 81
4.2 Power ON 82
4.2.1 Power ON the analyzer 82
4.2.2 Power ON the printer 82
4.2.3 Power ON the operational PC 82
4.3 Log in 83
4.4 Checks prior to measurement 84
4.4.1 Checks on the consumable parts 84
4.4.2 Check reagent volume 87
4.5 Checks after measurement (at the end of the day of work) 88
4.5.1 Check the measurement results 88
4.5.2 Checks at the end of the day 88
4.5.3 Cleaning 88
4.6 Sleep function 89
4.6.1 Sleep setting 89
4.6.2 Sleep mode 92
4.6.3 Manual wake-up from sleep mode. 93
4.7 Power OFF 94
4.7.1 Power OFF the operational PC 94
4.7.2 Power OFF the analyzer 94
4.7.3 Power OFF the printer 94

Chapter 5 Check calibration and QC results 95

5.1 Check calibration results 95
5.2 ISE Calibration (option) 96
5.2.1 Perform ISE calibration 96
5.2.2 Result of ISE Calibration 97
5.3 Check QC results 98
5.3.1 QC graph 98
5.3.2 QC Results (details) 101
5.3.3 QC Results (Daily) 105
5.3.4 QC Results (Cumulative) 110

Chapter 6 Test selection 114

6.1 Sample setting 114
6.2 Test selection 115
 Table of Contents

6.2.1 Normal sample (N) 119

6.2.2 Emergency sample addition (STAT) 122
6.2.3 QC sample (Q) 123
6.3 Test selection (other sample categories) 124
6.3.1 Calibrator (C) 124
6.3.2 Multi-Calibrator 125
6.3.3 Diluted calibration 127
6.3.4 Blank sample 128
6.3.5 Mask 129
6.3.6 Orderless 130
6.3.7 Sample pipette wash 131
6.3.8 ISE calibrator (option) 132
6.3.9 ISE cleaning (option) 133
6.3.10 ISE Etching (option) 134
6.3.11 ISE activation (option) 135
6.4 Template 136
6.5 Test selection (online) 137
6.5.1 Online sample selection 137

Chapter 7 Measurement 139

7.1 Start measurement 139
7.1.1 Measurement condition 139
7.1.2 Check for remaining volume of reagents 139
7.1.3 To start measurement 140
7.1.4 Emergency stop 142
7.1.5 Continuous Measurement Mode 143
7.1.6 Orderless measurement 144
7.2 Monitor 145
7.2.1 Monitor 145
7.2.2 Round 149
7.3 Sample addition 151
7.3.1 Emergency sample addition 151
7.3.2 Normal sample addition 152
7.4 Measurement results 153
7.4.1 Screen display 153
7.4.2 Live Print Out 153
7.4.3 Flags 153
7.5 After measurement completion 154
Table of Contents

Chapter 8 Measurement results 155

8.1 Data search 155
8.1.1 Measurement results 155
8.1.2 Time course 162
8.2 Print 164
8.2.1 Normal format 164
8.2.2 Report format 164
8.3 Saves printing setting 165

Chapter 9 Quality Control setting 166

9.1 QC settings 166
9.2 QC Sample Registration 169

Chapter 10 Patient information 171

10.1 Patient information registration 171
10.2 Definition setting 173

Chapter 11 Daily checks 175

11.1 Back up 175
11.2 Daily checks 179
11.3 Daily cleaning 180

Chapter 12 Option 181

12.1 ISE unit 181
12.2 Barcode Reader 181
12.2.1 Reagent barcode reader 181
12.2.2 Sample barcode reader 181
12.2.3 Barcode label specifications for sample and reagent 182
12.2.4 Sample identification code 184
12.3 External tank sensors 186
12.4 Degassing unit 186
12.5 Clot detection sensor unit 186
 Table of Contents

CA-270 Operator's Manual <Advanced>

Chapter 13 Reagent registration 187
13.1 Reagent codes 187
13.2 Reagent bottle registration 189

Chapter 14 Chemistry parameter setting 192

14.1 Setting of chemistry parameters 1 192
14.2 Setting of normal range 199
14.3 Setting of chemistry parameters 2 200
14.4 Setting of Chemistry parameters for ISE (option) 206
14.5 Setting of Serum Indices 209
14.6 Calculated test setting 212
14.7 Profile setting 216
14.8 Template Setting 218
14.9 Measurement order setting 221
14.10 Wash program setting 223

Chapter 15 Calibration registration and settings 225

15.1 Calibration registration 227
15.2 Diluted calibration 230
15.3 Multi-Calibrator 232
15.4 Result of ISE calibration (option) 233

Chapter 16 Printer setting 234

16.1 Printer report format modification 234
16.2 Live Print out setting 236

Chapter 17 System settings 237

17.1 Host communication setting 238
17.2 The sample barcode reader setting 242
17.3 Alarm sound setting 243
17.4 Popup control setting 244
17.5 Sample Type Setting 244
17.6 Reagent bottle size setting 245
17.7 Normal range setting 245
17.8 Auto Template setting 245
17.9 Optional Field setting (for maintenance only) 246
17.10 Other settings 247
17.11 Login/logout setting 250
17.11.1 Accessible screens for each user level 251
Table of Contents

Chapter 18 Maintenance 253

18.1 Periodical checks 255
18.1.1 Sample/reagent pipette 255
18.1.2 Washing unit 257
18.1.3 Stirrer 258
18.1.4 Sample container 259
18.1.5 Reagent container 260
18.1.6 Water blank 261
18.1.7 Work table 262
18.1.8 External Tanks 263
18.1.9 Tube wash 264
18.1.10 Cuvettes 269
18.1.11 Halogen lamp 273
18.1.12 ISE cleaning (option) 274
18.2 Parts replacement 275
18.2.1 Halogen lamp 276
18.2.2 Syringe tip 279
18.2.3 Cuvette 283
18.2.4 Stirrer 292
18.2.5 ISE electrodes (option) 294
18.2.6 ISE pump tube (option) 297
18.2.7 L solution and Ref solution for ISE unit (option) 299
18.2.8 When leaving the analyzer for long period power supply OFF 301
18.3 Daily maintenance 302

Chapter 19 Troubleshooting 306

19.1 Procedures 306
19.1.1 Operation environment 306
19.1.2 Contact our technical support 306
19.2 Power problems 307
19.2.1 Procedure 307
19.3 Result problems 308
19.3.1 When any troubleshooting is required 308
19.3.2 Preparation of reagents, calibrators, and QC samples 309
19.3.3 Frequent error patterns 310
19.4 Malfunction 311
19.4.1 Detection of mechanical problems 311
19.5 Alarm 312
19.5.1 Alarm screen 312
19.5.2 To solve the errors 312
 Table of Contents

19.5.3 File output of alarm information 313

19.6 Flags 314
19.6.1 Flags 314
19.6.2 Range flags 314
19.6.3 Error flag list 314
19.6.4 ISE error flags (option) 317
19.7 ISE error codes (option) 318
19.8 Troubleshooting for ISE module (Option) 318
19.8.1 Troubleshooting for ISE errors/problems 321
19.8.2 Procedure to clear the flow path 327

Chapter 20 Specification 329

20.1 Technical Specification 329
20.2 Analysis Specifications 334
Table of Contents
 Foreword

Foreword
FURUNO Electric Company thanks you for selecting and purchasing the FURUNO
Fully Automated Clinical Chemistry Analyzer.
Prior to use, please read this operator’s manual carefully and follow the recommended
procedures for operation and maintenance.

Intended Use

⚫ This analyzer is designed to measure the human specimen (Serum, Plasma,

Urine and so on) and is used with Windows PC, and the measurement result can
be printed out.
⚫ The operator’s manual is for clinical laboratory technologists, who operate t he
analyzer.
⚫ The contents in the manual are subject to change without notice.
⚫ The contents of this manual are described for the clinical laboratory technologists
who operate this analyzer.
⚫ The contents of this manual may be changed without a previous notic e in the
future.
⚫ The analyzer designed to quantitatively measure samples (blood cells, serum,
plasma, and urine) collected from humans with combination of reagents.
⚫ The product is a clinical chemistry analyzer that categorized as in vitro diagnostic
medical devices.
⚫ The detection target of this product depends on the reagen ts used in
combination.
⚫ The product is not intended to be provided in the context of a physiological or
pathological state.
⚫ The product is not intended to be provided in the context of co ngenital physical or
mental impairments.
⚫ The product is not intended to be provided in the context of the predisposition to a
medical condition or a disease.
⚫ The product is not intended to be provided in the context of the determination of
the safety and compatibility with potential recipients.
⚫ The product is not intended to be provided in the context of the prediction of
treatment response or reactions.
⚫ The product is not intended to be provided in the context of the definition or
monitoring of therapeutic measures.
⚫ This product does not identify the test object.
⚫ This product is not a companion diagnostic agent.
⚫ Do not reuse this product.

1
Foreword

Precaution for use and installation environment

This section describes notes when using the analyzer, the installation environment
required for normal operation, standard accessory, and warning labels.
Prior to use, please read the manual.
Not using procedures which the manufacturer recommends will void the warranty.

1. Safety precautions
1.1 Prevention of damage and ignition
Please observe the following precautions to prevent damage and i gnition of the
analyzer.
⚫ Install the analyzer under the installation environment and conditions
described in the manual.
⚫ When changing the installation site, contact our servicing or sales division.
⚫ Please use an operational PC which is compliant with the l ocal/national
regulations in order to prevent damage by application of overvoltage.

1.2 Prevention of electric shock

Please observe the following precautions to prevent electric shock caused by the use
of the analyzer.
⚫ Do not detach the front, the rear, or the side cover during measurement.
⚫ In case of spill or leakage inside the analyzer, do not treat by yourself and
contact the technical support. Improper handling may lead to electric shock.

1.3 Prevention of injury

Please observe the following precautions to prevent injury while using the analyzer.
⚫ Do not touch moving or opening parts during operation.
⚫ For halogen lamp replacement, turn the power off and wait for the lamp to get
cold for more than 30 minutes. Then perform replacement. Direct contact
with the heated lamp may cause burn injury.
⚫ For safety reasons, follow the instructions on the labels attached to the
analyzer and the operator’s manual.
⚫ For printers, refer to its accompanying operator’s manual.
⚫ If any malfunction or abnormal heat generation occurs due to mechanical
troubles, contact our servicing division.
⚫ When cleaning the pipettes, be careful not to injure yourself with their tips.
⚫ When manually moving a pipette horizontally or v ertically, make sure to hold
the arm close to the shaft and not to the end.
⚫ When using alcohol for cleaning, make sure that there is no fire around since
it is flammable.

2
 Foreword

1.4 Protection of eyes

Follow the precautions to protect eyes.

⚫ Do not look directly at the lighted halogen lamp. It may cause eye injury.

1.5 To ensure the accuracy of measurement data

⚫ Do not detach the front, the rear, or the side cover during measurement.
⚫ Do not open top cover during measurement.
⚫ If the lid of Reagent Container or Sample Container is open during
measurement, the measurement will be aborted.
⚫ Do not open the lid of the ISE unit during measurement.
⚫ Perform QC measurement for system integrity.
⚫ As for maintenance checks and periodical parts replacement, follow the
instructions on this manual.
⚫ For handling reagent, quality control sample, or calibrator, follow the
manufacturer’s or sales representative’s specific instructions.

1.6 Disposal of waste

Special attention is required for disposal of waste and used samples. The analyzer
has each tube for the high-concentrated and the low concentrated wastes to discharge
the waste separately. Follow the precautions below.

⚫ Reagent, quality control sample, calibrator, or wash solution may contain

some substances that are regulated under your local/national guidelines or
effluent standard. Contact the manufacturers or sales representatives for
disposal under your local/national guidelines.

1.7 Prevention of infection

Improper handling of samples may cause infection. Please observe the following
precautions to prevent infection.

⚫ Do not touch directly samples, reagents, or waste that may be infectious.

Note that touching scattered samples may lead to infection. In case of
handling them, make sure to wear protective gloves, masks and goggles f or
preventing infection. If you touch them accidentally, follow your operating
procedure and consult a physician as required. If any infectious liquids
recognized on the analyzer, wipe them off immediately.

3
Foreword

1.8 Handling of reagents

Please observe the following precautions to prevent injury.

⚫ Some reagents are strong acid or strong alkali. Be careful not to touch
them directly with hands or spill over your clothes. If they mistakenly spill
over your skin or clothes, immediately wash thoroughly with water and soap.
If they contact eyes, flush thoroughly with plenty of water and consult a
physician.

1.9 Prevention of affect on other facility/equipment

⚫ Install appropriate power supply wiring not to affect other m ajor instruments
(such as surgical instruments) or the facilities from the system failure.

1.10 Precautions for Handling of C-1 Solution

Please follow the precautions below for the handling of C-1 solution used for cleaning
of the analyzer.
⚫ For the validity date, refer to the label on the bottle.
⚫ The validity date is 6 months after opening.
⚫ Follow the instructions on the label to prepare diluted C-1 solution.
⚫ Use purified water for the diluent. Use of tap water as diluent may generate
brown deposits (corroded iron) or white deposit (calcium chloride) after
several days.
⚫ When the bottle is expired, the sodium hypochlorite contained in the solution
may be decomposed and the amount of effective chlorine may be reduced. In
case of expiry, dispose of such bottles.
⚫ Do not mix the solution with acidic material or stron g alkaline material.
⚫ Keep the solution away from zinc plating or metals such as iron, ferric oxide,
copper or copper alloy, or it may corrode them.
⚫ When pouring the solution to another container, wash the container with
purified water and dry it completely before use.

4
 Foreword

1.11 Precautions for Handling of Detergent

Please follow the precautions below for the handling of Wash solution No.3 (acidic
detergent), Wash solution No.9 (alkaline detergent) and Wash solution No.10-2
(neutral detergent) for cleaning of the analyzer.
⚫ For the validity date, refer to the label on the bottle.
⚫ Dispose of the bottle when it is expired.
⚫ Make sure to wear protective gloves, masks and goggles when handling the
solution.
⚫ If the solution contact your skin, eyes or mouth, immediately prov ide first aid
such as flushing with water and seek medical attention if necessary.
⚫ Do not mix the solution with acidic material, alkaline material or sodium
hypochlorite mixture.
⚫ When pouring the solution to another container, wash the container with
purified water and dry it completely before use.

1.12 Cyber security precautions

Please ensure the cybersecurity of medical devices in accordance with the laws and
regulations applicable in your region.
⚫ It can be connected to an external network or the Internet via a operational PC
with software installed, and Cyber risks are also assumed with recording
media used for data exchange (USB flash drive, etc.) and USB used to
connect with operational PCs.
⚫ Customers are required to implement risk management against cyber risks
and take necessary security measures.
⚫ System diagram

⚫ Regarding recording media (USB flash drive, etc.), please use only devices
that have been confirmed to be safe and free from malware infections.
⚫ Please set a login password for the analyzer and manage passwords
5
Foreword

appropriately.
⚫ It is necessary to implement anti-malware measures on the operational PC
connected to the analyzer. In addition, when connecting to a network, it is
necessary to make sufficient firewall settings on computers, server devices,
etc. used to connect to the Internet or external networks. If no precautions are
taken, do not connect to the network.
⚫ Please make regular backups.
⚫ Information regarding end of support for medical devices. The EOL of analyzer
is 7 years from the date we notify you that it will be discontinued. EOS is one
year after EOL. If EOS arrives before the end of Windows OS extended
support, we will release software compatible with the next version of Windows
at least 6 months before the end of extended support, so please migrate to the
latest Windows OS environment.
⚫ Information about obtaining the latest software. Please contact the store of
purchase.
⚫ Customer Security Documentation are available on our website.
https://www.furuno.com/en/medical/cyber-security/
⚫ SBOM (Software Bill of Materials) and MDS2 (Medical Device Security
Disclosure Statement by Manufacturer/Seller), Please contact us.
⚫ Contact information regarding cyber security.
FURUNO ELECTRIC CO., LTD.
2-20 Nishinomiyahama, Nishinomiya, Hyogo 662-0934, Japan
https://www.furuno.co.jp/en/csr/sociality/customer/product_security.htm/

6
 Foreword

2. Precautions for Use

Follow the precautions for safe and efficient operation.

2.1 General precautions for use of the analyzer

A. Use of samples

⚫ The analyzer is designed to measure human specimen (such as serum,

plasma, and urine). Some samples may not be measurable depending on
the methods or reagents. In such cases, contact the manufacturer or sales
representatives.

⚫ Apply samples that contain no suspended particles. As for serum samples,

apply those with no blood clots. Use of serum samples with blood clots or
urine samples with suspended particles may cause the analyzer’s pipette to
get clogged, and adversely affect the analysis processing.

⚫ Note that there are some cases where a significant clinical affect is achieved
depending on chemical substances which coexist with samples (such as
medication, anticoagulant, and preservative).

⚫ If sample pretreatment particularly for the analysis method is required,

consult the relevant reagent manufacturers and sales representatives.
Regarding the advisability of serum separation agents, refer to their
manufacturers.

B. Storage of samples

⚫ Store samples in an appropriate manner. Samples stored under an

inappropriate environment may deteriorate in quality. (For example, blood
kept in cold storage recognizes increased potassium level.)

⚫ To prevent samples from evaporating, do not leave the sample containers

unsealed for a long time. Evaporated sample may affect accuracy of
analysis processing.

7
Foreword

C. Pretreatment and handling of samples

⚫ Fibrins contained in serum may clog the pipettes. When separating serum,
make sure that blood is clotted enough. Samples used for measurement
shall be free of fibrin.

⚫ To apply urine as a sample, if there is suspension of particles in the urine

sample, centrifugalize the urine sample so that the suspended particles get
precipitated.

⚫ If sample pretreatment particularly for the measurement methods is required,

consult the relevant reagent manufacturers and sale s representatives.
Regarding the advisability of serum separation agents, refer to their
manufacturers.

D. Handling of reagents, calibrators, and control samples

⚫ For storing, handling, and use of reagents, calibrators, and quality control
samples, follow the instructions of the relevant manufacturers and sales
representatives.

⚫ Reagents, calibrators, and quality control samples stored under

inappropriate condition, even though they are within the specified expiry
date, may affect accuracy of measurement results. For storage, follow the
instructions specified on their packaging, container or attached documents.

⚫ For stability after opening the package, refer to the relevant manufacturers
and sales representatives.

⚫ Be sure to perform calibration after each reagent replacement. To obtain

correct measurement results, appropriate calibration is required.

E. Water quality standard

⚫ Water purified intended for clinical laboratory use is required to meet the
NCCLS C3-A3 Type II Guideline. It is also recommenced to meet the
NCCLS C3-A3 Type I and the CLSI C3-A4 Guidelines.

F. Reagent interference of assay method-to-method

⚫ Reagent contaminated from other reagents may adversely affect the

measurement results in the analysis process. Refer to the relevant
manufacturers and sales representatives for details because the influence is
different by each reagent.

8
 Foreword

G. Analysis performance

⚫ Under hemolysis, turbidity or increased bilirubin level condition in samples,

the medical agent or its metabolic products may adversely affect
measurement results. Refer to the relevant manufacturers and sales
representatives for details.

⚫ Be careful not to enter erroneous patient information to prevent possible

measurement errors.

H. Connection of supply/drain tubes

⚫ Make sure that there is no bending or loops for tube connection between
connector and tank. Inappropriate connection may cause troubles including
tube disconnection during operation, leakage, etc.

⚫ Make sure to prevent air bubbles from entering purified water into the
analyzer.

I. Using of the genuine cuvettes made by FURUNO

⚫ Apply the specific cuvettes that are approved by FURUNO.

J. Electromagnetic waves, noise, etc.

⚫ Do not install the analyzer near the equipment that generates an abnormal
noise.

⚫ Turn off a portable radio or cellular phone near the analyzer. Abnormal
noise or electromagnetic waves generated from the portable radio or cellular
phone may cause malfunction of the analyzer.

⚫ Do not install the analyzer near the medical equipment that may generate
electromagnetic waves.

K. Operational environment of the analyzer

⚫ Operate the analyzer with temperature: 15 to 30°C, humidity: 45 to 85% and

temperature variation: less than ±2°C per hour.

⚫ Use purified water with temperature 5 to 25°C. Operation out of the

recommended range may adversely affect measurement results.

L. Monitor, keyboard, and mouse

⚫ Do not handle monitor, keyboard, and mouse with wet hand (water, reagents,
etc) to prevent failure.
9
Foreword

M. Points to check at measurement

Follow your operation standards on the points to check at measurement.

Check the following points at least:

⚫ Quality of purified water

⚫ Remaining amount of reagents and wash solutions

⚫ Calibration results

⚫ QC measurement data

⚫ Measurement results

⚫ No leakage from Sample Pipette, Reagent Pipette, and tubes.

⚫ No suspended particles or air bubbles in samples.

⚫ Enough amounts of samples required for measurement.

N. Maintenance checks and periodical parts replacement

⚫ Follow the instructions on the manual for maintenance checks and periodical
parts replacement.

⚫ Perform calibration after each major parts replacement.

⚫ Use consumable and replacement parts we recommend. Use of

non-recommended consumables or parts may adversely affect the accuracy
and safety of the analyzer.

⚫ The used parts after replacement may be infected. For disposal, refer to
the relevant manufacturers and sales representatives and follow your
company or national regulation.

O. Backup of data

⚫ Periodically back up data such as parameters and measurement results

saved in the analyzer. It will enable data recovery at unexpected events
such as analyzer failure and power interruption.

P. Virus check

⚫ The analyzer is not equipped with virus check software. Prepare a

designated USB memory for the analyzer. Check the USB memory for virus
prior to a use with the analyzer with a PC with anti-virus software installed.

10
 Foreword

Q. Prohibition of use for purposes other than those intended

⚫ Do not use the analyzer for purposes other than those intended.

R. Cleaning of covers

⚫ When external covers such as covers, work table, and touch panel display
become dirty, wipe and clean them with a neutral detergent moistened
gauze.
Note that touching scattered samples may lead to infection.

S. Other cautions

⚫ If accidentally any reagent or sample contacts mucous, or if any reagent or

sample is swallowed, immediately consult a physician f or the instructions.

⚫ It is recommended to enter patient information through the host computer to

avoid entering erroneous information.

T. Operation problems

⚫ In the event of operation problems, do not play with the analyzer and leave
repair work to authorized experts.

U. Defects caused by external pressure

⚫ Be careful not lean on the analyzer or put your hands or feet on it.

⚫ Note that excessive pressure may damage the sample tray or the reagent
tray.

V. Temperature check before measurement

⚫ Check the IRU temperature displayed on the screen before measurement. If

the temperature is not within 37+-0.1ºC, contact our servicing division.

⚫ If the temperature is not within 37+-0.5ºC at the start of or during

measurement, an alarm will be generated to stop the operation.

⚫ Check the RCU temperature displayed on the screen before measurement. If

the temperature is not within 8-15ºC, contact our servicing division.

⚫ If the temperature is not within 8-15ºC at the start of or during measurement,

an alarm will be generated to stop the operation.

11
Foreword

W. Software version check

⚫ Refer to “4.7 List of installed software” to check the version of each software.
Using incorrect versions may lead to measurement errors.

⚫ For the latest software versions and the correct combination, contact our
servicing division.

X. General precautions on ISE unit

⚫ Reagents (such as L Solution, Ref Solution, H Solution, Cleaning solution,

Etching, and urine diluents) are required to be stored in a cold dark place.

⚫ After long-term interval or immediately after installation, measurement or

calibration results may be beyond the acceptable range. In this case,
perform ISE priming more than 10 times for the ISE pumping ready for
operation.

⚫ When applying the ISE unit, do not turn OFF the analyzer. L Soluti on is
automatically discharged into the ISE electrodes every five minutes to
prevent the electrodes from drying.

⚫ Check all the electrodes are properly installed into the ISE module prior to
operation. If not properly installed, L solution may leak inside the analyzer
and cause mechanical errors.

⚫ If the solution contacts your skin, eyes or mouth, immediately provide first
aid such as flushing with water and seek medical attention if necessary.

12
 Foreword

General precautions for use of medical electrical equipment

(For safety and prevention of danger)

The following is general precautions for use of medical electrical equipments. Please
read this manual to fully understand and handle properly.
If the equipment is not used in a manner specified by the manufacturer, the protection
may be impaired.

1. Only qualified personnel shall use the analyzer.

2. The following precautions shall be taken when the analyzer is install ed.

⚫ Keep the analyzer away from any other water.

⚫ Avoid areas where the analyzer may be adversely affected by atmospheric

pressure, temperature, humidity, ventilation, sunlight, dust, air containing salt,
or sulfur, etc.

⚫ Do not expose the analyzer to inclination, vibration, shock (including shock

during transportation) and pay attention to the state of safety.

⚫ Do not install the analyzer in a place adjacent to a storage room of chemicals

or a place where any gas is likely to be generated.

⚫ Check frequency, voltage and permissible current (or power consumption).

⚫ Make sure that the analyzer is correctly and well grounded.

⚫ Secure the space (minimum 300mm) at the left hand of analyzer to turn off
the analyzer at emergency situation easily.

⚫ In the case of carrying the analyzer (weight: approx. 120 kg), at least four
persons should lift the analyzer by holding tightly the handle at the bottom of
analyzer.

3. The following precautions shall be taken before using the analyzer.

⚫ Confirm that the analyzer operates correctly by periodically checking contact

status of switches, polarity, dial setting, and maters, etc.

⚫ Make sure that the analyzer is correctly and completely grounded.

⚫ Make sure that all necessary electrical cables are correctly and completely
connected.

13
Foreword

⚫ Special care shall be taken not to result in misdiagnosis or any danger to

analyzer or human body when the analyzer is used in conjunction with other
equipment.

4. The following precautions shall be taken during operation.

⚫ Do not exceed the required period and dosage for the diagnosis and
treatment.

⚫ Take immediate corrective measures including shutdown of analyzer when

any malfunction is detected.

⚫ Avoid any possibilities of direct access from patients.

5. The following precautions shall be taken after use of the analyzer.

⚫ Turn off the power after every operational switch and control is restored to its
pre-use state as directed.

⚫ Do not apply extra force when disconnecting the line cord plugs from
receptacles.

⚫ Storage areas:
(1) Keep the analyzer away from any other water.
(2) Avoid areas where the analyzer may be adversely affected by atmospheric
pressure, temperature, humidity, ventilation, sunlight, dust, air containing
salt or sulfur, etc.
(3) Do not expose the analyzer to inclination, vibration, shock (including shock
during transportation), etc. and pay attention to the state of safety.
(4) Do not store the analyzer in the storage area of chemicals or a place where
any gas is likely to be generated.

⚫ Organize and store the accessory parts and cords after they have been
cleaned.

⚫ Keep the analyzer clean not to cause any inconvenience to the next use.

6. In the event of trouble, do not play with the analyzer and leave repair work to
authorized experts.

7. Do not make over the analyzer.

8. Conduct maintenance checks regularly.

⚫ Perform periodical checks on the analyzer and its parts.

⚫ Make sure to check that the analyzer operates normally and safely when it is
reused after being kept unused for some time.

14
 Foreword

9. The following precautions shall be taken when the cleaning procedure will be
performed.

⚫ Appropriate decontamination should be carried out if contaminated

substance is scattered inside and outside the analyzer.

⚫ If appropriate decontamination solvents or cleaning solvents are not used

and they come into contact with the analyzer or parts of the analyzer, the
hazardous situation may occur.

⚫ Please contact our servicing division if there is any problem about

decontamination or cleaning agents.

10. For disposal of the analyzer, please contact our servicing division in advance.

11. When moving the analyzer, please contact our servicing division in advance.

12. When USB flash drive is used as the external storage device, don't remov e the
flash drive from USB port while the flash drive's indicator is lighting. Otherwise,
the data in the flash drive may be broken and/or the trouble on the analyzer may
cause.

15
Foreword

3. Warning and caution labels

A. Label description

The following labels are affixed on the major hazardous places within the analyzer and
added in their described parts of this manual.
Warning, biological hazard

Warning, electric shock

Warning, risk of injury

General warning, caution, risk of danger

Follow the instruction described on the operator’s manual.

B. Labels affixed on the analyzer

The following labels are affixed on the major hazardous places.

Warning, electric shock (power switch))

Warning, hot surface (lamp case)

Warning, contains hazardous materials (pipette cover, stirrer unit cover,

supply/drain tube connection, lid of Sample Container, high conc.
wastewater tank and low conc. wastewater tank)

16
 Foreword

The location of each label is as follows.

17
Foreword

4. Installation environment

⚫ Installation operation (such as unpacking, installation, and operation check)

will be performed by our approved service representative.

A. Installation environment conditions

The analyzer shall be installed;

⚫ In a place that is not subject to direct sunlight.

⚫ In a place that is not exposed to direct wind, rain or any other water. (The
analyzer shall be installed indoors.)

⚫ In a dustless place.

⚫ In a place that is not subject to vibration or sound.

⚫ In not inclined but horizontal place (slope: 1/200 or less).

⚫ On the floor that is strong enough to support the weight of the whole analyzer
system (approx. 120kg).

⚫ In a place that is not subject to voltage variation (less than ±10%).

⚫ Not near noise sources (facility or equipment). Avoid placing the analyzer
under the fluorescent light.

⚫ At the height of 2,000 meters above sea-level or lower. (Use the analyzer
only indoors.)

⚫ Avoid areas where the analyzer may be adversely affected by atmospheric

pressure, temperature, humidity, ventilation, sunlight, dust, air containing
salt or sulfur, etc.

⚫ Do not store the analyzer in the storage area of chemicals or a place where
any gas is likely to be generated.

B. 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 air
conditioning.

18
 Foreword

4.1 Space
Refer to the figure below for space required for installation including space for
maintenance and for exhaust ventilation.
⚫ A space of at least 300mm at the left side of analyzer to easily power off the
analyzer at the emergency situation.
⚫ A space of at least 150mm at the back of the analyzer for adequate
ventilation.
⚫ A space of at least 500mm at the front of the analyzer for operation and
maintenance.
⚫ Place the analyzer (weighing approx. 120kg) on the table or workbench
durable enough.

19
Foreword

4.2 Power supply

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

⚫ Do not use any power cord other than the one supplied with the analyzer.

⚫ Installation work of power supply needs to be done by qualified personnel

only.

20
 Foreword

4.3 Water supply and drainage

The six kinds of the supply/drain tube connections are identified at the right side of the
analyzer. The external tank sensors are available for installation (option).

Type of water supply and drainage Type of tube Remarks

Purified water supply Purified water Silicon tube Analyzer – Purified (system)

water tank (20L)

High conc. wastewater Wastewater from washing unit Silicon tube Analyzer – High conc.

(drain nozzle # 1 and 2) wastewater tank (10L)

Low conc. wastewater Wastewater from washing unit Silicon tube Analyzer – Low conc.

(drain nozzle # 3, 4, and 5) wastewater tank (20L)

Trough Silicon tube

Wash solution 1 supply Wash Solution No. 3 Silicon tube Analyzer-

Wash solution1 tank (5L/2L)

Wash solution 2 supply Wash Solution No. 9 Silicon tube Analyzer-

Wash solution2 tank (5L/2L)

⚫ The water supply system and the low conc. wastewater drainage system
need to be placed prior to the analyzer installation.

⚫ Place the high conc. wastewater tank for high conc. waste.

⚫ Dispose of the high conc. waste according to your local/national guidelines.

21
Foreword

4.4 Component list

A. Component list

No. Name Model/standard Qty Remarks

1 CA-270 1 Analyzer

2 A set of accessories 1 Refer to accessories list

B. Accessories list

Refer to the accessory list for details.

22
 Foreword

4.5 Preparation equipment and supplies

Introducing the Preparation equipment and supplies that customers need to prepare when
installing the equipment.
Item Purpose

Reagent Reagents used after delivery of the analyzer.

Refrigerator Save reagents, samples, standards and controls.

4.6 Software operating environment

Item Specification

OS Windows 10 Pro (32bit/64bit)

*Microsoft.NET FrameWork 3.5 required
CPU Intel® Core™ i3 or higher

Hard Disc More than 20 GB free space

Memory 32bit: 4GB or more, 64bit: 8GB or more

VGA 1280 x 1024 or more

Color Depth 320,000 colors or more

Serial port RS232C (only when using ASTM)

Ethernet 10/100/1000Base-T

Sound function Sound function + speaker (when using alarm sounds)

CD/DVD-ROM At the time of analyzer installation

Printer Printer with the driver corresponding to the operational software

⚫ Make sure that the external storage device will not cause any system failure
from virus, etc. We do not guarantee any system failure caused by the
computer virus.

⚫ Do not install or use other application software on the operational PC. We

do not guarantee the system performance under other application
installation.

⚫ If the operational PC is to be connected to any public network, be sur e to

enable Windows Defender Firewall only for the adapter connected to the
network and open only specific remote ports by setting the Firewall state to
“ON”, Inbound connections to “Block” and Outbound connections to “Block”.

⚫ Please use an operational PC which is compliant with the local/national

regulations in order to prevent damage by application of overvoltage.

23
Foreword

4.7 List of installed software

A. List of software installed on operational PC

Program Name Program No. Usage

User interface 2550534XXX User Interface for the system

*”XXX" indicates software number.

B. List of software installed on the analyzer

Program Name Program No. Usage

Unit Main 2550535XXX Handle the mechanical movement

Unit LIQ 2550537XXX Handle liquid level detection

Unit DTR 2550536XXX Handle the work of detector unit

Unit ISE 2550501XXX Handle ISE unit

Unit SPT 2550538XXX Handle clot detection

*”XXX" indicates software number.

C. Check program version No.

System (F9) > Versions

Program version numbers can be checked in this screen.

24
 Foreword

4.8 System

5. Statement for EMC requirement

Emission compliance

⚫ This equipment has been designed and tested to CISPR 11 Class A. In

domestic environment it may cause radio interference, in which case, you
may need to take measures to mitigate the interference.

6. In case of serious incident

⚫ In case of any serious incident that has occurred in relation to the use of the
analyzer, please report to the technical support and the competent authority
of the Member State in which the user and/or the patient is establish ed.

25
Foreword

26
 Chapter 1. Unit name and its function

Chapter 1 Unit name and its function

Here is described on the outline of the analyzer the unit name and its function.

1.1 General
The analyzer is a desktop fully automated clinical chemistry analyzer with t hroughput
of 270 tests per hour.
Connect to an external operational PC for operation. The measurement results can
be printed out from a printer.
This analyzer enables to connect to a host computer, when needed (ASTM Protocol
capable).

Seventy-two cuvettes, semi-disposable type, where the samples are reacted with
reagents, are located on the Incubation reaction unit (IRU), the inside of which is kept
at 37ºC constantly. After mixing reagent and sample in the cuvette in the Incubation
reaction unit, perform absorbance measurement for reaction liquid every 13 seconds.
Wavelength(s) (to maximum 2 wavelengths) used for a measurement can be chosen
from 12 pre-specified wavelengths.

The sample tray is detachable and can accommodate maximum 40 tube -holders and
10 cup-holders. The reagent tray is also detachable and can accommodate maximum
50 bottles. The Reagent container has a cooling function to keep a constant
temperature (8 - 15ºC). The Barcode reading system as an optional unit enables to
read information on the reagents and samples.

27
Chapter 1. Unit name and its function

1.2 Unit name

1.2.1 Analyzer overview

Figure 1.2-1

Figure 1.2-2

28
 Chapter 1. Unit name and its function

Figure 1.2-3

Figure 1.2-4

29
Chapter 1. Unit name and its function

1.2.2 Function for each unit

Figure 1.2-5

Figure 1.2-6

30
 Chapter 1. Unit name and its function

Figure 1.2-7

Figure 1.2-8

31
Chapter 1. Unit name and its function

Function for each unit is follows.

No Unit Function
.
1 Incubation reaction unit This unit is regulated at 37±0.1ºC to promote liquid
reaction with 72 cuvettes capacity.
2 Detector unit Measures the absorbance of the reaction liquid during
reaction process.
Disperses the light from the halogen lamp as a source of
light with a grading method and measures 2 selected
wavelengths at one time.
3 Sample pipette unit Aspirates a sample from the Sample container and
dispenses it into the cuvette in the Incubation reaction unit
or into the ISE unit.
After dispensing the sample, the pipette is cleaned in the
trough after use.
4 Reagent pipette unit Aspirates a reagent in the Reagent container and
dispenses it into the cuvette in Incubation reaction unit.
After dispensing the reagent, the pipette is cleaned in the
trough after use.
5 Stirrer unit It is paddle-type stirrer to mix the reagent and the sample
within the cuvette.
For stirring speed, select from 5 levels (low to high).
6 Washing unit Cleans the cuvettes after use.
7 Sample container Holds sample tubes or cups (maximum 40 sample tubes
and 10 sample cups). A barcode reader as an optional
unit allows sample identification from the barcode labels on
the bottles.
8 Reagent container Holds maximum 50 reagent bottles.
It is refrigerated at 8-15ºC when the analyzer is ON.
A barcode reader as an optional unit allows reagent
identification from the barcode labels on the bottles.
9 Sample syringe unit Aspirates and dispenses the samples or purified water by
moving its plungers up and down.
10 Reagent syringe unit Aspirates and dispenses the reagents or purified water by
moving its plungers up and down.
11 Wash syringe unit Aspirates and dispenses the wash solution or purified
water by moving its plungers up and down in Washing unit.
12 Supply water unit Supplies purified water or wash solution to the relevant
units, and discharges the wastewater into the external
tanks.
13 Trough unit Cleans the sample pipette, the reagent pipette, or the
stirrer.
14 Subtank unit Supplies purified water to each syringe after removing air
bubbles in the water.
15 External Tanks Each tank stores purified water or wash solution for
operation use, or wastewater generated from operation.

32
 Chapter 1. Unit name and its function

16 ISE unit Measures the concentration of sodium (Na), potassium (K)

(option) and chloride (CI) contained in serum, plasma, or urine by
ion electrodes.
17 Sample barcode Reads the barcode labels on the sample and reagent
reader, bottles.
Reagent barcode
reader (option)
18 Clot detection sensor It is installed in the sample syringe to detect any clots in
unit (option) the sample pipette.
19 Degassing unit Removes air bubbles in the purified water for stable
(option) measurement results.
20 External tank sensor Detects the liquid level within each tank and sends the
(option) report to the operational PC.

33
Chapter 2. Basic operation and analysis procedure

Chapter 2 Basic operation and analysis procedure

Here is described on basic operation and measurement flow.

2.1 Principles
Spectrophotometry analyzes the concentration of the target substance quantitatively by
irradiating the reaction solution of a sample and reagent dispensed into the cuvette in
the incubator, and measuring the absorbance of the substance (the light absorbance
level of the substance).

Substances in the reaction

solution absorb light

Absorbance is
measured from the
strength of the light
Light from the lamp
after passing through

Cuvette containing reaction solution

Figure 2.1-1

This assay method is referred to as absorption photometry and is based on the

Beer-Lambert law. Beer-Lambert law is a combination of the following two laws:

⚫ Lambert's law
Absorbance is proportional to its light path (how far the light travels).
⚫ Beer's law
Absorbance is proportional to its concentration.

34
 Chapter 2. Basic operation and analysis procedure

As all of the reaction solutions of reagent and sample are put in cuvettes of the same
size, their light paths are constant. Under those conditions, measuring of the
absorbance of a sample (calibrator), whose concentration of the target substance is
previously known, enables creation of a calibration curve indicating the relationship
between concentration and absorbance of the substance.
The concentration of the target substance is obtained by comparing the absorbance of
each sample against this calibration curve.

Absorbance calculated by the measurement

Absorbance of calibrator

0.5 Calibration
Curve
Absorbance of a sample
0.25

Conc.
50 100

Concentration of a sample Concentration of calibrator

Figure 2.1-2

35
Chapter 2. Basic operation and analysis procedure

2.2 Measurement flow

2.2.1 Basic measurement flow

A. Turn ON the analyzer.

Turn ON the analyzer and the operational PC.

B. Perform preparatory operation.

The analyzer becomes stand-by mode after preparatory operation.

⚫ Check the ISE unit and its related units (option)

Check each of the ISE electrodes, L solution bag, and Ref solution bag is
properly installed.

⚫ Perform preparatory operation.

The pop-up message appears to confirm for the preparatory operation
execution.
Click the [OK] button and execute the preparatory ope ration.
It takes approx. 20 min. (including the time the Incubation reaction unit and
halogen lamp become stabilized.)

C. Daily Checks at the beginning of the day

Check supply/drain tubes, external tanks, and printer.

D. Prepare calibration curves.

Calibration curve for each method is required for measurement.

Perform calibration to prepare the calibration curve for each method. Based on the
registered calibration curve, concentration is calculated from absorbance obtained at
normal samples measurement.
To obtain accurate measurement results, recommend to perform calibration after
turning ON the analyzer once a day.

36
 Chapter 2. Basic operation and analysis procedure

E. Measure QC samples.

Check whether measurement results on the QC samples are valid after calibration
curve registration.
Perform QC management to check the variation of the results using QC graph which
QC measurement results have been accumulated on the QC samples at daily
operation.
If the measurement results are within the acceptable range, there is no proble m on the
accuracy of the system.

F. Measure normal samples.

Measure the normal samples after registering calibration curves and checking that
there is no problem on the QC management.

G. Obtain measurement results.

After measurement, check the measurement results on the screen or the printout.

H. Checks and cleaning at the end of the day

Perform end-of-the-day maintenance checks after completing all measurement.

Refer to "4.5 Checks after measurement (at the end of the day of work).”
As the end-of-the-day checks, it is available to set sleep mode to make the analyzer
awake automatically.
During the sleep mode, it allows Reagent container to keep refrigerated with the
analyzer ON.
It also allows ISE priming at the designated time to prevent ISE electrodes from drying
when applying the ISE unit (option).

I. If alarm occurs

If alarm occurs during operation, alarm message appears on the screen.

For the alarm message, refer to “Chapter 19 Troubleshooting” and follow.

37
Chapter 2. Basic operation and analysis procedure

2.2.2 Normal sample measurement

Here is described on the measurement procedure on normal samples.
Following are required for measurement:

⚫ Necessary calibration curves for the measurement are registered.

⚫ Samples for the required calibration curves are placed in the Sample
container.

⚫ Calibrators for the calibration curves are placed in the Sample container.

A. Reagent management

1. With reagent barcode reader

Run (F5) > Inventory

Click the [Reagent Scan] button to rotate Reagent tray in the Reagent container.
By the rotation, barcode reader reads barcode labels on the reagent bottles and
sends the information for reagent management.
Click the [Reagent Scan] button prior to measurement.

2. Without reagent barcode reader

Run (F5) > Inventory

Register the reagent information per position in the Reagent container by
double-clicking or pressing the [space] key after selecting each column of the
reagent name, type, lot, etc.
Click the “Save” icon to register the information.

B. Measurement start

Run (F5) > Monitor

Press [F1] key or click [►] to start measurement. The following warm-up procedure is
performed automatically;

1. Perform initialization for each unit.

2. Perform priming for the sample and the reagent syringes. Perform ISE priming
when applying the ISE unit (option).

3. Perform water blank measurement for the initial use of cuvette s.

4. Rotates the Sample container and confirms test orders.

38
 Chapter 2. Basic operation and analysis procedure

C. R1 reagent measurement

The R1 reagent measurement will be performed under the conditions that enoug h
volume of each of necessary reagents, purified water, wash solutions, and diluent is
ready.

1. R1 reagent dispensing
Reagent pipette aspirates R1 reagent in the Reagent container and dispenses it
into the cuvette in the Incubation reaction unit.
Incubation reaction unit and Reagent container rotate to the designated position
where the pipette enables to perform aspiration and dispensing of reagent.

2. Sample dispensing
Sample pipette aspirates a sample in the Sample container and dispenses it
into the cuvette containing R1 reagent in the Incubation reaction unit.
Incubation reaction unit and Sample container rotate to the designated position
where the pipette enables to perform aspiration and dispensing of samples.

3. Mixing
Stirrer unit enables to mix R1 and sample in the cuvette.
For this mixing, the cuvette moves to the stirring position by Incubation reaction
unit rotation.

4. Photometry
After mixing reagent and sample in the cuvette in the Incubation reaction unit,
Detector unit measures the reaction absorbance every 13 seconds.
Wavelength(s) (to maximum 2 wavelengths) used for a measurement can be
chosen from 12 pre-specified wavelengths.

Figure 2.2-1

39
Chapter 2. Basic operation and analysis procedure

D. R2 reagent measurement

1. R2 reagent dispensing
Reagent pipette aspirates R2 reagent in the Reagent container and dispenses it
into the cuvette containing R1 and sample in the Incubation reaction unit.
Incubation reaction unit and Reagent container rotate to the designated position
where the pipette enables to perform aspiration and dispensing of reagent.

2. Mixing
Stirrer unit mixes R1, R2, and the sample in the cuvette.
For this mixing, the cuvette moves to the stirring pos ition by Incubation reaction
unit rotation.

3. Photometry
After mixing reagent and sample in the cuvette in Incubation reaction unit,
Detector unit measures the reaction absorbance every 13 seconds.
Wavelength(s) (to maximum 2 wavelengths) used for a measur ement can be
chosen from 12 pre-specified wavelengths.

Figure 2.2-2

E. Washing

Washing unit disposes the reaction liquid in the cuvette after measurement and
cleans the cuvette with wash solution and purified water.
The cleaned cuvette is reused for next measurement.

40
 Chapter 2. Basic operation and analysis procedure

2.2.3 ISE measurement (option)

The ISE unit measures the concentration of sodium (Na), potassium (K), and chloride
(CI) contained in serum, plasma, or urine by ion electrodes.

⚫ The sample pipette directly dispenses the serum or plasma sample into the
ISE unit for measurement.

⚫ Urine is automatically diluted at the specified ratio (dilution:6, urine sample: 1).
The sample pipette dispenses it into USE unit for measurement.

⚫ For applying urine diluents, reagent code and the name need to be registered
in advance.

A. ISE Calibration

Perform 2-point calibration using L solution and H solution to obtain the slope.
The slop will be applied for concentration conversion for ISE measurement.
The expected values of the slope for each electrode are given in the following tabl e:

Slope (mV/decade)
Sodium: 38-65
Potassium: 37-67
Chloride: 28-53

1. H solution dispensing
Sample pipette aspirates H solution in the Sample container and dispenses it
into the ISE unit.

2. Measurement
Start measurement for H solution dispensed into the ISE unit. (Approx. 1 min.)
L solution is placed within the analyzer. It is automatically discharged into the
ISE electrodes by the ISE unit.

ISE calibration is required to perform every 8 hours when applying the ISE unit.
When turning OFF the analyzer, calibration results will be deleted.
Therefore, calibration is required when restarting the analyzer.

41
Chapter 2. Basic operation and analysis procedure

B. ISE measurement (serum and plasma)

1. Sample dispensing
Sample pipette aspirates a sample in the Sample container and dispenses it
into the ISE unit.

2. Measurement
ISE unit starts sample measurement. (Approx. 1 min.)

C. ISE measurement (urine)

1. Sample dilution
Reagent pipette aspirates urine diluent in the Reagent container and dispenses
it into the cuvette in the Incubation reaction unit.

2. Sample dilution
Sample pipette aspirates a sample in the Sample container and dispenses it
into the cuvette with urine diluent.

3. Mixing
Stirrer unit mixes urine diluent and sample in the cuvette.

4. Sample dispensing
Sample pipette aspirates the diluted sample in the cuvette and dispenses it into
the ISE unit.

5. Measurement
ISE unit starts sample measurement. (Approx. 1 min.)

D. ISE prime

Fill the ISE unit tube with L solution.

During stand-by mode or sleep mode, L solution is discharged into ISE electrodes
every 5 minutes automatically.
ISE prime is required for the following purposes.

⚫ To prevent the ISE electrodes from drying

⚫ To monitor the analyzer status by performing 1-point correction of the ISE unit.

42
 Chapter 2. Basic operation and analysis procedure

E. ISE cleaning (regular cleaning)

Perform ISE cleaning weekly to remove impurities on the electrodes generated by ISE
measurement.

1. Dispensing ISE Cleaner

Sample pipette aspirates ISE Cleaner in the Sample container and dispenses it
into the ISE unit.

2. Cleaning
Perform cleaning after dispensing ISE Cleaner into the ISE unit. (Approx. 12
min.)

F. ISE Etching

Perform ISE Etching weekly to remove impurities on Na electrode generated by ISE

measurement.

1. Dispensing ISE Etching

Sample pipette aspirates ISE Etching in the Sample container and dispenses it
into the ISE unit.

2. Cleaning
Perform cleaning after dispensing ISE Etching into the ISE unit. (Approx. 12
min.)

G. ISE Activation

Dispense tested serum or QC sample into the ISE unit to obtain stable ISE
measurement results.
ISE activation needs to be performed after ISE electrode replacement.

1. Dispensing
Sample pipette aspirates the tested serum or QC sample in the Sample
container and dispenses it into the ISE unit.

2. Activation
Start ISE activation. (Approx. 10 min.)

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Chapter 2. Basic operation and analysis procedure

2.3 Analysis process

2.3.1 Sample and reagent dispensing
A. Sample and Reagent volume

Sample volume: 1.5 – 35.0 µL per test

Reagent volume: 20 – 250 µL per test (R1 reagent), 20 – 180 µL per test (R2 reagent)

Perform reagent aspiration from reagent bottles (position #1 – 50) in the Reagent
container.
Required total volume (sample and reagent): 100 – 350 µL

⚫ Dummy volume in the pipette

A consumed volume, called “Dummy volume” needs to be considered when
specifying the required total sample or reagent volume. It is structurally
consumed as the small volume of sample or reagent may line the internal wall of
the pipette.

It is required 7µL for sample pipette, 15µL for reagent pipette as dummy volume .
Therefore, the total required volume of reagent or sa mple in normal
measurement is as follows.
Total volume = dispensing volume specified on the [C hemistry Parameters 1]
screen + dummy volume

When dispensing a sample in ISE measurement, the dummy volume for th e

sample pipette is 20µL due to applying different syringe pump type.
Therefore, the total required volume of a sample in ISE measurement is as
follows.
Total consumed volume (83µL) = fixed (63µL) + dummy (20µL)

B. Sample container

Outer: 40 sample tubes (20 sample tubes per layer)

Inner: 10 sample cups

C. Reagent container

Outer: 25 reagent bottles (bottle size: 20mL)

Inner: 25 reagent bottles (bottle size: 70mL)

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 Chapter 2. Basic operation and analysis procedure

D. Stirrer unit

1. Dispense R1 and sample into a cuvette in the Incubation reaction unit.

2. Mix them.

3. Dispense R2 into the cuvette.

4. Mix them again.

Enables to select “stirring speed” (none or 5 stirring levels) on the [Chemistry
Parameters1]” screen. For stirring speed, select from 5 levels, (“Slow” to
“Fastest”).

E. Dispensing flow

Dispense reagent and sample into the cuvette which cleaned in the Washing unit and
mix them.

1. Regular measurement with undiluted sample

<1> R1 reagent dispensing
<2> Dispense a sample into a cuvette.
<3> Mix it.
<4> Dispense R2 reagent into the cuvette.
<5> Mix the solution.

Figure 2.3-1

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Chapter 2. Basic operation and analysis procedure

2. Regular measurement with diluted sample

Prepare two cuvettes for each of sample dilution and measurement.
<1> Dispense diluent into the cuvette for dilution.
<2> Dispense R1 reagent into the cuvette for measurement.
<3> Dispense a sample into the cuvette for dilution.
<4> Mix the solution in the cuvette for dilution.
<5> Dispense the diluted sample into the cuvette for measurement.
<6> Mix the solution in the cuvette for measurement.
<7> Dispense R2 reagent into the cuvette for measurement.
<8> Mix the solution in the cuvette for measurement.

Figure 2.3-2

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 Chapter 2. Basic operation and analysis procedure

3. Reagent blank measurement without containing purified water

<1> Dispense R1 reagent into the cuvette.
<2> Mix it.
<3> Dispense R2 reagent into the cuvette
<4> Mix the solution.

Figure 2.3-3

4. Reagent blank measurement with containing purified water

Prepare two cuvettes for each of purified water aspiration and measurement.
<1> Dispense purified water into the cuvette for purified water.
<2> Dispense R1 reagent into the cuvette for measurement.
<3> Aspirates purified water from the cuvette for purified water and
dispenses it into the cuvette for measurement.
<4> Mix the solution in the cuvette for measurement.
<5> Dispense R2 reagent into the cuvette for measurement.
<6> Mix the solution in the cuvette for measurement.

Figure 2.3-4

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Chapter 2. Basic operation and analysis procedure

5. ISE measurement
<1> Dispense purified water into a cuvette.
Since this measurement does not require any cuvette, fill the cuvette
with purified water.
<2> Dispense a sample into the ISE unit.

Figure 2.3-5

6. ISE measurement for diluted samples

Prepare a cuvette for diluting the sample.
<1> Dispense diluent into the cuvette for dilution.
<2> Dispense the sample into the cuvette for dilution.
<3> Mix the solution in the cuvette for dilution.
<4> Aspirates the diluted sample from the cuvette for dilution and dispense it
into the ISE unit.

Figure 2.3-6

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 Chapter 2. Basic operation and analysis procedure

F. Sample dilution

High concentrated sample beyond the measurement range needs to be d iluted prior to
measurement.
Specify “Sample Volume (µL)”, “Diluted Sample (µL)” and “Diluent (µL)” on the
[Chemistry Parameters1] screen.
The measurement results are calculated using the concentration corrected by dilution
ratio.

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Chapter 2. Basic operation and analysis procedure

2.3.2 Absorbance measurement

A. Wavelengths

After mixing reagent and sample in the cuvette in the Incubation reaction unit, perform
absorbance measurement for reaction liquid in the Detector unit every 13 seconds.
The Detector unit disperses the light from halogen lamp as a source of l ight with a
grading method and measures 12 wavelengths (340, 380, 415, 450, 510, 546, 570, 600,
660, 700, 750, 800nm) at one time.
Wavelength(s) (to maximum 2 wavelengths) used for a result can be chosen from the
pre-specified 12 wavelengths.

B. Reaction time

Required reaction time for measurement varies depending on the applied reagent type.

R1 reagent + sample: approx. 10 min.

R1 + R2 reagent + sample: approx. 5 min. (R1) and approx. 5 min. (R2),

Measuring point: 23 points (R1) and 23 points (R2)

Measurement cycle: approx. 13 sec.

Figure 2.3-7

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 Chapter 2. Basic operation and analysis procedure

2.3.3 Assay Techniques

There are two fundamental types: Endpoint assays and Rate Assays
Here are described on four assay techniques.

A. 1 Point End

This is an endpoint assay to measure the absorbance value after the specific tim e.
When one data collected for the specific measurement range, apply it as the
absorbance. When two data collected, the average value of them is applied as th e
absorbance.

Dispense the reagent and measure the absorbance after the specific time.
Under the case as ( A: Absorbance of the measurement range, C: Water blank, B:
Reagent blank).

⊿ABS = (A－C)－B

Figure 2.3-8

Specify by methods whether to apply reagent blank or not.

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Chapter 2. Basic operation and analysis procedure

B. 2-Point End

This is an endpoint assay to measure absorbance values of 2 measuring points after

the specific time.
Absorbance is obtained from the difference between the initial and last points of the
specified measurement ranges.
Dispense the reagent and measure absorbance after the specific time.
Under the case as (A1 and A2: Absorbance of the measurement ranges, C: Water
blank, B: Reagent blank, d: correction coefficient),

⊿ABS = A2-C-B2 - d*(A1-C-B1)

Figure 2.3-9

Specify by methods whether to apply reagent blank or not.

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 Chapter 2. Basic operation and analysis procedure

When the sample reaction only is required for reading, the sample is dilute d after
dispensing R2 reagent, it results in the concentration difference between before and
after diluting. Dilution factor is applied for correcting the concentration diff erence in
dilution (after R2).

Dilution factor
d = (S+R1)/(S+R1+R2)

Figure 2.3-10

Where there is no volume difference between measurement range 1 and 2,

⚫ The method for R1 reagent is applied.

⚫ Both measurement ranges 1 and 2 are positioned after dispensing R2 reagent.

No dilution factor need to be applied in the above conditions.

⊿ABS = （A2-B2-C）- (A1-B1-C)

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Chapter 2. Basic operation and analysis procedure

C. 1 Point Rate

The 1 Point Rate assay is to measure the value of absorbance change per a unit of
time.
Obtain the value of absorbance change per minute from the slope at the specified time
using least square approximation line based on data between the specified
measurement ranges.
The rate assay is to convert the absorbance slope per 1 minute in the linear gradient
range and obtain the value of the absorbance change.

Where ⊿ABSA: absorbance change per minute in sample, ⊿ABSB: absorbance

change per minute in reagent blank,
⊿ABS = ⊿ABSA - ⊿ABSB

Figure 2.3-11

Specify by methods whether to apply reagent blank or not.

Where there is no correction needed in reagent bank,

⊿ABS = ⊿ABSA

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 Chapter 2. Basic operation and analysis procedure

D. 2 Point Rate (Double Kinetic Assay)

The 2 Point Rate assay is to measure the absorbance change between the specified 2
points per unit time.
Perform measurement at two measurement ranges. Obtain the value of the
absorbance change per minute from the slopes at the specified time using least square
approximation line based on data between the specified measurement ranges.

Calculate the slope of the absorbance between measurement range 1 and 2.

Where: ⊿ABSA1 = slope of the absorbance in sample at measurement range 1,
⊿ABSB1 = slope of the absorbance in reagent blank at measurement range 1,
⊿ABSA2 = slope of the absorbance in sample at measurement range 2,
and ⊿ABSB2 = slope of the absorbance in reagent blank at measurement range 2,

⊿ABS = (⊿ABSA2-⊿ABSB2)- d*(⊿ABSA1-⊿ABSB1)

Figure 2.3-12

Where: d = dilution factor,

d = (S+R1)/(S+R1+R2)

Where there is no correction needed in reagent bank,

⊿ABS = ⊿ABSA2- d*⊿ABSA1

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Chapter 2. Basic operation and analysis procedure

Where there is no volume difference between measurement range 1 and 2,

⚫ The method for R1 reagent is applied

⚫ Both measurement range 1 and 2 are positioned after dispensing R2 reagent.

Above conditions, there is no need for applying the dilution factor.

Therefore: d=1

⊿ABS = (⊿ABSA2-⊿ABSB2)- (⊿ABSA1-⊿ABSB1)

Figure 2.3-13

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 Chapter 2. Basic operation and analysis procedure

2.3.4 Blank measurement

A. Water blank measurement

Water blank measurement is to measure the absorbance after dispensing purified

water into the cuvette.
It is required for every cuvette that is used for measurement. The results will be
applied for correcting the differences between the cuvettes.
The results will be also applied for evaluating the condition of the cuvettes’
contamination.

B. Reagent blank measurement

Reagent blank measurement is to measure the absorbance of the cuvette conta ining
reagent. Correcting the sample absorbance by reagent blank value makes more
accurate measurement results.
There are four kinds of reagent blank measurements:
1. R1 reagent
2. R1 + R2 reagents
3. R1 reagent + purified water
4. R1 + R2 + purified water

For setting, select the [Chemistry Parameters 2] screen for specifying number of
measurement (Single to Triplicate) and reagent blank conditions (such as purified
water required or not) at the Reagent blank measurement at calibration.

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Chapter 2. Basic operation and analysis procedure

2.3.5 Calibration curve parameters

There are six calibration curve parameters for calculating measurement results.
Below are described on each calibrator, correction, ⊿ABS conversion formula, and
concentration conversion formula.

A. Factor

Enter the value of the slope obtaining by linear expression to specify. Intercept is
correctable by measuring blank sample (C1).

Calibrator: No calibration is required. This is only use for correction by C1 blank.

Absorbance change: ⊿ABS = ax + b (where x: concentration)
Where K: predefined by reagent test

Figure 2.3-14

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 Chapter 2. Basic operation and analysis procedure

B. Linear

Obtain the linear expression by measurement results of several calib rators.

Calibrator: More than 2 points required among C1 and C2-C7

Absorbance change: ⊿ABS = ax + b
Obtain the values of a and b by linear regression.

Figure 2.3-15

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Chapter 2. Basic operation and analysis procedure

C. Point to point

Obtain the linear expression among measuring points by several calibrators.

Calibrator: More than 3 points required among C1 and C2-C7

Absorbance change: ⊿ABS = ax + b
Obtain “a,b” by linear regression for each measuring point.

Figure 2.3-16

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 Chapter 2. Basic operation and analysis procedure

D. Log-Logit

Obtain the log formula by measurement results of several calibrators.

Calibrator: More than 3 points required among C1 and C2-C7

Absorbance change: ⊿ABS = k / ( r + exp(-ax^3 - bx^2 - cx - d)) + 1)

Figure 2.3-17

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E. Spline / Spline 2

Obtain the spline curve by measurement results of several calibrators.

Calibrator: More than 3 points required among C1 and C2-C7

Absorbance change: ⊿ABS = ax^3 + bx^2 + cx + d
Obtain max. 6 cubic equations by applying cubic equation for each measuring point
(C1 to C7).

Figure 2.3-18

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 Chapter 2. Basic operation and analysis procedure

Difference between “Spline” and “Spline2”

When using “Spline”, the lines at the measuring points (C1 to C 2) and (Cn-1 to Cn)
show straight linear regression if obtaining abnormal calibration curve. (Refer to
Figure 2.2-19 and 2.2-20 below.)
When using “Spline2”, slopes between both ends of the calibration curves (C1 to C2)
and (Cn-1 to Cn) become zero.

Figure 2.3-19

Figure 2.3-20

Perform calibration for both “Spline” and “Spline2” and select the appropriate
calibration parameter which can be showed an appropriate calibration curve.

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Chapter 2. Basic operation and analysis procedure

F. Exponential

Obtain the approximation formula of an exponential function by measurement results of

several calibrators.

Calibrator: More than 3 points required among C1 and C2-C7

Absorbance change: ⊿ABS = ax^3 + bx^2 + cx + d

Figure 2.3-21

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 Chapter 3. Basic operation

Chapter 3 Basic operation

Here is described on basic operation of the analyzer.

3.1 Key operation

Operates the analyzer using the computer keyboard and mouse.
Functions for each key are as follows:

1. [F1]: Start measurement

Press this key to start or restart measurement.

2. [F2]: Stop sampling

Press this key to stop dispensing of sample or reagent.
The window appears for modification of the reagent information.
However, measurement is continued only for the samples after dispensing.

3. [F3]: Emergency sample addition (STAT)

Press this key to add an emergency sample.

4. [F4]: Alarm
Press this key to display the alarm screen.

5. [F5]: Run (F5)

Press this key to switch to the [Run (F5)] menu.

6. [F6]: Parameter (F6)

Press this key to switch to the [Parameter (F6)] menu.

7. [F7]: Calibration (F7)

Press this key to switch to the [Calibration (F7)] menu.

8. [F8]: QC (F8)
Press this key to switch to the [QC (F8)] menu.

9. [F9]: System (F9)

Press this key to switch to the [System (F9)] menu.

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10. [F10]: Maintenance (F10)

Press this key to switch to the [Maintenance (F10)] menu.

11. [F11]: Switch to tab menu (upward) within the selected menu.
Press this key to switch the tab menu upward.

12. [F12]: Switch to tab menu (downward) within the selected menu.
Press this key to switch the tab menu downward.

13. [Shift] + [F1]: Start orderless measurement

Press the above keys at the same time to start orderless measurement.

14. [Shift] + [Esc]: Alarm sound stop

Press the above keys at the same time to stop alarm sound.

15. [Ctrl] + [F2]: Emergency stop

Press the above keys at the same time to immediately stop operation.

16. [Ctrl] + [F5]: Print screen

Press the above keys at the same time to printout the current screen.
This function is not available during measurement process.

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3.2 Operation screen

3.2.1 Icons
Here is described on the icons and their functions displayed on the screen.

A. Menu icons

1. Run (F5)
Press the icon to switch to the [Run (F5)] menu.

⚫ Monitor
Press this icon to switch to the [Monitor] screen.

⚫ Round
Press this icon to switch to the [Round] screen.

⚫ Test Selection
Press this icon to switch to the [Test Selection] screen.

⚫ Results
Press this icon to switch to the [Results] screen.

⚫ Inventory
Press this icon to switch to the [Inventory] screen.

⚫ Wakeup Setup
Press this icon to switch to the [Wakeup Setup] screen.

⚫ Auto Template
Press this icon to switch to the [Auto Template] screen.

⚫ Patient Information
Press this icon to switch to the [Patient Information] screen.

⚫ Daily Maintenance
Press this icon to switch to the [Daily Maintenance] screen.

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2. Parameter (F6)
Press the icon to switch to the [Parameter (F6)] menu.

⚫ Chemistry Parameters 1
Press this icon to switch to the [Chemistry Parameters 1] screen.

⚫ Chemistry Parameters 2
Press this icon to switch to the [Chemistry Parameters 2] screen.

⚫ Chemistry Parameters for ISE

Press this icon to switch to the [Chemistry Parameters for ISE] screen.

⚫ Serum Indices
Press this icon to switch to the [Serum Indices] screen.

⚫ Calculated Test
Press this icon to switch to the [Calculated Test] screen.

⚫ Profile
Press this icon to switch to the [Profile] screen.

⚫ Order
Press this icon to switch to the [Order] screen.

⚫ Wash Program
Press this icon to switch to the [Wash Program] screen.

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3. Calibration (F7)
Press the icon to switch to the [Calibration (F7)] menu.

⚫ Calibration Registration
Press this icon to switch to the [Calculation Registration] screen.

⚫ Diluted Calibration
Press this icon to switch to the [Diluted Calculation] screen.

⚫ Multi-Calibrator
Press this icon to switch to the [Multi-Calibrator] screen.

⚫ Result of ISE Calibration

Press this icon to switch to the [Result of ISE Calibration] screen.

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Chapter 3. Basic operation

4. QC (F8)
Press the icon to switch to the [QC (F8)] menu.

⚫ QC Graph
Press this icon to switch to the [QC Graph] screen.

⚫ QC Results (Detail)
Press this icon to switch to the [QC Results (Detail)] screen.

⚫ QC Results (Daily)
Press this icon to switch to the [QC Results (Daily)] screen.

⚫ QC Results (Cumulative)
Press this icon to switch to the [QC Results (Cumulative)] screen.

⚫ QC Settings
Press this icon to switch to the [QC Settings] screen.

⚫ QC Sample Registration
Press this icon to switch to the [QC Sample Registration] screen.

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5. System (F9)
Press the icon to switch to the [System (F9)] menu.

⚫ System Setup 1
Press this icon to switch to the [System Setup 1] screen.

⚫ Define Report Format

Press this icon to switch to the [Define Report Format] screen.

⚫ Reagent Registration
Press this icon to switch to the [Reagent Registration] screen.

⚫ Versions
Press this icon to switch to the [Versions] screen.

⚫ Backup Procedures
Press this icon to switch to the [Backup Procedures] screen.

⚫ System Setup 2
Press this icon to switch to the [System Setup 2] screen.

⚫ Definition
Press this icon to switch to the [Definition] screen.

⚫ Normal Range
Press this icon to switch to the [Normal Range] screen.

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6. Maintenance (F10)
Press the icon to switch to the [Maintenance (F10)] menu.

⚫ Sequence
Press this icon to switch to the [Sequence] screen.

⚫ Water Blank
Press this icon to switch to the [Water Blank] screen.

⚫ Working Hour Counters

Press this icon to the [Working Hour Counters] screen.

⚫ Performance
Press this icon to switch to the [Performance] screen.

⚫ Sensor
Press this icon to switch to the [Sensor] screen.

⚫ Volume Adjustment (for maintenance only)

Press this icon to switch to the [Volume Adjustment] screen.

⚫ Setup Password
Press this icon to switch to the [Setup Password] screen.

⚫ DTR Positioning
Press this icon to switch to the [DTR Positioning] screen.

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7. Shutdown
Pop-up message appears for system shutdown.

8. Sleep
Displays the window for sleep mode.
In the operational mode: Before sleep setting window appears.
In the sleep mode: Confirmation window to wake-up from sleep mode appears.

9. Alarm (F4)
Press this icon to switch to the [Alarm] screen.

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B. Operational icons

1. Save
Saves the setting.

2. Cancel
Cancels the setting.

3. Delete
Deletes the selected 1 item.

4. Delete All
Deletes all of the selected items.

5. Search
Starts searching.

6. Print
Executes printing.

7. Execute
Executes the selected function.

8. Close

Close the current screen and return to the previous screen.

9. […]
Specify a directory to be saved or loaded.

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3.2.2 Status
The pop-up message indicating the system status appears in the upper left of the
screen.
Following are the displayed messages.

1. Not ready
Not ready for connection between the analyzer and the operational PC. Or the
analyzer is OFF.

2. Pre-ready
The analyzer is ON, however, preparatory operation such as dispensing into
cuvettes and priming has not been completed.

3. Ready
It is ready for starting measurement.

4. Measurement
Measurement is performed.

5. STAT-measurement
Measurement for an emergency sample is performed as a priority.
Measurement for normal samples and QC samples is not performed.

6. MSStopping
Dispensing is stopped due to sample addition.
Or dispensing is completed.

7. ESStopping
Since an error occurs, dispensing is stopped.

8. Sleeping
The analyzer is in sleep mode.

9. Maintenance
Maintenance procedures are performed.

10. Emergency Stop

The analyzer is emergency stopped due to errors or user’s operation.

11. Sampling stop in progress

The error that continuous dispensing is not performed occurs.

12. Sampling stop complete

The measurement has been completed after the dispensing interruption due to
an error.

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13. Maintenance complete

Maintenance procedures are completed.

14. Em Stop in progress

Emergency stop is executed.

15. Em Stop Complete in progress

Ending procedure for Emergency stop is performed.

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3.3 Data save

Data to be saved from operational software is as follows.

⚫ System parameter
System parameter indicates data related to measurement conditions.
This is not included test orders and results information.

⚫ Database
Database indicates data related to the analyzer such as measurement
conditions and results information.

The data can be saved to the hard disk (HD) or an external memory medium (such as a
USB memory).
It is also available to return the designated operational status by loading the previous
data from the HD or external memory medium.

System (F9) > Backup Procedures

Figure 3.3-1

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Chapter 3. Basic operation

A. System parameter

1. Save Parameters
Saves the system parameters.

2. Load Parameters
Loads the system parameters.

3. [...]
Select the directory to save or load the system parameters.

B. Database

1. Save Database
Saves the database.

2. Load Database
Loads the database.

3. [...]
Select the directory to save or load the database.

C. Load previous database

Loads the previous database.

⚫ It is recommended to periodically save the system pa rameters and database

for security.

⚫ Reboot your operational PC after loading the system parameters or database.

⚫ Do not turn the analyzer or the operational PC OFF during backup process.
Data corruption may occur if the power is OFF during backup process.

⚫ Do not turn the analyzer or the operational PC OFF during the waiting time for
save or load the database. Data corruption may occur if the power is OFF
during the waiting time for save or load the database.

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 Chapter 4. Preparation and ending procedure for measurement

Chapter 4 Preparation and ending procedure for measurement

Here is described on the required checks at the beginning of and after the day of work.

4.1 Checks prior to use (at the beginning of the day)

4.1.1 External Tanks
Check the following points on the external tank condit ion.

⚫ Enough purified water in the purified water tank

⚫ Enough capacity in the wastewater tank

⚫ Enough wash solution in the wash solution tank

Follow the procedures for preparation of external tank below.

A. Installation of external tanks and supply/drain tubes

Install external tanks (such as purified water, wash solution 1 and 2, and wastewater
(high conc. and low conc.)) at the right side of the analyzer and connect to the analyzer
with their corresponding tubes. For each connecting position of the supply/drain
tubes, refer to “Foreword, 4.3 Water supply and drainage.”

Figure 4.1-1

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Chapter 4. Preparation and ending procedure for measurement

⚫ External Tanks 1: Purified (system) water tank (Volume: 20L)

2: High conc. wastewater tank (Volume: 10L)
3: Wash solution 1 tank (Volume: 5L)
4: Wash solution 2 tank (Volume: 5L)
5: Low conc. wastewater tank (Volume: 20L)

⚫ Supply/drain tube A: Purified water supply tube (1 pc)

B: Wash solution 1 supply tube (1 pc)
C: Wash solution 2 supply tube (1 pc)
D: Low conc. waste tube (2 pcs)
E: High conc. waste tube (1 pc)

B. External Liquid Level Sensors (option)

An external liquid level sensor (option) is available to detect the volume of each
external tank.
Check that each of the corresponding external liquid level sensors of purified water
tank, wash solution tank, wastewater tank (high conc.) and wastewater tank (low conc.)
is properly installed.

Figure 4.1-2

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 Chapter 4. Preparation and ending procedure for measurement

4.1.2 Supply/drain Tubes

Check the following points on the connection of the supply/drain tubes.

⚫ The tip of the supply tube is positioned at the bottom of the purified wate r tank.

⚫ The tip of the supply tube is positioned at the bottom of the wash solution tank.

⚫ The tip of the wastewater tube is not in touch with the liquid level of
wastewater in the tank.

Figure 4.1-3

4.1.3 ISE unit (option)

Check the following points on the ISE unit.

⚫ Apply the ISE electrodes (sodium, potassium, chloride, and reference) and the
tube unit within valid terms.

⚫ Enough volume in the L solution (450mL)

⚫ Enough volume in the Ref solution (140mL)

⚫ Perform ISE cleaning on a weekly basis.

⚫ Perform ISE Etching on a weekly basis.

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4.2 Power ON
4.2.1 Power ON the analyzer
Power ON the analyzer and start up. Power supply switch is located on the left side of
the analyzer.
When the analyzer is ON, the LED orange lamp is ON.
When ready for connection between the analyzer and the oper ational PC, the LED
green lamp is ON.
After the power ON, execute preparatory operation.
ISE unit (option) is automatically in preparatory operation after the power ON. Before
the power ON, make sure to confirm properly installed the ISE electrodes, the L
solution, and the Ref solution.

4.2.2 Power ON the printer

Power ON the printer connecting to the operational PC to become the printer in
standby mode.
Also check enough paper set in the printer.

4.2.3 Power ON the operational PC

Power ON the operational PC and launch a user interface by double-clicking

.icon on the desk top.

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4.3 Log in
When starting up the operational software after power ON the analyzer and the
operational PC, the screen appears to enter log-in name and password.

Enter the log-in name and the password. Press icon.

Figure 4.3-1

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Chapter 4. Preparation and ending procedure for measurement

4.4 Checks prior to measurement

4.4.1 Checks on the consumable parts

Maintenance (F10) > Working Hour Counters

Check the condition for each consumable part prior to measurement.

Figure 4.4-1

A. Total Working Hours

Displays the total working time.

B. Total Test

Displays the total number of measurement.

C. Time Disp/Test Disp

Toggle switch (to display between the numbers of tests and the used hours)
The numbers of tests (unit: 1000 tests) are displayed in default setting ([Time Disp.]
button displayed). By clicking this button, the display switches the used hours for the
parts ([Test Disp] button displayed).

D. Halogen lamp

Displays the use of the halogen lamp in hours .

Replacement cycle: 1000 hours

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 Chapter 4. Preparation and ending procedure for measurement

E. Syringe Tip

Displays remaining hours and tests of each syringe tip.

1. Reagent Syringe (RPPR)

Displays the remaining hours of reagent syringe (RPPR) tip.
Replacement cycle: 150 hours

2. Reagent Syringe (RPPW)

Displays the remaining hours of reagent syringe (RPPW) tip.
Replacement cycle: 150 hours

3. Sample Syringe (SPPS)

Displays the remaining hours of sample syringe (SPPS) tip.
Replacement cycle: 150 hours

4. Sample Syringe (SPPW)

Displays the remaining hours of sample syringe (SPPW) tip.
Replacement cycle: 150 hours

5. Wash Syringe (WPP 1 – 4)

Displays the remaining hours of wash syringe (1-4) tip.
Select the wash syringe tip from drop-down menu.
Replacement cycle: 400 hours (WPP1)
400 hours (WPP2)
400 hours (WPP3)
400 hours (WPP4)

F. Maintenance Cycle

Displays the valid days till the next periodical check.

1. Month 6
Displays the valid days till the next 6-month periodical check.

2. Year 1
Displays the valid days till the next 1-year periodical check.
After parts periodical replacement, click the [RESET] button to set to the default value.

⚫ If the remaining time or day goes under 0, the alarm sound occurs.

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G. Working Hour of ISE (option)

Displays the use of each ISE consumable part.

1. Na Electrode
Displays the use of the Na electrode (in days).
Replacement cycle: 360 days

2. Cl Electrode
Displays the use of the Cl electrode (in days).
Replacement cycle: 90 days

3. K Electrode
Displays the use of the K electrode (in days).
Replacement cycle: 180 days

4. Ref Electrode
Displays the use of the Ref electrode (in days).
Replacement cycle: 360 days

5. Pump Tube
Displays the use of the tube unit (in days).
Replacement cycle: 180 days

6. L Solution
Displays the use of the L solution (in mL).
Capacity: 450mL

7. Ref Solution
Displays the use of the Ref solution (in mL).
Capacity: 140mL

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4.4.2 Check reagent volume

Run (F5) > Inventory

Figure 4.4-2

Check whether the remaining volume of reagents in the Reagent container is enough
for running the ordered tests.
When applying the reagent barcode reader, click the [Reagent Scan] button every time
adding the reagent on the Reagent container to update the reagent information.
Click the [Reagent Scan] button to rotate the Reagent container and read the barcode
labels that includes the type, number, and full volume of each reagent.

1. Vol (mL)
Displays the remaining volume (mL) of the reagent bottle.

2. Tests
Displays the available numbers of tests using the current reagent volume.

3. Total
Displays the available numbers of tests using the total volume of the reagents in
the Reagent container (when installing several bottles for the same reagent) .

⚫ If not enough volume of the reagent, the alarm sound occurs when starting
measurement.

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4.5 Checks after measurement (at the end of the day of work)
4.5.1 Check the measurement results
Check the measurement results.
Refer to “Chapter 8 Measurement results” for details.

4.5.2 Checks at the end of the day

Check the following points after the end of work.

1. Empty the wastewater tank.

2. Certainly close the lids of the reagent bottles.

3. Remove the samples in the Sample container.

4.5.3 Cleaning
For decontamination on the work table, the pipettes, and the stirrer, prepare neutral
detergent moistened gauze and wipe it.

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4.6 Sleep function

The sleep function is a stand-by function with power-saving feature when not operating
during a certain period of time. When entering or waking up from sleep mode,
preparatory operation will be performed automatically.
The following functions are active under sleep mode.

⚫ Refrigeration in the Reagent container

⚫ Overflow (wastewater leakage) detection

⚫ Automatic ISE priming (option)

Specify the wake-up time from sleep mode to restart the analyzer automatically.
Specify the preparatory operation at wake-up to automatically execute them.

⚫ Do not turn the operational PC OFF during sleep mode.

4.6.1 Sleep setting

Run (F5) > Wakeup Setup

Figure 4.6-1

This screen enables to specify the wake-up setting from sleep mode.

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A. Wakeup time/procedure setting

Figure 4.6-2

1. Specify the wake-up time from sleep mode. Specify the time by each day of
week using up and down buttons or keyboard.

2. Specify the procedure (OFF, Proc 1, or Proc 2) from drop-down menu.

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B. Sleep settings at wake-up

Figure 4.6-3

Specify sleep settings (Proc 1 and Proc 2) at wake-up from drop-down menu.

1. Prime
Specify the number of priming (from 0 to 5) from drop-down menu.

2. Sample Pipette Wash

Specify each number of the sample pipette wash (from 0 to 5) with purified
water (system water) and wash solution in each procedure from drop-down
menu.

3. Reagent Pipette Wash

Specify each number of the reagent pipette wash (from 0 to 5) with purified
water (system water) and wash solution in each procedure from drop-down
menu.

4. Cuvette Wash
Specify the number of the cuvette wash (from 0 to 5) from drop -down menu.

⚫ When applying wash solutions for each pipette wash or cuvette wash, place
the wash solutions in the Reagent container or the Sample container and
register the positions in the [Inventory] or the [Test Selection] screen.

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4.6.2 Sleep mode

Sleep
To enter the sleep mode, follow the procedure below.

1. Click the “Sleep” icon.

2. The following pop-up message appears.

Figure 4.6-4

3. Specify the operation on the pop-up message before entering the sleep mode.

⚫ ISE Maintenance
Specify the number of the ISE cleaning (from 0 to 5) from drop -down menu.
Perform ISE cleaning, followed by ISE Etching and ISE Activation.
When selecting “0”, no ISE cleaning (including ISE Etching and ISE Activation)
performed.

⚫ Sample Pipette Wash

Specify the number of the sample pipette wash (from 0 to 5) with purified water
(system water), and wash solution from drop-down menu.

⚫ Reagent Pipette Wash

Specify the number of the reagent pipette wash (from 0 to 5) with purified water
(system water) and wash solution from drop-down menu.

⚫ Cuvette Filling
Specify the cuvette filling (Water, Detergent, or OFF) from drop -down menu.

⚫ Soak Pipettes and Stirrers

Specify to perform the presoak wash (for Sample Pipette, Reagent Pipette and
Stirrer) or not by checking the checkbox.

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⚫ Stirrer Trough Wash

Specify whether to wash the stirrers by the troughs or not, by checking the
checkbox.

4. The preparatory operations specified at the above step 3 are processing, and
then enter the sleep mode.

⚫ When applying wash solutions for each pipette wash or cuvette filling, place
the wash solutions in the Reagent container or the Sample container and
register the positions in the [Inventory] or the [Test Selection] screen.

⚫ When checking ON “Soak Pipettes and Stirrers”, specify “Water” or

“Detergent” for “Cuvette Filling”.

4.6.3 Manual wake-up from sleep mode

Follow the procedure below when manually wake-up from sleep mode.

1. Click the “Sleep” icon.

2. The following pop-up message appears.

Figure 4.6-5

3. Click the [OK] button to restart the analyzer from sleep mode.

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4.7 Power OFF

4.7.1 Power OFF the operational PC

Shutdown

A. Power OFF

Power OFF the operational PC by the following procedure.

1. Click the “Shutdown” icon.

2. Then click the [Power Off] button.

3. The operational PC will be turned OFF automatically.

B. Cancel

1. Click the “Shutdown” icon.

2. Then click the [Cancel] button.

3. Returns to the operation screen.

4.7.2 Power OFF the analyzer

Turn OFF the power supply switch at the left side of the analyzer.

4.7.3 Power OFF the printer

After turning off the analyzer, turn OFF the printer according to its operator’s manual.

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Chapter 5 Check calibration and QC results

Here is described on how to check the calibration and QC measurement data results.
This confirmation is required at the beginning of a day of measurement.

5.1 Check calibration results

Calibration (F7) > Calibration Registration

Confirm the calibration results prior to measurement.

Figure 5.1-1

1. Select the Method No. from drop-down menu.

2. The calibration results and the curve are displayed for the selected method.

3. Two calibration results for the two reagent lot numbers (New and Old) can be
saved.
Select the Reagent Lot (New or Old) to display either of the calibration results.

4. After checking the results, perform calibration if necessary. Creates and

updates the calibration curves.

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5.2 ISE Calibration (option)

5.2.1 Perform ISE calibration

⚫ Place H solution in the Sample container and register the order prior to ISE
calibration. For the order procedure, refer to “6.3.8 ISE Calibrator (option).”

Run (F5) > Daily Maintenance

Figure 5.2-1

ISE calibration needs to be performed at the beginning of t he day of work and every 8
hours.

1. Check that the H solution is placed on the designated position that registered in
the [Test selection] screen, and then click the [ISE Calibration] button.

2. ISE calibration is performed.

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5.2.2 Result of ISE Calibration

Calibration (F7) > Result of ISE Calibration

Figure 5.2-2

Check the results of the ISE calibration on this screen after performing the ISE
calibration.
Acceptable range for each ion is as follows.

⚫ Na: 38 - 65

⚫ K: 37 – 67

⚫ Cl: 28 – 53

When the result is within the acceptable range, "0000" is displayed in “ERROR CODE”.
If other number except “0000” is displayed, refer to “Chapter 19 Troubleshooting” and
solve the problem.

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5.3 Check QC results

Confirm the QC measurement data results at the beginning of a day of measurement.

5.3.1 QC graph

QC (F8) > QC Graph

This screen is available to display the QC graphical results indicating three colors to
indentify whether any error occurs.
Two display types (daily and cumulative) are selectable for QC graph from drop-down
menu.

Figure 5.3-1

A. Search area

This area enables to specify the QC measurement data results for search.

Figure 5.3-2

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1. Method No.
Method # can be selected by pressing the [Space] key, or from drop-down menu.
Or enter the method # directly.

2. Method Name
The method name is automatically displayed after selecting the method #.

3. Sample Type
Select the Sample type (Serum, Urine, Plasma, or Others) from drop-down
menu.

4. Date
Select the date.
Enter the date directly or select the date from the pop -up calendar from
drop-down menu.

5. Display Type
Select the Display type (daily or cumulative) from drop-down menu.

⚫ Daily: Displays the results for a day that specified on “Date”.

⚫ Cumulative: Displays the results for latest 30 days from a day that specified on
“Date".

6. QC Sample Name
Select the QC sample name from drop-down menu.
The QC sample names in the drop-down menu correspond to the method
names and sample type that specified in the [QC Settings] screen.

7. S Lot
The lot number of QC sample is displayed.

8. Search
Start searching under the specified conditions.

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B. Graph area

This area enables to display QC graph that specified at the search area.

1. Display Type “Daily”

Figure 5.3-3

2. Display Type “Cumulative”

Figure 5.3-4

3. Units for QC graphs

QC graph displays in number of data (N), Mean (X), Standard deviation (SD),
Coefficient of variance % (CV) by statistical calculation of all QC data by
sample.
N: (number of data samples)
X: (Mean value)
SD: (Standard deviation)
CV: (Coefficient of variance)

Results with error are not included.

Graph indicates in the following color description.

(Black): NORMAL
(Yellow): WARNING
(Red): ERROR

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5.3.2 QC Results (details)

QC (F8) > QC Results (Detail)

QC and the judgment results are displayed per measurement round by the specified
method item and date.

Figure 5.3-5

A. Search area

This area enables to specify the QC measurement data results for search.

Figure 5.3-6

1. Method No.
Select method #.
Select by pressing the [Space] key to display the method list, or from drop -down
menu.
Or enter the method # directly.

2. Method Name
The method name is automatically displayed after selecting the m ethod #.
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3. Sample Type
Select the Sample type (Serum, Urine, Plasma, or Others) from drop-down
menu.

4. Date From
Specify the date for search starting.

⚫ □ Enable

<When checking "Enable" ON>

Enter the date directly or select the date from the pop -up calendar from
drop-down menu.
<When checking "Enable" OFF>
The target for searching covers all existed QC data. Not available to specify
the date to start searching.

⚫ Round No.
Enter the Round # (1 to 99) for search starting.

5. To
Specify the date for search ending.

⚫ □ Enable
<When checking "Enable" ON>
Enter the date directly or select the date from the pop -up calendar from
drop-down menu.
<When checking "Enable" OFF>
The target for searching covers all existed QC data. Not available to specify
the date to end searching.

⚫ Set the search ending date that comes after the search start date.

⚫ Round No.
Enter the Round # (1 to 99) for search ending.

6. Output Result
Select output destination from drop-down menu.

⚫ Monitor: Displays on screen.

⚫ Print: Outputs from printer.

⚫ File: Saves in CSV format.

When selecting “File”, press the […] button to specify the destination folder.

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7. Search
Start searching under the specified conditions.

8. Delete
Deletes the specified results.
When clicking the "Delete" icon, the pop-up warning message appears for
confirmation.

Figure 5.3-7

Click the [OK] button to delete the results specified on the search area.
Click the [Cancel] button to cancel the deletion.

If the selected lines exceed 1000 lines, clicking the “Delete” icon displays the
following pop-up message to indicate unable to delete.

Figure 5.3-8

Click the [OK] button and change the search condition for retry searching.

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B. Search result list

This area enables to display QC results list that specified at the search area.

Figure 5.3-9

1. Date
Indicates the QC measurement date as the year/month/date format.

2. Round No.
Indicates Round # (1 – 99).

3. No.
When performing several measurements at the same round, it indicates the
number of measurement.

4. Method Name
Displays the method name.

5. QC Sample Name
Displays the Sample ID for QC sample.

6. S Lot
The lot number of QC sample is displayed.

7. Conc.
Indicates QC results (in concentration) in 7 digits (0 – 9999999).

8. Warning/Error
Indicates the results in concentration if the searched QC results meet the QC
rules specified as “WARNING” or “ERROR” in the [QC Settings] screen.
The highest priority error should be displayed if more than 2 errors have found
in the judgment results.

⚫ Indicates max. 3 samples per method for the above items # 5 to 8.

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5.3.3 QC Results (Daily)

QC (F8) > QC Results (Daily)

This screen indicates the summed up QC results for the specified QC samples per day.

Figure 5.3-10

A. Search area

This area enables to specify the QC measurement data for search.

Figure 5.3-11

1. Method No.
Select method #.
Select by pressing the [Space] key to display the method list, or from drop-down
menu.
Or enter the method # directly.

2. Method Name
The method name is automatically displayed after selecting the method #.

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3. Sample Type
Select the Sample type (Serum, Urine, Plasma, or Others) from drop-down
menu.

4. S Lot
The lot number of QC sample is displayed.

5. QC Sample Name
Select the QC sample name” from drop-down menu.

⚫ When specifying the method names,

Select the QC sample name from the registered QC samples for the method
item.

⚫ When not specifying the method names,

Select the QC sample from all of the registered QC samples.

6. Date
Specify the date for searching QC results.
Enter the date directly or select the date from the pop -up calendar from
drop-down menu.

7. Round No.
Enter the Round # (1 to 99) for search.

8. Output Result
Select output destination from drop-down menu.

⚫ Monitor: Displays on screen.

⚫ Print: Outputs from printer.

⚫ File: Saves in CSV format.

When selecting “File”, press the […] button to specify the destination folder.

9. Search
Start searching under the specified conditions.

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10. Delete
Deletes the specified results.
When clicking the “Delete” icon, the pop-up warning message appears for
confirmation.

Figure 5.3-12

Click the [OK] button to delete the results specified on the search area.
Click the [Cancel] button to cancel the deletion.

If the selected lines exceed 1000 lines, clicking the “Delete” icon displays the
following pop-up message to indicate unable to delete.

Figure 5.3-13

Click the [OK] button and change the search condition for retry searching.

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B. Search result list

This area enables to display QC results in the method items that specified at the
search area.

Figure 5.3-14

1. Method Name
Displays the method name.

2. N
Displays the number of the corresponding QC results.

3. Mean (X)
Displays the average concentration calculated from the results.
The fraction part is followed the specified “Decimal Point” in the [Chemistry
Parameters 1] screen.
The QC results with error are excluded.

4. -2SD
Indicates the -2SD value (in “-999.999” format) calculated from the latest target
results that are out of the -2SD range.
If the calculation is invalid due to 1 or less result, the value will be displayed in
blank.

5. +2SD
Indicates the +2SD value (in “999.999” format) calculated from the latest target
results that are out of the +2SD range.
If the calculation is invalid due to 1 or less result, the value will be displayed in
blank.

6. SD
Indicates the standard deviation (SD) value (in “999.999” format) calculated
from the results.
If the calculation is invalid due to 1 or less result, the value will be displayed in
blank.
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7. CV
Displays the coefficient of variance % (CV) calculated from the results.

8. Min
Indicates the minimum value of the searched results.

9. Max
Indicates the maximum value of the searched results.

10. Warning/Error
Indicates the results in concentration if the searched QC results meet the QC
rules specified as “WARNING” or “ERROR” in the [QC Settings] screen.
The highest priority error should be displayed if more than 2 errors have found
in the judgment results.

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5.3.4 QC Results (Cumulative)

QC (F8) > QC Results (Cumulative)

This screen indicates the summed up QC results for the specified QC samples for the
specified period.

Figure 5.3-15

A. Search area

This area enables to specify the QC measurement data results for search.

Figure 5.3-16

1. Method No.
Method # can be selected by pressing the [Space] key, or from drop-down
menu.
Or enter the method # directly.

2. Method Name
The method name is automatically displayed after selecting the method #.

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3. Sample Type
Select the Sample type (Serum, Urine, Plasma, or Others) from drop-down
menu.

4. S Lot
The lot number of QC sample is displayed.

5. QC Sample Name
Select the QC sample name from drop-down menu.

⚫ When specifying the method names,

Select the QC sample name from the registered QC samples for the method
item.

⚫ When not specifying the method names,

Select the QC sample from all of the registered QC samples.

6. Date From
Specify the date for search starting.

⚫ □ Enable
<When checking "Enable" ON>
Enter the date directly or select the date from the pop -up calendar from
drop-down menu.

<When checking "Enable" OFF>

The target for searching covers all existed QC data. Not available to specify
the date to start searching.

7. To
Specify the date for search ending.

⚫ □Enable
<When checking "Enable" ON>
Enter the date directly or select the date from the pop -up calendar from
drop-down menu.

<When checking "Enable" OFF>

The target for searching covers all existed QC data. Not available to specify
the date to end searching.

⚫ Set the search ending date that comes after the search start date.

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8. Output Result
Select output destination from drop-down menu.

⚫ Monitor: Displays on screen.

⚫ Print: Outputs from printer.

⚫ File: Saves in CSV format.

When selecting “File”, press the […] button to specify the destination folder.

9. Search
Start searching under the specified conditions.

10. Delete
Deletes the specified results.
When clicking the “Delete” icon, the pop-up warning message appears for
confirmation.
Click the [OK] button to delete the results specified on the Search area. Click
the [Cancel] button to cancel the deletion.

B. Search result list

This area enables to display QC results in the method items that specified at the
search area.

Figure 5.3-17

1. Method Name
Displays the method name.

2. N
Displays the number of the corresponding QC results.

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3. Mean (X)
Displays the average concentration calculated from the results.
The fraction part is followed the specified “Decimal Point” in the [Chemistry
Parameters 1] screen.
The QC results with error are excluded.

4. -2SD
Indicates the -2SD value (in “-999.999” format) calculated from the latest target
results that are out of the -2SD range.
If the calculation is invalid due to 1 or less result, the value will be displayed in
blank.

5. +2SD
Indicates the +2SD value (in “999.999” format) calculated from the latest target
results that are out of the +2SD range.
If the calculation is invalid due to 1 or less result, the value will be displayed in
blank.

6. SD
Indicates the standard deviation (SD) value (in “999.999” format) calculated
from the results.
If the calculation is invalid due to 1 or less result, the value will be displayed in
blank.

7. CV
Displays the coefficient of variance % (CV) calculated from the results.

8. Min
Indicates the minimum value of the searched results.

9. Max
Indicates the maximum value of the searched results.

10. Warning/Error
Indicates the results in concentration if the searched QC results meet the QC
rules specified as “WARNING” or “ERROR” in the [QC Settings] screen.
The highest priority error should be displayed if more than 2 errors have found
in the judgment results.

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Chapter 6 Test selection

6.1 Sample setting

Here is described on sample setting in the Sample container.
There are two trays (Outer and Inner) in the Sample container.

A. Outer tray

Layer 1: position # 1 - 20
Layer 2: position # 21 – 40

Figure 6.1-1

B. Inner tray

Inner tray: position # 41 – 50

Figure 6.1-2

C. Sample tubes and cups

1. Sample tubes (in Outer tray):

Diameter: 12 – 16 mm
Length: 75 – 100 mm
Since this analyzer does not have piercing function, remove the rubber cap from
the sample tube in advance.

2. Sample cups (in Inner tray):

Normal size: 17mm“ϕ”×38mm (2.0ml)
Pediatric size: 14mm“ϕ”x 25mm (0.5ml)

⚫ Set a sample cup for “Pediatric” on the specific sample tube (diameter: 13mm,
length: 85mm) and place it in the Outer tray.

D. Sample positioning

Measurement starts in numeric order accordingly. The samples in the Inner tray are
measured prior to those in the outer tray. Tray selection varies depending on the
sample type.
When performing calibration at the same round, assign younger position # for the
calibrators than the position # for the normal samples.

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6.2 Test selection

Run (F5) > Test Selection

Order a measurement test for each sample category (normal sample, emergency
sample, calibrator, and etc.).
Specify the location of the ISE wash solution and wash solution for the sample pipette
wash on this screen.

Figure 6.2-1

⚫ When using other barcode reader type,

the keyboard connector type or handy type (keyboard wedges) is available to
enter the sample ID in the [Test Selection] screen. When applying your
handy barcode reader, check the “Sample Barcode” ON.

1. Start
Specify the start position # in the Sample tray.
Select the position # (1 to 50) from drop-down menu.
Or specify the position directly from SID list.
For the samples with Barcode labels, do not specify position # and leave as
blank.
The position # 41 to 50 is not available for normal and emergency samples.

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2. End
Specify the end position # to copy or delete. (This is effective only when
checking on “C/D”.)

⚫ Sample Barcode Reader (option)

When applying barcode reader for Sample ID, no position assignment is
required.
Depending on the Sample category, reading barcode labels from barcode
reader allows to register and measure automatically.
For details, refer to the method list for each Sample category.

3. Sample Category
Specify the Sample Category from drop-down menu.
Sample Category Description

Normal Order registration for normal sample

STAT Order registration for emergency sample

Calibrator Order registration for calibrator

Multi-Calibrator Order registration for multi-calibrator

Diluted Calibration Order registration for diluted calibrator

QC Sample Order registration for QC Sample

Blank Order registration for blank sample

Mask Registration for mask function

Orderless Registration for orderless measurement function

Wash Solution Order registration for Sample pipette wash solution

ISE Calibrator Order registration for H solution

ISE Cleaning Order registration for ISE cleaner

ISE Etching Order registration for Etching

ISE Activation Order registration for ISE Activator

4. Template
Select the Template from drop-down menu.

5. Round
Select the round to be edited. Select the round from “Current Round” (1 st),
“Next Round” (2 nd) and “Round After Next” (3 rd).

6. Cup
Select “Normal” or “Pediatric” from drop-down menu.

7. Sample Barcode
Check the “Sample Barcode” ON when applying barcode reader to enter the
sample ID.

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8. C/D
Check “C/D” ON when copying or deleting the registered order.

9. E
Check “E” ON when specifying normal sample as an emergency sample.

10. SID
Enter the Sample ID.

11. Sample Type

Select the Sample Type (Serum, Urine, Plasma, or Others) from drop-down
menu.

12. Normal Range

Select or enter the Normal Range from a pop-up window for registration.

13. PID
Select or Enter the Patient ID (PID) from a pop-up window for registration.

14. Collection Date

Enter blood collection date.

15. Physician
Select or enter Physician name from a pop-up window for registration.

16. Department
Select or enter the Department from a pop-up window for registration.

17. Sample Comment

Select the Sample comment from drop-down menu if any registered information.

18. Number
Specify measurement number for replicate measurement. (This is effective for
normal sample and emergency sample.)

19. Sample Volume

Select the Sample volume (Low, Normal, or High) for initial measurement from
drop-down menu. For the figures for each volume, specify in the [Chemistry
Parameters1] screen.

20. SID List

Indicates information on the sample ID and its category, etc.

21. Restart
Perform to restart measurement. (Effective only when adding a sample.)

22. Rotate Sample Container

It gives the Sample tray rotation. (Effective only when adding a sample.)

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23. Acquire orders

It receives the order information from Host computer.
It is effective in “On Line Batch” or “On Line Real time” mode.

24. Obtain the next order

Obtain order information that registered for future rounds. Order for “Next
Round” will be transferred to “Current Round”, and order for “Round After Next”
will be transferred to “Next Round”. “Round After Next” will be vacant.

25. Save
Saves the setting.

26. Cancel
Cancels the editing data.

27. Print
Printouts the registered orders.

28. Delete
Deletes the “Pos” information you select.

29. Delete All

Deletes all of “Pos” information you registered.

30. Method display

This area indicates the method status for normal and ISE measurement in color
description.
The highest warning (in RED) will be displayed if more than two warnings are
applied.

Priority Background Warning description

High Red Calibration invalid or required.

Low Yellow QC measurement invalid or required.

- Gray The method is masked, or will not be run.

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6.2.1 Normal sample (N)

Measurement starts in “Pos” numerical order.
Inner tray is not available for normal samples.

Figure 6.2-2

A. Order setting procedure (with sample barcode reader)

1. Select "blank” on the Start# from drop-down menu.

2. Enter the Sample ID.

3. Specify the methods.

Check the method name ON to specify.

4. Click the “Save” icon to confirm the order.

B. Order setting procedure (without sample barcode reader)

1. Select the Start# from drop-down menu for a sample.

2. Select the sample cup (“Normal” or “Pediatric”) from drop-down menu.

3. Select “Normal” in the Sample category from drop-down menu.

4. To preferentially order a normal sample as Emergency, check ON at “E” when

adding the sample on the tray.

5. Enter “Sample ID”.

Available entry range: 3 to 15 digits
In the default setting, the assigned Pos. # automatically becomes the Sample
ID.

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⚫ Not available to assign Sample ID for 89990000 – 99999999 (other category

IDs).

⚫ When selecting “Pediatric” for sample cup, the Sample ID is assigned the
number with 8999 as first 4 digits.
When entering last 4 digits of the Sample ID, the first 4 digits will be added
automatically.

6. Select the Sample type (Serum, Urine, Plasma, or Others) from drop-down
menu.

7. Select the Sample volume (Low, Normal, or High) from drop-down menu.
For each volume of the sample, specify on the [Chemistry Parameters 1]
screen.

8. Select or enter the Normal range.

In the default setting, it is “Human Auto”.
Normal range is automatically selected from patient information such as age
and gender on PID registration screen and applied for judgment.
When not specifying in age of the patient, “G2” is applied. When not specifying
in gender, “Male“ is applied.

9. Select or enter the Patient ID from a pop-up window for registration.

When entering new PID, register all necessary items for the PID.
For the registered PID, select from PID list on the pop -up window.

10. Specify blood collection date.

In the default setting, collection date will be the entry date, however, it can be
modified by entering directly or clicking on the calen dar from drop-down menu.

11. Select or enter the Physician, the Department, and the Sample Comment.
Directly enter or select from the definition list on a pop-up window for
registration.

12. Specify the Number (number of measurement) for the selected method from
drop-down menu.
In the default setting, it is "01". The available range is “1 – 99”.
When selecting “2” or more at “No.”, auto rerun is not performed.

13. Specify the method.

When checking ON at the method name, its measurement will be ordered.
Check boxes for ISE measurement and profile (set of Methods) are located in
the lower part of the screen.

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14. Click the “Save” icon to save the order.

The sample ID on the Pos. # appears in the order list on the left side of the
screen after saving the order.

C. Copy procedure

To copy the same order to several sample orders,

1. Select the Start # as the beginning Position # for copying from drop-down menu.

2. Check “C/D" ON.

3. Select the End # as the end Position # for copying from drop-down menu.

4. When copying an existing order, no need to specify the methods.

When copying a new order to several positions, specify the methods for the
copied orders.

5. Click the “Save” icon to save the order.

D. Delete procedure

1. Click the “Delete All” icon to delete all orders.

2. When deleting the specific order, select the SID or PID on the SID list and click
the “Delete” icon.

3. When deleting a series of SID, check “C/D” ON.

Specify the Start # and the End # and click the “Delete” icon.

4. Click the “Save” icon to save the order.

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6.2.2 Emergency sample addition (STAT)

Measurement starts in “Pos” numerical order. When adding an emergency sample
during measurement in process, the emergency measurement is given priority over the
normal samples. Inner tray is not available for emergency samples.

Figure 6.2-3

A. Order setting procedure (with sample barcode reader)

1. Enter the Sample ID.

2. Specify the methods.

Check the method name ON to specify.

3. Click the “Save” icon to save the order.

B. Order setting procedure (without sample barcode reader)

1. Select the Start# (among the designated STAT positions) from drop-down menu.

2. Select “STAT” in the Sample category from drop-down menu.

3. Select the sample cup.

Select the cup type (“Normal” or “pediatric”) from drop-down menu.

4. Specify the Sample ID.

When selecting “Normal” for sample cup, enter SID # (001 to 899) in 3 digits.
When selecting “Pediatric” for sample cup, enter SID # (01 to 99) in 2 digits.

⚫ The SID# for Emergency sample is started with “99000” in 8 digits.

⚫ The SID# is classified by sample cup type.

- When selecting "Normal” as sample cup, “99000” as the first 5 digits is added
in the SID.
- When selecting "Pediatric” as sample cup, “990009” as the first 6 digits is
added in the SID.

5. Enter “Patient ID”.

For registration, refer to “6.2.1. Normal sample (N)”.

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6.2.3 QC sample (Q)

Order a QC sample measurement.
Measurement starts in “Pos” numerical order
Both outer and inner trays are available for setting QC samples.
When setting the QC samples in inner tray, they are measured prior to those in outer
tray.

Figure 6.2-4

A. Order setting procedure (with sample barcode reader)

Under managing with barcode reader, the analyzer recognizes the necessary
information from barcode labels.
No order registration is required except placing necessary QC samples in the Sample
container.

B. Order setting/Delete procedure (without sample barcode reader)

For the QC samples set in inner tray or without managing with barcode reader, follow
the procedure below.

1. Select the Start# from drop-down menu.

2. Select “QC sample” in the Sample category from drop-down menu.

3. Select the QC name from drop-down menu.

4. The registered method items are automatically selected.

5. Click the “Save” icon to save the order. The SID for the QC sample is listed on
the SID list.

6. For deleting, click the SID on the SID list, click “Delete” icon.
For the deletion confirmation, click the “Save” icon.

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6.3 Test selection (other sample categories)

6.3.1 Calibrator (C)
Order a calibration measurement.
Measurement starts in “Pos” numerical order.
Calibrator is available to set in both Inner and Outer trays.
The calibrators in Inner tray will be measured first.

Figure 6.3-1

A. Order setting procedure (with sample barcode reader)

Under managing with barcode reader, the analyzer recognizes the necessary
information from barcode labels.
No order registration is required except placing necessary calibrators in the Sample
container.

B. Order setting/Delete procedure (without sample barcode reader)

For the calibrators set in Inner tray or without managing with barcode reader, follow the
procedure below.

1. Specify the Pos. # (1 – 50) for calibrator from drop-down menu.

2. Select “Calibrator” in the Sample category from drop-down menu.

3. Select the Sample type (Serum, Urine, Plasma, or Others) from drop-down
menu.

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4. Specify the method. When checking ON at the method name, its measurement
will be ordered.
(This is available to select only 1 method. When selecting several methods to
prepare the calibration curve for each method using a single set of calibrators,
select “Multi-Calibrator.”)
The method that registered on the [Calibration Registration] screen is avail able
to be ordered.

5. Click the “Save” icon to save the order.

6. For deleting, click the SID on the SID list, click the “Delete” icon.
For the deletion confirmation, click the “Save” icon.

6.3.2 Multi-Calibrator
Order a multi-calibration measurement
Using a single set of calibrators, prepare several calibration curves for the methods.
Measurement starts in “Pos” numerical order.
Multi-Calibrators can be set in both Inner and Outer trays. The multi-calibrators in the
Inner tray will be measured first.

Figure 6.3-2

A. Order setting procedure (with sample barcode reader)

Under managing with barcode reader, the analyzer recognizes the necessary
information from barcode labels.
No order registration is required except placing necessary multi-calibrators in the
Sample container.

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B. Order setting/Delete procedure (without sample barcode reader)

For the multi-calibrators set in Inner tray or without managing with barcode reader,
follow the procedure below.

1. Specify the Pos. # (1 – 50) for multi-calibrator from drop-down menu.

2. Select “Multi-Calibrator” in the Sample category from drop-down menu.

3. Select the Sample type (Serum, Urine, Plasma, or Others) from drop-down
menu.

4. Select a multi-calibrator name on “MS” from drop-down menu.

5. The registered method items are ordered.

6. Select number of measurement on “No.” from drop-down menu. When

performing regular calibration, select "Full” on “No.” from drop -down menu.
When performing recalibration, select the calibrator # (C1 to C7) for calibrator
on the SID list.

7. Click the “Save” icon to save the order. The SID for the Multi-Calibrator
sample is listed on the SID list.

8. For deleting, click the SID on the SID list, click the “Delete” icon.
For the deletion confirmation, click the “Save” icon.

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6.3.3 Diluted calibration

Order a diluted calibration measurement with automatic dilution of a calibrator several
times and prepare a multi-point calibration curve.
Prior to the measurement, conditions for diluting are required to be set on the [Diluted
Calibration] screen.
Diluted Calibrators are available to set in both Inner and Outer trays.
The Diluted Calibrator in the Inner tray will be measured first.

Figure 6.3-3

A. Order setting procedure (with sample barcode reader)

Under managing with barcode reader, the analyzer recognizes the necessary
information from barcode labels.
No order registration is required except placing necessary diluted calibrators in the
Sample container.

B. Order setting/Delete procedure (without sample barcode reader)

For the diluted calibrators set in Inner tray or without managing with barcode reader,
follow the procedure below.

1. Specify the Start# for the Diluted Calibrator from drop-down menu.

2. Select “Diluted calibration” in the Sample category from drop-down menu.

3. Select the Sample type (Serum, Urine, Plasma, or Others) from drop-down
menu.

4. Specify the method. Check the method ON for the measurement order.

5. Click the “Save” icon to save the order. The SID for the Diluted calibration
sample is listed on the SID list.

6. For deleting, click the SID on the SID list, click the “Delete” icon.
For the deletion confirmation, click the “Save” icon.

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6.3.4 Blank sample

Order a blank sample (C1: no-concentration calibrator) measurement for recalibration.
Measurement starts in “Pos” numerical order. Blank sample is available to set in both
Inner and Outer trays. The blank samples in Inner tray will be measured first.

Figure 6.3-4

A. Order setting procedure (with sample barcode reader)

Under managing with barcode reader, the analyzer recognizes the necessary
information from barcode labels.
No order registration is required except placing necessary blank samples in the
Sample container.

B. Order setting/Delete procedure (without sample barcode reader)

For the blank samples set in Inner tray or without managing with barcode reader, follow
the procedure below.

1. Specify the Start# for a blank sample from drop-down menu.

2. Select “Blank” in the Sample category from drop-down menu.

3. Select the Sample type (Serum, Urine, Plasma, or Others) from drop-down
menu.

4. All of the methods registered on the [Parameter (F6)] > [Chemistry Parameters
2] screen are ordered to correct a calibration curve using C1 Blank.

5. Click the “Save” icon to save the order. The SID for the blank sample is listed
on the SID list.

6. For deleting, click the SID on the SID list, click the “Delete” icon.
For the deletion confirmation, click the “Save” icon.

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6.3.5 Mask
The Mask setting allows to set methods not performed. The methods indicate in a
measureable status that has analysis conditions, the calibration curves, and its
reagents in the Reagent container.

Figure 6.3-5

A. Mask selection/release

1. Select “Mask” in the Sample category from drop-down menu.

2. Select the Mask type (Normal, QC sample, or Calibrator) from drop-down menu.

3. The mask status on the methods is displayed.

4. By checking the method ON to unselect the mask, the method becomes

unmasked and measurable status. Check the checkmark again to remove the
checkmark. It becomes the mask status active.

5. To make all methods masked, click the [Mask All] button.

After clicking this button, it is changed into the [Clear All] button.

6. To make all methods unmasked, click the [Clear All] button.

7. Click the “Save” icon to save the order.

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6.3.6 Orderless
Orderless selection allows to perform measurement in all methods available for all
samples in the Sample container.
Prior to orderless measurement, specify the methods to be measured.
For the orderless measurement, refer to “7.1.6 Orderless measurement.”

Figure 6.3-6

A. Setting procedure for orderless measurement

1. Select “Orderless” in the Sample category from drop-down menu.

2. Select the Sample type (Serum, Urine, Plasma, or Others) from drop-down
menu.

3. Select the Normal range from the pop-up list by clicking the drop-down menu.
It is “Human Auto” as the default setting.
Normal range is automatically selected from patient information such as age
and gender registered in the [Patient Information] screen and applied for
judgment.
When not specifying in age of the patient, “G2” is applied. When not specifying
in gender, “Male” is applied.

4. Specify the Number (number of measurement) for the selected method from
drop-down menu.
It is "01" as the default setting. The available range is “1 – 99”.
When selecting “2” or more, auto rerun is not performed.

5. Specify the methods to be measured or not.

When checking ON at the method name, its measurement will be ordered.

6. Click the “Save” icon to save the order.

⚫ When some orders specified in the [Test Selection] screen, the orders are
measured prior to the orderless measurement.

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6.3.7 Sample pipette wash

Register the position of the wash solution for cleaning the sample pipette.
With the sample barcode reader, the position of the wash solution is confirmed by
reading the barcode label.
Without the sample barcode reader, the wash solution position needs to be specified.
Apply Wash solution C-1 solution by making a 1% Wash solution C-1 solution.

Figure 6.3-7

A. Setting procedure for wash solution

1. Select the Start # from drop-down menu for the wash solution.

2. Select “Wash Solution” in the Sample category from drop-down menu.

3. Click the “Save” icon to save the order.

⚫ SID list indicates the SID No. “96000201” as the Sample ID code.

B. Deletion procedure for wash solution

1. Select the Start # from drop-down menu for the wash solution.

2. Click the “Delete” icon to delete the order.

3. Click the “Save” icon to confirm the deletion.

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6.3.8 ISE calibrator (option)

Register the position of ISE calibrator (H Solution) for ISE calibration. For the ISE
calibration, refer to “5.2.1 Perform ISE calibration.”

⚫ 500 µL of H solution is required for one ISE calibration procedure.

Figure 6.3-8

A. Setting procedure for ISE calibrator

1. Select the Start # from drop-down menu for the ISE calibrator.

2. Select “ISE Calibrator” in the Sample category from drop-down menu.

3. Click the “Save” icon to save the order.

⚫ SID list indicates the SID No. “96000001” as the Sample ID code.

B. Deletion procedure for ISE calibrator

1. Select the Start# from drop-down menu for the ISE calibrator.

2. Click the “Delete” icon to delete the order.

3. Click the “Save” icon to confirm the deletion.

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6.3.9 ISE cleaning (option)

Register the position of ISE Cleaner for ISE cleaning.
For the ISE cleaning, refer to “18.1.10 ISE cleaning (option).”

⚫ 500 µL of ISE cleaning solution (ISE Cleaner) is required for one ISE cleaning
procedure.

⚫ ISE activation is automatically performed during ISE cleaning. Prior to ISE

cleaning, place the ISE activator in the Sample container and register the
information in the [Test Selection] screen. For the registration procedure, refer
to “6.3.11 ISE activation (option).”

Figure 6.3-9

A. Setting procedure for ISE cleaning solution

1. Select the Start # from drop-down menu for the ISE cleaning solution.

2. Select “ISE Cleaning” in the Sample category from drop-down menu.

3. Click the “Save” icon to save the order.

⚫ SID list indicates the SID No. “96000201” as the Sample ID code.

B. Deletion procedure for the ISE cleaning solution

1. Select the Start # from drop-down menu for the ISE cleaning solution.

2. Click the “Delete” icon to delete the order.

3. Click the “Save” icon to confirm the deletion.

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6.3.10 ISE Etching (option)

Register the position of ISE etching solution for cleaning Na electrode.

For the ISE Etching, refer to “18.2.5 ISE electrodes (option).”

⚫ 500 µL of ISE etching solution is required for one ISE Etching procedure.

⚫ ISE activation is automatically performed during ISE Etching. Prior to ISE

Etching, place the ISE activator in the Sample container and register the
information in the [Test Selection] screen. For the registration procedure, refer
to “6.3.11 ISE activation (option).”

Figure 6.3-10

A. Setting procedure for the ISE Etching

1. Select the Start # from drop-down menu for the ISE Etching.

2. Select “ISE Etching” in the Sample category from drop-down menu.

3. Click the “Save” icon to save the order.

⚫ SID list indicates the SID No. “96000301” as the Sample ID code.

B. Deletion procedure for the ISE Etching

1. Select the Start # from drop-down menu for the ISE Etching.

2. Click the “Delete” icon to delete the order.

3. Click “Save” icon to confirm the deletion.

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6.3.11 ISE activation (option)

Register the position of ISE activator (serum or specific QC sample). ISE activation is
required for stable results after electrode replacement. For the ISE activation, refer to
“C. Procedure on the ISE etching” of “18.2.5 ISE electrodes (option).”

⚫ 500 µL of ISE activator is required for one ISE activation procedure.

Figure 6.3-11

A. Setting procedure for the ISE activation

1. Select the Start # from drop-down menu for the ISE activator.

2. Select “ISE Activation” in the Sample category from drop-down menu.

3. Click the “Save” icon to save the order.

⚫ SID list indicates the SID No. “96000401” as the Sample ID code.

B. Deletion procedure for the ISE activation

1. Select the Start # from drop-down menu for the ISE activator.

2. Click the “Delete” icon to delete the order.

3. Click the “Save” icon to save the order.

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6.4 Template
Order a template order on the designated position that set the sample in the sample
tray with its specified methods as a set order.
The template is required to register in the [Auto Template] screen prior to selecting in
the [Test Selection] screen. For registering the template setting, refer to “14.8
Template setting.”

Figure 6.4-1

1. Select the template # in the Template from drop-down menu.

2. After selecting the template #, the following pop-up message appears to

overwrite the order information of the registered screen. To overwrite the
information, click the [OK] button.

Figure 6.4-2

3. Click the “Save” icon to save the order.

⚫ The template function is not available for the normal samples.

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6.5 Test selection (online)

6.5.1 Online sample selection
For online test order, host communication is required with either “ Online real time” or
“Online batch mode”.

<When applying the Sample barcode reader>

When selecting “On line Real time” at the Host Communication Mode on the [System
Setup 1] screen, automatically receives orders from host connection and no need the
order setting.
When selecting “On Line Batch” at the Host Communication Mode on the [System
Setup 1] screen, it needs to obtain orders from host communication.

<When not applying the Sample barcode reader>

When selecting “On Line Real time” at the Host Communication Mode on the [System
Setup 1] screen, it needs to register the position # and the SID to specify the position #
manually placed on the sample tray.
When selecting “On Line Batch” at the Host Communication Mode on the [System
Setup 1] screen, it needs to register the position # and the SID to specify the position #
manually placed on the sample tray. It also needs to obtain orders from host
communication.

A. Order setting procedure (in the “On Line Batch mode” with the Sample barcode
reader)

1. Select "blank” on the Start # from drop-down menu.

2. Enter the Sample ID.

3. Click the [Acquire orders] button.

The order information including the methods can be downloaded from host
connection.

4. Click the “Save” icon to confirm the order.

B. Order setting procedure (in the On Line Real time mode without the Sample
barcode reader)

1. Select the Start # from drop-down menu.

2. Enter “Sample ID”.

3. Click the “Save” icon to confirm the order.

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C. Order setting procedure (in the On Line Batch mode without the Sample
barcode reader)

1. Select the Start # from drop-down menu.

2. Enter “Sample ID”.

3. Click the [Acquire orders] button.

The order information including the methods can be downloaded from host
connection.

4. Click the “Save” icon to confirm the order.

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Chapter 7 Measurement
Here are described on the measurement procedures.

7.1 Start measurement

7.1.1 Measurement condition
Following conditions are required to be satisfied prior to the measurement.

1. Each lid for Sample container, Reagent container, and ISE unit is closed.

2. The temperature inside the Reagent container is kept less than 15ºC.

3. The temperature range inside the Incubation Reaction unit is within 37±0.5ºC.

4. Halogen lamp is stable. (20 minutes or more has passed after turning ON.)

5. More than 48 usable cuvettes are installed in the Incubation Reaction unit.

6. Subtank inside the analyzer contains enough purified water.

7. There is no water leakage inside the analyzer.

8. There are enough reagents for measurement methods.

7.1.2 Check for remaining volume of reagents

Check necessary reagents with sufficient remaining volume are placed in the Reagent
container prior to measurement.
It is available to check overview of reagent position in the [Run (F5)] > [Monitor] screen
and more detail information on the reagents in the [Run (F5)] > [Inventory] screen.

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7.1.3 To start measurement

1. To start measurement, click the “Start” icon in the [Monitor] screen or press the
[F1] key.

Figure 7.1-1

2. When “Continuous Measurement Mode” (refer to “18.10 Other settings”) is set

as “Auto”, the following pop-up message appears. When “OK” is clicked, the
cuvette water placement after the measurement will be skipped. When
“Cancel” is clicked, the analyzer performs the normal wash process after the
measurement.

Figure 7.1-2

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3. The following pop-up message appears. Specify the preparatory and ending
operation.

Figure 7.1-3

<Measurement preparing>

⚫ Prime
Enter the number of priming (0 to 99).

⚫ Sample Pipette Wash

Specify the SPT wash (system water, wash solution or OFF) from drop -down
menu.
Prior to use of the wash solution, register its information on the [Test Selection]
screen.

⚫ ISE Prime
Enter the number of ISE priming (0 to 99).

⚫ ISE Cleaning
Specify to perform ISE cleaning or not (ON or OFF) from drop -down menu.

⚫ ISE Calibration
Specify to perform ISE calibration or not (ON or OFF) from drop -down menu.

<Template>
When applying an order from the registered template, specify the template
number from drop-down menu.

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<After measuring maintenance>

⚫ Sample Pipette Wash

Specify the number of the sample pipette wash (0 to 5) using system water and
wash solution from drop-down menu.
Prior to use of the wash solution, register its information on the [Test Selection]
screen.

⚫ Reagent Pipette Wash

Specify the number of the reagent pipette wash (0 to 5) using system water and
wash solution from drop-down menu.
Prior to use of the wash solution, register its information on the [Reagent
Registration] screen. Refer to step 10 of "17.10 Other settings” and specify the
wash solution for use.

⚫ Soak Pipettes and Stirrers

Specify the presoak pipette/stirrer wash (ON or OFF) from drop-down menu.

⚫ Stirrer Trough Wash

Specify to perform stirrer wash by trough or not (ON or OFF) from drop-down
menu.

⚫ Cuvette Filling
Specify the cuvette filling operation after measurement (water, detergent, or
OFF) from drop-down menu.
Prior to use of the wash solution, register its information on the [Reagent
Registration] screen. Refer to step 11 of "17.10 Other settings” and specify the
wash solution for use.

4. Click the [Start] button for measurement start.

7.1.4 Emergency stop

For emergency stop, press the [Ctrl] and [F2] keys at the same time.
If any error occurs in measurement starts, follow the above key procedure to make the
analyzer emergency stop and confirm the alarm message.
Opening the lid for the Sample container, the Reagent container, or the ISE unit cover
during operations causes the analyzer emergency stop.

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7.1.5 Continuous Measurement Mode

The setting for “Continuous Measurement Mode” is available in [System (F9)] >
[System Setup 1] screen. By changing this setting, the user can shorten the roun d
completion procedure and can start be the next round sooner.

Figure 7.1-4
A. Enable

When “Continuous Measurement Mode” (refer to “17.10 Other settings”) is set

as “Enable”, the following pop-up message appears. When “OK” is clicked, the
cuvette water placement after the measurement will be skipped. When
“Cancel” is clicked, the analyzer performs the normal wash process after the
measurement.

Figure 7.1-5

When “OK” is clicked, the cuvette water placement after the measurement will
be skipped. When “Cancel” is clicked or a certain period of time is passed, the
analyzer performs the normal wash process after the measurement.

B. Disable

The analyzer performs the normal wash process after the measurement.

C. Auto

The pop-up message appears that asks whether a continuous measurement will
be performed. When “OK” is clicked, the cuvette water placement after the
measurement will be skipped. When “Cancel” is clicked, the analyzer performs
the normal wash process after the measurement. (See also “7.1.3 To start
measurement”)

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7.1.6 Orderless measurement

Orderless measurement enables to perform measurement without any registration in
advance.
Perform Orderless measurement by pressing the [Shift]+[F1] keys at the same time
after placing samples (sample tubes or cups) in the Sample container.

Figure 7.1-6

It is performed for all applicable methods registered for the reagents.

This function is available with or without the Sample BCR.
Without applying the sample BCR, the positions where the samples that are not placed
on are recognized as a sample error (SS).

For measurement, necessary reagents are required to be plac ed on the Reagent

container and registered.
If the volume of the reagents is insufficient before or during measurement, the methods
are not applicable.

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7.2 Monitor
7.2.1 Monitor

Run (F5) > Monitor

The following operation is available from the [Monitor] screen.

⚫ Measurement start

⚫ Confirmation for Measurement start time, estimated time of sampling

completion, and estimated time of all processes

⚫ Addition for emergency samples or normal samples

⚫ Confirmation/modification for reagent in the Reagent container

⚫ Reset of reagent remaining volume

Figure 7.2-1

The following operation is available from the [Monitor] screen.

A. Upper area

Figure 7.2-2

Icon Description

Measurement start time

Estimated end time of measurement

Measurement end time

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B. Reagent container (left side of the screen)

Figure 7.2-3

Icon Name Functions

Volume Reset Reset of reagent remaining volume

Setup of reagents Check and change of the reagents in the Reagent

container

(For details, refer to "D. Reagent bottle information.”)

Color Information Color description of the measurement methods

(For details, refer to "E. Color information.”)

C. Sample container (right side of the screen)

Figure 7.2-4

Icon Name Functions

STAT Add a normal sample or emergency sample.

Start Start measurement.

Sample Information List of the sample type and measurement progress

(For details, refer to "F. Sample information.”)

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D. Reagent bottle information

Figure 7.2-5

E. Color Information

Figure 7.2-6

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F. Sample Information

Icon Status Description

Calibrator Calibrator registered.

QC Sample QC sample registered.

Normal Normal sample registered.

STAT Emergency sample registered.

Maintains Other sample or wash solution registered.

No Order No sample registered.

Sampling Started Dispensing for the ordered method completed.

Range Over Measurement complete with result out of technical range.

Rerun Required Measurement complete with the result required rerun.

Error Measurement complete with error.

Process Complete Measurement complete and validated.

Not Processed Dispensing is not completed.

No test Ordered No order registered.

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7.2.2 Round

Run (F5) > Round

The [Round] screen displays the detail measurement progress for each sample.

Figure 7.2-7

A. System status area

This upper area indicates system status on the measurement round.

1. Incubator
Displays the temperature in the Incubation Reaction unit.

2. Lamp
Displays the required time to stabilize the light of halogen lamp.

3. Round No.
Displays the round # of the current measurement.

4. Start time
Displays start time for the measurement.

5. Estimated time of sampling completion

Displays the estimated completion time for sampling.

6. Estimated time of all processes

Displays estimated completion time for the measurement.

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B. Measurement progress area

This lower area consists of a list on the detailed round information.

The list indicates the Patient ID, Sample ID, Method name, and current measurement
progress by position #.

1. Pos
Displays the position # in the Sample tray.

2. PID
Displays the Patient ID.

3. SID
Displays the Sample ID.

4. Method
Displays the method name.

⚫ R1: R1 reagent dispensing completed

When completing R1 dispensing into cuvette, “*” is displayed.
The columns from “R1” to “O2” indicates "*" in the same manner.
If any errors occur, “E” is displayed.

⚫ S: Sample dispensing completed

⚫ M1: First mixing completed

⚫ O1: First solution completed

⚫ R2: R2 reagent dispensing completed

⚫ M2: Second mixing completed

⚫ O2: Second solution completed

5. Result
Displays the measurement results.

6. C.N.
Displays the cuvette # of the current measurement.

7. Error
If any error occurs, its error flag (2-3 digit code) will be displayed.

8. Report Time
Displays the remaining time (min.) for the round completion.

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7.3 Sample addition

7.3.1 Emergency sample addition
Following is the procedure on adding emergency samples during measurement.

1. Click the “STAT” icon on the [Monitor] screen or press the [F3] key.

Figure 7.3-1

2. When the analyzer stops dispensing and ready for the sample addition, the
following pop-up message appears.

Figure 7.3-2

3. Register the order as the emergency sample on any of the designated positions.
For the order registration procedure, refer to “6.2.2. Emergency sample addition
(STAT).”
(Registration with the sample BCR is available to leave the position as blank.
It is also available to perform registration prior to emerg ency sample addition
procedure. When measurement in “On-Line" mode, save the order without
ticking any methods.)

4. Open the Sample addition lid and place the sample on the designated position.
When there is no available position in the emergency sample slo ts, click the
[Rotate Sample Container] button in the [Test Selection] screen to rotate the
sample tray.

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5. Click the [Restart] or [F1] button to restart measurement.

After the sample addition, rotate the sample container and start dispensing only
for the emergency sample addition.
During this procedure, it is not available for another sample addition.

⚫ Procedure for Sample container rotation

1. Click the position to be placed on the SID list.
2. Close the STAT lid and click the [Rotate Sample Container] button.
3. The designated slot moves to the first position on the STAT slots. Place
the sample.
4. Repeat this procedure as needed.

7.3.2 Normal sample addition

It is the same procedure as the Emergency Sample addition when adding normal
samples during measurement.
The pop-up message appears, then click the [Normal] button.

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7.4 Measurement results

7.4.1 Screen display
The [Run (F5)] > [Monitor] screen enables you to confirm the remaining reagent volume
and sample status during measurement.
More detailed status is listed on the [Run (F5)] > [Round] screen.
The measurement results are also indicated in the list on the [Run (F5)] > [Round]
screen.

7.4.2 Live Print Out

Checking “Enable” ON on the “Live Print Out” in the [System Setup1] screen enables
to automatically print out the results when completing the measurement.
Two formats available: “Normal” and “Report”

A. Printing setting
Automatically printout setting is available by checking “Enable” ON or OFF at the “Live
Print Out”.
Refer to “8.2 Print” for details.

B. Printout header
It is available to add a header as list format.
Refer to “8.2 Print” for details.

C. QC report
It is available to print out QC report with the results of QC measurement.
Refer to “8.2 Print” for details.

7.4.3 Flags
Under the following conditions during or after measurement, range or error flag will be
added with the measurement results.

⚫ If the measurement results are out of the normal range (above or below), the
range flag is on.
⚫ If any error occurs during measurement, the error flag is on.

Each flag is displayed in the [Results] screen.

When ordering for printout of the measurement results, the flag is included on the
results printout.

For the error flag list, refer to “20.6.2. Range flags” and “20.6.3. Error flag list.”

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7.5 After measurement completion

After sample measurement, the ending procedure is performed.
The measurement process is completed after washing cuvettes and dispensing purified
water into the cleaned cuvettes.
No sample addition is available after the ending procedure.

Basically all orders are deleted after measurement. However, the orders are not
deleted resulting from the uncompleted measurement in the following cases:

⚫ Sample or reagent shortage during measurement

⚫ Other errors occurred.

⚫ Emergency stop was executed.

⚫ Measurement aborted due to any other reasons .

If the above reasons cause measurement stops, find the appropriate solution (such as
a supplementation of reagents or samples, and troubleshooting for the errors) and
handle. Rerun the measurement if necessary.

When completing measurement, follow the procedure accordingly.

⚫ Disposal of the used samples

⚫ Check of remaining reagents volume

⚫ Supplementation of purified water or wash solutions

⚫ Disposal of waste

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Chapter 8 Measurement results

Here are described on the search, printout, and data storage for the measurement
results.

8.1 Data search

8.1.1 Measurement results

Run (F5) > Results

Search the results to display them in numerical value, printout, and save as file.
To search the results, the following search options are required.

Figure 8.1-1

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A. Search area

This area allows for the results search by several search options.

Figure 8.1-2

1. Sample Category
Select the Sample category for search from drop-down menu.

⚫ All
⚫ Normal
⚫ STAT
⚫ Calibrator
⚫ ISE Calibrator
⚫ QC Sample
⚫ Test Number

When selecting “All”, the results for “Normal”, “STAT”, and “QC Sample” are
retrieved.
When searching the results for “Diluted Calibration”, “Multi-Calibrator”, and
“Blank” sample, select “Calibrator”.

2. ID
Select ID for search (SID or PID) from drop-down menu.
When changing the ID type, the registered information on “From” and “To” is
deleted.

3. Sample Type
Select the Sample type for search from drop-down menu.
Select from “All”, “Serum”, “Urine”, “Plasma”, or “Others”.
When selecting “All”, all results are retrieved.

4. From/To
Select the ID for search.

⚫ When selecting “SID”, enter SID # (up to 15 digits) on “From” and “To”.
⚫ When selecting “PID”, enter PID # (up to 20 digits) on “From” and “To”.

Enter lower ID# on "From” and higher ID # on “To”.

When entering “*”, all of the selected ID are retrieved.

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5. Date
Enter the measurement date.

⚫ [From]
Enter the Date "From”.
When the checkmark "Enable" is OFF, all results are retrieved.

⚫ [To]
Enter the Date "To”.
When the checkmark "Enable" is OFF, all results are retrieved.

6. Round No.
Enter the round # (1 to 99) for search.
When not specifying the round #, enter “*”.

⚫ When completing a measurement, the latest round # of the measurement is

automatically displayed.

7. Method (displayed only when selecting “QC sample” as the Sample category.)
Select the appropriate method # from drop-down menu.

8. Name (displayed only when selecting “QC sample” as the Sample category.)
When selecting the method # on the “Method”, the method name is displayed
here.

9. Send
Select the host transmission results in On Line mode.
This is available only when selecting “All", “Normal” or “STAT” as the Sample
category.

⚫ ALL: all results will be sent to the host

⚫ OK: Results that sent successfully to the host will be sent to the host again.

⚫ NG: Results that not sent to the host will be sent to the host.

10. Output result

Select output destination from drop-down menu.

⚫ Monitor Displays on screen.

⚫ Normal Print: Prints with the standard format.

⚫ Report Print: Prints with the report format. This format is available
only when selecting “Normal" or “STAT” as the Sample
category.

⚫ File: Saves in the specific CSV file. […] button enables to

specify the destination folder to be saved.

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⚫ Time Course (File) Saves in the specific CSV file. The […] button
enables to specify the destination folder to be saved.

11. Select Test

Select method items for search.
Click the [Select Test] button to display the method list. Select the methods to
show on the results. ((Blue: effective / background color: not effective)

12. Select Output

Select the method to output.
When any of the methods are selected from a search result list (D), this button
becomes available.

⚫ Output the methods selected in the search result list from the specified
output destination.

⚫ By clicking a method with pressing the [Space] key, the method will be
switching “Select” or “Not Selected”.

⚫ By clicking a method with pressing [Ctrl] key at the same time, the method
you select will be switching “Select” or “Not Selected”.

⚫ By clicking a method with pressing [Space] key at the same time, range
selection is available from the line selected in the last to the newly selected
line.

⚫ With holding and pressing Shift key and click ↑or ↓ key at the same time, the
selected line will be changed to the upper / lower line.

13. Search
Starts searching.
Mouse pointer turns into an hourglass during searching.
If the result number exceeds 2000, the search discontinues. Change the
search condition and try again.

14. Delete
Deletes the searched results from database.
When clicking the [Delete] button, the pop-up message appears for confirmation.
To delete, click the [OK] button. To cancel, click the [Cancel] button.

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B. Results details area

This area displays the result details by selecting one result.

Figure 8.1-3

1. Result
Displays the concentration of the results.

2. Judgment
Displays normal range judgment “H” or “L”.

3. Technical Range
Displays technical range judgment “>” or “<”.

4. Flag
Displays error flags.

5. R1 Lot
Displays the reagent 1 (R1) lot #.

6. R2 Lot
Displays the reagent 2 (R2) lot #.

7. ABS
Displays the absorbance value.
This is not displayed when selecting “Calibrator” or “ISE Calibrator” as Sample
category.

8. Error Code
Displays ISE error codes. If the results with no ISE error codes, it is displayed
as “0000”.

9. Cuvette #
Displays the cuvette #.

10. QC Judgment
Displays the QC judgment for the results when selecting “QC sample” as the
Sample Category.
Displays 3 judgments for each QC sample.
If there are more than three errors or warnings, the highest priority error or
warning codes (from left) are displayed. (For details on the fags, refer to 9.1
QC settings.”)

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11. Delete
Deletes the searched results from database.
When clicking the “Delete” icon, the pop-up message appears for confirmation.
To delete, click the [OK] button. To cancel, click the [Cancel] button.

C. Previous Results area

This area displays the latest results (when selecting “All”, “Normal”, or “STAT”).
Max. 5 results are listed.

Figure 8.1-4

1. Date
Displays the measurement date.

2. Result
Displays the measurement results.

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D. Search result list

Figure 8.1-5

Displays the search result by specified conditions.

The result selected from this list is displayed in the Results details area.
The result which has just completed is also available to view in this list.
This list is available to view the hidden parts of the list using scroll bars.

1. ID
Displays Patient ID for sample (or QC sample name for QC sample)

2. Date
Displays the measurement date.

3. Round No.
Displays the round #.

4. SID
Displays Sample ID.

5. Method
Displays method name.

6. Result
Displays the measurement results.

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8.1.2 Time course

The time course (absorbance) of the measurement results can be displayed, printed,
and saved.
For the time course for ISE methods and method-to-method calculation, printout is not
available.

Figure 8.1-6

A. Procedure

Select the measurement results to be output from search result list. (Refer to “8.1.1.
Measurement results.”)
Click the results from search result list to display the result details.

1. Output Time Course

⚫ Graph
Time course of the selected results is displayed on screen.

Figure 8.1-7

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⚫ Print
Time course of the selected results is displayed on screen.
When printing the display screen, press the [Print screen] button.

Figure 8.1-8

⚫ File
Saves the selected time course results in the specific CSV file.
The […] button enables to specify the destination folder to be s aved.

Figure 8.1-9

M1: Measuring point 1

M2: Measuring point 2
S2: Primary wavelength
W2: Water blank (primary wavelength)
R2: Reagent blank (primary wavelength)
S1: Secondary wavelength
W1: Water blank (secondary wavelength)
R1: Reagent blank (secondary wavelength)

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8.2 Print
Connecting to a printer enables to print the measurement results and setting contents.
Click the “Print” icon on each screen to print the setting contents.
For print setting, refer to “Chapter 16 Printer setting.”

8.2.1 Normal format

---------------------------------------------------------------------------------

Header (line 1) 2009/10/15 13:27

Sno.:001011 ID: Date: 2009/10/15 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 00 001.25

g/dl g/dl mg/dl

---------------------------------------------------------------------------------

1-line header is printed in normal format. (1 line: max. 20 characters and font size: 20
pt)

8.2.2 Report format

The report format is available to print out the results in report fo rmat.
-------------------------------------------------------------------------------

Header (line 1)

Header (line 2)

Header (line 3)

Header (line 4)

Header (line 5)

Print Date: 2005/07/04 Print Time: 13.39

Name: Date: 2005/07/04

Sno: Time: 13:32

Sample: Sex:

Comment: Age:

Physician: SSNo:

Department:

Method Units Results Flag Normal Range

TP g/dl 5.2 SS 0.0- 6.5

CHO mg/dl 18.2 SS 0.0- 199.0

--------------------------------------------------------------------------------

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1. Header
Header is available to configure the header up to five lines.
First line: max. 20 characters with 20 pt font size
Line 2 to 5: max. 50 characters with 10 pt font size per line

2. Patient information
Patient information is printed.

3. Measurement results
The measurement results are available to include information on flag and
normal range on the results report.
The results are available to customize report layout configuration.

8.3 Saves printing setting

1. Save
To save the printing setting, click the “Save” icon.

2. Cancel
To cancel the printing setting, click the “Cancel” icon.

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Chapter 9. Quality Control setting

Chapter 9 Quality Control setting

Here is described on the setting procedure to judge the quality of measurements and to
register the QC samples.

9.1 QC settings

QC (F8) > QC Settings

Specify the method and the QC sample for analysis.
It is available to register up to three QC samples per method.
Specify standard deviation for each method and QC rules.

Figure 9.1-1

1. Method No.
Select the Method No. from drop-down menu.
After selecting the method no., the name is displayed on the Method name.

2. Sample type
Select the Sample type (Serum Urine, Plasma, or Others) from drop-down
menu.

3. Interval
Enter the QC validity (from 0 to 999) in minute.
If "0", no check for QC validity will be performed.
If the QC validity has expired, the test will be displayed in yellow. The
measurement results will be added the flag (CXP flag) indicating that the QC
validity has expired.
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4. Mode
Select the mode for mean calculation used for judgment from drop-down menu.

⚫ Mean-R The mean value entered is used as reference.

The judgment value becomes the difference between the
entered mean values and the actual measurement results.

⚫ X-R The mean is calculated from the results obtained on the latest
QC results. The number of the latest QC results used for
mean calculation must be specified in the No. field. Judgment
value becomes the difference between the calculated mean
values and the actual measurement results.

5. No.
Specify the number of the latest QC results for mean value calculation (from 1
to 99) when selecting “X-R” in the Mode.

6. Test without QC
Specify “Disable” or “Enable" from drop-down menu.

7. QC Sample Name
Select the QC sample name from drop-down menu.

8. Mean Value
Enter the Mean value. (Mean-R)
When selecting “X-R” in the Mode, the mean value calculated from the
measurement results is displayed automatically.

9. SD
Enter the SD value (from 0.001 to 999.999).

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10. Rules
10 kinds of the error flags or warning flags can be specified.
The QC results are plotted on the result graph with colors indicating each
status.

⚫ INACTIVE: black

⚫ WARNING: yellow
⚫ ERROR: red

The highest priority error should be displayed if more than two errors or
warnings have found in the judgment result.

Error and warning description Code

Current result exceeds 2SD 1:2S

Current result exceeds 3SD 1:3S

Current result exceeds 4SD 1:4S

Last 2 results exceeds 2SD 2:2S

2 in last 3 results exceed 2SD 2/3:2S

Range exceeds 4SD R:4S

Any 3 results exceed 1SD 3:1S

Any 4 results exceed 1SD 4:1S

Serial 10 results exceed mean 10:X[+], 10:X[-]

Serial 7 results show increase/decrease 7:T[+], 7:T[-]

11. Registered QC Samples

The registered QC sample names are displayed.

12. Save
Saves the changes.

13. Cancel
Cancels the changes without save.

14. Print
Prints the QC settings.

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9.2 QC Sample Registration

QC (F8) > QC Sample Registration

This screen is available to register QC sample names up to 40 kinds (from Q1 to Q40).
The methods for the specified QC sample are displayed.

Figure 9.2-1

1. QC Sample ID
Select the QC Sample ID No. from drop-down menu. (1 to 40)

2. QC Sample Name
Enter the QC sample name. (up to 20 alphanumeric c haracters)

3. Sample Type
Select the Sample type (Serum Urine, Plasma, or Others) from drop-down
menu.

4. QC Sample Lot. No.

Enter the lot no. for the QC sample. (up to 6 alphanumeric characters)

5. Used methods
The methods corresponding to the specific QC sample are displayed.

6. Registered QC Samples
The registered QC sample names are displayed.

7. Save
Saves the changes.

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8. Cancel
Cancels the changes without save.

9. Delete
Deletes the registered QC sample ID.

<Procedure for deletion>

Select the QC Sample ID No. and press the “Delete” icon.
For saving, press the “Save” icon.
The pop-up message appears for confirmation.
Click the [OK] button to delete the ID. Click the [Cancel] button for
cancellation.

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Chapter 10 Patient information

Here is described on how to register patient information and its settings.

10.1 Patient information registration

Run (F5) > Patient Information

This screen is available to register the patient information.
The registered patient information on this screen can be selected from the [Test
Selection] screen.

Figure 10.1-1

1. Patient ID
Enter the Patient ID.
When the Patient ID is already existed, the information will be displayed.

2. Patient Name
Enter the patient name.

3. Classification
Select the classification from drop-down menu.
Classification data can be registered from the [System (F9)] > [Definition]
screen.

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4. Ward
Select the ward from drop-down menu.
Ward data can be registered from the [System (F9)] > [Definition] screen.

5. Bed No.
Enter the bed number (up to 10 alphanumeric characters).

6. Blood Type
Select the blood type from drop-down menu.

7. Medical Chart
Enter the medical chart number (up to 10 alphanumeric characters).

8. Social Security No.

Enter the social security number (up to 13 alphanumeric characters ).

9. Date of Birth
Enter the date of birth.
For entry, check the mark “Enable” ON and click the drop-down menu to select
the date from the calendar.

10. Age
It is automatically displayed from the Date of Birth.

11. Gender
Select the gender from drop-down menu.

12. Race
Select the race from drop-down menu.
Race data can be registered from the [System (F9)] > [Definition] screen.

13. Comments
Enter the patient information directly (up to 40 alphanumeric characters).

14. Reference 1 (Optional Field 1)

Enter any comments (up to 10 alphanumeric characters). The information that
previously entered is selectable from drop-down menu.

15. Reference 2 (Optional Field 2)

Enter any comments (up to 10 alphanumeric characters). The information that
previously entered is selectable from drop-down menu.

16. List
Displays the patient information list.

17. Record Count

The number of the registered patient information is displayed.

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10.2 Definition setting

System (F9) > Definition

Register the patient information and the related options for the measurement
orders.
The options registered on this screen are selectable in the [Normal Range] and
the [Test Selection] screens.

Figure 10.2-1

Select the Definition type from drop-down menu and edit the information for
each.
Following are the lists selectable from drop-down menu.

⚫ Physician: physician name (up to 32 alphanumeric characters)

⚫ Department: department name (up to 32 alphanumeric characters)

⚫ Race: race (up to 16 alphanumeric characters)

⚫ Sample Comment: comment on each sample (up to 15 alphanumeric

characters)

⚫ Ward: ward name (up to 20 alphanumeric characters)

⚫ Classification: (up to 20 alphanumeric characters)

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Add or edit the information in the following procedure.

A. Adding the definitions.

1. Select the Definition type from drop-down menu.

2. Click the [Add] button.

3. Enter the information on the entry field.

4. Click the “Save” icon.

B. Editing the definitions.

1. Select the Definition type from drop-down menu.

2. Select the information to be edited on the option list and click the [Edit] button.

3. Edit the information on the entry field.

4. Click the “Save” icon.

C. Deleting the definitions

1. Select the Definition type from drop-down menu.

2. Select the information to be deleted on the option list.

3. Click the [Delete] button.

4. Click the “Save” icon.

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Chapter 11 Daily checks

Here is described on daily maintenance procedure for analyzer accuracy and stability.

11.1 Back up

System (F9) > Backup Procedures

This screen is available to backup or load the database for system parameters and
measurement results.

Figure 11.1-1

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A. System Parameters backup

Perform backup procedure for system parameters.

Data backup for system parameters are follows:

⚫ Calibration setting

⚫ Calculated test setting

⚫ QC setting

⚫ Patient information

⚫ Multi-Calibrator

⚫ Method names and chemistry parameters

⚫ Normal range setting

⚫ Maintenance setting

⚫ Wash program setting

⚫ Reagent code

⚫ Reagent condition on the Reagent container

⚫ Order information (for inner tray)

⚫ Profile setting

⚫ Mask selection

⚫ Wake-up time/procedure setting from sleep mode

⚫ System settings

⚫ Template setting

⚫ Setting condition for Pre-measurement and Post-measurement

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Click the Directory [...] button and specify the directory before saving or loading.

1. Save Parameters
Perform backup procedure for system parameters.
When saving, the file name: “DBBack” is created in the specified destination to
be saved.

2. Load Parameters
Perform loading procedure for system parameters.
Click the [Load] button. The following pop-up message appears.

Figure 11.1-2

To execute, click the [OK] button. When completing the procedure, the
following pop-up message appears.

Figure 11.1-3

If any loading failure or no files in the specified directory, the following message
appears.
Perform reloading after confirmation.

Figure 11.1-4

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3. Directory
Select the directory to save or load the system parameters.
Specify HD on the operational PC or a USB flash memory as the destination
before saving or loading.

Figure 11.1-5

Specify the folder to save and click the [Open] button.

B. Database backup (HD)

Perform backup procedure for all data including measurement results.

Click the Directory […] button and specify the destination before saving or loading the
database.

1. Save Database
Click the [Save] button to perform data backup.
When saving, the file name: “DBBackupsave” is created in the spe cified
destination to be saved.

2. Load Database
Click the [Load] button to perform database loading.

3. Directory
Click the […] button to specify the destination before saving or loading the
database.
Specify HD on the operational PC or a USB flash memory as the destination to
save or load the database.

C. Load previous database

Database is automatically saved to HD after completion of each round.

Click the [Exec] button to load the previous database.

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11.2 Daily checks

Perform the following checks everyday to maintain the analyzer in good condition.

A. Before daily measurement

Refer to “4.4 Checks prior to measurement” and perform the checks.

B. Before the day begins

Refer to “4.1 Checks prior to use (at the beginning of the day) and perform the checks.

C. At end of the day

Refer to “4.5.2 Checks at the end of the day” and perform the checks.

D. Weekly

Check the following points on a weekly basis.

⚫ Supply/drain pumps
Check that each of the supply/drain pumps is in good condition.

⚫ Cuvettes
No contamination on the surface of the cuvettes
No cracks or defects on the cuvettes

⚫ ISE cleaning
Check that ISE cleaning is performed accordingly.

E. Other checks

Check the following points as needed.

⚫ Each solution for ISE unit (option)

Check the validity date of the solution for ISE module.

F. Replacement of consumable parts

Replace the following consumable parts periodically.

⚫ Halogen lamp

⚫ Syringe tip

⚫ Cuvettes

⚫ Stirrer

⚫ ISE electrodes (option)

For each of the replacement cycle and its procedure, refer to “Chapter 18 Maintenance
B. Consumable parts.”

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Chapter 11. Maintenance

11.3 Daily cleaning

Perform the analyzer cleaning and decontamination proc edure.

A. Daily

1. Cleaning for each unit

⚫ Sample/reagent pipette

⚫ Washing unit

⚫ Stirrer

⚫ Sample container

⚫ Reagent container

2. Cleaning of work bench

B. Weekly

1. ISE cleaning (option)

2. ISE Etching (option)

C. Every two weeks

1. Tube wash (when Degassing unit is applied)

D. Monthly

⚫ Supply/drain tubes cleaning

⚫ External tanks cleaning

⚫ Tube wash (when Degassing unit is not applied)

E. Other

⚫ Cuvettes cleaning
For details of cleaning and its procedure for each part, refer to “18.1 Periodical
checks”.

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 Chapter 12. Option

Chapter 12 Option

12.1 ISE unit

The ISE unit is installed inside the analyzer. This unit enables to measure sodium,
potassium, and chloride concentrations using the electrodes.

Figure 12.1-1

12.2 Barcode Reader

12.2.1 Reagent barcode reader

The reagent barcode reader is installed to the Reag ent container. This enables to
read the barcode labels on the reagent bottles and register the information by scanning
barcodes.

12.2.2 Sample barcode reader

The sample barcode reader is installed to the Sample container. This enables to read
the barcode labels on the sample tubes to recognize the sample.

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Chapter 12. Option

12.2.3 Barcode label specifications for sample and reagent

A. Sample barcode specifications

Type SID digit number Check digit Effective characters

UPC-A 10 digits *1 1 digit, Modulus 10 Numbers (0 to 9)

UPC-E *2 1 digit, Modulus 10 Numbers (0 to 9)

6 digits

JAN-13 12 digits 1 digit, Modulus 10 Numbers (0 to 9)

JAN-8 7 digits 1 digit, Modulus 10 Numbers (0 to 9)

ITF 3 to 15 digits 1 digit, Modulus 10 Numbers (0 to 9)

NW7
3 to 15 digits 1 digit, Modulus 16 Numbers (0 to 9), Symbols (-,$,/,.,+)
(CODABAR)
Alphanumeric (0 to 9, capital letters), Symbols
CODE39 3 to 8 digits 1 digit, Modulus 43
(-,.,&,/,+,%)
CODE128 Alphanumeric (0 to 9, capital letters), Symbols
3 to 15 digits 2 digits, Modulus 103
(set A) (!,#,$,%,(,),+,.,-,/,:,;,<,=,>,?,@,\)
Alphanumeric (0 to 9, capital and small
CODE128
3 to 15 digits 2 digits, Modulus 103 letters), Symbols
(set B)
(!,#,$,%,(,),+,-,.,/,:,;,<,=,>,?,@,\,),{,},~)
CODE128
3 to 15 digits 2 digits, Modulus 103 Numbers (0 to 9)
(set C)
*1
When using “UPC-A” for the sample barcode type, add “0” digit on the head of SID to make it 11 digits in total..
*2
When using “UPC-E” for the sample barcode, add “0” on the head of SID to make it 7 digits in total.

B. Barcode structure

Figure 12.2-1

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 Chapter 12. Option

C. Sample barcode label specifications

Bar module width 0.25 mm to 1.00 mm

Barcode height 12 mm or higher

Barcode length 73 mm or shorter, including the quiet zone

Quiet zone 4 mm or 10 times the length of the minimum module width, whichever the

greater

Printing Black on the white background

Quality standard must comply with the ANSI MH10.8M standard.

Barcode label location

D. Reagent barcode label specifications

Bar module width 0.25 mm to 1.00 mm

Barcode height 12 mm or higher
Barcode length 68 mm or shorter, including the quiet zone
Quiet zone 4 mm or 10 times the length of the minimum module
width, whichever the greater
Printing Black on the white background
Quality standard must comply with the ANSI MH10.8M
standard.
Barcode label location

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 Chapter 12. Option

12.2.4 Sample identification code

Sample category can be identified by using each of the dedicated barcode structure as
shown below.
General
Identification SID Digit
Sample category identification Details
code (SID) No.
code (*)

Normal sample xxxxxxxxxxxxxxx 3 – 15 xxxxxxxxxxxxxxx-nn1 xxxxxxxxxxxxxxx : Sample identification code

nn : Number of measurement

Normal sample xxxxxxxxxxxxxxx 3 – 15 xxxxxxxxxxxxxxx-nn1 xxxxxxxxxxxxxxx : Sample identification code

(emergency) nn : Number of measurement

Normal sample xxxxxxxxxxxxxxx 3 – 15 xxxxxxxxxxxxxxx-nn1 xxxxxxxxxxxxxxx : Sample identification code

(pediatric) nn : Number of measurement

Online sample xxxxxxxxxxxxxxx 3 – 15 xxxxxxxxxxxxxxx-nn1 xxxxxxxxxxxxxxx : Sample identification code

nn : Number of measurement

Online sample xxxxxxxxxxxxxxx 3 – 15 xxxxxxxxxxxxxxx-nn1 xxxxxxxxxxxxxxx : Sample identification code

(pediatric) nn : Number of measurement

Emergency sample 99000xxx 8 99000xxx-nn1 xxx : Sample identification code

nn : Number of measurement

Emergency sample 990009xx 8 990009xx-nn1 xx : Sample identification code

(pediatric) nn : Number of measurement

QC sample 970000xx 8 990000xx-nn1 xx : Sample identification code

nn : Number of measurement

Calibrator 98xxxxxy 8 98xxxxxy-nnm xxxxx : Reagent identification code

y : Classification (1 to 7)

nn : Number of measurement

m : Number of repetition

Multi-Calibrator 950000xy 8 950000xy-nnm x : Set number

y : Classification (1 to 7)

nn : Number of measurement

m : Number of repetition

Diluted Calibration 93xxxxx0 8 93xxxxxy-nnm xxxxx : Reagent identification code

y : Classification (1 to 7)

nn : Number of measurement

m : Number of repetition

Orderless sample 920000xx 8 920000xx-nnm Xx : Sample position code

nn : Number of measurement

m : Number of repetition

Blank sample 9510000x 8 9510000xnnm X : Sample identification code

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 Chapter 12. Option

General
Identification SID Digit
Sample category identification Details
code (SID) No.
code (*)

nn : Number of measurement

m : Number of repetition

Reagent blank 91xxxxx1 8 91xxxxx1nnm xxxxx : Reagent identification code

nn : Number of measurement

m : Number of repetition

⚫ The general identification code corresponds to the SID with a suffix added
depending on the number of measurements performed on that specific
sample.

⚫ The general identification code is displayed on the SID column in the Round
screen.

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Chapter 12. Option

12.3 External tank sensors

There are 2 types: transmission type photometric sensor for wash solution tank and
float type sensor for the wastewater tank. By linking the analyzer s oftware, the alarm
message appears when the wastewater tank becomes full or supply tank or wash
solution tank becomes under the specific level.

12.4 Degassing unit

This unit is installed inside the analyzer. This unit improves the accuracy of
dispensing by removing the air bubbles in the purified water supplied to the sample
dispensing system.

12.5 Clot detection sensor unit

Detects clots in the sample pipette.
This sensor monitors the pressure inside the sample pipette and helps detection of
clogs.
This function may not detect every clot in a sample. Actual sample condition should
be check and confirmed by operator prior to measurement.

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 Chapter 13. Reagent registration

Chapter 13 Reagent registration

Here is described on how to register the reagent codes and the reagent bottles.

13.1 Reagent codes

System (F9) > Reagent Registration

Prior to measurement, the necessary reagents including wash solutions and diluents
need to be registered.

Figure 13.1-1

Reagents and the bottle information that already registered are displayed in this
screen.
The reagent list indicates the registered reagent names on the left side of the screen.
Modify or delete the registered reagent information by clicking the cod e or name on the
list. To add reagent information, enter the reagent code and name on the blank
column directly.

Enter the reagent code (from 0 to 9, up to 5 digits). Code starting with ”000” or ending
with "00" cannot be used as reagent code.

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Chapter 13. Reagent registration

A. Registration procedure

1. Reagent Code
Enter a new reagent code in 5 numeric characters (00101-99999).

2. Reagent Name
Enter a new reagent name up to 6 alphanumeric and signs.

3. Reagent bottle types

The default reagent bottle types are indicated.
Available reagent bottle types are specified on the [System (F9)] > [System
Setup 2] screen. Max. 3 types can be specified.

4. R1
Check the mark “R1” ON to specify the initial volume of the registered reagent
bottle (unit: mL).
Check the mark “Stability Check” Enable ON to activate the stability check and
enter the stability term in days (from 0 to 99).

5. R2
Check the mark “R2” ON to specify the initial volume of the registered reagent
bottle (unit: mL).
Check the mark “Stability Check” Enable ON to activate the stability check and
enter the stability term in days (from 0 to 99).

⚫ The initial date for stability check corresponds to the registration date of the
reagent. Reagent out of date will be displayed with yellow background.

6. Wash Solution
Check the mark “Wash Solution” to specify the initial volume of the registered
wash solution bottle (unit: mL).

7. Diluent
Check the mark “Diluent” to specify the initial volume of the registered wash
solution bottle (unit: mL). Click [Save] icon to save changes.

B. Editing procedure

1. Display of bottle information

When clicking the reagent code or name on the list, the bottle information of the
reagent is displayed.

2. Editing of bottle information

Edit the bottle information to be modified. Click [Save] icon to save changes.

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13.2 Reagent bottle registration

Run (F5) > Inventory

Figure 13.2-1

Prior to measurement, place the necessary reagents in the Reagent container and
register the information in the [Inventory] screen.
The list on the [Inventory] screen indicates the reag ent information on the Reagent
container such as its type and its remaining volume.

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Chapter 13. Reagent registration

A. Reagent registration procedure (with reagent barcode reader) (option)

When placing the new reagent bottles, click the [Reagent Scan] button to update the
reagent information.
By clicking the [Reagent Scan] button, the barcode reader reads the barcode labels on
the reagent bottles to automatically obtain the necessary information on the reagent s
such as type, number, and bottle volume in full and register in the operational PC.

1. Reagent bottle placement

Place the necessary reagent bottles in the Reagent container.

2. [Reagent Scan] button

Add a reagent bottle in the Reagent container and press the [Reagent Scan]
button to automatically register the bottle information by scanning its barcode
labels.
When the barcode information already entered manually, the information on the
same position will be overwritten with the newly information from BCR. If not
added at the same position, the manually registered barcode # will be remained.
For the position where the BCR cannot read its barcode label, the existing
information will not be deleted.
It is also available to perform a barcode scan automatically when the lid of the
Reagent container is open/closed. This function can be set on the [System
(F9)] > [System Setup] screen.

⚫ When not equipped with Reagent BCR, the [RCU scan] button is invisible.

3. Remaining Volume Reset

This button is available to initialize the specified reagent bottle volume.

4. Clear added information

This button is available to delete the reagent information (such as the lot # and
validity term) of the specified bottle.

B. Reagent registration procedure (without reagent barcode reader)

1. Reagent bottle placement

Place the necessary reagent bottles in the Reagent container.

2. Selection of reagent name

Double-click the name column on the designated position of the list, and select
the name from drop-down menu.

3. Entry of reagent information

Enter the necessary information for the reagent registration.

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⚫ Reagent Type
Double-click the reagent type column on the designated position of the list, and
select the type from drop-down menu.

⚫ Lot
Double-click the lot column on the designated position of the list, and enter the
lot # directly (001-999).
When the lot # is not required, leave the column blank.

⚫ Size
Double-click the size column on the designated position of the list, and select
the size from drop-down menu.
All bottle types are available for the position # 1 to 25. The 20mL bottle size is
only available for the position # 25 to 50.

⚫ Vol (mL)
Double-click the Vol (mL) column on the designated position of the list, and
enter the remaining volume in mL directly.
When registering a new reagent, the volume of the reagent indicates max.
volume of the bottle.

⚫ The initial volume of the remaining reagent bottle indicates the v olume
deducting its dead volume from each reagent bottle volume.

⚫ Method
The method column indicates the registered method name.

⚫ Total
Displays the available number of measurements using all the reagents in the
Reagent container.

⚫ Expiry
Double-click the expiry column on the designated position of the list, and select
the date from the calendar.
When the expiry date is not required, leave the column blank.

⚫ Stability
Displays the stability term (in days) for the reagent bottle.
This is effective only for the reagents that checked the “Stability Check” ON in
the [Reagent Registration] screen.

4. Remaining Volume Reset

This button is available to initialize the specified reagent bottle volume.

5. Clear added information

This button is available to delete the reagent information (such as the lot # and
validity term) of the specified bottle.

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Chapter 14. Chemistry parameter setting

Chapter 14 Chemistry parameter setting

Here is described on chemistry parameter setting.

14.1 Setting of chemistry parameters 1

Parameter (F6)] > Chemistry Parameters 1

Specify measuring condition for each method prior to measurement.

Figure 14.1-1

1. Method No.
Select or enter method number. (1 to 60)
Regarding the registered methods, select from the list displayed by pressing the
[Space] key, or from drop-down menu. When specifying the number, the
registered information is automatically displayed.

2. Method Name
Select or enter method name (up to 6-digit alphanumeric and signs).
Regarding the registered methods, select from the list displayed by pressing the
[Space] key, or from drop-down menu. When specifying the number, the
registered information is automatically displayed.
The list displays the record of method names that already registered (up to 200
items).

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3. Print Name
Enter a print name (up to 15 digit alphanumeric and signs). The specified print
name will be printed out as the method name of print or file output. When not
specified, the method name registered in “Name” will be printed out.

4. Method Color
Specify color for the method. (from 60 colors)

5. Sample type
Select the sample type (Serum, Urine, Plasma, or Others) from drop-down
menu.

6. Unit
Specify the measuring unit for printout and host communication. (up to 6-digit
alphanumeric and signs)

7. Assay Type
Select the assay type (Rate or End) from drop-down menu.

8. Measuring Points
Specify the measuring points to be used for calculation of concentration.
Specify the starting and ending points of measuring points.
Set the points as “Start” < “End”. When selecting End assay, it is also
available to set the points as “Start”= “End”. When specifying the measuring
point 2, set the points as “Measuring point 1 < Measuring point 2”.
Select “Disable” when the measuring point 2 is not needed.

⚫ It is required at least 100µL in a cuvette as total volume for obtaining accurate

measurement results.

9. Wave length

⚫ Prime.
Select the primary wavelength among 12 wavelengths from drop -down menu.

⚫ Sec.
Select the secondary wavelength among 12 wavelengths from drop -down menu.
When not specifying the secondary wavelength, select “Disable” from
drop-down menu.

10. Normal
Enter the sample volume (1.5 – 35 µL with an increment step of 0.1µL) for
normal run.
Available to specify 3 levels (Low, Normal, and High) of the sampling volume.
Make sure to set the volume for each level as “Low < Normal < High”.
Check the mark "Dilution" ON to make the sample dilution active.

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⚫ Prior to applying the sample dilution function, it is required to register the

diluents.

11. Diluted Sample (µL)

When applying the sample dilution function, enter the dispensing sample
volume (1.5 - 35 µL with an increment step of 0.1µL) for the diluted sample.

12. Diluent (µL)

Enter the diluent volume (20 - 250 µL with an increment step of 1.0µL) for the
diluent.

13. Rerun (High/Prozone)

Specify the rerun volume (1.5 – 35 µL with an increment step of 0.1µL) when the
values are over the technical range.
If not required rerun, enter ”0”.
For the specific sample setting, follow same procedure as “Normal”.

14. Rerun (Low)

Specify the rerun volume (1.5 – 35 µL with an increment step of 0.1µL) when the
values are under the technical range.
If not required rerun, enter ”0”.
For the specific sample setting, follow same procedure as “Normal”.

15. Reagent Name

Specify reagent name for R1 and R2.
When not specifying the R2 reagent, select “Disable” from drop -down menu.
Reagents can be selected by pressing the [Space] key, or from drop-down
menu.

16. Reagent (µL)

Enter the R1 reagent volume (20 – 250 µL with an increment step of 0.1µL) and
R2 reagent volume (20 – 180 µL with an increment step of 0.1µL).

17. Water (µL)

Enter the purified water volume in diluting the reagent.
Enter the R1 reagent diluent (20 – 250 µL with an increment step of 1µL) and R2
reagent diluent (20 – 180 µL with an increment step of 1µL). When not
specifying water dilution, leave it as blank.

⚫ Total volume to run a measurement needs to be set from 100 to 350 µL.

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18. Diluent
Select the diluent when applying the sample dilution function.
Diluent can be selected by pressing the [Space] key, or from drop-down menu.
When not applying the sample dilution function, select “Disable” from
drop-down menu.

19. Sample Ppt. Wash

Specify the reagent name for washing.
Perform sample pipette wash before sample dispensing during measurement
and stirrer wash in the cuvette. (one wash: 400µL required)
Wash solution can be selected by pressing the [Space] key, or from drop-down
menu.
The items registered as wash solutions are displayed. When not specifying
the wash solution, select “Disable” from drop-down menu.

20. Stirring Speed

Specify stirring speed.
Five levels are available to select depending on the viscosity of the reagent.

⚫ Fastest For reagent of extremely high viscosity

⚫ Very Fast For reagent of particularly high viscosity

⚫ Fast For reagent of high viscosity

⚫ Middle Standard stirring

⚫ Slow For reagent of low viscosity

⚫ None No stirring of the reagent

21. Normal Range

Specify the normal range concentration values for different patient generation
ranges (max. 50 ranges).
Define the limit values for the registered normal ranges.
Enter the min. and max. normal range values for different patient generation
ranges (from 0 to 9999999). For the decimal places, set the Decimal Point
from drop-down menu.

⚫ Min When the results are lower than the min. value, the results are
flagged with a "L”.
⚫ Max When the results are higher than the max. value, the results are
flagged with a "H”.
When both of the min. and max. values are set as “0”, no normal range
judgment is performed.
For registration of the normal range name, go to [System(F9)] > [Normal Range]
screen.

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For modification of the registered patient generation ranges, go to [System(F9)]

> [System Setup2] screen.

22. Technical Range

For reliable measurement results, specify the range with the min. and max.
values for photometric and reagent reaction tests.
When the results are higher or lower out of the limit range, the results will be
added with “>” or “<” signs. The results are outputted with the limit range of
the concentration and absorbance values. The measurement will be
automatically rerun when the Auto Rerun function is ON.

⚫ (Conc.)
Specify the upper and lower limit values in concentration. (from 0 to 999999)

⚫ (mAbs./10)
Specify the upper and lower limit values in absorbance. (from -999999 to
999999)

23. Previous Result Comparison (%)

Specify the acceptable range of the difference compared to the previous results
for the patient ID.
The measurement will be automatically rerun for the out of range result s when
the Auto Rerun function is ON.
Displays the value (from 0 to 9999999) in mAbs ./10 and the percentage (%).
Rerun will be performed if either of the settings applies to the result. (For the
decimal places, set the Decimal Point from drop-down menu.)

24. Abnormal Range

When the results are higher or lower out of the specified range, the results will
be added with the “$” sign.
Specify the upper and lower limit values (from 0 to 9999999) in concentration.
For the decimal places, set the Decimal Point fr om drop-down menu.

25. Panic Range

When the results are higher or lower out of the specified range, the results will
be added with the “!” sign.
Specify the upper and lower limit values (from 0 to 9999999) in concentration.
For the decimal places, set the Decimal Point from drop-down menu.

26. Decimal Point

Specify the decimal places to indicate the measurement values.

27. Profile SI

⚫ Enable
SI is automatically performed.

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⚫ Disable
SI is not automatically performed when selected.

28. Copy
Copy the information set on this screen. Check the mark “Copy” ON to specify
the method no. or the method name to be copied.

29. Import/Export
The method information can be exported/imported to/from the USB flash
memory.

⚫ Import
Press the […] button to select the folder to retrieve the method from.
Press the [Import] button.
After importing the data, the method name appears in the “Name” box.
The method name that has already existed in the database is not overwritten.
When multiple methods are saved in the selected folder, all methods are subject
for importing.

⚫ Export
Press the […] button to select the folder to save the method to.
Press the [Export] button.
After exporting the data, the same method name folder is created in the
selected folder.
If the same folder (or sub folder) name already exists, the existed data is
overwritten with the new folder.

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⚫ Min. and max. required volume for reaction

Min. volume: 100µL
Max. volume: 350µL
Sampling (Low/Normal/High）+R1(Reagent) + R1(Water) + R2 (Reagent) + R2
(Water)

⚫ Auto Rerun
- For Auto rerun setting, refer to “17.10 Other settings.”

Only applicable for normal or STAT sample.

No automatic rerun for reruned sample.
Following is the conditions for auto rerun:
* Error flags (LIN, PRO, ABS)
Rerun measurement under the high/prozone conditions.
* Out of the Technical range (high)
Rerun measurement under the high/prozone conditions.
* Out of the Technical Range (low)
Rerun measurement under the rerun conditions (low).
(If Errors (LIN, PRO, or ABS) occur at the same time, rerun measurement will be
performed under the high/prozone conditions.)
- For ISE rerun setting, refer to “17.10 Other settings.”

⚫ Volume correction for rerun results

When the sample volume for rerun is different from initial volume, the result will
be offset using offset formula.
When specifying different sample volumes, the results cannot be compared
because final volume will be different. Rerun results can be corrected to no rmal
results using the following offset formula.
Corrected rerun results = rerun result×(normal volume percentage/rerun volume
percentage) where:
Normal volume percentage=(S/(S+R1+R2))
Rerun volume percentage=(SR/(SR+R1+R2))
R1 ：R1 volume
R2 ：R2 volume
S ：Normal sample volume
SR ：Rerun sample volume at the rerun (high limit)
：Rerun sample volume at the rerun (low limit)

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14.2 Setting of normal range

System (F9) > Normal Range

Specify the normal range name applying for the measurement results judgment (up to
50 names).

Figure 14.2-1

1. Click the normal range No. to add the range name.

2. The entry window appears. Enter the range name.

3. Click the “Save” icon.

⚫ Normal Range No. 01 to 06 is preset as default setting.

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14.3 Setting of chemistry parameters 2

Parameter (F6) > Chemistry Parameters 2

Specify measuring condition for each method prior to measurement.

Figure 14.3-1

A. Method selection area

Enter the necessary information on chemistry parameter s 2.

Figure 14.3-2

1. Method No.
Specify or enter method no.
Registered methods can be selected by pressing the [Space] key, or from
drop-down menu.

2. Method Name
When specifying the number, the registered information is automatically
displayed.

3. Sample
Specify the chemistry parameter depending on the Sample type. Select the
sample type (Serum, Urine, Plasma, or Others) from drop-down menu.

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B. Limit check area

Figure 14.3-3

1. Duplicate Limit
Perform variation check of the duplicate or triplicate measurement in each of the
calibration points.
Specify the limit value (from 1 to 99,999) of absorbance difference (mAbs./10) in
duplicate or triplicate measurement. In case of triplicate measurement, the
maximum and minimum values will be used for the variation check.
When the variation is higher than the specified duplicate limit value, “DUP” flag
will be added. Calibration will not be updated when the “DUP” flag is
displayed.

2. Sensitivity Limit
Perform sensitivity limit check. Variation between the first and last points of
calibration is checked.
Specify the sensitivity limit value in mAbs./10 (from 1 to 99999). When the
variation is lower than the specified sensitivity limit value, “SEN” flag will be
added. Calibration will not be updated when the “SEN” flag is displayed.

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3. Linearity Limit
Linearity of time course reaction will be checked. This check is applied only for
rate assay. This check is not applied during calibration measurement.
Specify the threshold value in percentage (from 0.1 to 99.9) and the absorbance
value (from 1 to 99999) in mAbs/10 per min.
Moving average of the first 3 measurement points (△ABS1) and last 3
measurement points (△ABS2) will be used for calculation of linearity.
Linearity will be judged by comparing slope rate between △ABS1 and △ABS2.
For 2 point rate assay, measuring points of second measuring range will be
used.
Linearity %: |△ABS1-△ABS2| / |△ABSt| x 100 %
If the linearity rate calculated from above is higher than the specified limit, the
linearity error occurs. The “LIN” flag will be added with the results.
The linearity check will not be performed in the following cases.

⚫ The assay type is not defined “Rate”.

⚫ |△ABSslope | is lower than the threshold value.

⚫ |△ABSfirst - △ABSlast | is lower than the threshold value.

⚫ Less than 4 measuring points are set for measuring points.

⚫ Another error with higher priority occurs.

⚫ The selected sample category is QC sample or ISE.

4. Prozone Limit
Perform prozone limit check. Not applied during calibration measurement.
Specify the prozone limit percentage (from 0.00001 to 99.99999) and select
“Higher” or “Lower” depending on the reaction type. Select starting and ending
points for slope 1(△ABS1) and 2 (△ABS2). These two slopes will be
compared for the judgment of prozone. Enter sensitivity limit value in
mAbs./10. Prozone limit check will not be performed when △ABS1 is under
the sensitivity limit value. Prozone limit check will be judge d by the following
formula:
Prozone = (Slope △ABS2 / Slope △ABS1) x 100 %

△ABS1 = (A1F-A1S) / (T1F-T1S)

△ABS2 = (A2F-A2S) / (T2F-T2S)

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5. Absorbance Limit
Perform absorbance limit check. This check is applied for only rate assay.
Specify the reaction type (increase / decrease) and the absorbance limit in
mAbs./10 (from 1 to 999999).
Upper limit will be checked for increase reaction and lower limit will be checked
for decrease reaction.
Absorbance for the calculation will be obtained using the following formula:
(Absorbance of primary wavelength) – (water blank of primary wavelength) <
limit
The absorbance value within the measuring range 1 is checked for 1-point rate
assay, and the absorbance value within the measuring range 2 is checked for
2-point rate assay.
"AB1" flag will be added when the only first point of measuring point is within the
absorbance limit or all the points are out of the absorbance limit. The result is
not calculated in this case.
"AB2" flag will be added when only two measuring points or less than 1
measuring point from total measuring points are within the limit. Measurement
result will be calculated using only those points within the limit. When 6 or
more continuous measuring points are within the limit, the “AB2” flag is not
displayed.

C. Blank measurement area

1. Blank measurement
Specify the measuring condition for reagent blank.

⚫ Disable reagent blank and C1 blank

The reagent blank and C1 (first point of calibration) blank are not performed. It
is required to perform full calibration.

⚫ Enable C1Blank (Factor or Linear)

The C1 (blank sample) absorbance value will be used to offset calibration curve.
Only valid for factor and linear type of calibration.

⚫ Enable reagent blank

The blank is performed without sample or with system wa ter instead of the
sample to obtain reagent blank absorbance of R1/R2 reagents. Reagent blank
value will be used to offset the sample measurement result. Calibration curve
will not be offset after reagent blank measurement.

⚫ Enable reagent blank for C1

Reagent blank value will be used for the first calibration point (C1) to offset
calibration curve.
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2. Measurement of Reagent Blank during Run

Select when to perform the blank measurement.
This option is effective only when selecting “Enable reagent blank” or “Enable
reagent blank for C1 (Linear)”.

⚫ Daily
The reagent blank measurement is performed on a daily basis. Reagent blank
measurement will be performed at the beginning of each run.

⚫ Next Run
The reagent blank measurement is performed at the beginning of each run.

⚫ None
The reagent blank measurement is not performed automatically. Latest
reagent blank will be used for calculation and offset.

3. Reagent blank measurement at calibration

Select sample condition for the reagent blank.

⚫ Reagent blank (No sample)

Only the reagent is used for reagent blank measurement.

⚫ Reagent blank (system water)

The reagent blank is performed with the corresponding reagent volume and the
system water is used for a sample.

4. The number of measurement

Select the number of measurement for reagent blank.

⚫ Single
Determines the reagent blank value in one measurement results.

⚫ Duplicate
Determines the reagent blank value as an average between two measurement
results.

⚫ Triplicate
Determines the reagent blank value as a median among three measuremen t
results.

5. Reagent blank limit checks

Select the Duplicate Limit check box and enter the absorbance limit in mAbs ./10
to perform a check on the variation of the reagent blank.
Tick the Duplicate Limit ON and enter the limit (from 1 to 99999).

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D. Instrument Factor

The instrument factor setting allows a correction using a linear equation of the results
obtained on the instrument to be consistent with other instrument.

Figure 14.3-4

Specify the slope (a) and intercept (b) of the correlation factor. The result will
be offset using a linear equation: y=ax+b.
a is the slope (from -99.99 to 99.99)
b is the intercept (from -999.99 to 999.99)

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14.4 Setting of Chemistry parameters for ISE (option)

Parameter (F6) > Chemistry Parameters for ISE

Specify measuring condition for ISE parameters.

Figure 14.4-1

A. Sample selection area

Enter the necessary information on samples.

Figure 14.4-2

1. Sample Type
Specify the ISE chemistry parameter depending on the sample type.
Select the Sample type (Serum, Urine, Plasma, or Others) from drop-down
menu.

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2. ISE Type
Select the ISE type from drop-down menu.
When selecting "Others” in the sample type, “ISE” or “ISE(U)” is selectable in
the ISE type.
When selecting “Serum" or “Plasma” in the sample type, “ISE” in the ISE type is
selected.
When selecting “Urine” in the sample type, “ISE(U)” in the ISE type is selected.

3. Urinary Diluent
When selecting “ISE(U)” in the ISE type, select ISE diluent form drop-down
menu.

B. Correction area for ISE Instrument Factor

The instrument factor setting allows a correction using a linear equation of the results
obtained on the instrument to be consistent with other instrument.

Figure 14.4-3

1. Instrument Factor
Specify the slope and intercept of the correlation factor for each electrode in
correction area for the ISE correlation factor.
Enter the correlation factor for Na, K, and Cl for correction using a linear
equation: y=ax+b.
a is the slope (from -99.99 to 99.99)
b is the intercept (from -999.99 to 999.99)

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C. Normal range setting area

Specify the normal range values for ISE results in the normal range names registered
in the [Normal Range] screen.

Figure 14.4-4

1. Normal Range
Specify the limit values for each normal range.
Define the limit values (min. and max.) for each electrode (Na, .K, or Cl).
Validation range:
Na: 0～999.9
K: 0～99.99
Cl: 0～999.9
Lower value: The flag “L” will be added when the measurement value is under
the lower limit.
Higher value: the flag “H” will be added when the measurement value is over the
higher limit.

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14.5 Setting of Serum Indices

Specify measuring condition for serum information to perform SI measurement.
Prior to SI measurement setting, select “Enable” at the Profile SI on the [Chemistry
Parameters 1] screen.

⚫ Criteria
Under hemolysis, turbidity or increased bilirubin level condition in serum, the
medical agent or its metabolic products may adversely affect measurement
results.
This analyzer enables to indicate hemolysis, turbidity or increased bilirubin
level of a sample and the qualitative judgment from the numeric results.

Parameter (F6) > Serum Indices

Figure 14.5-1

A. Reagent selection area (for maintenance only)

Figure 14.5-2

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1. Reagent Type
Select the reagent type (R1 or Dil) from drop-down menu.

2. Reagent Name
Select the reagent name from drop-down menu.

3. Volume
Enter dispensing reagent volume (from 20 to 350) in µL.

4. Sampling Volume
Enter sampling volume in µL.

B. Factor setting area (for maintenance only)

Figure 14.5-3

1. Factor A to Factor F
Enter factor A, B, C, D, E, and F (from 0 to 999999).

C. Instrument factor area (for maintenance only)

Figure 14.5-4

1. Hemolytic, Lipid, and Icteric

Enter the slope (a) and intercept (b) for hemolytic, lipid, and icteric for correction
using a linear equation: y=ax+b.
a: -99.9 to 99.9
b: -999.99 to 999.99

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D. Judgement range setting area

Figure 14.5-5

1. Hemolytic, Lipid, and Icteric

Hemolytic ：Judgment range setting for hemolytic
Lipid ：Judgment range setting for lipid
Icteric ：Judgment range setting for icteric
Enter the qualitative limit up to 5 characters (left column).
e.g.). When specifying “0” < “1” in Hemolytic, “H0” will be printed out on the
results that values in hemolytic is higher than 1.
Enter the qualitative threshold value (from 0 to 999999) (right column).

E. SI automatic selection area (for maintenance only)

Figure 14.5-6

1. Profile SI Mode
Select serum information automatic selection mode from drop-down menu.

⚫ Enable
SI is automatically selected when specifying SI as measurement method in the
[Test Selection] screen.

⚫ Disable
SI is not automatically selected when not specifying SI as measurement method
in the [Test Selection] screen.

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14.6 Calculated test setting

Specify the method to method calculation.
The method to method calculation is performed when all the tests in the calculation are
ordered. This calculation results is considered as a measurement result. (For
example, “A/G” ratio is automatically calculated using the results of “TP” and “ALB”.)

Parameter (F6) > Calculated Test

Figure 14.6-1

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A. Method selection area

Figure 14.6-2

1. Calculated Test No.

Enter the method number (from 3001 to 3040).

2. Calculated Test Name

Enter the method name (up to 6 alphanumeric and signs).
When specifying a method name already registered, the information is
automatically displayed.

3. Print Name
Specify method name for printout (up to 15 alphanumeric and signs).
The method name is output as the file or on the report. When the print name is
not specified, the calculated test name will be used.

4. Sample type
Select the sample type (Serum, Urine, Plasma, or Others) from drop -down
menu.

5. Unit
Specify the measuring unit for printout and host communication.
Up to 6 alphanumeric and signs.

6. Decimal Point
Select the decimal places displayed as the measurement results.
(from 0 to 5)

7. Expression
Enter the calculation method (up to 10 methods).
Double-click the method name from the method list to enter the expression.
When entering the calculation method, check that there are no errors in the
formula. If any errors, it cannot be saved.

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B. Normal range setting area

Figure 14.6-3

1. Normal Range
Enter the values using method to method calculation for the normal range
names registered in the [Normal Range] screen.
Select the range value and double-click to edit.
“Max” value must be higher than “Min” value. When entering the Min. value
only, the max. value of the result will not be checked. When entering the Max.
value only, the min. value of the result will be not verified.
When measurement result is lower than the min. value, the result will be flagged
with a "L". When measurement result is higher than the max. value, the result
will be flagged with a “H”.

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C. Method list area

Figure 14.6-4

1. Calculation symbols (“+”, “-”, “*”, “/”, “(”, “)”)

Click the calculation symbol to enter it into the expression area.

2. Method No. list

Double-click the method name from the method list to enter into the expression.

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14.7 Profile setting

Parameter (F6) > Profile

Figure 14.7-1

This setting is available to register a profile as a group of measurement methods.

Up to 20 different profiles can be registered for a sample type.

A. Profile setting area

Figure 14.7-2

1. Profile No.
Specify or enter the Profile No. (from 1 to 20).

2. Profile Name
Enter the profile name (up to 10 alphanumeric and signs).
If a profile is already registered for the profile number, it will be automatically
displayed.

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3. Sample Type
Select the Sample type (Serum, Urine, Plasma, or Others) from drop-down
menu and specify the methods.

B. Method selection area

Figure 14.7-3

All methods registered for the Sample type are displayed.

Tick the method ON to be added for the profile.

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14.8 Template Setting

Run (F5) > Auto Template

Figure 14.8-1

This screen is available to set the samples on the Sample tray with its specified
methods as a set order “Template”.
This function enables to automatically start measurement for the registered template
at the designated time.

A. Template setting area

Figure 14.8-2

1. Template No.
Select Template no. (from 1 to 10).

2. Template Name
Enter the Template name (up to 6 alphanumeric and signs) directly or display it
from drop-down menu.

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B. Time reservation area

Figure 14.8-3

1. Auto Template
Select the Auto Template (Enable or Disable) from drop-down menu.

2. Day/Week
Select the Day or Week and specify the date to perform the auto template
function.
When selecting “Day”, select “*” (everyday), “E” (end of the month), or specific
date of the month.
When selecting “Week”, select from “Monday” to “Sunday”.

3. Time/Round No.
Select the Time or Round No.
Specify the duration or the designated round #.

When selecting the [Test Selection] screen at the registered time, the following pop-up
message appears indicating whether to implement the registered template setting.
Click the [OK] button to implement the template order. Or click the [Cancel] button to
cancel the template order.

Figure 14.8-4

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C. Order registration area

Figure 14.8-5

Specify the position # and the methods for each sample.

Refer to “Chapter 6 Test Selection” for registration.

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14.9 Measurement order setting

Parameter (F6) > Order

Figure 14.9-1

This screen is available to specify the measurement order and the print order.

A. Measurement order area

Figure 14.9-2

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1. Measurement Order
Specify the method order.
Drag the method name into the designated order number to change the order
for measurement.

2. Same Order
Tick the same order ON to make the print order as same as the measurement.

B. Print order area

Figure 14.9-3

1. Print Order
Specify the print order.
Drag the method name into the designated order number to change the order
for print. Tick the same order ON to make the print order as same as the
measurement.

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14.10 Wash program setting

To wash reagent pipette that commonly used in several parameters, the reagent
pipette wash program is available to set in the interval between the methods. Since
this reagent pipette wash is performed during measurement, it may reduce the number
of the measurements.

Parameter (F6) > Wash Program

Figure 14.10-1

A. Method selection area

Figure 14.10-2

1. Method 1
Select the reagent in Method 1 from drop-down menu.
When selecting all methods, tick “All” ON.

2. Method 2
Select the reagent in Method 2 from drop-down menu.
When selecting all methods, tick “All” ON.

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B. Pipette Wash setting area

Figure 14.10-3

1. Reagent Type
Select the reagent type (Disable, R1, R2, or Wash Solution) from drop-down
menu.
Select “Disable” when not performing reagent pipette wash.

2. Reagent Name
Select the reagent name from drop-down menu.

C. Cuvette wash setting area

Figure 14.10-4

1. Extra Cuvette Wash

In case of incompatibility between reagents that cannot be solved by
measurement order, use the new cuvette instead of the cuvette in use for
measurement.
Select the extra cuvette wash (Disable or Enable) from drop-down menu.
A cuvette previously used for the set method will not be reused.
The used cuvette will have washing cycles by checking the Extra Cuvette Wash
“Enable” ON.
After completing the extra cuvette wash, the cuvette can be used for all
methods including the set method.

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 Chapter 15. Calibration registration and settings

Chapter 15 Calibration registration and settings

Here is described on the preparation of the calibration curves prior to measurement.

A. Calibration curve

Prior to sample measurement, it needs to register the calibration curve for each
method. To register the calibration curve, perform calibration using max. 7
calibrators.
Periodical calibration for each method is required for measurement accuracy and
reliability. The validity check function is available for the calibration curves and the
calibrator.
For the calibration curve calculation, refer to “2.2.5 Calibration curve parameters.”

B. Calibration

There are 2 kinds of calibrations.

1. Full calibration
Prepare a calibration curve using all necessary calibrators and prepare and
update the master calibration curve.

2. Recalibration
Update the work calibration curve using one-point or two-point calibration.
When the calibration curve is selected as “linear”, perform one -point correction
using C1 calibrator. When the calibration curve is selected as “Log-Logit”,
“Spline”, “Spline 2”, or “Exponential”, perform correction using one-point or
two-point calibration.
Perform one-point calibration correction using one point other than the first
point of calibration (C1) and two-point calibration corrections using “C1” and
another point.

C. Calibration curve parameters

There are 2 calibration curves.

1. Master
Indicates the calibration curve obtained from full calibration.

2. Work
Indicates the calibration curve obtained from recalibration.
For the normal measurement, the work calibration curve is a pplied.
When recalibration is not performed, master calibration curve is used as work
calibration curve.

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D. New/Old calibration curve

When using different lot numbers of the same reagent, each of the calibration curves is
respectively stored as “New” or “Old”.
In the regular measurement, the calibration curve stored as “New” is applied, however,
when performing measurement using the same lot number that stored the calibration
curve as “Old”, the "Old" data is applied.
The following are examples of the calibration curves “New” and “Old”.

⚫ Examples:
1st: The calibration curve is stored in “New”.
2nd: The new calibration curve with different lot number is stored in “New”.
The 1st calibration curve is transferred from “New” to “Old”.
3rd: The new calibration curve with different lot number is stored in “New”.
The 1st calibration curve is deleted in “Old”.
The 2nd calibration curve is transferred from “New” to “Old”.

⚫ When changing the lot number of the reagent, perform full calibration.

When performing calibration with the same lot number of the reagent, the calibration
curve in “New” is transferred to “Old”. The newly obtained calibration curve is stored
in “New”.
If any error occurs during calibration, the calibration result will not be applied as a
calibration curve.
In case of the expired reagent, the existing calibration result is applied as the
calibration curve.

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15.1 Calibration registration

Calibration (F7) > Calibration Registration

Figure 15.1-1

1. Method No.
Select the method #.
Select by pressing the [Space] key to display the method list, or from drop -down
menu. Or enter the method # directly.

2. Method Name
The method name is automatically displayed after selecting the method #.

3. Sample Type
Select the sample type (Serum Urine, Plasma, or Others) from drop-down
menu.

4. Replication
Select the number of calibration measurement from drop-down menu. The
calculation varies depending on the number of the calibration measurement.

⚫ Duplicate
Perform calibration twice for each calibration point and calculate the mean value
from the 2 calibration results.
⚫ Triplicate
Perform calibration three times for each calibration point and calculate the mean
value from the 3 calibration results.

5. Check Interval
Specify the valid term (from 1 to 99 days) for the calibration result.
“0” indicates no valid term for the calibration result.

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6. Test without Calibration

Specify to restrict to measure the method without valid calibration curve.
Select “Disable” or “Enable” from drop-down menu. When selecting“Disable”,
the ordered method will be proceeded without this restriction. Existing
calibration will be used for calculation. When selecting “Enable”, the method
without valid calibration curve is restricted.

7. Calibration Type
Select the calibration type (Factor, Linear, Point To Point, Log-Logit, Spline,
Spline2, or Exponential) from drop-down menu.

8. Reagent Lot
Select the reagent lot (New or Old) from drop-down menu.

9. Add
Clears the WORK/MASTER information when selecting "Old” in Reagent Lot.

10. Calibrator Name

Enter the calibrator name (up to 8 alphanumeric characters).

11. Conc.
Enter the concentration values (from 0 to 9999999) for each calibration point
from C1 to C7. It needs to specify the setting prior to calibration measurement.
When specifying the calibration curve as “Factor”, no needs to enter
concentration values.

12. WORK
Indicates the absorbance values for the calibration results.
Master corresponds to full calibration, whereas Work corresponds to
recalibration. It is available to edit the absorbance values by the calibration
type except "Factor”.

13. MASTER
Indicates the absorbance values for the full calibration results. It is available to
edit the absorbance values by the calibration type except "Factor”.

14. Calibrator Lot. No.

Enter the lot # for the calibrator. It is available to enter the calibrator lot # for
the calibration type except "Factor”. When all calibration points share the
same calibrator lot #, check the ”All” ON.

15. K
When selecting the calibration curve as “Factor”, enter K value (from
-99999.999 to 99999.999, except 0). When selecting the calibration curve as
“Linear”, K value will be calculated and displayed automatically according to the

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calibration result.

16. C1 Blank
Displays when selecting “Linear” or "Factor” in the calibration type.
The check mark indicates that blank measurement is selected as “Enable C1
Blank (Factor or Linear)" in the [Chemistry Parameters 2] screen to perform C1
blank measurement.

17. Reagent Blank for C1

Displays when selecting “Linear” in the calibration type.
The check mark indicates that blank measurement is selected as “Enable
reagent blank for C1(Linear)" in the [Chemistry Parameters 2] screen to set the
reagent blank value as C1. When using this function, C1 does not need to be
placed on the Sample tray for calibration measurement.

18. Reagent Lot No. (R1) (R2)

The reagent lot numbers are displayed for R1 and R2 reagents. The reagent
lot number displayed is switched by changing the Reagent lot (“New” or “Old”).

19. Last
Displays the last calibration date. The date displayed in “Last” column is
changed by switching the Reagent lot (“New” or “Old”).

20. Graph
The graph displays the Master calibration curve in red and the Work calibration
curve in blue. The graph indicates absorbance value (vertical line) and
concentration (horizontal line).

21. Reagent blank

The last reagent blank result (mAbs./10) is displayed as well as its latest
measurement date.

22. Blank
The last C1 blank result (mAbs./10) is displayed as well as its latest
measurement date. Available for only Factor or linear calibration type.

23. Concentration conversion simulator

Calculate the concentration value by the absorbance value using the calibration
curve. Select the Calibration Curve (“Work” or “Master”) from drop -down menu.
Enter the absorbance value (-999999 to 999999). Click the [Recalculation]
button for recalculation. The concentration value after conversion is displayed
in the Conc. (0 to 9,999,999).

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15.2 Diluted calibration

Calibration (F7) > Diluted Calibration

Figure 15.2-1

Perform calibration after auto dilution setting for the calibrator into several
concentrations from the highest concentration.

1. Method No.
Select the method #.
Select by pressing the [Space] key to display the method list, or from drop -down
menu. Or enter the method # directly.

2. Method Name
The method name is automatically displayed after selecting the method #.

3. Sample Type
Select the sample type (Serum Urine, Plasma, or Others) from drop-down
menu.

4. Calibrator Lot. No.

Displays the calibrator lot #.
If using different calibrator lot number by each concentration, only the lot
number corresponding to the higher concentration will be displayed f rom the
registered information in the [Calibration(F7)] > [Calibration Registration]
screen.

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5. Conc.
The concentration value displayed is the value of the original cal ibrator that
registered in the [Calibration(F7)] > [Calibration Registration] screen.

6. Sample (uL), Diluent (uL)

The default value is displayed after calculating the highest concentration
calibrator with the specified concentration.
The approximate value is displayed in red if not performing in a target dilution
rate within the available dispensing range.
The sample volume can be edited within the range.

⚫ The available dispensing range

Sample volume: 1.5 to 35 μL with an increment step of 0.1 μL
The diluent volume: 20 to 250μL with an increment step of 1.0 μL
Specify the total volume of the sample and the diluents within 70 to 285μL.

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15.3 Multi-Calibrator

Calibration (F7) > Multi-Calibrator

Figure 15.3-1

This is to define the methods using the same multi calibrator.

1. Multi-Calibrator No.
Select the multi-calibrator # (from 1 to 10) from drop-down menu.

2. Multi-Calibrator Name
Enter the multi-calibrator name (up to 6 alphanumeric and signs).

3. Sample Type
Select the sample type (Serum, Urine, Plasma, or Others) from drop-down
menu.

4. Method
Check the mark ON to select the methods to be associated with the
multi-calibrator.

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15.4 Result of ISE calibration (option)

Calibration (F7) > Result of ISE Calibration

Figure 15.4-1

The screen enables to display the latest ISE calibration results.

1. Date Time
Displays the last calibration date and time.

2. Na (38-65), K (37-67), Cl (28-53)

Acceptable range for each ion is displayed between brackets. When
calibration results are out of range, a "H" or "L" flag is added in red.

3. ERROR CODE
In case of errors on one of the electrodes during the calibration, the calibration
result will be indicated in red and the error code will be displayed.
For details on the error codes, refer to “19.7 ISE error codes (option)”.

4. Voltage
Displays the calibration voltage in each electrode low and high standard value.

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Chapter 16. Printer setting

Chapter 16 Printer setting

Here is described on the printer settings.

16.1 Printer report format modification

System (F9) > Define Report Format

Figure 16.1-1

Specify the printer report format and the print copies.

This screen is available to modify the item name on the format.

1. Header
The header (5 lines) layout enables to change by drag and drop.

2. Print date and time

The layout of the print date and the print time enables to change by drag and
drop.

3. Patient information
The layout of each item on the patient information enables to change by drag
and drop. Also enables to edit the item within the following specified
characters by double-clicking it.

⚫ Patient (up to 8 alphanumeric characters)

⚫ ID: patient ID (up to 6 alphanumeric characters)

⚫ SID: sample ID (up to 6 alphanumeric characters)

⚫ Sample Type (up to 12 alphanumeric characters)

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⚫ Comment: comment by sample (up to 12 alphanumeric characters)

⚫ Physician (up to 12 alphanumeric characters)

⚫ Department (up to 12 alphanumeric characters)

⚫ Medical Chart (up to 12 alphanumeric characters)

⚫ Classification (up to 16 alphanumeric characters)

⚫ Bed No. (up to 12 alphanumeric characters)

⚫ Collection Date (up to 20 alphanumeric characters)

⚫ Date: measurement date (up to 8 alphanumeric characters)

⚫ Time: measurement time (up to 8 alphanumeric characters)

⚫ Gender (up to 10 alphanumeric characters)

⚫ Age (up to 6 alphanumeric characters)

⚫ SS No.: social security number (up to 10 alphanumeric characters)

⚫ Race (up to 8 alphanumeric characters)

⚫ Ward (up to 8 alphanumeric characters)

⚫ Blood type (up to 12 alphanumeric characters)

⚫ Reference 1: same as “Optional Field 1” specified in the [System Setup 2]

screen (up to 10 alphanumeric characters).

⚫ Reference 2: same as “Optional Field 2” specified in the [System Setup 2]

screen (up to 10 alphanumeric characters).

4. Results display
The layout of each result item enables to change by drag and drop.

⚫ Method

⚫ Results

⚫ units

⚫ Flag

⚫ Normal Range

⚫ RLot1: Lot # of R1 reagent

⚫ RLot2: Lot # of R2 reagent

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5. Enable Print Label

Specify the header printed ON or OFF.

6. Max Line By Page

Specify the maximum lines per page.

7. Print Copy Number

Specify the number of copies for printout.

16.2 Live Print out setting

System (F9) > System Setup 1

Figure 16.2-1

This screen is available to specify automatic result printout setting (ON/OFF) and edit
the header printed on each report.

1. Enable <default setting: OFF>

When the “Enable" is ON, the result report (normal or report type) is
automatically printed after the measurement. (when connecting to the printer.)

2. Enable Live QC Report <default setting: OFF>

When the “Enable" is ON, the result report is automatically printed after the QC
measurement. (when connecting to the printer.)

3. Printout Header
The header printed on each report can be specified up to 5 lines.
(Line 1: up to 20 alphanumeric characters, Line 2 to 5 for each : up to 50
alphanumeric characters)

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 Chapter 17. System settings

Chapter 17 System settings

Here is described on system settings on the analyzer.
It is available to specify the system settings on the [System Setup 1] and the [System
Setup 2] screens.

System (F9) > System Setup 1

Figure 17.1-1

System (F9) > System Setup 2

Figure 17.1-2

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17.1 Host communication setting

Figure 17.1-3

A. Host Communication Mode <Default setting: Off line>

Select the host communication mode from the following.

1. Off Line
The measurement is executed according to the analyzer settings without
communication to host computer.

2. On Line Batch
The measurement is executed according to the orders received from host
computer.
For the order inquiry to host computer, it needs to operate manually.
The measurement results automatically send to host computer.

3. On Line Real time

The measurement is executed according to the orders received from host
computer.
The analyzer reads the barcode labels on the Sample container and
automatically inquires the orders to host computer for measurement.
The measurement result is automatically sent to host computer.

B. Host Details Mode <Default setting: Auto rerun>

Select the host details mode from the following.

This setting is only available when the “On Line Real time” is selected.

1. Auto rerun
Host rerun will be executed without the order inquiry to the host computer.

2. Confirm host for rerun

Host rerun will be executed only when the host computer requires for rerun after
the order inquiry.

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3. Inquire host for rerun

Host rerun will be executed when the host computer sends any responses after
the order inquiry.

C. Host Communications

Specify the communication setting to host computer.

1. Baud Rate <default setting: 9600>

Select the rate (19200, 9600, 4800, 2400, 1200, 300) from drop -down menu.

2. Data Bit <default setting: 8bit>

Select the data bit (7bit or 8bit) from drop-down menu.

3. Stop Bit <default setting: 1bit>

Select the stop bit (1bit or 2bit) from drop-down menu.

4. Parity Bit <default setting: Even>

Select the parity bit (None, Even, or Odd) from drop -down menu.

5. Protocol (E1381) <default setting: Normal>

Select the protocol (Normal or No Handshake) from drop-down menu.

6. [Details] button

Figure 17.1-4

⚫ Full compliance with ASTM rules <default setting: ON>

Specify the transmission format to the host computer whether to comply with
ASTM rules. When the checkmark is ON, fully complied with ASTM rules.
Under this setting, Rerun flags, QC measurement results, or QC flags will not be
transmitted. Calculated test sends the results to the host computer.
When the checkmark is OFF, not complied with ASTM rules. Under this setting,
Rerun flags, QC measurement results, or QC flags will be transmitted.

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Chapter 17. System settings

⚫ ASTM ISE Separation <default setting: OFF>

When ordering ISE tests from the host computer, specify the format to separate
ISE or not.
When Checkmark is ON, ISE will be separated into Na, K, and Cl.

⚫ Send with CR <default setting: ON>

Specify the text from the host computer with CR or not.
When the checkmark is ON, it sends with CR.
When the checkmark is OFF, it sends without CR.

⚫ Check CheckSum <default setting: ON>

Specify the checksum setting for data transmission.
When the checkmark is ON, the checksum setting is active.
When the checkmark is OFF, the checksum setting is not performed.

⚫ Specimen Type 17 <default setting: ON>

Specify the command “O” on the 16th or 17th sample type field.
When the checkmark is ON, use the 17th sample type field.
When the checkmark is OFF, use the 16th sample type field.

⚫ Add sequence number to SID of QC sample <default setting: OFF>

This setting enables to identify the results when performing QC measurements
several times for the specific sample or method at the same round.
When the checkmark is ON, an added SID part is transmitted to the host
computer when notifying Result record messages.
When the checkmark is OFF, the added SID part is not transmitted to the host
computer when notifying Result record messages.

Figure 17.1-5

⚫ Communication Timeover settings

Specify the timeout setting.

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 Chapter 17. System settings

- Batch order:
Specify the batch order to the host computer from 1 to 60 sec.
<default setting: 40 sec.>
- Low Layer ENQ:
Specify the low layer ENQ from 1 to 60 sec.
<default setting: 15 sec.>
- Real time order:
Specify the data reception from 1 to 60 sec.
<default setting: 30 sec.>

⚫ Retry settings
Specify the number of each retry for high layer and lower layer.
High layer: select the number (1 to 6) from drop-down menu.
<default setting: 6.>
Lower layer: select the number (1 to 6) from drop-down menu.
<default setting: 3>

⚫ Result unit
Specify the result transmission unit.
Select “By Method” or “By Sample".
<default setting: By Method>

⚫ Sample Type Setting

Specify the default sample type when omitting the sample type in transmission
message from the host computer.
Select (Serum, Urine, Plasma, or Others) from drop-down menu.
<default setting: Serum>

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Chapter 17. System settings

17.2 The sample barcode reader setting

Figure 17.2-1

1. Sample number increment <default setting: Numeric only>

Select the barcode type from the following.

⚫ Numeric only

⚫ Alphanumeric (uppercase)
⚫ Alphanumeric (lowercase and uppercase)

2. Upper sample number

The SID prefix is specified and applied to all sample b arcodes (up to 14 digits).

3. Digit <default setting: 15>

Specify the whole digit number of the sample barcode (up to 15 digits).
The digits except its prefix in the whole sample barcode are automatically
generated.

4. Sample Barcode <default setting: Disable>

Select "Enable" or "Disable” by ticking.

5. Barcode type (1 to 4)
Select the barcode type for the sample barcode reader from drop-down menu.
This setting is available when "Enable” is selected for the sample barcode.

⚫ UPC(JAN): With check digit

⚫ NW7: With check digit

⚫ NW7: Without check digit

⚫ Code39: With check digit (up to 8 digits)

⚫ Code39: Without check digit

⚫ ITF: With check digit

⚫ ITF: Without check digit

⚫ Code128: With check digit

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 Chapter 17. System settings

17.3 Alarm sound setting

Figure 17.3-1

1. Enable Sound for sampling completion <default setting: ON>

When the checkbox is ON, audible alarm is effective at the sampling
completion.

2. Enable Error Level

The level of the audible alarms is specified.

⚫ Off: Alarm sound is OFF

⚫ Emergency Stop: When the analyzer occurs emergency stops (level 1).

⚫ Sampling Stop: When the analyzer stops sampling (level 2).

The audible alarm sounds at the level 1 and 2.

⚫ Unit Alarm: When the warning messages occurs (level 3)

The audible alarm sounds at the level 1, 2 and 3.

3. Alarm Volume <default setting: 3>

Select the alarm volume from drop-down menu.

⚫ Off: No audible alarm

⚫ 1 - 9: Volume 1 (minimum) to 9 (maximum)

4. Round Completion Alarm <default setting: 15>

Select the alarm activation time (sec.) from drop-down menu.

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17.4 Popup control setting

Figure 17.4-1

It is available to specify the pop-up message displayed automatically ON or OFF.

For the L3 users, the pop-up message including “Don’t show this again.” with the
checkbox appears.
When the checkbox is ON, the pop-up message does not appear at the same
condition.
To modify the setting, it is available to click the “Enable/Disable” on the designated
column on the list.

⚫ "Enable”: displays the pop-up message,

⚫ “Disable”: NOT display the pop-up message

The following are the pop-up messages specified in the default setting.

1. Please confirm system logout. (Popup512)

2. Check remaining volume of wash solution (Popup900)

17.5 Sample Type Setting

Figure 17.5-1

Set the default sample type for the calibrator, when the analyzer is operated by “Online
batch” or “Online real-time” and also the sample barcode is enabled. (When the user
do not register the sample position manually)
Define the sample tray position for each sample type.

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 Chapter 17. System settings

17.6 Reagent bottle size setting

Figure 17.6-1

Select 2 sizes out of the 3 reagent bottle sizes as the default setting.

⚫ 70: 70mL bottle

⚫ 20Sq: 20mL square bottle

⚫ 20Rd: 20mL round bottle

⚫ When using the 20mL square bottle, the reagent bottle adaptor needs to be
attached.

17.7 Normal range setting

Figure 17.7-1

It is available to specify the patient generation range for normal range.

Enter the designated number for each box and specify each of the age ranges.

17.8 Auto Template setting

Figure 17.8-1

1. Enable Auto Template

When the checkbox ON, the auto template setting is effective.

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17.9 Optional Field setting (for maintenance only)

Figure 17.9-1

It is available to specify the names of the “Optional Field 1” and Optional Field 2”,
which are corresponding to “Reference 1” and “Reference 2” of the [Patient
Information] screen.

1. Optional Field 1
Specify the name of “Optional Field 1”.

2. Optional Field 2
Specify the name of “Optional Field 2”.

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 Chapter 17. System settings

17.10 Other settings

Figure 17.10-1

1. Disable extrapolated results <default setting: OFF>

⚫ When the checkbox is ON, the concentration conversion out of the calibration
curve is calculated under the C1 or the Cn concentration.
⚫ When the checkbox is OFF, the concentration conversion is calcula ted
extended to out of range of the C1 or the Cn concentration.

2. Auto scan for Reagent Container <default setting: ON>

When the checkbox is ON, the reagent barcode reader automatically scan when
the Reagent container is open/closed.

3. Check remaining reagent volume <default setting: ON>

When the checkbox is ON, the remaining volume of the reagent is checked at
the measurement start.

4. Lamp voltage control off <default setting: ON>

Select the halogen lamp low control function ON or OFF.
The halogen lamp low control function helps to make the durable hours longer
by reducing the voltage of the halogen lamp on the follow ing state:
<1> at start-up
<2> after measurement
<3> after maintenance sequence
<4> after sleep mode

⚫ When the checkbox is ON, the halogen lamp low control function is OFF.

⚫ When the checkbox is OFF, the halogen lamp low control function is ON.

⚫ When the halogen lamp low control function is ON, it takes approx. 2 min to
switch the voltage level.

5. Initial Result of Rerun <default setting: OFF>

When the checkbox is ON, only the rerun result will be transmitted to the Host.

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6. Enable ISE Rerun <default setting: ON>

When the checkbox is ON, the automatic rerun will be performed for the ISE
measurement.
The ISE rerun is performed without corresponding to the “Auto Rerun” ON/OFF
setting.

7. Auto Rerun <default setting: OFF>

When the checkbox is ON, the automatic rerun is performed.

8. Print test sequence number <default setting: OFF>

When the checkbox is ON, the number of the measurements is printed on the
report.

9. Enable Auto Backup <default setting: OFF>

When the checkbox is ON, the automatic backup is performed.

10. Book orders for future round

When the checkbox is ON, the user can book order for future rounds (Next
Round and Round After Next) from [Test Selection] screen.

11. Reagent Code for Reagent Pipette Wash

Select the wash solution for the reagent pipette wash from drop-down menu that
registered in the [Reagent Registration] screen.

12. Reagent Code for Cuvette Water Placement

Select the wash solution for the cuvette water placement from drop -down menu
that registered in the [Reagent Registration] screen.

13. Remaining test calculation

Select the calculation method for the number of remaining test for each reagent.
The remaining numbers of tests as calculation results are displayed in the
“Total” column in the [Inventory] screen.

⚫ Reagent Code: Calculate using total remaining volume by each

reagent code.

⚫ Reagent Lot: Calculate using total remaining volume by each lot

number in the same reagent code.

14. Clot detection sensitivity <default setting: 2>

Select the sensitivity level of clot detection sensor from “0” to “3”.
“0” indicates invalid and “3” as most sensitive level.

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15. Continuous measurement mode

Select the setting about “Continuous measurement mode”, that shorten the
ending procedure to be prepared for the next round faster.
Select the setting from “Enable”, “Disable” and “Auto”.
When “Enable” or “Auto is selected, the analyzer shortens the ending procedure.
When ”Disable” is selected, the analyzer performs the normal ending procedure.

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Chapter 17. System settings

17.11 Login/logout setting

It is available to register a new user, to change a password, to change user's level or to
delete a user.

Maintenance (F10) > Setup Password

Figure 17.11-1

1. User Name
Select the user name from drop-down menu or enter it directly.

2. User Level
Specify the user level from drop-down menu.

3. Old Password
Enter the old password.

4. New Password
Enter the new password.

5. New Password Check

Reenter the new password for confirmation.

⚫ It is available to set on the [Maintenance (F10)] > [Setup Password] screen.

This setting is only available for the L3 users.

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 Chapter 17. System settings

17.11.1 Accessible screens for each user level

○: accessible △: partially accessible ×: unavailable

Main menu Sub menu L1 L2 L3 Remarks

Run (F5) Monitor ○ ○ ○

Round ○ ○ ○
Test Selection ○ ○ ○
Results - L1 users cannot delete
results.
△ ○ ○ - "Test number" for sample
category is available only for
L3 users.
Inventory - L1 users cannot delete
△ ○ ○ reagents from the inventory.

Wakeup Setup × ○ ○
Auto Template ○ ○ ○
Patient Information - L1 users cannot delete the
△ ○ ○ patient information.

Daily Maintenance ○ ○ ○
Parameter (F6) Chemistry Parameters 1 × ○ ○
Chemistry Parameters 2 × ○ ○
Chemistry Parameters for - L1 users are available to only

△
ISE check normal ranges.
○ ○ - L2 and L3 users can print the
chemistry parameter for ISE.
Serum Indices × ○ ○
Calculated Test × ○ ○
Profile × ○ ○
Order × ○ ○
Wash Program × ○ ○
Calibration (F7) Calibration Registration × ○ ○
Diluted Calibration × ○ ○
Multi-Calibrator × ○ ○
Result of ISE Calibration ○ ○ ○
QC (F8) QC Graph ○ ○ ○
QC Results (Detail) × ○ ○ - L1 users cannot delete QC
test results.
- L1 users cannot delete QC
QC Results (Daily)
△ ○ ○ test results.
QC Results (Cumulative) - L1 users cannot delete QC
△ ○ ○ test results.

QC Settings × ○ ○
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Chapter 17. System settings

Main menu Sub menu L1 L2 L3 Remarks

QC Sample Registration × ○ ○
System (F9) System Setup 1 × ○ ○
Define Report Format × ○ ○
Reagent Registration × ○ ○
Versions ○ ○ ○
Backup Procedures × ○ ○
System Setup 2 × ○ ○
Definition × ○ ○
Normal Range × ○ ○
Maintenance Sequence × × ○
(F10) Water Blank - Not available for L1 users to

△
change the judgment value, to
○ ○ print, to output results, and to
replace cuvettes.
Working Hour Counters - Available for L3 users to
reset the working hour of

△
parts.
× ○ - L2 and L3 users can use
"Time/Test Disp" button and
"Print" button.
Performance - Only L3 users can perform

△ △
"Automatic Gain", "Check
○ Lamp" and "Detector Check
Start".
Sensor × × ○
Setup Password - L1 users can change the
password of current user.
△ △ ○ - L2 users can add, remove, or
change the password of L1
and L2 users.
Detector Position Hidden Hidden ○
Shut Down ○ ○ ○
Sleep Before Sleep ○ ○ ○
Alarm (F4) Alarm - Only L3 users can output
△ △ ○ alarm information by electrical
file with CSV format.

Maximum number of users 20 10 5

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 Chapter 18. Maintenance

Chapter 18 Maintenance
Maintenance procedure is required for the analyzer accuracy and reliability. Perform
maintenance procedures under your own responsibility.
There are daily and periodical checks including consumables and parts replacement.
Some procedure requires the specific tools or the careful handling due to hazardous
operation. It needs to be performed by our approved technician.

⚫ If any malfunctions occur after maintenance, stop using the analyzer and
contact our technical support.

⚫ When performing maintenance procedures by yourself, pay attention in safety.

⚫ We shall not be responsible for any claims from the maintenance results done
by neither our technical persons nor our approved technicians.

A. Daily checks

Perform checks at the beginning and the end of the day under the user’s responsibility.
For the maintenance procedures, refer to “Chapter 4 Preparation and ending
procedure for measurement” and “Chapter 11 Daily checks.”

B. Consumable parts

SUPPLIES LIST
No. Item name Description Page

1 Wash Solution C-1 Strong alkaline wash solution 18.1.8/9

2 Wash Solution No.3 Acid wash solution ―

3 Wash Solution No.9 Alkaline wash solution ―

4 Wash Solution No.10-2 Neutral wash solution ―

Op L Solution ISE calibrator 18.2.10

Op Ref Solution Reference solution for ISE 18.2.10

Op H Solution ISE calibrator ―

Op Diluent Diluent for ISE ―

Op ISE Cleaner ISE wash solution ―

Op Etching ISE etching solution ―

Op ISE Electrode (Na) Electrode for ISE 18.2.5

Op ISE Electrode (K) Electrode for ISE 18.2.5

Op ISE Electrode (Cl) Electrode for ISE 18.2.5

Op ISE Electrode (Ref) Electrode for ISE 18.2.5

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The following check is required for the analyzer accuracy and reliability.

Periodical check
No. Check Item Cleaning cycle Page

1 Sample/reagent pipette washing Daily 18.1.1

2 Sample/reagent pipette cover cleaning Daily 18.1.1

3 Supply/drain nozzles washing Daily 18.1.2

4 Washing unit base cleaning Daily 18.1.2

5 Stirrer washing Daily 18.1.3

6 Stirrer unit cover cleaning Daily 18.1.3

7 Sample container cleaning Daily 18.1.4

8 Reagent container cleaning Daily 18.1.5

9 Water blank check Daily 18.1.6

10 Worktable cleaning Weekly 18.1.7

11 External tanks cleaning Monthly 18.1.8

12 Tube wash Monthly (*1) 18.1.9

13 Cuvettes check As needed 18.1.10

14 Halogen lamp check As needed 18.1.11

Op ISE cleaning Weekly 18.1.12

Op ISE Etching Weekly 18.2.5 B

*1: When applying the Degassing unit (option), perform tube wash every 2 weeks.
Parts replacement
No. Check Item Replacement cycle Page

1 Halogen lamp Every 1000 work hours 18.2.1

2 Syringe Tip (SPPS) Every 300 work hours 18.2.2

3 Syringe Tip (SPPW) Every 300 work hours 18.2.2

4 Syringe Tip (RPPS) Every 150 work hours 18.2.2

5 Syringe Tip (RPPW) Every 150 work hours 18.2.2

6 Syringe Tip (WPP1-4) Every 300 work hours 18.2.2

7 Cuvette Every 3 months (recommended) 18.2.3

8 Stirrer Every 3 months (recommended) 18.2.4

Op ISE Electrode (Na) Every 360 days 18.2.5

Op ISE Electrode (K) Every 180 days 18.2.5

Op ISE Electrode (Cl) Every 90 days 18.2.5

Op ISE Electrode (Ref) Every 360 days 18.2.5

Op ISE pump tube Every 180 days 18.2.6

Op: option

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 Chapter 18. Maintenance

18.1 Periodical checks

18.1.1 Sample/reagent pipette

A. Check the following points.

⚫ The sample or reagent is dispensed in good condition during measurement.

⚫ The surface of the pipette is not contaminated.

⚫ There is no liquid leakage at the upper part of the pipette.

⚫ No bending in the pipette.

B. Cleaning

⚫ Before the cleaning procedure, make sure to turn off the analyzer.

⚫ Disposable gloves must be worn by the operator to avoid any adherence o f

liquids directly to the skin.

⚫ In manual operating, hold the neck of shaft for the unit and raise or rotate the
arm.

⚫ Prevent the cuvettes on the Incubation reaction unit from contamination of any
dust or liquids.

⚫ In the case of using alcohol, should not be close to fire or high temperature
parts/units, because the alcohol is flammable liquid.

⚫ Be careful not to injure yourself with the tip of a pipette, etc.

1. Hold and raise the sample or the reagent pipette by hand.

2. Wipe the pipette from top to bottom with the alcohol moistened gauze.

⚫ When wiping the pipette, do not apply extra force to it. It is very important
that the pipette is vertically set so that the analyzer can function correct ly.
Improper alignment may cause the damages of the pipette and/or i naccurate
analysis results.

Figure 18.1-1

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Chapter 18. Maintenance

3. Insert the cleaning pointer of the pipette cleaning jig into the point of the pipette
to clean the inside of the pipette.

⚫ Two needles of the pipette cleaning jig on both sides: the thin (for the sample
pipette) and the thick type (for the reagent pipette). Distinguish the needle
type from the intended usage part.

Figure 18.1-2

4. Wipe the pipette cover entirely with the neutral detergent moistened gauze.

Figure 18.1-3

5. After cleaning inside the Sample pipette, perform the pipette wash with purified
water by pressing the [Sample Pipette Wash] button in the [Run (F5)] > [Daily
Maintenance] screen.

⚫ Prior to the sample pipette wash, place wash solution C-1 (diluted to 100 times
with purified water) in the Sample container and register the order. For the
procedure, refer to “6.3.7 Sample pipette wash.”

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18.1.2 Washing unit

A. Check the following points.

⚫ No contamination on the surface of the supply/drain nozzles.

⚫ No liquid leakage at the upper part of the supply/drain nozzles.

⚫ No bending in the supply/drain nozzles.

B. Cleaning

⚫ Before the cleaning procedure, make sure to turn off the analyzer.

⚫ Disposable gloves must be worn by the operator to avoid any adherence of

liquids directly to the skin.

⚫ Prevent the cuvettes on the Incubation reaction unit from contamination of any
dust or liquids.

⚫ In the case of using alcohol, should not be close to fire or high temperature
parts/units, because the alcohol is flammable liquid.

1. Raise the knob of the washing unit by hand slowly.

2. Wipe the supply/drain nozzles with the alcohol moistened gauze gently. Avoid
bending the nozzles while cleaning.

⚫ 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 may cause the damages of the nozzle and/or inaccurate
analysis results.

3. Wipe the Washing unit base with the neutral detergent moistened gauze.

Figure 18.1-4

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Chapter 18. Maintenance

18.1.3 Stirrer

A. Check the following points.

⚫ No contamination in the stirrer.

⚫ No bending or broken in the stirrer.

B. Cleaning

⚫ Before the cleaning procedure, make sure to turn off the analyzer.

⚫ Disposable gloves must be worn by the operator to avoid any adherence of

liquids directly to the skin.

⚫ Prevent the cuvettes on the Incubation reaction unit from contamination of any
dust or liquids.

1. Hold and raise the arm of the Stirrer unit slowly.

2. Wipe the stirrer with the neutral detergent moistened gauze gently. Avoid
bending the stirrer while cleaning.

3. Wipe the Stirrer unit cover with the neutral detergent moistened gauze.

Figure 18.1-5

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 Chapter 18. Maintenance

18.1.4 Sample container

A. Check the following points.

⚫ No contamination in the inner surface of the Sample container.

B. Cleaning

⚫ Before the cleaning procedure, make sure to turn off the analyzer.

⚫ Disposable gloves must be worn by the operator to avoid any adherence of

liquids directly to the skin.

1. Check that the reagent pipette is not positioned on the Sample container. If the
pipette is on the Sample container, move it away slowly from the Sample
container.

2. Remove the sample trays (both Inner and Outer) and the lid.

3. Wipe the sample trays (both Inner and Outer) and the lid with the neutral
detergent moistened gauze.

4. Wipe the inner surface of the Sample container with the neutral detergent
moistened gauze.

Figure 18.1-6

5. Attach the sample trays (both Inner and outer) and the lid in the reve rse
procedure of the step 2.

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Chapter 18. Maintenance

18.1.5 Reagent container

A. Check the following points.

⚫ No contamination in the inner surface of the Reagent container.

B. Cleaning

⚫ Before the cleaning procedure, make sure to turn off the analyzer.

⚫ Disposable gloves must be worn by the operator to avoid any adherence of

liquids directly to the skin.

1. Confirm that the reagent pipette is not positioned on the Reagent container. If
the pipette is on the Reagent container, move it away slowly from the Reagent
Container.

2. Remove the reagent tray and the lid.

3. Wipe the reagent tray and the lid with the neutral detergent moistened gauze.

4. Wipe the inner surface of the Reagent container with the neutral detergent
moistened gauze.

Figure 18.1-7

5. Attach the reagent tray and the lid in the reverse procedure of the step 2.

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18.1.6 Water blank

Perform water blank measurement to check the condition of the optical system
including cuvettes.

A. Check the following points.

1. Check each of the cuvette status in the [Maintenance] > [Water Blank] screen.
The absorbance results of all wavelengths for all cuvettes are displayed. The
values exceeding the threshold value among the selected wavelengths
indicates in red. The values exceeding the threshold value among other
wavelengths indicates in yellow.

Figure 18.1-8

⚫ The threshold for water blank is preset at 5000mAbs/10.

Do not change the threshold unless instructed otherwise.

2. Confirm that the values of all cuvettes are within the threshold value.

⚫ If the cuvettes are indicated in red or yellow, check if they are clean.
Refer to “18.1.10 Cuvettes”.

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Chapter 18. Maintenance

18.1.7 Work table

A. Check the following points.

⚫ No contamination on the work table.

B. Cleaning

⚫ Before the cleaning procedure, make sure to turn off the analyzer.

⚫ Disposable gloves must be worn by the operator to avoid any adherence of

liquids directly to the skin.

1. Wipe the surface of the work table and the outer surface with the neutral
detergent moistened gauze.

Figure 18.1-9

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 Chapter 18. Maintenance

18.1.8 External Tanks

A. Check the following points.

⚫ No contamination inside the following external tanks.

Purified (system) Water Tank: 20L x 1
Low conc. Wastewater Tank: 20L x 1
High conc. Wastewater Tank: 10L x 1
Wash Solution Tank: 5L x 2

B. Cleaning

1. Discharge purified water, wastewater, or wash solution from each of the external
tanks.

2. Pour the Wash solution C-1 diluent (diluted to 100 times with purified water) into
the external tank.
The diluent volume for each tank varies depending on the tank size.

⚫ Purified water tank: Diluent 2L (20mL of Wash solution C-1)

⚫ Low conc. wastewater tank: Diluent 2L (20mL of Wash solution C-1)

⚫ High conc. wastewater tank: Diluent 1L (10mL of Wash solution C-1)

⚫ Wash solution tank: Diluent 500mL (5mL of Wash solution C-1)

3. Shake the tank to wash inside of the tank entirely with the wash solution and
presoak for 10 min.

4. Discharge the diluent from the external tank.

5. Wash inside the external tank with purified water thoroughly. (Purified water
tank and wash solution tank)

⚫ Wash thoroughly inside the external tank with purified water to completely
remove wash solution component.

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18.1.9 Tube wash

Perform tube wash periodically to prevent tubes and subtank from bacteria.
Click the [Tube wash] button in the [Run(F5)] > [Daily Maintenance] screen and
perform the cleaning step 1 to 6. Perform the tube wash procedure indicated in the
screen.

⚫ Perform the tube wash procedure every 4 weeks.

⚫ When applying the Degassing unit (option), perform tube wash every 2 weeks.

A. Preparation

⚫ Wash solution C-1 diluent (diluted to 100 times with purified water) (5 L)

⚫ Purified water (20 L)

⚫ Gauze or paper towel

B. Storage for wash solution C-1

⚫ For the validity date, refer to the label on the bottle.

⚫ The validity date is 6 months after opening.

C. Precautions for wash solution C-1

⚫ Prepare wash solution C-1 diluent followed by the instructions on the label.

⚫ For preparing diluent, use purified water (ion-exchanged water). If using tap
water, brown deposits (corroded iron) or white deposits (calcium chloride) may
be generated after several days passed.

⚫ If the product expires, sodium hypochlorite contained in the product is

decomposed and effective chlorine is reduced. Therefore, dispose of an
expired product in an appropriate manner.

⚫ Do not mix the product with acid material.

⚫ Do not make the product contact with zinc plating or metals including iron,
ferric oxide, copper, copper alloy, etc. to prevent corrosion of them.

⚫ When re-sampling the product into another container, use the container that
completely clean by rinsing it with pure water and dry it.

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D. Cleaning

1. Click the [Tube wash] button in the [Run(F5)] > [Daily Maintenance] screen.

Figure 18.1-10

2. The [Tube Wash Procedures] screen appears.

Figure 18.1-11

3. Click the “Print” icon to print out the procedure on the screen.

⚫ Click the “Cancel” icon to cancel the cleaning procedure.

4. Perform cleaning procedure. For details, refer to the following “E. Cleaning
procedure”.

5. When completing the cleaning procedure, the previous screen “Daily

Maintenance” appears automatically.

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E. Cleaning procedure

Follow the cleaning step 1 to 6 on the screen.

The only icon corresponding to the step becomes active.
The checkbox at the completed step automatically becomes tick ed. When
repeating the same step, it needs to remove the checkmark.

1. Rinsing the wash solution tubes with purified water

Figure 18.1-12

(1) Connect the tubes from the wash solution 1 and 2 supply to the sys tem
water tank. Click the “Execute” icon.

2. Preparatory operation

Figure 18.1-13

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(1) Discharge the purified water from the system water tank. Fill the tank
with 5 L of the wash solution C-1 diluent.
(2) Connect the supply tubes for the system water and the wash s olution 1
and 2 to the system water tank filled with the wash solution C -1 diluent.
(3) Click the “Shutdown” icon and power OFF the analyzer.
(4) Dismount the Side panel R. Discharge the remaining liquid in the
subtank.
Dismounting procedure for subtank
Loosen the 3 screw lids at the upper part of the subtank and disconnect the
subtank float sensor assembly and its tubes from the subtank.

Figure 18.1-14

(5) Install the empty subtank and mount the Side panel R to original
position.
Mounting procedure for subtank
Connect the subtank float sensor assembly and its tubes to the subtank and
tighten the 3 screw lids.

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Figure 18.1-15

(6) Power ON the operational PC and the analyzer.

⚫ After log-in, the previous screen appears automatically.

3. Cleaning supply tubes

Figure 18.1-16

(1) Confirm that the supply tubes for the system water and the wash solution
1 and 2 are connected to the system water tank filled with the wash
solution C-1 diluent. Click the “Execute” icon.

4. Rinsing the supply tubes with purified water

Figure 18.1-17

(1) Disconnect the supply tubes for the system water and the wash solution
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1 and 2 from the system water tank filled with the wash solution C-1
diluent.
(2) Discharge the wash solution C-1 diluent from the system water tank and
rinse inside the tank with purified water. Then fill the tank with purified
water up to the full level.
(3) Connect the supply tubes for the system water and the wash solution 1
and 2 to the system water tank filled with purified water. Click the
“Execute” icon.

5. Subtank remaining liquid disposal

Figure 18.1-18

(1) Click the “Shutdown” icon and power OFF the analyzer.
(2) Dismount the Side panel R and discharge the remaining liquid at the
subtank.
(3) Install the empty subtank and mount the Side panel R to original
position.
(4) Power ON the operational PC and the analyzer.

⚫ After log-in, the previous screen appears automatically.

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6. Ending procedure

Figure 18.1-19

(1) Check that the system water supply tube is properly connect ed to the
system water tank.
(2) Connect the supply tubes for the wash solution 1 and 2 are connected to
the relevant wash solution tanks. Click the “Execute” icon.

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18.1.10 Cuvettes

Perform water blank measurement to check any dirt on the cuvettes.

A. Check the cuvette status.

1. Select the [Run (F5)] > [Daily Maintenance] screen. Click the [Check water
blank] button to perform water blank measurement.

Figure 18.1-20

2. Check each of the cuvette status in the [Maintenance] > [Water Blank] screen.
The absorbance results of all wavelengths for all cuvettes are displayed.
The values exceeding the threshold value among the selected wavelengths
indicates in red. The values exceeding the threshold value among other
wavelengths indicates in yellow.

Figure 18.1-21

3. Confirm that the values of all cuvette are within the threshold value.

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B. Cuvette cleaning

1. Select the [Run (F5)] > [Daily Maintenance] screen. Click the [Wash cuvette]
button to perform the cuvette cleaning.

Figure 18.1-22

2. Click the [Check water blank] button again. Confirm that the values of all
cuvette are within the threshold value.

⚫ After cuvette cleaning, if the value still indicates out of the threshold values,
needs to replace it with the new one.
⚫ If more than 24 cuvettes with out of the threshold values, measurement cannot
start.

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18.1.11 Halogen lamp

Perform lamp check to check the condition of the halogen lamp.

⚫ Halogen lamp needs to be replaced every 1000 work hours.
⚫ Use new cuvettes for lamp check. Dirty cuvettes cannot be used for che cking
the condition of the halogen lamp. For the replacement procedure, refer to
“18.2.3. Cuvettes”.

A. Check the following points.

1. Select the [Maintenance (F10)] > [Performance] screen. Click the [Check lamp]
button to perform lamp check.

2. Confirm that the voltage value for each wavelength is 8.3V or higher.
Values that are lower than 8.3V are indicated in red.

Figure 18.1-23

⚫ The threshold for lamp check is preset at 8.3V.

Do not change the threshold unless instructed otherwise.
⚫ If the voltage value for each wavelength is lower than 8.3V, replace the
halogen lamp. Refer to “18.2.1 Halogen lamp”.

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18.1.12 ISE cleaning (option)

ISE cleaning needs to be performed weekly.

⚫ Place the ISE cleaning (ISE Cleaner) in the Sample container and register the
order prior to ISE cleaning. For the registration procedure, refer to “6.3.9.
ISE cleaning (option).”
⚫ ISE activation is automatically performed during ISE cleaning. Place the ISE
activator in the Sample container and register the order. For the registration
procedure, refer to “6.3.11 ISE activation (option).”

A. Cleaning

1. Check that the ISE cleaning and the ISE activator are placed on the designated
positions that registered in the [Test selection] screen, and then click the [ISE
Cleaning] button in the [Run (F5)] > [Daily Maintenance] screen.

2. Perform ISE cleaning and ISE activation.

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18.2 Parts replacement

As parts replacement procedures, only dismounting procedures are explained here.
Mounting procedures are omitted because they are basically the reverse of the
dismounting procedures. Exceptionally, mounting procedures or remarks are
described in cases where adjustment or special care is required.
The following items are required for parts replacement.

Item Description

Silicon Oil (KF-96H-50000CS) For coating on the syringe tip

Syringe tip insertion jig For syringe tip replacement (accessories)

MIX paddle jig For stirrer replacement (accessories)

Screwdriver For parts replacement (accessories)

Pliers For syringe tip replacement

Hex Wrench 1.5 mm (for stirrer replacement)

⚫ For the information on Silicon Oil (KF-96H-50000CS), contact the suppliers for
details.

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18.2.1 Halogen lamp

A. Procedure

⚫ The lamp case may be very hot. Power OFF the analyzer and wait 30
minutes or more before starting this procedure.

⚫ Wear disposable gloves in handling the halogen lamp to prevent malfunction

from grease contamination from hands.

1. Loosen the screw and remove the Mosaic DTR.

Figure 18.2-1

2. Disconnect the connector of the halogen lamp.

3. Loosen the screw (M3×35) from the lamp case. (The screw on the lamp case
cannot be dismounted.)

Figure 18.2-2

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4. Dismount the lamp case by lifting up the knob.

Figure 18.2-3

5. Loosen the two screws (M3×8) and remove the halogen lamp.

Figure 18.2-4

6. Attach the new halogen lamp and reassemble in the reverse procedure of the
step 1 to 5.

7. Power the operational PC and the analyzer ON.

8. Initialize the working hour counters for halogen lamp after replacement in the
[Maintenance (F10)] > [Working Hour Counters] screen.
Click the [RESET] button on the Halogen Lamp.

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9. Click the [Automatic Gain] button in the [Maintenance (F10)] > [Performance]
screen.

Figure 18.2-5

10. Confirm that the gain value for each wavelength is higher than 10.

⚫ If the automatic gain fails, E6501 will be generated. Check the message on the
alarm for the solution.
⚫ If the gain value for each wavelength is lower than 10, contact our servicing
division.

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18.2.2 Syringe tip

A. Procedure

⚫ Before the cleaning procedure, make sure to turn off the analyzer.

⚫ Disposable gloves must be worn by the operator to avoid any adherence of

liquids directly to the skin.

⚫ The syringe tip replacement procedure described be low can be applied for
each of the syringes. Perform the replacement periodically.

1. Remove the 2 screws and dismount the Side panel R (or the Side panel L).

Figure 18.2-6

Figure 18.2-7

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2. Remove the screw and dismount the syringe block.

⚫ Since the plunger guide is attached to SPPS syringe only, plunger guide is
removed by hand with screwing it.

Figure 18.2-8

3. Pull down the plunger and dismount it.

4. Remove the syringe tip by pulling it with pliers.

⚫ When removing the tip, never damage the plunger. When it is difficult to
remove the tip, cut it from the plunger by cutter knife.

Figure 18.2-9

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5. Insert the new corresponding tip into the hole of the syringe insertion jig.

⚫ In the tip type: TEF050 (3.26) and TEF250 (7.29), replace the O -ring on the
plunger.

Type T-0510 TEF050 TEF250

Unit name (S1.4) (3.26) (7.29)

SPPS O

SPPW O

RPPR O

RPPW O

WPP（1-4） O

Figure 18.2-10

6. Hold the plunger vertically and insert it.

⚫ After O-ring replacement on the plunger, replace with the new syringe tip.
(TEF250)

⚫ Never bend or damage the plunger during the replacement.

Figure 18.2-11

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7. Apply uniformly silicon oil (KF-96H-50000CS) to the syringe tip.

Figure 18.2-12

8. Insert the plunger back into the syringe carefully and push it upward.

9. Attach the syringe block.

10. Attach the right side panel in the reverse procedure of the step 1.

11. Power ON the operational PC and the analyzer.

12. Initialize the working hour counters for Syringe tip after replacement in the
[Maintenance (F10)] > [Working Hour Counters] screen. Click the [RESET]
button on the designated unit.

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18.2.3 Cuvette

There are two cuvette types (resin or glass) available as option. Replacement
procedure is same for both cuvette types. However, the shape and the replacement
cycle vary depending on each type.

A. Procedure (for one cuvette replacement)

⚫ Disposable gloves must be worn by the operator to avoid any adherence of

liquids directly to the skin.

1. Select the cuvette # to be replaced in the [Water Blank] screen.

Figure 18.2-13

2. Click the [Cuvette Replacement] button.

Figure 18.2-14

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3. When the replacement is ready, the following pop-up message appears.

Figure 18.2-15

4. Loosen the screw and dismount the Mosaic DTR.

Figure 18.2-16

5. Loosen the two screws and remove the cuvette holder.

⚫ When removing the cuvette holder, handle carefully in the screws not to drop
them.

Figure 18.2-17

6. Replace the cuvette with the new one.

⚫ The new cuvette needs to be rinsed with the diluted wash solution C -1 before
use.
If the cuvette not rinsed before use, it may effect on the measurement results

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⚫ When replacing,
Resin type: hold the upper handles of the cuvette.
Glass type: hold the upper part of the ground glass sides.

⚫ To avoid any scratches on the cuvette, remove the cuvette holder first and
then perform cuvette replacement.

Figure 18.2-18

7. Mount the cuvette holder in the reverse procedure of the step 5.

8. Mount the Mosaic DTR in the reverse procedure of the step 4.

9. Click the [OK] button on the pop-up message indicated in the step 3.

Figure 18.2-19

10. The pop-up message appears for the cuvette placement confirmation.
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Click the [OK] button when confirming that all the cuvettes are placed on the
specified positions.

Figure 18.2-20

11. Select the [Run (F5)] > [Daily Maintenance] screen.

12. Select “Wash Bottle” from drop-down menu at the right side of “Pour water into
cuvettes” and click the [Pour water into cuvettes] button.

⚫ Place the reagent bottle filled with the wash solution C -1 (diluted to 100 times)
in the Reagent container.
⚫ Register the bottle information as the wash solution in the [Reagent
Registration] screen.

⚫ Register the diluted wash solution C-1 as “Wash Solution” at the Reagent code
for Cuvette Water Placement in the [System Setup 1] screen.

Figure 18.2-21

13. Leave the analyzer in the ready mode for more than 1 hour.

⚫ When rinsing the new cuvette with the diluted wash solution C-1, it needs
more than 1 hour presoak.

14. Perform adjustment after cuvette replacement described in the procedure C.

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B. Procedure (for replacement of a number of cuvettes at the same time)

⚫ Prior to replacement procedure, make sure to turn OFF the analyzer.

⚫ Disposable gloves must be worn by the operator to avoid any adherence of

liquids directly to the skin.

1. Loosen the screw and dismount the Mosaic-DTR.

Figure 18.2-22

2. Move the cuvettes to be replaced in the front position by rotating the Incubation
Reaction unit to right (or left) by hand.

⚫ Before rotating the Incubation reaction unit, raise each of the unit to the upper
position. Make sure that the wash nozzle or the stirrer is not inserted into the
cuvette.

3. Loosen the two screws and dismount the cuvette holder.

⚫ When dismounting the cuvette holder, handle carefully in the screws not to
drop them.

Figure 18.2-23

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4. Replace the cuvettes with the new ones.

⚫ The new cuvette needs to be rinsed with the diluted wash solution C -1 before
use.
If the cuvette not rinsed before use, it may effect on the measurement results .

⚫ When replacing,
Resin type: hold the upper handles of the cuvette.
Glass type: hold the upper part of the ground glass sides.

⚫ To avoid any scratches on the cuvette, remove the cuvette holder first and
then perform cuvette replacement.

Figure 18.2-24

5. Mount the cuvette holder in the reverse procedure of the step 3.

6. Mount the Mosaic-DTR in the reverse procedure of the step 1.

7. Turn ON the analyzer and the operational PC.

8. Select the [Run (F5)] > [Daily Maintenance] screen.

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9. Select “Wash Bottle” from drop-down menu at the right side of “Pour water into
cuvettes” and click the [Pour water into cuvettes] button.

⚫ Place the reagent bottle filled with the wash solution C -1 (diluted to 100 times)
in the Reagent container.

⚫ Register the bottle information as the wash solution in the [Reagent

Registration] screen.

⚫ Register the diluted wash solution C-1 as “Wash Solution” at the Reagent code
for Cuvette Water Placement in the [System Setup 1] screen.

Figure 18.2-25

10. Leave the analyzer in the ready mode for more than 1 hour.

⚫ When rinsing the new cuvette with the diluted wash solution C -1. It needs
more than 1 hour presoak.

11. Perform adjustment after cuvette replacement described in the procedure C.

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C. Adjustment after cuvette replacement

1. Select the [Run (F5)] > [Daily Maintenance] screen.

2. Select “System Water” from drop-down menu at the right side of “Pour water
into cuvettes” and click the [Pour water into cuvettes] button.

Figure 18.2-26

3. Select the [Maintenance (F10)] > [Detector Position] screen.

4. Click the "Execute” icon.

Figure 18.2-27

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5. Select the [Run (F5)] > [Daily Maintenance] screen. Click the [Check water
blank] button to perform water blank measurement.

Figure 18.2-28

6. Check each of the cuvette status in the [Maintenance] > [Water Blank] screen.
The absorbance results of all wavelengths for all cuvettes are displayed.
The values exceeding the threshold value among the selected wavelengths
indicates in red. The values exceeding the threshold value among other
wavelengths indicates in yellow.

Figure 18.2-29

7. Confirm that the values of all cuvette are within the threshold value.

⚫ If the values are over the threshold after replacement, contact our servicing
division.

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18.2.4 Stirrer

A. Procedure

⚫ Before the replacement procedure, make sure to turn off the analyzer.

⚫ Disposable gloves must be worn by the operator to avoid any adherence of

liquids directly to the skin.

1. Hold and raise the arm of the Stirrer unit.

2. Loosen the screw and remove the stirrer paddle.

⚫ When loosening the screw, be careful not to drop the loosen screw into the
inside the analyzer.

Figure 18.2-30

3. Set the new stirrer paddle on the MIX paddle jig.

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4. Attach the upper part of the MIX paddle jig on the Stirrer unit arm base.

⚫ Attach the upper part of the MIX paddle jig on the Stirrer unit arm base
precisely. If incorrect fixing, it may cause malfunction in th e Stirrer unit.

Figure 18.2-31

5. Tighten the screw and fix the stirrer paddle.

⚫ When tightening the screw, do not tighten it too strongly. If too tightened, the
stirrer paddle may be damaged.

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18.2.5 ISE electrodes (option)

There are four ISE electrodes: sodium (Na), potassium (K), chloride (Cl), and
reference.

A. Procedure

⚫ Disposable gloves must be worn by the operator to avoid any adherence of

liquids directly to the skin.

1. Click the [ISE Electrode Exchange] button in the [Run(F5)] > [Daily
Maintenance] screen.

2. A pop-up message appears. Click the [OK] button. After discharging the
liquid from the tube, the shut-down procedure will be continued.

3. After confirming the operational PC OFF, power OFF the analyzer.

4. Loosen the 2 screws and dismount the Side panel R.

5. Loosen the screw and open the ISE module cover.

Figure 18.2-32

6. Dismount the electrode to be replaced.

Figure 18.2-33

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⚫ The Ref electrode has 2 connectors to be disconnected when replacing the

electrode. For the upper position connect the tube labeled "R7” and for the
lower position connect the tube labeled "E1”.

⚫ No replacement on the L.B.

Figure 18.2-34

7. Install the new electrode.

⚫ Check that each electrode is placed on the designated position. (Ref, Na, Cl,
K, and L.B. from the left).

⚫ Tear off the protective seal on the new electrode. (Ref electrode only)

⚫ Check that the O-ring is attached on one side of the electrode.

Figure 18.2-35

8. Close the ISE module cover and tighten the screw.

9. Mount the Side panel R.

10. Power ON the analyzer and the operational PC.

11. Follow the start-up message and perform preparatory operation. When
canceling the preparatory operation, perform ISE priming one time in the [Run
(F5)] > [Daily Maintenance] screen.

12. Click the [RESET] button to reset the electrode work hours in the [Maintenance
(F10)] > [Working Hour Counters] screen.

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13. After performing replacement, perform etching, activation, and calibration.

The required maintenance procedures vary depending on each electrode.
Refer to the following table for electrode maintenance procedure.
Etching Activation Calibration

Ref Electrode O O

Na Electrode O O O

Cl Electrode O O

K Electrode O O

Figure 18.2-36

B. Procedure on the ISE Etching

1. Place each of the sample cups filled with the Etching solution and the ISE
activator on the Sample tray.

2. Specify the “ISE Etching” order in the [Run(F5)] > [Test Selection] screen. For
the setting, refer to "6.3.10 ISE Etching (option)” for details. Specify the “ISE
activation” order in the [Run(F5)] > [Test Selection] screen. For the setting,
refer to "6.3.11 ISE activation (option)” for details.

⚫ ISE activation is automatically performed during ISE etching. Place the ISE
activator in the Sample container and register the order.
For the registration procedure, refer to “6.3.11 ISE activation (option).”

3. Click the [ISE Etching] button in the [Run (F5)] > [Daily Maintenance] screen.

C. Procedure on the ISE Activation

⚫ Apply serum or specific QC samples as the ISE activator.

1. Place the sample cup filled with the ISE activator on the Sample tray.

2. Specify the “ISE Activation” order in the [Run (F5)] > [Test Selection] screen.
For the setting, refer to "6.3.11 ISE activation (option)” for details.

3. Click the [ISE Activation] button in the [Run (F5)] > [Daily Maintenance] screen.

D. Procedure on the ISE Calibration

1. Place the sample cup filled with the H solution on the Sample tray.

2. Specify the “ISE Calibration” order in the [Run (F5)] > [Test Selection] screen.
For the setting, refer to "6.3.8 ISE calibrator (option)” for details.

3. Click the [ISE Calibration] button in the [Run (F5)] > [Daily Maintenance] screen.

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18.2.6 ISE pump tube (option)

A. Procedure

⚫ Disposable gloves must be worn by the operator to avoid any adherence of

liquids directly to the skin.

1. Disconnect the connection caps from the L solution and the Ref solution.

⚫ Put paper towel to the tip of the circulation tube of the Ref solution bag to
prevent the leak of Ref solution.

Figure 18.2-37

2. Click the “Shut Down” icon. After confirming the operational PC OFF, power
OFF the analyzer.

3. Loosen the 2 screws and dismount the side panel R.

4. Unhook the pump tube cover and open it.

Figure 18.2-38

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5. Remove the pump tube from the ISE unit.

Figure 18.2-39

6. Connect the new pump tube into the ISE unit.

⚫ Connect the upper position tubes labeled L3, R3, and E2 from the left.

⚫ Connect the lower position tubes labeled L4, R4, and WASTE from the left.

7. Close the pump tube cover.

8. Mount the Side panel R.

9. Insert each of the tube tips of the connection caps of the L solution bag and the
Ref solution bag into the bottom.

10. Power ON the analyzer and the operational PC.

11. Follow the start-up message and perform preparatory operation. When
canceling the preparatory operation, perform ISE priming one time in the [Run
(F5)] > [Daily Maintenance] screen.

12. Click the [RESET] button to reset the pump tube work hour in the [Maintenance
(F10)] > [Working Hour Counters] screen.

13. Perform the ISE calibration and confirm the result values are within the
expected range.

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18.2.7 L solution and Ref solution for ISE unit (option)

A. Procedure

⚫ Disposable gloves must be worn by the operator to avoid any adherence of

liquids directly to the skin.

1. Loosen the screw and dismount the Mosaic ISE.

Figure 18.2-40

<L solution replacement procedure>

2. Remove the connection cap with the tube from the L solution bag
<L Solution bag>

Figure 18.2-41

3. Click the [ISE Drain] button in the [Run (F5)] > [Daily Maintenance] screen.

4. Attach the connection cap with the new L solution bag. When attaching the
connection cap, hold the spout of each bag and attach it to the bag. Insert the
tube tip of the connection cap into the bottom of the bag.
Go on to the following step (7).

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<Ref solution replacement procedure>

<Ref solution bag>

5. Remove the connection cap and attach it to the new Ref solution bag. When
replacing the Ref solution bag, put paper towel to the tip of the circulation tube
of the Ref solution bag to prevent the leak of Ref solution.

6. Click the [ISE Drain] button in the [Run (F5)] > [Daily Maintenance] screen.
When performing the ISE Drain, put paper towel to the tip of the circulation tube
of the Ref solution bag to prevent the leak of Ref solution.

Figure 18.2-42

7. Attach the Mosaic ISE.

8. Click the [RESET] button to reset L Solution and Ref Solution at the work hour
for ISE in the [Maintenance (F10)] > [Working Hour Counters] screen.

9. Perform ISE priming one time in the [Run (F5)] > [Daily Maintenance] screen.

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18.2.8 When leaving the analyzer for long period power supply OFF

Prior to power the analyzer OFF for a long period (two days or more), perform ISE
drain to clean and drain the tubes with the purified water.

A. Procedure

1. Remove the connection cap and tube from L Solution bag. Disconnect only the
tube of the connection cap from the Ref solution bag. Perform ISE drain.

2. Prepare a container such as a beaker of purified water and put the tip of the
removed tubes from the L Solution and the Ref Solution in the water.

3. Prepare a container for waste. Put the circulation tube from the Ref Solution into
the container. Perform ISE drain.

4. Remove the tubes for the L Solution and the Ref Solution from the container of
the purified water. Perform ISE drain.

5. Check that there is no remaining water within the tubes and the isolator.

6. Seal up each mouth of the L Solution bag and the Ref Solution bag with such as
a parafilm. Dismount both of the bags out of the analyzer and store them.

7. Prior to power ON the analyzer, make sure to install the electrodes, the L
Solution bag, and the Ref Solution bag appropriately.

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18.3 Daily maintenance

This screen is available for daily maintenance, periodical check, consumables and
parts replacement.

Run (F5) > Daily Maintenance

Figure 18.3-1

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A. Operation area

Figure 18.3-2

1. Initialization
Place back each unit to the default position.

2. Check water blank

Perform water blank measurement to check the cuvette quality for use.
Perform measurement using all wavelengths for all of the cuvettes. The
results can be checked in the [Maintenance (F10)] > [Water Blank] screen.

3. Wash cuvette
Perform the cuvette cleaning.

4. Pour water into cuvettes

Fill the cuvette with the purified water or the wash solution.

5. Waste water from cuvettes

Discharge the purified water or the wash solution from the cuvette.

6. Sample Pipette Wash

Perform the sample pipette wash.

7. Ascend/Descend Stirrer
Move the Stirrer unit vertically.

8. Ascend/Descend Washer
Move the Washing unit vertically.

9. Tube Wash
Perform tube wash periodically to prevent tubes and subtank from bacteria.

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10. ISE Prime (option)

Fill the tube with the L solution to remove the air bubbles in the tubing .
Perform priming at the specified number of times.

11. ISE Calibration (option)

Perform 2-point calibration using the ISE calibrator that registered in the [Run
(F5)] > [Test Selection] screen.

12. ISE Cleaning (option)

Perform cleaning of the ISE unit and its tubing using ISE Cleaner that registered
in the [Run (F5)] > [Test Selection] screen.
Perform ISE cleaning followed by ISE activation.

13. ISE Etching (option)

Perform Na electrode cleaning using ISE etching solution that registered in the
[Run (F5)] > [Test Selection] screen.
Perform ISE etching followed by ISE activation.

14. ISE Electrode Exchange (option)

Perform ISE electrode exchange when replacing the ISE electrodes and its
pump tube. After discharging the liquid from the ISE electrode tubing,
automatically shut down the operational PC.
Prior to this procedure, make sure to disconnect the tubes from the L solution
bag and the Ref solution bag.

15. ISE Activation (option)

Perform the ISE activation after the ISE electrode replacement to increase the
adaptation.

16. ISE Drain (option)

Perform to discharge the liquid from the ISE unit. Prior to this procedure, make
sure to disconnect the tubes from the L solution bag and the Ref solution bag.

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B. Prime area

Figure 18.3-3

Fill the tube with the purified water or the wash solution to remove the air bubbles in the
tube. After priming, it is available to select the execution of the sleep mode or shut
down automatically.

1. Prime
Perform priming at the specified number of times.

2. Prime and Sleep

Perform priming at the specified number of times and enter the sleep mode.

3. Prime and Shutdown

Perform priming at the specified number of times and shut down the operational
PC.

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Chapter 19 Troubleshooting
Here is described on instructions to solve problems that occur in the analyzer.

19.1 Procedures
19.1.1 Operation environment

If any errors occur when using the analyzer, check the following points.

⚫ Preparation and storing of reagents

⚫ Preparation and handling of samples

⚫ Operating instructions for the analyzer

⚫ Maintenance procedure

⚫ If a mechanical or electrical problem is suspected, do not perform inspection

of the analyzer by yourself. Contact our sales representatives or technical
support.

19.1.2 Contact our technical support

When you contact our technical support regarding the measurement results or
mechanical problems, prepare the following information.

A. Operation problems

⚫ Serial number

⚫ Method information that assume problems

⚫ Description on the problem

⚫ Manufacturer's serial number and the lot number of the reagent, the calibrator,
and QC sample

⚫ Latest results on the calibrator

⚫ Latest results on the QC sample

⚫ Measurement results

B. Instrument problems

⚫ Serial number

⚫ Software version number

⚫ The relevant alarm message and the error description

⚫ Other instruments or maintenance related information

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19.2 Power problems

19.2.1 Procedure

If you have any problems starting the analyzer, check the following points.

⚫ Main switch on the left hand side of the analyzer: ON

⚫ Main fuse

⚫ Breaker in the electrical system

A. Main fuse

1. Make sure that the main switch of the analyzer is OFF.

2. Unplug the power cable from the analyzer.

3. Turn the fuse holder with a flat-blade screwdriver and pull it out.

Figure 19.2-1

4. Replace the fuses with the new ones that enclosed in accessory kit.

Fuse

Figure 19.2-2

5. Put back the fuse holder in reverse procedure of the step 3.

6. Plug the power cable.

7. Turn ON the analyzer.

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19.3 Result problems

19.3.1 When any troubleshooting is required

The analytical errors include the results with flags and unexpected values.
The troubleshooting is required in the following cases.

⚫ Error flags on the calibrator results.

⚫ Error flags on the QC sample or normal sample results

⚫ The QC sample results out of the normal range.

Check the following points on results of the calibrators, the QC samples, or the normal
samples.

⚫ The results on the specific method are high in all samples.

⚫ The results on the specific method are low in all samples.

⚫ Randomly resulted in the unexpected values.

⚫ The unexpected values on all methods for the specific sample.

⚫ The unexpected values in several results.

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19.3.2 Preparation of reagents, calibrators, and QC samples

Check the following point on the widely plotted results.

When preparing reagents, calibrators, and QC samples, be sure to follow its procedure
described on each operator’s manual.

A. Preparation of reagents

⚫ No change of reagents?

⚫ Validity term of the reagent

⚫ Correct procedure for the preparation?

⚫ Prepared with fresh decontaminated deionized water and correct diluents?

B. Preparation of QC samples

⚫ Correct procedure for the preparation?

⚫ Stored under the recommended storing?

⚫ Validity term of the QC sample before preparation

⚫ Prepared using the pipette that volume calibrated?

⚫ Validity term of the lot number of the QC sample.

⚫ Prepared with the correct diluents?

C. Preparation of calibrators

⚫ No change of the lot number?

⚫ Prepared with correct volume?

⚫ Stored under the recommended storing?

⚫ Validity term of the calibrator before preparation

⚫ Prepared using the volume-calibrated pipette?

⚫ Validity term of the lot number of the calibrator

⚫ Prepared with the correct diluents?

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19.3.3 Frequent error patterns

A. The results on the specific method are high in all samples.

Cause Action

The calibration result is not correct. Check the preparation of the calibrator. Check that

the calibration setting is appropriate. Re-calibrate if

necessary.

The temperature in Incubation Reaction unit is too Check the temperature displayed in the screen. If

high. the temperature does not indicate within 37+-0.1ºC,

contact our technical support.

The reagent has not been appropriately prepared. Check the preparation of the reagent.

The calibrator has not been appropriately prepared. Check the preparation of the calibrator.

B. The results on the specific method are low in all samples.

Cause Action

The validity term of the reagent is expired. Refer to its operator’s manual regarding the stability

of the prepared reagent.

The reagent has not been appropriately prepared. Check the preparation of the reagent.

The reagent has not been appropriately stored. For storing, refer to its operator’s manual.

The temperature in Incubation Reaction unit is too Check the temperature displayed in the screen. If

low. the temperature does not indicate within 37+-0.1ºC,

contact our technical support.

The calibrator has not been appropriately prepared. Check the preparation of the calibrator.

The dispensing volume of the reagent is too high. Check that there is no leakage or dripping on the

joint area of the reagent dispensing system.

C. Randomly resulted in the unexpected values.

Cause Action

Contamination is observed in the sample pipette or Perform pipette washing and confirm that enough

the reagent pipette. volume of the wash solution is dispensed into the

trough area.

Fibrins are observed in the specific sample tubes or Perform the sample pipette wash to remove fibrins.

the sample cups.

Insufficient volume supplied from the external tank. Check that the supply tube is positioned at the

lower than the liquid level. If any problems,

contact our technical support.

The insufficient stirring is observed. Check that the stirrer rotates at the center of the

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Cause Action

cuvette in appropriate speed. Check the stirring

condition whether there is no abnormal noise such

as scratch sound in the cuvette.

D. The unexpected values on all methods for the specific sample.

Cause Action

The reagent has not been appropriately prepared. Perform new preparation of reagent referring to the

operator’s manual.

The validity term of the reagent is expired. The Perform new preparation of reagent referring to the

reagent is observed contamination. The reagent is operator’s manual.

discolored.

E. The unexpected values in several results.

Cause Action

The liquid leakage is recognized at the dispensing Check the tube connections at the pipette and the

system (the sample pipette or the reagent pipette). syringe.

The temperature in Incubation Reaction unit is out Check the temperature displayed in the screen. If

of the expected range. the temperature does not indicate within 37+-0.1ºC,

contact our technical support.

The insufficient stirring is observed. Check that the stirrer rotates at the center of the

cuvette in appropriate speed. Check the stirring

condition whether there is no abnormal noise such

as scratch sound in the cuvette.

19.4 Malfunction
Perform troubleshooting within the operator’s manual level. For the complicated
problems, contact our technical support.

19.4.1 Detection of mechanical problems

All mechanical functions are controlled by the system of the analyzer. If any
mechanical problems occur in the analyzer, the system immediately recognizes and
displays the error message to inform.
If the problems cause any troubles in the performance, the sampling stop or the
emergency stop is executed. In the sampling stop mode, the measurement continues
processing, which of the samples are not affected the errors. If the error affects the
whole measurement processing, the emergency stop is immediately executed.

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19.5 Alarm
19.5.1 Alarm screen

Alarm

Figure 19.5-1

If any problems occur, alarms become active.

If the alarm becomes active, the operational PC beeps the alarm sounds and the alarm
icon in the screen becomes blinking in red.

To display the alarm description, click the “Alarm” icon.

The alarm screen has two areas:
1. Alarm message list: indicates the Alarm No. and the status.
2. Alarm Message Details: indicates the alarm explanation and action to at the
bottom of the screen.

19.5.2 To solve the errors

To solve the error, confirm the alarm explanation and action displayed at the bottom of
the screen when clicking the concern alarm on the list.
If the error cannot be solved, contact our technical support.

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19.5.3 File output of alarm information

Click the […] button and specify the directory to save a file. Click the “Save” icon to
save the latest alarm data in a csv format.

The following information are included in the file:

⚫ Alarm No.

⚫ Date Time: Date and time when the alarm occurred.

⚫ Message: Quick message (indicating analyzer status when the alarm

occurred.)

⚫ Details: a detail message for the alarm (indicating its suspect, check and
action)

⚫ This function is available for L3 User only.

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19.6 Flags
19.6.1 Flags

Under the following conditions during or after measurement, range or error flags will be
added with the measurement results.

⚫ If the measurement results are out of the normal range (above or below),
range flag is on.

⚫ If any errors occur during measurement, error flag is on.

Each flag is displayed in the [Results] screen.

When ordering for printout of the measurement results, the flag is i ncluded on the
results printout.

19.6.2 Range flags

Flag Descriptions

H When the measurements results are above the normal range, the result will be flagged with a “H”.

L When the measurements results are below the normal range, the result will be flagged with a “L”.

> When the measurement results are above the technical range, the result will be flagged with “>”.

< When the measurement results are below the technical range, the result will be flagged with “<”.

r The “r" indicates the rerun measurement result.

♭ When the sample volume “Low” is selected.

♯ When the sample volume “High” is selected

19.6.3 Error flag list

Error
Cause Action
flag

SPS The sample pipette is clogged.

Check the following points.

SS Sample shortage
⚫ Is the sample pipette clogged?

Not detected liquid level in sample dispensing.

SI1 ⚫ Enough sample volume?
Out of detection range in liquid level when sample
⚫ No damages, bending, or contamination in the
dispensing.
sample pipette?
SI2 Diluted sample shortage
⚫ No objects within the sample pipette movable
Out of detection range in liquid level when
SI2 area?
dispensing the diluted sample.

R1S R1 reagent shortage. Check the following points.

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Error
Cause Action
flag

Out of detection range in liquid level when R1

⚫ Enough volume in reagent, diluents, or wash
reagent dispensing.
solutions?
R2 reagent shortage
R2S ⚫ No damages, bending, or contamination in the
Out of detection range in liquid level when R2
reagent pipette?
reagent dispensing.
⚫ No objects within the reagent pipette movable
Diluent shortage
DS area?
Out of detection range in liquid level when diluents

dispensing.

Wash solution shortage.

WS
Out of detection range in liquid level when

dispensing the wash solution.

R1B Not found R1 reagent bottle.

R1S Not enough volume of R1 reagent.

Check and undertake the following points.
R2B Not found R2 reagent bottle.
⚫ Register the relevant reagent bottle, diluents
R2S Not enough volume of R2 reagent. bottle, or wash solution bottle in the [Inventory]

DB Not found the diluent bottle. screen.

DS Not enough volume of the diluents. ⚫ Check that there is enough volume of the

reagent, diluents, or wash solution in each bottle.

WB Not found the wash solution bottle.

WS Not enough volume of the wash solution.

Check the following points.

⚫ Is the reagent with the different lot # loaded in the

LOT Used the different lot # reagent at the same round. Reagent container?

⚫ Is the lot information for the reagent registration in

the [Inventory] screen correct?

SPW Failed the sample pipette wash.

Failed the reagent pipette wash before R1

R1W
dispensing.
If any error flag is on, some alarm occurs in the
Failed the reagent pipette wash before R2
R2W analyzer. Check the alarm screen and solve the
dispensing.
problems.
The temperature in the Incubation reaction unit is too

TE1 low.

(35ºC or lower)

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Error
Cause Action
flag

The temperature in the Incubation reaction unit is too

TE2 high.

(39ºC or higher)

The temperature in the Reagent container is too

TE3 high.

(15ºC or higher)

EST Abnormal condition occurs during measurement.

Check the following points.

⚫ Properly performed calibration for the relevant

CLM No calibration curves registered. method?

⚫ Used the same lot # of the reagent at

measurement as the one at the calibration?

Check and undertake the following points.

⚫ Perform cuvette wash in the [Daily Maintenance]

screen.

WBE Not measured due to the cuvette contamination. ⚫ Check that there is no contamination in the

surface of the cuvette.

⚫ No cracks or defects on the cuvette. Replace with

the new cuvette if any defects found.

EXP The validity term of the reagent is expired. Use the reagent with valid term.

STB The stability term of the reagent is expired. Use the reagent with valid stability term.

CTO The calibration valid term is expired. Perform calibration and measurement again.

CXP The valid term of QC measurement is expired. Perform QC measurement and measurement again.

Check the following points.

⚫ Was calibration for the relevant method properly

Abnormal condition occurs during the concentration performed?

CA?
conversion. ⚫ Was ISE calibration properly done? (option)

⚫ Did the measurement results show out of the

technical range?

Check the following points.

OVR Concentration conversion error in the calibrator ⚫ Is correct information registered in the

[Calibration Registration] screen?

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Error
Cause Action
flag

⚫ No problems on the quality of the calibrator and

its storage?

The value is beyond the specified linearity limit range,

LIN Linearity Limit error and recognized dispersion in the time-course data for

rate assay.

The value is beyond the specified limit range and

PRO Prozone Limit error
recognized the prozone effect in the time-course data.

The value is beyond the specified absorbance limit for

rate assay when the only first point of measuring point

AB1 Absorbance Limit1 error
is within the absorbance limit or all the points are out

of the absorbance limit.

The value is beyond the specified absorbance limit for

rate assay when only two measuring points or less

AB2 Absorbance Limit2 error than 1 measuring point from total measuring points

are within the limit. Check that 6 or more

continuous measuring points are within the limit.

The calibration results in the duplicate or triplicate

DUP Duplicate Limit error
measurement are beyond the specified limit.

The calibration results are beyond the limit specified

SEN Sensitivity Limit error the absorbance difference between Min. and Max

concentrations.

Check the following points.

Used the different lot # of the reagent in the
CLT ⚫ Used the same lot # of the reagent at
measurement from the one at the calibration.
measurement as the one at the calibration?

Check the following points.

CAL Calibration failed. ⚫ Enough calibrators in the Sample container?

⚫ Any alarm messages during measurement?

19.6.4 ISE error flags (option)

ISE error flag Cause Action

IE1 No response from the ISE unit. Check the following points.

IE2 Not received the measurement result

⚫ Enough sample volume?
from the ISE unit.
⚫ Is the inside of the ISE module clogged?
IE3 The busy status in the ISE electrodes.

⚫ Is any liquid leakage inside the ISE module?

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19.7 ISE error codes (option)

When an error occurs during ISE calibration, an error is displayed in the Results of ISE
Calibration screen. The table below displays the error codes with their description.

The error code for ISE module is a 4 digit code:

⚫ 0XXX: electrode errors

⚫ IXXX: ISE module errors

A. Normal

⚫ The code displays “0000” in the normal operation.

B. Electrodes errors

⚫ The first digit is “0” and other digits are except “0”.

⚫ The second digit is the error code for Na electrode.

⚫ The third digit is the error code for K electrode.

⚫ The fourth digit is the error code for Cl electrode.

Error code Description

0 Normal

1 2-point calibration: response alert.

2 2-point calibration: stability alert.

3 2-point calibration: reference potential alert.

4 2-point calibration: sensitivity alert.

5 Normal concentration sample: calibration potential alert.

6 Normal concentration sample: sample potential response alert.

7 Normal concentration sample: sample potential response alert + calibration

potential alert.

8 High/Low concentration sample: no alert.

9 High/Low concentration sample: reference potential alert.

A High/Low concentration sample: sample potential response alert.

B High/Low concentration sample: sample potential response alert + calibration

potential alert.

C. ISE module errors

Error code Alarm Description

I001 2075 The pumping speed adjustment is beyond the limit.

I021, I022 2076 Cannot detect L solution at LB1 sensor.

I023, I024 2077 Incorrect supplying quantity of L solution (LB1).

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Error code Alarm Description

I025 2085 Incorrect supplying quantity of L solution (LB2).

I026 2084 Cannot detect L solution at LB2 sensor.

I031, I032 2078 Cannot detect H solution at LB1 sensor.

I033, I034 2079 Incorrect supplying quantity of H solution (LB1).

I035 2087 Incorrect supplying quantity of H solution (LB2).

I036 2086 Cannot detect H solution at LB2 sensor.

I041, I042 2080 Cannot detect the sample at LB1 sensor.

I043, I044 2081 Incorrect supplying quantity of the sample.(LB1)

I045 2089 Incorrect supplying quantity of the sample.(LB2)

I046 2088 Cannot detect the sample at LB2 sensor.

I091 2082 Detects abnormal condition at LB sensor check.

I101 2083 Hardware abnormal.

I996 1975 ISE communication failure.

I997 1978 ISE module is under unmeasurable state.

I998 1984 ISE is working.

I999 1980- ISE Unit errors.

1983

D. ISE rerun

If the errors for ISE electrodes and the communication status are in the following
conditions, the ISE rerun will be performed.
For the setting, refer to “17.9 Other setting.”

1. Electrodes errors
If any errors in either of the electrodes (Na, K, or Cl), ISE rerun will be
performed without outputting the all electrode results.

Error code Description

5 Normal concentration sample: calibration potential alert.

6 Normal concentration sample: sample potential response alert.

7 Normal concentration sample: sample potential response alert + calibration

potential alert.

9 High/Low concentration sample: reference potential alert.

A High/Low concentration sample: sample potential response alert.

B High/Low concentration sample: sample potential response alert + calibration

potential alert.

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2. Communication status
When no errors occur, ISE rerun will be performed in the following conditions.

⚫ Recovery status of the high concentration sample: under stabilizat ion after the
high concentration sample measurement.

⚫ Retry status of potential acquisition: under stabilization of the Reference

potential.

⚫ Recovery status from pumping errors: under stabilization of pumping .

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19.8 Troubleshooting for ISE module (Option)

If the user would try to perform ISE related operations when any obstacle such as fibrin
is clogged in the flow path of the ISE module, it may cause the leakage from the
sample port and damage the ISE module. One of following alarms will be generated
when clog might be happened on the ISE module.
Adapt suitable measures (removing obstacles in the flow path) to prevent ISE module
from the breakage.

19.8.1 Troubleshooting for ISE errors/problems

A. Troubleshooting for Alarm 2082

Cause Counter measure

LB sensor is defected. Contact technical support.

B. Troubleshooting for Alarm 2083

Cause Counter measure

Reboot the analyzer and the operational PC. When the trouble
ISE module is defected.
still occurs, contact technical support.

C. Troubleshooting for alarms related to liquid sending malfunction

Alarms related to liquid sending malfunction are; 2075, 2076, 2077, 2078, 2079, 2080,
2081, 2084, 2085, 2086, 2087, 2088 and 2089.
Cause Counter measure

An obstacle is clogged in a flow path Remove obstacles in a flow path.

Tube is disconnected. Attach tubes firmly.

ISE pump tube have been used longer Replace ISE pump tube.

than 6 months

ISE pump tube is depleted. Replace ISE pump tube.

ISE electrodes are misaligned. Attach ISE electrodes firmly.

O-ring on ISE electrode is came off. Install O-ring on ISE electrodes firmly.

Seal on Ref electrode is not torn off Tear off the seal on Ref electrodes

The analyzer is left for long time with Contact technical support.

alarms related to liquid sending

malfunction.

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D. Troubleshooting for ISE calibration error (All methods)

Cause Counter measure

Ref electrode has been used longer than Replace Ref electrode.

12 months.

ISE activation is not performed after the Perform ISE activation.

maintenance for ISE module.

ISE cleaning is not performed on directed Perform ISE cleaning.

terms.

H solution is concentrated. Use new H solution.

Sample port is got dirty. Clean sample port

ISE electrodes are misaligned. Attach ISE electrode firmly.

Sample Pipette is clogged. Remove clog in sample pipette.

L solution or Ref solution is getting short. Replace L solution or Ref solution.

Cap of L or Ref solution bag was opened. Replace L solution or Ref solution.

O-ring on ISE electrode is came off. Install O-ring on ISE electrodes firmly.

The analyzer is switched OFF when ISE Replace defective electrode or Ref electrode.

module has liquid in its flow path.

The analyzer is left for long time with Replace defective electrode or Ref electrode.

alarms related to liquid sending

malfunction.

Ref electrode is deteriorated. Replace Ref electrode.

E. Troubleshooting for ISE calibration error (Na)

Cause Counter measure

ISE etching is not performed on directed Perform ISE etching.

term.

Na electrode has been used longer than Replace Na electrode.

12 months.

Na electrode is deteriorated. Replace Na electrode.

F. Troubleshooting for ISE calibration error (K)

Cause Counter measure

K electrode has been used longer than 6 Replace K electrode.

months.

K electrode is deteriorated. Replace K electrode.

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G. Troubleshooting for ISE calibration error (Cl)

Cause Counter measure

Cl electrode has been used longer than 3 Replace Cl electrode.

months.

Cl electrode is deteriorated. Replace Cl electrode.

H. Troubleshooting for ISE measurement errors (All methods)

Cause Counter measure

Ref electrode has been used longer than Replace Ref electrode.

12 months.

ISE calibration is not performed. Perform ISE calibration.

ISE activation is not performed after the Perform ISE activation.

maintenance for ISE module.

ISE cleaning is not performed on directed Perform ISE cleaning.

terms.

Sample port is got dirty. Clean sample port

Sample Pipette is clogged. Remove clog in sample pipette.

L solution or Ref solution is getting short. Replace L solution or Ref solution.

Anticoagulant other than Heparin is used Use Heparin for anticoagulation.

for serum measurement.

O-ring on ISE electrode is came off. Install O-ring on ISE electrodes firmly.

The analyzer is switched OFF when ISE Replace defective electrode or Ref electrode.

module has liquid in its flow path.

The analyzer is left for long time with Replace defective electrode or Ref electrode.

alarms related to liquid sending

malfunction.

Ref electrode is deteriorated. Replace Ref electrode.

I. Troubleshooting for ISE measurement errors (Na)

Cause Counter measure

ISE etching is not performed on directed Perform ISE etching.

term.

Na electrode has been used longer than Replace Na electrode.

12 months.

Na electrode is deteriorated. Replace Na electrode.

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J. Troubleshooting for ISE measurement errors (K)

Cause Counter measure

K electrode has been used longer than 6 Replace K electrode.

months.

K electrode is deteriorated. Replace K electrode.

K. Troubleshooting for ISE measurement errors (Cl)

Cause Counter measure

Cl electrode has been used longer than 3 Replace Cl electrode.

months.

Cl electrode is deteriorated. Replace Cl electrode.

L. Troubleshooting for poor reproducibility (All methods)

Cause Counter measure

Ref electrode has been used longer than Replace Ref electrode.

12 month.

ISE activation is not performed after the Perform ISE activation.

maintenance for ISE module.

ISE cleaning is not performed on directed Perform ISE cleaning.

terms.

Sample port is got dirty. Clean sample port

Sample Pipette is clogged. Remove clog in sample pipette.

L solution or Ref solution is getting short. Replace L solution or Ref solution.

Anticoagulant other than Heparin is used Use Heparin for anticoagulation.

for serum measurement.

O-ring on ISE electrode is came off. Install O-ring on ISE electrodes firmly.

The analyzer is switched OFF when ISE Replace defective electrode or Ref electrode.

module has liquid in its flow path.

Ref electrode is deteriorated. Replace Ref electrode.

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M. Troubleshooting for poor reproducibility (Na)

Cause Counter measure

ISE etching is not performed on directed Perform ISE etching.

term.

Na electrode has been used longer than Replace Na electrode.

12 months.

Na electrode is deteriorated. Replace Na electrode.

N. Troubleshooting for poor reproducibility (K)

Cause Counter measure

K electrode has been used longer than 6 Replace K electrode.

months.

K electrode is deteriorated. Replace K electrode.

O. Troubleshooting for poor reproducibility (Cl)

Cause Counter measure

Cl electrode has been used longer than 3 Replace Cl electrode.

months.

Cl electrode is deteriorated. Replace Cl electrode.

P. Troubleshooting for QC sample measurement

Cause Counter measure

Referring a different lot of QC sample. Refer to same lot of QC sample.

QC sample is concentrated or diluted. Use new QC sample.

Range is not defined correctly. Define correct range for QC measurement.

Q. Troubleshooting for poor accuracy (All methods)

Cause Counter measure

Incorrect factor is set. Set correct factor.

Sample which has stored for a long term is Use new sample for the measurement.

used for the measurement.

Anticoagulant other than Heparin is used Use Heparin for anticoagulation.

for serum measurement.

Ref electrode has been used longer than Replace Ref electrode.

12 months.

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Chapter 19. Troubleshooting

Cause Counter measure

ISE activation is not performed after the Perform ISE activation.

maintenance for ISE module.

ISE cleaning is not performed on directed Perform ISE cleaning.

terms.

Sample port is got dirty. Clean sample port

Sample Pipette is clogged. Remove clog in sample pipette.

L solution or Ref solution is getting short. Replace L solution or Ref solution.

Anticoagulant other than Heparin is used Use Heparin for anticoagulation.

for serum measurement.

O-ring on ISE electrode is came off. Install O-ring on ISE electrodes firmly.

The analyzer is switched OFF when ISE Replace defective electrode or Ref electrode.

module has liquid in its flow path.

The analyzer is left for long time with Replace defective electrode or Ref electrode.

alarms related to liquid sending

malfunction.

Ref electrode is deteriorated. Replace Ref electrode.

R. Troubleshooting for poor accuracy (Na)

Cause Counter measure

ISE etching is not performed on directed Perform ISE etching.

term.

Na electrode has been used longer than Replace Na electrode.

12 months.

Na electrode is deteriorated. Replace Na electrode.

S. Troubleshooting for poor accuracy (K)

Cause Counter measure

K electrode has been used longer than 6 Replace K electrode.

months.

K electrode is deteriorated. Replace K electrode.

T. Troubleshooting for poor accuracy (Cl)

Cause Counter measure

Cl electrode has been used longer than 3 Replace Cl electrode.

months.

Cl electrode is deteriorated. Replace Cl electrode.

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19.8.2 Procedure to clear the flow path

1. Confirm that the operational PC and the analyzer are turned OFF.

2. Loosen 2 screws and dismount the Side panel R.

3. Check if any liquid remains in the sample port.

Figure 19.8-1

A. If liquid is remained on the sample port;

1. Loosen a screw to open ISE module cover.

2. Pull out a tube which is connected to the right side of ISE module (bes ide the LB
sensor).

3. Insert the tip of a manual pipette which has 1 to 5mL of capacity, to aspirate
remaining liquid from the tube.

4. Check if remaining liquid inside the tube smoothly flows into the pipette. If not
repeat the step A-2 until it flows smoothly.

5. Remove all of electrodes and wipe off liquid on electrodes.

6. Visually check if there is any obstacle remains in the flow path of electrodes.

7. When there is an obstacle and cannot be removed, replace the electrode to a

new one. If it is easy to remove an obstacle, or if the electrode has no obstacle,
reinstall electrodes onto ISE module.

8. Insert the tube which is pulled out at step A-1 to an original position.

9. Close ISE module cover. Turn ON the operational PC and start User Interface
software, then turn ON the analyzer.

10. Perform ISE prime and check if liquid flows smoothly with no alarms.

11. Mount Side panel R.

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B. If liquid is not remained on the sample port;

1. Perform ISE prime and check if liquid flows smoothly with no alarms.

2. When liquid remains on the sample port after ISE prime, follow steps A-3 to
A-10.

3. Mount Side panel R.

C. Procedure necessary after the leakage

When the leakage from the sample port is already happened, follow steps below.

1. Confirm that the operational PC and the analyzer are turned OFF.

2. Loosen 2 screws and dismount the Side panel R.

3. Wipe out liquid leaked from the sample port completely.

4. Follow steps A-3 to A-10.

If system still continues to generate Alarm 2075 even if those steps were successfully
done, leave the ISE module opened for 1 day to dry out.

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 Chapter 20. Specification

Chapter 20 Specification

20.1 Technical Specification

1 Name of device Clinical Chemistry Analyzer CA-270

2 Usage General chemistry as photometric assay

Immunology as photometric assay (Latex reagent available)

3 Assay type 1 point end, 2 point end, 1 point rate, and 2 point rate

4 Type of calibration Factor, Linear, Point to point, Log-logit, Exponential, Spline, and Spline 2

5 Throughput 270 tests per hour

6 Incubation time Reagent 1 assay: 10 minutes (R1)

Reagent 2 assay: 5 minutes (R1) + 5 minutes (R2)

(Reagent 1 and regent 2 assays can be set at the same time)

7 Sample type Serum, Plasma, and Urine

8 Number of simultaneous 50 methods (Max.) + 3 electrolyte (Na, K and Cl) methods (option)

measurement

9 Components (1) Analyzer: Chassis Unit

Incubation Reaction Unit

Sample Container Unit

Sample Pipette Unit

Reagent Container Unit

Reagent Pipette Unit

Sample Pump Unit

Reagent Pump Unit

Wash Pump Unit

Detector Unit

Stirrer Unit

Supply Water Unit

Trough Unit

Washing Unit

Subtank

Power Supply Unit

Control Unit

(2) External Tanks: Purified Water Tank

Wastewater Tank

Wash Solution Tank

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(3) Option: ISE Unit

Degassing Unit

Sample Barcode Reader

Reagent Barcode Reader

Clot Detection Sensor Unit

External Tank Sensor

9-1 Incubation Reaction Unit

Heating method: Direct heating by silicon-rubber heater (towards the

aluminum heat block)

Heating range: 37±0.1℃

9-2 Cuvette

Material: Resin / Glass

Size (outside): 6(W) x 16.4(D) x 31.2(H) mm (Resin)

6(W) x 7(D) x 30.2(H) mm (Glass)

Light length: 5mm

Quantity: 72

Minimum reaction volume: 100μL

Maximum reaction volume: 350μL

9-3 Sample Container

Tube: Diameter: 12mm to 16mm, Length: 75mm to 100mm

(Sample volume (pediatric cup): 50 to 100μL)

Holding structure: Detachable turn table

(Two layer structure: outer tray and inner tray)

Number of sample tube: Outer tray: 40 Sample tubes or Sample cups (Max.)

Inner tray: 10 Sample cups (Max.)

9-4 Sample Pipette Unit

Number of pipettes: 1

Liquid level detection: Micropipette with a liquid level sensor by sensing a

change of capacitance

Sampling volume: Normal sample: 1.5µL to 35µL

ISE sample: 53µL (option)

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 Chapter 20. Specification

9-5 Reagent Container

Holding structure: Detachable turn table

Number of reagent bottles: 50 bottles (Max.)

(70mL, 20mL-round, and 20mL-square bottles)

Outer layer: 25 bottles(20mL bottle)

Inner Tray: 25 bottles (70mL bottle)

Cooling method: Cooing with peltier elements

Cooling range: 8 to 15℃

9-6 Reagent Pipette Unit

Number of pipettes; 1

Liquid level detection: Micropipette with a liquid level sensor by sensing a

change of capacitance

Sampling volume: R1: 20µL to 250µL, R2: 20µL to 180µL

9-7 Sample Pump Unit

Pump type: Syringe pump

9-8 Reagent Pump Unit

Pump type: Syringe pump

9-9 Wash Pump Unit

Pump type: Syringe pump

9-10 Detector Unit

Method: Measurement of absorbance (12 wavelength

simultaneous measurement)

Selectable Wavelength: 12 wavelength (340 to 800nm)

Wavelength selection: Grating method

Light source: Tungsten halogen lamp

Cooling for light source: Air-cooled by fan

9-11 Stirrer Unit

Stirring mechanism: Stirrer (stirrer paddle) driven by a stepping motor (in 5

speeds)

9-12 Supply Water Unit:

Washing Unit waste pump: 5 (High concentrated wastewater: WU1, WU2, Low

concentrated wastewater: WU3 to WU5)

Trough wastewater outlet: Free fall

Subtank water supply pump: 1

Trough water supply pump: 4

9-13 Trough Unit

Pipette Trough: 2

Stirrer Trough: 2

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9-14 Washing Unit

Cleaning mechanism: 12 cleaning steps

1st step: Nozzle 1 drainage + Wash solution supply

2nd step: Nozzle 1 drainage + Wash solution supply

3rd step: Nozzle 2 drainage + Purified water supply

4th step: Nozzle 3 drainage

5th step: Nozzle 3 Wash solution supply

6th step: Presoak in Wash solution

7th step: Nozzle 4 drainage + Purified water supply

8th step: Water blank measurement

9th step: Water blank measurement

10th step: Water blank measurement

11th step: Nozzle 5 drainage (Water blank measurement + Wipe)

12th step: Nozzle 5 drainage (Wipe)

9-15 Subtank Unit

Tank capacity: 800mL

9-16 Power Supply Unit

Power requirement: AC100V to 120V, 6.5A (Max.)

AC200 to 240V, 3.3A (Max.)

50/60Hz

Power Consumption: 650VA

Permissible voltage variation: ±10% (Max.)

9-17 Purified (system) Water Tank, Wash Solution Tank

Tank capacity/quantity: Purified (system) Water Tank (20L): 1

Wash Solution Tank (5L): 2

9-18 Wastewater Tank

Tank capacity/quantity: High Concentrated Wastewater Tank (10L): 1

Low Concentrated Wastewater Tank (20L): 1

10 Other major functions:

- Auto Startup, Shut off and sleep

- Interruption of STAT sample

- Automatic sample dilution

- Water blank measurement

- Reagent blank measurement

- Profile Order

- Auto template function

- Print format edit function

- Host communication (RS-232C)

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11 Environmental Requirement:

Operating Temperature: 15 to 30℃ (Acceptable range: 2℃/hour)

Storage Temperature: -10 to 50℃

Operating Humidity: 45 to 85% or less (No condensation)

Humidity (storage/transport): 45 to 85% or less

Operating Pressure: 800 to 1060hPa

Pressure (storage/transport): 500 to 1060hPa

12 Dimensions

Outside dimensions: W870mm x D670mm x H625mm

Mass: 120kg (Max.)

13 Connectors to analyzer

(1) Electrical connectors:

- Power Connector
- RJ-45 modular jack (analyzer - operational PC)
- D-sub receptacle (analyzer optional external tank rack)
(2) Supply/drain tubes:

- Purified water inlet

- High Concentrated wastewater outlet
- Low Concentrated wastewater outlet
- Trough, Subtank overflow wastewater outlet
- Wash solution 1 inlet
- Wash solution 2 inlet
14 Maximum sound level
75dB (at the location 1m or longer distant from the analyzer with its cover closed)
15 Transient overvoltage
Overvoltage category II
16 Rated pollution degree
Pollution degree 2

17 The rating and characteristics of fuses

Type Size Rating Characteristics Location and Parts No.

PCB:25P4102
Glass tube fuse 5x20mm 5A/250V Slo-Blo
(ASP/RCU-DRV) F1
PCB:25P4102
Glass tube fuse 5x20mm 10A/250V Slo-Blo
(ASP/RCU-DRV) F2
PCB:25P4101
Glass tube fuse 5x20mm 10A/250V Slo-Blo
(MAIN-DRV) F1, F2
Fuse Holder
Ceramic tube fuse 5x20mm 10A/250V Slo-Blo
(AC input) F1, F2
18 Safety regulations
EN61010-2-101:2017, IEC61010-2-101:2015
19 EMC regulations
EN61326-2-6:2013, IEC61326-2-6:2012
20 Product Life
7 years
21 Holding Period of Maintenance Parts
7 years after the analyzer is installed

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20.2 Analysis Specifications

1 Available numbers of analysis method: Up to 240 methods (Serum: 60, Plasma: 60, Urine: 60, Others: 60)

2 Normal range: 50 ranges

6 types = Gender (2 kinds) x Age (3 generations), Others = 44

types

3 Multi-calibrator: Capable of 10 set definition

4 QC sample: Capable of 40 samples registration

5 Profile: Capable of 20 set definition

6 Method to method calculation: Capable of 40 calculations definition

7 Auto template: Capable of 10 set definition

8 Test selection: Normal sample: 1,000 samples (Max.)

Emergency sample: 100 samples (Max.)

9 Reagent registration: 200 types (Max.)

10 Number of reagent bottles installed: 50 bottles (Max.)

11 Measurement results: Measurement results: 1,000,000 tests

Sample time course: 60,000 tests

Calibration results: 25,000 tests

Calibration time course: 6,000 tests

12 Calibration curve: Number of methods x 2 (Old/New): 480 curves

13 QC measurement results: Up to 50,000 tests (for approximately 1 year)

14 Number of identifiable patients: 30,000 patients

15 Number of maximum rounds per day: 99 rounds per day

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 MedEnvoy Global B.V.
Prinses Margrietplantsoen 33 - Suite 123
2595 AM The Hague The Netherlands

OM-E7229-0K

April, 2010
March, 2024